| Objective:A controlled clinical trial was conducted by external using of Qicao Erzhu San to treat high risk cervical HPV infection to explore and excavate potential medical applications and unique advantages of external treatment methods of traditional Chinese medicine for high risk cervical HPV infection.Methods:1. A total of 100 cases from outpatient service of department of gynaecology and women’s health care, and physical examination center of Changzhou TCM hospital from March to December in 2015 were enrolled into study after strict screening. All subjects was randomly divided into treatment group (n=50) and control group (n=50). There were no obvious differences in age, HR-HPV loads and disease severity between the two groups.2. External using of Qicao Erzhu San was performed in the treatment group (composed of radix astragali, radix arnebiae seu lithospermi, atractylodes macrocephala koidz, rhizoma zedoariae, glabrous greenbrier rhizome and borneol) by uniformly spraying on infected parts, while XinFuNing (Recombinant Human Interferon a2b Vaginal Effervescent Capsules) was used in the control group. Both were used 10 times/a menstrual cycle for 3 menstrual cycles. To check treatment results at the 4th months.3. Changes of HR-HPV loads, TCM syndromes, and levels of Treg cells in peripheral blood and mucosal injury of genital tract were observed respectively in the two groups for comparative analysis of efficacy between the two groups.Results:1 The total effective rate of HR-HPV loads declining in the treatment group was 64%, while in the control group was 72%, there was no obvious difference between the two groups (P>0.05).2. The total effective rate of improvement of TCM syndrome in the treatment group was 54%, while in the control group was 30%, there was a significant difference between the two groups (P<0.01).3. Compared levels of CD4+CD25+CD127lowTreg cells in peripheral blood before (8.05±1.55%) and after treatment (7.26±1.18%) in the treatment group, there was a significant difference (P< 0.05); while in the controll group was before (8.05±1.55%) and after treatment (7.26±1.18%), there was there was no obvious difference (P<0.05); Comparison between the two groups, there was no obvious difference before the treatment but after the treatment there was a significant difference (P<0.05).4 The total effective rate of improvement of mucosal injury of genital tract in the treatment group was 88%, while in the controll group was 70%, there was a significant difference between them(P<0.05).Conclusions:External using of Qicao Erzhu San can effectively reduce HPV loads of high-risk cervical HPV infection, improve patients’ clinical autonomic symptoms and down-regulate levels of Treg cells in peripheral blood and repair mucosal injury of genital tract, which achieved definite clinical curative effect. It was safe and reliable and worth to be popularized. |