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At least 163 records · Page 9Linked to original sources

PubMed1995

Interferon-alpha therapy for chronic myelogenous leukemia.

PURPOSE: To provide a status report on the use of interferon (IFN)-alpha in patients with chronic myelogenous leukemia (CML). DATA SOURCES: Data on IFN-alpha therapy for CML collected from published articles identified in a MEDLINE computer search. RESULTS: Previously untreated patients with low-risk factors and early-stage disease consistently had the best results in clinical trials. A dose response was seen, with patients treated with dosages of 5 million units (MU)/m2 per day showing the greatest incidence of cytogenetic remissions. In addition, randomized trials showed a survival advantage for IFN-alpha-treated patients. In studies comparing IFN-alpha therapy to chemotherapy, IFN-alpha produced significantly more major and durable cytogenetic responses than chemotherapy did. In studies combining IFN-alpha and chemotherapy, patients had significantly more cytogenetic responses, although more patient accrual and follow-up data are needed to offer conclusive statements concerning durability of response. IFN-alpha also showed activity in maintaining remissions after both chemotherapy and bone marrow transplantation. CONCLUSIONS: IFN-alpha has significant activity in patients with CML, with best results at dosages of 5 MU/m2 per day. At these dosages, in patients with early-stage, Philadelphia+ CML, hematologic response rates of 70% to 80% and cytogenetic response rates of 50% (approximately 20% of which were complete) are seen. One randomized trial shows a survival advantage with cytogenetic response in IFN-alpha-treated patients, and this advantage appears to be unrelated to the degree of that response. These questions remain under study.

Antineoplastic Agents↗

PubMed1998

The Health On the Net Code of Conduct for medical and health Websites.

Internet has become one of the most used communication media. This and the fact that no constraining information publishing policy exists have created an urgent need to control the quality of information circulating through this media. To this purpose, the Health On the Net Foundation has initiated the Code of Conduct (HONcode) for the health/medical domain. This initiative proposes guidelines to information providers, with the aim, on the one hand, of raising the quality of data available on the Net and, on the other hand, of helping to identify Internet sites that are maintained by qualified people and contain reliable data. The HONcode mainly includes the following ethical aspects: the author's credentials, the date of the last modification with respect to clinical documents, confidentiality of data, source data reference, funding and the advertising policy. This article presents the HONcode and its evolution since it was launched in 1996.

Advertising↗

PubMed1999

Fluorescence spectroscopy for diagnosis of squamous intraepithelial lesions of the cervix.

OBJECTIVE: To calculate receiver operating characteristic (ROC) curves for fluorescence spectroscopy in order to measure its performance in the diagnosis of squamous intraepithelial lesions (SILs) and to compare these curves with those for other diagnostic methods: colposcopy, cervicography, speculoscopy, Papanicolaou smear screening, and human papillomavirus (HPV) testing. DATA SOURCES: Data from our previous clinical study were used to calculate ROC curves for fluorescence spectroscopy. Curves for other techniques were calculated from other investigators' reports. To identify these, a MEDLINE search for articles published from 1966 to 1996 was carried out, using the search terms "colposcopy," "cervicoscopy," "cervicography," "speculoscopy," "Papanicolaou smear," "HPV testing," "fluorescence spectroscopy," and "polar probe" in conjunction with the terms "diagnosis," "positive predictive value," "negative predictive value," and "receiver operating characteristic curve." METHODS OF STUDY SELECTION: We found 270 articles, from which articles were selected if they reported results of studies involving high-disease-prevalence populations, reported findings of studies in which colposcopically directed biopsy was the criterion standard, and included sufficient data for recalculation of the reported sensitivities and specificities. TABULATION, INTEGRATION, AND RESULTS: We calculated ROC curves for fluorescence spectroscopy using Bayesian and neural net algorithms. A meta-analytic approach was used to calculate ROC curves for the other techniques. Areas under the curves were calculated. Fluorescence spectroscopy using the neural net algorithm had the highest area under the ROC curve, followed by fluorescence spectroscopy using the Bayesian algorithm, followed by colposcopy, the standard diagnostic technique. Cervicography, Papanicolaou smear screening, and HPV testing performed comparably with each other but not as well as fluorescence spectroscopy and colposcopy. CONCLUSION: Fluorescence spectroscopy performs better than colposcopy and other techniques in the diagnosis of SILs. Because it also permits real-time diagnosis and has the potential of being used by inexperienced health care personnel, this technology holds bright promise.

