目的 探讨盐酸帕洛诺司琼注射液预防肿瘤化疗所致呕吐的有效性和安全性.方法 采用双盲双模拟、随机、阳性药平行对照,对使用含顺铂或阿霉素高度致吐性化疗方案的患者,于化疗前30分钟分别静脉推注盐酸帕洛诺司琼注射液0.25mg(试验组)或盐酸格拉司琼注射液3mg(对照组),观察患者急性呕吐、延迟性呕吐及不良反应发生情况.结果 入组38例患者,其中试验组20例,对照组18例.试验组对化疗引起的急性呕吐(24小时内)有效率(RR)与对照组相比无显著性差异(85.00％ vs.77.78％,P=0.566),试验组对延迟性呕吐(24小时～120小时)有效率与对照组有统计学差异(65.00％ vs 27.78％,P=0.028).两组分别有15.00％和16.67％的受试者出现便秘、头痛等(P=0.888).结论 盐酸帕洛诺司琼注射液能够有效预防肿瘤化疗所致急性呕吐及延迟性呕吐,安全性好.%Objective To investigate the efficacy and safety of palonosetron hydrochloride injection for preventing chemotherapy-induced vomiting. Methods This study was performed as a randomized, double-blind control clinical trial. The patients were randomized to receive a single dose of palonosetron 0. 25 mgCtreatment group) ,or granisetron 3 mg ( control group ). The acute emetic episodes, delay emetic episodes, and nausea were observed. Results 38 patients randomized to the clinical trail, and 20 cases treated with palonosetron, 18 cases treated with granisetron. The proportion of patients with no emetic episodes during the 24 h after chemotherapy administration (acute period) in treatment group and control group were no different (85.00% vs. 77. 78%, P = 0. 566). The proportion of patients with delay emetic episodes during (24h -5 days after chemotherapy) in the treatment group was similar to those of in the control group (65. 00% vs 27. 78%, P=0. 028). 15. 00% and 16. 67% of patients in the treatment group and control group appeared constipation and headache (P = 0.888) . Conclusion Palonosetron hydrochloride is effective and safe for prevention of vomiting induced by chemotherapy.
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