十二味菝葜颗粒治疗寻常型银屑病的病例对照研究

A Case Control Study on the Treatment of Psoriasis Vulgaris with Shierwei Baqia Granules

目的 评价十二味菝葜治疗寻常型银屑病(PV)的疗效和安全性。方法 采用随机临床病例对照方法,选择2017年9月—2018年6月就诊于空军特色医学中心皮肤科的49例PV患者作为研究对象,按随机数字表法将患者分为研究组和对照组。研究组给予十二味菝葜颗粒,对照组给予克银丸。比较2组银银屑病皮损面积和严重程度指数(PASI)、皮肤病生活质量的差异以及药物安全性,评价十二味菝葜治疗PV的效果。结果 本次研究共纳入PV患者49例;其中研究组(十二味菝葜组)29例,年龄19~62岁;对照组(克银丸组)20例,年龄23~65岁;2组间性别、年龄、体质量指数(BMI)和治疗前PASI比较差异均无统计学意义(均P>0.05)。PASI疗效指数比较,研究组治疗PV的疗效优于对照组,且差异有统计学意义(P<0.05)。2组临床疗效比较差异无统计学意义(P>0.05)。2组皮肤病生活质量指数(DLQI)评分的改善情况比较差异无统计学意义(P>0.05)。研究组:治疗后丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、尿素氮(BUN)、肌酐(Cr)、总胆红素(TBIL)、γ-谷氨酰转肽酶(γ-GT)均在正常范围内。治疗后对照组出现1例药物性肝损伤。ALT、AST、BUN、Cr、TBIL和γ-GT均未见明显异常。结论 十二味菝葜颗粒治疗PV疗效较好,用药安全,为临床用药提供了循证依据。

Objective In order to evaluate the efficacy and safety of Shierwei Baqia granules in the treatment of psoriasis vulgaris(PV).Methods From September 2017 to June 2018,49 patients with PV in the dermatology department of the Air Force Medical Center were selected as the research objects.They were divided into study group and control group according to the random number table.The study group was treated with Shierwei Baqia granules,and the control group was treated with Keyin pills.The severity of psoriasis,the quality of life of skin diseases and the safety of drugs in different groups was compared to evaluate the effects of Shierwei Baqia granules in the treatment of PV.All participants completed psoriasis area and severity index(PASI)at baseline.Results A total of 49 patients with PV were included in this study.Among them,there were 29 cases in the study group(Shierwei Baqia granules group),aged from 19 to 62 years old.The control group(Keyin pills group)included 20 cases,aged from 23 to 65 years.There were no significant differences in gender,age,body mass index(BMI)and psoriasis area severity index(PASI)before treatment between two groups(P>0.05).According to the PASI score,the curative effects of the study group were better than those of the control group in the treatment of PV,and the differences were statistically significant(P<0.05).There were no statistically significant differences in clinical efficacy between two groups(P>0.05).There were no statistically significant differences in the improvement of dermatology life quality index(DLQI)score between two groups(P>0.05).Study group:after treatment,alanine transaminase(ALT),aspartate aminotransferase(AST),urea nitrogen(BUN),creatinine(Cr),total bilirubin(TBIL),γ-glutamyl transpeptidase(γ-GT)were in the normal range.After treatment,except for one case of drug-induced liver injury in the control group,no obvious abnormality was observed in ALT,AST,BUN,Cr,TBIL andγ-GT.Conclusion The effectiveness and safety of Shierwei Baqia granules in the treatment of PV,which would provides evidence-based basis for clinical medication.