Carcinoma in Situ↗

PubMedDate not supplied

Emerging standardization in pharmacoeconomics.

In this study, we reviewed pharmacoeconomic guidelines from the United Kingdom, Spain, Italy, Australia, Canada, and the United States to determine areas of emerging standardization. We examined the published literature, publication guidelines of major health journals, and published and unpublished recommendations from various task forces and conferences on related topics. The review revealed several general principles for which there was consensus across guidelines. These common features included the importance of using and reporting transparent methods so that readers can easily understand what calculations are being performed on which data elements, minimizing bias, and providing justification for the methods and assumptions used. Differences were detected across guidelines on the following topics: type of pharmacoeconomic assessment, perspective, comparators and data sources, data analysis, cost analysis, future cost analysis, outcomes assessment, modeling, time horizon, discounting, disclosure, and generalizability. Evolution of economic guidelines hinges on whether the primary goal is to increase the consistency or increase the validity of economic assessments. Some balance between these two objectives is desirable.

Cost-Benefit Analysis↗

PubMed1992

Hepatocyte culture systems for artificial liver support: implications for critical care medicine (bioartificial liver support).

OBJECTIVE: The primary purpose of this review article is to familiarize critical care practitioners with newly developing techniques of hybrid artificial liver support. Implantable and extracorporeal hepatocyte culture systems are emphasized based on their current experimental and clinical status. DATA SOURCES: Data used to prepare this document were obtained from the authors' personal files, as well as the computerized MEDLINE database. Medical headings used include: liver, artificial organs, cell culture, growth hormones, extracellular matrix, and transplantation. Only articles published in English have been cited. STUDY SELECTION: All studies are discussed in which hepatocyte culture systems have been used to support human patients with liver failure. All studies reported the patient's condition before therapy, duration of therapy, and outcome after therapy in order to be included in this review. Since the number of clinical trials is small at this time, animal studies were used to demonstrate application of other systems in the treatment of experimentally induced liver failure. Similar selection criteria were used to select animal studies for review. All initially identified human studies met these selection criteria. DATA EXTRACTION: Independent extraction by multiple observers. DATA SYNTHESIS: Liver failure, resulting from infection, drugs, or as a part of the multiple organ failure syndrome, remains a major cause of morbidity, mortality, and resource allocation. Current therapy is limited to supportive care, along with liver transplantation. Because of these therapeutic limitations, hybrid artificial liver systems have been proposed for temporary and long-term hepatic support. Several animal studies and a small number of preliminary human studies indicate that hepatocyte culture systems are capable of supporting nearly all essential hepatic functions and may supply biologically active substances that promote regeneration and repair of the damaged liver being supported. Hybrid systems may be constructed from materials that serve as immunoprotective barriers against host defenses. CONCLUSIONS: During the past decade, important progress has been made with hybrid artificial liver support systems. Cell culture technology has progressed sufficiently so that an artificial liver, composed of metabolically active hepatocytes, may be a potential reality in the foreseeable future. Both implantable and extracorporeal artificial liver support systems have been developed to provide metabolic support during acute liver failure, or to serve as a bridge to solid organ transplantation. Implantable hepatocyte systems, however, require a prolonged period for intraperitoneal engraftment and vascularization, not typically available to patients with acute liver failure. For this reason, extracorporeal hybrid designs offer the greatest hope for on-line treatment of acute liver failure. Such systems are entering the final stages of animal testing.

Animals↗

PubMed1993

Introduction of new technology into critical care practice: a history of HA-1A human monoclonal antibody against endotoxin.

