盐酸帕洛诺司琼预防化疗引起恶心呕吐的Ⅱ期临床研究  

Phase Ⅱ clinical trial of palonosetron hydrochloride in prevention of chemotherapy induced nausea and vomiting

作　　者：张百红[1] 岳红云[2] 徐佳维[1] 陈龙[1] 王海忠[1] 王湘辉[1] 

机构地区：[1]兰州军区兰州总医院肿瘤科,甘肃兰州730050 [2]兰州军区兰州总医院眼科,甘肃兰州730050

出　　处：《现代肿瘤医学》2012年第4期820-822,共3页Journal of Modern Oncology

摘　　要：目的:观察盐酸帕洛诺司琼预防化疗引起的恶心呕吐的疗效和不良反应。方法:采用随机、双盲、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,对照药为盐酸托烷司琼注射液。对化疗后1-5天的恶心改善、止吐疗效和不良反应进行评价。结果:共入选19例患者,全部可评价疗效。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和盐酸托烷司琼5mg的止吐有效率分别为40.7%和38.9%,恶心改善率均为74.4%,两药的疗效差异无统计学意义(P>0.05)。盐酸帕洛诺司琼的不良反应主要为全身疼痛、寒战和皮肤瘙痒。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 observe the efficacy and safety of palonosetron hydrochloride in prevention of nausea and vomit induced by chemotherapy.Methods： This was a randomized,double crossover phase II trial that 0.25mg palonosetron hydrochloride was compared with 5mg tropisetron.The efficacy and safety was evaluated by prevention of vomit and improvement of nausea in a period of 5 days after chemotherapy.Results： Nineteen patients were enrolled,eighteen cases were assessable.Response rate of prevention of vomit were 40.7% vs 38.9% for palonosetron vs tropisetron,and the improvement of nausea were 74.4%.There were no significant differences between these two drugs（P0.05）.Conclusion： Palonosetron hydrochloride is effective and safe for prevention of nausea and vomit induced by chemotherapy.

关 键 词：Ⅱ期临床研究 止吐药 盐酸帕洛诺司琼 盐酸托烷司琼 化学治疗 

分 类 号：R730.5[医药卫生—肿瘤]