复方苦参注射液减轻放射性肺损伤和改善生活质量的临床研究

Clinical research of alleviating radiation-induced lung injury and improving the quality of life by compound Kushen injection

目的探讨复方苦参注射液在肺癌患者放疗中减轻放射性肺损伤和改善生活质量的作用。方法将符合入组标准的229例肺癌患者按随机数字表法分为试验组111例和对照组118例。对照组仅予单纯放射治疗（6MV-XRay），治疗组在放疗的基础上，加用复方苦参注射液。分别对患者用药后0、2、3个月的急性肺损伤情况和用药前后Karnofsky评分状况进行评价。结果试验组用药后第2个月末急性放射性肺损伤发生率为0级49．53％（53／107），1级42．06％（45／107），2级7．48％（8／107），3级0．93％（1／107）；对照组0级32．48％（38／117），1级58．12％（68／117），2级9．40％（1／117），3级0。试验组用药后第3个月末急性放射性肺损伤发生率为0级62．96％（68／108），1级33．33％（36／108），2级1．85％（2／108），3级1．85％（2／108）；对照组0级35．34％（41／116），1级49．14％（57／116），2级11．21％（13／116）。3级4．31％（5／116）。两组间第2个月末和第3个月末急性放射性肺损伤分级比较差异有统计学意义（P〈0．05）；两组治疗后Karnofsky评分改善率分别为41．44％（46例）和11．02％（13例），稳定率分别为50．45％（46例）和66．10％（78例），降低率分别为8．11％（9例）和22．88％（27例），试验组高于对照组（P〈0．05）。结论复方苦参注射液能减轻患者放疗不良反应，提高生活质量，是肺癌患者较理想的辅助治疗药物之一。

Objective To investigate the effect of compound Kushen injection on the decrease of radiation-induced lung injury and improving the quality of life for patients with lung cancer during radiotherapy. Methods 229 lung cancer patients who meet the required criteria were separated randomly into two groups：treatment group and control group. Acute radiation-induced lung injury was assessed after applying Kushen injection on 0, 2 and 3 months among these patients. Karnofsky was assessed before and after the treatment. Results The incidences of level 0, l, 2 and 3 acute radiation-induced lung injury were 49.53 % （53/107）, 42.06 % （45/107）, 7.48 % （8/107） and 0.93 % （1/107） respectively for treatment group and 32.48 % （38/117）, 58.12 % （68/117）, 9.40 % （ll/ll7） and 0 for control group by the end of second month of medication. The incidences of level 0, l, 2 and 3 acute radiation-induced lung injury were 62.96 % （68/108）, 33.33 % （36/108）, 1.85 % （2/108） and 1.85 % （2/108） respectively for treatment group and 35.34 % （4/116）, 49.14% （57/116）, 11.21% （13/116）, 4.31% （5/116） for control group by the end of third month of medication. There were significant difference about the incidence of acute radiation-induced lung injury between the two groups. The results of Karnofsky between the treatment group and control group showed that the improvement rates were 41.44 % （46 cases） and 11.02 % （13 cases）, the stable rates were 50.45 % （56 cases） and 66.1% （78 cases） and the decrease rates were 8.11% （9 cases） and 22.88 % （27 cases）. The differences were statistically significant （P 〈 0.05）. Conclusion Compound Kushen injection is one of ideal medicines for the auxiliary therapy for lung cancer, it can reduce radiation-induced side-effect and improve quality of life.