OBJECTIVES: HA-1A, a monoclonal antibody against endotoxin, was thought to be effective in treating patients with Gram-negative sepsis. Because of this possibility, many clinicians felt obligated to use the drug and assumed that its product license application would be approved by the U.S. Food and Drug Administration (FDA). Nevertheless, the efficacy of HA-1A was not conclusively demonstrated by a first clinical trial. The FDA rejected the product license application and requested a second clinical trial, which was suspended after excess mortality was noted in patients treated with HA-1A. This review of the history of the drug was prepared to provide clinicians and sepsis investigators with information about HA-1A and, by extension, the process by which new technology is introduced into critical care practice. DATA SOURCES: Data used to prepare this review were obtained from the author's personal files as well as the computerized MEDLINE database. STUDY SELECTION: Studies were selected for their relevance to the history of HA-1A and their relevance to the introduction of potentially useful medical technology. DATA EXTRACTION: The author extracted all applicable data. DATA SYNTHESIS: Although the first clinical trial of HA-1A suggested that the drug was effective in treating patients with Gram-negative bacteremia with or without shock, further analysis by the FDA indicated a benefit only for bacteremic patients with shock. Furthermore, the original study design was not followed, leading in part to the FDA's refusal of the product license application. Concern also was raised over the issue of identifying which patients should receive HA-1A and the cost of the drug, which would have put it past the reach of some American hospitals and thereby, would have conflicted with the ethical principle of social justice. Finally, the second trial suggested that HA-1A might be harmful. CONCLUSIONS: Due to the FDA's action, the issues raised about HA-1A, and the results of the two clinical trials, clinicians should not use the drug. The history of HA-1A provides insights about how new technology is and will be introduced into critical care practice.

Antibodies, Monoclonal↗

PubMed1995

Physicians do not have a responsibility to provide futile or unreasonable care if a patient or family insists.

OBJECTIVE: This article was written to argue that physicians are not ethically obligated to provide care which they consider futile, unreasonable, or both, either voluntarily or in response to patient or surrogate demands. DATA SOURCES: Data used to prepare this article were drawn from published articles, including original investigations, position papers and editorials in the author's personal files. STUDY SELECTION: Articles were selected for their relevance to the subjects of medical ethics, the concepts of futility and medical reasonableness, case law, and healthcare reform. DATA EXTRACTION: The author extracted all applicable data. DATA SYNTHESIS: Physicians may feel obligated to provide care in all clinical circumstances due to the single master view of medicine and the ethical principle of autonomy. However, care may be considered futile according to several definitions of that word, including that which describes futile treatment as something that does not benefit the patient as a whole. Furthermore, care may be considered unreasonable if it is excessive and not generally agreed upon. Physician refusal to provide futile or unreasonable care is supported by the ethical principles of nonmaleficence, beneficence, and distributive justice. The last principle is particularly relevant in the current climate of healthcare reform. CONCLUSIONS: Although the issue of physician refusal of requested care has not been resolved by case law or legal statute, it is supported by compelling ethical principles. Physicians are not ethically required to provide futile or unreasonable care, especially to patients who are brain dead, vegetative, critically or terminally ill with little chance of recovery, and unlikely to benefit from cardiopulmonary resuscitation.

Adult↗

PubMed1996

Cardiopulmonary resuscitation: what cost to cheat death?

OBJECTIVES: To review the various outcomes from cardiopulmonary resuscitation (CPR), the factors that influence these outcomes, the costs associated with CPR, and the application of cost-analyses to CPR. DATA SOURCES: Data used to prepare this article were drawn from published articles and work in progress. STUDY SELECTION: Articles were selected for their relevance to the subjects of CPR and cost-analysis by MEDLINE keyword search. DATA EXTRACTION: The authors extracted all applicable data from the English literature. DATA SYNTHESIS: Cost-analysis studies of CPR programs are limited by the high variation in resources consumed and attribution of cost to these resources. Furthermore, cost projections have not been adjusted to reflect patient-dependent variation in outcome. Variation in the patient's underlying condition, presenting cardiac rhythm, time to provision of definitive CPR, and effective perfusion all influence final outcome and, consequently, influence the cost-effectiveness of CPR programs. Based on cost data from previous studies, preliminary estimates of the cost-effectiveness of CPR programs for all 6-month survivors of a large international multicenter collaborative trial are $406,605.00 per life saved (range $344,314.00 to $966,759.00), and $225,892.00 per quality-adjusted-life-year (range $191,286.00 to $537,088.00). CONCLUSIONS: Reported outcome from CPR has varied from reasonable rates of good recovery, including return to full employment to 100% mortality. Appropriate CPR is encouraged, but continued widespread application appears extremely expensive.

