OK-432胸腔给药治疗癌性胸腔积液的临床研究

THE CLINICAL STUDY OF TREATING CARCINOMATOUS PLEURAL EFFUSION WITH INTRAPLEURAL ADMINISTRATION OF OK-432

目的 :观察OK 4 32治疗癌性胸腔积液的临床疗效及调节免疫功能的作用。方法 :癌症伴胸腔积液病人 32例随机分为 2组 :实验组为OK 4 32治疗组 16例 ;对照组为IL 2治疗组 16例。所有患者均经胸腔穿刺并埋置软管尽量放尽胸水 ,实验组OK 4 32总量 2 5KE ,分 3次注入胸腔 ;对照组IL 2总量 4 0 0万U ,分 4次注入胸腔。检测实验组患者治疗前后外周血CD3+、CD4 +、CD8+、CD4 +/CD8+、NK细胞水平 ,同时检测外周血血浆TNF α、IL 1β、IL 6。 结果 :按Miller标准 ,OK 4 32治疗癌性胸水总有效率为 81 2 5% ,IL 2治疗总有效率为 75% ,两组疗效差异无显著性 (Fisher精确概率P >0 .0 5) ;OK 4 32治疗后 ,患者外周血CD4 +、CD4 +/CD8+、NK细胞水平有显著性提高 (P <0 0 5) ,TNF α、IL 1β、IL 6均有显著性提高 (P <0 0 1或P <0 0 5)。结论 :OK 4 32治疗癌性胸水具有很好的疗效 ,OK 4 32可以改善肿瘤患者细胞免疫功能和增强细胞因子的表达。

Objective:To evaluate the efficacy of OK 432 (streptococcal preparation) in treating carcinomaous pleural effusion and observe the regulation of patients'immunol function.Methods:32 patients who had been diagnosed cancer complicated with carcinomatous pleural effusion were treated in the respiratory systematic ward from Oct.1997 to Mar.1999.They were divided into 2 groups randomly:test group treated by OK 432 and control group treated by IL 2(Interleukin 2) respectively had 16 patients.All patients were treated by tube drainage at first,then followed by 25KE intrapleural instillation of OK 432 for three times in 9 days or 4 Million units intrapleural instillation of IL 2 for four times in 2 weeks.T lymphocyts subpopulation CD 3 +,CD 4 +,CD 8 +,CD 4 +/CD 8 +NK and serum cytokins TNF α,IL 1β,IL 6 of patients in test group were tested pre and post therapy.Results:The effective rate was 81.25% in test group,and 75% in control group,but there was no significant difference in 2 groups;in patients' peripheral blood,CD 4 +,CD 4 +/CD 8 +,NK,TNF α,IL 1β,IL 6 had improved after treatment with OK 432,and there was significant difference pre and post therapy.Conclusion:Treatment of carcinomatous pleural effusions with OK 432 has good efficacy,and OK 432 can improve patients' T lymphocyte immunol function and enhance the expression of cytokins.