国产托烷司琼治疗由顺铂引起恶心呕吐的临床观察
Clinical Study on Efficacy and Safety of Domestic Tropisetron in Prevention of Nausea and Vomiting Induced by Cisplatin Chemotherapy
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摘要: 目的:探讨国产托烷司琼治疗由顺铂(DDP)引起的消化道反应的临床疗效。方法:采用多中心、随机、自身交叉对照的方法,对72例接受含顺铂的联合化疗肿瘤患者,随机分为A、B两组。止吐方案:国产托烷司琼5mg,静滴,第1～5天,欧必亭5mg,静滴,第1～5天。结果:国产托烷司琼控制急性呕吐(第1～3天)的有效率分别为96.9%(63/65)、89.2%(58/65)、81.5%(53/65),欧必亭控制急性呕吐(第1～3天)的有效率分别为96.9%(63/65)、90.8%(59/65)、83.1%(54/65),两组无统计学差异(P>0.05)。国产托烷司琼控制第4～5天呕吐的有效率分别为73.8%、81.5%,欧必亭控制第4～5天呕吐的有效率分别是80.0%、83.1%,无统计学差异(P>0.05)。两组不良反应相似。未见头痛、腹部不适及锥体外系症状发生。结论:国产托烷司琼与欧必亭治疗以顺铂为主的化疗方案所致的恶心、呕吐,均取得相似的效果,且不良反应轻微,具有很好的耐受性,可作为预防含有顺铂联合化疗所致恶心、呕吐的一线治疗。Abstract: Objective: To evaluate the effects and safety of Domestic tropisetron in prevention of nausea and vomiting induced by cisplatin chemotherapy. Methods: The multicentral, ramdomized and self- cross method was applied. A total of 65 patients who received two consecutive course of cisplatin based chemotherapy were randomized between domestic tropisetron (trial group) 5 mg intravenously at day 1 to 3, or tropisetron (control group) 5 mg intravenously at day 1 to 3. Results: For acute nausea, the response rate was 96.9% (63/65), 89.2% (58/65), 81.5% (53/65) in the trial group and 96.9% (63/65), 90.8% (59/65), 83.1% (54/65) in the control group (P>0.05). The overall and complete response rate of the delayed nausea were similar between two groups (P>0.05). The adverse effects were mild and well tolerated. Conclusions: Domestic Tropisetron can well effectively prevent the acute and can delay the nausea induced by cisplatin chemotherapy.
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