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PubMed2006

Therapeutic apheresis: use of human serum albumin, fresh frozen plasma and cryosupernatant plasma in therapeutic plasma exchange.

In therapeutic plasma exchange, patient plasma is removed and a colloid replacement solution is infused in its stead. A solution of 4-5% human serum albumin in saline is the recommended replacement solution in most instances, even though it leads to transient mild deficiencies of most plasma proteins. Albumin solutions are pasteurized to inactivate viruses, carry a very low risk of febrile and allergic reactions, and are convenient to store and administer. Fresh frozen plasma, which must be type specific and needs to be ordered in advance and thawed before use, carries a higher risk of reactions; however, it replaces all plasma constituents and is appropriate for patients with thrombotic thrombocytopenic purpura or a pre-existing coagulopathy. Neither cryosupernatant plasma, which is relatively depleted of the proteins in cryoprecipitate, nor pooled plasma that has been virally inactivated with organic solvents and detergents has been shown to be superior to fresh frozen plasma for any indication.

Blood Component Removal↗
PubMed1999

Assimilating new therapeutic interventions into clinical practice: how does hypertension compare with other therapeutic areas?

Medical research has helped to clarify the benefits of some therapies for improving the treatment or outcome associated with cardiovascular disease. However, the adoption of these approaches into routine clinical practice is, in many cases, inadequate. Consequently, there are many missed opportunities to reduce the burden of morbidity and mortality from cardiovascular disease. This review summarizes the factors that may prevent modified behavior in medical practice and the effectiveness of interventions that influence change. There are many barriers that may prevent or slow the adoption of new therapeutic advances into routine clinical practice. As a result, the use of well-proven, efficacious therapy can be suboptimal. Because of this underuse, the realized benefits of treatment are below the potential benefits. Adoption of new therapies is highly dependent on the use of interventions to promote clinical change. However, the effectiveness of different types of interventions varies greatly. Nevertheless, there is a wide range of strategies available that can be used to induce real changes in practice performance and potentially improve patient outcomes. It is essential that future intervention strategies focus on improving adoption of new therapies into clinical practice. The physician must be encouraged to prescribe proven treatments to those patients who stand to benefit most. In addition, better systems of care should be developed that improve the identification of patients as suitable candidates for proven treatments and sustain their long-term commitment to therapy.

Adrenergic beta-Antagonists↗
PubMed1989

5-FU therapeutic monitoring with dose adjustment leads to an improved therapeutic index in head and neck cancer.

This 4 year study reports on a pharmacokinetic study for the widely used regimen of cis-platin plus continuous 5-day 5-FU as first-line chemotherapy of head and neck cancer, and the benefit of such data for real-time therapy management. Pharmacokinetic analysis of 177 cycles for 77 patients from a group of 89 patients (group 1; 228 cycles) revealed that both the time-concentration product (AUC) for the entire cycle and the half-cycle AUC (AUC0-3 days) were predictive of cycle toxicity. Real-time analysis of individual AUC0-3 days was used to decide whether to reduce the dose during the second half of the cycle for a total of 249 cycles (81 patients; group 2). The dose in the second half of the course was reduced in 40% of the group 2 courses. There was a statistical difference in complete response rates between group 1 (31%) and group 2 (47%), (0.02 less than P less than 0.05) and a statistically significant reduction was observed in the incidence of toxic cycles (greater than grade 2, group 1 = 20% versus group 2 = 12.4%; 0.02 less than P less than 0.05). Pharmacokinetic follow-up of these patients has proved to be an objective means to improve therapeutic index significantly.

Adult↗
PubMed2002

What's therapeutic about the therapeutic milieu?

