化毒超微粉治疗湿毒瘀阻证女性下生殖道HR-HPV持续感染30例临床研究

Clinical Study on Resolving Toxin Ultrafine Powder( 化毒超微粉) in the Treatment of 30 Cases of Persistent High-Risk Human Papilloma Virus Infection in Women with Damp Toxin Stagnation Syndrome

目的观察化毒超微粉治疗湿毒瘀阻证女性下生殖道高危人乳头瘤病毒(HR-HPV)持续感染的临床疗效及安全性。方法将60例湿毒瘀阻证女性下生殖道HR-HPV持续感染患者随机分为治疗组和对照组各30例,治疗组给予化毒超微粉阴道喷撒,每次3g;对照组给予重组人干扰素a2b阴道泡腾胶囊1粒阴道放置。两组均为隔日1次,10次为1个疗程,月经期停药,连续使用3个疗程。于治疗结束12个月后观察两组患者HR-HPV转阴率、中医证候疗效、临床疗效及不良反应的发生情况,治疗前后比较中医证候积分及Reid阴道镜评分(RCI)总分。结果治疗后治疗组HR-HPV转阴率为83.33%,明显高于对照组的60.00%(P=0.045);治疗组中医证候疗效显效率为96.70%,明显高于对照组的50.00%(P<0.05);治疗组临床疗效总有效率为86.7%,明显高于对照组的63.3%(P<0.05)。两组治疗后中医证候积分、RCI总分均较本组治疗前下降,且治疗组下降更明显(P<0.01)。两组患者治疗期间均未出现不良反应。结论化毒超微粉能够有效清除女性下生殖道HR-HPV持续感染,改善临床症状,且安全性好。

Objective To observe the clinical efficacy and safety of Resolving Toxin Ultrafine Powder(化毒超微粉)for the treatment of low-reproductive tract high-risk human papilloma virus(HR-HPV)infection in women with damp toxin stagnation syndrome.Methods A total of 60 female patients with persistent HR-HPV infection of damp toxin stagnation syndrome were randomly divided into a treatment group and a control group,with 30 cases in each group.The treatment group was given Resolving Toxin Ultrafine Powder vaginal spray,3 g each time.The control group was given 1 vaginal effervescent capsule of recombinant human interferon a2 b to the vagina.Both groups were treated once every other day,10 times for a course of treatment.The drug was discontinued during menstruation,and 3 consecutive courses of treatment were used.Twelve months after the end of treatment(after treatment),the HR-HPV negative rate,the efficacy of traditional Chinese medicine(TCM)syndromes,the clinical efficacy,and the occurrence of adverse reactions were observed in both groups of patients.The total scores of TCM syndromes and the Reid colposcope score(RCI)were compared before and after treatment.Results After treatment,the HR-HPV negative rate in the treatment group was 83.33%,which was significantly higher than the control group′s 60.00%(P=0.045).TCM syndrome effective rate of the treatment group was 96.70%,which was significantly higher than that of the control group(50.00%,P<0.05);the total effective rate of clinical efficacy in the treatment group was 86.7%,which was significantly higher than the 63.3%in the control group(P<0.05).The TCM syndrome scores and RCI total scores after treatment were decreased compared with those before treatment in the 2 groups,and the decline was more significant in the treatment group(P<0.01).No adverse reactions occurred during the treatment in both groups.Conclusions Resolving Toxin Ultrafine Powder can effectively clear the female genital tract HR-HPV infection,improve clinical symptoms,with safty.