紫术消瘤散对持续性HPV感染患者阴道微生态的影响

Effect of Zishu Xiaoliu Powder on Vaginal Microecology in Patients with Persistent HPV Infection

摘要: 目的：研究紫术消瘤散对宫颈高危型人乳头瘤病毒(HR-HPV)持续感染湿热瘀结型患者阴道菌群的调控作用，探讨紫术消瘤散清除人乳头瘤病毒的作用机制。方法：通过随机对照的临床试验研究，选取来源于福建省第二人民医院妇科门诊及体检中心，符合间隔12个月或以上，连续两次同一亚型HR-HPV检测为阳性者，且严格遵循三阶梯(HPV + TCT–阴道镜检查–宫颈活检)的诊疗规范，经由宫颈活检病理明确诊断为 ≤ LSIL，中医辨证为湿热瘀结型的患者64例，按随机数字表法分为治疗组和对照组。每组32例。治疗组：紫术消瘤散宫颈局部上药，每3天1次，1次4 g，1个月1个疗程，连续使用3个疗程。对照组：予阴道用乳杆菌活菌胶囊，每晚睡前清洗外阴后塞入阴道深部，10天为1个疗程，连续用药3个疗程。观察两组治疗前后患者HPV转阴率、中医证候积分、阴道微生态指标(菌群密集度、菌群多样性、优势菌、pH、Nugent评分)的变化。结果：① 治疗组HR-HPV转阴率(65.6%)比对照组(37.5%)高，差异有统计学意义(P < 0.05)。② 两组经治疗后中医症候积分均较治疗前下降，治疗组积分下降情况较对照组更为显著，结果均有统计学意义(P < 0.05)。③ 两组治疗后菌群密集度、菌群多样性、优势菌、Nugent评分较治疗前均明显改善，差异有统计学意义(P < 0.05)。结论：紫术消瘤散、阴道用乳杆菌活菌胶囊均能够在一定程度恢复阴道微生态平衡、逆转HR-HPV感染，值得临床推广。

Abstract: Objective: To study the regulatory effect of Zishu Xiaoliu Powder on vaginal flora in patients with persistent cervical high-risk human papillomavirus (HR-HPV) infection of damp-heat stasis type, and to explore the mechanism of action of Zishu Xiaoliu Powder in clearing human papillomavirus. Methods: Through a randomized controlled clinical trial, patients from the gynecological outpatient clinic and physical examination center of the Second People’s Hospital of Fujian Province who were positive for the same subtype of HR-HPV for two consecutive times with an interval of 12 months or more and strictly followed the three-step (HPV + TCT-colposcopy-cervical biopsy) diagnosis and treatment standards were selected. 64 patients were diagnosed as ≤LSIL by cervical biopsy pathology and damp-heat stasis type by TCM syndrome differentiation. They were divided into treatment group and control group according to the random number table method. 32 cases in each group. Treatment group: Zishu Xiaoliu Powder was applied topically to the cervix, once every 3 days, 4g each time, 1 month as a course of treatment, and 3 courses of treatment were used continuously. Control group: Lactobacillus capsules were used for vaginal use, and the capsules were inserted deep into the vagina after cleaning the vulva every night before going to bed. 10 days was a course of treatment, and 3 courses of treatment were used continuously. The changes in the HPV negative conversion rate, TCM syndrome scores, and vaginal microecological indicators (bacterial density, bacterial diversity, dominant bacteria, pH, and Nugent score) of the two groups of patients before and after treatment were observed. Results: ① The HR-HPV negative conversion rate in the treatment group (65.6%) was higher than that in the control group (37.5%), and the difference was statistically significant (P < 0.05). ② After treatment, the TCM symptom scores of both groups decreased compared with those before treatment, and the score decrease in the treatment group was more significant than that in the control group, and the results were statistically significant (P < 0.05). ③ After treatment, the density, diversity, dominant bacteria, and Nugent scores of the two groups were significantly improved compared with those before treatment, and the differences were statistically significant (P < 0.05). Conclusion: Zishu Xiaoliu Powder and Vaginal Lactobacillus Live Capsules can restore the balance of vaginal microecology and reverse HR-HPV infection to a certain extent, and are worthy of clinical promotion.