While the milieu of an inpatient facility is considered a treatment modality, extant literature focuses on the staff's role in creating the milieu rather than the patient's perception of it. Not since Goffman's Asylums (1961) has there been an in-depth examination of the phenomenal world of the hospitalized psychiatric patient. In this study, eight inpatients (ages 23 to 58) on the acute psychiatric unit of a metropolitan general hospital participated in phenomenological interviews about their experience of the environment. The essential meaning of the hospital was refuge from self-destructiveness. Prominent aspects of patients' experience within the place of refuge were three interrelated themes (like me/not like me, possibilities/no possibilities, and connection/disconnection). Universally, patients perceived peer-administered "therapy" as the most beneficial aspect of their hospitalization. They expressed longing for a deeper connection with staff and more intensive insight-oriented therapies. Although their needs for safety, structure, and medication were met, patients were not gaining greater understanding of their dysfunctional patterns of behavior. Renewed emphasis must be placed on the nurse-patient relationship and the therapeutic alliance.

Adult↗
PubMed1999

International study of expert judgment on therapeutic use of benzodiazepines and other psychotherapeutic medications: IV. Therapeutic dose dependence and abuse liability of benzodiazepines in the long-term treatment of anxiety disorders.

Despite decades of relevant basic and clinical research, active debate continues about the appropriate extent and duration of benzodiazepine use in the treatment of anxiety and related disorders. The primary basis of the controversy seems to be concern among clinicians, regulators, and the public about the dependence potential and the abuse liability of benzodiazepines. This article reports systematically elicited judgments on these issues by a representative panel of 73 internationally recognized experts in the pharmacotherapy of anxiety and depressive disorders, a panel which was constituted by a multistage process of peer nomination. The criterion for inclusion at each stage was the nomination by at least two peers as one of the "professionally most respected physicians of the world with extensive experience and knowledge in the pharmacotherapy of anxiety and depressive disorders." Sixty-six respondents (90%) completed a comprehensive questionnaire covering a wide range of topics relevant to the therapeutic use of benzodiazepines and other medications that might be used for the same purposes. Overall, the expert panel judged that benzodiazepines pose a higher risk of dependence and abuse than most potential substitutes but a lower risk than older sedatives and recognized drugs of abuse. There was little consensus about the relative risk of dependence and abuse among the benzodiazepines. Differences between benzodiazepines with shorter and longer half-lives in inducing withdrawal symptoms are much less clear during tapered than during abrupt discontinuation. There was little agreement about the most important factors contributing to withdrawal symptoms and failure to discontinue benzodiazepines. The pharmacologic properties of the medication may be the most important contributors to withdrawal symptoms. In contrast, the clinical characteristics of the patient may be the most important contributors to failure to discontinue medication. The experts' judgment seems to support the widespread use of benzodiazepines for the treatment of bona fide anxiety disorders, even over long periods. The experts generally viewed dependence and abuse liability as clinical issues amenable to appropriate management, as for other adverse events related to therapy. However, more definitive clinical research on the remaining controversial issues is urgently needed to promote optimal patient care.

Anti-Anxiety Agents↗
PubMed1999

Relationships among patient and therapist ratings of therapeutic alliance and patient assessments of therapeutic process: a study of cognitive therapy with long-term mentally ill patients.

The therapeutic alliance as rated by therapists and patients was assessed every 5 weeks throughout the treatment period in an in-patient treatment program for schizophrenic and other long-term mentally ill patients. The patients (N = 26) also assessed perceived curative factors (Curative Factors Questionnaire) and made therapy session evaluations (Session Evaluation Questionnaire). The most important patient rated factors showing a relationship with therapist-rated alliance were in the initial phase of treatment depth in the therapy sessions, in the working phase the experience of involvement in the treatment, and in the discharge phase perceived helpfulness of encouragement and reassurance. The investigation of curative factors, session evaluations, and alliance as rated by patients showed a relationship in the initial phase between alliance and encouragement, reassurance and awareness, in the working phase between alliance and depth in sessions and "talking to someone who understands," and in the discharge phase between alliance and self-understanding and problem solution.

