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、
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 simu.lator 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, experi.mental group were administered a simulator of granisetron dispersible tablet and control group were administered a granisetron dispers.ible tablet （ 1mg） . The acute emetic episodes, delayed emetic episodes, nausea, physical status and VAS scores was recorded, admin.ister 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 ad.ministration （ 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.chemothera.py） 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 sec.ond day of chemotherapy（P=0.0090）. There we
出处
《临床肿瘤学杂志》
CAS
2014年第11期961-966,共6页
Chinese Clinical Oncology
