Chinese Evidence-Based Medicine Center/The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
J Infect. 2010 May;60(5):320-30. doi: 10.1016/j.jinf.2010.02.005. Epub 2010 Feb 13.
To evaluate the effectiveness and safety of Mycobacterium vaccae (MV) in prevention of tuberculosis (TB) among high risk people.
Database of MEDLINE, EMBASE, BIOSIS, SCI, Cochrane Central Register of Controlled Trials, CBM, CNKI and VIP were searched till July 2009. Randomized controlled trials (RCTs) or non-randomized controlled clinical trials (CCTs) investigating MV as interventions in people at high risk of TB were identified for critical appraisal. Two reviewers independently performed data extraction and quality assessment. Effectiveness of MV was summarized in different group of risk people through RevMan 5.0 by The Cochrane Collaboration.
Thirteen studies were included. Risk difference (RD) of protection index (PI), its 95% confidence interval (95%CI) and the P value were as following: MV vs. Isoniazid (INH): 0.02 (-0.01, 0.05) (P=0.12); MV vs. (INH plus RFT): 0.00 (-0.00, 0.00) (P=1.00); MV vs. Blank: 0.04 (0.00, 0.08) (P=0.03) for soldiers with PPD strong positive; 0.00 (-0.00, 0.00) (P=0.05) for students with PPD strong positive; 0.20 (0.05, 0.36) (P=0.01) for aged people of clinical cured pulmonary TB, and 0.08 (0.01, 0.14) (P=0.03) for type 2 diabetes mellitus. In HIV-infected people, The Risk Ratio (RR) of MV vs. CV (control vaccine) of positive stimulation index (SI) (> or = 3) in lymphocyte proliferation assays (LPA) to Mycobacterium vaccae sonicate (MVS) was 2.39 with 95% CI (1.56, 3.66), P<0.0001. Immunization had no adverse effects on CD4 cell count or HIV viral load. The most frequent adverse effects of MV were induration and sore arm.
Available evidence shows that MV is effective in preventing TB in PPD strong positive/type 2 diabetes mellitus/aged people of clinical cured pulmonary TB, and is safe, well-tolerated and effective in inducing biologically relevant immune response against TB in HIV-infected patients. High-quality trials aimed at different groups of high risk people are encouraged.
评估卡介苗（MV）预防高危人群结核病（TB）的有效性和安全性。
检索 MEDLINE、EMBASE、BIOSIS、SCI、Cochrane 对照试验中心注册数据库、CBM、CNKI 和 VIP，检索截止日期为 2009 年 7 月。对 MV 作为高危人群 TB 干预措施的随机对照试验（RCT）或非随机对照临床试验（CCT）进行严格评价。两位评审员独立进行数据提取和质量评估。采用 Cochrane 协作网 RevMan 5.0 软件汇总不同风险人群的 MV 有效性。
纳入 13 项研究。保护指数（PI）的差异风险（RD）及其 95%置信区间（95%CI）和 P 值如下：MV 与异烟肼（INH）：0.02（-0.01，0.05）（P=0.12）；MV 与（INH 加 rifampicin，RFT）：0.00（-0.00，0.00）（P=1.00）；MV 与空白：PPD 强阳性士兵 0.04（0.00，0.08）（P=0.03）；PPD 强阳性学生 0.00（-0.00，0.00）（P=0.05）；临床治愈的肺结核老年患者 0.20（0.05，0.36）（P=0.01）；2 型糖尿病患者 0.08（0.01，0.14）（P=0.03）。在 HIV 感染患者中，MV 与对照疫苗（CV）对淋巴细胞增殖试验（LPA）中 MV sonicat（MVS）阳性刺激指数（SI）（≥3）的风险比（RR）为 2.39，95%CI（1.56，3.66），P<0.0001。免疫接种对 CD4 细胞计数或 HIV 病毒载量没有不良影响。MV 最常见的不良反应是硬结和手臂疼痛。
现有证据表明，MV 对 PPD 强阳性/2 型糖尿病/临床治愈的肺结核老年患者预防结核病有效，且在 HIV 感染患者中安全、耐受良好，能有效诱导针对结核病的生物学相关免疫应答。鼓励针对不同高危人群进行高质量试验。
