Alam A F M Mahbubul, Azad Mohammad Abul Kalam, Hassan M Masudul, Islam Sajeda, Islam Md Nazrul, Choudhury Minhaj Rahim, Haq Syed Atiqul
Rheumatology, Mymensingh Medical College, Mymensingh, BGD.
Rheumatology, Bangladesh Medical University, Dhaka, BGD.
Cureus. 2025 Jun 17;17(6):e86211. doi: 10.7759/cureus.86211. eCollection 2025 Jun.
The present study aimed to determine the efficacy and safety of thalidomide compared to sulfasalazine (SSZ) in moderate to severe cases of ankylosing spondylitis (AS) in Bangladesh.
This experimental study was conducted from January 2017 to December 2018 in the Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. The experimental study included 93 adult patients with moderate to severe AS (47 received thalidomide, and 46 received SSZ). Change in disease status was considered an efficacy endpoint, while the prevalence of adverse events was considered a safety endpoint.
Thalidomide showed better efficacy compared to SSZ in terms of disease activity index (Bath Ankylosing Spondylitis Disease Activity Index) (2.84 vs. 4.49, p < 0.001). Secondary endpoints such as functional index (Bath Ankylosing Spondylitis Functional Index) (2.32 vs. 3.34, p = 0.021), patients' global assessment (2.92 vs. 4.11, p < 0.001), physician global assessment (2.67 vs. 3.60, p < 0.001), spinal pain score (2.52 vs. 3.31, p = 0.025), swollen joint count (0.05 vs. 0.40, p < 0.001), morning stiffness (2.08 vs. 3.27, p < 0.001), erythrocyte sedimentation rate (28.17 mm vs. 34.25 mm, p = 0.023), and C-reactive protein (9.57 mg/l vs. 21.34 mg/l, p = 0.027) were also better in the thalidomide group. Moreover, a significantly higher number of patients achieved 40% improvement in the thalidomide group compared to the SSZ group (90% vs. 10%, p < 0.001). Pedal edema was the most common adverse event (16, 46%) in the thalidomide group, followed by somnolence (13, 37%), drowsiness (12, 34%), dry mouth (11, 31%), and skin rash (11, 31%). On the other hand, anorexia (17, 48%), headache (15, 43%), and gastric irritation (10, 28%) were common adverse events in the SSZ group.
Despite a few mild side effects, thalidomide is effective and safe in comparison with SSZ for treating patients with moderate to severe AS for short-term assessment.
本研究旨在确定在孟加拉国中度至重度强直性脊柱炎（AS）病例中，沙利度胺与柳氮磺胺吡啶（SSZ）相比的疗效和安全性。
本实验研究于2017年1月至2018年12月在孟加拉国达卡的班加班杜·谢赫·穆吉布医科大学（BSMMU）风湿病科进行。该实验研究纳入了93例中度至重度AS成年患者（47例接受沙利度胺治疗，46例接受SSZ治疗）。疾病状态的变化被视为疗效终点，而不良事件的发生率被视为安全性终点。
在疾病活动指数（巴斯强直性脊柱炎疾病活动指数）方面，沙利度胺显示出比SSZ更好的疗效（2.84对4.49，p<0.001）。次要终点如功能指数（巴斯强直性脊柱炎功能指数）（2.32对3.34，p=0.021）、患者整体评估（2.92对4.11，p<0.001）、医生整体评估（2.67对3.60，p<0.001）、脊柱疼痛评分（2.52对3.31，p=0.025）、肿胀关节计数（0.05对0.40，p<0.001）、晨僵（2.08对3.27，p<0.001）、红细胞沉降率（28.17mm对34.25mm，p=0.023）和C反应蛋白（9.57mg/l对21.34mg/l，p=0.027）在沙利度胺组也更好。此外，与SSZ组相比，沙利度胺组有显著更多的患者病情改善了40%（90%对10%，p<0.001）。足部水肿是沙利度胺组最常见的不良事件（16例，46%），其次是嗜睡（13例，37%）、困倦（12例，34%）、口干（11例，31%）和皮疹（11例，31%）。另一方面，厌食（17例，48%）、头痛（15例，43%）和胃部刺激（10例，28%）是SSZ组常见的不良事件。
尽管有一些轻微的副作用，但在短期评估中，与SSZ相比，沙利度胺治疗中度至重度AS患者是有效且安全的。
