阿瑞匹坦联合昂丹司琼和地塞米松预防化疗诱发恶心和呕吐的疗效及安全性

目的 评估阿瑞匹坦联合昂丹司琼和地塞米松预防化疗诱发恶心和呕吐(CINV)的疗效及安全性.方法 本研究是前瞻性非随机、自身对照的单中心研究,入组43例接受中、高度致吐风险化疗的患者.所有患者在化疗前使用阿瑞匹坦(125mg第1天,80 mg第2～3天)联合昂丹司琼(16 mg第1～3天)和地塞米松(10 mg第1～3天)进行预防止吐治疗(阿瑞匹坦组).同一患者使用相同剂量的昂丹司琼联合地塞米松(自身对照组)作自身前后对照.主要研究终点为化疗后120 h内完全有效率(没有呕吐和没有使用解救治疗患者比例).根据美国国立癌症研究所的通用毒性标准(NCI-CTC 4.0)评估不良反应.结果 阿瑞匹坦组总体完全有效率为72.1％ (31/43),优于自身对照组51.2％(22/43,x2 =3.98,P＜0.05).对于急性期呕吐(化疗后＜24h),阿瑞匹坦组完全有效率为83.7％ (36/43),对照组为74.4％(32/43,x2=1.12,P＞0.05).对于延迟期呕吐,两组完全有效率分别为76.7％(33/43)和55.8％(24/43,x2 =4.21,P＜0.05).两种止吐方案毒性和不良事件相似.结论 阿瑞匹坦联合昂丹司琼和地塞米松方案能够有效预防中、高度致吐化疗药物引起的恶心和呕吐,且安全性良好.

Efficacy and safety of aprepitant combined with ondansetron and dexamethasone in the prevention of chemotherapy-induced nausea and vomiting

Objective To evaluate the efficacy and safety of the new combination (aprepitant/ondansetron/dexamethasone) in the prevention of chemotherapy-induced nausea and vomiting (CINV).Methods This was a prospective non-randomized,self-control single site study,and 43 patients receiving high and moderate emetic risk chemotherapy were enrolled.All patients received the following regimen for the prevention of CINV (day 1,125 mg aprepitant,16 mg ondansetron,and 10 mg dexamethasone before chemotherapy;and days 2-3,80 mg aprepitant,16 mg ondansetron,and 10 mg dexamethasone each day).The same dose of ondansetron and dexamethasone was used as self-control in the previous or next course of the chemotherapy in the same patient.The primary end point was the proportion of patients with complete response (no emesis and no rescue therapy) during the 120 h post-chemotherapy.Toxicity assessments were conducted using the NCI-CTC investigator guide (version 4.0).Results The overall complete response (CR) rates were 72.1％ in the aprepitant group (31/43) versus 51.2％ in the self-control group (22/43;x2 =3.98,P ＜ 0.05).For theacute phase (＜24 h post-chemotherapy),the CR rates were 83.7％ (36/43) in the aprepitant group and 74.4％ (32/43) in the self-control group (x2 =1.12,P ＞ 0.05).For the delayed phase,the CR rates were 76.7％ (33/43) and 55.8％ (24/43),respectively (x2 =4.21,P ＜ 0.05).Toxicity and adverse events were comparable in both groups.Conclusion The combination of aprepitant,ondansetron and dexamethasone is effective and well tolerable for CINV prevention in cancer patients receiving high and moderate emetic risk chemotherapy.