Cardiopulmonary Resuscitation↗

PubMed1999

Prevention and management of overwhelming postsplenectomy infection--an update.

OBJECTIVES: To review the diagnosis and management of overwhelming postsplenectomy infection and to discuss various preventative measures. DATA SOURCES: Data used to prepare this article were drawn from published articles and work in progress. STUDY SELECTION: Articles were selected for relevance to the subject after location by a MEDLINE key word search. DATA EXTRACTION: The literature was reviewed to summarize the etiology and pathophysiology of postsplenectomy sepsis. Preventative strategies were outlined with a particular emphasis on education, immunoprophylaxis, and chemoprophylaxis. DATA SYNTHESIS: Although physicians have become increasingly aware of overwhelming postsplenectomy infection in children, many remain unaware of the risk to asplenic or hyposplenic adults who may have no underlying medical problems. Recent studies have shown that many patients who have had splenectomies have had neither appropriate vaccinations nor teaching that would explain the lifelong nature of their risk. The increasing incidence of penicillin-resistant pneumococci represents a major area of therapeutic and prophylactic concern. The identification of Howell-Jolly bodies on a peripheral blood smear should alert physicians to the need for follow-up to document possible hyposplenism. Attention has focused on a three-pronged attack to this problem, including education, immunoprophylaxis, and chemoprophylaxis. CONCLUSIONS: Overwhelming postsplenectomy infection should be largely preventable if appropriate precautions are taken. Physicians need to know of the spectrum of diseases associated with hyposplenism and how patients noted to have Howell-Jolly bodies should be investigated. They should also be aware of appropriate guidelines for management of patients with asplenia or hyposplenism.

Adult↗

PubMed1988

Adolescent hopefulness in illness and health.

Hopefulness is believed to be a significant element in the human response to illness, but its clinical impact has not been documented due to conceptual and operational difficulties. This article generates a definition of hopefulness from well and ill adolescents. The study's conceptual orientation included the beliefs that hope is a contributing factor in health maintenance and is especially vital for individuals experiencing life-threatening illness. Grounded theory methodology was used. Interviews, observations and health records were data sources. Data were analyzed during the cross-comparative method. A panel approach was used to assess the reliability and validity of the induced categories. Theoretical saturation on a definition was achieved. Adolescents with cancer had a dimension in the definition not found in the other two groups. The added dimension had a focus on "others" in contrast to only "self."

Adolescent↗

PubMed1992

Isradipine--another calcium-channel blocker for the treatment of hypertension and angina.

OBJECTIVE: To review the pharmacology, pharmacokinetic disposition, dose recommendations, adverse effects, drug interactions, and efficacy of isradipine in patients with hypertension or ischemic heart disease. DATA SOURCES: Data from scientific literature were extracted, evaluated, and summarized for presentation. A MEDLINE search was conducted using the following indexing terms: isradipine, calcium-channel blockers, hypertension, and angina pectoris. Experiences from studies evaluating isradipine reported in the form of articles, abstracts, or proceedings involving patients or healthy subjects were considered for inclusion. STUDY SELECTION: Special consideration was given to clinical studies that had been designed in a blind, randomized fashion. Studies that compared the effectiveness and safety of isradipine with another antihypertensive or antianginal agent or placebo were included. DATA EXTRACTION: Data from human studies published in the English language were evaluated. Trials were evaluated according to sample size, design, and adequacy of description of therapeutic response. DATA SYNTHESIS: Isradipine is a new dihydropyridine calcium-channel blocker that appears to exert less negative inotropic activity than nifedipine and to selectively inhibit sinoatrial conduction. Pharmacokinetic parameters are quite variable and considerably more work is needed to better describe the kinetic disposition of isradipine. Antihypertensive efficacy has been demonstrated extensively in a number of short-term trials. Antianginal efficacy also has been observed in a few short-term trials and is comparable to that of isosorbide dinitrate and nifedipine. Extensive experience with isradipine is minimal and no clear-cut advantages over existing compounds have been noted thus far. CONCLUSIONS: The place of isradipine in the therapy of hypertension and myocardial ischemia is unclear and its routine use cannot yet be recommended based solely on clinical grounds.

Angina Pectoris↗

PubMed1993

Nabumetone: a "nonacidic" nonsteroidal antiinflammatory drug.

