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PubMed2002

Immunogenicity of therapeutic proteins: clinical implications and future prospects.

BACKGROUND: Therapeutic proteins have revolutionized the treatment of many diseases. In the near future, many more therapeutic proteins are likely to become available for an increasingly wide range of indications. OBJECTIVES: This article reviews the incidence, causes, and consequences of formation of antibodies to therapeutic proteins and suggests ways to address issues surrounding immunogenicity. METHODS: Searches of MEDLINE and EMBASE databases were performed, covering the period 1990 to May 2002. Search terms included immunogenicity, antibodies, and the names of specific therapeutic proteins and classes of therapeutic proteins. Bibliographies of retrieved articles were not searched. RESULTS: All exogenous proteins, including therapeutic ones, have the potential to cause antibody formation. The reported incidence of antibody formation with therapeutic proteins varies widely between proteins and between studies (depending on the assay techniques used). The clinical consequences of antibody formation vary with the type of antibody present; for example, neutralizing antibodies are more likely to cause loss of efficacy than nonneutralizing antibodies. The immunogenicity of therapeutic proteins can be influenced by many factors, including the genetic background of the patient, the type of disease, the type of protein (human or nonhuman), the presence of conjugates or fragments, the route of administration, dose frequency, and duration of treatment. Manufacturing, handling, and storage can introduce contaminants, or alter the 3-dimensional structure of the protein via oxidation or aggregate formation. Various means have been suggested by which therapeutic proteins might be modified to reduce their immunogenicity, including PEGylation, site-specific mutagenesis, exon shuffling, and humanization of monoclonal antibodies. In the future, it may even be possible to predict the immunogenicity of new therapeutic proteins more accurately, using specifically designed animal models, including nonhuman primates and transgenic mice. CONCLUSIONS: Scientists and clinicians are becoming increasingly aware of the importance of assessing the immunogenicity of new molecules as they are introduced, and of existing molecules whenever they are modified or their manufacturing process is changed. Immune responses to therapeutic proteins are usually only of clinical significance if they are associated with the development of treatment resistance. Although various means to reduce the immunogenicity of therapeutic proteins have been suggested, monitoring for antibodies during clinical trials and postmarketing surveillance remains an important issue for all therapeutic proteins.

Animals↗

PubMed1998

Therapeutic use of cannabis: clarifying the debate.

The debate regarding therapeutic use of cannabis is being confused by a lack of distinction between therapeutic and social use of cannabis. Separate consideration of therapeutic and social use would enable strategies to minimise any negative social impact of therapeutic use. For therapeutic use of cannabis to be considered on its own merits, greater emphasis needs to be placed on scientific evidence of therapeutic efficacy. At present the evidence is limited, it mostly relates to the use of synthetic cannabinoids, and much of it fails to compare cannabis with the best therapies available for the conditions of interest. Claims of therapeutic efficacy tend to be based on opinion and anecdote rather than the results of controlled studies. Further research is needed to clarify the potential therapeutic benefits, to enable claims of therapeutic use to be objectively assessed and to enable informed decisions to be made about the relative risks and benefits for any individual using cannabis for therapeutic purposes. Further research is required to clarify the efficacy of pure, synthetic cannabinoids compared to cannabis, the most effective route of administration, and the importance of delivering a known dose. The most likely value of cannabis is as an adjunct, rather than a replacement for, current medical approaches. The potential therapeutic benefits of cannabis will be greatest for those conditions where long-term cannabis use, with its attendant health risks, is not an issue and where the patient has the capacity to titrate dose against symptoms. There is sufficient evidence of potential therapeutic benefit to justify the facilitation of further research.

Journal Article↗

PubMed2003

Comparing methods of establishing the aPTT therapeutic range of heparin.

