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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

One hundred ninety-three asymptomatic patients with hereditary coagulation disorders and human immunodeficiency virus (HIV) infection were studied in a controlled trial of zidovudine (ZDV) versus a placebo (with an average of 9.7 months on study). Pretreatment characteristics were well balanced between the placebo and drug-treated groups, including CD4 distributions, types of clotting disorders, transaminase abnormalities, and use of various hemostatic agents. At the time of analysis, 161 patients either were still receiving treatment or had previously reached an endpoint of disease progression while receiving treatment. Twenty-five patients withdrew voluntarily. The toxic effects noted included granulocytopenia and anemia, especially in older patients, and subjective symptoms of asthenia, malaise, and nausea, consistent with the known consequences of treatment with 300 mg ZDV five times daily. There was a trend toward more diagnoses of acquired immunodeficiency syndrome (AIDS), advanced or early AIDS-related complex (ARC), single ARC symptoms, or death in placebo recipients as compared with those receiving ZDV (22 v 13). Because older patients with hemophilia have more rapid disease progression, the same efficacy analysis was performed in the 89 patients aged more than 30 years who were receiving treatment. In this subgroup, there was a similar trend (11 v 6). With regard to the most advanced problems of the infection among the older patients, there were five patients who were newly diagnosed with AIDS or died in the placebo group versus none in the ZDV group (P = .02) among the older patients. The pretreatment distribution of CD4 counts for the placebo and ZDV groups were similar, but patients aged more than 30 years had significantly (P less than .049) fewer CD4 cells than patients aged less than 30 years. A beneficial ZDV effect is also supported by a trend toward higher CD4 counts (a 48-cell increase in the ZDV group at 24 weeks as compared with a four-cell increase in the placebo group) and a significant (P = .03) difference in weight gain in the ZDV patients aged more than 30 years (8 pounds) as compared with the older placebo patients (aged more than 30 years) (2 pounds) at week 24. The findings in the asymptomatic hemophilic patients aged more than 30 years support a useful effect of ZDV, which is similar to observations in the larger study of its use in asymptomatic, nonhemophilic patients.
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PMID:Placebo-controlled trial to evaluate zidovudine in treatment of human immunodeficiency virus infection in asymptomatic patients with hemophilia. NHF-ACTG 036 Study Group. 183 Oct 59

The chemistry, pharmacology, pharmacokinetics, assay methodologies, adverse effects, and dosage of levamisole are described, and the clinical studies of levamisole therapy in patients with colorectal carcinoma are reviewed. Levamisole is a synthetic, orally active agent that has antihelmintic and immunomodulatory properties. It is capable of inducing T-cell differentiation and restoring depressed effector functions of peripheral lymphocytes and phagocytes to normal. The drug is well absorbed from the gastrointestinal tract after oral administration and is extensively metabolized by the liver. Gas chromatography and high-performance liquid chromatography are the most common methods used to measure concentrations of levamisole in biologic fluids. Levamisole combined with fluorouracil has been associated with a one-third reduction in recurrence and risk of death in patients with surgically resected Dukes stage C colon cancer; this combination is now recommended as standard therapy in these patients. Uses in patients with rectal carcinoma, Dukes stage B colon cancer, metastatic colon cancer, other malignancies, or nonmalignant disorders remain investigational. Common adverse effects include nausea, abdominal pain, vomiting, diarrhea, metallic or altered taste, flulike symptoms, mood elevation, insomnia, hyperalertness, dizziness, and headache. The most serious adverse effect associated with levamisole is granulocytopenia. The FDA-approved dosage of levamisole is 50 mg orally every eight hours for three days every two weeks. Levamisole therapy is to be initiated no earlier than 7 and no later than 30 days after surgery and is to be continued for one year. Levamisole combined with fluorouracil has been associated with a one-third reduction in recurrence and risk of death in patients with resected stage C colon cancer. Further research is needed to more clearly define the mechanism of action, optimum dose and scheduling, and clinical efficacy of levamisole in treating other malignancies.
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PMID:Levamisole in the adjuvant treatment of colon cancer. 200 37