OBJECTIVE: To review the pharmacology, pharmacokinetic disposition, dosage recommendations, adverse effects, drug interactions, and efficacy of nabumetone in patients with selected rheumatic disorders and soft-tissue injuries. DATA SOURCES: Data from scientific literature were extracted, evaluated, and summarized for presentation. A MEDLINE search was conducted using the following indexing terms: antiinflammatory agents, nonsteroidal, nabumetone, rheumatoid arthritis (RA), and osteoarthritis (OA). Studies evaluating nabumetone reported in articles, abstracts, or proceedings involving human subjects were considered for inclusion. STUDY SELECTION: Special consideration was given to clinical studies using double-blind, randomized, parallel, controlled designs. Studies comparing the effectiveness and safety of nabumetone with placebo and other nonsteroidal antiinflammatory drugs (NSAIDs) were included. DATA EXTRACTION: Data from human studies published in the English language were evaluated. Trials were assessed according to study design, sample size, and description of outcomes. DATA SYNTHESIS: Nabumetone is a nonacidic prodrug that is metabolized to an active nonsteroidal antiinflammatory moiety, 6-methoxy-2-naphthylacetic acid (6-MNA). 6-MNA is a structural analog of naproxen. Like naproxen and other NSAIDs, 6-MNA possesses analgesic, antipyretic, and antiinflammatory activity, 6-MNA has a prolonged elimination half-life, ranging from 17 to 74 hours, which allows for once-daily dosing. The efficacy of nabumetone for treating symptoms of RA and OA has been established in controlled clinical trials. Nabumetone also has been studied in ankylosing spondylitis and soft-tissue injuries. Adverse effects associated with nabumetone are similar to those associated with other NSAIDs. Gastrointestinal reactions occur most frequently in the form of abdominal pain or indigestion, nausea, or vomiting. Central nervous system adverse effects occur less frequently, and are followed in order of occurrence by rashes. CONCLUSIONS: Nabumetone is a prodrug metabolized to an active metabolite structurally related to naproxen. Studies have demonstrated the efficacy of nabumetone, but no advantages over the many other NSAIDs now available.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1993

Meaningful interpretation of risk reduction from clinical drug trials.

OBJECTIVE: To illustrate the concepts of relative and absolute risk reduction, and by example, present and discuss the results of prevention trials that have evaluated the impact of drug therapy on cardiovascular disease. Additional approaches to evaluating the results of prevention trials are also presented. DATA SOURCES: Data were gathered from eight frequently quoted major cardiovascular intervention trials. CONCLUSIONS: Reference to large reductions in relative risk in review papers, newspapers, and at professional meetings can lead to false expectations among clinicians and patients regarding the potential impact of the treatment in individual patients. When making decisions about preventive drug therapy, clinicians are encouraged to examine measures other than relative risk reduction and to include the patient in the decision process. Educators should emphasize these other measures of outcome and not rely solely on relative risk reduction in discussing particular areas of therapeutics.

Canada↗

PubMed1994

Tacrolimus, a new immunosuppressant--a review of the literature.

OBJECTIVE: To review the clinical pharmacology, pharmacokinetics, adverse effects, therapeutic uses, and current status of tacrolimus. DATA SOURCES: Data from scientific literature were identified by a MEDLINE search. The data were extracted, evaluated, and summarized for presentation. Experiences from studies evaluating tacrolimus in the form of articles, abstracts, letters to the editor, or proceedings were considered for inclusion. STUDY SELECTION: Open and controlled clinical and animal trials were reviewed in evaluating the pharmacology, pharmacokinetics, and adverse effects of tacrolimus. DATA EXTRACTION: Data from animal and human studies published in the English literature were evaluated. DATA SYNTHESIS: Tacrolimus is an 822-kDa macrolide antibiotic that has potent immunosuppressive properties. The mechanism of action is similar to that of cyclosporine in that it ultimately blocks the production of interleukin 2, thereby inhibiting further T-lymphocyte proliferation. Tacrolimus is metabolized solely in the liver and the metabolites are primarily excreted in the bile. The elimination half-life of tacrolimus is approximately 8.5 h, and is prolonged in hepatic dysfunction. Tacrolimus has shown efficacy in the prophylaxis of allograft rejection in both animals and human clinical trials, and has been used effectively to rescue patients who have exhibited refractory rejection failing cyclosporine prophylaxis. Adverse effects requiring tacrolimus dosage adjustment include nephrotoxicity, neurotoxicity, alterations in glucose metabolism, and infection or susceptibility to malignancy. CONCLUSIONS: To date, trials comparing tacrolimus with cyclosporine are not available in the literature; however, tacrolimus appears to be useful in rescuing grafts, particularly liver grafts that fail cyclosporine-based immunosuppression. Direct comparisons with cyclosporine are needed to define the role of tacrolimus as primary transplant therapy.

