Efficacy and safety of Tripterygium wilfordii hook F versus acitretin in moderate to severe psoriasis vulgaris: a randomized clinical trial.
Efficacy and safety of Tripterygium wilfordii hook F versus acitretin in moderate to severe psoriasis vulgaris: a randomized clinical trial.
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DOI：
10.4103/0366-6999.151069
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发表时间：
2015-02-20
影响因子：
6.1
通讯作者：
Liu TJ
中科院分区：
文献类型：
--
作者：
Wu C;Jin HZ;Shu D;Li F;He CX;Qiao J;Yu XL;Zhang Y;He YB;Liu TJ
很少有临床试验评价雷公藤多甙与阿维A治疗银屑病的疗效和安全性。我们的目的是比较疗效和安全性的TwHF相比，阿维A在治疗中重度寻常型银屑病。将银屑病面积严重程度指数（PASI）评分≥ 10且银屑病累及体表面积≥ 10%的成人随机分为TwHF组（20 mg，每日3次）或阿维A组（30 mg，每日1次）。疗程8周。在基线和第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。采用配对t检验或方差分析对数据进行分析。共入组115例患者（58例TwHF; 57例阿维A）。TwHF组中位PASI评分改善了50.4%，阿维A组改善了42.7%。在2、4和8周时，两组之间的PASI改善中位数无显著差异。在2、4和8周时，两组之间的PASI 25、PASI 50、PASI 75和PASI 90反应也无显著差异。有一个显着增加天冬氨酸转氨酶和甘油三酯的水平在TwHF组（P = 0.026和P = 0.011，分别）。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（P = 0.030，P < 0.01，P < 0.01）。在8周内，TwHF和阿维A组之间的治疗效果没有显著差异，但TwHF组的治疗相关不良事件较少。
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.