BACKGROUND: The American College of Chest Physicians (ACCP) recommends that the activated partial thromboplastin time (aPTT) therapeutic range for unfractionated heparin be defined as the aPTT corresponding to a heparin concentration of 0.3-0.7 micro/mL by heparin anti-factor Xa assay. This recommendation suggests that a therapeutic range defined in this manner should be superior to traditional empiric therapeutic ranges of 1.5-2.5 times the control. A pilot study was conducted to evaluate the ACCP recommendation for heparin monitoring. OBJECTIVE: To compare heparin dosage adjustments guided by a heparin concentration-derived therapeutic range (HCDTR) with those influenced by traditional empiric therapeutic ranges for the aPTT. METHODS: This study was conducted in 2 phases. In phase 1, the various aPTT therapeutic ranges were established and/or defined. The first empiric therapeutic range (E1) was established by performing an aPTT test on healthy volunteers. This E1 was defined as 1.5-2.5 times the mean normal aPTT. A second empiric therapeutic range (E2) was defined as 1.5-2.5 times the patient's baseline aPTT. The aPTT HCDTR had been defined in a previous study as 48-61 seconds. In phase 2, heparin dosage adjustment decisions guided by each empiric range and the HCDTR for the aPTT were compared with heparin dosage adjustment decisions guided by actual heparin concentrations. Decisions were in agreement when both the aPTT result and plasma heparin concentration indicated the same dosage change. Forty patients had a bedside aPTT determined prior to receiving continuous infusion heparin and again within 48 hours of heparin initiation. Plasma heparin concentration by anti-factor Xa assay was performed on the blood samples obtained after heparin initiation. Heparin dosage adjustment decisions were evaluated by determining the agreement of each aPTT test result with the corresponding plasma heparin concentration. An overall level of agreement (defined as the % of decisions that were in agreement) for each aPTT therapeutic range was determined. RESULTS: The level of agreement in dosage adjustment decisions between heparin concentration and E1, E2, and HCDTR was 28/40 (70%), 28/39 (72%), and 23/40 (58%), respectively (p = 0.34). Heparin dosage adjustment decisions based on an aPTT HCDTR did not significantly differ from heparin dosage adjustment decisions guided by traditional empiric therapeutic ranges for a bedside aPTT. CONCLUSIONS: This pilot study showed similar heparin dosage adjustment decisions using an empiric aPTT therapeutic range versus a heparin concentration-derived aPTT therapeutic range.

Adult↗

PubMed1986

[Studies on the occupational maladjustment syndrome. (Part 3). In reference to the therapeutic system for the OMA syndrome and the industrial physician's roles].

In order to ascertain the effects of the newly-devised therapeutic system (described later) and clarify the industrial doctor's roles, a study was made on 96 patients with O.M.A.S. (34 in core group, 26 in dropout group, 15 in other group, 13 in transient reaction group and 8 in special job maladjustment group) whom we had directly treated. The subjects of the present study were 54 patients with O.M.A.S. who were treated in the clinic (our clinic) at the Dept. of Mental Health, Osaka Prefectural Institute of Public Health during the past 19 years and 42 patients who were examined in the company's clinic (this company consists of 15,000 employees) where we have practiced mental hygiene of industrial medicine during the past 15 years. Two typical cases in respect of the therapeutic system are presented. We developed a newly-devised therapeutic system of O.M.A.S. (I. Medical examination, II. Counselling for the patients and their family, III. Psychiatric rehabilitation, and IV. Therapeutic advices for their colleagues or superiors in their working place). Of the 96 patients, 81 were reinstated to their office and are at work by using the therapeutic system. Of 96 patients it was necessary for 59 to accept the therapeutic advices. In 49 of 59 patients (Accepted group), doctor's therapeutic advices were accepted by their colleagues or superiors in their working place. In the remaining 10 patients (Refused group) treated by our clinic, the therapeutic advices were refused. Accepted group was observed to be more adaptable to their jobs than refused group. As to the therapeutic content we manipulated their conditions as follows: therapeutic transposition in 27 patients, reduction of duty and guidance of work in 18 patients, and therapeutic preliminary reappointment in 13 patients. It is considered that the industrial doctor of mental hygiene plays an important role in order to establish the therapeutic system of O.M.A.S.

Adaptation, Psychological↗

PubMed1987

Systematic preclinical study on the therapeutic properties of recombinant human interleukin 2 for the treatment of metastatic disease.

