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).
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)。