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PubMed2003

Limited evolution of HIV antiretroviral drug resistance-associated mutations during the performance of drug resistance testing.

We investigated the evolution of HIV reverse transcriptase (RT)- and protease-associated antiretroviral (ARV) drug resistance mutations during the time taken to perform genotypic drug resistance testing. Thirty treatment-experienced patients who were adherent to therapy and who underwent genotypic drug resistance testing provided blood samples at randomization and when reviewing the test results (baseline). Patients remained on their existing therapy between randomization and baseline. The predominant HIV strains in 10 patients (33%) either lost and/or gained primary RT inhibitor (RTI)- or protease inhibitor (PI)-associated resistance mutations during the testing period. Of the 9 patients with RT mutations, 2 lost, 5 gained, and 2 both lost and gained RTI resistance mutations. One patient gained a significant PI-associated resistance mutation on an existing PI-resistant background. The evolution that occurred in the RT may have altered the effectiveness of subsequent ARV therapy in some patients. Neither viral load at randomization, ARV drug class used at randomization, time between collection of blood samples, duration of current therapy, nor number of ARV drugs used influenced gain or loss of resistance mutations. There was a significant association between duration of previous ARV therapy and gain of RTI-associated resistance mutations ( p =.02), however. In general, our results suggest that patients should continue current therapy until test results are available. A few patients would be expected to gain ARV drug-associated resistance mutations during this time, however.

Adult↗
PubMed1986

Colloidal bismuth subcitrate and ranitidine in the short-term treatment of benign gastric ulcer. An endoscopically controlled trial.

Colloidal bismuth subcitrate (CBS) in the form of a chewable tablet has been compared with ranitidine in the short-term treatment of benign gastric ulcers. Eighty patients were admitted to this randomised single blind study. Endoscopic control was carried out after 4 weeks, and after 8 weeks when healing was incomplete or had not occurred at the 4-week examination. After 1 month of therapy the healing rates were 70% with CBS and 62.5% with ranitidine (P = not significant). At two months the corresponding cure rates were 87.5% and 79%, respectively (P = not significant). Antacid consumption was higher in the group treated with ranitidine, but the difference was not statistically significant. Patient cooperation was good and similar in the two groups. These findings confirm that CBS, in tablet form, is at least as effective as ranitidine in the acute treatment of benign gastric ulcers.

Adult↗
PubMed2002

Amelioration of accelerated collagen induced arthritis by a novel calcineurin inhibitor, ISA(TX)247.

OBJECTIVE: To examine the efficacy and toxicity of ISA(TX)247, a novel calcineurin inhibitor, in comparison to cyclosporine (cyclosporin A, CSA) and placebo in established collagen induced arthritis. ISA(TX)247 has up to 3-fold greater potency than CSA in an in vitro whole blood calcineurin inhibition assay and in in vivo solid organ and cell transplantation models. Phase I clinical trials show no discernible nephrotoxicity. METHODS: Type II collagen immunized DBA/Lac J mice with established arthritis were randomized to treatment with ISA(TX)247 (125/250/500 microg/mouse), CSA (250/500 microg/mouse), or drug vehicle, by daily intraperitoneal injection for 10 days from the onset of clinical arthritis. RESULTS: A significant dose dependent reduction in clinical severity was observed in ISA(TX)247 treated but not in CSA treated animals 10 days after the onset of established arthritis, and when examined by area under the curve analysis during the treatment period. Significant improvement in paw swelling (p < 0.001), synovial histology (p < 0.001), and articular cartilage damage scores (p = 0.002) was also noted in ISA(TX)247 treated animals, even in the 125 pg dose group (p = 0.03 for paw swelling and synovial histology). By comparison, CSA had no significant effect on either synovial inflammation or articular cartilage damage. ISA(TX)247 (500 microg dose group) was the only treatment to significantly decrease the development of proximal interphalangeal joint erosions (p < 0.05). A significant reduction in Type II collagen antibody titer was noted in ISA(TX)247 animals in both 250 microg (p = 0.02) and 500 microg (p = 0.004) dosage groups, but only in the 500 microg group for CSA (p = 0.004). Treatment was well tolerated, with no significant toxicity in ISA(TX)247 groups. CONCLUSION: ISA(TX)247 demonstrates efficacy and safety in the treatment of established collagen induced arthritis. Together with its improved potency and nephrotoxicity profile in comparison to CSA, this agent warrants further clinical investigation in autoimmune disease. Phase II studies in rheumatoid arthritis have been initiated.