Ranitidine was first marketed in 1981; since then many patients have been treated such that much experience has been accumulated on the safety of this histamine H2-receptor antagonist in the treatment of gastroduodenal disease. A wide array of ranitidine-associated side effects has been described, but infrequently. As so much information is now available, the aim of this review is to assess the weight of evidence for a causal link between ranitidine and the reported side effects. Overall, ranitidine is well tolerated. The incidence of general side effects at less than 2% is very similar to placebo. Headaches, tiredness, dizziness and mild gastrointestinal disturbance (e.g. diarrhoea, constipation and nausea) are among the most frequent complaints, but have very seldom resulted in stopping treatment. Cardiovascular side effects are extremely rare and unpredictable with the usual doses of oral ranitidine (at most 1 in 1 million patients). They mostly comprise sinusal bradycardia and atrioventricular blockade, especially after rapid intravenous administration, receding after cessation of the drug. Clinical studies, however, have not shown a significant pharmacological effect of ranitidine on the cardiovascular system via H2-receptors, even though individual sensitivities cannot be ruled out in a few isolated reports. Ranitidine is unlikely to be directly hepatotoxic: a transient change in liver function tests has been noted in only 1 in 100 to 1 in 1000 patients. Several cases of mixed hepatitis have been reported, but very few were fully documented. The incidence of ranitidine-associated acute hepatitis has been estimated to be less than 1 in 100,000 patients. Neuropsychiatric complications may be less common and clinically quite similar to those reported with cimetidine, i.e. confusion, disorientation, hallucinations, delirium. These side effects have occurred especially in critically ill and multiple-therapy patients, or patients with chronic renal or hepatic failure, so that the direct causal link with ranitidine treatment was often difficult to ascertain. Even though an H2-receptor-mediated effect is an attractive hypothesis (since similar complications were noted with other H2-receptor antagonists), other mechanisms have been suggested to play a role, e.g. cholinergic or histaminic effects. The overall incidence of neuropsychiatric complications is probably markedly less than 1%. White cell injury (i.e. agranulocytosis) appears to be the most frequent haematological complication, even though case reports are very few and poorly documented.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Side effects of ranitidine. 204 87

The new fluorinated adenine analog, fludarabine, has been tested for efficacy in many tumor types over the past ten years. Two other similar nucleoside analogs are currently available for commercial use. Cytarabine is used principally as an antileukemic agent, and vidarabine as an antiviral. Unlike vidarabine, fludarabine is resistant to deactivation by adenosine deaminase. Data from Phase I and II trials suggest that fludarabine is potentially effective in a number of leukemias, including acute lymphocytic leukemia, acute nonlymphocytic leukemia, and chronic lymphocytic leukemia (CLL). Unfortunately, the doses required to achieve adequate response in the acute leukemias (greater than 75 mg/m2) were above the maximum tolerated dose, resulting in intolerable granulocytopenia, thrombocytopenia, and a life-threatening neurotoxic syndrome. In CLL: however, the dose required to achieve a satisfactory response is well within tolerated limits. Long-term survival statistics are not yet available, but historical perspective strongly correlates response to other agents with increased survival times. Toxicities seen at dose regimens of 15-40 mg/m2/d for five consecutive days include somnolence, metabolic acidosis, confusion, fatigue, nausea, vomiting, increase in serum creatinine and aminotransferase concentrations, and pulmonary and hepatic abnormalities. Mild to severe hematologic toxicity has been observed at all dose levels.
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PMID:Fludarabine: a review. 206 37