Attitude of Health Personnel↗
PubMed1988

Italian collaborative study on the utilization of therapeutic drug monitoring in hospital departments. Italian Collaborative Group on Therapeutic Drug Monitoring.

A population base of 6,367 in-patients from 28 general hospital wards was included in a nation-wide project aimed at documenting the extension and criteria of therapeutic drug monitoring (TDM). On randomly selected index days over a 3-month period details of age, clinical status, renal and liver function, diseases, drug therapies, and drug monitoring of all in-patients of eight different clinical specialties were recorded and analyzed. A total of 648 requests for 387 patients (16.3% of the population given drugs for which TDM was available in the hospital) was traced. Digoxin was the most frequently monitored drug (481 requests for 289 patients), accounting for 74% of the overall requests. This finding is consistent with the yearly activity of the laboratories of the same hospitals, which documented that 63% of the whole in-hospital analytical work (29,396 out of 46,692 requests) concerned digoxin. From a more qualitative point of view, data are provided that document a largely inappropriate use of TDM, which was employed only for 20% of patients who might have benefited from it.

Digoxin↗
PubMed2000

Elective, non-therapeutic ventilation: a reply to Browne et al., "The ethics of elective (non-therapeutic) ventilation.

Browne, Gillett and Tweeddale propose that the use of non-therapeutic elective ventilation (EV) to secure transplantable organs is ethically indefensible. Their argument centres around several propositions: that explicit patient consent for EV is essential, but since it is not included in the consent process for donation from the patient, using it constitutes assault; that inferring consent for EV from the consent to donate itself is ethically and logically indefensible; and that explicit consent from next-of-kin should neither be sought nor honoured in view of the stress EV may cause to staff and families. This article examines their reasoning and suggests that it is fatally flawed. It argues further that in most cases of donation, not using EV may itself be unethical.

Disclosure↗
PubMed1982

Therapeutic progress: review IV. Therapeutic drug monitoring: can it improve the treatment of epilepsy?

Our ability to measure plasma drug concentrations under steady-state conditions has meant that the daily dose of phenytoin, and a few other anticonvulsants drugs, can be safely adjusted to suit the individual epileptic's seizure pattern and drug metabolizing capacity. With correct timing of samples and interpretation of results, therapeutic drug monitoring can lead to, and maintain, complete freedom from seizures for some patients and an appreciable reduction in frequency for many others. There are large numbers of epileptics, however, who continue to suffer needlessly because clinical practice has lagged behind our expertise in drug assay and our understanding of pharmacokinetics. We are not using our knowledge sufficiently to benefit the epileptic population as a whole.

Anticonvulsants↗
PubMed2004

The erbB family: targets for therapeutic development against cancer and therapeutic strategies using monoclonal antibodies and tyrosine kinase inhibitors.

The overexpression and aberrant function of members of the erbB family of receptors, particularly erbB1 (also known as epidermal growth factor receptor), and its ligands in many human cancers have provided a rationale for targeting this signaling network with novel approaches. erbB1 is a selective target for inhibiting cancers because its activation often confers a proliferative advantage. Activation of the erbB1 tyrosine kinase provides signals that drive dysregulated proliferation, invasion, metastasis, angiogenesis, and cell survival, and its inhibition has potential in both the treatment and prevention of these malignancies. Based on the structure and function of erbB1, two therapeutic strategies have been developed. The first uses human monoclonal antibodies (MAbs) generated against the receptor's ligand-binding extracellular domain. These MAbs block binding of receptor-activating ligands, and, in some cases, can induce receptor endocytosis and downregulation. The second uses small molecules that compete with adenosine triphosphate (ATP) for binding to the receptor's kinase pocket, thereby blocking receptor activation and the transduction of postreceptor signals. Early clinical studies suggest that both approaches are well tolerated and can induce clinical activity in many common malignancies.

Antibodies, Monoclonal↗
PubMed1992

[A study to increase the therapeutic effects of adoptive immunotherapy in vivo. Influence on the generation of lymphokine activated killer (LAK) cells and therapeutic effects of LAK cells with anti-tumor drug (cyclophosphamide)].

