摘要
目的 应用多中心、双盲、安慰剂随机的研究方法对蒿秦化斑优化方治疗多形性日光疹(PLE)的临床疗效及安全性进行评价.方法 依据诊断、纳入及排除标准,将126例于首都医科大学附属北京中医医院、北京中医医院顺义医院、北京回民医院皮肤科门诊就诊的多形性日光疹患者,采用2∶1比例随机分为治疗组与对照组,治疗组84例口服蒿秦化斑优化方颗粒,对照组42例口服安慰剂.每周观察1次,连续观察4周后进行疗效评价.比较2组治疗前后湿疹面积及严重程度指数(EASI)评分(红斑、丘疹、表皮剥脱、渗出/结痂、苔藓化和受累面积);中医主要临床证候评分(瘙痒、心烦、口渴、小便黄和大便干);皮肤病生活质量指数(DLQI)量表、健康状况调查问卷(SF-36)及安全性指标进行疗效判定.结果 治疗4周后,治疗组愈显率(76.92％)及总有效率(94.87％)均较对照组提高(P＜0.001);EASI评分较对照组明显下降(P＜0.001),其中红斑、丘疹、受累面积均较对照组明显改善(P＜0.05).治疗组治疗4周后中医证候评分总分较对照组明显下降(P＜0.05).治疗4周后治疗组患者生理机能、生理职能、躯体疼痛、社会功能、情感职能评分较对照组提高(P＜0.05),DLQI评分较对照组明显降低(P＜0.05).2组患者治疗前后安全性指标未出现异常,无不良事件发生.结论 口服蒿秦化斑优化方可有效改善PLE患者临床症状和体征及生活质量,且无明显不良反应.
Abstract
Objective In order to investigate the efficacity and safety of Haoqin Huaban optimized decoction by using multicenter,double-blinded,and placebo randomized controlled method.Methods According to the criteria of diagnosis,inclusion,and exclusion,126 patients with polymorphic light eruption(PLE),from Beijing Hospital of traditional Chinese medicine(TCM),Beijing Shunyi Hospital of TCM,Beijing Huimin Hospital were filtered out.The patients were randomly divided into trcatment group and control group.Eighty-four patients in the treatment group were treated with granular Haoqin Huaban optimized decoction.Forty-two patients in the control group received oral placebo.The observation would be taken once a week,four times constantly with an assessment of therapeutic efficacy.The assessment was divided into four parts:first,the eczema area and severity index(EASI)scale which include erythema,papules,epidermal exfoliation,exudation/c rusting,lichen and affected area.Second,the scores of TCM main clinical syndromes which consist of pruritus,upset,thirst,yellow urine,dry stool.Third,life quality is composed of dermatology life quality index(DLQI)scale and health questionnaire(SF-36)scale.Last,patient safety indicators prior and after the therapeutic need to be monitored.Results After four weeks of treatment,the healing rate(76.92％)and total effective rate(94.87％)in the treatment group were significantly higher than those in the control group(P＜0.001).Compared with the control group,EASI score decreased significantly in the treatment group(P＜0.001),and erythema,papules and affected area improved significantly in the treatment group(P＜0.05).The total score of TCM syndrome in the treatment group decreased significantly compared with the control group(P＜0.05).After four weeks of treatment,the scores of physiological function,physiological function,physical pain,social function and role function in the treatment group were higher than those in the control group(P＜0.05),and the DLQI score was significantly lower than that in the control group(P＜0.05).There were no abnormal values among safety indicators and no adverse events happened.Conclusion Haoqin Huaban optimized decoction can effectively improve the clinical symptoms and signs of patients with PLE without obvious adverse reactions.
基金项目
国家自然科学基金(81774309)
北京中医医院顺义医院院级项目(SYYJ-201806)
全国中医临床优秀人才研修项目(国中医人教函[2022]1号)
维普
万方数据