Front Med:中药配方治疗原发性干燥综合征的随机对照临床试验研究

2021-10-21 Vivi MedSci原创

目前西医治疗干燥综合征的方法有限,探讨中药方剂治疗原发性干燥综合征的疗效和安全性

干燥综合征(SS)是一种以干燥、疲劳和疼痛为主要特征的慢性炎症性自身免疫性疾病,目前西医治疗SS的方法有限。为探讨中药方剂治疗原发性SS的疗效和安全性,台湾台中中山医科大学附属医院进行了一项为期12周的随机、双盲、安慰剂对照临床试验

根据符合欧美共识组(AECG)的分类标准,该研究纳入42例SS患者,年龄在20 - 80岁之间,随机分为中药治疗组和安慰剂组(2:1)。中药组:早餐后服甘芦饮颗粒6g,晚餐后服加味逍遥散6g,配合酸枣仁汤1g,夜交藤1g。对照组的患者接受的安慰剂的外观和味道与治疗组相同,但剂量只有治疗组的十分之一。干燥综合征患者报告指数(ESSPRI)作为第12周的主要结局指标,次要结局指标为干燥综合征疾病活动指数(SSDAI)、患者对病情活动度的总体评估(PGA)、视觉模拟量表(VAS)、多维疲劳量表、健康调查简表 (SF-36) 和匹兹堡睡眠质量指数量表(PSQI)。

42例患者随机分为中药治疗组28例,对照组14例。研究期间,中药组脱落5例,对照组脱落7例。在第12周,两组的ESSPRI评分均有改善。治疗组ESSPRI评分下降0.62分(95% CIP=0.557),安慰剂组下降0.91分(P=0.557)。但两组间无明显差异。PSQI组的睡眠时间为−0.61,与安慰剂组相比,睡眠时间的改善大于−0.21 (P=0.914)。

虽然ESSPRI评分未显示中药方治疗干燥综合征的疗效,也有其他的不足,但是PSQI评分显示,该配方可以延长患者的睡眠时间,还可以降低血清IgG水平和患者血压。这为临床治疗干燥综合征提供一定的参考。

 

文献来源:

Chen HH, Lai JN, Yu MC, Chen CY, Hsieh YT, Hsu YF, Wei JC. Traditional Chinese Medicine in Patients With Primary Sjogren's Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Front Med (Lausanne). 2021 Sep 28;8:744194. doi: 10.3389/fmed.2021.744194.

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