Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Department of Rheumatology and Immunology, ZhuJiang Hospital of Southern Medical University, Guangzhou, China.
J Ethnopharmacol. 2022 Mar 1;285:114731. doi: 10.1016/j.jep.2021.114731. Epub 2021 Oct 8.
Fengshi Gutong Capsule (FSGTC) is a traditional Chinese herbal medicine that is composed of seven herbs. It has been widely used for the treatment of joint pain in China. However, the clinical evidence supporting its use in patients with ankylosing spondylitis (AS) is lacking.
This study aims to explore the efficacy and safety of FSGTC in the treatment of AS.
This randomized, controlled, double-blinded, double-dummy trial enrolled patients with active AS defined as Bath Ankylosing Spondylitis Disease ActivityIndex (BASDAI) ≥ 4 or Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) ≥ 2.1. Eligible patients were randomized (1:1:1) into combination group (FSGTC plus imrecoxib), FSGTC group (FSGTC plus imrecoxib placebo) or imrecoxib group (imrecoxib plus FSGTC placebo) over a 4-week treatment. The primary endpoint was the composite outcome measure of the Assessment in Ankylosing Spondylitis 20% (ASAS20) response at week 4. The secondary endpoints included ASDAS-CRP, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), patient's global assessment of disease activity (PGTA) and safety.
Of the 180 randomized patients, 159 patients (88.3%) completed the 4-week treatment. ASAS20 response rate at week 4 was achieved by 27.5% in imrecoxib group, compared with 37.0% in combination group (P > 0.05) and 37.0% in FSGTC group (P > 0.05). In comparison to imrecoxib group, there were significantly greater improvements of ASDAS-CRP and PTGA in combination group and greater improvement of ASDAS-CRP in FSGTC group while the rest of the secondary endpoints shown similar improvement. The incidence of gastrointestinal adverse events in imrecoxib group (15.7%) was significantly higher than that of FSGTC group (1.9%) and without a significant difference to combination group (7.4%).
FSGTC alone or combined with NSAIDs has therapeutic efficacy in decreasing disease activity of active AS patients and with good gastrointestinal tolerability after 4-week of treatment.
风湿骨痛胶囊（FSGTC）是一种中药复方制剂，由七种草药组成。它在中国被广泛用于治疗关节疼痛。然而，支持其在强直性脊柱炎（AS）患者中使用的临床证据尚缺乏。
本研究旨在探讨 FSGTC 治疗 AS 的疗效和安全性。
这项随机、对照、双盲、双模拟试验纳入了符合以下标准的活动性 AS 患者：Bath 强直性脊柱炎疾病活动指数（BASDAI）≥4 或伴有 C 反应蛋白的强直性脊柱炎疾病活动评分（ASDAS-CRP）≥2.1。合格的患者被随机分为三组（1:1:1）：联合组（FSGTC 加伊美昔康）、FSGTC 组（FSGTC 加伊美昔康安慰剂）或伊美昔康组（伊美昔康加 FSGTC 安慰剂），治疗时间为 4 周。主要终点是第 4 周时 ASAS20 缓解的综合衡量标准。次要终点包括 ASDAS-CRP、BASDAI、Bath 强直性脊柱炎功能指数（BASFI）、Bath 强直性脊柱炎度量指数（BASMI）、患者疾病活动的整体评估（PGTA）和安全性。
在 180 名随机患者中，有 159 名（88.3%）完成了 4 周的治疗。伊美昔康组第 4 周时 ASAS20 缓解率为 27.5%，联合组为 37.0%（P>0.05），FSGTC 组为 37.0%（P>0.05）。与伊美昔康组相比，联合组的 ASDAS-CRP 和 PGTA 显著改善，FSGTC 组的 ASDAS-CRP 也有显著改善，而其余次要终点的改善情况相似。伊美昔康组（15.7%）胃肠道不良事件的发生率明显高于 FSGTC 组（1.9%），与联合组（7.4%）无显著差异。
FSGTC 单独或与 NSAIDs 联合使用在 4 周的治疗后，对降低活动性 AS 患者的疾病活动度具有疗效，且具有良好的胃肠道耐受性。