Adjuvants, Immunologic↗
PubMed2004

[Experimental study on inhibitory effect of langchuangjing granule on lupoid change of kidney in lupus-prone mice].

OBJECTIVE: To study the effect and mechanism of Langchuangjing Granule (LCJ) in inhibiting the lupoid change of kidney in lupus-prone mice. METHODS: Intervention therapy was applied to three group of BW female mice of lupus, 3 months in age, for 6-12 weeks with LCJ, prednisone and LCJ + prednisone respectively to observe the dynamic development of disease, changes of CD4+, CD8+ and CD54 expression, and the effect on pathology of renal corpuscles. RESULTS: Both western and Chinese medicines can partially improve the symptoms and plasma CD4+ and CD8+ distribution, inhibit the increase of serum ICAM-1 content and the high expression of CD54 in surface of lymphocyte of peripheral blood, suppress the atrophy of renal corpuscles and the proliferation of mesangial cell. The optimal effect was showed by the combination of LCJ and prednisone. CONCLUSION: LCJ could effectively control and improve the genesis and development of lupoid changes in model mice, and regulate the cellular immune function, inhibit the excessive immune reaction, and improve the pathology of lupoid nephritis, it could cooperate with western medicine to give full play of its effective role and show the superiority in treatment.

Animals↗
PubMed2005

Teaching evidence-based medicine in a managed care setting: from didactic exercise to pharmacopolicy development tool.

OBJECTIVES: To implement a residency-based program for the teaching of evidence-based medicine in an Israeli HMO and to incorporate this effort into the HMO's routine drug policy formulation process. METHODS: Residents and preceptors participating in the family practice residency program in The Leumit Health Fund, 1 of the 4 HMOs operating in Israel, were invited to participate in a workshop for the formulation of guidelines for antibiotic treatment of the common infectious diseases encountered in primary care. The participants were allocated to teams consisting of a preceptor (an attending physician) and a resident physician, with each team choosing a different disease to analyze. Upon completion of the program, a questionnaire was sent to all residents and preceptors who participated in the workshop to evaluate attitudes concerning the outcomes of the program. RESULTS: Guidelines for the treatment of 14 infectious diseases commonly seen in the primary care setting were formulated. The program was accepted by the participants, who ultimately cooperated with the relevant HMO stakeholders in the formulation of official HMO policies for drug prescribing. CONCLUSION: The utilization of family practice residents is a feasible method of formulating in-house clinical practice guidelines for a managed care setting. The program was mutually beneficial for both the residents and for the stakeholders in the HMO.

Communicable Diseases↗
PubMed1987

[Termination rules in therapeutic trials. Application of sequential methods in 2 clinical trials in hematology].

In haematology, randomized clinical trials often use survival or disease-free interval as response criterion (censored data). For ethical reasons, interim analyses are usually performed, but these interim analyses lead to an increasing Type I error. Sequential methods allow for repeated testing. Three sequential methods are well-adapted to censored data: group sequential analysis, the sequential probability ratio test and the triangular test. The triangular test has the best properties: it allows an early termination of the trial whatever the difference between the treatment groups and without the risk of long duration trials. Sequential analyses can be performed at the same frequency as the usual interim analyses. These three sequential procedures have been applied to the analysis of two cooperative trials in haematology. It appears that the use of sequential methods has to be recommended in the design of randomized clinical trials with a censored response criterion.

Antibiotics, Antineoplastic↗
PubMed2000

Socioeconomic costs of rheumatic diseases. Implications for technology assessment.