Absorption↗

PubMed1994

Tacrine: first drug approved for Alzheimer's disease.

OBJECTIVE: To review the pharmacology, biopharmaceutics/pharmacokinetics, clinical efficacy, adverse effects, and therapeutic considerations regarding the use of tacrine in patients with Alzheimer's disease. DATA SOURCES: Data from the scientific and professional literature were analyzed, interpreted, and summarized. Citations were obtained by performing a MEDLINE search using the following indexing terms: tacrine, tetrahydroaminoacridine, and Alzheimer's drug therapy. Data also were obtained from a summary of the New Drug Application (Summary Basis of Approval of Cognex) and from the approved product labeling. STUDY SELECTION: Studies in Alzheimer's disease have been plagued by methodologic inconsistencies and deficiencies. Only efficacy studies subsequent to the Food and Drug Administration's (FDA) issuance of recommendations for studies in Alzheimer's disease (1991) were used. Therefore, only double-blind, placebo-controlled, parallel design studies of at least three-month's duration using the Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Clinical Interview-Based Impression of Change as efficacy parameters were included. DATA EXTRACTION: Trials were assessed according to the criteria listed above. Results were evaluated on the basis of both completed patients and last observation carried forward models. DATA SYNTHESIS: Tacrine is a cholinesterase inhibitor that increases the availability of acetylcholine in muscarinic neurons. It has a mean bioavailability after oral administration of about 17 percent and an elimination half-life of approximately three hours. Although drug interactions are poorly studied, tacrine is metabolized by isoenzyme P-450IA2 and may interact with other drugs metabolized by this isoenzyme. Tacrine has been shown to have efficacy in mildly to moderately impaired Alzheimer's patients on both psychometric testing and a clinician's structured interview. Although efficacious, its effects are not dramatic, and it does not affect the ultimate course of the disease. Adverse effects are frequent, and significantly elevated hepatic transaminase concentrations may occur in approximately 25 percent of patients. CONCLUSIONS: Tacrine is the first drug approved by the FDA for treatment of Alzheimer's disease. Although it may improve psychometric test scores in mild to moderately impaired patients, it is not a panacea and does not affect the course of the disease. Patients must be monitored closely for elevated transaminase, cholinergic adverse effects, and interactions with drugs metabolized through P-450IA2.

Alanine Transaminase↗

PubMed1995

Cigarette smoking and clinically significant drug interactions.

OBJECTIVE: To review clinically significant drug interactions associated with cigarette smoking. DATA SOURCES: Data from scientific literature were identified by using a MEDLINE search. Data were extracted, evaluated, and summarized for this review. STUDY SELECTION: Findings and experiences were selected from clinical, epidemiologic, and pharmacokinetic studies; review articles; case studies; abstracts; letters to the editor, and proceedings. DATA EXTRACTION: Data from human studies published in English were evaluated. Only interactions deemed clinically significant are included in this review. Conclusions derived from review articles on the subject of smoking and drug interactions also were used. DATA SYNTHESIS: Cigarette smoking can affect drug therapy via pharmacokinetic and pharmacodynamic mechanisms. Pharmacokinetic drug interactions are presented for theophylline, tacrine, insulin, flecainide, propoxyphene, propranolol, diazepam, and chlordiazepoxide. Pharmacodynamic interactions are described for antihypertensive and antianginal agents, antilipidemics, oral contraceptives, and histamine2-receptor antagonists. CONCLUSIONS: Cigarette smoking can reduce the efficacy of certain drugs or make drug therapy more unpredictable. Pharmacokinetic interactions may cause smokers to require a larger dosage of certain drugs through an increase in plasma clearance, a decrease in absorption, an induction of cytochrome P450 enzymes, or a combination of these factors. Pharmacodynamic interactions may increase the risk of adverse events in smokers with cardiovascular or peptic ulcer disease, and in women who smoke and use oral contraceptives. Healthcare professionals should pay special attention to patients with these profiles and should try to prevent cigarette smoking or encourage patients to discontinue this addictive habit.

