阿西美辛治疗强直性脊柱炎在真实世界研究中的疗效和安全性评价

张家鑫; 胡立冬; 冀肖健; 王一雯; 宋川; 朱剑; 黄烽

doi:10.3969/j.issn.2095-5227.2022.03.004

阿西美辛治疗强直性脊柱炎在真实世界研究中的疗效和安全性评价

Effectiveness and safety of Acemetacin in treatment of ankylosing spondylitis: A real-world study

摘要

摘要:
背景近20年来，生物制剂已广泛应用于治疗强直性脊柱炎(ankylosing spondylitis，AS)，但非甾体抗炎药(non-steroidal anti-inflammatory drugs，NSAIDs)仍是AS治疗的基石。由于NSAIDs中阿西美辛在治疗AS方面应用广泛，且NSAIDs的选择相对缺乏临床证据，因此阿西美辛治疗AS的研究可以为临床医生在NSAIDs治疗AS选择方面提供依据。
目的探究真实世界中阿西美辛治疗AS的有效性和安全性。
方法利用中国强直性脊柱炎前瞻性影像队列的前瞻性观察性研究。将2016年6月- 2019年9月就诊于解放军总医院风湿科门诊的AS患者根据用药种类分为阿西美辛组及其他NSAIDs组，比较两组在基线期、3个月和6个月时的总体评估(patient general assessment，PGA)、总体背痛、夜间背痛和AS疾病活动评分(ankylosing spondylitis disease activity score，ASDAS)、Bath AS功能指数(Bath ankylosing spondylitis functional index，BASFI)、C反应蛋白和不良事件发生情况。
结果研究共纳入1 115例AS患者，阿西美辛组992例，其他NSAIDs组123例。在基线期，两组各项临床特征差异均无统计学意义(P>0.05)。在治疗3个月后，与其他NSAIDs组相比，阿西美辛组总体背痛、BASFI下降更明显(P＜0.05)。在治疗6个月后，阿西美辛组较其他NSAIDs组在PGA、总体背痛、夜间背痛、BASFI、ASDAS和C反应蛋白水平方面改善更明显(P均＜0.05)。用药期间15例患者出现轻度肝功能异常，其中阿西美辛组9例，其他NSAIDs组6例。两组均未观察到严重不良反应。
结论在真实世界研究中，阿西美辛治疗AS具有较好的疗效和安全性。

Abstract:
Background Biological DMARDs have been widely used in the treatment of ankylosing spondylitis (AS) in the last two decades, but non-steroidal anti-inflammatory drugs (NSAIDs) still serve as the cornerstone in the treatment of AS. Given the wide use of Acemetacin in AS and relative lack of clinical evidence on the selection of NSAIDs in the treatment of AS, the investigation on Acemetacin treating AS is of great significance.
Objective To investigate the effectiveness and safety of Acemetacin in the treatment of AS.
Methods Data on efficacy and safety in 1 115 patients from the Chinese Ankylosing Spondylitis Imaging Cohort (CASPIC) were collected by the Smart-phone SpondyloArthritis Management System (SpAMS). From June 2016 to September 2019, patients admitted to the Department of Rheumatology and Immunology, the First Medical Center of Chinese PLA General Hospital were divided into Acemetacin group and other NSAIDs group according to the medication type. Physician-reported assessments (PGA), overall back pain, nocturnal back pain, AS disease activity score (ASDAS), Bath AS functional index (BASFI), C-reactive protein (CRP) and adverse events at baseline, 3 and 6 months after treatment were compared between the two groups.
Results Totally 1 115 patients with AS were registered, of whom 992 were treated with Acemetacin and 123 were treated with other NSAIDs. There were no significant differences in baseline data between the two groups. The results showed that total back pain and BASFI were significantly improved after three-month treatment of Acemetacin, while comparing to other NSAIDs (P=0.027 and 0.015, respectively). After six-month treatment, patients taking Acemetacin showed greater improvement in PGA (P=0.013), total back pain (P=0.049), nocturnal back pain (P=0.047), BASFI (P=0.042), ASDAS (P=0.007) and CRP (P=0.032) compared to those taking other NSAIDs. During the follow-up periods, no serious adverse event was reported. Mild abnormal liver function occurred in 9 patients treated with Acemetacin and in 6 patients treated with other NSAIDs.
Conclusion Acemetacin shows better efficacy in the treatment of ankylosing spondylitis comparing with other NSAIDs.

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