The availability of recombinant human interleukin 2 (rH IL 2) has resulted in its clinical utilization both as a single agent and in combination with lymphokine-activated killer cells. In this report, we discuss the effects of rH IL 2, administered by various routes, on effector cell function, pharmacokinetics and bioavailability, and therapeutic activity. Studies of the pharmacokinetics of in vitro natural killer (NK) cell augmentation by rH IL 2 revealed that a short exposure to high levels of rH IL 2 can augment NK cell activity; however, a prolonged exposure (greater than 12 h) was required to augment NK cell activity at lower doses of rH IL 2. These observations suggested that chronic administration of rH IL 2 might improve immunomodulatory and therapeutic activity. This hypothesis was supported by the results of studies in which we treated experimental and spontaneous metastasis, which revealed that the daily i.p. administration of rH IL 2 resulted in significantly greater therapeutic activity than administration three times/week. The therapeutic protocol for daily i.p. administration had a biphasic dosage optimum, such that low dose therapeutic activity was observed at approximately 100-1000 units/animal in the treatment of experimental metastases or 10 to 100 units/animal in the treatment of spontaneous metastases. There was a second dosage optimum at greater than or equal to 100,000 units/animal rH IL 2 delivered i.p. on a daily basis. Intermediate doses had no significant therapeutic activity. Additional studies revealed that low dose therapeutic activity was not observed in nude mice. In contrast, therapeutic activity was observed in nude mice at high doses of rH IL 2 suggesting that low dose activity was associated with a T-cell-mediated effect, whereas high dose activity may have been mediated by NK or lymphokine-activated killer-like cells. This observation was in agreement with the dose response for T-cell adjuvant activity supporting the hypothesis that low dose therapeutic activity was T-cell associated, because adjuvant activity was observed when rH IL 2 was given daily at approximately 100 units/animal for 3 days, and higher doses had no activity or had a suppressive effect. Because we were concerned about the pharmacological aspects of rH IL 2 treatment, we also examined its therapeutic properties after continuous administration i.p. by osmotic pumps. Under these conditions, therapeutic activity was observed after administration of 600 units/h, whereas lower or higher doses did not have significant therapeutic activity.

Adjuvants, Immunologic↗

PubMed2005

[Therapeutic interchange standardization for antiotensin II receptor antagonists in the treatment of hypertension in the hospital setting].

INTRODUCTION: Standardization of the therapeutic inter change process in the hospital setting by the establishment and spreading of standard criteria has been defined as an activity conducent to increased health care quality, and hence improved patient care. OBJECTIVE: To establish standardized therapeutic swapping for angiotensin II receptor antagonists (ARA-II) in the treatment of blood hypertension, and to evaluate the suitability of therapeutic interchange in an integrated individualized drug dispensation system. MATERIAL AND METHODS: Standardized therapeutic inter-change was performed based on therapeutic equivalence criteriafor ARA-Ils such as candesartan, eprosartan, irbesartan, losartan,olmesartan, telmisartan, and valsartan, according to the pharmacodynamic characteristics, dosage recommendations, pharmacokinetic characteristics and interactions of each one of them. The suitability of therapeutic interchange was assessed in terms of standardization or adaptation to this practice developed by using percentage adherence in the previous 12 months (period A) and during the 12 months following its implementation and spread(period B). RESULTS: The only ARA-II included in the hospital's pharmacotherapeutic guide is losartan, on which standardized therapeutic interchange for initial and maintenance doses of any drug within this class was based. The overall number of interchanges per-formed was 417-216 during period A and 201 during period B. Implementing therapeutic swapping has significantly increased adherence to explicitly established criteria by 35.2% (95% CI:25.9 to 44.5%). Similarly, during period B a reduction in the variability of therapeutic interchanges among various pharmacists was observed regarding losartan dosage. DISCUSSION: The standardization of therapeutic interchange procedures for ARA-lls allowed a reduction of the variability seen in this process, and hence the potential for medication-related problems. Another benefit of the spread of therapeutic swapping has been an increased adjustment of medical prescriptions to the hospital's pharmacotherapeutic guide.

Angiotensin II Type 1 Receptor Blockers↗

PubMed1982

Therapeutic substitution practices in short-term hospitals.

Hospital policies concerning the automatic interchange of therapeutically equivalent drugs were examined. A questionnaire was sent to the chief pharmacists at 6326 shot-term hospitals throughout the United States. The survey items solicited demographic data and formulary policies on generic and therapeutic substitution. A total of 2437 (39%) usable questionnaires were returned. Approximately 40% of the hospitals reported that their formulary system allows the stocking of a single product to represent a given therapeutic category. A total of 751 hospitals reported that their formulary system allows automatic dispensing of the therapeutically equivalent drug product without contacting the physician for permission. Therapeutic substitution was found particularly prevalent in federally owned hospitals. There were regional variations in the existence of therapeutic substitution. Factors that appeared to be associated with therapeutic substitution were: drug use review activity, medical school affiliation, existence of a formulary system, perceptions of favorable view by the state board of pharmacy, and favorable perception of the savings generated through bid purchasing. Reasons for not engaging in therapeutic substitution included the following: (1) would not be accepted by the physicians, (2) interferes with physicians' right to select the drug, (3) unnecessary risk of civil liability, (4) violation of laws, and (5) expected benefits do not justify the cost. Most respondents thought that physicians are usually aware of therapeutic substitutions that occur. Although they were a minority, a large percent of the respondents had a formulary system that allowed automatic interchange of generically inequivalent products within a therapeutic class of drugs. The influence of therapeutic substitution on drug therapy outcomes and cost savings need to be evaluated.

