Clinical Medical College of Jining Medical University, Jining, 272067, Shandong Province, China.
Department of Emergency, Jining No. 1 People's Hospital, No. 6 Jian kang Road, Jining, 272011, Shandong Province, China.
Clin Rheumatol. 2022 Oct;41(10):2929-2938. doi: 10.1007/s10067-022-06220-0. Epub 2022 May 30.
Several studies have demonstrated the benefits of thalidomide as a treatment for patients with ankylosing spondylitis (AS); however, published literature reported controversial results. We conducted a meta-analysis to systematically evaluate the efficacy of thalidomide in AS patients. PubMed, Embase, Cochrane Library, Web of Science, Wanfang Data, and China National Knowledge Infrastructure (CNKI) were searched for relevant studies. The Q test and I statistic were used to examine between-study heterogeneity. Fixed- or random-effects models were selected based on study heterogeneity. The risk difference (RD), absolute risk reduction (ARR), and weighted mean difference (WMD) with 95% confidence intervals (CI) were pooled for dichotomous or continuous data, as appropriate. Sensitivity analyses, funnel plots, and the Begg's tests were also performed. Overall, 19 trials with 1471 patients were included. The effectiveness of thalidomide alone and combined with other drugs was significantly higher than the control group, and the pooled RDs were 0.15 (95% CI: 0.10-0.20, I = 0%) and 0.20 (95% CI: 0.14-0.25, I = 13.4%), respectively. Thalidomide treatment yielded significant improvements in secondary outcomes for patients with AS. The adverse reaction rate for thalidomide alone was low than that for the control group (ARR = 0.08, 95% CI: 0.01-0.15, I = 0.0%), while there was no significant difference in the safety between the group in which thalidomide was combined with other drugs and the control (ARR = 0.03, 95% CI: - 0.04-0.10, I = 41.1%). The findings suggest that thalidomide improves the effectiveness of AS treatment, which should be considered by physicians. However, owing to the inclusion of several low-quality and Chinese studies, additional rigorous randomized controlled trials (RCTs) are needed in the future to confirm the results of this meta‑analysis.
已有多项研究证实沙利度胺治疗强直性脊柱炎（AS）的有效性，但文献报道结果存在争议。本研究采用荟萃分析方法系统评价沙利度胺治疗 AS 的疗效。计算机检索 PubMed、Embase、Cochrane Library、Web of Science、万方数据知识服务平台和中国知网，收集沙利度胺治疗 AS 的随机对照试验（RCT），采用 Q 检验和 I 2 检验评估异质性，根据异质性结果选择固定效应模型或随机效应模型进行分析。二分类变量采用风险差（RD）及其 95%置信区间（CI）表示，连续性变量采用加权均数差（WMD）及其 95%CI 表示。敏感性分析、漏斗图和 Begg 检验用于评估发表偏倚。共纳入 19 项 RCT，包含 1471 例患者。结果显示，与对照组相比，沙利度胺单药和联合用药组的疗效显著提高，RD 分别为 0.15（95%CI：0.10-0.20，I 2 =0%）和 0.20（95%CI：0.14-0.25，I 2 =13.4%）；在次要结局方面，沙利度胺治疗也能显著改善 AS 患者的病情。沙利度胺单药组的不良反应发生率低于对照组（RD=-0.08，95%CI：0.01-0.15，I 2 =0%），而沙利度胺联合用药组与对照组之间的安全性差异无统计学意义（RD=-0.03，95%CI：-0.04-0.10，I 2 =41.1%）。结果表明，沙利度胺可提高 AS 的治疗效果，值得临床医生关注。但由于纳入研究质量不高，且包含较多中文文献，需要更多高质量的 RCT 进一步验证本研究的结论。
