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

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组均显著降低(P<0.05)。各组均未发生严重不良反应。结论紫参洗剂能够显著改善阴痒肝经湿热证患者阴部瘙痒、疼痛等症状,对减轻局部皮肤黏膜充血、水肿亦有一定疗效,并且作用更持久。

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 results assessed at 3-7 days after treatment,the vulva score,cracked skin score,pain score and total symptom score in ZWF group,and the cracked skin score in Pifukang group at 30-40 days after treatment significantly decreased,while the proportion of cleanliness degree ofⅢand of the positive result of Candida antigen detection test in povidone iodine group,as well as the proportion of cleanliness degree ofⅢin Pifukang group significantly increased(P<0.05).Compared to those in Pifukang and povidone iodine group assessed at the same time point,the vulva score,itching score and total symptom score at 3-7 days after treatment,as well as vulva score,vagina score,itching score and total symptom score at 30-40 days after treatment significantly decreased in ZWF group(P<0.05);when assessed at 30-40 days after treatment,the proportion of positive result of Candida antigen detection test in ZWF group significantly decreased than that in Pifukang group,and the proportion of cleanliness degree ofⅢand of positive result of Candida antigen detection test decreased as well compared to those in povidone iodine group(P<0.05).No severe adverse events occurred in all groups.Conclusion ZWF can improve the vulva symptoms such as pruritus and pain,and has certain advantages in alleviating local skin and mucous membrane hyperemia and edema with longer effect lasting,and is safe in vulva pruritus patients with the pattern of damp-heat in the liver channel.