Drug Prescriptions↗

PubMed1999

Current opinions on therapeutic drug monitoring of immunosuppressive drugs.

The pharmacokinetics of the immunosuppressive drugs cyclosporine, tacrolimus, mycophenolate mofetil (MMF), and sirolimus are complex and unpredictable. A narrow therapeutic index unique to each patient, as well as variable absorption, distribution, and elimination, are characteristics of these drugs. Therapeutic drug monitoring plays a key role in helping clinicians maintain blood and plasma levels of immunosuppressive drugs within their respective therapeutic ranges. Variation in concentrations outside the narrow therapeutic ranges can result in adverse clinical outcomes. Therapeutic drug monitoring ensures that concentrations are not too high or too low, thereby reducing the risks of toxicity or rejection, respectively. Therapeutic monitoring of immunosuppressive drugs has been based on several choices of assay and biologic fluid (i.e., whole blood, plasma) appropriate for a particular drug. High-performance liquid chromatography (HPLC) remains the gold standard among assay methods used to monitor immunosuppressive drugs. Although HPLC is the assay of choice for cyclosporine, newer monoclonal assays are suitable as well for routine monitoring. HPLC is also widely used for therapeutic drug monitoring of mycophenolic acid, the active metabolite of MMF, and an immunoassay (used in European centers) has been developed. Therapeutic drug monitoring of tacrolimus has been improved with the recent development of assays with greater sensitivity and specificity for tacrolimus than those previously available. No commercial assays are currently available for the therapeutic monitoring of sirolimus. It is also important to identify a specific pharmacokinetic parameter for each individual drug, whether it is trough or area under the concentration-time curve, that may be most useful as a tool for optimal therapeutic drug monitoring in clinical practice. With an increased understanding of the pharmacokinetics of immunosuppressive drugs, therapeutic drug monitoring guidelines will be more clearly defined to ensure the safe and effective management of transplant recipients.

Cyclosporine↗

PubMed2005

Therapeutic working relationships with people with schizophrenia: literature review.

AIM: The aim of this paper is to review the evidence for the necessity and sufficiency of therapeutic relationships when working with people with enduring mental health problems, such as schizophrenia. BACKGROUND: The value of therapeutic relationships in mental health nursing has been the subject of some debate within the profession. This debate has centred on the spectrum of beliefs about therapeutic relationships, ranging from the position that the relationship is both necessary and sufficient to enable change, to more technical approaches, to therapeutic intervention which de-emphasises the influence of the relationship. METHODS: Searches for published material in English between 1986 and 2003 were carried out using the following databases: Cumulative Index of Nursing and Allied Health Literature; MEDLINE; Applied Social Sciences Index and Abstracts; Sociological abstracts; and social service abstracts. The search terms were: therapeutic alliance; therapeutic relationship; working alliance; and nurse-patient relationships. Papers chosen for inclusion in the review were those with a research focus on the elements and potential benefits/costs of therapeutic relationships in nursing. RESULTS: People who experience a relationship as being therapeutic appear to have better outcomes. A consistent finding of a number of meta-analyses is that therapeutic relationships characterized by facilitative and positive interpersonal relationships with the helper have in-built benefits, and that this is an important element of advanced techniques. In order for cognitive behavioural therapy to be successful, people need to feel understood and involved in the therapeutic relationship. CONCLUSION: Therapeutic relationships are necessary but not sufficient to enable change when working with people with schizophrenia.

Cognitive Behavioral Therapy↗

PubMed1987

Preclinical approaches to the treatment of metastatic disease: therapeutic properties of rH TNF, rM IFN-gamma, and rH IL-2.

