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未治疗过的结核病患者中分枝杆菌 vaccae 作为抗结核化学疗法的佐剂治疗：一项荟萃分析。

Mycobacterium vaccae as adjuvant therapy to anti-tuberculosis chemotherapy in never-treated tuberculosis patients: a meta-analysis.

机构信息

Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.

出版信息

PLoS One. 2011;6(9):e23826. doi: 10.1371/journal.pone.0023826. Epub 2011 Sep 6.

DOI:10.1371/journal.pone.0023826
PMID:21909406
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3167806/
Abstract

OBJECTIVE

To evaluate the effectiveness and safety of heat-killed M. vaccae added to chemotherapy of never-treated tuberculosis (TB) patients.

METHODS

The databases of Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, SCI, CBM, VIP and CNKI were searched. Randomized controlled trials (RCT) and Controlled clinical trials (CCT) comparing M. vaccae with or without a placebo-control injection as adjuvant therapy in the chemotherapy of never-treated TB patients were included. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 5.0 software by The Cochrane Collaboration.

RESULTS

Fifty four studies were included. At the end of the follow-up period, Pooled RR (Risk Ratio) and its 95% CI of sputum smear conversion rate were 1.07 (1.04, 1.10) in TB patients without complications, 1.17 (0.92, 1.49) in TB patients with diabetes mellitus, 1.02 (0.94, 1.10) in TB patients with hepatitis B, and 1.46 (0.21, 10.06) in TB patients with pneumosilicosis. In elderly TB patients the RR was 1.22 (1.13, 1.32). Analysis of each time point during the follow-up period showed that M. vaccae could help to improve the removal of acid-fast bacilli from the sputum, and promote improvement of radiological focal lesions and cavity closure. Compared with the control group, the differences in levels of immunological indicators of Th1 such as IL-2 and TNF-α were not statistical significant (P = 0.65 and 0.31 respectively), and neither was that of IL-6 produced by Th2 (P = 0.52). An effect of M. vaccae of prevention of liver damage was found in TB patients with hepatitis B (RR 0.20 and 95% CI (0.12, 0.33). No systemic adverse events were reported.

CONCLUSION

Added to chemotherapy, M. vaccae is helpful in the treatment of never-treated TB patients in terms of improving both sputum conversion and X-ray appearances.

摘要

目的

评估加热杀死的 M. vaccae 联合初治结核病（TB）患者化疗的有效性和安全性。

方法

检索 Medline、Embase、Biosis、Cochrane 对照试验中心注册库、SCI、CBM、VIP 和中国知网（CNKI）数据库。纳入比较加热杀死的 M. vaccae 联合或不联合安慰剂对照注射作为初治 TB 患者化疗辅助治疗的随机对照试验（RCT）和对照临床试验（CCT）。两位评价者独立提取数据和评价质量。采用 The Cochrane Collaboration 的 RevMan 5.0 软件进行数据分析。

结果

共纳入 54 项研究。在随访期末，无并发症 TB 患者痰涂片转阴率的合并 RR（风险比）及其 95%CI 为 1.07（1.04，1.10），糖尿病 TB 患者为 1.17（0.92，1.49），乙型肝炎 TB 患者为 1.02（0.94，1.10），矽肺 TB 患者为 1.46（0.21，10.06）。老年 TB 患者 RR 为 1.22（1.13，1.32）。对随访期间每个时间点的分析表明，M. vaccae 可帮助提高痰中抗酸杆菌的清除率，并促进影像学局灶性病变和空洞闭合的改善。与对照组相比，Th1 免疫指标如 IL-2 和 TNF-α的水平差异无统计学意义（分别为 P = 0.65 和 0.31），Th2 产生的 IL-6 也无统计学意义（P = 0.52）。在乙型肝炎 TB 患者中发现 M. vaccae 具有预防肝损伤的作用（RR 0.20，95%CI（0.12，0.33）。未报告全身性不良反应。

结论

加热杀死的 M. vaccae 联合化疗有助于改善初治 TB 患者的痰转阴和 X 线表现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/de3367b3f824/pone.0023826.g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/deddcffdd873/pone.0023826.g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/f97c1a7622eb/pone.0023826.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/51dd63404b28/pone.0023826.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/8417d6133f3c/pone.0023826.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/de3367b3f824/pone.0023826.g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/deddcffdd873/pone.0023826.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/ce5001ec8585/pone.0023826.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/f97c1a7622eb/pone.0023826.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/51dd63404b28/pone.0023826.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/8417d6133f3c/pone.0023826.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c76/3167806/de3367b3f824/pone.0023826.g006.jpg

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