OBJECTIVES: To study the socioeconomic impact of rheumatic illness in Sweden and to discuss the consequences for technology assessment studies. METHODS: A cost-of-illness study based on data from official statistics and treatment studies. RESULTS: The total socioeconomic cost was 52 billion Swedish kronor (SEK) in 1994. The imbalance between direct (10% of total) and indirect costs (90 effectiveness of the healthcare sector, the need for new treatment methods, appropriate information systems, and technology assessment studies as well as the institutional arrangements for rehabilitation and basic medical research. CONCLUSIONS: A discussion of solutions for financial cooperation between county councils and regional social insurance offices should be considered. The new biotechnological pharmaceuticals will increase the cost for drugs in health care about 20 times, but the total socioeconomic cost for society may remain at the same level due to a decrease of inpatient costs and indirect costs for loss of production as well as a decrease of transfer payments from social insurance. It is unavoidable that the new pharmaceuticals require priority discussions and active resource allocation in health care and in other sectors of society.

Cost of Illness↗
PubMed1995

[A prospective randomized clinical trial comparing intra-arterial chemotherapy alone and when combined with hyperthermia for metastatic liver cancer].

To evaluate the efficacy of intra-arterial chemotherapy combined with hyperthermia for metastatic liver cancer, our cooperative study group carried out a randomized clinical trial comparing intra-arterial chemotherapy alone and intra-arterial chemotherapy combined with hyperthermia. Patients were treated with combined chemotherapy of epirubicin (EPIR), mitomycin C (MMC), 5-fluorouracil (5-FU), by hepatic infusion using a subcutaneously implanted reservoir. Hyperthermia (8MHz radiofrequency) was usually performed for 40-60 min every week, and intra-arterial chemotherapy was performed immediately before hyperthermia. Twenty-six patients were registered by telephone contact and allocated at random to groups treated with either intra-arterial chemotherapy alone (14 patients) or combination therapy (12 patients). The response rate was 7% in the chemotherapy alone group (1 PR among 14 evaluable patients), and 40% in the combination therapy group (4 PR among 10 evaluable patients). Our results suggest that intra-arterial chemotherapy combined with hyperthermia is a useful modality for the treatment of metastatic liver cancer.

Adult↗
PubMed1987

A breast cancer Nutrition Adjuvant Study (NAS): protocol design and initial patient adherence.

To evaluate the feasibility of using a reduction in dietary fat intake as a component of treatment regimens for patients with resected breast cancer, a multi-disciplinary cooperative group protocol was developed. Females 50 to 75 years of age with stage II breast cancer who completed primary local therapy were eligible for randomization to a Control Dietary Group in which dietary fat intake was to remain unchanged from baseline level (at approximately 38% of calories derived from fat) and an Intensive Intervention Dietary Group designed to reduce dietary fat intake. Both Dietary Groups were given tamoxifen 20 mg/day. To facilitate early experience with dietary regimen delivery, patients entered during an initial pilot phase could receive any chemotherapy and/or hormonal treatment. A prerandomization nutrition 'run-in' of clinically eligible patients assessed adherence to nutrition data collection procedures and screened patients for nutrition eligibility criteria. Of 59 patients beginning 'run-in', 49 were randomized and, at present, 32 have completed at least three months follow-up. The change in dietary fat intake (as assessed by Four Day Food Records) seen in both arms is outlined below. Formula see table. The 56% reduction in total daily fat gram intake achieved in the Intensive Intervention Dietary Group suggests that protocols designed to reduce dietary fat intake in an adjuvant treatment setting can be developed and implemented using a multi-institutional, cooperative group approach.

Adult↗
PubMed1987

Chemotherapy of metastatic seminoma: the Southeastern Cancer Study Group experience.

From 1978 to 1984, 62 patients with advanced seminoma of testicular or extragonadal origin were entered on two consecutive Southeastern Cancer Study Group (SECSG) protocols. All patients had progressive disease and were stratified according to tumor burden. Randomization on SEG 78-GU240 was cisplatin, vinblastine, and bleomycin (PVB), with or without doxorubicin; on SEG 81-GU332, randomization was to PVB or cisplatin, etoposide (VP-16), and bleomycin (PVP16B). Dosages of etoposide, vinblastine, and doxorubicin were decreased by 25% in patients who had received prior radiotherapy. Thirty patients (55%) had received prior chest and/or abdominal radiotherapy. Overall, 41 of 60 evaluable patients (68%) achieved a complete remission (CR) and 37 patients are alive and free of disease. CR was obtained in 13 of 15 patients (87%) with minimal disease, 13 of 16 (81%) with moderate disease, and 15 of 29 (52%) with advanced disease. Patients with no prior radiotherapy or limited-field (chest or abdomen) radiotherapy were more likely to achieve CR than those with prior chest and abdominal radiotherapy (75% v. 42%). Using univariate analysis, the extent of disease is the only significant prognostic factor, whereas both extent of disease and extent of prior radiotherapy are significant in a multivariate analysis. This study confirms the chemosensitivity of metastatic seminoma in a cooperative group setting and defines prognostic factors useful for comparison of other chemotherapeutic trials in seminoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2000