The present studies were undertaken to examine the immunotherapeutic properties of recombinant murine interferon-gamma (rM IFN-gamma), recombinant human tumour necrosis factor (rH TNF), and recombinant human interleukin-2 (rH IL-2) in preclinical metastasis models. It was observed that these cytokines have disparate mechanisms of therapeutic activity as well as different optimal therapeutic protocols. Thus, not only is the dose important to the therapeutic activity of each of the agents; so also is the route of administration, schedule of administration, duration of administration, and sequence of administration. The rM IFN-gamma has a narrow window of activity, with a bell-shaped therapeutic response with a dosage optimum at 50,000 U/animal of rM IFN-gamma administered 3 times per week. In contrast, rH IL-2 has optimal therapeutic activity for the treatment of metastatic disease after i.p. as compared to i.v. administration. This appears to be associated with the serum pharmacokinetics, since longer serum concentrations are achieved following i.p. administration although lower serum levels are also achieved. RH IL-2 has a biphasic dose-response curve for therapeutic activity with optima from 100 to 1000 U/animal and at doses greater than 100,000 U/animal. The lower doses appear to be associated with T cell augmentation whereas the higher doses are associated with NK cell or LAK cell augmentation. RH TNF has therapeutic activity for the treatment of metastatic disease after i.v. but not i.p. administration. High levels of rH TNF are readily detected in the serum following i.v. administration, with a serum half-life of approximately 30 min. In contrast, only minimal serum TNF activity is observed after i.p. administration, suggesting that this may be the origin of the increased therapeutic activity following i.v. administration. Furthermore, rH TNF has additive therapeutic activity when administered in conjunction with suboptimal doses of rM IFN-gamma. Unfortunately, the additive therapeutic activity of rM IFN-gamma and rH TNF is also associated with increased toxicity. However, in preliminary experiments it was found that the b.i.d. administration of aspirin at 25 mg/kg resulted in decreased toxicity. In summary, the recombinant cytokines provide a challenge both preclinically and clinically to the development of optimal therapeutic protocols, and suggest that close attention must be paid to the dose, route, schedule, duration, and sequence of their administration.

Animals↗

PubMed1999

Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial.

BACKGROUND: Nasal continuous positive airway pressure (NCPAP) is widely used as a treatment for obstructive sleep apnoea. However, to date there are no randomised controlled trials of this therapy against a well-matched control. We undertook a randomised prospective parallel trial of therapeutic NCPAP for obstructive sleep apnoea compared with a control group on subtherapeutic NCPAP. METHODS: Men with obstructive sleep apnoea, defined as an Epworth sleepiness score of 10 or more and ten or more dips per h of more than 4% SaO2 caused by obstructive sleep apnoea on overnight sleep study, were randomly assigned therapeutic NCPAP or subtherapeutic NCPAP (about 1 cm H2O) for 1 month. Primary outcomes were subjective sleepiness (Epworth sleepiness score), objective sleepiness (maintenance of wakefulness test), and SF-36 questionnaire measurements of self-reported functioning and well-being. FINDINGS: 107 men entered the study: 53 received subtherapeutic NCPAP and 54 therapeutic NCPAP. Use of NCPAP by the two treatment groups was similar: 5.4 h (therapeutic) and 4.6 h (subtherapeutic) per night. Subtherapeutic NCPAP did not alter the overnight number of SaO2 dips per h compared with baseline, and thus acted as a control. Therapeutic NCPAP was superior to subtherapeutic NCPAP in all primary outcome measures. The Epworth score was decreased from a median of 15.5 to 7.0 on therapeutic NCPAP, and from 15.0 to 13.0 on subtherapeutic NCPAP (between treatments, p<0.0001). Mean maintenance-of-wakefulness time increased from 22.5 to 32.9 min on therapeutic NCPAP and, not significantly, from 20.0 to 23.5 min on subtherapeutic NCPAP (between treatments p<0.005). Effect sizes for SF-36 measures of energy and vitality were 1.68 (therapeutic) and 0.97 (subtherapeutic) NCPAP (between treatments p<0.0001). For mental summary score, the corresponding values were 1.02 and 0.4 (between treatments p=0.002). INTERPRETATION: Therapeutic NCPAP reduces excessive daytime sleepiness and improves self-reported health status compared with a subtherapeutic control. Compared with controls, the effects of therapeutic NCPAP are large and confirm previous uncontrolled clinical observations and the results of controlled trials that used an oral placebo.

Adult↗

PubMed2006

From evidence to clinical practice: effective implementation of therapeutic hypothermia to improve patient outcome after cardiac arrest.

