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HIV高流行地區DR-TB(抗藥性結核病)治療的不良藥物反應情形:系統性回顧及整合分析(meta-analysis)

發佈日期

2017/05/22

內  容

TB-PRACTECAL trial

方便有效且降低毒性的MDR-TB治療處方實用臨床試驗(Pragmatic Clinical Trial for More Effective Concise and Less Toxic Treatment Regimen(s),TB-PRACTECAL)是一個多核心、雙盲、多組研究且採隨機控制的第2-3階段試驗,由無國界醫師聯盟(Médecins Sans Frontières ,MSF)發起的臨床試驗,試驗目的在於評估以Badquiline 及Pretomanid搭配現有或重新啟用之TB藥物的短程治療處方對MDR-TB或XDR-TB患者的效果。該試驗的首位病患以隨機方式選取,並於2017年1月17日開始接受治療。
關於試驗的其他資訊可於下列網站查詢: https://www.msf.org.uk/content/tb-practecal

最新發表
1、 HIV高流行地區DR-TB(抗藥性結核病)治療的不良藥物反應情形:系統性回顧及整合分析(meta-analysis)
J Antimicrob Chemother. 2017 Apr 16. doi: 10.1093/jac/dkx107. [Epub ahead of print]
Schnippel K(1,)(2), Firnhaber C(2,)(3), Berhanu R(4,)(5), Page-Shipp L(6), Sinanovic E(1).

目的:估計HIV高流行地區(至少20%病患感染)DR-TB治療的不良藥物反應或事件(Adverse drug reactions or events, ADR)的發生情形。

方法:我們以系統性回顧的方式從PubMed及Scopus搜尋相關文章進行整合分析,匯整統計有發生不良藥物反應事件病患的比例,並計算相對風險的95%信賴區間。

結果:共搜尋24篇世代觀察的研究。10篇列入整合分析,共計2,776名列入ADR的研究對象中,有1,943人已感染HIV病毒(70.0%)。平均有83%(95%信賴區間:82%-84%)個案曾發生1次以上的ADR。其中7篇研究(n=664)提及研究對象在接受DR-TB治療期間曾發生嚴重ADR,24%(95%信賴區間:21%-27%)病患曾發生至少一次嚴重ADR。24篇研究中,有16篇研究分析HIV感染者發生ADR的相對風險,其中9篇研究顯示感染HIV病毒與藥物相關的ADR並無顯著相關。目前沒有足夠的資訊可以分析發生ADR的風險,是否與接受HIV抗反轉錄病毒藥物或免疫抑制有關(immunosuppression, CD4 count)。

結論:目前尚無以WHO建議抗藥性結核治療且研究對象中有20%以上為HIV感染者的隨機臨床試驗被發表。幾乎所有接受DR-TB治療的病患(83%)曾發生ADR。然而並未發現ADR與合併感染HIV病毒有顯著相關性,須有更進步的研究來確認有接受HIV抗反轉錄病毒藥物或免疫抑制(immunosuppression, CD4 count)的病患是否會增加發生ADR的風險。


TB-PRACTECAL
The Pragmatic Clinical Trial for More Effective Concise and Less Toxic MDR-TBTreatment Regimen(s) (TB-PRACTECAL) is a multi-center, open label, multi-arm, randomized, controlled phase II-III trial. TB-PRACTECAL, a Médecins Sans Frontières (MSF) sponsored clinical trial, aims to evaluate short treatment regimens that contain bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary MDR- and XDR-TB. The trial’s first patient was randomized and started treatment on January 17, 2017. Additional information on the trial can be found at https://www.msf.org.uk/content/tb-practecal.

PUBLICATIONS
1. Adverse drug reactions during drug-resistant TB treatment in high HIV prevalence settings: a systematic review and meta-analysis.
J Antimicrob Chemother. 2017 Apr 16. doi: 10.1093/jac/dkx107. [Epub ahead of print]
Schnippel K(1,)(2), Firnhaber C(2,)(3), Berhanu R(4,)(5), Page-Shipp L(6), Sinanovic E(1).

OBJECTIVES: To estimate the prevalence of adverse drug reactions or events (ADR) during drug-resistant TB (DR-TB) treatment in the context of settings with high HIV prevalence (at least 20% of patients).

METHODS: We conducted a systematic review and meta-analysis of articles in PubMed and Scopus. Pooled proportions of patients experiencing adverse events and relative risk with 95% CI were calculated.

RESULTS: The search yielded 24 studies, all observational cohorts. Ten reported on the number of patients experiencing ADR and were included in the meta-analysis representing 2776 study participants of whom 1943 were known to be HIV infected (70.0%). An average of 83% (95% CI: 82%-84%) of patients experienced one or more ADR. Among the seven articles ( n  =   664 study participants) with information on occurrence of severe ADR, 24% (95% CI: 21%-27%) of patients experienced at least one severe ADR during drug-resistant TB treatment. Sixteen of the 24 studies analysed the relative risk of ADR by HIV infection, nine of which found no statistically significant association between HIV infection and occurrence of drug-related ADR. There was insufficient information to disaggregate risk by concomitant treatment with HIV antiretrovirals or by immunosuppression (CD4 count).

CONCLUSIONS: No randomized clinical trials were found for WHO-recommended treatment of drug-resistant TB treatment where at least 20% of the cohort was coinfected with HIV. Nearly all patients (83%) experience ADR during DR-TB treatment. While no significant association between ADR and HIV coinfection was found, further research is needed to determine whether concomitant antiretrovirals or immunosuppression increases the risks for HIV-infected patients.

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