Clin Infect Dis:接受贝达喹啉或德拉马尼治疗的耐药结核病患者的临床结局

2020-04-14 MedSci原创 MedSci原创

前言

前言

 

       目前,耐多药结核病(multidrug resistant tuberculosis,MDR-TB)仍然是全球严重的公共卫生问题之一,素有“传染性癌症”之称。据世界卫生组织(WHO)估算,2017年全球有超过50万例MDR-TB。MDR-TB患者的治疗疗程长,但治疗效果却不理想。

 

研究背景

 

      贝达喹啉和德拉马尼是治疗MDR-TB的新药。贝达喹啉是50多年来首个获得FDA批准的抗结核药,而德拉马尼已获得欧洲药品管理局(EMA)的“有条件批准”。 虽然最近WHO的指南中包含了使用上述药物使用的指导和建议,但关于这两种药物治疗的临床疗效的数据仍然有限,且缺少对比以贝达奎林和以德拉马尼为基础的治疗方案的研究。

 

研究方法

 

      研究人员在格鲁吉亚进行了一项前瞻性观察性研究,纳入MDR结核病患者(≥16岁),患者接受了以贝达喹啉或德拉马尼为主的治疗方案。每月进行了痰液培养、最小抑制浓度测试和不良事件监测。研究主要结果是培养物转化率和临床结局。

 

研究结果

基线特征

 

      在接受研究的156名MDR肺结核患者中,100名患者同意入组,其中95名患者接受了以贝达喹啉(n=64)或德拉马尼(n=31)为基础的治疗方案,患者在年龄、体重指数、药物使用率和合并症方面类似。曾接受过治疗(56%)和肺空洞(61%)的患者比例很高。最常见的联合药物包括利妥昔单抗、氯法西明、环孢霉素和一种氟喹诺酮类药物。

表1. 基线特征

 

痰培养转化率和临床结局

 

     以贝达喹啉(4,IQR 4-4)和德拉马尼(4,IQR 3.5-5)为基础的治疗方案的患者接受的有效药物治疗时间的中位数(549天vs. 533天)相似。

 

      整个队列在两个月和六个月的痰培养转化率分别为58%,88%和90%。校正分析后,与德拉马尼相比,接受贝达喹啉治疗的患者的痰培养转化率在两个月(67% vs. 47%,P=0.10)和六个月(95% vs. 74%,P<0.01)较高。

 

      68例(72%)MDR-TB患者取得良好的初始预后,其余27例(28%)患者的预后较差,包括死亡(2%),衰竭(7%)和失访(19%)。校正分析后,与德拉马尼相比,接受贝达喹啉治疗的患者的临床预后更好(96% vs. 72%,P<0.01)。

表2. 痰培养转化率和临床结局

 

不良事件

 

      治疗过程中,获得性药物耐药率在接受德拉马尼与贝达喹啉的患者中显著高于贝达喹啉(36% vs. 10%,P <0.01)。两名患者因肝毒性和严重皮疹需要过早停用贝达喹啉,另一名患者因肝毒性需要停用德拉马尼。4例患者发生了严重的肝炎(ALT>正常时间的5倍),其中3例为贝达喹啉治疗者(一名患者需要暂时中断贝达喹啉的治疗)。

 

讨论

 

      鉴于以往MDR结核病的治疗方案疗效不佳、不良事件发生率高,因此迫切需要开发新的治疗方法,最近的WHO耐药治疗指南也强调了这一点。该研究证明在一组既往治疗率高、空洞性疾病和耐药的MDR结核病患者中,贝达喹啉可以获得较高的成功率。此外,该研究还首次比较了基于贝达喹啉与基于德拉马尼治疗方案的患者的临床疗效,结果支持WHO最近的指南,将贝达喹啉作为所有MDR结核病患者的A类优先药物,而德拉马尼作为C类药物,在没有足够的A类和B类药物可用时推荐使用。

 

     研究所纳入的95例患者中,采用了64种特有的初始治疗方案。这一研究结果显示出可用的治疗方案的广泛性,并且当使用相同的主要药物治疗时,有许多有效的治疗方案,从而使临床医生能够根据临床评估调整治疗方案,并提供以患者为中心的护理。

 

      该观察性队列研究为新批准的抗结核药物的临床治疗结果增加了新的研究基础。在缺乏贝达喹啉与德拉马尼的随机对照试验数据的情况下,该研究结果有助于为临床医生和国家结核病项目提供关于贝达喹啉与德拉马尼的相对疗效的信息。

 

      研究的局限性在于观察性研究设计引入因无法评估或无法控制的混杂因素而产生了偏倚。此外,缺乏delamanid MIC测试也使得研究人员无法确定基线和获得性药物耐药性。基于既往研究报道,格鲁吉亚以前没有使用过德拉马尼,因此不太可能存在基线抗德拉马尼的情况。但是,如果存在基线耐药性,则可以部分解释德拉马尼治疗失败的原因。

 

研究意义及展望

 

     该研究结果表明,在MDR结核病患者中,与以德拉马尼为基础的治疗方案相比,以贝达喹啉为基础的治疗方案可获得更高的痰液培养转化率,更好的临床结局,和更低的获得性耐药率。

 

参考文献

R R KempkerL Mikiashvili, et al., Clinical Outcomes among Patients with Drug-resistant Tuberculosis receiving Bedaquiline or Delamanid Containing Regimens. Clin Infect Dis. 2019 Nov 12:ciz1107. doi: 10.1093/cid/ciz1107. 

 

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    2020-04-16 一天没事干

    很好的学习机会

    0

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