OBJECTIVES: Therapeutic hypothermia has been recommended for postcardiac arrest coma due to ventricular fibrillation. However, no studies have evaluated whether therapeutic hypothermia could be effectively implemented in intensive care practice and whether it would improve the outcome of all comatose patients with cardiac arrest, including those with shock or with cardiac arrest due to nonventricular fibrillation rhythms. DESIGN: Retrospective study. SETTING: Fourteen-bed medical intensive care unit in a university hospital. PATIENTS: Patients were 109 comatose patients with out-of-hospital cardiac arrest due to ventricular fibrillation and nonventricular fibrillation rhythms (asystole/pulseless electrical activity). INTERVENTIONS: We analyzed 55 consecutive patients (June 2002 to December 2004) treated with therapeutic hypothermia (to a central target temperature of 33 degrees C, using external cooling). Fifty-four consecutive patients (June 1999 to May 2002) treated with standard resuscitation served as controls. Efficacy, safety, and outcome at hospital discharge were assessed. Good outcome was defined as Glasgow-Pittsburgh Cerebral Performance category 1 or 2. MEASUREMENTS AND MAIN RESULTS: In patients treated with therapeutic hypothermia, the median time to reach the target temperature was 5 hrs, with a progressive reduction over the 18 months of data collection. Therapeutic hypothermia had a major positive impact on the outcome of patients with cardiac arrest due to ventricular fibrillation (good outcome in 24 of 43 patients [55.8%] of the therapeutic hypothermia group vs. 11 of 43 patients [25.6%] of the standard resuscitation group, p = .004). The benefit of therapeutic hypothermia was also maintained in patients with shock (good outcome in five of 17 patients of the therapeutic hypothermia group vs. zero of 14 of the standard resuscitation group, p = .027). The outcome after cardiac arrest due to nonventricular fibrillation rhythms was poor and did not differ significantly between the two groups. Therapeutic hypothermia was of particular benefit in patients with short duration of cardiac arrest (<30 mins). CONCLUSIONS: Therapeutic hypothermia for the treatment of postcardiac arrest coma can be successfully implemented in intensive care practice with a major benefit on patient outcome, which appeared to be related to the type and the duration of initial cardiac arrest and seemed maintained in patients with shock.

Coma↗

PubMed2006

Assessment of therapeutic misconception in older schizophrenia patients with a brief instrument.

OBJECTIVE: "Therapeutic misconception," or conflation of goals and procedures of clinical research with those of usual clinical care, is an important topic in research ethics because it may impede informed consent. How best to assess therapeutic misconception is unclear. Also unclear is to what degree patients with severe mental illnesses, such as schizophrenia, may manifest these beliefs. METHOD: With a hypothetical, double-blind, placebo-controlled trial as a stimulus, the authors examined the frequency of a key aspect of therapeutic misconception with a true/false scale in 87 middle-age and older patients with schizophrenia or schizoaffective disorder. They also analyzed the demographic, clinical, neurocognitive, and decision-making correlates of therapeutic misconception and examined the psychometric properties of a scale designed to measure therapeutic misconception. RESULTS: Subjects showed variable performance on the therapeutic misconception measure. Nearly one-third answered all questions correctly; two-thirds answered four or more of the six items correctly. Patients with less education or worse cognitive functioning manifested higher levels of therapeutic misconception. Degree of therapeutic misconception was inversely associated with understanding, appreciation, and reasoning scores on the MacArthur Competence Assessment Tool for Clinical Research but was not associated with severity of psychopathology. The scale showed fair internal consistency. CONCLUSIONS: As in studies of other patient populations, patients with schizophrenia show a substantial incidence of beliefs associated with therapeutic misconception. Further work should focus on refining measures of therapeutic misconception, identifying participants or protocols (e.g., higher-risk studies) in which it may warrant greater concern, and developing educational interventions to mitigate it.

Age Factors↗

PubMed2006

Therapeutic failure-related hospitalisations in the frail elderly.

