基于真实世界数据的芍苓方治疗寻常型银屑病的疗效与安全性分析

Effectiveness and Safety of Shaoling Formula for Psoriasis Vulgaris:A Real-World Data Analysis

目的通过真实世界数据分析方法,评价芍苓方治疗寻常型银屑病的疗效和安全性。方法采用单中心、回顾性、单臂、真实世界临床研究的设计方法,收集广东省中医院病历系统数据库10年间有关芍苓方治疗寻常型银屑病患者的病例信息,患者予芍苓方内服,外用润肤剂作为基础治疗,疗程为2个月以上。以医师对病情整体评分(PGA)、体表受累面积(BSA)、银屑病皮损面积和严重程度指数(PASI)和瘙痒视觉模拟评估(VAS)作为疗效指标;以不良事件(AE)的发生情况作为安全性评价指标。结果最终纳入符合标准的银屑病患者共1374例,其中64.4%是男性,首诊PGA为(3.3±1.0)分,PASI为(6.3±5.6)分,BSA为(8.6±15.1)%,瘙痒VAS为(4.0±2.4)分。治疗后患者PGA、PASI、BSA、瘙痒VAS评分较治疗前明显改善,差异有统计学意义(P<0.05);患者血尿常规、肝肾功能、凝血、血脂方面的医学检查未见有临床意义的变化;不良事件分析中未发现与药物相关的严重不良事件。结论芍苓方主要用于治疗中度寻常型银屑病患者,可有效地改善和减轻患者的皮损症状、受累面积以及瘙痒症状,且临床用药安全性好。

Objective The aim of this study is to evaluate the effectiveness and safety of Shaoling formula for psoriasis vulgaris by analyzing real-world data in clinical practice.MethodsA single-center,retrospective,singlearm,real-world clinical study was conducted.From Guangdong Provincial Hospital of Chinese Medicine,electronic medical records of Shaoling formula for Psoriasis Vulgaris within 10 years were collected.All patients were given Shaoling formula for oral administration and moisturizers as an adjuvant role for over 2 months.The effectiveness and safety of the treatment were evaluated by physician’s global assessment(PGA),body surface area(BSA),psoriasis area and severity index(PASI),visual analogy score(VAS)for pruritus,and adverse events(AE).Results A total of 1374 patients were included in our study.The percentage of males was 64.4%.The value before initial treatment of PGA,PASI,BSA and VAS was(3.3±1.0),(6.3±5.6),(8.6±15.1)%,and(4.0±2.4)respectively.After treatment,all the evaluation indices were improved with statistical significance(P<0.05).And,there was no statistically significant difference of medical examinations before and after treatment,including blood and urine routine tests,liver and kidney function tests,the coagulation function test and the blood lipid examination.There was no severe adverse events relating to practical medicines.Conclusion Shaolingformula is effective for moderate psoriasis vulgaris,which can reduce skin lesion,surface area,and related symptoms(i.e.itch).And,the safety of the drugs has been proved.