【摘要】 目的评价上海海天医药科技开发有限公司生产的盐酸帕洛诺司琼注射液(试验药物)防治化疗诱发恶心、呕吐的有效性与安全性。方法采用随机、双盲、自身交叉、阳性药对照研究设计,将入组患者随机分为AB周期(A周期为试验周期,分属于试验组;B周期为对照周期,分属于对照组。以下的BA周期与之相反)与BA周期,用相同的方案(含表阿霉素或顺铂)化疗2周期。AB周期化疗采用试验药物预防呕吐,BA周期用齐鲁制药有限公司生产的盐酸帕洛诺司琼注射液(对照药物)替代试验药物。NCI CTC AE-3.0版方法评价受试者2周期化疗后第1~5日的恶心、呕吐、食欲以及全身情况。结果试验组和对照组各有17例病例可评价疗效,18例可评价安全性。2组药物治疗化疗后呕吐的总有效率均为100%;按照治疗全程呕吐、急性呕吐、迟发性呕吐分层,2组在完全缓解、部分缓解和轻微缓解方面均无差异;治疗恶心和食欲减退的疗效相近。不良反应轻微,主要为疲乏、便秘、头晕、头痛等。结论试验药物与对照药物在止吐疗效及毒性反应等方面均没有差异。更多还原

【Abstract】 Objective To evaluate the effectiveness and security of Palonosetron Hydrochloride Injection(test drug) produced by Shanghai Haitian Pharmaceutical Corporation,which is used to prevention and cure nausea and vomiting that induced by chemotherapy.Methods A random,self-crossover,double blind and positive control drug experimental design was employed,patients was grouped into AB and BA by random,and received same chemotherapy scheme(contains epirubicin or cisplatin) 2 cycles.The group AB adopted test drug to prevent vomiting in the first chemotherapy cycle,and adopted Palonosetron Hydrochloride Injection produced by Qilu Pharmaceutical Corporation(comparison drug) as the replacement in the second.NCI-CTC AE 3.0 edition method was employed to evaluate the nausea,vomiting,anorexia,and physical condition of the participants in the first 1-5 days after 2 cycles’ chemotherapy.Results In both treat group and comparison group,17 cases could be evaluated in effectiveness and 18 cases in security.Both drug had a total effectiveness of 100% in treating chemotherapy’s vomiting;if sorted by throughout vomiting,acute vomiting,and delayed vomiting,no difference existed between both group in complete alleviation,partial alleviation and slight alleviation;the effectiveness of treating nausea and anorexia were similar.Adverse reactions,including tired,constipation,giddy,headache etc.was slight.Conclusion No difference exists between both test drug and comparison drug in preventing vomiting and toxicity induced by chemotherapy.更多还原