【摘要】 目的观察和评价采用注射用国产福沙匹坦双葡甲胺预防恶性肿瘤患者进行高度致吐性化疗所致的恶心、呕吐的有效性、安全性及耐受性。方法该项研究为前瞻性、随机、双盲双模拟、平行对照、全国多中心的注册Ⅲ期临床试验。符合入排标准的患者,以1∶1的比例随机进入试验组（福沙匹坦组）和对照组（阿瑞匹坦组）,即在接受格拉司琼和地塞米松的基础上,分别给予单一剂量的福沙匹坦或模拟剂（150 mg静脉滴注,d₁）或者进口阿瑞匹坦片或模拟剂（125 mg口服,d₁; 80mg,d₂、d₃）。主要疗效观察指标是化疗后总观察期（0～120 h,overall phase,OP）内呕吐获得完全有效的患者比例（呕吐完全缓解率,CRR）。对于主要疗效终点采用非劣效的模型评价,非劣效性界值是10%;采用CMH χ²检验比较两组之间CRR的差异。结果 22家研究中心共纳入649例受试者,全分析集（FAS）为主分析集,其中有639例进入FAS分析,632例进入符合方案集（PPS）。OP期内,试验组CRR为79.25%（252/318）,对照组为82.17%（258/314）,两组间差异无统计学意义（P=0.351）;其中,无论化疗方案中是否含顺铂,OP期内福沙匹坦的CRR均不劣于阿瑞匹坦。两组不良事件均可耐受,最常见的不良事件为便秘,可对症处理。结论国产福沙匹坦能够有效地预防国人高度致吐性抗肿瘤化疗引起的恶心和呕吐,且安全性和耐受性良好。因此,国产福沙匹坦可能成为临床上防治高度致吐性化疗药物/方案引起的恶心和呕吐的新的选择。更多还原

【Abstract】 Objective To observe and evaluate the efficacy and safety of the domestic fosaprepitant in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy in Chinese cancer patients.Methods It was a well-designed,randomized,double-blind,double-simulation,parallel control and multicenter phase Ⅲ clinical trial.The cancer patients meeting the entry and exclusionary standards were randomized with 1 ∶1 ratio into fosaprepitant group（ fosaprepitant 150 mg iv,d₁） or aprepitant control group（ aprepitant 125 mg,po,d₁; 80 mg d₂,d₃）,which were all on the basis of combination with granisetron and dexamethasone.The primary endpoint was the percentage of patients who achieved complete response（ CRR） during overall phase（ 0-120 h,OP） after chemotherapy.It was assessed by using a non-inferiority design model,with a non-inferiority margin of 10%.The difference of the CRR was compared between two groups with Chi-square analysis.Results The 649 patients from 22 cancer centers were all included into the trial.The full analysis set（ FAS） was the main analysis set.639 cases were included in the FAS,and 632 patients were included in the per protocol analysis（ PPS）.The percentage of patients with a complete response in the fosaprepitant group was not inferior to that in the aprepitant group（ 79.25% vs.82.17%,P = 0.351） during OP.Whether the cisplatin-based chemotherapy or not,the CRR of fosaprepitant group was not inferior to the aprepitant group.Both regimens were well tolerated.The most common adverse event was constipation which may be symptomatic treated.Conclusion In the trial the domestic fosaprepitant was shown more effective,safe and well-tolerated control of the nausea and vomiting induced by the highly emetogenic chemotherapy in Chinese cancer patients.Thus it will provide a new option for the prevention and treatment of nausea and vomiting induced by highly emetogenic chemotherapy.更多还原