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PubMed2002

Armed therapeutic viruses: strategies and challenges to arming oncolytic viruses with therapeutic genes.

Oncolytic viruses are attractive therapeutics for cancer because they selectively amplify, through replication and spread, the input dose of virus in the target tumor. To date, clinical trials have demonstrated marked safety but have not realized their theoretical efficacy potential. In this review, we consider the potential of armed therapeutic viruses, whose lytic potential is enhanced by genetically engineered therapeutic transgene expression from the virus, as potential vehicles to increase the potency of these agents. Several classes of therapeutic genes are outlined, and potential synergies and hurdles to their delivery from replicating viruses are discussed.

Animals↗
PubMed1995

A review of the hepatotoxicity of paracetamol at therapeutic or near-therapeutic dose levels, with particular reference to alcohol abusers.

The number of published reports associating hepatotoxicity with paracetamol ingestion at therapeutic or near-therapeutic dose levels is small but is, nevertheless, suggestive of a relationship. There is however, mounting evidence that certain groups of patients, such as alcohol-dependent people, patients receiving enzyme-inducing drugs (particularly anti-convulsant and anti-tuberculosis medications) as well as those with certain infectious diseases, are rendered more susceptible to paracetamol-induced hepatotoxicity. Seventy-four case reports where therapeutic or near-therapeutic doses of paracetamol resulted in hepatic injury are reviewed and factors and mechanisms which might explain this apparently increased vulnerability to damage are discussed.

Journal Article↗
PubMed2001

Modification of clearance of therapeutic and potentially therapeutic proteins.

Advances in biochemistry, protein chemistry and molecular biology over the last twenty-five years have spurred the increased use and development of proteins as injectable therapeutic agents. Introduction of proteins into the circulation exposes them to numerous different cells, enzymes and routes of extravasation that contribute to their clearance and their catabolism. Overly rapid clearance, particularly of small proteins, can limit therapeutic efficacy. Many strategies have been devised to retard the clearance of therapeutic or potentially therapeutic proteins, but relatively few proteins with clearance-retarding modifications are in clinical use. Proteins have been chemically modified towards this end by covalent attachment of polyethylene glycol or dextran chains or by protein-protein cross-linking. Genetic modification has also been employed to fuse proteins of interest to long-lived plasma proteins like albumin or immunoglobulins, or portions of these proteins. While all modifications may reduce the biological activity of the protein of interest or elicit antibody formation in recipient animals or patients, there now exists sufficient experience in this area that an optimal clearance-extending strategy can often be designed and successfully executed. With the explosive growth of genomic and proteomic information, an exponentially increasing number of engineered proteins are likely to be developed, with a probable need for clearance-related modification.

Animals↗
PubMed1982

Therapeutic drug monitoring: a survey of sub- and supra-therapeutic serum drug levels in a large teaching hospital.

One thousand five hundred serum drug levels lying outside the defined therapeutic range have been followed up by the clinical pharmacology service at the Royal Adelaide Hospital over a thirteen month period. It was found that digoxin, phenytoin and theophylline were the most frequently monitored drugs. Blood levels outside the therapeutic range tended to be on the high side with digoxin, but were usually sub-therapeutic for the other two. Drug related toxicity was observed in 11.2 percent of those with a high serum level. Several potential drug interacting situations were also noted during the study. The value of therapeutic drug monitoring, to maximise efficacy of therapy and minimise side effects, is stressed. However, correct blood sampling, based on a knowledge of the clinical pharmacology and pharmacokinetics of the drug, must be performed in order to obtain optimal benefit from this exercise.

Carbamazepine↗
PubMed1998

Determination of the active moiety of BX661A, a new therapeutic agent for ulcerative colitis, by studying its therapeutic effects on ulcerative colitis induced by dextran sulfate sodium in rats.

