雷莫司琼治疗恶性肿瘤化疗所致胃肠道反应的随机对照研究

Randomized controlled study on ramosetron treatment of gastrointestinal reaction associated with chemotherapy in malignant tumor

目的观察雷莫司琼治疗恶性肿瘤化疗所致的食欲不振、恶心、呕吐等胃肠道反应的疗效和安全性。方法60例恶性肿瘤患者,采用随机交叉对照的方法,间隔3-4周的两次相同方案的化疗前30 min静脉注射雷莫司琼0.3 mg或昂丹司琼8 mg,观察化疗后3 d内食欲、恶心、呕吐情况,以及其引起的不良反应,比较两种止吐药的疗效。结果化疗后0-6 h雷莫司琼对胃肠道反应的完全控制率为70.0%.与昂丹司琼56.7%的控制率差别无统计学意义(P>0.05);6-48 h间雷莫司琼完全控制率53.3%-56.7%,高于昂丹司琼30.0%-38.3%的控制率(P<0.05)。120例次的化疗中共出现便秘28例次(23. 3%),肝功能异常13例次(10.8%),头痛9例次(6.7%).颜面潮红、发热感4例次(3.3%),无其他严重不良反应发生,均未中止治疗。结论与昂丹司琼相比,雷莫司琼是高效率、作用时间持久、安全性高的止吐药。

Objective To observe the efficacy and safety of ramosetron in the gastrointestinal reactions such as anorexia, nausea and vomiting caused by chemotherapy in malignant tumor. Methods Sixty patients confirmed malignancies were randomized to receive 0.3 mg ramostron in first cycle and 8mg ondansetron 30 minutes in the second cycle before 2 cycles same chemotherapy as group AB, the BA group received these drugs in the reverse sequence in this randomized, self-crossover control trial. The efficacy of two drugs were estimated by the incidence of anorexia, nausea and vomiting and further adverse events in 3 days after chemotherapy. Results The complete control rates of gastrointestinal reaction were similar in both the groups treated with ramosetron and ondansetron （70. 0% vs 56. 7% ） in 0-6 hours; ramosetron had a high level of complete control than ondansetron （53.3-56.7% vs 30.0-38.3%, P〈0. 05） in 6-48 hours. During all chemotherapy, 23.3% experienced constipation （28/120）, 10.8% hypohepatia （13/120）, 6.7% headache （9/120）, 3.3% face congestion and fever sensation （4/120）, no serious adverse events happened. Conclusion Ramosetron is a safe, effective and long-lasting function antiemetic than ondansetron.