复方苦参注射液防治原发性肺癌放射性肺炎的多中心、随机对照临床研究  

Multi-center,randomized,controlled clinical study of radiation pneumonitis treated with compound matrine injection in primary lung cancer patients

作　　者：侯炜[1] 刘杰[1] 石闻光[1] 林洪生[1] 

机构地区：[1]中国中医科学院广安门医院肿瘤科,北京100053

出　　处：《中国新药杂志》2013年第17期2065-2068,共4页Chinese Journal of New Drugs

基　　金：十一五国家科技支撑计划"非小细胞肺癌中医综合治疗方案的研究"(2006BAI04A05);中医药行业科研专项"基于临床科研一体化技术平台的肺癌等疾病中医药临床诊疗研究"(200707001)

摘　　要：目的：评价复方苦参注射液防治原发性肺癌放射性肺炎的有效性和安全性。方法：采用多中心、随机、开放、平行对照的研究方法,观察232例（试验组113例、对照组119例）原发性肺癌患者,两组均采用放射治疗,试验组在放疗d 1开始给予复方苦参注射液15 mL,qd,静脉滴注,连用14 d为1周期,间隔2~4 d后开始第2周期,共治疗2周期。全部治疗结束后随访观察3个月评价疗效。结果：急性放射性肺损害发生率试验组为36.70%,对照组为64.66%。1,2,3级放射性肺损害,试验组与对照组分别为33.03%,49.14%;1.83%,11.21%;1.83%,4.31%（P〈0.05）。临床症状总有效率试验组为47.79%,对照组为21.01%（P〈0.05）。卡氏评分提高、稳定、降低,试验组分别为41.59%,50.44%,7.96%,对照组分别为11.76%,65.55%,22.69%（P〈0.05）。不良事件试验组发生率0%,对照组0.84%（P〉0.05）。结论：复方苦参注射液能够降低原发性肺癌急性放射性肺损害的发生及严重程度,改善临床症状,提高患者体力状况,研究期间未观察到复方苦参注射液相关的不良反应。Objective： To evaluate efficacy and safety of compound matrine injection（CMI） in the treatment of radiation pneumonitis in primary lung cancer patients.Methods： In a multicenter,randomized,open,parallel-group study,we observed 232 patients（113 in CMI group and 119 in control group） in the patients with primary lung cancer.All patients treated with radiation therapy in both groups,and the patients in CMI group received intravenous infusion of CMI 15 mL per day for 14 days as a cycle,and the second cycle was followed after intervals of 2 to 4 days.After 3 month follow-up,the efficacy and safety of CMI were evaluated.Results：The incidence of acute radiation-induced lung injury was 36.70% in CMI group and 64.66% in control group.Grade I II III radiation-induced lung damage occurred in 33.03%,1.83% and 1.83% patients in CMI group,and 49.14%,11.21% and 4.31% in control group（P 0.05）.Clinical remission rate was 47.79% in CMI group and 21.01% in control group（P 0.05）.For the rate of Karnofsky score,improvement,stability and reduction rates were 41.59%,50.44% and 7.96% in CMI group,and 11.76%,65.55% and 22.69% in the control group（P 0.05）.The incidence of adverse events was 0% in CMI group and 0.84% in control group（P 0.05）.Conclusion： CMI can reduce the incidence and severity of acute radiation-induced lung injury in primary lung cancer patients,relieve clinical symptoms,and improve physical condition of patients.No CMI related adverse reactions have been observed during the study period.

关 键 词：放射性肺炎 复方苦参注射液 临床研究 

分 类 号：R286[医药卫生—中药学]