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PubMed2006

Efficacy of the combination of cisplatin with either gemcitabine and vinorelbine or gemcitabine and paclitaxel in the treatment of locally advanced or metastatic non-small-cell lung cancer: a phase III randomised trial of the Southern Italy Cooperative Oncology Group (SICOG 0101).

BACKGROUND: Triplet regimens were occasionally reported to produce a higher response rate (RR) than doublets in locally advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was conducted to assess (i) whether the addition of cisplatin (CDDP) to either gemcitabine (GEM) and vinorelbine (VNR) or GEM and paclitaxel (PTX) significantly prolongs overall survival (OS) and (ii) to compare the toxicity of PTX-containing and VNR-containing combinations. PATIENTS AND METHODS: Stage III or IV NSCLC patients were randomly assigned to (i) GEM 1000 mg/m(2) and VNR 25 mg/m(2) on days 1 and 8 (GV arm); (ii) GEM 1000 mg/m(2) and PTX 125 mg/m(2) on days 1 and 8 (GT arm); (iii) GV plus CDDP 50 mg/m(2) on days 1 and 8 (PGV arm); and (iv) GT plus CDDP 50 mg/m(2) on days 1 and 8 (PGT arm). Treatments were repeated every 3 weeks for a maximum of six cycles. RESULTS: A total of 433 (stage III, 160; stage IV, 273) patients were randomly allocated to the study. RR was 48% [95% confidence interval (CI), 42% to 54%] for triplets and 35% (95% CI, 32% to 38%) for doublets (P = 0.004). Median progression-free survival (6.1 versus 5.5 months, P = 0.706) and median OS (10.7 versus 10.5 months, P = 0.379) were similar. CDDP significantly increased the occurrence of severe neutropenia (35% versus 13%), thrombocytopenia (14% versus 4%), anaemia (9% versus 3%), vomiting (6% versus 0.5%), and diarrhoea (6% versus 2%). Conversely, frequency of severe neutropenia (30% versus 17%) and thrombocytopenia (11% versus 6%) was significantly higher with VNR-containing regimens. CONCLUSIONS: Adding CDDP to GV or GT significantly increased RR, but did not prolong the OS of patients. Among doublets, the GT regimen should be preferred in view of its better safety profile.

Adenocarcinoma↗
PubMed1982

Can dropout and other noncompliance be minimized in a clinical trial? Report from the Veterans Administrative National Heart, Lung and Blood Institute cooperative study on antihypertensive therapy: mild hypertension.

Long-term clinical trials must face the problem of participants who drop out before the study is closed or who in other ways do not comply with the protocol. In a joint Veterans Administration-National Heart, Lung and Blood Institute study of mild hypertension, 1,012 men and women, 21 to 50 years of age with diastolic pressure from 85 to 105 mm Hg, were randomized into two double-blind treatment groups and followed for up to 30 months. The data were analyzed for factors related to dropout and to medication and visit noncompliance. Large differences in dropout and compliance rates were found by clinic and age but not by treatment allocations (active vs. placebo) nor race-sex. In addition, noncompliance was 78%-118% higher in participants who subsequently chose to drop out of the study. Indications were that the attitude of a clinic towards participant complaints, willingness to temporarily reduce medication and vigorous pursuit of those who failed to keep appointments were important factors in reducing dropout. Strategies for minimizing dropout and noncompliance must be part of the study protocol, clinic personnel should be trained in using such strategies, and both clinic and participant compliance should be centrally monitored.

Adult↗
PubMed1991

The Canadian cooperative trial of cyclophosphamide and plasma exchange in progressive multiple sclerosis. The Canadian Cooperative Multiple Sclerosis Study Group.

