Department of Clinical Medicine, Ningxia Medical University, Yinchuan, 750004, China.
Department of Dermatovenereology, Ningxia Medical University General Hospital, Yinchuan, 750004, China.
Br J Dermatol. 2017 Jun;176(6):1446-1455. doi: 10.1111/bjd.15316. Epub 2017 May 2.
Drugs that are currently used in the treatment of psoriasis are associated with drawbacks such as rapid recrudescence, high costs and unwanted side-effects. Oxymatrine has a long history of clinical use in the treatment of hepatitis and cancer in China.
To explore the efficacy and safety of intravenous oxymatrine in patients with severe plaque psoriasis.
A total of 67 patients were randomly allocated to receive oxymatrine injections (0.6 g per day for 8 weeks) or acitretin capsules (0.75 mg kg per day from week 0 to week 2 and 20-30 mg per day from week 3 to week 8) and followed up for another 24 weeks. The primary end point was the percentage of patients with ≥ 50% reduction of Psoriasis Area and Severity Index (PASI 50) at week 32. The secondary end points included the skin classification grade and the Dermatology Quality of Life Index (DLQI) score. Side-effects were recorded throughout the whole study to assess the safety profile.
Treatment with oxymatrine or acitretin for 8 weeks significantly decreased PASI score, skin classification grade and DLQI score (P < 0.001), with no significant differences between the oxymatrine and acitretin groups in terms of PASI 50. However, at week 32, the relapse rate in the oxymatrine group was significantly lower than that of the acitretin group (P < 0.001). Moreover, while there was an increase in the number of patients with metabolic abnormalities in the acitretin group, a significant reduction was observed in the oxymatrine group. Furthermore, rates of adverse reactions were significantly decreased in the oxymatrine group compared with that of the acitretin group (P < 0.001).
Treatment with oxymatrine effectively ameliorated severe plaque psoriasis, and was accompanied by only minor adverse effects.
目前用于治疗银屑病的药物存在快速复发、成本高和不良反应等缺点。氧化苦参碱在中国用于治疗肝炎和癌症已有很长的临床应用历史。
探讨静脉注射氧化苦参碱治疗重度斑块状银屑病的疗效和安全性。
将 67 例患者随机分为氧化苦参碱组（0.6 g/d，连续 8 周）和阿维 A 酯组（0 周至 2 周时 0.75 mg·kg-1·d-1，3 周至 8 周时 20~30 mg/d），并随访 24 周。主要终点是第 32 周时达到银屑病面积和严重程度指数（PASI）改善 50%（PASI 50）的患者比例。次要终点包括皮肤分级和皮肤病生活质量指数（DLQI）评分。整个研究过程中记录不良反应以评估安全性。
氧化苦参碱或阿维 A 酯治疗 8 周后，PASI 评分、皮肤分级和 DLQI 评分均显著降低（P＜0.001），氧化苦参碱组和阿维 A 酯组之间在 PASI 50 方面无显著差异。但在第 32 周时，氧化苦参碱组的复发率明显低于阿维 A 酯组（P＜0.001）。此外，阿维 A 酯组的代谢异常患者数量增加，而氧化苦参碱组则显著减少。此外，氧化苦参碱组的不良反应发生率明显低于阿维 A 酯组（P＜0.001）。
氧化苦参碱治疗重度斑块状银屑病有效，且不良反应轻微。