To enhance the effect of adoptive immunotherapy (AIT), we investigated the induction and characteristics of lymphokine activated killer (LAK) cells and also analyzed the combined effects of AIT with an antitumor drug (cyclophosphamide: CPA) in mice models. LAK cells were generated from C57/BL/6 (B6) spleen cells. The spleen cells were passed through a nylon wool column and cultured in RPMI-1640 medium containing 10% FCS and 2 x 10(3) units of human recombinant IL-2 (hr IL-2) for up to 14 days. During this period, the time kinetic analyses of the LAK cells' cytotoxicity and motility were performed. The cytotoxicities against Lewis Lung Carcinoma (3LL), evaluated by standard 51Cr release assay, gradually increased during the cultured period, and the motilities, determined by a modified version of the Boyden chamber method, greatly increased within the first 7 days' incubation. Based on these in vitro findings, we examined the efficacy of AIT alone or in combination with chemotherapy (CPA) in in vivo studies. AIT was performed in the following way: LAK cells were intravenously infused and rIL-2 was intraperitoneally administered for 5 consecutive days following LAK cell administration. CPA was intraperitoneally administered. The therapy protocols were as follows. There were seven experimental groups. Group I; the mice were infused with 3-day cultured LAK cells (3DLAKs) on the second day after tumor inoculation (day 2). Group II; the mice were infused with 3DLAKs on day 5. Group III; 10-day cultured LAK cells (10DLAKs) on day 2. Group IV; 10DLAKs on day 5. Group V (AIT and CPA combination); AIT (10DLAKs) was started on day 5 followed by CPA on day 10. Group VI; CPA was performed on day 5 followed by AIT (10DLAKs) on day 10. Group VII; CPA was performed on day 5 without AIT. Each group consisted on 15 mice. The therapeutic efficacies were evaluated by calculating the median survival time of each group. The results of these experiments were as follows (mean +/- SD); Group I's median survival time was 16.8 +/- 3.2 days, Group II 15.1 +/- 2.1 days, Group III 19.2 +/- 5.4 days, Group IV 16.1 +/- 4.8 days, Group V 23 +/- 6.3 days, Group VI 32 +/- 8.4 days and Group VII 22 +/- 5.1 days. These results suggested that the efficacy of AIT is closely related to the LAK cells' cytotoxicity and motility. Although AIT alone in the advanced tumor bearing host had a limited effect, combination with CPA improved it's efficacy.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗
PubMed2001

Therapeutic biomechanics concepts and clinical procedures to reduce implant loading. Part II: therapeutic differential loading.

Practical laboratory procedures were suggested in order to provide a modified occlusal anatomy to reduce implant loading. The concept of differential mobility caused by the flexion between a natural tooth/periodontal ligament interface with its supporting bone, compared with the stiffness of the implant/bone interface, was described. When individual tooth-supported and implant-supported prostheses coexist in the same arch, this differential mobility can shift the loading disproportionately from the natural teeth to the implants. A new concept of therapeutic differential loading is introduced and a clinical technique of differential occlusal adjustment is described to bring about a more favorable distribution of loading to all the supporting bone. Long-term natural tooth intrusion can cause implant overload. Therefore, it is suggested that periodic differential occlusal adjustment procedures be used to re-establish a long-term balance of loading between individual implant- and tooth-supported prostheses within the same arch.

Biomechanical Phenomena↗
PubMedDate not supplied

[Therapeutic interventions in intensive care units: analysis according to therapeutic intervention scoring system-28 (TISS-28)].