To find out whether non-specific immunosuppression is beneficial in multiple sclerosis (MS) a randomised, placebo-controlled, single-masked trial was carried out in nine university centres. 168 patients with clinically or laboratory-supported definite MS in progressive phase (deterioration by at least 1.0 on the expanded disability status scale [EDSS] in the previous year) were randomised to receive intravenous cyclophosphamide and oral prednisone (n = 55); daily oral cyclophosphamide, alternate day prednisone (22 weeks), and weekly plasma exchange (20 weeks) (n = 57); or placebo medications and sham plasma exchange (n = 56). All patients were followed for at least 12 months (mean 30.4 months) by a monitoring neurologist, who was aware of treatment allocation, and an evaluating neurologist, who was not. The primary analysis was a comparison of rates of treatment failure (worsening of evaluating neurologist's assessment of EDSS by 1.0 or more on two consecutive 6-monthly assessments). There were no significant differences among the groups in this primary analysis (19 [35%] treatment failures with cyclophosphamide; 18 [32%] with plasma exchange; 16 [29%] with placebo). Nor were there any differences in the proportions improved, stabilised, or worsened at each 6 month assessment or in the mean change in the EDSS at the final assessment (0.81 cyclophosphamide; 0.69 plasma exchange; 0.69 placebo). A slight trend favouring the plasma exchange group at 12-24 months of follow-up was not sustained at the final assessment. This study fails to confirm previous reports that immunosuppressive treatments result in stabilisation or improvement in progressive MS.

Adult↗
PubMed2006

Cost-effectiveness of drug-eluting stents: real-world scrutiny of the BASKET trial of real-world usage.

This editorial examines incremental cost-effectiveness analysis as a decision-making tool to guide the allocation of scarce financial resources. BASKET (Basel Stent Kosten Effektivitats Trial) evaluated the cost-effectiveness of drug-eluting stents in a real-world setting. Results of this study are examined in relation to similar assessments and alternative plausible assumptions are explored and presented in the context of real-world sensitivity analysis.

Angioplasty, Balloon, Coronary↗
PubMed1988

Principles and methods of managerial cost-accounting systems.

An introduction to cost-accounting systems for pharmacy managers is provided; terms are defined and examples of specific applications are given. Cost-accounting systems determine, record, and report the resources consumed in providing services. An effective cost-accounting system must provide the information needed for both internal and external reports. In accounting terms, cost is the value given up to secure an asset. In determining how volumes of activity affect costs, fixed costs and variable costs are calculated; applications include pricing strategies, cost determinations, and break-even analysis. Also discussed are the concepts of direct and indirect costs, opportunity costs, and incremental and sunk costs. For most pharmacy department services, process costing, an accounting of intermediate outputs and homogeneous units, is used; in determining the full cost of providing a product or service (e.g., patient stay), job-order costing is used. Development of work-performance standards is necessary for monitoring productivity and determining product costs. In allocating pharmacy department costs, a ratio of costs to charges can be used; this method is convenient, but microcosting (specific identification of the costs of products) is more accurate. Pharmacy managers can use cost-accounting systems to evaluate the pharmacy's strategies, policies, and services and to improve budgets and reports.

Accounting↗
PubMed1983

Lack of potentiation of vincristine-induced neurotoxicity by VP-16-213.

Due to a recent alarming report suggesting that the severe neurotoxicity observed following treatment with a multiagent chemotherapy regimen might be due to the interaction of vincristine and VP-16-213, the neurologic toxicity data from a randomized trial conducted by the Bowman Gray School of Medicine and the Piedmont Oncology Association in small cell carcinoma of the lung have been analyzed. Of 102 patients evaluable for toxicity, 50 were treated with a combination of cyclophosphamide, adriamycin, and vincristine (CAV) and 52 received this regimen plus VP-16-213. Vincristine dosage was the same in both arms of the study. When analyzed by severity, neurologic complications were similar in both treatment groups: Grade 1-2 neurotoxicity occurred in 55% of patients on both arms and grade 3-4 neurotoxicity was observed in six (12%) patients on the CAV arm and four (8%) on the CAV-VP-16-213 arm. Addition of VP-16-213 to vincristine did not potentiate vincristine-induced neurotoxicity when administered in this dose-schedule relationship.

Adult↗
PubMed1985

Comparative growth and biochemical response of very low birthweight infants fed own mother's milk, a premature infant formula, or one of two standard formulas.