BACKGROUND AND OBJECTIVE: Although therapeutic failure may be a common cause of drug-related morbidity in older adults, few studies have focused on this problem. The study objective was to determine the frequency and types of, and the factors associated with, therapeutic failure leading to hospitalisation in frail, elderly patients, using a new instrument named the Therapeutic Failure Questionnaire (TFQ). METHODS: The sample included 106 frail, hospitalised elderly patients enrolled in a 1-year-long health service intervention trial at 11 Veterans Affairs Medical Centres. The TFQ was developed by a team of clinical geriatricians and tested for reliability by two clinical pharmacists and a geriatrician on a sample of 32 patients. To establish validity, a geriatrician retrospectively reviewed the computerised medication records and clinical charts for these patients and applied the TFQ to determine probable therapeutic failures at the time of hospital admission. RESULTS: Inter- and intra-rater reliability for the TFQ were very good (kappa = 0.82 for both). Overall, 11% of patients had one or more probable therapeutic failures (TFQ scores between 4 and 7) leading to hospitalisation. Cardiopulmonary disease was a common 'indicator' of therapeutic failure and was often the result of non-adherence. The only factor associated with therapeutic failure occurrence was severe chronic kidney disease (crude odds ratio 5.87; 95% CI 1.20, 28.69; p = 0.01). CONCLUSIONS: The TFQ was able to identify several cases of probable therapeutic failure leading to hospitalisation in frail, elderly patients. Non-adherence to effective therapies for chronic serious cardiopulmonary disease was a common cause of therapeutic failure and represents a target for interventions to reduce hospitalisation. Further research on the occurrence, risk factors for and types of therapeutic failure is needed in a larger cohort of older non-veterans.

Aged↗

PubMedDate not supplied

Therapeutic touch and the terminally ill: healing power through the hands.

I hope it has become apparent that the use of Therapeutic Touch can be a useful addition to more conventional hospice treatments. Also, it can be a very rewarding and fulfilling experience for the patient. It has been so for me. I feel extremely fortunate to have been given the opportunity of introducing Therapeutic Touch into the Allegheny Hospice, a program of Allegheny General Hospital in Pittsburgh, Pennsylvania. We are still in the early stages of implementation. Currently, we are initiating a research program to accomplish the following with respect to Therapeutic Touch: Demonstrate that Therapeutic Touch does, in fact, yield the same results when performed in a hospice setting as when performed in other settings established by prior research. Establish the degree to which drug levels can be reduced (if any) by the introduction of Therapeutic Touch into the treatment regimen and still maintain an acceptable level of pain control. Demonstrate that the quality of life can be improved for the patients and their families through the use of Therapeutic Touch over the current treatment methods not using Therapeutic Touch. Establish sufficient documentation for respective insurance providers to justify future payment for this treatment. It is envisioned that this program will be accomplished later this year. Our hospice organization is a very dynamic one, dedicated to bringing the best possible care to our patients. In addition to the aforementioned Therapeutic Touch research program, we have just embarked on another research effort to determine the advantages of using a "Low Pressure Air Mattress" to reduce the incidence and severity of skin breakdown. This has the potential to improve the quality of life not only of the patient but also of the care giver. In this day and age when many seem to have severely neglected the sick and elderly, there is a great opportunity for creative, compassionate people to become involved in hospice programs around the country. In so doing, you could render an invaluable service to your fellow, man, and, at the same time, achieve a deep sense of fulfillment. Anyone wishing to become involved in a hospice program or interested in learning Therapeutic Touch may contact me at Allegheny Hospice, a Allegheny Center, 6th floor, Pittsburgh, Pa., 15212.

Education, Nursing, Continuing↗

PubMed1998

[Prescriptions of low therapeutic value imposed on primary care].

OBJECTIVES: 1. To quantify the percentage of prescriptions of low therapeutic value, and the associated pharmaceutical expenditure, which the specialist incurs for the general practitioner. 2. To determine which are the therapeutic groups of low therapeutic value most often delegated in this way, and so determine the profile of the specialists who recommend most medication with insufficient benefits. DESIGN: A descriptive, crossover, prospective study based on all the prescriptions of the month of March (21 days) to 4156 patients from the town of Es Castell (5720 inhabitants), Menorca. MATERIAL AND METHODS: The variables to be evaluated were defined and classified in scales. They included prescription, packages, working age/pensioner, origin (General Practitioner, Specialist, Private, Emergency), cost of the prescription, specialties broken down into anatomical-therapeutic groups, whether it was chronic or acute medication, and whether it was of high or low therapeutic value. RESULTS: Of the 3599 packages prescribed, 1993 were generated from outside the PC practice (55.3%). Of the 6069411 pesetas of expenditure in the period studied, 38.5% was due to general practitioners, 59.1% specialists, and 2.3% emergency services. 12.7% (456) of the packages prescribed were of low therapeutic value, of which 52.6% corresponded to the general practitioners' prescriptions, 45.6% to the specialists' and 4.5% to private practice. However, of the 523224 pesetas of expenditure, 62% was for specialists' prescriptions and only 36% for the general practitioners'. On comparing the profiles of prescriptions of low therapeutic value coming from specialists and direct from Primary Care, differences were found. The "cardiovascular" group accounted for 40.9% of specialist prescriptions and only 11.3% of G.P. ones; "central nervous system" (psychiatry, neurology) accounted for 24.5% and 12.1%, respectively. "Respiratory", however, was the opposite: 3.8% specialist and 25% G.P. Similarly the "others" category and 18.8% for specialists against 37.1% for G.P.s. CONCLUSIONS: It can be inferred that there is shared responsibility in the public health system between specialists and G.P.s for prescribing products of low therapeutic value. However, since the medication that specialists prescribe is dearer, they cause more expenditure than the packages of low therapeutic value, which they delegate to G.P.s.

