紫参洗剂坐浴治疗阴痒肝经湿热证60例临床观察  

Zishen Wash Formula(紫参洗剂)for Vulva Pruritus with Damp-heat in the Liver Channel Syndrome in 60 Cases

作　　者：史梅莹[1] 丁永芬[1] 汤玲 赖娟[1] 徐先敏 王浩[1] 邓博雅 程玲[1] 张雯 魏萌 王慧鸽 史欣德[4] 吴立娟[5] 田飞飞 尹春红 SHI Meiying;DING Yongfen;TANG Ling;LAI juan;XU Xianmin;WANG Hao;DENG Boya;CHENG Ling;ZHANG Wen;WEI Meng;WANG Huige;SHI Xinde;WU Lijuan;TIAN Feifei;YIN Chunhong(Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing,100102;Dongzhimen Hospital,Beijing University of Chinese Medicine;National Institute for Communicable Disease Control and Prevention;Graduate School,Chinese Academy of Chinese Medicine Sciences,Chinese Center for Disease Control and Prevention;School of Public Health,Capital Medical University;Beijing Rehabilitation Hospital,Capital Medical University)

机构地区：[1]中国中医科学院望京医院,北京市100102 [2]北京中医药大学东直门医院 [3]中国疾病预防控制中心传染病预防控制所 [4]中国中医科学院研究生院 [5]首都医科大学公共卫生学院 [6]首都医科大学附属北京康复医院

出　　处：《中医杂志》2021年第21期1911-1916,共6页Journal of Traditional Chinese Medicine

基　　金：中央本级重大增减支项目(2060302)。

摘　　要：目的观察紫参洗剂治疗阴痒肝经湿热证的临床疗效及安全性。方法将180例阴痒肝经湿热证患者随机分为紫参洗剂组、皮肤康组、聚维酮碘组,每组60例。紫参洗剂组给予紫参洗剂,每日1剂;皮肤康组给予皮肤康洗液每次20 ml,1∶20兑水;聚维酮碘组给予聚维酮碘溶液,每次50 ml,兑水700 ml。各组均每日1次,坐浴10~15 min,疗程均为7天。评价患者治疗前、停药3~7天、停药30~40天的临床症状评分,包括外阴评分、阴道评分、瘙痒评分、疼痛评分、皴裂评分、症状总评分,实验室检查指标(阴道分泌物镜检、白色念珠菌抗原检测、细菌性阴道病检测),分别于停药3~7天、停药30~40天时判定中医证候疗效,并进行安全性评价。结果紫参洗剂组、皮肤康组、聚维酮碘组停药3~7天中医证候疗效总有效率分别为98.31%、86.44%、96.61%,停药30~40天分别为100%、86.27%、85.19%,紫参洗剂组均高于皮肤康组和聚维酮碘组(P<0.01)。与本组治疗前比较,除聚维酮碘组皴裂评分外,各组停药3~7天及停药30~40天的其余各临床症状和症状总积分,清洁度Ⅲ度、白色念珠菌抗原检测阳性、细菌性阴道病检测阳性例数,以及皮肤康组、聚维酮碘组停药3~7天的镜下阴道毛滴虫例数均减少(P<0.05)。与本组停药3~7天比较,停药30~40天紫参洗剂组外阴评分、皴裂评分、疼痛评分、症状总评分和皮肤康组皴裂评分均降低,聚维酮碘组的清洁度Ⅲ度、白色念珠菌抗原检测阳性例数和皮肤康组的白色念珠菌抗原检测阳性例数显著增加(P<0.05)。与皮肤康组、聚维酮碘组同时间比较,紫参洗剂组停药3~7天外阴评分、瘙痒评分和症状总评分,停药30~40天外阴评分、阴道评分、瘙痒评分和症状总评分均降低(P<0.05);停药30~40天紫参洗剂组白色念珠菌抗原检测阳性例数较皮肤康组显著降低,清洁度Ⅲ度、白色念珠菌抗原检测阳性例数较聚维酮碘Objective To investigate the clinical effectiveness and safety of Zishen Wash Formula(紫参洗剂,ZWF)for treatment of vulvae pruritus with the pattern of damp-heat in the liver channel.Methods A total of 180 cases of vulvae pruritus with the pattern of damp-heat in the liver channel were randomised into ZWF group,Pifukang group and povidone iodine group,with 60 patients in each group.The ZWF group was given ZWF,one dose daily,while the other two groups were administered with hip bath of 20 ml Pifukang Lotion(肤康洗液)at the ratio of 1∶20 with water,and the povidone iodine group was given hip bath with 50 ml povidone iodine added with 700 ml water.All the administrations were performed once daily,10 to 15 minutes each time for seven days.The scores of clinical symptoms including vulva score,vagina score,itching score,pain score,cracked skin score and total symptom score were assessed before treatment,3 to 7 days after treatment and 30 to 40 days after treatment.The indicators of laboratory tests including vaginal discharge test,Candida antigen detection test,bacterial vaginosis detection were assessed 3 to 7 days after treatment and 30 to 40 days after treatment to obtain the effects on traditional Chinese medicine syndromes,and the safety was evaluated.Results The effective rate of ZWF group was 98.31%at 3 to 7 days after treatment and 100%at 30 to 40 days after treatment,both significantly higher than that of Pifukang group(86.44%and 86.27%)and povidone iodine group(96.61%and 85.19%)(P<0.01).Compared to those before treatment,the scores of clinical symptoms in all groups except for cracked skin score in povidone iodine group,the proportion of cleanliness degree ofⅢ,the proportion of positive result of Candida antigen detection test,and of bacterial vaginosis detection both at 3-7 days and 30-40 days after treatment,as well as the number of trichomonas vaginalis under microscopic test in Pifukang and povidone iodine group at 3-7 days after treatment significantly decreased(P<0.05).Compared to those resu

关 键 词：阴痒 紫参洗剂 中药外洗 肝经湿热证 中医证候疗效 

分 类 号：R271.9[医药卫生—中西医结合]