5-[4-(2-Carboxyethylcarbamoyl)phenylazo]salicylic acid disodium salt dihydrate (CAS 80573-04-2, BX661A) is being developed as a therapeutic drug for ulcerative colitis. To determine the active therapeutic moiety of BX661A, the therapeutic effects with single and combined administration of 5-aminosalicylic acid (5-ASA), 4-aminobenzoyl-beta-alanine (4-ABA) and 4-amino-N-2-pyridinyl-benzenesulfonamide (CAS 144-83-2, sulfapyridine, SP) on ulcerative colitis induced by dextran sulfate sodium (DSS) in rats were investigated, and the following results were obtained. 1. BX661A at doses of 30, 100 and 300 mg/kg (p.o.) dose-dependently decreased the erosion area (mm2) in the large intestine with % inhibition values of 28.7, 49.1 and 61.6%, and the shortening of the large intestine with % inhibition values of 17.1, 25.7 and 48.6%, respectively. Salazosulfapyridine (SASP) at doses of 30 and 100 mg/kg (p.o.) decreased the erosion area (mm2) in the large intestine with % inhibition values of 30.7 and 45.3%, respectively, but did not improve the shortening of the large intestine. However, at a dose of 300 mg/kg (p.o.) SASP, the % inhibition value of the erosion area in the large intestine was reduced. 2. A single intrarectal administration of 5-ASA (105 mg/kg, i.r.) significantly decreased the erosion area (mm2) in the large intestine, but a single administration of 4-ABA or SP did not show any significant effect on the erosion area. Combined administration with 5-ASA (105 mg/kg, i.r.) and 4-ABA (142.8 mg/kg, i.r.) significantly decreased the erosion area (mm2) in the large intestine with a % inhibition value of 63.8%. On the other hand, the efficacy of 5-ASA disappeared with combined administration with SP (% inhibition value of 7.3%). These results suggest that 5-ASA is the active moiety for the therapeutic effects of BX661A and indicate that the efficacy of 5-ASA disappears with the combined use of SP, but not of 4-ABA. Therefore, it seems that BX661A is clinically safe and more effective than SASP in the treatment of patients with ulcerative colitis.

Alanine↗
PubMedDate not supplied

Should nurses practice therapeutic touch? Should nursing schools teach therapeutic touch? .

This article argues that in the current setting of nursing practice, therapeutic touch should be treated as a religious practice. The article examines the religious sources of the ideas and documents the connection with the teachings of particular religious groups. Recognizing therapeutic touch as a religious issue requires new kinds of approaches in the practice and teaching of therapeutic touch in nursing.

Curriculum↗
PubMed1988

Reporting therapeutic discourse in a therapeutic community.

Research in nurses' communications has concentrated on nurse to patient interactions. Those few studies which focus on nurse to nurse communications seem to be generated by a pragmatic and normative concern with effective information sharing. In this paper, which describes one aspect of a larger case study of a hospital-based therapeutic community, the description and analysis of nurses' reports flows not from a normative model of professional practice, but rather an exploration of how professional practice is articulated as discourse in nurses' written accounts. Foucault's ideas about therapeutic discourse inform the theoretical framework of the research. Ethnomethodological concerns with the importance of documentary analysis provide the methodological rationale for examining nurses' 24-hour report documents, as official discourse, reflecting therapeutic practice in this setting. A content analysis of nurses' reports, collected over a period of 4 months, demonstrated the importance of domesticity and ordinary everyday activities in nurses' accounts of hospital life. Disruption to the 'life as usual' domesticity in the community seemed to be associated with admission to and discharge from the hospital when interpersonal and interactional changes between patients occur. It is suggested that nurses in general hospital wards and more orthodox psychiatric settings might usefully consider the impact of admissions and discharges on the group of patients they manage, and make this a discursive focus of their work.

Communication↗
PubMed1998

[Advanced hepatocellular carcinoma: therapeutic results in 110 patients and therapeutic strategy].

The prognoses of 110 patients with advanced hepatocellular carcinoma (HCC) in stages III and IV were studied retrospectively. These patients were treated mainly by transarterial chemoembolization (TAE) or chemoinfusion using Lipiodol. Some of the patients underwent percutaneous ethanol injection therapy (PEIT) or tumor resection following TAE. Hepatic function, tumor stage, vascular involvement, type of tumor invasion, number of tumors and number of treatments affected the prognosis of the patients. The prognosis was better in the Child A group than in Child B and C. In the Child C group, the prognosis was markedly poor, and was least affected by any treatment. The prognoses in the patients with multiple nodular lesions, massive or diffuse lesions, were much poorer than those with a few nodular lesions. Tumor thrombosis in the central portal vein and distant metastasis greatly exacerbated the therapeutic results. Repeat therapy yielded a favorable therapeutic result when hepatic function was tolerable. Surgical intervention and PEIT were an effective therapy in a few patients. In advanced HCC, liver function and tumor extension should be fully evaluated, and it is important to determine the most effective therapeutic modalities to improve the survival of patients.

