白芍总苷联合左西替利嗪及他克莫司软膏治疗严重面部激素依赖性皮炎的疗效和安全性评价

目的 评估白芍总苷联合左西替利嗪及他克莫司软膏治疗严重面部糖皮质激素（简称激素）依赖性皮炎的疗效和安全性。 方法 共入组98例严重面部激素依赖性皮炎患者，其中63例（试验组）口服白芍总苷胶囊联合左西替利嗪并外用他克莫司软膏治疗， 35例（对照组）单纯口服左西替利嗪及外用他克莫司软膏治疗。治疗后第2和4周、停药后2周随访观察患者面部症状及体征，并进行评分，计算有效率。 结果 临床随访过程中脱落8例，其中试验组脱落3例，对照组脱落5例，最后完成治疗患者共90例。治疗2周后试验组和对照组的有效率分别为50.0%（30/60）和16.7%（5/30），两组比较差异有统计学意义（P ＜ 0.05）；治疗4周后试验组和对照组的有效率分别为93.3%（56/60）和60.0%（18/30），两组比较差异有统计学意义（P ＜ 0.05）。停药2周后，所有试验组患者症状总积分持续下降，对照组中53.3%（16/30）患者症状总积分持续下降，26.7%（8/30）患者症状总积分不变，20.0%（6/30）患者症状总积分较停药时上升。两组均无严重不良反应。 结论 白芍总苷胶囊可以提高左西替利嗪及他克莫司软膏治疗面部严重激素依赖性皮炎的疗效。

Assessment of the efficacy and safety of total glucosides of paeony combined with levocetirizine and tacrolimus ointment for the treatment of severe facial corticosteroid-dependent dermatitis

Mao Hongqun*, Luan Chao, Zong Wenkai, Yao Xu, Liu Yi, Lin Lin, Cui Pangen, Chen Min. *Department of Dermatology, Fuyang Hospital of Traditional Chinese Medicine, Fuyang 311400, Zhejiang, China Corresponding author: Chen Min, Email: drchenmin@126.com 【Abstract】 Objective To evaluate the efficacy and safety of total glucosides of paeony combined with levocetirizine and tacrolimus ointment for the treatment of severe facial corticosteroid-dependent dermatitis. Methods Ninety-eight patients with severe facial corticosteroid-dependent dermatitis were enrolled in this study, and assigned into the test group （n = 63） and control group （n = 35）. The test group were treated with oral total glucosides of paeony capsules and levocetirizine as well as topical 0.03% tacrolimus ointment, and the control group with oral levocetirizine and topical 0.03% tacrolimus ointment only. The facial symptoms and signs of patients were observed and scored at week 2 and 4 after starting treatment as well as at week 2 after drug withdrawal. The response rate in these patients was calculated. Results Totally, 8 patients （3 in the test group and 5 in the control group） were lost to follow up, and the remaining 90 patients completed the treatment finally. The response rate in the test group was significantly higher than that in the control group at week 2 （50.0% （30/60） vs. 16.7% （5/30）, P < 0.05） and 4 （93.3% （56/60） vs. 60.0% （18/30）, P < 0.05） after starting treatment. During the 2 weeks after drug withdrawal, total symptom scores continuously decreased in all the patients in the test group and in 53.3% （16/30） of the patients in the control group, maintained unchanged in 26.7% （8/30） and increased in 20.0% （6/30） of the patients in the control group. No severe adverse reactions were observed in either of the two groups during the study period. Conclusion Total glucosides of paeony capsules can improve the efficacy of levocetirizine and topical tacrolimus ointment for the treatment of severe facial corticosteroid-dependent dermatitis.