甲磺酸托烷司琼预防化疗引起胃肠道反应的临床研究

Tropisetron mesylate in the prevention of chemotherapy-induced gastrointestinal reactions

目的 :比较甲磺酸托烷司琼和盐酸托烷司琼 (商品名 :欧必亭 )控制由顺铂、多柔比星 (阿霉素 )化疗所致胃肠道反应的疗效和不良反应。方法 :采用开放、随机自身交叉对照方法。 39例接受含顺铂和 (或 )多柔比星化疗的肿瘤患者随机进入AB ,BA组。AB组第 1周期化疗止吐给予甲磺酸托烷司琼 ,第 2周期给予盐酸托烷司琼 ;BA组则相反。同一患者接受的第 1 ,2周期化疗方案完全相同。结果 :入组患者中 ,9例未按试验要求完成观察 ,故可评价疗效患者 30例。A周期可评价不良反应 35例 ,B周期 36例。全组患者用甲磺酸托烷司琼后对食欲的影响 ,对恶心和呕吐的控制与盐酸托烷司琼相似 ,两组间差异无显著性 (均为P >0 .0 5 )。与两药可能相关的不良反应为轻度 ,均可耐受。结论 :国产甲磺酸托烷司琼治疗顺铂。

Objective:To compare the efficacy and side effects between tropisetron mesylate(TPTM) and tropisetron hydrochloride (TPTH) in prevention of chemotherapy_induced gastrointestinal reactions .Methods:Open, randomized self_cross over control trial was carried out. Thirty nine cancer patients who received chemotherapy containing cisplatin (DDP) and doxorubicin(adriamycin,ADM) were randomly divided into AB and BA study groups. The patients in AB group were treated with TPTM in the first cycle and TPTH in the second cycle, and those in BA group were treated with the two drugs in reverse order. Chemotherapy regimens were same in the first cycle and second cycle for one patient.Results:Nine patients were excluded because the observation protocol was not completed. Therefore efficacy could be evaluated in 30 patients.Adverse reactions were evaluated in 35 patients in A cycle and 36 patients in B cycle. The effectiveness of TPTM and TPTH was similar for the treatment of anorexia, nausea and vomiting ( P >0.05). Side reactions which may be drug_related were mild and also well tolerated in both groups.Conclusions:TPTM and TPTH are similar in the efficacy and side effects for the prevention of gastrointestinal reactions induced by chemotherapy containing DDP and ADM.