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document
[ Randomized controlled study of OK-432 in the treatment of cancerous pleurisy ] . 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 .
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Intervention_Pharmacological
OK-432
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Intervention_Pharmacological
OK-432 , streptococcus preparation
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Intervention_Pharmacological
OK-432
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Intervention_Control
control group .
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Intervention_Pharmacological
50 mg of adriamycin and a combination chemotherapy of MFC ( mitomycin
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Intervention_Pharmacological
ara-C
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Intervention_Pharmacological
OK-432
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Outcome_Physical
cancerous pleurisy
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Outcome_Mortality
survived significantly longer
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Outcome_Adverse-effects
skin reaction
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Participant_Condition
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 .