Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China.
J Evid Based Med. 2011 May;4(2):122-9. doi: 10.1111/j.1756-5391.2011.01121.x.
To evaluate the effectiveness and safety of Mycobacterium vaccae (M.vaccae, MV) for prevention of HIV-associated tuberculosis (TB).
MEDLINE, Embase, Biosis, the Cochrane Central Register of Controlled Trials, SCI, CBM, VIP, and CNKI were searched for relevant randomized controlled trials (RCTs) and non-randomized controlled trials (NRCTs). The GRADE approach was used for quality assessment. Data were analyzed using RevMan 5.0 software.
were described or pooled using relative risks (RRs) for binary outcomes with 95% confidence intervals (CIs). Results Seven studies were included, and the methodological quality assessment found there was a risk of methodological bias. The evidence quality of the critical endpoint was moderate. The incidence of definite TB was (33/1006 vs. 52/1007, P = 0.03). The levels of IFN-γ response to M. vaccae sonicate (MVS) in MV recipients increased compared to baseline or control groups after three or five doses. MV recipients' level of lymphocyte proliferation assays (LPAs) in response to MVS was higher than that of the saline group after a five-dose series (RR = 2.49, 95% CI 1.40 to 4.41, P = 0.002). Compared to hepatitis B vaccine (HBV) recipients, LPAs to MVS were not significantly different in the MV group vs. saline group, or vs. HBV, after a three-dose series (RR and 95% CI were 0.20 (-0.03 to 0.44) and 1.13 (0.26 to 4.91), respectively). Changes in CD4+ cell count and HIV viral load after immunization were not statistically significant. MV immunization had no systematic adverse effects.
The current evidence indicates that MV is safe and well-tolerated. It appears to prevent HIV-infected patients with CD4+≥ 200/mm(3) from contracting TB by enhancing their immunogenicity. Yet, because of the relatively low quality of the available evidence, well-designed and -conducted RCTs are needed.
评估卡介苗（MV）预防 HIV 相关结核病（TB）的有效性和安全性。
检索 MEDLINE、Embase、Biosis、Cochrane 对照试验中心注册库、SCI、CBM、VIP 和中国知网（CNKI），以查找相关的随机对照试验（RCT）和非随机对照试验（NRCT）。采用 GRADE 方法进行质量评估。使用 RevMan 5.0 软件进行数据分析。
采用二项结局的相对风险（RR）描述或合并，置信区间（CI）为 95%。结果：共纳入 7 项研究，方法学质量评估发现存在方法学偏倚风险。关键结局的证据质量为中等。确定型 TB 的发生率为（33/1006 比 52/1007，P=0.03）。MV 组接受三剂或五剂 MV 后，对 M. vaccae 超声提取物（MVS）的 IFN-γ 反应水平较基线或对照组升高。MV 组接受五剂系列 MVS 后，淋巴细胞增殖试验（LPA）对 MVS 的反应水平高于生理盐水组（RR=2.49，95%CI 1.40 至 4.41，P=0.002）。与乙肝疫苗（HBV）组相比，MV 组与生理盐水组或 HBV 组在接受三剂系列免疫后，MVS 的 LPA 无显著差异（RR 和 95%CI 分别为 0.20（-0.03 至 0.44）和 1.13（0.26 至 4.91））。免疫接种后 CD4+细胞计数和 HIV 病毒载量的变化无统计学意义。MV 免疫接种无系统不良反应。
目前的证据表明，MV 安全且耐受良好。它似乎通过增强免疫原性来预防 CD4+≥200/mm³的 HIV 感染者患 TB。然而，由于现有证据质量相对较低，需要进行精心设计和实施的 RCT。