Very low birthweight (VLBW) infants weighing less than 1,600 g at birth were fed their own mother's milk (OMM) or randomly assigned to receive one of three formulas: a "humanized" formula (SF), a partially modified casein-predominant cow's milk formula (CF), or a premature formula (PF). All infants were fed at 120 kcal/kg/day where possible. PF infants had significantly greater weight increments (28.0 g/day) than those on OMM (19.4 g/day), SF (18.9 g/day), and CF (18.2 g/day). Those on PF also had greater increments of length, head circumference, and skin-fold thickness than those on the other two formulas and greater length increments than those on OMM. Dynamic skinfold measurements suggested that no infants accumulated excessive amounts of interstitial fluid. Infants on the two standard formulas had significantly greater base deficits, whereas those on CF also had higher urea values. Those on OMM had lower phosphate and higher alkaline phosphatase values than the other groups. Thus VLBW infants fed a premature formula had better growth and fewer biochemical problems than those on standard formulas, whereas supplementation of OMM may be necessary to ensure optimal growth and bone mineralization.

Alkaline Phosphatase↗
PubMed2003

The prognostic relevance of estimates of proliferative activity in early breast cancer.

AIMS: Immunohistochemical estimates of cell proliferation evaluated with MIB-1 antibody have been suggested as prognostic indicators in different types of carcinoma. This study investigates whether MIB-1 scores add additional prognostic impact when evaluated together with classical clinicopathological parameters at diagnosis in early breast cancer patients. MATERIALS AND METHODS: Tumour specimens from 365 consecutively treated breast cancer patients were immunostained for MIB-1 and evaluated under the microscope using systematic random sampling accomplished by the CAST-grid system. RESULTS: The systematic random sampling technique resulted in MIB-1 estimates with very high interobserver and intraobserver reproducibilities (P < 0.0001). Median MIB-1 was 16% (range 0-83%). Patients were stratified by MIB-1 in tertiles, and increasing MIB-1 was significantly associated with poor overall and disease-specific survival in node-positive patients, but not in node-negative patients. High MIB-1 was significantly related to large tumour size, and strongly associated with high grade, high mitotic score, negative oestrogen receptor status and young age. In multivariate analysis, both with and without malignancy grade and number of mitoses included in the analysis, MIB-1 estimates showed no independent prognostic impact. CONCLUSIONS: High MIB-1 estimates did not add independent prognostic information at diagnosis when evaluated together with classical prognostic markers of early breast cancer.

Adult↗
PubMed1986

Extracranial-intracranial bypass surgery: a critical analysis in light of the International Cooperative Study.

The ability of extracranial-intracranial bypass surgery to alter favorably the natural history of ischemic cerebrovascular disease remains in question. A recently completed prospective randomized multicenter cooperative trial failed to confirm the hypothesis that the procedure prevents further cerebral ischemia in patients with atherosclerotic internal carotid artery or middle cerebral artery disease. We analyze findings of the study in detail, including possible effects on the natural history of the disease beyond the immediate perioperative period. Potential sources of bias that may have unpredictably affected the study are discussed. These include observational bias (patient and therapist not blinded), "randomization-to-treatment" bias (high morbidity after randomization but before operation), and "prerandomization" or allocation bias (patients in the study representing a selected sample of the population with cerebrovascular disease). The extensive analysis of secondary subgroups with small numbers of patients is discussed in light of the statistical methods used. Two particular classes of patients not addressed in the study who might benefit from the procedure are defined. They are patients failing the best available medical therapy and patients with clearly documented hemodynamic compromise. Possible indications for bypass surgery are suggested for the various lesions in light of the trial and of recent reports on the natural history and pathophysiology of ischemic cerebrovascular disease. Selected cases illustrating these indications are presented.

Adult↗
PubMed1983

A comparative study of bupropion and amitriptyline in depressed outpatients.

A double-blind controlled trial comparing a standard antidepressant drug, amitriptyline, with a new compound, bupropion, was conducted at six centers. There was a placebo washout, after which patients were assigned in a randomized fashion to one of the two treatments. No significant difference was found in therapeutic response to the two drugs after 4 weeks of treatment. Anticholinergic and cardiovascular side effects were less common in the bupropion-treated patients.

