Wu Chao, Jin Hong-Zhong, Shu Dan, Li Feng, He Chun-Xia, Qiao Ju, Yu Xiao-Ling, Zhang Ying, He Yi-Bo, Liu Tie-Jun
Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Chin Med J (Engl). 2015 Feb 20;128(4):443-9. doi: 10.4103/0366-6999.151069.
Few clinical trials have evaluated the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) compared with acitretin in psoriasis. We aimed to compare the efficacy and safety of TwHF compared with acitretin in the treatment of moderate to severe psoriasis vulgaris.
Adults with Psoriasis Area Severity Index (PASI) score ≥ 10 and psoriasis-affected body surface area ≥ 10% were randomized into a TwHF (20 mg, 3 times a day) or acitretin group (30 mg, once a day). The treatment course lasted for 8 weeks. Patients were assessed at baseline and at 2, 4, and 8 weeks. Laboratory tests were performed at baseline, week 4, and week 8. The data were analyzed using paired samples t-test or analysis of variance (ANOVA).
A total of 115 patients was enrolled (58 TwHF; 57 acitretin). The median PASI score improved in the TwHF group by 50.4% and in the acitretin group by 42.7%. There was no significant difference in median PASI improvement between two groups at 2, 4, and 8 weeks. There was also no significant difference in PASI 25, PASI 50, PASI 75, and PASI 90 response between the two groups at 2, 4, and 8 weeks. There was a significant increase in the level of aspartate transaminase and triglycerides in the TwHF group (P = 0.026 and P = 0.011, respectively). In the acitretin group, there was a significant increase in the level of alanine transaminase, cholesterol, and high-density lipoprotein (P = 0.030, P < 0.01, and P < 0.01, respectively).
There was no significant difference in treatment efficacy between the TwHF and acitretin groups within 8 weeks, but there were fewer treatment-related adverse events in the TwHF group.
与阿维A相比，评估雷公藤多苷（TwHF）治疗银屑病疗效和安全性的临床试验较少。我们旨在比较TwHF与阿维A治疗中度至重度寻常型银屑病的疗效和安全性。
银屑病面积和严重程度指数（PASI）评分≥10且银屑病累及体表面积≥10%的成年人被随机分为TwHF组（20毫克，每日3次）或阿维A组（30毫克，每日1次）。疗程持续8周。在基线、第2、4和8周对患者进行评估。在基线、第4周和第8周进行实验室检查。数据采用配对样本t检验或方差分析（ANOVA）进行分析。
共纳入115例患者（58例TwHF组；57例阿维A组）。TwHF组PASI评分中位数改善了50.4%，阿维A组改善了42.7%。在第2、4和8周时，两组PASI中位数改善情况无显著差异。在第2、4和8周时，两组在PASI 25、PASI 50、PASI 75和PASI 90反应方面也无显著差异。TwHF组天冬氨酸转氨酶和甘油三酯水平显著升高（分别为P = 0.026和P = 0.011）。在阿维A组，丙氨酸转氨酶、胆固醇和高密度脂蛋白水平显著升高（分别为P = 0.030、P < 0.01和P < 0.01）。
TwHF组和阿维A组在8周内治疗疗效无显著差异，但TwHF组治疗相关不良事件较少。
