Dalhousie University, Halifax, Nova Scotia, Canada.
Med Sci Monit. 2010 Sep;16(9):RA187-90.
This meta-analysis examined all randomized controlled trials (RCTs) comparing pharmacotherapy for systemic sclerosis (SSc)-interstitial lung disease (ILD) with placebo or alternative drugs on pulmonary function tests (PFTs), quality of life, dyspnea, skin thickness, and adverse events.
MATERIAL/METHODS: Forty studies were identified, and from these 2 RCTs examining cyclophosphamide and 1 examining bosentan met inclusion criteria (studies had to be randomized, have at least 20 SSc-ILD patients, and have PFTs as primary outcomes).
Differences between groups for change of PFT scores between baseline and 12 months were not significant when the 3 trials were combined. The treatment effect of cyclophosphamide versus placebo on forced vital capacity revealed a mean difference of 3.30% (95% confidence interval, 0.06-6.54). Diffusing capacity and total lung capacity did not change.
This conservative yet significant effect of cyclophosphamide demonstrates the need for further investigation of its effectiveness on patient-important outcomes such as dyspnea and quality of life, which could not be evaluated by this meta-analysis. It may be that studies in SSc-ILD need outcomes that are more sensitive to change.
本荟萃分析考察了所有比较药物治疗系统性硬皮病（SSc）-间质性肺病（ILD）与安慰剂或其他药物的随机对照试验（RCT），这些药物对肺功能测试（PFTs）、生活质量、呼吸困难、皮肤厚度和不良事件的影响。
材料/方法：确定了 40 项研究，其中 2 项研究检查了环磷酰胺，1 项研究检查了波生坦，符合纳入标准（研究必须是随机的，至少有 20 例 SSc-ILD 患者，并且 PFTs 为主要结局）。
当将 3 项试验合并时，在基线和 12 个月之间，PFT 评分的组间差异不显著。环磷酰胺与安慰剂相比，用力肺活量的治疗效果显示平均差异为 3.30%（95%置信区间，0.06-6.54）。弥散量和肺总量没有变化。
环磷酰胺的这种保守但显著的效果表明，需要进一步研究其对患者重要结局的有效性，如呼吸困难和生活质量，这无法通过本荟萃分析来评估。可能是 SSc-ILD 研究需要更敏感的结局来衡量变化。
