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为了确定长期口服尼莫地平对卵巢癌患者使用顺铂化疗引起的神经毒性具有潜在的保护作用,本文对年龄在70岁以下,并经组织学确定为FIGO Ic～Ⅳ期上皮性卵巢癌患者进行了试验性研究和安慰剂一对照剂双盲随机试验。 在试验性研究中,一组连续应用剂量不断增加的尼莫地平,以评估其耐受性。于第一次脉冲化疗前24h开始,连续应用27周,在末次顺铂化疗后再用12周。剂量为30 mg,4次/d;60 mg,3次/d;60nag和90 mg,4次/d。最大剂量360mg/d。在随机取样试验中,尼莫地平/安慰剂是在第一疗程化疗首日开始,并在化疗结束后又继续应用12周。尼莫地平的开始剂量为90mg,4次/d,但在试验后期,为减轻某些患者对药物的不适反应而减少剂量。神经毒性的程度依据WHO神经毒性分级评分。
In order to determine the long-term oral administration of nimodipine in patients with ovarian cancer cisplatin-induced neurotoxicity has a potential protective effect, the age of 70 years of age, and histologically identified as FIGO Ic ~ Ⅳ epithelial ovarian cancer patients A pilot study and placebo-controlled double-blind randomized trial. In a pilot study, a series of consecutive doses of nimodipine were administered to assess their tolerability. Begin 24 hours before the first pulse of chemotherapy, continuous application of 27 weeks, 12 weeks after the last cisplatin chemotherapy. Dose was 30 mg, 4 times / d; 60 mg, 3 times / d; 60 nag and 90 mg, 4 times / d. The maximum dose of 360mg / d. In randomized trials, nimodipine / placebo started on the first day of the first course of chemotherapy and continued for another 12 weeks after the end of chemotherapy. The initial dose of nimodipine is 90 mg, 4 times / d, but in the late part of the trial, the dosage is reduced to relieve some patients of an unpleasant reaction to the drug. The degree of neurotoxicity is based on the WHO Neurotoxicity Rating Scale.