A Phase I study of intravenous (IV) bolus 4'-0-tetrahydropyranyladriamycin (Pirarubicin) was done in 55 patients in good performance status with refractory tumors. Twenty-six had minimal prior therapy (good risk), 23 had extensive prior therapy (poor risk), and six had renal and/or hepatic dysfunction. A total of 167 courses at doses of 15 to 70 mg/m2 were evaluable. Maximum tolerated dose in good-risk patients was 70 mg/m2, and in poor-risk patients, 60 mg/m2. The dose-limiting toxic effect was transient noncumulative granulocytopenia. Granulocyte nadir was on day 14 (range, 4-22). Less frequent toxic effects included thrombocytopenia, anemia, nausea, mild alopecia, phlebitis, and mucositis. Myelosuppression was more in patients with hepatic dysfunction. Pharmacokinetic analyses in 21 patients revealed Pirarubicin plasma T 1/2 alpha (+/- SE) of 2.5 +/- 0.85 minutes, T beta 1/2 of 25.6 +/- 6.5 minutes, and T 1/2 gamma of 23.6 +/- 7.6 hours. The area under the curve was 537 +/- 149 ng/ml x hours, volume of distribution (Vd) 3504 +/- 644 l/m2, and total clearance (ClT) was 204 + 39.3 l/hour/m2. Adriamycinol, doxorubicin, adriamycinone, and tetrahydropyranyladriamycinol were the metabolites detected in plasma and the amount of doxorubicin was less than or equal to 10% of the total metabolites. Urinary excretion of Pirarubicin in the first 24 hours was less than or equal to 10%. Activity was noted in mesothelioma, leiomyosarcoma, and basal cell carcinoma. The recommended starting dose for Phase II trials is 60 mg/m2 IV bolus every 3 weeks.
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PMID:A phase I study of 4'-0-tetrahydropyranyladriamycin. Clinical pharmacology and pharmacokinetics. 222 62

Neutropenic enterocolitis is a recognized complication of immunosuppression or chemotherapy for leukemia. It presents as severe abdominal pain and tenderness, fever, and diarrhea associated with granulocytopenia. Gastrointestinal symptoms associated with chemotherapy for head and neck neoplasms include nausea and emesis, but not acute abdominal distress. We present, to our knowledge, the first case of neutropenic enterocolitis in a patient receiving cisplatin and fluorouracil chemotherapy for metastatic head and neck cancer.
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PMID:Neutropenic enterocolitis. A new complication of head and neck cancer chemotherapy. 229 18

A prospective study was performed to evaluate the feasibility of full dose chemotherapy given on schedule in elderly patients with unfavourable non-Hodgkin's lymphoma, stage IE, III and IV. Using a combination regimen of six courses of cyclophosphamide, mitoxantrone, vincristine and prednisone (CNOP) given every 4 weeks, no serious toxicity was encountered in a group of 30 consecutive patients with a mean age of 70.4 years. A 60% complete response rate was observed and a total response rate of 90%. The disease-free survival of complete responders was 50% at 1 year. The overall survival was also 50% at 1 year. In 148 courses of CNOP only two serious infectious episodes were noted, i.e. one herpes zoster infection and one case of bronchopneumonia. Asymptomatic transient thrombocytopenia and granulocytopenia were commonly observed. Nadirs of white blood cells were WHO grade 1, 2, 3 and 4 in six, five, twelve and two patients respectively and nadirs of thrombocytopenia were WHO grade 0 and 1 (22 patients) or 2 (three patients). Based on low white blood cell counts, a delay of 1 week before administration of the next course of CNOP was necessary in 7% of the courses. No dose reductions were applied. Toxicity other than transient granulocytopenia was minor and consisted of alopecia and nausea. WHO grade 0-2. CNOP related toxicity was never a reason to stop treatment. It is concluded that CNOP chemotherapy without initial dose reduction in elderly patients with intermediate and high grade malignant non-Hodgkin's lymphoma is feasible and that no major toxicity is observed.
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PMID:Full dose chemotherapy in elderly patients with non-Hodgkin's lymphoma: a feasibility study using a mitoxantrone containing regimen. 239 Apr 69