Adult↗
PubMed2000

Therapeutic hypothermia for head injury.

BACKGROUND: Mild to moderate induced hypothermia has been used in the treatment of head injury for over 50 years, although few randomised controlled trials have been performed. Recent encouraging results from small, single-centre trials and consistent findings of a cerebral protection effect of cooling in laboratory models of global ischaemia has led to a renewed interest in the area. OBJECTIVES: To determine whether the use of mild therapeutic hypothermia in the treatment of moderate and severe head injury improves short-term control of intracranial pressure (ICP) and long-term functional outcome. SEARCH STRATEGY: Electronic searches of the Injuries Group trial registry and EMBASE for any relevant randomised trials, supplemented by hand searching of conference proceedings and reference lists of relevant articles. SELECTION CRITERIA: All randomised controlled trials of mild hypothermia versus control (open or normothermia) in the treatment of patients with any closed head injury requiring hospitalisation. Mild hypothermia was defined as local or systemic cooling to a target temperature of at most 34-35 degrees Celsius for a period of at least 12 hours. Outcome was all-cause mortality and death or severe disability at the end of the scheduled follow-up period. All trials were assessed by two reviewers, and included or excluded on a consensus basis. DATA COLLECTION AND ANALYSIS: Eleven potential trials of therapeutic hypothermia for head injury were found, of which two are ongoing and one is awaiting assessment. The eight remaining trials were included in the systematic review. Data on death, GOS score at final follow-up, complications and ICP were sought and extracted, either from published material or by contact with the investigators. Mantel-Haenzel odds ratios and 95% confidence intervals were calculated for death and death and severe disability for each trial on an intention-to-treat basis. No quantitative synthesis of data on either complications or ICP was attempted. Trials of immediate and deferred hypothermia were analysed separately. MAIN RESULTS: Active immediate hypothermic treatment was associated with a 33% non-significant (p=0.16) reduction in the odds of death at the end of treatment or final follow-up, (OR 0.67, 95% confidence interval 0.38 to 1.17), and a 61% reduction (p=0.004) in the odds of being dead or severely disabled, (OR 0.39, 95% confidence interval 0.20 to 0.74). Similar effect sizes were found for delayed hypothermia. These results are, however, based on a few small trials each of less than 100 patients. A multi-centre trials of hypothermia versus control in 392 patients will be reporting results in 1999, providing substantially more evidence than is currently available. REVIEWER'S CONCLUSIONS: Although this review would suggest a strong positive effect of therapeutic hypothermia, the results are based on several small trials carried out in single, specialist centres. The results of a large multi-centre trial are expected in 1999 and will more than treble the available evidence. Until these results have been released, it would be inappropriate to make any short-term recommendations for clinical practice or research.

Craniocerebral Trauma↗
PubMed2002

Manufacture and composition of fresh frozen plasma and virus-inactivated therapeutic plasma preparations: correlation between composition and therapeutic efficacy.

The clinical efficacy of the therapeutic plasma used in the treatment of congenital and acquired severe coagulopathy depends on the potency of clotting factor and inhibitor activities. The composition of plasma strongly depends on the conditions under which it is produced. A low citrate anticoagulant-to-blood ratio, short intervals between donation and plasma separation and rapid freezing markedly improve the preservation of unstable coagulation factors. The influence of different leukocyte reduction filters on plasma quality still requires clarification. Recent trials on long-term storage conditions suggest that keeping plasma at -30 degrees C or colder over a period of 24-36 months prevents substantial decrease in clotting factor activities including factor VIII (FVIII). Three types of therapeutic plasma are currently available. Quarantine-stored fresh frozen plasma (FFP) contains physiological activities of therapeutically relevant plasma proteins, but carries a risk of transmitting blood-borne viruses that cannot be detected by human immunodeficiency virus (HIV) and hepatitis B and C screening. In contrast, solvent/detergent-treated plasma (SDP) and methylene blue/light-treated plasma (MBP) is virtually free of HIV and hepatitis C virus (HCV) subtypes. Virus inactivation procedures can have the consequence of reducing several clotting factors and inhibitors in SDP and MBP to varying degrees. However, pooling of plasma units before solvent/detergent (SD) treatment results in well-standardized protein levels of SDP. At least five prospective trials and four observational studies covering different clinical settings suggest that SDP and FFP do not substantially differ in their clinical efficacy or in their tolerance. By way of contrast, there is a lack of data about the clinical efficacy and tolerance of MBP compared to FFP.

