含利福平或利福喷丁的结核预防治疗方案的完成情况、安全性和疗效：一项个体患者数据网络荟萃分析。
Completion, safety, and efficacy of tuberculosis preventive treatment regimens containing rifampicin or rifapentine: an individual patient data network meta-analysis.
机构信息
Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
Denver Health and Hospital Authority and Division of Infectious Diseases, Department of Medicine, University of Colorado, Denver, CO, USA.
出版信息
Lancet Respir Med. 2023 Sep;11(9):782-790. doi: 10.1016/S2213-2600(23)00096-6. Epub 2023 Mar 23.
BACKGROUND
3 months of weekly rifapentine plus isoniazid (3HP) and 4 months of daily rifampicin (4R) are recommended for tuberculosis preventive treatment. As these regimens have not been compared directly, we used individual patient data and network meta-analysis methods to compare completion, safety, and efficacy between 3HP and 4R.
METHODS
We conducted a network meta-analysis of individual patient data by searching PubMed for randomised controlled trials (RCTs) published between Jan 1, 2000, and Mar 1, 2019. Eligible studies compared 3HP or 4R to 6 months or 9 months of isoniazid and reported treatment completion, adverse events, or incidence of tuberculosis disease. Deidentified individual patient data from eligible studies were provided by study investigators and outcomes were harmonised. Methods for network meta-analysis were used to generate indirect adjusted risk ratios (aRRs) and risk differences (aRDs) with their 95% CIs.
FINDINGS
We included 17 572 participants from 14 countries in six trials. In the network meta-analysis, treatment completion was higher for people on 3HP than for those on 4R (aRR 1·06 [95% CI 1·02-1·10]; aRD 0·05 [95% CI 0·02-0·07]). For treatment-related adverse events leading to drug discontinuation, risks were higher for 3HP than for 4R for adverse events of any severity (aRR 2·86 [2·12-4·21]; aRD 0·03 [0·02-0·05]) and for grade 3-4 adverse events (aRR 3·46 [2·09-6·17]; aRD 0·02 [0·01-0·03]). Similar increased risks with 3HP were observed with other definitions of adverse events and were consistent across age groups. No difference in the incidence of tuberculosis disease between 3HP and 4R was found.
INTERPRETATION
In the absence of RCTs, our individual patient data network meta-analysis indicates that 3HP provided an increase in treatment completion over 4R, but was associated with a higher risk of adverse events. Although findings should be confirmed, the trade-off between completion and safety must be considered when selecting a regimen for tuberculosis preventive treatment.
FUNDING
None.
TRANSLATIONS
For the French and Spanish translations of the abstract see Supplementary Materials section.
背景
每周使用利福喷丁加异烟肼（3HP）治疗 3 个月，再加上每日使用利福平（4R）治疗 4 个月，被推荐用于结核病预防治疗。由于这些方案尚未进行直接比较，我们使用个体患者数据和网络荟萃分析方法，比较了 3HP 和 4R 在完成率、安全性和疗效方面的差异。
方法
我们通过检索 PubMed，检索了 2000 年 1 月 1 日至 2019 年 3 月 1 日期间发表的随机对照试验（RCT），进行了个体患者数据的网络荟萃分析。合格的研究比较了 3HP 或 4R 与 6 个月或 9 个月的异烟肼治疗，并报告了治疗完成情况、不良事件或结核病发病情况。合格研究的研究人员提供了符合条件的研究的个体患者数据，并对结果进行了协调。使用网络荟萃分析方法生成间接调整后的风险比（aRR）和风险差异（aRD）及其 95%置信区间（CI）。
结果
我们纳入了来自 6 项试验的 17572 名来自 14 个国家的参与者。在网络荟萃分析中，接受 3HP 治疗的患者完成治疗的比例高于接受 4R 治疗的患者（aRR 1.06 [95%CI 1.02-1.10]；aRD 0.05 [95%CI 0.02-0.07]）。对于导致药物停药的治疗相关不良事件，3HP 组的风险高于 4R 组，无论严重程度如何（aRR 2.86 [2.12-4.21]；aRD 0.03 [0.02-0.05]）和 3-4 级不良事件（aRR 3.46 [2.09-6.17]；aRD 0.02 [0.01-0.03]）。在其他不良事件定义和不同年龄组中也观察到了类似的 3HP 风险增加。3HP 和 4R 治疗组的结核病发病率无差异。
结论
在没有 RCT 的情况下，我们的个体患者数据网络荟萃分析表明，3HP 可提高治疗完成率，但与不良事件风险增加相关。尽管研究结果有待证实，但在选择结核病预防治疗方案时，必须考虑完成率和安全性之间的权衡。
资助
无。
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