Clinical therapeutics
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Clinical therapeutics · Jan 1992
Comparative Study Clinical Trial Controlled Clinical TrialClinical and endocrine effects of leuprorelin acetate in pre- and postmenopausal patients with advanced breast cancer.
Premenopausal Study. Twenty-five pre- or perimenopausal patients with advanced breast cancer were treated with leuprorelin acetate 3.75 mg (n = 9) or 7.5 mg (n = 16) every 4 weeks. Serum levels of gonadotrophins and oestrogens were suppressed markedly by both doses and there was no indication that the lower dose was less effective as an oestrogen suppressant. ⋯ Endocrine effects after 4 weeks' treatment included major suppression of serum gonadotrophins to below 10% of pretreatment values and decreases in the level of serum testosterone in 12 of 14 patients. In this group there were no changes in oestradiol levels, although we had previously observed suppression in postmenopausal patients treated with goserelin. In common with other gonadotrophin-releasing hormone analogues, leuprorelin acetate cannot be recommended as a treatment for postmenopausal breast cancer.
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Clinical therapeutics · Jan 1992
Multicenter Study Clinical TrialTreatment of endometriosis with leuprorelin acetate depot: a German multicentre study.
During the past decade, the development of various gonadotrophin-releasing hormone (Gn-RH) agonists, which induce reversible hypo-oestrogenism has opened a new area in the medical management of endometriosis. In an open, multicentre phase III study, the efficacy, tolerance and safety of the Gn-RH agonist leuprorelin acetate were tested. The preliminary results of 104 women treated in seven German centres are presented. ⋯ During the 6 months' treatment, laboratory parameters showed no significant deviations from normal; only total cholesterol, high-density lipoprotein cholesterol and alkaline phosphatase increased. Treatment results were judged as good and satisfactory in 82% and 11% of cases, respectively. On the basis of this study, it can be concluded that leuprorelin acetate treatment is safe, well tolerated and effective in the medical management of endometriosis and endometriosis-related complaints.
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Clinical therapeutics · Jan 1992
Multicenter Study Clinical TrialExperience with leuprorelin acetate depot in the treatment of fibroids: a German multicentre study.
Between October 1988 and October 1990 in a noncomparative multicentre study, 114 patients were treated for uterine fibroids with the gonadotrophin-releasing hormone (Gn-RH) agonist, leuprorelin acetate depot. The mean age of the women was 33 years and 55.3% of them had a history of infertility. After confirmation of the diagnosis by ultrasound and/or operation, treatment began between day 1 and 3 of the cycle with leuprorelin acetate depot 3.75 mg subcutaneously. ⋯ Liver and lipid metabolism was almost unaffected, although increasing calcium and alkaline phosphatase serum levels as well as an increased urinary calcium/creatinine ratio demonstrated an increased metabolic turnover of the bone. Haemoglobin concentrations, however, increased in those cases with fibroid-related anaemia. Thus the slow-release form of leuprorelin acetate is an adjunct to myomectomy especially in those women in whom family planning is not yet completed.
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Clinical therapeutics · Sep 1991
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialRandomized comparison of cefotaxime and ceftriaxone in patients with uncomplicated gonorrhea.
Cefotaxime is a third-generation cephalosporin with excellent in vitro antimicrobial activity against Neisseria gonorrhoeae, including beta-lactamase-producing strains. A single, 1-gm, intramuscular dose has previously been shown to be effective in the treatment of uncomplicated gonorrhea. A randomized, multicenter study was conducted to evaluate the efficacy and safety of a lower, 500-mg dose of cefotaxime in comparison with ceftriaxone 250 mg, the standard treatment for uncomplicated gonorrhea. ⋯ Bacteriologic eradication rates were 95% in the cefotaxime group and 100% in the ceftriaxone group (P = 0.119). Adverse events that were possibly related to the study drug occurred in 3% and 8% of patients in the cefotaxime and ceftriaxone groups, respectively. Cefotaxime 500 mg appears to be a safe and cost-effective alternative to ceftriaxone 250 mg for the treatment of uncomplicated gonorrhea.
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Clinical therapeutics · May 1991
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialTreatment of arthritis with topical capsaicin: a double-blind trial.
The neuropeptide substance P has been implicated in the pathogenesis of inflammation and pain in arthritis. In this double-blind randomized study, 70 patients with osteoarthritis (OA) and 31 with rheumatoid arthritis (RA) received capsaicin (a substance P depletor) or placebo for four weeks. The patients were instructed to apply 0.025% capsaicin cream or its vehicle (placebo) to painful knees four times daily. ⋯ According to the global evaluations, 80% of the capsaicin-treated patients experienced a reduction in pain after two weeks of treatment. Transient burning was felt at the sites of drug application by 23 of the 52 capsaicin-treated patients; two patients withdrew from treatment because of this side effect. It is concluded that capsaicin cream is a safe and effective treatment for arthritis.