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[目的]评价盐酸青藤碱缓释片治疗强直性脊柱炎(ankylosing spondylitis,AS)的临床疗效和安全性。[方法]采用随机对照临床试验,试验组给予柳氮磺胺吡啶和盐酸青藤碱缓释片联合治疗;对照组给予柳氮磺胺吡啶治疗,两组均使用同种非甾体抗炎药美洛昔康作为基础治疗,随访1年的临床资料。[结果]试验组在BathAS活动指数(BASDAI)、BathAS功能指数(BASFI)、腰背晨僵时间、C反应蛋白等方面缓解情况明显优于对照组,差异有统计学意义(P﹤0.05)。[结论]盐酸青藤碱缓释片与柳氮磺胺吡啶合用,与单用柳氮磺胺吡啶相比,能够明显缓解强直性脊柱炎的临床症状,有效阻断强直性脊柱炎的自然病程,而毒副作用无明显增加。
[Objective] To evaluate the clinical efficacy and safety of sinomenine hydrochloride sustained-release tablets in the treatment of ankylosing spondylitis (AS). [Methods] A randomized controlled clinical trial was conducted in which the experimental group was treated with sulfasalazine and sinomenine hydrochloride sustained-release tablets. The control group was treated with sulfasalazine. Both groups were treated with the same non-steroidal anti-inflammatory drug Merlot Xi Kang as a basis for treatment, followed up for 1 year of clinical data. [Results] The experimental group was significantly better than the control group in the BathAS activity index (BASDAI), BathAS function index (BASFI), lumbar morning back stiffness and C-reactive protein, the difference was statistically significant (P <0.05). [Conclusion] Sinomenine hydrochloride sustained-release tablets combined with sulfasalazine can significantly relieve the clinical symptoms of ankylosing spondylitis and effectively block the natural course of ankylosing spondylitis compared with sulfasalazine alone No significant increase in side effects.