Adolescent↗
PubMed2004

Inhibitory effect of methylation inhibitor 5-aza-2-deoxycytidine on bile duct cancer cell line in vivo and in vitro.

BACKGROUND: Since the resection rate is low for bile duct cancer and the drugs used for chemotherapy are less effective, we studied the inhibitory effects of 5-aza-2-deoxycytidine (ZdCyd) on bile duct cancer cell line QBC939 in vivo and in vitro and its possibility in clinical treatment. METHODS: The survival and apoptosis rates of QBC939 after treatment with different dose of ZdCyd were detected by methyl thiazoy tetrazolium (MTT) and flow cytometry. The cooperative effect of ZdCyd with other chemotherapeutic drugs was also studied with MTT. The cancer cells were transplanted into nude mice, which were pre-treated with ZdCyd after tumor occurrence. RESULTS: ZdCyd decreased the cell survival rate, blocked the cell cycle at G1 phase, and increased the apoptosis rate. These effects were dose and time-dependent. ZdCyd also increased the anti-tumor effects of other chemotherapeutic drugs when used in combination. The tumor occurrence rate was lower in the ZdCyd pre-treated cells than in the untreated cells in nude mice, and ZdCyd was found to inhibit tumor growth. CONCLUSION: ZdCyd can inhibit the growth of QBC939 in vivo and in vitro through induction of cell apoptosis and has the cooperative effect on bile duct cancer cell when it is used with other chemotherapeutic drugs.

Animals↗
PubMed1985

[Coronary disease. Medical or surgical treatment?].

Aortocoronary bypass procedures have been proven to be effective in relieving angina pectoris. Whether the procedure actually prolongs life, on the other hand, still remains a matter of controversy. Many prospective and randomized studies have been undertaken in Europe and in the United States on this subject. The results of 6 of these studies are reported and discussed: the Seattle Heart Watch, the Veterans Administration Study, the Cooperative American Study on Unstable Angina, the Cooperative European Study on Coronary Artery Surgery, results of findings from Duke University, and the randomized Coronary Artery Surgery Study. Analysis of results of these prospective studies is of value in establishing a therapeutic approach to coronary artery disease.

Angina, Unstable↗
PubMedDate not supplied

The effects of fendosal, aspirin and placebo on postoperative dental pain. A dose-ranging and efficacy study.

The purpose of this study was to characterize the analgesic dose-effect curve of orally administered fendosal, relative to aspirin 650 mg and placebo. A total of 153 patients experiencing moderate to severe pain due to extraction of impacted molar teeth completed this two-part, single-dose, double-blind, randomized trial. In part I, the possible treatments were placebo, aspirin 650 mg, fendosal 100 mg and fendosal 200 mg. In part II, fendosal 400 mg replaced the fendosal 100 mg treatment. A nurse-observer collected subjective reports of pain intensity and relief at 30 minutes and hourly for eight hours. Fendosal 100 mg was not an analgesic dose but 200 and 400 mg were on the ascending portion of the dose-effect curve. Fendosal 200 mg was superior to placebo and about equal to aspirin in total effect but not peak effect. Fendosal 400 mg was statistically superior to both fendosal 200 mg and placebo. Fendosal 400 mg appears to provide analgesia similar to that of aspirin 650 mg but with a substantially longer duration. Only a few mild side effects were reported.

Adolescent↗
PubMed1997

Relative contributions of advanced glycation and nitric oxide synthase inhibition to aminoguanidine-mediated renoprotection in diabetic rats.