A total of 77 patients with nasopharyngeal carcinoma were retrospectively reviewed for the effectiveness of combining chemotherapy (CT) with radical radiotherapy (RT). From 1972 to 1976, 26 patients were treated with a relatively short course of radical RT alone: 52-55 Gy/16 Fx/4 wk (study 1). From 1977 to 1982, 29 patients were also treated with radical RT alone, but with a more prolonged fractionation schedule: 65-70 Gy/26-28 Fx/6.5-7 wk (study 2). In 1983, the policy was to combine CT and RT. From 1983 to 1987, 22 patients received four to six courses of CMU regimen (consisting of cyclophosphamide, methotrexate, and UFT, a 5-fluorouracil analog) after completion of radical RT (study 3). The three studies were comparable with regard to patient characteristics: histologic type, stage, sex, and age distribution. There were no significant differences in survival and relapse figures between study 1 and study 2, but study 3 compared favorably with study 1 and study 2 in actuarial survival, relapse-free survival, relapse rate, and median relapse time. A mild nausea and transient granulocytopenia during CT was the only side effect encountered. In conclusion, the use of CT in combination with RT appeared to increase significantly the chance of long-term survival and probable cure.
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PMID:Improved results in the treatment of nasopharyngeal carcinoma using combined radiotherapy and chemotherapy. 249 65

From December, 1985 to October, 1987, 16 patients aged from 14 to 62 (median 34) with acute leukemia in relapse (10 affected by ANLL and 6 by ALL) were treated with the following regimen: Idarubicin 12 mg/m2/day on days 1-2-3, Ara-C 600 mg/m2 twice a day from day 1 to 6. Twelve patients (75%) achieved complete remission (C.R.). Two (12%) died during the induction phase from alveolar pneumonitis. One patient was resistant. The median duration of C.R. and survival was respectively 12 (range 6 to 100 +) and 23 weeks (4 to 108 +). The median duration of granulocytopenia was 16 days (range 10 to 24 days). The most frequent non-hematological complications consisted of nausea, vomiting, diarrhea and mucositis. Four patients had hepatic and splenic microabscesses of suspected mycotic etiology, and one showed a transient cardiac arrhythmia. The C.R. rate obtained in this series may be considered satisfaying since all but 3 patients were on treatment at the time of relapse. Yet the short duration of C.R. suggests the opportunity of performing consolidation cycles or suprelethal therapy followed by bone marrow transplantation.
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PMID:Idarubicin combined with intermediate-dose cytosine arabinoside in the treatment of refractory acute leukemia. 249 85

Although a 39-year-old male received the curative operation of total gastrectomy for advanced scirrhous carcinoma of the stomach, recurrence of cancer was occurred soon after the surgery, accompanied by hemorrhagic diathesis from DIC. The abdominal CT scan examination revealed the rapid enlargement in the size of the several lymphnodes around the abdominal aorta, and the blood chemistry tests showed marked increase of the serum CEA value. The sequential chemotherapy with intermediate dose of MTX and 5-FU in conjunction with OK-432 was started to treat the case. This chemotherapy was carried out once a week for 5 times and consequently DIC was led to the perfect remission. Furthermore, CEA level decreased within normal range, and the size of the enlarged lymphnodes at paraaortic area diminished remarkably. Although he complained of nausea and loss of appetite during the treatment, no severe adverse effects such as granulocytopenia, diarrhea, or loss of hair were observed. The successful result in this patient suggests that sequential therapy of intermediate dose of MTX and 5-FU with administration of OK-432 may be effective in the treatment of advanced scirrhous carcinoma of the stomach.
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PMID:[Effect of sequential MTX/5-FU therapy for a case of disseminated intravascular coagulation syndrome associated with recurrence of gastric cancer--a case report]. 255 83


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