目的：观察复方苦参注射液联合奈达铂胸腔内注入治疗肺癌恶性胸腔积液的临床疗效及安全性。方法：将112例确诊为肺癌恶性胸腔积液患者，按随机数字表法分为治疗组及对照组各56例。2组患者均采用胸膜腔内中心静脉导管置入联合药物注射，待胸腔积液消失或每日引流量＜100 ml时，治疗组患者给予胸腔注入复方苦参注射液30 ml、奈达铂60 mg、地塞米松10 mg，对照组患者给予胸腔注入奈达铂60 mg、地塞米松10 mg。2组患者均1周给药1次，连用4次，治疗结束后评价疗效及观察不良反应。结果：治疗组患者总有效率为80.4％（45／56），对照组为58.9％（33／56），2组差异有统计学意义（P＜0.05）；治疗组患者生活质量改善率为76.8％（43／56），高于对照组的55.4％（31／56），2组差异有统计学意义（P＜0.05）；治疗组患者发生胃肠道反应、胸痛及骨髓抑制等不良反应较对照组轻。结论：复方苦参注射液联合奈达铂胸腔内注入治疗肺癌恶性胸腔积液是一种安全、可行的治疗方法，疗效肯定，且不良反应较轻。%OBJECTIVE:To evaluate the efficacy and safety of Compound Kushen injection plus nedplatin for malignant pleural effusion in patients with lung cancer.METHODS: 112 patients with lung cancer and malignant pleural effusion were randomly assigned to either treatment group or control group of 56 cases each.The patients in both groups were inserted with central venous catheter in pleural cavity for drainage of pleural effusion.After clearance of pleural effusion or when the daily volume of drainage was less than 100 ml, the patients in the treatment group were intrapleurally injected with Kusen injection (30 ml) plus nedaplatin (60 mg) and dexamethasone (10 mg) weekly for four consecutive weeks, while the patients in the control group were intrapleurally injected with nedaplatin nedaplatin (60 mg) plus dexamethasone (10 mg) weekly for four consecutive weeks.After treatment completion, the curative efficacy and adverse drug reactions in the two groups were evaluated.RESULTS:The total effeetive rate was 80.4%(45/56) in the treatment group vs.58.9%(33/56) in the control group, showing statistically significant difference between the two groups ( P <0.05 ) .76.8% ( 43/56 ) in the treatment group vs.55.4% ( 31/56 ) in the control group showed improvement in quality of life, showing statistically significant difference between the two groups ( P<0.05).The adverse drug reactions including gastrointestinal reactions, chest pain, bone marrow suppression etc were milder in the treatment group than in the control group.CONCLUSIONS:Compound Kushen injection plus nedaplatin was proved to be a safe and feasible therapy with confirmed efficacy and mild adverse reaction in treatment of malignant pleural effusion in patients with lung cancer.
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