Clinical Trials as Topic↗

PubMed1996

Pharmacotherapy of aggressive behavior.

OBJECTIVE: To review the definition, clinical characteristics, prevalence, etiology, neurochemistry, and pharmacologic treatment of aggressive behavior, and provide recommendations regarding the use of specific pharmacologic agents for treating aggressive behavior. DATA SOURCES: Data from the scientific literature were analyzed, interpreted, and summarized. An English-language MEDLINE search yielded clinical trials, case reports, letters, and review articles addressing the etiology and pharmacotherapy of aggression. STUDY SELECTION: Because few well-controlled studies are available in aggression research, all literature addressing the pharmacologic treatment of aggressive behavior, as well as the neurochemistry and psychobiology of aggressive behavior, was reviewed. DATA EXTRACTION: The literature was reviewed on the basis of the particular pharmacotherapy and the specific population used. A separate review of the treatment of aggressive behavior in the elderly was included. DATA SYNTHESIS: The literature was assessed for applicability to clinical practice and usefulness to the general clinician. Recommendations were made from the primary literature in conjunction with trends in clinical practice. Pharmacotherapy is a primary mainstay of treatment for aggressive patients. In individuals for whom behavioral intervention alone is unsuccessful, drug therapy should be initiated along with continued nonpharmacologic intervention. Short-acting benzodiazepines and high-potency antipsychotic agents are effective in treating acute aggression on a short-term or as needed basis. Agents such as lithium, beta adrenergic blockers, carbamazepine, valproic acid, buspirone, trazodone, serotonin reuptake inhibitors, and clozapine may be useful in the chronic management of aggressive behavior. Every attempt should be made to streamline drug therapy in patients with chronic aggression and comorbid psychiatric disorders. CONCLUSIONS: On the basis of available research and extensive clinical experience, lithium or propranolol should be considered as first-line antiaggressive agents in patients without comorbid psychiatric disorders. A minimum trial period for assessing drug efficacy should last at least 6-8 weeks at maximum tolerated dosages. Patients responding to pharmacotherapy should be reevaluated every 3-6 months, and periodic medication tapers and/or drug-free periods should be attempted.

Aggression↗

PubMed1998

Intraperitoneal thrombolytic therapy for peritoneal dialysis-associated peritonitis.

OBJECTIVE: To review the literature pertaining to the use of adjunctive thrombolytic therapy for the treatment of peritoneal dialysis-associated peritonitis (PDAP). DATA SOURCES: A MEDLINE search was conducted (January 1966-December 1997) to find articles using the terms peritonitis, peritoneal dialysis, and each thrombolytic drug. References from these articles were then reviewed to identify further sources. DATA EXTRACTION: Representative case reports and clinical trials are summarized in this report. Information regarding thrombolytic dosing, administration techniques, and reported efficacy rates are included from both case reports and clinical trials. DISCUSSION: Thrombolytic agents administered intraperitoneally appear to facilitate antibiotic penetration into the biofilm formed by certain bacteria. Numerous case reports of intraperitoneal thrombolytic adjunctive therapy for recurrent or persistent PDAP have indicated that these agents may have a role in the treatment of selected patients. Urokinase and streptokinase are the only thrombolytics that have been studied. They appear to have similar efficacy, but the adverse drug event rate with streptokinase is unacceptably high. The efficacy of therapy with urokinase is probably inferior to removal of the peritoneal dialysis catheter, but, if successful, allows for the continuation of peritoneal dialysis therapy. CONCLUSIONS: In conjunction with appropriate antibiotic therapy, intraperitoneal instillation of urokinase should be reserved for patients who develop two or more episodes of recurrent or persistent PDAP in the absence of poor compliance and in whom dialysis catheter removal should be avoided (i.e., they cannot tolerate hemodialysis).

Clinical Trials as Topic↗