阿瑞匹坦预防弥漫大B细胞淋巴瘤化疗所致恶心、呕吐的疗效及安全性研究

Efficacy and safety of aprepitant in prevention of nausea and vomiting induced by chemotherapy in patients with diffuse large B-cell lymphoma

目的 评估神经激肽1（NK1）受体拮抗剂阿瑞匹坦联合泼尼松、托烷司琼预防R-CHOP或CHOP方案化疗所致恶心、呕吐（CINV）的疗效及安全性.方法 选择2015年10月至2016年1月天津市人民医院90例弥漫大B细胞淋巴瘤（DLBCL）患者,接受R-CHOP或CHOP方案治疗.采用随机数字表法分为两组,阿瑞匹坦组45例,于第1天化疗前1 h口服阿瑞匹坦125 mg及泼尼松100 mg,静脉滴注托烷司琼10 mg,化疗后2 h静脉滴注托烷司琼5 mg;第2、3天口服阿瑞匹坦80 mg及泼尼松100 mg,静脉滴注托烷司琼10 mg;第4、5天口服泼尼松100 mg.对照组45例,于第1天化疗前1 h口服泼尼松100 mg,静脉滴注托烷司琼10 mg,化疗后2 h静脉滴注托烷司琼5 mg;第2、3天口服泼尼松100 mg,静脉滴注托烷司琼10 mg;第4、5天口服泼尼松100 mg.每天记录患者CINV发生次数及缓解治疗方法.记录整个周期CINV完全缓解率（无呕吐且未用缓解药物）和整个周期无呕吐率,采用生活功能指数（FILE）问卷评估CINV对患者生命质量的影响.结果阿瑞匹坦组CINV完全缓解率为77.8％（35/45）,高于对照组的55.6％（25/45）,差异有统计学意义（χ2=5.000,P=0.025）;阿瑞匹坦组无呕吐率为82.2％（37/45）,高于对照组的62.2％（28/45）,差异有统计学意义（χ2=4.486,P=0.034）.阿瑞匹坦组和对照组FILE问卷平均得分分别为（113±10）和（100±11）分,差异有统计学意义（t=12.437,P〈0.001）.两组止吐药物相关不良反应发生率比较,差异均无统计学意义（均P〉0.05）.结论 阿瑞匹坦联合托烷司琼、泼尼松可有效改善DLBCL患者R-CHOP或CHOP方案化疗所致的恶心、呕吐.

Objective To evaluate the efficacy and safety of neurokinin1 （NK1） receptor antagonist aprepitant combined with prednisone and tropisetron in prevention of nausea and vomiting （CINV） induced by R-CHOP or CHOP regimen. Methods A total of 90 patients with diffuse large B-cell lymphoma （DLBCL） who accepted R-CHOP or CHOP regimen in the People＇＇s Hospital of Tianjin from October 2015 to January 2016 were divided into aprepitant group （45 cases） and the control group （45 cases） according to the random number table. In aprepitant group, day 1： aprepitant 125 mg 1 h before chemotherapy, prednison 100 mg, tropisetron 10 mg, and tropisetron 5 mg 2 hours after chemotherapy;day 2-3：aprepitant 80 mg and prednison 100 mg, tropisetron 10 mg; day 4-5： prednison 100 mg. In the control group, day 1： prednison 100 mg 1 h before chemotherapy, tropisetron 10 mg, and tropisetron 5 mg 2 h after chemotherapy; days 2-3： prednison 100 mg, tropisetron 10 mg; day 4-5： prednison 100 mg. Data on nausea, vomiting and remission treatment were collected every day. The complete remission （CR） rates of CINV without vomiting and remission drugs in the whole cycle were recorded. Functional living index-emesis questionnaire （FILE） was used to assess the effect of CINV on the life quality of the patients. Results CR in aprepitant group was higher than that in the control group （77.8 % vs. 55.6 %, χ2= 5.000, P= 0.025）. The rate of no vomiting in aprepitant regimen was higher than that in the control regimen （82.2 % vs. 62.2 %, χ2 = 4.486, P= 0.034）. The average scores of FILE between the two groups were （113 ±10） and （100 ±11） scores respectively, and there was a significant difference （t=12.437, P〈0.001）. The related adverse reactions of vomiting-stopping drugs in both groups had no statistical difference. Conclusion The aprepitant combined with tropisetron and prednisone can improve effectively nausea and vomiting induced by R-CHOP or CHOP chemotherapy regimen for DLBCL patients.