Cross-Over Studies↗

PubMed1988

Correlation of immunomodulatory and therapeutic activities of interferon and interferon inducers in metastatic disease.

The mechanism of therapeutic activity of recombinant murine interferon-gamma (rMu IFN-gamma) and the IFN inducer polyinosinic-polycytidylic acid solubilized with poly-L-lysine in carboxy methyl cellulose (pICLC) in treating metastatic disease was investigated by comparing effector cell augmentation with therapeutic activity in mice bearing experimental lung metastases (B16-BL6 melanoma). Effector cell functions in spleen, peripheral blood, and lung (the organ with tumor) were tested after 1 and 3 weeks of rMu IFN-gamma or pICLC administration (intravenous, three times a week). In these studies, natural killer (NK), lymphokine-activated killer (LAK), cytolytic T lymphocytes (CTL) (against specific and nonspecific targets), and macrophage tumoricidal and tumoristatic activities were measured. rM IFN-gamma and pICLC had therapeutic activity and immunomodulatory activity in most assays of immune function examined. Specific CTL activity of pulmonary parenchymal mononuclear cells (PPMC), but not in splenocytes or peripheral blood lymphocytes (PBL), during week 3 and not during week 1, correlated with the therapeutic activity of rMu IFN-gamma and of pICLC. Macrophage tumoricidal activity in PPMC, but not in alveolar macrophages, also correlated with the therapeutic activity of rMu IFN-gamma, but the opposite was true for the therapeutic activity of pICLC. NK activity of PPMC, but not of splenocytes or PBL, during week 1 correlated with the therapeutic activity of pICLC; in contrast, NK activity at any site did not correlate with the therapeutic activity of rMu IFN-gamma. LAK activity at any site did not correlate with the therapeutic activity of either agent.

Animals↗

PubMed2003

Prophylactic and therapeutic enoxaparin during pregnancy: indications, outcomes and monitoring.

OBJECTIVES: To evaluate the efficacy and safety of prophylactic and therapeutic enoxaparin in pregnancy. STUDY DESIGN: Three-year prospective audit. SETTING: Tertiary level obstetric hospital. POPULATION: Fifty-two women who received subcutaneous enoxaparin, either a prophylactic dose (40 mg daily) in 26 pregnancies or therapeutic dose (1 mg/kg twice daily) in 32 pregnancies. MATERIALS AND METHODS: Pregnant women treated with enoxaparin were prospectively entered into a register. Data were retrieved by case note review. MAIN OUTCOME MEASURES: Pregnancy outcomes, treatment complications and anti-Xa levels. RESULTS: In the prophylactic group there were no fetal losses, thromboembolic events or complications related to enoxaparin. In the therapeutic group there were four first trimester miscarriages, a termination and 27 live births. Therapeutic enoxaparin prevented further thromboembolism without complications. One woman was treated with intermediate dose enoxaparin when she presented at 5 weeks' gestation on warfarin and 7 weeks after a venous thromboembolism. She developed a recurrent pulmonary embolus 3 weeks later and was subsequently treated with therapeutic enoxaparin. In the therapeutic group the enoxaparin dose/kg correlated poorly with anti-Xa levels, and dose adjustments were made. Therapeutic mean (SD) trough and peak anti-Xa levels were 0.33 U/mL (0.14) and 0.86 U/mL (0.24) in the first trimester and 0.48 U/mL (0.19) and 0.84 U/mL (0.23) in the third trimester. CONCLUSIONS: In the present series, prophylactic and therapeutic enoxaparin treatment during pregnancy was effective and safe. Studies are required to determine the optimal duration of treatment with therapeutic enoxaparin following venous thromboembolism in pregnancy and the clinical relevance of anti-Xa monitoring.

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