Abstract： Objective： To observe the clinical effect of the therapy of modified Zhibai Dihuang Tang combined with Recombinant Human Interferon on high-risk human papilloma virus(HR-HPV) infection complicated with grade I cervical intraepithelial neoplasia(grade I CIN). Methods：A total of 80 patients with HR-HPV of deficiency of kidney and dampness-heat type complicated with grade I CIN were selected and randomly divided into the observation group and the control group， with 40 cases in each group. Both groups were given antiviral therapy with Recombinant Human Interferon α-2b Vaginal Effervescent Capsules. The observation group was additionally treated with modified Zhibai Dihuang Tang，and the two medicine was used simultaneously for 14 days per month and for 3 months. Before and after treatment，the changes of traditional Chinese medicine(TCM) syndrome scores， indexes of immune function， including CD3 + ， CD4 + ， CD8 + and CD4 +/CD8 + ， and quality of life which was evaluated by the scores of World Health Organization Quality of Life Brief Version(WHOQOL- BREF) in the two groups were recorded. After three months of treatment， the negative conversion rates of human papillomavirus(HPV)， clinical effects and incidence of adverse reactions in the two groups were counted. Results：After three months of treatment， the total clinical effective rate was 87.50% in the observation group and 62.50% in the control group，the difference being significant(P＜0.05). The HPV negative conversion rate was 82.50% in the observation group and 60.00% in the control group， the difference being significant(P＜0.05). The TCM syndrome scores in the two groups were decreased when compared with those before treatment， and the TCM syndrome score in the observation group was lower than that in the control group， differences being significant(P＜0.05). Compared with before treatment，The levels of CD3+ ，CD4+and CD4+/CD8+ in the two groups were increased(P＜0.05)； the levels of CD3 + ， CD4 + and CD4 +/CD8 + in observation group were higher than those in control group， and the level of CD8 + was lower(P＜0.05). Compared with before treatment，the scores of physical health，mental health，surrounding environment，social relationship and total scores in the two groups were increased. Physical health， mental health scores and total scores in observation group were higher than those in control group， differences being significant(P＜0.05). Conclusion： The therapy of modified Zhibai Dihuang Tang based on the Recombinant Human Interferon α- 2b Vaginal Effervescent Capsules for patients with HR- HPV infection complicated with grade I cervical intraepithelial neoplasia can not only improve the TCM syndromes， reverse the grade I CIN lesions and promote the HPV negative conversion，but also improve the immune function of the body and improve the quality of life of patients.