Shi Huijuan, Chen Dongmei, Si Jiawei, Zou Qian, Guo Yatao, Yu Jiayu, Li Cheng, Wang Fang
Innovation Team for Skin Disease Diagnosis and Treatment Technology and Drug Discovery and Development, Department of Dermatovenereology, General Hospital of Ningxia Medical University, 804 Shengli South Street, Yinchuan, 750004, Ningxia, China.
Department of Dermatovenereology, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.
Dermatol Ther (Heidelb). 2024 Jun;14(6):1659-1670. doi: 10.1007/s13555-024-01181-5. Epub 2024 May 26.
The management of erythrodermic psoriasis (EP), a rare but severe type of psoriasis, is challenging, especially in patients with concomitant chronic hepatitis B (CHB). We previously demonstrated that oxymatrine treatment alleviated severe plaque psoriasis, but its therapeutic potential in treating EP remains unexplored. This study was to assess the efficacy and safety of oxymatrine for the treatment of EP, with attention to concomitant CHB.
In this investigator-initiated clinical trial, four consecutive patients with EP, including two (A and B) with concomitant CHB, were treated with intravenous administration of oxymatrine as monotherapy for 8 weeks, and scheduled to be followed up for a minimum of 24 weeks. The primary outcome was at least 75% improvement in the psoriasis area and severity index (PASI 75) at week 32. Secondary outcomes included the body surface area (BSA) score, dermatology life quality index (DLQI)], and safety.
Patients A, B, and C achieved PASI 75 at treatment completion and week 32, demonstrating improvements of 77.4%, 97.2%, and 100% in PASI, respectively. Their BSA and DLQI were also improved significantly at week 32 and throughout follow-up of 37, 57, and 105 weeks, respectively. The viral loads in patients A and B with CHB decreased modestly. Patient D discontinued after follow-up for 19 weeks, and the primary outcome could not be analyzed. No adverse events were reported during treatment and follow-up.
Oxymatrine appears to be efficacious and safe for the treatment of patients with EP, including those with concomitant CHB.
This study was registered at the Chinese Clinical Trial Registry ( www.chictr.org.cn ; Registration number ChiCTR-TRC-14004301).
红皮病型银屑病（EP）是一种罕见但严重的银屑病类型，其治疗颇具挑战性，尤其是对于合并慢性乙型肝炎（CHB）的患者。我们之前证明氧化苦参碱治疗可缓解重度斑块状银屑病，但其治疗EP的潜力仍未得到探索。本研究旨在评估氧化苦参碱治疗EP的疗效和安全性，并关注合并CHB的情况。
在这项研究者发起的临床试验中，连续4例EP患者，包括2例（A和B）合并CHB的患者，接受静脉注射氧化苦参碱单药治疗8周，并计划至少随访24周。主要结局是在第32周时银屑病面积和严重程度指数（PASI 75）改善至少75%。次要结局包括体表面积（BSA）评分、皮肤病生活质量指数（DLQI）以及安全性。
患者A、B和C在治疗结束时及第32周时达到PASI 75，PASI分别改善了77.4%、97.2%和100%。他们的BSA和DLQI在第32周以及分别为37周、57周和105周的整个随访期间也有显著改善。合并CHB的患者A和B的病毒载量略有下降。患者D在随访19周后停药，无法分析主要结局。治疗和随访期间未报告不良事件。
氧化苦参碱治疗EP患者，包括合并CHB的患者，似乎有效且安全。
本研究在中国临床试验注册中心（www.chictr.org.cn；注册号ChiCTR-TRC-14004301）注册。
