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Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Oxymatrine appears to be efficacious and safe for the treatment of patients with EP, including those with concomitant CHB.
BACKGROUND: This study was registered at the Chinese Clinical Trial Registry ( www.chictr.org.cn ; Registration number ChiCTR-TRC-14004301).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Oxymatrine appears to be efficacious and safe for the treatment of patients with EP, including those with concomitant CHB.
BACKGROUND: This study was registered at the Chinese Clinical Trial Registry ( www.chictr.org.cn ; Registration number ChiCTR-TRC-14004301).
摘要：
背景：红皮病性银屑病（EP）的治疗，一种罕见但严重的牛皮癣,具有挑战性，尤其是伴随慢性乙型肝炎（CHB）的患者。我们以前证明，氧化苦参碱治疗缓解严重斑块型银屑病，但其在治疗EP方面的治疗潜力仍有待探索。本研究旨在评估氧化苦参碱治疗EP的疗效和安全性。注意伴随CHB。
方法：在这项由研究者发起的临床试验中，4例EP患者，包括两个（A和B）伴随CHB，用静脉注射氧化苦参碱作为单一疗法治疗8周，并计划随访至少24周。主要结果是在第32周，银屑病面积和严重程度指数（PASI75）至少改善了75％。次要结果包括体表面积（BSA）评分，皮肤病学生活质量指数（DLQI）]，和安全。
结果：患者A，B,C在治疗完成和第32周时达到PASI75，表现出77.4%的改善，97.2%,在PASI中100%，分别。他们的BSA和DLQI在第32周以及整个37、57和105周的随访期间也显着改善，分别。CHB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。
结论：氧化苦参碱对EP患者的治疗似乎是有效和安全的，包括那些伴随CHB。
背景：本研究已在中国临床试验注册中心注册（www.chictr.org.cn；注册号ChiCTR-TRC-14004301）。
方法：在这项由研究者发起的临床试验中，4例EP患者，包括两个（A和B）伴随CHB，用静脉注射氧化苦参碱作为单一疗法治疗8周，并计划随访至少24周。主要结果是在第32周，银屑病面积和严重程度指数（PASI75）至少改善了75％。次要结果包括体表面积（BSA）评分，皮肤病学生活质量指数（DLQI）]，和安全。
结果：患者A，B,C在治疗完成和第32周时达到PASI75，表现出77.4%的改善，97.2%,在PASI中100%，分别。他们的BSA和DLQI在第32周以及整个37、57和105周的随访期间也显着改善，分别。CHB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。
结论：氧化苦参碱对EP患者的治疗似乎是有效和安全的，包括那些伴随CHB。
背景：本研究已在中国临床试验注册中心注册（www.chictr.org.cn；注册号ChiCTR-TRC-14004301）。
