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支气管癌患者皮内注射卡介苗的分层随机研究:不可手术患者生活质量延长但生存期未延长

A stratified randomized study of intradermal BCG in patients with carcinoma of the bronchus: prolongation of quality but not length of life in inoperable patients.

作者信息

Anthony H M, Madsen K E, Mason M K, Templeman G H

出版信息

Cancer. 1978 Oct;42(4):1784-92. doi: 10.1002/1097-0142(197810)42:4<1784::aid-cncr2820420417>3.0.co;2-m.

Abstract

This paper reports the results of a stratified, randomized trial of monthly intradermal injections of Glaxo BCG in addition to conventional therapy (surgery, radiotherapy or no treatment) in a consecutive series of 75 men with confirmed bronchial carcinoma. BCG treatment did not significantly prolong survival but had consistenly more effect in prolonging the period in good general condition and in "acceptable" clinical condition. These were significantly prolonged among the BCG patients (all histopathologies) treated with a full course of radiotherapy (p = 0.01, p = 0.005) and among the 43 patients with squamous carcinoma after adjustment for treatment and general prognostic factors (ratio of observed to expected deaths (O/E) for BCG 0.65, P = 0.025). There was a tendency for BCG patients with oat cell carcinoma to survive less well than controls (O/E for BCG 1.40 not significant). Within comparable groups of patients with squamous carcinoma the delay in decline of general condition was accompanied by reduced weight loss.

摘要

本文报告了一项分层随机试验的结果。该试验对75例确诊为支气管癌的男性患者,在常规治疗(手术、放疗或不治疗)基础上,每月皮内注射葛兰素卡介苗。卡介苗治疗并未显著延长生存期,但在延长总体状况良好和“可接受”临床状况的时间方面,始终具有更明显的效果。在接受全程放疗的卡介苗治疗患者(所有组织病理学类型)中,以及在43例鳞状细胞癌患者中,经治疗和一般预后因素调整后,这些时间显著延长(卡介苗组观察到的与预期死亡之比(O/E)为0.65,P = 0.025)。燕麦细胞癌的卡介苗治疗患者有生存期不如对照组的趋势(卡介苗组O/E为1.40,无显著性差异)。在鳞状细胞癌患者的可比组中,总体状况下降延迟伴随着体重减轻减少。

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