Bull World Health Organ. 1972;46(3):371-85.
This paper reports the 15-year results of a controlled clinical trial of BCG and vole bacillus vaccines in the prevention of TB. Among 54 239 participants, 583 cases of TB developed, of which 70% were of pulmonary TB and 15% of tuberculous pleural effusion without evidence of pulmonary TB. The annual incidence (per 1 000) of TB was 0.28 among the 13 598 BCG-vaccinated participants and 1.28 among the tuberculin-negative unvaccinated participants admitted concurrently (a 78% reduction); for vole bacillus vaccine (5 817 participants) the figures were 0.29 and 1.50 (an 81% reduction). Protection extended to all forms of TB (in particular, 10 cases of tuberculous meningitis or miliary pulmonary TB developed in unvaccinated, and none in vaccinated, participants) and was similar in the two sexes. It decreased gradually during the period but was still substantial (59% for BCG vaccine and 73% for vole bacillus vaccine) 10-15 years after vaccination; no definite conclusion can yet be reached on the level of protection after 15 years. The annual incidence of TB in those with strong positive reactions to tuberculin on entry was particularly high (3.75) in the first 2.5 years, reflecting active infections acquired before entry; those with weaker positive reactions on entry had a lower incidence throughout than the tuberculin-negative unvaccinated group, indicating that a degree of naturally acquired immunity (though less than that conferred by vaccination) was associated with the low-grade tuberculin sensitivity. The incidence of every form of TB decreased steeply during the 15 years, except for genito-urinary TB of which there were 3, 5, and 14 cases in successive 5-year periods, principally among initially tuberculin-positive participants. This report also presents the findings with respect to nontuberculous diseases, discusses the place of vole bacillus vaccination, and describes a method for assessing the applicability of mass BCG vaccination in a given epidemiological situation.
本文报告了一项关于卡介苗和田鼠杆菌疫苗预防结核病的对照临床试验的15年结果。在54239名参与者中，发生了583例结核病，其中70%为肺结核，15%为结核性胸膜炎且无肺结核证据。在13598名接种卡介苗的参与者中，结核病的年发病率（每1000人）为0.28，同期入院的结核菌素阴性未接种疫苗的参与者中为1.28（降低了78%）；对于田鼠杆菌疫苗（5817名参与者），相应数字分别为0.29和1.50（降低了81%）。保护作用涵盖所有形式的结核病（特别是，未接种疫苗的参与者中发生了10例结核性脑膜炎或粟粒性肺结核，而接种疫苗的参与者中无一例发生），且在两性中相似。在接种疫苗后的这段时间内，保护作用逐渐降低，但在接种后10至15年时仍相当显著（卡介苗疫苗为59%，田鼠杆菌疫苗为73%）；对于15年后的保护水平，目前尚无明确结论。入组时结核菌素强阳性反应者在前2.5年中结核病的年发病率特别高（3.75），这反映了入组前获得的活动性感染；入组时结核菌素阳性反应较弱者在整个研究期间的发病率低于结核菌素阴性未接种疫苗组，这表明一定程度的自然获得性免疫（尽管低于接种疫苗所赋予的免疫）与低度结核菌素敏感性相关。除了泌尿生殖系统结核外，每种形式的结核病发病率在15年期间均急剧下降，泌尿生殖系统结核在连续的5年期间分别有3例、5例和14例，主要发生在最初结核菌素阳性的参与者中。本报告还介绍了关于非结核性疾病的研究结果，讨论了田鼠杆菌疫苗接种的地位，并描述了一种评估在特定流行病学情况下大规模接种卡介苗适用性的方法。