Blood Coagulation Factors↗
PubMed1999

Therapeutic sclerokeratoplasty versus therapeutic penetrating keratoplasty in refractory corneal ulcers.

PURPOSE: To assess the efficacy of newer surgical technique of sclerokeratoplasty in cases of refractory corneal ulcers of the cornea and to compare it with therapeutic penetrating keratoplasty. METHODS: A randomized, prospective clinical trial in 20 eyes with refractory corneal ulcers was undertaken. Ten eyes each underwent sclerokeratoplasty (group I) or therapeutic penetrating keratoplasty (group II). Infections were considered cured if there was no evidence of corneal infiltration for 1 month following keratoplasty. Postoperative complications, visual acuity (VA), keratometry and graft status were evaluated with both the procedures after a minimum follow up of 1 year. RESULTS: Postoperative complications included epithelial defects, shallow anterior chamber, uveitis and secondary glaucoma, which were present following both procedures, with no significant difference in the frequency of complications between the two techniques (P < 005), Graft clarity and VA with both procedures were comparable. Significantly reduced astigmatism of < 1 D was seen in six eyes in group II in comparison with group I, where astigmatism of > 1.5 D was present in six eyes. Two eyes in group II developed re-infection, of which one was re-operated on, and the other developed endophthalmitis. CONCLUSIONS: Sclerokeratoplasty is a useful alternative to therapeutic penetrating keratoplasty in cases of refractory corneal ulcers with optimum clinical and useful visual outcome.

Adult↗
PubMed2005

[Is there a German history of evidence-based medicine? Methodic standards of therapeutic research in the early 20th century and Paul Martini's "Methodology of therapeutic investigation" (1932)].

The article addresses the history of evidence-based medicine in Germany. Its aim was to reconstruct the standard of clinical-therapeutic investigation in Germany at the beginning of the 20 (th) century. By a historical investigation of five important German general medical journals for the time between 1918 and 1932 an overview of the situation of clinical investigation is given. 268 clinical trails are identified, and are analysed in view of their methodological design. Heterogeneous results are found: While few examples of sophisticated methodology exist, the design of the majority of the studies is poor. A response to the situation described can be seen in Paul Martini's book "Methodology of Therapeutic Investigation", first published in 1932. Paul Martini's biography, his criticism of the situation of clinical-therapeutic investigation of his time, the major points of his methodology and the reception of the book in Germany and abroad are described.

Evidence-Based Medicine↗
PubMed2006

Gene therapy as a therapeutic approach for the treatment of rheumatoid arthritis: innovative vectors and therapeutic genes.

In recent years, significant progress has been made in the treatment of rheumatoid arthritis (RA). In addition to conventional therapy, novel biologicals targeting tumour necrosis factor-alpha have successfully entered the clinic. However, the majority of the patients still has some actively inflamed joints and some patients suffer from side-effects associated with the high systemic dosages needed to achieve therapeutic levels in the joints. In addition, due to of the short half-life of these proteins there is a need for continuous, multiple injections of the recombinant protein. An alternative approach might be the use of gene transfer to deliver therapeutic genes locally at the site of inflammation. Several viral and non-viral vectors are being used in animal models of RA. The first gene therapy trials for RA have already entered the clinic. New vectors inducing long-term and regulated gene expression in specific tissue are under development, resulting in more efficient gene transfer, for example by using distinct serotypes of viral vectors such as adeno-associated virus. This review gives an overview of some promising vectors used in RA research. Furthermore, several therapeutic genes are discussed that could be used for gene therapy in RA patients.

Adenoviridae↗
PubMed2003

Experimental therapeutics in Huntington's disease: are models useful for therapeutic trials?

