治疗用粘质沙雷氏菌菌苗(S311)治疗癌性胸腔积液的Ⅱ期临床研究

The phase Ⅱ clinical trial of Seratia Marcescens Anticancer Vaccine (S311)for malignant pleural effusions

目的 评价S311治疗癌性胸腔积液的疗效及毒副作用。方法 经胸穿或闭式引流抽净胸水后 ,胸腔注入S3110 .32mg ,每周 1次 ,连续 3周 ,停药后观察 1个月评价疗效。结果 2 41例患者完成胸腔注入S311治疗 ,总有效率 92 .1%。主要的不良反应为发热和胸痛 ,发生率分别为 81.0 %和 5 2 .2 %。少数患者出现寒战、呼吸困难、恶心、呕吐 ,个别患者出现肝功能异常。结论 粘质沙雷氏菌菌苗 (S311)是一种治疗癌性胸腔积液的有效药物。

Objective To evaluate the effect and adverse reactions of Seratia Marcescens Anticancer Vaccine (S311) in the treatment of malignant pleural effusions. Methods 0.32?mg of S311 was administered into intracavity once a week, for successive three weeks, after draining off the pleural cavity completely by thoracocentesis or chest drainage. Results Two hundred and forty-one patients with malignant effusions finished the arrangement of S311 therapy. The overall response rate was 92.1%. The main adverse reactions were fever and pleuritic pain. Some patients had chill, dyspnea, nausea and vomiting. Liver dysfunction was observed in a few cases. Conclusion S311 is an effective drug for malignant pleural effusions.