PDF(Pubmed)
Abstract：
Mycophenolate mofetil (MMF) and azathioprine (AZA) are immunomodulatory treatments in interstitial lung disease (ILD). This systematic review aimed to evaluate the efficacy of MMF or AZA on pulmonary function in ILD.
Population included any ILD diagnosis, intervention included MMF or AZA treatment, outcome was delta change from baseline in per cent predicted forced vital capacity (%FVC) and gas transfer (diffusion lung capacity of carbon monoxide, %DLco). The primary endpoint compared outcomes relative to placebo comparator, the secondary endpoint assessed outcomes in treated groups only.
Randomised controlled trials (RCTs) and prospective observational studies were included. No language restrictions were applied. Retrospective studies and studies with high-dose concomitant steroids were excluded.
The systematic search was performed on 9 May. Meta-analyses according to drug and outcome were specified with random effects, I2 evaluated heterogeneity and Grading of Recommendations, Assessment, Development and Evaluation evaluated certainty of evidence. Primary endpoint analysis was restricted to RCT design, secondary endpoint included subgroup analysis according to prospective observational or RCT design.
A total of 2831 publications were screened, 12 were suitable for quantitative synthesis. Three MMF RCTs were included with no significant effect on the primary endpoints (%FVC 2.94, 95% CI -4.00 to 9.88, I2=79.3%; %DLco -2.03, 95% CI -4.38 to 0.32, I2=0.0%). An overall 2.03% change from baseline in %FVC (95% CI 0.65 to 3.42, I2=0.0%) was observed in MMF, and RCT subgroup summary estimated a 4.42% change from baseline in %DLCO (95% CI 2.05 to 6.79, I2=0.0%). AZA studies were limited. All estimates were considered very low certainty evidence.
There were limited RCTs of MMF or AZA and their benefit in ILD was of very low certainty. MMF may support preservation of pulmonary function, yet confidence in the effect was weak. To support high certainty evidence, RCTs should be designed to directly assess MMF efficacy in ILD.
CRD42023423223.
Population included any ILD diagnosis, intervention included MMF or AZA treatment, outcome was delta change from baseline in per cent predicted forced vital capacity (%FVC) and gas transfer (diffusion lung capacity of carbon monoxide, %DLco). The primary endpoint compared outcomes relative to placebo comparator, the secondary endpoint assessed outcomes in treated groups only.
Randomised controlled trials (RCTs) and prospective observational studies were included. No language restrictions were applied. Retrospective studies and studies with high-dose concomitant steroids were excluded.
The systematic search was performed on 9 May. Meta-analyses according to drug and outcome were specified with random effects, I2 evaluated heterogeneity and Grading of Recommendations, Assessment, Development and Evaluation evaluated certainty of evidence. Primary endpoint analysis was restricted to RCT design, secondary endpoint included subgroup analysis according to prospective observational or RCT design.
A total of 2831 publications were screened, 12 were suitable for quantitative synthesis. Three MMF RCTs were included with no significant effect on the primary endpoints (%FVC 2.94, 95% CI -4.00 to 9.88, I2=79.3%; %DLco -2.03, 95% CI -4.38 to 0.32, I2=0.0%). An overall 2.03% change from baseline in %FVC (95% CI 0.65 to 3.42, I2=0.0%) was observed in MMF, and RCT subgroup summary estimated a 4.42% change from baseline in %DLCO (95% CI 2.05 to 6.79, I2=0.0%). AZA studies were limited. All estimates were considered very low certainty evidence.
There were limited RCTs of MMF or AZA and their benefit in ILD was of very low certainty. MMF may support preservation of pulmonary function, yet confidence in the effect was weak. To support high certainty evidence, RCTs should be designed to directly assess MMF efficacy in ILD.
CRD42023423223.
摘要：
目的：霉酚酸酯（MMF）和硫唑嘌呤（AZA）是间质性肺病（ILD）的免疫调节治疗方法。本系统综述旨在评估MMF或AZA对ILD肺功能的疗效。
方法：人群包括任何ILD诊断，干预包括MMF或AZA治疗，结果是预测用力肺活量（％FVC）和气体转移（一氧化碳的弥散肺活量，%DLco）。主要终点比较结果相对于安慰剂比较，次要终点仅评估治疗组的结局.
方法：纳入随机对照试验（RCTs）和前瞻性观察性研究。未应用语言限制。回顾性研究和伴随高剂量类固醇的研究被排除。
结果：系统检索于5月9日进行。根据药物和结果进行荟萃分析，随机效应，I2评估了建议的异质性和分级，评估,开发和评估评估了证据的确定性。主要终点分析仅限于RCT设计，次要终点包括根据前瞻性观察性或RCT设计进行的亚组分析.
结果：共筛选了2831种出版物，12例适用于定量合成。包括三个MMFRCT，对主要终点没有显着影响（％FVC2.94，95％CI-4.00至9.88，I2=79.3％；％DLco-2.03，95％CI-4.38至0.32，I2=0.0％）。在MMF中观察到%FVC相对于基线的总体变化为2.03%(95%CI0.65至3.42,I2=0.0%),和RCT亚组总结估计%DLCO与基线相比有4.42%的变化(95%CI2.05至6.79,I2=0.0%)。AZA研究有限。所有估计都被认为是非常低的确定性证据。
结论：MMF或AZA的RCTs有限，它们在ILD中的益处的确定性非常低。MMF可能支持肺功能的保护，然而，对这种效果的信心却很弱。为了支持高确定性证据，RCT应设计为直接评估ILD中MMF的疗效。
■CRD42023423223。
方法：人群包括任何ILD诊断，干预包括MMF或AZA治疗，结果是预测用力肺活量（％FVC）和气体转移（一氧化碳的弥散肺活量，%DLco）。主要终点比较结果相对于安慰剂比较，次要终点仅评估治疗组的结局.
方法：纳入随机对照试验（RCTs）和前瞻性观察性研究。未应用语言限制。回顾性研究和伴随高剂量类固醇的研究被排除。
结果：系统检索于5月9日进行。根据药物和结果进行荟萃分析，随机效应，I2评估了建议的异质性和分级，评估,开发和评估评估了证据的确定性。主要终点分析仅限于RCT设计，次要终点包括根据前瞻性观察性或RCT设计进行的亚组分析.
结果：共筛选了2831种出版物，12例适用于定量合成。包括三个MMFRCT，对主要终点没有显着影响（％FVC2.94，95％CI-4.00至9.88，I2=79.3％；％DLco-2.03，95％CI-4.38至0.32，I2=0.0％）。在MMF中观察到%FVC相对于基线的总体变化为2.03%(95%CI0.65至3.42,I2=0.0%),和RCT亚组总结估计%DLCO与基线相比有4.42%的变化(95%CI2.05至6.79,I2=0.0%)。AZA研究有限。所有估计都被认为是非常低的确定性证据。
结论：MMF或AZA的RCTs有限，它们在ILD中的益处的确定性非常低。MMF可能支持肺功能的保护，然而，对这种效果的信心却很弱。为了支持高确定性证据，RCT应设计为直接评估ILD中MMF的疗效。
■CRD42023423223。