Biweekly irinotecan or raltitrexed plus 6S-leucovorin and bolus 5-fluorouracil in advanced colorectal carcinoma: a Southern Italy Cooperative Oncology Group phase II-III randomized trial.

PURPOSE: The aim of this randomised trial was to evaluate the activity and toxicity of a biweekly regimen including 6S-leucovorin-modulated 5-fluorouracil (LFA-5-FU), combined with either irinotecan (CPT-11 + LFA 5-FU) or raltitrexed (Tomudex) (TOM + LFA-5-FU), in advanced colorectal cancer patients, and to make a preliminary comparison of both these experimental regimens with a biweekly administration of LFA-5-FU modulated by methotrexate (MTX + LFA-5-FU). PATIENTS AND METHODS: One hundred fifty-nine patients with advanced colorectal carcinoma previously untreated for the metastatic disease (34 of them previously exposed to adjuvant 5-FU) were randomly allocated to receive: CPT-11, 200 mg/m2 i.v. on day 1, followed on day 2 by LFA, 250 mg/m2 i.v. infusion and 5-FU, 850 mg/m2 s i.v. bolus (arm A); TOM, 3 mg/m2 i.v. on day 1, followed on day 2 by LFA, 250 mg/m2 i.v. infusion and 5-FU, 1050 mg/m2 i.v. bolus (arm B); or MTX, 750 mg/m2 i.v. on day 1, followed on day 2 by LFA, 250 mg/m2 i.v. infusion and 5-FU, 800 mg/m2 i.v. bolus (arm C). Courses were repeated every two weeks in all arms of the trial. Response rate (RR) was evaluated after every four courses. The sample size was defined to have an 80% power to detect a 35% RR for each experimental treatment, and to show a difference of at least 4% in RR with the standard treatment if the true difference is 15% or more. RESULTS: The RRs were: 34% (95% confidence interval (95%, CI): 21%-48%) in arm A, including 3 complete responses (CRs) and 15 partial responses (PRs), 24% (95% CI: 14%-38%) in arm B, including 2 CRs and 11 PRs, and 24% (95% CI: 14%-38%), with 2 CRs and 11 PRs, in arm C. After a median follow-up time of 62 (range 18-108) weeks, the median time to progression was 38, 25, and 27 weeks for arm A, B, and C, respectively. With 94 patients still alive, the one-year probability of survival was 61%, 54%, and 59%, respectively. WHO grade 3 or 4 neutropenia and diarrhoea affected 46% and 16%, respectively, of patients treated with CPT-11 + LFA 5-FU. Median relative dose intensity over eight cycles (DI8) was 78% for CPT-11 and 82% for 5-FU. Severe toxicities of TOM + LFA-5-FU were neutropenia (16%) and diarrhoea (16%), but median relative DI8 was 93% for TOM, and 82% for 5-FU. CONCLUSIONS: CPT-11 + LFA-5-FU compares favorably in term of activity and toxicity with other combination regimens including CPT-11 and continuous infusional 5-FU. The hypothesis of a RR 15% higher than the MTX + LFA-5-FU treatment can not be ruled out after this interim analysis. The TOM + LFA 5-FU regimen showed a RR and a toxicity profile very close to the MTX + LFA 5-FU combination, and dose not deserve further evaluation in advanced colorectal cancer patients.

Adult↗
PubMed1982

Platelets and malignancy. Rationale and experimental design for the VA Cooperative Study of RA-233 in the treatment of cancer.

