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目的 观察甲磺酸托烷司琼控制顺铂、阿霉素所致胃肠道反应的作用及其不良作用 ,并与胃复安和欧必亭对照。方法 采用开放、多中心、中心内均衡随机、自身交叉对照方法。 2 92例随机分为AB、BA组 ,39例分为AC、CA组。AB组第 1个周期给予甲磺酸托烷司琼 ,第 2个周期给予胃复安 ,BA组则相反。AC组第 1个周期给予甲磺酸托烷司琼 ,第 2个周期给予欧必亭 ,CA组则相反。结果 在与胃复安及欧必亭的对照研究中 ,顺铂组和阿霉素组分别有 2 2 0例和 94例可评价疗效 ,甲磺酸托烷司琼控制顺铂、阿霉素化疗所致的食欲不振、恶心、呕吐的疗效优于胃复安 ,与欧必亭相近。甲磺酸托烷司琼的不良反应轻微 ,与欧必亭相似 ,未见有锥体外系症状。结论 甲磺酸托烷司琼能有效预防顺铂、阿霉素所致胃肠道反应 ,疗效明显优于胃复安 ,与进口药物欧必亭相似。不良反应轻 ,是安全有效的化疗止吐药
Objective To observe the effect of tropisetron on cisplatin and doxorubicin - induced gastrointestinal reactions and their adverse effects, and compare them with metoclopramide and. Methods The method of open, multi-center, intra-center equilibrium randomized and self-cross-matching method was used. 2 92 cases were randomly divided into AB, BA group, 39 cases were divided into AC, CA group. The first cycle of AB group was given tropisetron mesylate, the second cycle of metoclopramide, BA group is the opposite. Tropisetron mesylate was administered in the first cycle of the AC group, ophibitine in the second cycle, and contralateral to the CA group. Results In the control study with metoclopramide and Euripin, there were 220 cases and 94 cases evaluable in cisplatin group and doxorubicin group, respectively, and tropisetron mesylate controlled cisplatin and doxorubicin chemotherapy Induced loss of appetite, nausea, vomiting efficacy is better than metoclopramide, and European Pavilion will be similar. Tropisetron mesylate adverse reactions were mild, similar to the European Pavilion, no extrapyramidal symptoms. Conclusion Tropisetron mesylate can effectively prevent gastrointestinal reactions induced by cisplatin and doxorubicin, and its efficacy is obviously better than that of metoclopramide, which is similar to that of Euripin. Adverse reactions are light, safe and effective chemotherapy antiemetic drugs