Ryan Hannah, Yoo Jinho, Darsini Padmapriya
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Kyung Hee University, Seoul, Korea, South.
Cochrane Database Syst Rev. 2017 Mar 14;3(3):CD001876. doi: 10.1002/14651858.CD001876.pub3.
Corticosteroids used in addition to antituberculous therapy have been reported to benefit people with tuberculous pleurisy. However, research findings are inconsistent and raise doubt as to whether such treatment is worthwhile. There is also concern regarding the potential adverse effects of corticosteroids, especially in HIV-positive people.
To evaluate the effects of adding corticosteroids to drug regimens for tuberculous pleural effusion.
In April 2016, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, LILACS, Current Controlled Trials, and the reference lists of articles identified by the literature search.
Randomized controlled trials (RCTs) and quasi-RCTs that compared any corticosteroid with no treatment, placebo, or other active treatment (both groups should have received the same antituberculous drug regimen) in people diagnosed with tuberculous pleurisy.
Two review authors independently screened the search results, extracted data from the included trials, and assessed trial methodological quality using the Cochrane 'Risk of bias' tool. We analysed the data using risk ratios (RR) with 95% confidence intervals (CIs). We applied the fixed-effect model in the absence of statistically significant heterogeneity.
Six trials with 590 participants met the inclusion criteria, which were conducted in Asia (three trials), Africa (two trials), and Europe (one trial). Two trials were in HIV-negative people, one trial was in HIV-positive people, and three trials did not report HIV status.Corticosteroids may reduce the time to resolution of pleural effusion. Risk of residual pleural effusion on chest X-ray was reduced by 45% at eight weeks (RR 0.54, 95% CI 0.37 to 0.78; 237 participants, 2 trials, low certainty evidence), and 65% at 24 weeks (RR 0.35, 95% CI 0.18 to 0.66; 237 participants, 2 trials, low certainty evidence).Compared with control, corticosteroids may reduce the risk of having pleural changes (such as pleural thickening or pleural adhesions), on chest X-ray at the end of follow-up by almost one third (RR 0.72, 95% CI 0.57 to 0.92; 393 participants, 5 trials,low certainty evidence), which translates to an absolute risk reduction of 16%.One trial reported deaths in people that were HIV-positive, with no obvious difference between the groups; the trial authors' analysis suggests that the deaths observed in this trial were related to HIV disease rather than pleural TB (RR 0.91, 95% CI 0.64 to 1.31; 197 participants, 1 trial).We found limited data on long-term functional respiratory impairment on 187 people in two trials, which reported that average percentage predicted forced vital capacity was similar in the group receiving prednisolone and in the control group (very low certainty evidence).The risk of adverse events that led to discontinuation of the trial drug was higher in people with pleural TB receiving corticosteroids (RR 2.78, 95% CI 1.11 to 6.94; 587 participants, 6 trials, low certainty evidence). The trial in HIV-positive people reported on six different HIV-related infections, with no obvious differences. However, cases of Kaposi's sarcoma were only seen in the corticosteroid group (with 6/99 cases in the steroid group compared to 0/98 in the control group) (very low certainty evidence).
AUTHORS' CONCLUSIONS: Long-term respiratory function is potentially the most important outcome for assessing the effects of adjunctive treatments for people with pleural TB. However, the information on the impact of pleural TB on long-term respiratory function is unknown and could be eclipsed by other risk factors, such as concurrent pulmonary TB, smoking, and HIV. This probably needs to be quantified to help decide whether further trials of corticosteroids for pleural TB would be worthwhile.
据报道,在抗结核治疗基础上加用皮质类固醇对结核性胸膜炎患者有益。然而,研究结果并不一致,引发了对于这种治疗是否值得的质疑。同时也有人担心皮质类固醇的潜在不良反应,尤其是在艾滋病毒呈阳性的人群中。
评估在结核性胸腔积液的药物治疗方案中加用皮质类固醇的效果。
2016年4月,我们检索了Cochrane传染病组专业注册库、CENTRAL(Cochrane图书馆)、MEDLINE、Embase、LILACS、当前对照试验以及文献检索所识别文章的参考文献列表。
随机对照试验(RCT)和半随机对照试验,比较在诊断为结核性胸膜炎的人群中,任何皮质类固醇与不治疗、安慰剂或其他活性治疗(两组均应接受相同的抗结核药物治疗方案)的效果。
两位综述作者独立筛选检索结果,从纳入试验中提取数据,并使用Cochrane“偏倚风险”工具评估试验方法学质量。我们使用风险比(RR)及95%置信区间(CI)分析数据。在不存在统计学显著异质性的情况下,我们应用固定效应模型。
六项试验共590名参与者符合纳入标准,这些试验分别在亚洲(三项试验)、非洲(两项试验)和欧洲(一项试验)开展。两项试验针对艾滋病毒阴性人群,一项试验针对艾滋病毒阳性人群,三项试验未报告艾滋病毒感染状况。皮质类固醇可能缩短胸腔积液消退时间。八周时胸部X光显示残留胸腔积液的风险降低了45%(RR 0.54,95%CI 0.37至0.78;237名参与者,2项试验,低确定性证据),在24周时降低了65%(RR 0.35,95%CI 0.18至0.66;237名参与者,2项试验,低确定性证据)。与对照组相比,皮质类固醇可能使随访结束时胸部X光显示的胸膜改变(如胸膜增厚或胸膜粘连)风险降低近三分之一(RR 0.72,95%CI 0.57至0.92;393名参与者,5项试验,低确定性证据),这意味着绝对风险降低了16%。一项试验报告了艾滋病毒阳性人群中的死亡情况,两组之间无明显差异;试验作者的分析表明,该试验中观察到的死亡与艾滋病毒疾病而非胸膜结核有关(RR 0.91,95%CI 0.64至1.31;197名参与者,1项试验)。我们在两项试验中发现了关于187人的长期功能性呼吸障碍的有限数据,报告显示接受泼尼松龙治疗组和对照组的预计用力肺活量平均百分比相似(极低确定性证据)。接受皮质类固醇治疗的胸膜结核患者中,导致试验药物停用的不良事件风险更高(RR 2.78,95%CI 1.11至6.94;587名参与者,6项试验,低确定性证据)。针对艾滋病毒阳性人群的试验报告了六种不同的艾滋病毒相关感染,无明显差异。然而,卡波西肉瘤病例仅在皮质类固醇组中出现(类固醇组99例中有6例,而对照组98例中为0例)(极低确定性证据)。
长期呼吸功能可能是评估胸膜结核辅助治疗效果的最重要结果。然而,关于胸膜结核对长期呼吸功能影响的信息尚不清楚,可能会被其他危险因素(如并发肺结核、吸烟和艾滋病毒感染)掩盖。这可能需要进行量化,以帮助确定是否值得进一步开展针对胸膜结核的皮质类固醇试验。