Considerable evidence has accumulated in recent years which implicates blood coagulation reactions in the growth and spread of malignancy. In particular, platelets may accumulate on embolic tumor cells and facilitate their adhesion to the endothelium at distant sites perhaps by enhancing blood coagulation reactions. Alternatively, platelets may promote tumor cell proliferation by contributing a growth-promoting factor or through interactions mediated by prostaglandins. Inhibition of tumor growth and spread by platelet-inhibitory drugs has been demonstrated in several experimental tumor systems. Preliminary data suggest that similar effects may be seen in human malignancy. The purpose of this paper is to review relevant literature which provides the rationale for therapeutic trials of platelet-inhibitory drugs in human malignancy and to describe the experimental design for a trial involving one such drug, RA-233, in a recently established VA Cooperative Study.

Adenocarcinoma↗
PubMed2001

Expression of gp100, MART-1, tyrosinase, and S100 in paraffin-embedded primary melanomas and locoregional, lymph node, and visceral metastases: implications for diagnosis and immunotherapy. A study conducted by the EORTC Melanoma Cooperative Group.

With the recent availability of novel antibodies against melanoma antigens tyrosinase and MART-1, it is important to validate their usefulness in pathology practice and in screening patients for immunotherapy treatment. In the present study conducted by the Melanoma Cooperative Group of the European Organization for Research and Treatment of Cancer (EORTC-MCG), immunohistochemical staining for gp100 (antibodies NKI-beteb and HMB-45), MART-1 (A103), tyrosinase (T311), and S100 (S100) was compared on formalin-fixed and paraffin-embedded tumour lesions from 80 patients with 130 malignant melanoma lesions, comprising 44 primary tumours, 18 locoregional metastases, 41 lymph node metastases, and 27 visceral metastases from the lung, liver, and brain. A score between 0 and 5 was allocated to each immunohistochemically stained section. These scores were evaluated in a statistical analysis. S100 was by far the most sensitive marker in all four types of lesions tested. Apart from a significantly better performance for T311 in primary melanomas compared with HMB-45, no significant differences were observed between the four remaining antigens tested. Three settings were next investigated to determine whether the expression of melanoma antigens decreases with tumour progression. First, within the primary melanomas, only NKI-beteb and A103 staining showed a nearly significant negative correlation with Clark's level of invasion and a similar tendency was observed for these antibodies with Breslow thickness. Second, when comparing primary melanoma-metastasis pairs from the same patient, lymph node metastases showed less staining with NKI-beteb, HMB-45, A103, and T311, at a level near significance. This difference was not significant when comparing the primary tumour with visceral metastases, probably due to the lower numbers of pairs. Third, regarding tumour progression from primary melanoma to locoregional, to lymph node, to visceral metastasis, a significant decrease with progression was found only for T311. The apparently stable expression of most of the melanoma antigens, and the small contribution of decreased expression in melanoma tumour progression, supports the rationale for immunotherapy based on the melanoma immunogens gp100, MART-1, and tyrosinase.

Antigens, Neoplasm↗
PubMedDate not supplied

Chemotherapy versus allogeneic transplantation for very-high-risk childhood acute lymphoblastic leukaemia in first complete remission: comparison by genetic randomisation in an international prospective study.

BACKGROUND: The dismal prognosis of very-high-risk childhood acute lymphoblastic leukaemia could be improved by allogeneic haemopoietic cell transplantation. We compared this strategy with intensified chemotherapy protocols, with the aim to improve the outcome of children with very-high-risk acute lymphoblastic leukaemia in first complete remission. METHODS: A cooperative prospective study was set up in seven countries. Very-high-risk acute lymphoblastic leukaemia in first complete remission was defined by the presence of at least one of the following criteria: (1) failure to achieve complete remission after the first four-drug induction phase; (2) t(9;22) or t(4;11) clonal abnormalities; and (3) poor response to prednisone associated with T immunophenotype, white-blood-cell count of 100x10(9)/L or greater, or both. Children were allocated treatment by genetic chance, according to the availability of a compatible related donor, and assigned chemotherapy or haemopoietic-cell transplantation. The primary outcome was disease-free survival and analysis was by intention to treat. FINDINGS: Between April, 1995, and December, 2000, 357 children entered the study, of whom 280 were assigned chemotherapy and 77 related-donor haemopoietic-cell transplantation. 5-year disease-free survival was 40.6% (SE 3.1) in children allocated chemotherapy and 56.7% (5.7) in those assigned transplantation (hazard ratio 0.67 [95% CI 0.46-0.99]; p=0.02); 5-year survival was 50.1% (3.1) and 56.4% (5.9), respectively (0.73 [0.49-1.09]; p=0.12). INTERPRETATION: Children with very-high-risk acute lymphoblastic leukaemia benefit from related-donor haemopoietic-cell transplantation compared with chemotherapy. The gap between the two strategies increases as the risk profile of the patient worsens.

