济南假单胞菌苗（PJV）治疗恶性胸腔积液的临床验证总结

RESULTS OF PHASE Ⅱ TRIALS OF PSEUDOMONAS JINANENSIS VACCINE(PJV)IN TREATMENT OF PLEURAL EFFUSION

用济南假单胞菌苗胸膜腔内注射治疗恶性胸膜腔积液进行前瞻性Ⅱ期临床研究。病人共126例,其中肺癌合并胸膜腔积液者96例,乳腺癌13例,恶性淋巴瘤8例,其它肿瘤9例。2～8ml/次,1次/周。结果表明:总有效率为80.2%。其中肺癌合并胸水者的疗效为83.3%(80/96)、乳腺癌76.9%(10/13)、恶性淋巴瘤75%(6/8)、其它肿瘤55.5%(5/9)。其中有15例既往胸膜腔内曾注射丝裂霉素或顺铂无效,改用 PJV后其中8例有效。本品的主要副作用有发热和局部疼痛,少数病人有恶心、呕吐。

The results of a prospective multi-centre phases Ⅱ clinical trials onPJV,a new drug,in the management of malignant pleural effusions are presented.126 patients including 96 lung cancer,13 breast cancer,8 malignant lymphomas,and 9other malignancies,with malignant pleural effusion were evaluated.The over all re-sponse rate was 80 2% and the individual response rate was 83.3%(43 CR,37 PR,16NE)for lung cancer,76.9%(5 CR,5 PR,3 NE)for breast cancer,75.0%(3 CR,3PR,2 NE)for malignant lymphomas and 55.6%(3 CR,2 PR,4 NE )for other malig-nancies.15 patients who did not response to intrapleural Mitomycin or Cisplatin,8 ofthem responded after PJV.Fever,local pain,nausea and vomiting are the main sideeffects observed.