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Carbamazepine for prevention of chemotherapy-induced nausea and vomiting: a pilot study

机译:卡马西平预防化疗引起的恶心和呕吐的初步研究

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CONTEXT AND OBJECTIVE: Nausea and vomiting are major inconveniences for patients undergoing chemotherapy. Despite standard preventive treatment, chemotherapy-induced nausea and vomiting (CINV) still occurs in approximately 50% of these patients. In an attempt to optimize this treatment, we evaluated the possible effects of carbamazepine for prevention of CINV.DESIGN AND LOCATION: Prospective nonrandomized open-label phase II study carried out at a Brazilian public oncology service. METHODS: Patients allocated for their first cycle of highly emetogenic chemotherapy were continuously recruited. In addition to standard antiemetic protocol that was made available, they received carbamazepine orally, with staggered doses, from the third day before until the fifth day after chemotherapy. Considering the sparseness of evidence about the efficacy of anticonvulsants for CINV prevention, we used Simon's two-stage design, in which 43 patients should be included unless overall complete prevention was not achieved in 9 out of the first 15 entries. The Functional Living Index-Emesis questionnaire was used to measure the impact on quality of life.RESULTS:None of the ten patients (0%) presented overall complete prevention. In three cases, carbamazepine therapy was withdrawn because of somnolence and vomiting before chemotherapy. Seven were able to take the medication for the entire period and none were responsive, so the study was closed. There was no impact on the patients' quality of life.CONCLUSION: Carbamazepine was not effective for prevention of CINV and also had a deleterious side-effect profile in this population.
机译:背景与目的:恶心和呕吐是化疗患者的主要不便。尽管进行了标准的预防性治疗,这些患者中约有50%仍发生化学疗法引起的恶心和呕吐(CINV)。为了优化这种治疗方法,我们评估了卡马西平预防CINV的可能作用。设计和位置:在巴西公共肿瘤服务机构进行的前瞻性非随机开放标签II期研究。方法:连续招募分配到其第一轮高促发化疗的患者。除了提供标准的止吐方案外,他们从化疗前第三天到化疗后第五天口服卡马西平,剂量交错。考虑到抗惊厥药对CINV预防的有效性的证据稀少,我们采用了西蒙(Simon)的两阶段设计,其中应包括43例患者,除非前15项中的9项没有全面预防。结果:10名患者中没有一名(0%)表现出全面的预防。在三例中,卡马西平治疗因化疗前的嗜睡和呕吐而中止。整个疗程中有7名能够服用药物,但没有任何反应,因此该研究结束了。结论:卡马西平对预防CINV无效,并且在该人群中具有有害的副作用。

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