The present study aimed to identify the therapeutic interventions categories carried out in Intensive Care Units (ICU), finding out their prevalence and identifying their components according to TISS-28. The sample was composed of 89 adult patients who were consecutively admitted to the ICU of a university hospital in São Paulo city. Basic and Supportive Activities, Ventilatory, Cardiovascular and Renal were the TISS-28 that prevailed with a frequency of 73.0% and 100%. The frequency of the items considered Basic Activities were prevalent, that is, higher than 90.0%. The quantitative average of urinary debt was 98.2% concerning Renal Support. The results may mean quality of assistance provided to the clients, as they contribute to the human resources estimative and materials in the ICU as well.

Adult↗
PubMedDate not supplied

Quality of life as a therapeutic end-point. An analysis of therapeutic trials in hypertension.

The term 'quality of life' is finding increasing use in the popular press and the medical community. In both areas, its use often lacks precision: a comprehensive and universal definition probably does not exist. Indeed, the precise elements contributing probably vary from person to person and from time to time. There is broad agreement that 5 major areas always need assessment, including physical and emotional state, performance of social roles, intellectual function and general feelings of well-being or life satisfaction. A wide range of instruments has been employed in a large number of studies on the effects of antihypertensive agents on quality of life in the patient with hypertension. Hypertension represents a special problem in which the patient is thought to be free of related symptoms, and treatment designed to improve natural history brings with it the burden of adverse reactions. Although some insights have been gained on the relative influence of various therapeutic regimens on the quality of life of treated patients, in many of the studies too little consideration has been given to the use of instruments that have been validated in the patient population to be studied, to the power of the study and its design, to the contribution of confounding variables such as age and gender, and to evidence that short term trials (measured in weeks) can miss important changes that occur over months in a process where treatment is life-long. For these reasons, we believe, the literature on the subject is burdened by many reports that describe no difference among treatment regimens where important differences might exist. On the positive side, important advances have been made in our understanding of the elements that contribute to quality of life and in approaches to its assessment.

Humans↗
PubMedDate not supplied

Paroxetine. A review of its pharmacology, therapeutic use in depression and therapeutic potential in diabetic neuropathy.

Paroxetine is a selective serotonin reuptake inhibitor effective in a once-daily administration regimen in the treatment of depression. In elderly patients (aged > or = 60 years) with major depression, short term (6 weeks) treatment with paroxetine produces clinical improvements significantly superior to those seen with placebo and similar to those with tricyclic antidepressant agents, mianserin and fluoxetine. There is evidence that paroxetine has positive effects on co-existing anxiety and does not precipitate agitation. Paroxetine has also shown potential in the symptomatic treatment of diabetic neuropathy; however, further clinical experience is needed to confirm this preliminary result. Short term paroxetine therapy is associated with fewer anticholinergic and CNS adverse effects, but generally more gastrointestinal disturbances, than tricyclic antidepressants and mianserin. Unlike the tricyclic agents, paroxetine does not significantly affect cardiovascular function or impair psychomotor performance. This tolerability profile should be particularly beneficial in elderly patients, who are generally more susceptible than younger patients to the anticholinergic and CNS adverse events associated with tricyclic antidepressant drugs, and in whom there is a higher prevalence of pre-existing cardiovascular disease. It also suggests an important potential advantage over tricyclic antidepressants in the setting of overdosage. Thus, primarily because of its better tolerability profile and potentially lower toxicity in overdosage and in patients with cardiovascular disease, paroxetine appears to be a more attractive option than tricyclic antidepressants for the treatment of depression in late life. Future research should attempt to define more fully the efficacy of paroxetine as long term prophylactic therapy for recurrent depression and to assess how its overall therapeutic profile compares with other selective serotonin reuptake inhibitors in the elderly.

Adult↗
PubMed1998

Therapeutic drug monitoring of clozapine treatment. Therapeutic threshold value for serum clozapine concentrations.