Adolescent↗
PubMedDate not supplied

Sexual division of labor: energetic and evolutionary scenarios.

This article examines comparative energetic data on hunter-gatherers in the context of evolutionary scenarios of the sexual division of labor, with respect to both specific task allocation and overall levels of daily physical activity. The division of labor between men and women, well marked in contemporary foraging societies, was once posited as the "true watershed" for the evolution of the genus Homo. Some research on brain-wiring even links sex differences in cognitive and spatial abilities to sex-specific foraging activities. Most recent evolutionary arguments posit that men focus on hunting and women on gathering activities to realize potentially conflicting mating and parenting goals. A range of cooperative strategies (male/female and female/female) for child provisioning is also under investigation. Attention to energetic and reproductive trade-offs has usefully challenged the proposition that women are excluded from big-game hunting due to constraints of foraging ecology and reproduction. Simplistic assumptions about gender roles are thus increasingly questioned in anthropology, as well as in archaeology. Current models in behavioral ecology explore ways in which foraging practices vary with ecological circumstances, aiming to derive testable hypotheses from fine-grained data on the behavior of contemporary hunter-gatherers. Data on overall physical activity levels (PAL) can also serve to evaluate relative male/female workloads in modern groups, reconstruct hominid energy requirements and activity profiles, and examine changes with subsistence intensification. Male/female PAL ratios show that a task-specific division of labor does not readily extrapolate to 24-hour energy expenditure and that male/female differences in workloads were not necessarily reduced with the transition to agriculture. With respect to gender roles and PAL, a shift away from facile stereotypes of human behavior is evident. The challenge is to incorporate a range of behavioral responses to ecological circumstances in reconstructions of our evolutionary past.

Animals↗
PubMed1992

Global considerations affecting the health agenda of the 1990s.

The author explains why global problems, both known and unknown and unpredictable, are going to affect the health sector in the next few decades even more than they do today. Five examples are given of global health-related dilemmas that must be faced: (1) the worldwide aging of the population and the changing morbidity trends and physician supply needs this creates; (2) rising worldwide poverty, which has a direct relation to health status and has some new causes in this century; (3) ethical dilemmas, such as those resulting from new reproductive and life-prolonging technologies; (4) the need for adequate and affordable health care systems (the Canadian system is described and several misconceptions about it are clarified); and (5) the need to allocate scarce resources to meet practically infinite health care demands. The author concludes by listing some of the important actions that must be taken if we are to deal effectively with the dilemmas fostered by global problems: (1) people must be taught that their health status is the result of many factors in addition to their health care (e.g., socioeconomic status, lifestyle, the environment); (2) medical education must be refocused to prepare physicians to deal with global challenges; (3) there must be greater international cooperation (e.g., working together to share research and implement strategies to control AIDS); (4) countries must invest in worldwide efforts, such as family planning and primary education; and (5) international partnerships must be created to develop worldwide strategies, such as a global drug strategy.

Aging↗
PubMed1992

Public-private partnerships: the Connecticut model for financing long-term care.

Responses to the growing crisis in long-term care financing have included efforts to negotiate partnerships between the private and public sectors for the purpose of developing innovative models for long-term care insurance. One such set of models has been encouraged by support from the Robert Wood Johnson Foundation's "Long Term Care Insurance Program" grants. The Connecticut Partnership for Long Term Care uses a cooperative approach to encourage the development of private sector long-term care insurance products that are integrated with Medicaid eligibility determinations. The Connecticut model is described, accompanied by a history of its development, and a comparison is made with other models currently under consideration by national policy analysts.

Connecticut↗