目的 探讨宫颈炎康栓联合阴道用乳杆菌活菌治疗宫颈高危型人乳头瘤病毒（HR-HPV）感染的临床疗效。方法 采用回顾性队列研究设计，选取2023年5月—2026年1月于武汉市中医医院妇科门诊就诊、并经检查确诊为HR-HPV感染的84例患者作为研究对象，按治疗方案分为对照组与治疗组，每组各42例。对照组患者给予阴道用乳杆菌活菌胶囊，每次月经干净后第3天开始，每次给药1粒，每晚用药1次，连续用药10次为1个疗程，治疗组患者在对照组治疗方案的基础上加用宫颈炎康栓，每次给药1粒，隔日用药1次，与乳杆菌活菌胶囊交替置入阴道后穹窿部位。两组共连续治疗3个月经周期。观察两组临床疗效和HPV转阴效果，比较两组中医湿热下注证候积分、阴道微生态相关指标（pH值、清洁度、Nugent评分、H₂O₂异常率）、外周血细胞因子水平的变化。结果 疗程结束后，治疗组总有效率（90.48%）显著高于对照组（71.43%）（P＜0.05）。治疗后，两组患者带下量积分、带下色质积分、带下气味积分、外阴瘙痒积分、小腹坠胀积分及证候总积分均较治疗前出现显著下降（P＜0.05）；且治疗组各单项及证候总积分均低于对照组（P＜0.05）。治疗结束后3个月的复查结果显示，治疗组HPV转阴总有效率为83.33%，明显高于对照组的61.90%（P＜0.05）。治疗后，两组患者阴道pH值、Nugent评分、H₂O₂异常率、阴道清洁度异常率均较治疗前有所降低（P＜0.05）；且治疗组阴道pH值、Nugent评分、H₂O₂异常率、阴道清洁度异常率低于对照组（P＜0.05）。治疗后，两组患者干扰素-γ（IFN-γ）水平升高，白细胞介素-1β（IL-1β）、转化生长因子-β1（TGF-β1）水平较治疗前显著降低（P＜0.05）；且治疗后治疗组IFN-γ水平较对照组升高，而IL-1β、TGF-β1水平均降低（P＜0.05）。结论 在阴道用乳杆菌活菌基础上联合宫颈炎康栓治疗宫颈高危型HPV感染疗效确切，可有效提升HPV转阴率，改善患者临床症状与中医证候，纠正阴道微生态失衡状态，调控外周血细胞因子水平，适合临床推广应用。

Objective To investigate the clinical efficacy of Gongjingyankang Suppository combined with live lactobacillus in treatment of high-risk cervical HPV infection. Methods A retrospective cohort study design was adopted. 84 Patients who visited the gynecology outpatient department of Wuhan Hospital of Traditional Chinese Medicine from May 2023 to January 2026 and were diagnosed with HR-HPV infection through examination were selected as the research subjects. They were divided into control group and treatment group according to treatment plan, with 42 cases in each group. The control group patients were given Live Lactobacillus Capsule for Vaginal Use, the administration started on the third day after each menstrual period, with 1 capsule given each night. The treatment was continued for 10 consecutive days to form one course of treatment. The treatment group patients received the treatment plan of control group in addition to applying Gongjingyankang Suppository, 1 capsule was given each day, and the medication was taken every other day. The suppositories were placed in posterior fornix of vagina alternately with Lactobacillus live bacteria capsules. Both groups were treated continuously for 3 menstrual cycles. The clinical efficacy and HPV negative conversion effect of two groups were observed. The integrative syndrome scores of damp-heat descending syndrome, vaginal microecological related indicators (pH, cleanliness, Nugent score, H₂O₂ abnormal rate), and peripheral blood cytokine levels were compared between two groups. Results After treatment period ended, the total effective rate of treatment group (90.48%) was significantly higher than that of control group (71.43%, P < 0.05). After treatment, the scores for vaginal discharge volume, vaginal discharge color and quality, vaginal discharge odor, vulvar itching, lower abdominal distension, and total syndrome score of both groups decreased significantly compared to those before treatment (P < 0.05). And individual item scores and total syndrome scores of treatment group were lower than those of control group (P < 0.05). The re-examination results 3 months after treatment showed that the total effective rate of HPV turning negative in treatment group was 83.33%, significantly higher than that of control group (61.90%) (P < 0.05). After treatment, the vaginal pH, Nugent score, abnormal rate of H₂O₂, and abnormal rate of vaginal cleanliness of both groups decreased compared to those before treatment (P < 0.05). And vaginal pH, Nugent score, abnormal rate of H₂O₂, and abnormal rate of vaginal cleanliness of treatment group were lower than those of control group (P < 0.05). After treatment, the levels of interferon-γ (IFN-γ) increased, but interleukin-1β (IL-1β), and transforming growth factor-β1 (TGF-β1) in both groups decreased. The levels of IFN-γ in treatment group was higher than those in control group, and the levels of IL-1β and TGF-β1 were lower (P< 0.05). Conclusion The combined treatment of vaginal lactobacillus live bacteria and Gongjingyankang Suppository for cervical high-risk HPV infection has a definite therapeutic effect. It can effectively increase the rate of HPV turning negative, improve the clinical symptoms and TCM syndromes of patients, correct the imbalance of vaginal microecology, and regulate the levels of peripheral blood cytokines. It is suitable for clinical promotion and application.

R984

武汉市卫生健康委员会中医药科研项目（WZ22B10）；武汉市卫生健康委员会中医药重点科研项目（WZ24A04）；湖北省自然科学基金项目（2026AFC0865）；国家中医药管理局中医药创新与研究转化项目（CXZH2025018）