临床肿瘤学杂志

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盐酸帕洛诺司琼胶囊预防化疗性恶心呕吐的随机对照双盲多中心临床研究

罗林华1,2,管晓翔1,3,秦叔逵2,陈映霞2,石建华4,程颖5,郑荣生6,姚阳7,韩宝惠8,于世英9   

  1. 1 南京大学医学院 2 解放军八一医院全军肿瘤中心 3 南京军区南京总医院肿瘤内科 4 山东省临沂市肿瘤医院胸部肿瘤化疗科 5 吉林省肿瘤医院胸部肿瘤内科 6 蚌埠医学院第一附属医院肿瘤内科7 上海市第六人民医院肿瘤内科 8 上海交通大学附属胸科医院呼吸内科 9 华中科技大学同济医学院附属同济医院肿瘤中心
  • 收稿日期:2014-09-10 修回日期:2014-10-08 出版日期:2014-11-30 发布日期:2014-11-30
  • 通讯作者: 管晓翔,秦叔逵

A multicenter, double-blind, randomized control clinical trail of palonosetron hydrochloride capsules for prevention of chemotherapyinduced nausea and vomiting

LUO Linhua, GUAN Xiaoxiang, QIN Shukui, CHEN Yingxia, SHI Jianhua, CHENG Ying, ZHENG Rongsheng, YAO Yang, HAN Baohui, YU Shiying   

  1. School of Medicine, Nanjing University, Nanjing 210093, PLA Cancer Center, Bayi Hospital, Nanjing 210002, China
  • Received:2014-09-10 Revised:2014-10-08 Online:2014-11-30 Published:2014-11-30
  • Contact: GUAN Xiaoxiang,QIN Shukui

摘要: 目的 观察和评价国产新药盐酸帕洛诺司琼胶囊预防和控制化疗药物引起的恶心、呕吐的有效性和安全性。方法 采用随机、阳性药平行对照、双盲、双模拟的多中心临床试验方法,对使用中度致吐性化疗方案的恶性肿瘤患者,于第1天化疗前1h口服盐酸帕洛诺司琼胶囊1粒(0.5mg/粒)和盐酸格拉司琼分散片模拟剂1片(试验组)或口服盐酸格拉司琼分散片1片(1mg/片)和盐酸帕洛诺司琼胶囊的模拟剂1粒(对照组),化疗12h后试验组和对照组分别再次给予盐酸格拉司琼分散片模拟剂1片和盐酸格拉司琼分散片1片(1mg/片)。观察用药当天至化疗后5天患者出现急性恶心呕吐、延迟性恶心呕吐、体力状况变化情况和对恶心呕吐控制的满意程度VAS评分,必要时给予格拉司琼+地塞米松的解救性止吐治疗。
结果 7家研究中心共入组240例患者,试验组122例,对照组118例。经全数据分析集(FAS)分析,试验组与对照组急性呕吐的完全有效率差异无统计学意义(86.89% vs.85.47%,P=0.8338),经非劣效检验,试验组不亚于对照组(95%CI下界值=-7.33%,u=2.558,P=0.0105)。经符合方案数据集(PPS)分析,两组延迟性呕吐的完全控制率差异有统计学意义(74.38% vs. 61.54%,P=0.0490)。整个观察期内试验组的呕吐发生率为21.31%,明显低于对照组的33.33%(P=0.0422)。化疗第2天试验组与对照组出现呕吐的患者呕吐次数(次/例)分别为0.15±0.52和0.31±0.68,差异有统计学意义(P=0.0090);化疗第1~5天两组0级恶心发生率和PS评分的差异均无统计学意义(P>0.05);化疗第2~4天两组VAS评分的差异均有统计学意义(P<0.05)。试验组发生便秘和总胆红素升高各2例,对照组发生便秘4例和药物性皮炎1例,两组不良反应的发生率分别为3.28%和4.24%(P>0.05)。结论 国产盐酸帕洛诺司琼胶囊在预防中度致吐性化疗所致的急性恶心、呕吐与盐酸格拉司琼分散片疗效相当,而对延迟性呕吐的疗效优于盐酸格拉司琼分散片,且安全性好,给药方便,建议准予上市应用。

Abstract: Objective To observe and evaluate the efficacy and safety of palonosetron hydrochloride capsules made in China for prevention of chemotherapyinduced nausea and vomiting. Methods This study was performed as a multicenter, randomized, doubleblind control clinical trial. The patients were randomized to administer palonosetron hydrochloride capsule(0.5mg) and a simulator of granisetron dispersible tablet(experimental group), or a granisetron dispersible tablet(1mg) and a simulator of palonosetron(control group), each administered 1 hour before initiation of moderate emetogenic chemotherapy. After 12h for chemotherapy, experimental group were administered a simulator of granisetron dispersible tablet and control group were administered a granisetron dispersible tablet (1mg). The acute emetic episodes, delayed emetic episodes, nausea, physical status and VAS scores was recorded, administer rescue medication (granisetron combined with dexamethasone) was taken if patients needed.
Results A total of 240 patients from seven clinical research centers in China were randomized to the clinical trial with 122 patients in experimental group and 118 patients in control group. The proportion of patients with emetic episodes overall periods (0-7days) was lower in experimental group than in control group (21.31% vs.33.33%, P=0.0422). The proportion of patients with no emetic episodes during the 24h after chemotherapy administration (acute period) between experimental group and control group was no significant difference through full analysis set (86.89%vs.85.47%, P=0.8338), and the proportion of patients with no emetic episodes during delay (24h-7days post-chemotherapy) between experimental group and control group was significant difference through perprotocol set analysis(74.38% vs. 61.54%, P=0.0490). The average vomiting times of experimental group and control group were 0.15±0.52 and 0.31±0.68 respectively in second day of chemotherapy(P=0.0090). There were no significant difference for rates of grade 0 nausea and PS scores between two groups in 15 days of chemotherapy(P>0.05), except to VAS scores in 2-4 days of chemotherapy(P<0.05). The adverse reactions of experimental group and control group included constipation(2 cases), total bilirubin(2 cases) and constipation(4 cases), drug dermatitis(1 case),respectively. The adverse reaction rates between two groups were 3.28% and 4.24% respectively(P>0.05). Conclusion Palonosetron hydrochloride capsule is similar to granisetron for preventing chemotherapyinduced acute nausea and vomiting, and superior to granisetron for delayed nausea and vomiting. Palonosetron hydrochloride capsule is safe and convenient administration.

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