甲磺酸托烷司琼预防顺铂和阿霉素所致胃肠道反应的临床研究

Tropisetron Mesylate in the Prophylaxis of Gastrointestinal Reaction Induced by DDP and ADM

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 。

Objective To evaluate th efficacy and side effects of tropisetron mesylate(TPTM) for the prophylaxis of gastrointestinal reactions induced by DDP and ADM,and compare with metoclopramide and tropisetron.hydrochloride(TPTH).Methods A multicenter,open,randomized self crossover control trial was carried out.292 patients were devided into AB and BA group.The patients in AB group were treated by TPTM in the first cycle and metoclopramide in the second cycle,those in BA group were treated with the drugs in the reverse order.39 patients were devided into AC or CA group.The patients in AC group were treated by TPTM in the first cycle and TPTH in the second cycle,those in CA group were with the drugs in the reverse order.Results In control study of TPTM and metoclopramide,TPTH,DDP and ADM group 220 and 94 patients were evaluable for response respectively.TPTM was superior to metoclopramide in the control of anorexia,nausea and vomiting induced by DDP and ADM.The effectivenes of TPTM and TPTH were similar.The side effects of TPTM were mild and similar to those of TPTH.Conclusion TPTM can effectively prevent the gastrointestinal reaction induced by DDP and ADM.The side effects of TPTM are mild.