Masuno T, Kishimoto S, Ogura T, Honma T, Niitani H, Fukuoka M, Ogawa N
Department of Medicine III, Osaka University Medical School, Japan.
Cancer. 1991 Oct 1;68(7):1495-500. doi: 10.1002/1097-0142(19911001)68:7<1495::aid-cncr2820680705>3.0.co;2-6.
The efficacy and safety of intrapleural LC9018 (Yakult Co. Ltd., Tokyo, Japan) with or without doxorubicin (Adriamycin; Adria Laboratories, Columbus, OH) were evaluated in a randomized, controlled trial performed in 95 patients with malignant pleural effusions secondary to lung cancer. Seventy-six patients were eligible for the assessment of efficacy. The response rate for treatment with intrapleural doxorubicin plus LC9018 (38 patients) was 73.7%, which was significantly higher than the response rate of 39.5% for the control group treated with doxorubicin alone (38 patients) (P less than 0.01). The LC9018 group also showed a significantly greater improvement in performance status (PS) and symptoms (chest pain, chest discomfort, and anorexia) than the control group (P less than 0.05). A significant prolongation of survival was noticed in the LC9018 group (P less than 0.05). The main side effects of LC9018 were fever and transient hepatic dysfunction, but there were no serious adverse reactions. These results suggest that the intrapleural instillation of LC9018 can be recommended for the treatment of malignant pleural effusions.
在一项针对95例肺癌继发恶性胸腔积液患者开展的随机对照试验中，评估了单独或联合阿霉素（阿霉素；阿德里亚实验室，俄亥俄州哥伦布市）胸腔内注射LC9018（养乐多公司，日本东京）的疗效和安全性。76例患者符合疗效评估标准。胸腔内注射阿霉素加LC9018治疗组（38例患者）的缓解率为73.7%，显著高于单独使用阿霉素治疗的对照组（38例患者）的缓解率39.5%（P<0.01）。LC9018组在体能状态（PS）和症状（胸痛、胸部不适和厌食）方面的改善也显著大于对照组（P<0.05）。LC9018组患者的生存期显著延长（P<0.05）。LC9018的主要副作用是发热和短暂性肝功能障碍，但未出现严重不良反应。这些结果表明，胸腔内注射LC9018可推荐用于治疗恶性胸腔积液。
