S_(311)抗癌菌苗治疗癌性胸腔积液的临床研究

Treatment of malignant pleural effusion using S_(311) anticancer vaccine by intrapleural injection

目的 :探讨胸腔内注入S31 1 抗癌菌苗治疗癌性胸腔积液的疗效及毒副反应。方法 :病理确诊的癌性胸腔积液 6 4例 ,随机分为 2组 ,在排净胸水后治疗组 (32例 )胸腔内注入S31 1 抗癌菌苗 0 .16mg;对照组 (32例 )胸腔内注入顺铂 (DDP) 4 0mg m2 ,无效者一周后重复 1次 ,最多 3次 ,观察疗效、生活质量、生存率及毒副反应。结果 :治疗组 32例均可评价 ,对照组可评价者 30例。治疗组总有效率 90 .6 % ,对照组 6 0 .0 % ,差异有显著性 (P <0 .0 1) ;Karnofsky评分改善率治疗组和对照组分别为 84 .4 %和 5 3.3% ,差异呈显著性 (P <0 .0 1) ;治疗组 0 .5年、1年、1.5年生存率为 93.8%、6 2 .5 %和 4 0 .6 % ,分别高于对照组的 70 .0 %、36 .7%和 16 .7% ,差异有显著性 (P <0 .0 5 )。治疗组副反应主要是胸痛 (18.8% )和发热 (15 .6 % ) ,无骨髓抑制。对照组骨髓抑制、恶心呕吐反应明显 ,与治疗组比较差异有显著性 (P <0 .0 1)。结论 :胸腔内注入S31 1 抗癌菌苗治疗癌性胸腔积液有效率高、副反应小 。

Purpose:To evaluate the efficacy of treating malignant pleural effusion with S 311 anticancer vaccine by intrapleural injection.Methods:62 cases with malignant pleural effusion,after drainage, S 311 anticancer vaccine 0.16 mg was injected into the pleural cavity in therapy group (T),and cisplatine 40 mg/m 2 in control group (C).The treatment was repeated after a week , then the efficacy, quality of life, survival rate and toxicities was evaluated.Results:The response rate was 90.6% in T group and 60.0% in C group. There was statistical difference between the two groups ( P <0.01).The Karnofsky score is higher in T group than in C group ( P <0.01).The half year ,one year ,one and half year survival rates were 93.8% ,62.5% ,40.6% in T group and 70.0% ,36.7% ,16.7% in C group ( P <0.05).Main side reactions included pleuritic pain and fever in T group. No myelosuppression occurred in T group. Leukopenia , nausea and vomiting in C group were serious( P <0.01).Conclusions:The treatment by S 311 anticancer vaccine by intrapleural injection is regarded as an effective method for malignant pleural effusion,with only slight side effects.