盐酸帕洛诺司琼预防中重度化疗致吐药引起恶心呕吐的Ⅱ期临床研究

Phase Ⅱ trial of hydrochloride in prevention of moderately to severely emotogenic chemotherapy induced nausea and vomiting

目的:探讨盐酸帕洛诺司琼预防中重度化疗致吐药引起的恶心和呕吐的疗效和不良反应。方法:采用多中心、随机、双盲双模拟、自身交叉对照的研究方法。试验药为盐酸帕洛诺司琼注射液,对照药为盐酸昂丹司琼注射液。对化疗后1～5天的恶心程度、止吐疗效及不良反应进行评价。结果:共入选病例112例,104例可评价疗效。在接受以顺铂或阿霉素为主的化疗方案后,盐酸帕洛诺司琼0.25mg和盐酸昂丹司琼16mg的止吐有效率分别为77.08%和73.08%,恶心程度改善率分别为64.42%和62.50%,两药的疗效差异无统计学意义(P>0.05)。盐酸帕洛诺司琼注射液的不良反应主要为头痛和便秘。结论:盐酸帕洛诺司琼注射液能够预防化疗引起的恶心和呕吐,疗效和安全性较好。

Objective：To investigate the efficacy and safety of palonosetron hydrochloride in prevention of nausea and vomit induced by chemotherapy. Methods：This was a malticenter,randomized,double-blind, self-crossover phase Ⅱ trial that 0. 25mg palonosetron hydrochloride was compared with 16mg ondansetron. The efficacy was evaluated by prevention of vomit and improvement of nausea in a period of 5 days after chemotherapy. Safety was assessed according to NCl-CTC 3.0. Results： One hundred and twelve subjects were enrolled, 104 eases were assessable for efficacy. Palonosetron or ondansetron were given prior to cisplatin or adriamycin based regimen. Response rate of prevel]tion of vomit were 77.08% vs. 73.08% for palonosetron vs. ondansetron, and the improve of nausea were 64.42% vs. 62. 50% respectively. There were no significant differences between these two drugs. Conclusion：Palonosetron hydrochloride is effective and safe for prevention of nausea and vomit induced by chemotherapy.