PURPOSE OF REVIEW: Research conducted over the past 10 years has uncovered molecular mechanisms that are likely to be important in the early stages of Huntington's disease pathogenesis. This review summarizes the resources and strategies that are in place in order to exploit these new findings and use them to develop novel Huntington's disease therapeutics. The role that disease models will play in this process is discussed. RECENT FINDINGS: A wide variety of models of Huntington's disease have been developed including yeast, Caenorhabditis elegans, Drosophila melanogaster and mouse. These can be developed as screening assays for the identification of chemical compounds that show beneficial effects against a specific phenotype and for the cross validation of potential therapeutics. The first compounds arising through this drug development pipeline have been reported. Similarly, the preclinical screening of compounds in mouse models is being developed in a coordinated manner. SUMMARY: Our understanding of the molecular basis of Huntington's disease is increasing at an exponential rate. Over the next few years an increasing number of potential therapeutic compounds will have been identified. It will only be possible to take a small number of these through to phase III clinical trials. The challenge will be to use the in-vivo models of Huntington's disease to best predict which of these compounds should be pursued in the clinic, to avoid depleting the patient population willing to enter into trials, and demoralizing them by conducting repeated unsuccessful trials.

Acetamides↗
PubMed1981

New concepts in therapeutic photomedicine: photochemistry, optical targeting and the therapeutic window.

Advances in optics technology, synthetic photochemistry, and the science of photobiology make it possible to think beyond phototherapy and photochemotherapy which is dependent on direct photochemical alteration of metabolites or direct phototoxic insult to cells. This report discusses another gender of photomedicine therapy which includes in vivo photoactivation of medicines, photon-dependent drug delivery, and manipulation of host and exposure source to maximize therapeutic index. These therapeutic manipulations are made possible because the skin is highly overperfused and because non-ionizing electromagnetic radiation that enters skin and blood has adequate photon energy to cause electronic excitation. Radiation of 320-800 nm is not very directly phototoxic, is absorbed by a variety of relatively nontoxic photolabile molecules and has an internal dosimetric depth profile. This radiation can therefore be used to activate, deactivate, bind, release or biotransform medications in vivo in skin or other organs. The photochemist, synthetic chemist and photobiologist can collaborate to significantly increase therapeutic possibilities.

Humans↗
PubMed2004

Therapeutic angiogenesis for critical limb ischemia: design of the hepatocyte growth factor therapeutic angiogenesis clinical trial.

The objective of the HGF-STAT clinical trial is to determine whether perfusion can be improved by gene transfer with a plasmid DNA containing hepatocyte growth factor (HGF) in the affected limb of patients with unreconstructable critical limb ischemia (CLI). CLI results in a high rate of limb loss and impaired quality of life. The current therapeutic strategies, including bypass surgery and percutaneous interventions, are only successful in treating a subset of patients. Therapeutic angiogenesis is an investigational method that seeks to favorably impact tissue perfusion in CLI. HGF-STAT is a double-blind, parallel-group, placebo-controlled, dose-response study in 100 patients with unreconstructable CLI. Eligible subjects will be randomized 1:1:1:1 to receive saline placebo or one of three dose/regimens of HGF plasmid DNA. The selection of outcome measures, including the primary endpoint, and changes in transcutaneous oxygen pressure (TcPO2) from baseline to 3 months will be discussed. In conclusion, this study will help to determine whether therapeutic angiogenesis with HGF is a viable option in the treatment of patients with CLI.

Adult↗
PubMed2005

The use of metaphors in the service of the therapeutic alliance and therapeutic communication.

The use of metaphor as a conceptual and clinical tool in the treatment situation can enhance the therapeutic alliance and strengthen the effectiveness of therapeutic communication. The evolution of a special metaphoric system of communication in the course of the treatment situation enhances the positive alliance between patient and therapist. In a way analogous to the poetic use of metaphor, the therapeutic use of appropriate metaphors can be a powerful tool because a metaphor is a symbol that represents a condensation of multiple impulses, conflicts, fantasies, and affects. Case material will be presented to illustrate the use of metaphoric communication in the clinical situation.

Anger↗
PubMed1996

A therapeutic approach to erythrodermic psoriasis: report of a case and a discussion of therapeutic options.

In this case report a patient with therapeutically recalcitrant erythrodermic psoriasis is presented. After various attempts with several major therapies in this patient, the first substantial improvement was achieved using the combination of cyclosporine and calcipotriol, followed by the combination of UVB and calcipotriol. The therapeutic options for severe psoriasis are discussed, and since combined approaches seem to be an attractive alternative for severe psoriasis, mechanisms of synergy of combined therapeutic approaches are hypothesised.

Aged↗