Hong Dongsheng, Yang Zhihai, Han Shuyin, Liang Xingguang, Ma Kuifen, Zhang Xingguo
Department of Pharmacy, the First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
Department of Pharmacy, the First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, People's Republic of China ; College of Pharmaceutical Science, Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
Drug Des Devel Ther. 2014 Nov 25;8:2345-57. doi: 10.2147/DDDT.S73428. eCollection 2014.
Anakinra is the first interleukin-1 inhibitor to be used in clinical practice, and recent evidence showed that interleukin-1 plays a pivotal role in the pathogenesis of adult-onset Still disease (AoSD). However, data concerning efficacy with anakinra use in different clinical trials has not been evaluated, and the overall remission of AoSD with anakinra treatment has not been well defined.
We conducted a search on Embase, PubMed, and the Cochrane Library for relevant trials. Statistical analyses were conducted to calculate the overall remission rates, odds ratios (OR), and 95% confidence intervals (CI), by using either random effects or fixed effect models according to the heterogeneity.
Of the 273 articles that were identified, 265 were excluded. Eight studies were eligible for inclusion. The overall remission rate and complete remission rate of anakinra in AoSD patients were 81.66% (95% CI: 69.51%-89.69%) and 66.75% (95% CI: 59.94%-75.3%), respectively. Compared with the controls, the use of anakinra was associated with a significant remission in AoSD, with an OR of 0.16 (95% CI: 0.06-0.44, P=0.0005). There were also significant reductions of the dosage of corticosteroid (mean difference =21.19) (95% CI: 13.2-29.18, P<0.0001) from anakinra onset to the latest follow up time. Clinical and laboratory parameters were all improved, and anakinra was well tolerated in patients with AoSD. No evidence of publication bias was observed.
Our study has shown that anakinra is effective in remitting the manifestations of AoSD, with reduction of the dose of corticosteroid in patients with AoSD. Further, anakinra therapy was not associated with increased risk of adverse events, and it was well tolerated in patients with AoSD. Further research is still recommended to investigate these findings.
阿那白滞素是首个用于临床实践的白细胞介素-1抑制剂，近期证据表明白细胞介素-1在成人斯蒂尔病（AoSD）的发病机制中起关键作用。然而，不同临床试验中使用阿那白滞素的疗效数据尚未得到评估，且阿那白滞素治疗AoSD的总体缓解情况尚未明确界定。
我们在Embase、PubMed和Cochrane图书馆中检索相关试验。根据异质性，使用随机效应或固定效应模型进行统计分析，以计算总体缓解率、比值比（OR）和95%置信区间（CI）。
在检索到的273篇文章中，排除265篇。8项研究符合纳入标准。阿那白滞素治疗AoSD患者的总体缓解率和完全缓解率分别为81.66%（95%CI：69.51%-89.69%）和66.75%（95%CI：59.94%-75.3%）。与对照组相比，使用阿那白滞素与AoSD的显著缓解相关，OR为0.16（95%CI：0.06-0.44，P=0.0005）。从阿那白滞素开始使用到最近一次随访期间，皮质类固醇剂量也有显著降低（平均差值=21.19）（95%CI：13.2-29.18，P<0.0001）。临床和实验室参数均得到改善，且AoSD患者对阿那白滞素耐受性良好。未观察到发表偏倚的证据。
我们的研究表明，阿那白滞素可有效缓解AoSD的症状，并降低AoSD患者的皮质类固醇剂量。此外，阿那白滞素治疗与不良事件风险增加无关，且AoSD患者对其耐受性良好。仍建议进一步研究以验证这些发现。
