Law M R, Lam W K, Studdy P R, Pugsley W B, Hodson M E
Br J Dis Chest. 1982 Apr;76(2):151-6.
Seventy-eight patients entered a randomized study of postoperative intrapleural BCG in the treatment of bronchial carcinoma. 39 patients received BCG (Tice strain), of whom 17 took isoniazid, and there were 39 controls. There was a high rate of complications related to the use of intrapleural BCG, in both isoniazid and non-isoniazid treated groups. Postoperative infections occurred in eight BCG treated patients and one control; seven BCG treated patients but only one control developed prolonged postoperative chest pain. Empyema developed six months postoperatively in three of the BCG treated group. Furthermore BCG conferred no survival advantage at one year. We considered the complications to be of sufficient severity and incidence to discontinue the study.
78名患者进入了一项关于术后胸腔内注射卡介苗治疗支气管癌的随机研究。39名患者接受了卡介苗(Tice菌株)治疗,其中17名服用异烟肼,另有39名作为对照。在使用胸腔内卡介苗的患者中,无论是否接受异烟肼治疗,并发症发生率都很高。接受卡介苗治疗的患者中有8例发生术后感染,对照组有1例;接受卡介苗治疗的患者中有7例出现术后长时间胸痛,而对照组只有1例。卡介苗治疗组中有3例在术后6个月发生脓胸。此外,卡介苗在一年时并未带来生存优势。我们认为并发症的严重程度和发生率足以使我们终止该研究。