首页> 中文期刊> 《现代肿瘤医学》 >盐酸帕洛诺司琼预防化疗引起恶心呕吐的Ⅱ期临床研究

盐酸帕洛诺司琼预防化疗引起恶心呕吐的Ⅱ期临床研究

         

摘要

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 S 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 (P>0. 05). Conclusion: Palonosetron hydrochloride is effective and safe for prevention of nausea and vomit induced by chemotherapy.%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.

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