阿瑞匹坦预防含顺铂化疗方案所致恶心和呕吐的临床观察

目的探讨阿瑞匹坦预防顺铂3天方案所致的恶心、呕吐的临床疗效及不良反应。方法选取在浙江省肿瘤医院2014年8月1日至2015年6月20日接受含顺铂(75 mg/m^2,分3天给药)两药联合化疗方案的肺癌初治患者108例,根据止吐药物使用情况分为阿瑞匹坦组(n=54)和对照组(n=54)。阿瑞匹坦组接受阿瑞匹坦(125 mg口服,d1;80 mg口服,d_2~d_3)、托烷司琼(5 mg静滴,d1~d6)和地塞米松(12 mg口服,d1;8 mg口服,d2~d4)治疗;对照组同期使用托烷司琼(5 mg静滴,d_1~d_6)和地塞米松(12 mg口服,d1;8 mg口服,d_2~d_4)。观察两组化疗后急性期(0~24 h)、延迟期(24~120 h)呕吐的完全缓解率、化疗期间(0~120 h)3~4级恶心、呕吐的发生率。参照CTCAE 4.0对不良反应分级,采用呕吐生活功能指数(FLIE)评估两组生活质量。结果阿瑞匹坦组与对照组治疗急性呕吐的完全缓解率分别为90.7%和75.9%(P=0.039);两组治疗迟发性呕吐的完全缓解率分别为81.5%和61.1%(P=0.019)。化疗期间阿瑞匹坦组与对照组3~4级恶心和呕吐发生率分别为18.5%和37.0%(P=0.032)。阿瑞匹坦组与对照组患者生活质量评分分别为111.67±17.02和104.89±17.32(P=0.047)。阿瑞匹坦组患者便秘、呃逆症状的发生率明显高于对照组(P<0.05)。结论阿瑞匹坦预防顺铂3天方案的化疗方案所致恶心呕吐的疗效良好,能提高接受高致吐化疗方案肺癌患者的生存质量,不良反应有待进一步观察。

Clinical observation of aprepitant in the prevention of nausea and vomiting induced by cisplatin chemother-apy

Objective To observe the clinical efficacy and adverse reactions of aprepitant in the prevention of nausea and vomiting induced by cisplatin chemotherapy. Methods One hundred and eight patients with lung cancer receiving cisplatin（25 mg/m2， d1-d3）-containing chemotherapy regimens in Zhejiang Cancer Hospital from August 1， 2014 to June 20， 2015 were enrolled. The antiemetic regiem for aprepitant group consisted of aprepitant（125 mg po d1，80 mg po d2-d3）， tropisetron（5 mg iv d1-d6）and dexamethasone（12 mg po d1，8 mg po d2-d4）. The regimen for control group was tropisetron（5 mg iv d1-d6） and dexamethasone（12 mg po d1，8 mg po d2-d4）. The primary endpoints were the percentage of patients with a complete remission（no nausea and no salvage treatment） during the acute phase（0-24 h） and the delayed phase（24-120 h）. The secondary endpoint was the percentage of patients with severe nausea during the entire study period（0-120 h）. Common Terminology Criteria for Adverse Events （CTCAE）4.0 was adopted for classification for adverse reactions. The functional living index-emesis （FLIE）was adopted to assess patients’ quality of life. Results The complete remission rates of vomiting for acute period in aprepitant group and control group were 90.7% and 75.9%（P=0.039）， respectively. The complete remission rates of vomiting for delayed period in aprepitant group and control group were 81.5% and 61.1%（P=0.019）， respectively. The aprepitant group’s vomiting preventive effect was better than the control group. The percentage of patients with severe nausea during the entire study period in aprepitant group and control group were 18.5% and 37.0%（P=0.032）， respectively. The FLIE score of aprepitant group and control group were 111.67±17.02 and 104.89±17.32（P=0.047）， respectively. The percentages of constipation and singultation of aprepitant group were higher than those of control group. Conclusion The aprepitant is effective for nausea and vomiting induced by cisplatin-containing chemotherapy. Further clinical study is warranted to assess the adverse reactions.