Advanced glycation end products (AGEs) have previously been shown to be increased in the diabetic kidney. Aminoguanidine, an inhibitor of advanced glycation, has been shown to attenuate the development of AGEs as well as the progression of renal disease in experimental diabetes. However, the precise mechanisms through which aminoguanidine acts remain to be elucidated since it is also able to act as an inhibitor of nitric oxide synthase (NOS). This study has therefore compared the effects of aminoguanidine with the effects of two other inhibitors of NOS, L-NAME and methylguanidine, on the development of experimental diabetic nephropathy. Diabetic rats were randomised to receive no treatment, aminoguanidine (1 g/l in drinking water), L-NAME (5 mg/l in drinking water) or methylguanidine (1 g/l in drinking water). Diabetic rats had increased levels of albuminuria and urinary nitrite/nitrate excretion when compared to control rats. Renal AGEs measured by fluorescence as well as by a carboxymethyllysine reactive radioimmunoassay, were elevated in diabetic rats. No changes in inducible NOS (iNOS) protein expression were detected in experimental diabetes nor did aminoguanidine affect iNOS expression. Aminoguanidine did not affect blood glucose or HbA1c but it did prevent increases in albuminuria, urinary nitrites/nitrates and renal AGE levels as measured by fluorescence and radioimmunoassay. L-NAME and methylguanidine did not retard the development of albuminuria, nor did they prevent increases in renal AGE levels, as assessed by fluorescence. However, these treatments did prevent increases in AGEs, as measured by radioimmunoassay. This study indicates that the renoprotective effect of aminoguanidine in experimental diabetes cannot be reproduced by L-NAME or methylguanidine. It is likely that the effect of aminoguanidine is mediated predominantly by decreased AGE formation rather than via NOS inhibition. It also raises the possibility that inhibition of fluorescent AGE formation may be more renoprotective than inhibition of the formation of carboxymethyllysine-containing AGEs.

Administration, Oral↗
PubMed1991

Public and private donor financing for health in developing countries.

Among the many variables that influence the outcome of national health status in both developed and developing countries, the availability and efficiency of financing is critical. For 148 developing countries, annual public and private expenditures from domestic sources (1983) were estimated to be approximately $100 billion. For the United States alone, annual public and private costs for medical care are almost five times larger ($478 billion, 1988). In contrast to domestic expenditures, the total flow of donor assistance for health in 1986 was estimated to be $4 billion, approximately 5% of total current domestic expenditures by developing countries. Direct donor assistance for development purposes by the United States Government approximates 0.5% of the US federal budget (1988). Approximately 10% of all United States development assistance is allocated for health, nutrition, and population planning purposes. While the total health sector contribution is on the order of $500 million annually, the US contribution represents about 13% of health contributions by all external donors. In sub-Saharan Africa, all donor health allocations only reach 3.4% of total development assistance. While available data suggest that private and voluntary organizations contribute approximately 20% of total global health assistance, data reporting methods from private agencies are not sufficiently specific to provide accurate global estimates. Clearly, developing countries as a whole are dependent on the efficient use of their own resources because external financing remains a small fraction of total domestic financing. Nevertheless, improvement in health sector performance often depends on the sharing of western experience and technology, services available through external donor cooperation. In this effort, the available supply of donor financing for health is not restricted entirely by donor policy, but also by the official demand for external financing as submitted by developing countries. In perspective, the supply of financing for health greatly exceeds the receipt of well-articulated and officially approved proposals from developing countries. The major constraints that produce this imbalance are unfamiliarity of ministries of health with potential donor sources; passive approaches to external financing; unfamiliarity with proposal preparation; increasing competition within developing countries by competing sectors, such as industry and agriculture; limited numbers of trained personnel; and absence of an international system which is able to support developing countries in mobilizing external financing. Tested solutions to these issues have been applied in one geographic region.(ABSTRACT TRUNCATED AT 400 WORDS)

Delivery of Health Care↗
PubMed2003

Use of the TOMM in a criminal court forensic assessment setting.

Use of the Test of Memory Malingering (TOMM) in a criminal court forensic assessment setting was examined. Results indicated that those initially suspected of cognitive malingering and, thus, administered the TOMM, differed from others in this setting in ways that are consistent with descriptions of suspected cognitive malingerers in the existing literature. These defendants' TOMM scores were also consistent with those reported in samples characterized by relatively high base rates of cognitive malingering. Defendants whose TOMM scores met the recommended criteria for detecting malingering (n = 29) were more likely to report a previous head injury, to be viewed as only marginally cooperative or uncooperative during the course of the evaluation, and to be diagnosed with antisocial personality disorder than those who did not generate suspicious TOMM scores.

