Hosseinbalam Marziyeh, Nouri Rasool, Farajzadegan Ziba, Mottaghi Peyman
Department of Internal Medicine, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.
Health Information Technology Research Center, School of Management and Medical Information Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.
J Res Med Sci. 2023 Jan 31;28:3. doi: 10.4103/jrms.jrms_386_22. eCollection 2023.
The aim of the present systematic review and meta-analysis was to evaluate the therapeutic efficacy of bosentan, a dual endothelin receptor antagonist, for systemic sclerosis (SSc) patients with digital ulcers (DUs).
A systematic search of MEDLINE, Embase, Web of Science, and Scopus was done using appropriate keywords till September 2021. Weighted mean difference (WMD) as the effect of therapeutic efficacy of bosentan on continuous outcomes was an estimate. Furthermore, the pooled prevalence of diffuse SSc and limited SSc was computed. Fixed or random effects models when appropriate were used for data synthesis.
Totally, 469 patients, with a mean age ranging from 48.1 to 63.7 years, from 8 studies were included in the systematic review and meta-analysis. The pooled frequency of diffuse SSc and limited SSc was 56% (95% confidence interval [CI]: 39%, 73%) and 44% (95% CI: 27%, 61%). The pooled prevalence of new DUs following bosentan treatment was 21% (95% CI: 10%, 33%). The results of the meta-analysis showed a pooled mean decrease of WMD: -0.09 (95% CI: -0.020, 0.02, = 0.10), WMD: -2.82 (95% CI: -5.91, 0.27, = 0.07), and WMD: -6.65 (95% CI: -9.49, -3.82, < 0.001) in mean SSc-Health Assessment Questionnaire, pain, and Rodnan score, respectively. Our meta-analysis also indicated a significant pooled decrease in the number of new DUs in SSc patients compared to placebo subjects (WMD: -0.89 [95% CI: -1.40, -0.37; = 0.001]) and baseline values (WMD: -1.34 (95% CI: -1.95, -0.73; < 0.001).
Bosentan possibly is an efficacious treatment option for SSc-related DUs. Although further large-scale randomized clinical trials are required to confirm the preliminary finding and underlying mechanisms of action.
本系统评价和荟萃分析旨在评估双重内皮素受体拮抗剂波生坦对患有指端溃疡（DU）的系统性硬化症（SSc）患者的治疗效果。
使用适当的关键词对MEDLINE、Embase、Web of Science和Scopus进行系统检索，直至2021年9月。以加权平均差（WMD）作为波生坦对连续结果的治疗效果估计值。此外，计算了弥漫性SSc和局限性SSc的合并患病率。在适当情况下，使用固定效应或随机效应模型进行数据合成。
本系统评价和荟萃分析共纳入了来自8项研究的469例患者，平均年龄在48.1至63.7岁之间。弥漫性SSc和局限性SSc的合并频率分别为56%（95%置信区间[CI]：39%，73%）和44%（95%CI：27%，61%）。波生坦治疗后新出现DU的合并患病率为21%（95%CI：10%，33%）。荟萃分析结果显示，在系统性硬化症健康评估问卷、疼痛和罗德南评分方面，合并平均下降的WMD分别为：-0.09（95%CI：-0.020，0.02，P = 0.10）、-2.82（95%CI：-5.91，0.27，P = 0.07）和-6.65（95%CI：-9.49，-3.82，P < 0.001）。我们的荟萃分析还表明，与安慰剂组相比，SSc患者中新出现DU的数量显著合并减少（WMD：-0.89[95%CI：-1.40，-0.37；P = 0.001]），与基线值相比也显著减少（WMD：-1.34（95%CI：-1.95，-0.73；P < 0.001）。
波生坦可能是治疗SSc相关DU 的一种有效治疗选择。尽管需要进一步的大规模随机临床试验来证实这一初步发现及其潜在作用机制。
