Urata A, Nishimura M, Ota K
Gan To Kagaku Ryoho. 1983 Jun;10(6):1497-503.
A randomized controlled study was performed to evaluate the efficacy of intrapleural and systemic administration of OK-432, streptococcus preparation, in patients with cancerous pleurisy. A total of 53 patients were accessed to the study: 29 patients for the OK-432 group and 24 patients for the control group. Intrapleural instillation of 50 mg of adriamycin and a combination chemotherapy of MFC (mitomycin C 0.08 mg/kg, 5-FU 10 mg/kg, ara-C 0.8 mg/kg iv, weekly) were administered in both groups. In the OK-432 group intrapleural instillation of 2 units of OK-432 was administered daily until disappearance of pleural effusion; thereafter, 2 to 5 units of OK-432 were administered intradermally every other day. Patients with stage III in the OK-432 group survived significantly longer than those in the control group (P less than 0.05), but there was no significance between in patients with stage IV of both treatment groups. Also patients with PPD negative skin reaction at the time of beginning of treatment in the OK-432 group survived significantly longer than those in the control group (P less than 0.001), but there was no significance between both treatment groups in patients with PPD positive skin reaction at the time of beginning of treatment. Eighteen (62%) of 29 patients treated with OK-432 had a fever, but well tolerated.
进行了一项随机对照研究，以评估胸膜内和全身给予链球菌制剂OK-432对癌性胸膜炎患者的疗效。共有53例患者参与该研究：OK-432组29例，对照组24例。两组均给予胸膜内滴注50mg阿霉素以及MFC联合化疗（丝裂霉素C 0.08mg/kg、5-氟尿嘧啶10mg/kg、阿糖胞苷0.8mg/kg静脉注射，每周一次）。OK-432组每天胸膜内滴注2单位OK-432，直至胸腔积液消失；此后，每隔一天皮内注射2至5单位OK-432。OK-432组的III期患者存活时间明显长于对照组（P<0.05），但两个治疗组的IV期患者之间无显著差异。此外，OK-432组治疗开始时PPD皮肤反应阴性的患者存活时间明显长于对照组（P<0.001），但治疗开始时PPD皮肤反应阳性的患者在两个治疗组之间无显著差异。接受OK-432治疗的29例患者中有18例（62%）出现发热，但耐受性良好。