Adult↗
PubMed2001

Evaluation of ILAR classification criteria for juvenile idiopathic arthritis in Spanish children.

OBJECTIVE: To evaluate the proposed International League of Associations for Rheumatology (ILAR) classification criteria for juvenile idiopathic arthritis in a cohort of Spanish children. METHODS: One hundred twenty-five patients with chronic arthritis were categorized according to one of the traditional classifications and the proposed ILAR classification system after at least 6 months of disease. The traditional classifications included the European League Against Rheumatism (EULAR) criteria for pauciarticular, polyarticular rheumatoid factor (RF) negative, and systemic juvenile chronic arthritis (JCA), as well as for RF+ polyarthritis; the Vancouver criteria for juvenile psoriatic arthritis (JPsA); and the European Spondylarthropathy Study Group (ESSG) preliminary criteria for juvenile spondyloarthropathy (JSpA). RESULTS: The ILAR criteria classified 106/125 patients (84.8%). All patients with systemic and polyarticular JCA, RF+ polyarthritis, and definite juvenile psoriatic arthritis were reclassified in the corresponding ILAR category. In contrast, only 80% of pauciarticular JCA and 47% of JSpA patients could be allocated to the ILAR oligoarthritis (47/59 patients, 35 persistent and 12 extended) and enthesitis related arthritis (ErA. 8/17 patients) categories. Two children with probable PsA were reclassified in the RF- polyarthritis category. Nineteen patients (15.2%) were allocated to the ILAR "other arthritis" group, 13/19 because they did not fulfill criteria for any of the other categories (12 due to family history of psoriasis and one because of family history of HLA-B27 associated disease). The remaining 6 patients met criteria for 2 categories, RF- polyarthritis and either ErA (n = 5) or PsA (n = 1). No differences other than family history of psoriasis were found in any of the variables studied between pauciarticular JCA patients classified in the oligoarthritis (n = 47) and those in the "other arthritis" (n = 11) ILAR categories. CONCLUSION: The proposed ILAR criteria allocated 84.8% of the patients classified by traditional criteria. Family history of psoriasis (n = 12) and polyarticular onset of disease in patients with ErA (n = 5) were responsible for most of the exclusions from other ILAR categories.

Adolescent↗
PubMed1990

Discrimination between adaptive and neutral amino acid substitutions in vertebrate hemoglobins.

A discriminant analysis on the basis of the physicochemical properties of amino acid residues is developed to investigate the accumulation pattern of amino acid substitutions in a family of proteins. The application of this analysis to vertebrate hemoglobins reveals the following new results. (1) The major components of teleost fish and amphibian hemoglobins showing the Root effect are sharply discriminated from mammalian hemoglobins in several regions of the alpha and beta chains, whereas shark, minor components of teleost fish and amphibian, reptile, and bird hemoglobins showing no Root effect exhibit a gradual change to mammalian hemoglobin in a straightforward way. This result suggests at least two lines of molecular evolution in vertebrate hemoglobins. (2) The nonadult hemoglobin chains are allocated to the latter line, i.e., tadpole, zeta, and pi chains are similar to shark and trout I chains, and epsilon and gamma chains are similar to some of the reptile chains. (3) In any case, most of the amino acid residues causing the discrimination are located near the sites that carry the amino acid residues conserved well throughout all classes of vertebrates, suggesting that modifications adapting to the respective living conditions or respiratory organs have taken place effectively near the amino acid residues essential for the manifestation of cooperative oxygen binding. (4) The amino acid residues at other sites are changed from one to another species even within the same class, showing a constant substitution rate as a whole. These amino acid substitutions may be nearly neutral, being under a weak functional constraint. The number of sites allowing such neutral substitutions is rather small, less than one-half of all the sites in the adult hemoglobins of bird and mammal, whereas it amounts to two-thirds in teleost fish hemoglobins.

Amino Acid Sequence↗