Zodpey S P, Ambadekar N N, Thakur A
Clinical Epidemiology Unit, Government Medical College, Nagpur, India.
Public Health. 2005 Mar;119(3):209-16. doi: 10.1016/j.puhe.2004.04.007.
To estimate the effectiveness of Bacillus Calmette Guerin (BCG) vaccination in the prevention of leprosy. Study design. Population-based case-control study.
The study was carried out in Yavatmal District, Maharashtra, India. It included 364 cases of leprosy (diagnosed by the World Health Organization's criteria), born since 1962, that were detected during a leprosy survey conducted by the Government of Maharashtra in 2,175,514 people. Each case was pair-matched with one neighbourhood control for age, sex and socio-economic status. Exclusion criteria for controls included past or current history of tuberculosis or leprosy. BCG vaccination status was assessed by examination for the presence of a BCG scar, immunization records if available and information from subjects/parents of children. Subjects who were uncertain about BCG vaccination were not included.
A significant protective association between BCG and leprosy was observed [odds ratio=0.46, 95% confidence intervals (CI) 0.34-0.61]. Overall vaccine effectiveness (VE) was 54% (95% CI 39-66). BCG effectiveness against multibacillary, paucibacillary and single skin lesion leprosy was 68% (95% CI 26-86), 57% (95% CI 29-74) and 48% (95% CI 22-65), respectively. Analysis of linear trend revealed a significant linear association between the protective effect of BCG and the type of leprosy. The BCG vaccine was more effective in those aged < or =20 years compared with those aged >20 years (VE 61%, 95% CI), among females compared with males (VE 60%, 95% CI), in lower socio-economic strata compared with upper and middle strata (VE 57%, 95% CI), and in subjects who had a BCG scar size < or =5 mm compared with those with a BCG scar size >5 mm (VE 61%, 95% CI). However, these differences were not statistically significant, as reflected by the overlapping 95% CIs. The overall prevented fraction was 35% (95% CI 22-46).
The current study identified a beneficial role of BCG vaccination in the prevention of leprosy in the study population.
评估卡介苗（BCG）接种在预防麻风病方面的效果。研究设计：基于人群的病例对照研究。
该研究在印度马哈拉施特拉邦的亚瓦特马尔区开展。研究纳入了364例自1962年起出生、在马哈拉施特拉邦政府对2175514人进行的麻风病调查中被确诊的麻风病患者（根据世界卫生组织的标准诊断）。每例患者按年龄、性别和社会经济地位与一名社区对照进行配对。对照的排除标准包括过去或当前的结核病或麻风病史。通过检查是否存在卡介苗疤痕、如有免疫记录以及从受试者/儿童家长处获取的信息来评估卡介苗接种状况。不确定是否接种过卡介苗的受试者未被纳入。
观察到卡介苗与麻风病之间存在显著的保护关联[比值比=0.46，95%置信区间（CI）0.34 - 0.61]。总体疫苗效力（VE）为54%（95%CI 39 - 66）。卡介苗对多菌型、少菌型和单皮损麻风病的效力分别为68%（95%CI 26 - 86）、57%（95%CI 29 - 74）和48%（95%CI 22 - 65）。线性趋势分析显示卡介苗的保护作用与麻风病类型之间存在显著的线性关联。与20岁以上人群相比，卡介苗疫苗在20岁及以下人群中更有效（VE 61%，95%CI）；与男性相比，在女性中更有效（VE 60%，95%CI）；与中上层社会经济阶层相比，在较低社会经济阶层中更有效（VE 57%，95%CI）；与卡介苗疤痕大小>5mm的受试者相比，在疤痕大小≤5mm的受试者中更有效（VE 61%，95%CI）。然而，这些差异无统计学意义，95%CI重叠即反映了这一点。总体预防率为35%（95%CI 22 - 46）。
当前研究确定了卡介苗接种在研究人群预防麻风病方面的有益作用。
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