Erre Gian Luca, Sebastiani Marco, Fenu Maria Antonietta, Zinellu Angelo, Floris Alberto, Cavagna Lorenzo, Renzoni Elisabetta, Manfredi Andreina, Passiu Giuseppe, Woodman Richard John, Mangoni Arduino Aleksander
Dipartimento di Scienze Mediche, Chirurgiche e Sperimentali, Università degli Studi di Sassari, Sassari 07100, Italy.
Dipartimento di Specialità Mediche, Azienda Ospedaliero-Universitaria di Sassari, Sassari 07100, Italy.
J Clin Med. 2020 Aug 7;9(8):2560. doi: 10.3390/jcm9082560.
There is a paucity of head-to-head comparisons of the efficacy and harms of pharmacological treatments for systemic sclerosis-related interstitial lung disease (SSc-ILD).
We conducted a network meta-analysis (NMA) in order to compare the effects of different treatments with the placebo on change in forced vital capacity (FVC), change in diffusion lung capacity for CO (DLCO), serious adverse events (SAEs), discontinuation for adverse events and mortality in SSc-ILD. Standardized mean difference (SMD) and log odds ratio were estimated using NMA with fixed effects.
Nine randomized clinical trials (926 participants) comparing eight interventions and the placebo for an average follow-up of one year were included. Compared to the placebo, only rituximab significantly reduced FVC decline (SMD (95% CI) = 1.00 (0.39 to 1.61)). Suitable data on FVC outcome for nintedanib were not available for the analysis. No treatments influenced DLCO. Safety and mortality were also not different across treatments and the placebo, although there were few reported events. Cyclophosphamide and pomalidomide were less tolerated than the placebo, mycophenolate, and nintedanib.
Only rituximab significantly reduced lung function decline compared to the placebo. However, direct head-to-head comparison studies are required to confirm these findings and to better determine the safety profile of various treatments.
关于系统性硬化症相关间质性肺病（SSc-ILD）药物治疗的疗效和危害的直接对比研究较少。
我们进行了一项网状Meta分析（NMA），以比较不同治疗方法与安慰剂对SSc-ILD患者用力肺活量（FVC）变化、一氧化碳弥散量（DLCO）变化、严重不良事件（SAE）、因不良事件停药及死亡率的影响。使用固定效应的NMA估计标准化均数差（SMD）和对数比值比。
纳入了9项随机临床试验（926名参与者），比较了8种干预措施与安慰剂，平均随访1年。与安慰剂相比，只有利妥昔单抗显著降低了FVC下降（SMD（95%CI）=1.00（0.39至1.61））。无法获得用于分析的尼达尼布FVC结局的合适数据。没有治疗方法影响DLCO。各治疗组与安慰剂组在安全性和死亡率方面也没有差异，尽管报告的事件较少。环磷酰胺和泊马度胺的耐受性低于安慰剂、霉酚酸酯和尼达尼布。
与安慰剂相比，只有利妥昔单抗显著降低了肺功能下降。然而，需要直接的头对头比较研究来证实这些发现，并更好地确定各种治疗方法的安全性。