It has been suggested that the minimum effective serum clozapine concentration for an acceptable clinical response (threshold value) is about 400 micrograms/L. This article argues against the use of therapeutic drug monitoring (TDM) as a tool to obtain clozapine concentrations of > or = 400 micrograms/L in the individual patient from the start of clozapine treatment. The following arguments are presented: (i) because of a great interindividual variability of the clozapine concentration to dose ratio (C/D) it can be calculated that extremely high daily doses (900 to 1800 mg/day) would be necessary in 15% of patients to obtain a clozapine concentration of 400 micrograms/L; (ii) doses of 200 to 300 mg/day are commonly used in Central Europe. although about 80% of the patients can be expected to have clozapine concentration < 400 micrograms/L; (iii) in a double-blind study, no difference in clinical response was found between patients treated with clozapine in the concentration range of 200 to 300 micrograms/L, and a group with higher clozapine concentrations; (iv) positron emission topography (PET) studies indicate that maximum receptor occupancy is obtained at clozapine concentrations of about 200 micrograms/L and no further receptor occupancy is obtained by increasing clozapine concentrations to > or = 400 micrograms/L; (v) the frequency of both severe clozapine-induced adverse effects (seizure and confusion) and more common adverse effects increases with increasing doses/clozapine concentrations. It is concluded that the antipsychotic effects and adverse effects of clozapine occur over a very broad range of serum concentrations. In most countries the majority of patients are treated with clozapine concentrations well below the 400 micrograms/L suggested as threshold concentration for optimum response. Therefore clinical judgement should always be primarily used for dose adjustments. TDM is useful to follow compliance and to adjust for extreme serum concentrations and revealing drug interactions.

Antipsychotic Agents↗
PubMed1994

Nimesulide. An update of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy.

Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) administered orally or rectally twice daily for a variety of inflammatory and pain states. In mostly short term studies (up to 4 weeks), it was effective in reducing pain associated with osteoarthritis, cancer, thrombophlebitis, oral surgery and dysmenorrhoea in adults, reducing pain associated with general surgery in adults and children, and pain, fever and inflammation accompanying respiratory tract infections, otorhinolaryngological diseases and traumatic injury in adults and children. Nimesulide appeared to be at least as effective as other NSAIDs in all of these indications. Nimesulide has been well tolerated by adult, elderly and paediatric patients in clinical trials and large postmarketing surveillance studies. In general qualitative terms nimesulide exhibits the usual adverse events associated with NSAIDs (gastrointestinal, dermatological and neurological). However, it has a pharmacodynamic profile suggestive of a possibly reduced propensity to cause adverse gastrointestinal effects, although this has not been conclusively demonstrated in comparative clinical trials, many of which showed a similar incidence of such effects for nimesulide and the comparator agent. Additionally, nimesulide has been well tolerated by most aspirin (acetylsalicylic acid)- and/or NSAID-intolerant patients and in patients with asthma. Thus, available evidence indicates that nimesulide is an effective and well tolerated alternative to other NSAIDs in the short term treatment of pain and inflammation of osteoarthritis and various other causes.

Animals↗
PubMed1995

Nifedipine gastrointestinal therapeutic system (GITS). A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in hypertension and angina pectoris.

Nifedipine 'gastrointestinal therapeutic system' (GITS) is a recently developed formulation that slowly releases the drug into the intestinal tract over a 24-hour period. When administered once daily, it is of similar efficacy to sustained release formulations of felodipine, verapamil, and diltiazem and at least as effective as standard formulations of lisinopril and enalapril, and long-acting propranolol and atenolol in the treatment of patients with mild to moderate essential hypertension. Substitution of nifedipine GITS for conventional formulations of nifedipine, diltiazem or verapamil, maintained adequate control of anginal symptoms in patients with stable angina pectoris. Nifedipine GITS appears to maintain quality of life and is apparently better tolerated than those formulations of nifedipine which require 2 or 3 times daily administration in both elderly and younger patients. In addition, it has minimal effect on lipid and glucose metabolism and reverses left ventricular hypertrophy, and is thus suitable for treatment of the majority of patients with mild to moderate hypertension or angina pectoris.

Administration, Oral↗