Cai Jian-Fei, Wei Ya-Rong, Chen Yong, Zou Jun, Yan Shen, Guan Jian-Long
Department of Rheumatology and Immunology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Department of Neurology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Immun Inflamm Dis. 2024 Dec;12(12):e70057. doi: 10.1002/iid3.70057.
This study aimed to investigate the efficacy and safety of a triple therapy consisting of colchicine, thalidomide and total glucosides of paeony (TGP) in Behcet's disease (BD) patients with mucocutaneous involvement.
Totally 355 newly diagnosed BD patients with mucocutaneous involvement were recruited, who received dexamethasone and colchicine for the first 2 weeks, then they were categorized into "sustained triple-therapy (ST)" (n = 231) and "colchicine to triple-therapy (CT)" (n = 124) groups respectively: for ST group, patients received colchicine, thalidomide plus TGP from Month (M)0.5 to M12; for CT group, patients received colchicine from M0.5 to M2, then switched to colchicine, thalidomide plus TGP from M3 to M12.
The percentages of oral ulceration (at M1, M2) and genital ulceration (at M1) were lower in ST group compared to CT group, whereas there was no difference of other clinical manifestations (including uveitis, erythema nodosum, thrombosis, arterial involvement or nervous system involvement) at each time point between the two groups. For biochemical indexes, ESR was higher at M1 but rapidly reduced at M2 in ST group compared to CT group, while CRP level was similar at all time points between the two groups. For side effects, occurrences of drug-related cytopenia and diarrhea were increased, in ST group compared to CT group.
A triple therapy consisting of colchicine, thalidomide and TGP is more effective and equally tolerated compared to colchicine alone in treating BD patients with mucocutaneous involvement.
本研究旨在探讨秋水仙碱、沙利度胺和白芍总苷(TGP)三联疗法治疗白塞病(BD)皮肤黏膜受累患者的疗效和安全性。
共招募355例新诊断的BD皮肤黏膜受累患者,前2周给予地塞米松和秋水仙碱治疗,然后分别分为“持续三联疗法(ST)”组(n = 231)和“秋水仙碱序贯三联疗法(CT)”组(n = 124):ST组患者从第0.5个月(M)至第12个月接受秋水仙碱、沙利度胺加TGP治疗;CT组患者从M0.5至M2接受秋水仙碱治疗,然后从M3至M12改用秋水仙碱、沙利度胺加TGP治疗。
与CT组相比,ST组口腔溃疡(在M1、M2时)和生殖器溃疡(在M1时)的发生率较低,而两组在各时间点的其他临床表现(包括葡萄膜炎、结节性红斑、血栓形成、动脉受累或神经系统受累)无差异。对于生化指标,与CT组相比,ST组在M1时血沉较高,但在M2时迅速下降,而两组在所有时间点的CRP水平相似。对于副作用,与CT组相比,ST组药物相关血细胞减少和腹泻的发生率增加。
与单独使用秋水仙碱相比,秋水仙碱、沙利度胺和TGP组成的三联疗法在治疗BD皮肤黏膜受累患者时更有效且耐受性相当。