知柏地黄汤加减联合重组人干扰素治疗高危型人乳头状瘤病毒感染伴宫颈上皮内瘤变Ⅰ级临床研究

Clinical Study on Modified Zhibai Dihuang Tang Combind with Recombinant Human Interferon for High-Risk Human Papilloma Virus Infection Complicated with Grade I Cervical Intraepithelial Neoplasia

目的:观察知柏地黄汤加减联合重组人干扰素治疗高危型人乳头状瘤病毒(HR-HPV)感染伴宫颈上皮内瘤变Ⅰ级(CINⅠ级)的临床疗效。方法:将80例肾虚湿热型HR-HPV感染伴CINⅠ级患者随机分为观察组和对照组,每组40例。2组均予重组人干扰素α-2b阴道泡腾胶囊行抗病毒治疗,观察组加予知柏地黄汤加减治疗,2种药物同期使用,每个月使用14 d,连续使用3个月。记录2组治疗前后中医证候积分、免疫功能指标(CD3^(+)、CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+)比值)、生活质量[世界卫生组织生存质量测定量表简表(WHOQOL-BREF)评分]的变化。统计2组治疗3个月后的人乳头状瘤病毒(HPV)转阴率、临床疗效和不良反应发生率。结果:治疗3个月后,观察组临床疗效总有效率87.50%,对照组总有效率62.50%,2组比较,差异有统计学意义(P<0.05)。观察组HPV转阴率82.50%,对照组HPV转阴率60.00%,2组比较,差异有统计学意义(P<0.05)。2组中医证候积分均较治疗前降低,观察组中医证候积分低于对照组,差异均有统计学意义(P<0.05)。2组CD8^(+)水平较治疗前降低,CD3^(+)、CD4^(+)水平及CD4^(+)/CD8^(+)比值均较治疗前增加,差异均有统计学意义(P<0.05);观察组CD8^(+)水平低于对照组,CD3^(+)、CD4^(+)水平及CD4^(+)/CD8^(+)比值均高于对照组,差异均有统计学意义(P<0.05)。2组心理健康、生理健康、社会关系、周围环境评分及总分均较治疗前增加,观察组心理健康、生理健康评分及总分均高于对照组,差异均有统计学意义(P<0.05)。结论:在重组人干扰素α-2b阴道泡腾胶囊基础上加用知柏地黄汤加减治疗HR-HPV感染伴CINⅠ级患者,不仅能有效改善中医证候,逆转CINⅠ级病变,促进HPV转阴,还能提高机体的免疫功能,提高患者的生活质量。

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 Interferonα-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.