济南假单胞菌苗注射液治疗恶性胸腔积液的Ⅲ期临床观察

RESULTS OF PHASE Ⅲ CLINICAL TRIAL OF PSEUDOMONAS JINANENSIS VACCINE INJECTION(PVI)IN THE TREATMENT OF MALIGNANT PLEURAL EFFUSION

１９９３年４月～１９９４年９月间，作者用济南假单胞菌苗注射液（商品名佳代胞，简称ＰＶＩ）胸腔内注射治疗恶性胸膜腔积液，并进行了前瞻性多中心研究。在５０９例接受ＰＶＩ治疗的病人中，肺癌合并胸膜腔积液者３８２例、乳腺癌５４例、淋巴瘤１６例、其它肿瘤５７例，总有效率为８２．７％（４２１／５０９）。在对照组４１例接受顺铂治疗的病人中，肺癌３１例，乳腺癌６例，其它肿瘤４例，总有效率为６１．０％（２５／４１）。ＰＶＩ组的主要不良反应以发热和局部疼痛为主，而顺铂组的主要不良反应则是恶心、呕吐及骨髓抑制。

AbstractFrom April 1993 to September 1994,a prospective multicenter phase Ⅲ clinical trial on PVIin the management of malignant effusion was carried out.Five hundred and nine patients,includ-ing 382 with lung cancer, 54 with breast cancer, 16 with malignant lymphoma,57 with other ma-lignancies complicated with pleural effusion were treated with intrapleural injections of PVI.Theover-all response rate was 82.7%(421/509 ).For comparison,41 patients with cancer of thelung(n=31),breast(n= 6) and other sites(n=4)also complicated with pleural effusion weretreated by intrapleural PDD,The overall response rate in the latter treatment group was 61.0%(25/41).Fever and local pain were the major adverse reactions in the PVI treated patients whilenausea,vomiting and myelosuppression in the PDD-treated control patients.