【作者】 侯炜； 刘杰； 石闻光； 林洪生；

【机构】 中国中医科学院广安门医院肿瘤科；

【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d1开始给予复方苦参注射液15mL,qd,静脉滴注,连用14d为一周期,间隔2~4天后开始第二周期,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级、2级、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。更多还原

【Abstract】 Objective:To evaluate efficacy and safety of Compound Matrine Injection(CMI)in treatment of radiation pneumonitis of primary lung cancer patients.M ETHODS:In a multieenter,randomized,open,parallel-group study,we observed 232 cases(113 cases of observed group and control group 119 cases) in patients with primary lung cancer.All patients treated with radiation therapy in both groups,the patients in the observed group received CMI15 mL per day d1-14,intravenous infusion,with interval of 2 to 4 days followed the second period treatment.After 3 months Follow-up,the efficacy and safety of CMI were evaluated.Results:The incidence of acute radiation-induced lung injury in observed group and control group was 36.70%versus 64.66%t.Grade ⅠⅡⅢ radiation-induced lung damage in the observed group were 33.03%,49.14%,1,83%,and that in control group were 11.21%,1.83%,4.31%(P<0.05);Clinical remission rate was 47.79%in observed group and21.01%in the control group(P <0.05);The rate of Karnofsky score was improved,emain stability and reduced in the observed group were 41.59%,50.44%,7.96%,and that in the control group were 11.76%,65.55%,22.69%(P <0.05).The incidence of adverse events were 0%in the observed group and0.84%in the control group,(P> 0.05).Conclusions:CMI can reduce the incidence and severity of acute radiation-induced lung injury in primary lung cancer patinets.Meanwhile,CMI can relieve clinical symptoms,improve physical condition of patients,without CMI related adverse reactions was observed during the study period.更多还原