Huang Feng, Gu Jieruo, Liu Yi, Zhu Ping, Zheng Yi, Fu Jin, Pan Sharon, Le Shi
Department of Rheumatology, Chinese PLA General Hospital, Beijing, China.
Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.
Nonsteroidal anti-inflammatory drugs are the first-line option for treating ankylosing spondylitis (AS) in China. However, no large-scale controlled trials have been conducted in this ethnic population.
To evaluate the efficacy and safety of 6 weeks' treatment with celecoxib in patients with AS in China.
This Phase 3, double-blind, parallel-group study randomized patients with AS aged ≥18 to 65 years 1:1 to receive celecoxib 200 mg once daily or diclofenac sustained release 75 mg once daily. After 6 weeks, patients could use celecoxib 400 mg once daily or maintain blinded therapy. The primary efficacy end point was mean change from baseline at Week 6 for Patient's Global Assessment of Pain Intensity score (100-mm visual analog scale). Noninferiority was established if the upper bound of the CI was <10 mm. Secondary objectives included patients' and physicians' assessments of disease activity, change from baseline in C-reactive protein level, and safety.
In the per-protocol analysis set the least squares mean change from baseline in the Patient's Global Assessment of Pain Intensity score at Week 6 was -23.8 mm and -27.1 mm in patients receiving celecoxib (n = 111) and diclofenac (n = 108), respectively. The 2-sided 95% CI for the treatment difference (celecoxib - diclofenac) was -2.2 to 8.8. Overall, 4.2% and 6.7% of patients in the celecoxib and diclofenac groups, respectively, reported treatment-related adverse events. All were mild to moderate in severity.
Celecoxib 200 mg once daily is noninferior to diclofenac sustained release 75 mg once daily for pain treatment in Chinese patients with AS. ClinicalTrials.gov identifier: NCT00762463.
在中国，非甾体类抗炎药是治疗强直性脊柱炎（AS）的一线选择。然而，尚未在该种族人群中进行大规模对照试验。
评估塞来昔布治疗中国AS患者6周的疗效和安全性。
这项3期、双盲、平行组研究将年龄≥18至65岁的AS患者按1:1随机分组，分别接受每日一次200 mg塞来昔布或每日一次75 mg双氯芬酸缓释片治疗。6周后，患者可以使用每日一次400 mg塞来昔布或维持盲法治疗。主要疗效终点是第6周时患者对疼痛强度的整体评估评分（100毫米视觉模拟量表）相对于基线的平均变化。如果置信区间的上限<10毫米，则确定为非劣效性。次要目标包括患者和医生对疾病活动的评估、C反应蛋白水平相对于基线的变化以及安全性。
在符合方案分析集中，接受塞来昔布治疗的患者（n = 111）和接受双氯芬酸治疗的患者（n = 108）在第6周时患者对疼痛强度的整体评估评分相对于基线的最小二乘平均变化分别为-23.8毫米和-27.1毫米。治疗差异（塞来昔布-双氯芬酸）的双侧95%置信区间为-2.2至8.8。总体而言，塞来昔布组和双氯芬酸组分别有4.2%和6.7%的患者报告了与治疗相关的不良事件。所有不良事件的严重程度均为轻至中度。
对于中国AS患者的疼痛治疗，每日一次200 mg塞来昔布不劣于每日一次75 mg双氯芬酸缓释片。ClinicalTrials.gov标识符：NCT00762463。
