晚期肺癌养正消积胶囊联合化疗临床对照研究

Yangzhengxiaoji capsule combineded with chemotherapy for patients with advanced lung cancer

目的:观察养正消积胶囊联合化疗治疗晚期肺癌的临床疗效。方法:选取2011-06-01-2012-12-31山东省肿瘤医院(160例)和潍坊医学院附属医院(40例)收治的晚期肺癌患者200例。随机分为养正消积胶囊联合化疗组(n=100,非小细胞肺癌68例,小细胞肺癌32例)和开放性随机对照组(n=100,单纯全身化疗)。观察用药3个月后患者一般状况(KPS评分)、中医症候评分及近期疗效。结果:纳入最终统计分析的养正消积组(96例)和对照组(97例)基线状态无明显差异。养正消积组中医症候评分改善率为83.5%(81/97),一般状况评分改善率为35.1%(34/97),明显优于对照组的68.8%(66/96)和22.9%(22/96),P<0.05。养正消积组有效率(CR+PR)和临床获益率(CR+PR+SD)分别为31.9%(31/97)和82.4%(80/97),对照组分别为30.2%(29/96)和69.8%(67/96)。有效率比较差异无统计学意义,P=0.793;而临床获益率养正消积组高于对照组,差异有统计学意义,P=0.039。结论:养正消积胶囊配合全身化疗能改善临床症候和一般状况,可用于晚期肺癌的综合治疗。

OBJECTIVE：To evaluate the efficacy of Yangzhengxiaoji Capsule during chemotherapy for patients with advanced lung cancer. METHODS：Patients with advancer non-small cell lung cancer （n = 68） or small cell lung cancer （n 32） were administered with Yangzhengxiaoji Capsules during chemotherapy with open-labeled randomized controlled group （n= 100）. All the patients were collected from Shandong Cancer Hospital and Affiliated Hospital of Weifang Medi- cal College from June 1st, 2011 to December 31th, 2012. The performance status, Chinese traditional medicine symptom scores and tumor control rates were evaluated after treatments for three months. RESULTS： Totally 96 patients were trea- ted with chemotherapy with Yangzhengxiaoji Capsules while 97 patients with chemotherapy alone for final analysis. The baseline characteristics of two groups of patients were similar. The Chinese traditional medicine symptom and performance status were significantly improved in Yangzhengxiaoji group （83.5% and 35. 1%） as comparison with controlled group （68.8% and 22.9% ,P〈0.05）. The overall tumor control rate （CR ＋ PR） and clinical benefit rate （CR＋PR＋SD） were 31.9% （31/97） and 82.4% （80/97） in Yangzhengxiaoji group while 30.2% （29/96） and 69.8% （67/96） in controlled group, respectively. There was no significant difference in tumor control rate between two groups （P = 0. 793）. However, the clinical benefit rate in Yangzhengxiaoji group was higher than that in controlled group （P = 0. 039）. CONCLUSIONS： Yangzhengxiaoji Capsule used during chemotherapy can improve the symptom control and performance status,and may be used in multimodality treatment for advanced lung cancer.