大剂量复方苦参注射液治疗中晚期恶性肿瘤的有效性和安全性

Safety and effectiveness of large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors

目的评价大剂量应用复方苦参注射液治疗中晚期恶性肿瘤的有效性和安全性。方法采用非随机病例对照的研究方法，选取有明确病理诊断的中晚期肺癌和胃肠道肿瘤带瘤患者，依据治疗方案的不同，分为大剂量（20ml／d）应用苦参注射液的中药治疗组和化疗组各48例。结果中药治疗组有47例患者、化疗组有46例患者完成治疗。中药治疗组患者的临床受益率为83．0％，明显高于化疗组（69．6％，P〈0．01）。中药治疗组患者的Karnofsky评分提高率为57．4％，体重提高率为48．9％，均明显高于化疗组（30．4％和19．6％，P〈0．05）。中药治疗组仅有1例患者出现轻度皮肤刺激反应，未发现其他与大剂量应用复方苦参注射液有关的临床不良反应。结论对于中晚期恶性肿瘤患者大剂量应用复方苦参注射液安全、有效，推荐剂量为20ml／d。

Objective To evaluate the effectiveness and safety of large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors. Methods A non-randomized case control trial was conducted. Ninety six patients with pathologically confirmed advanced non-small-cell lung cancer, gastric cancer and colorectal cancer were divided into traditional Chinese medicine group and chemotherapy group, 48 cases each. Patients of the traditional Chinese medicine group received treatment with large dose of compound Sophoraflavescens Air injection （20 ml/d）, and 21 days as a cycle. Results Fortyseven patients of the traditional Chinese medicine group and 46 patients of the chemotherapy group completed their treatment, respectively. The clinical benefit rate （CBR） in the traditional Chinese medicine group was 83.0%, significantly higher than that in the chemotherapy group （69.6%） （P 〈0.01）. The Karnofsky performance status and weight improvement in the traditional Chinese medicine group was superior to that in the chemotherapy group （ P 〈 0.05 ）. Except the skin irritation in one patient in the traditional Chinese medicine group, there were no other clinical adverse effects related with the large dose compound Sophora flavescens Ait injection. Conclusions Large dose compound Sophoraflavescens Ait injection in the treatment of advanced malignant tumors is safe and effective. The recommended dose is 20 ml/d.