目的 探讨坤宝丸联合替勃龙治疗围绝经期综合征的临床疗效。方法 选取2021年10月—2024年8月首都医科大学附属北京康复医院收治的84例围绝经期综合征患者，按随机数字表法分为对照组和治疗组，每组各42例。对照组口服替勃龙片，1片/次，1次/d。治疗组在对照组治疗基础上口服坤宝丸，50 丸/次，2次/d。两组疗程均为3个月。观察两组临床疗效，比较两组治疗前后改良Kupperman绝经指数（KMI）、症状自评量表（SCL-90）、绝经期生存质量量表（MENQOL）评分及血清性激素水平和白细胞介素（IL）-1β、IL-8、超氧化物歧化酶（SOD）水平。结果 治疗后，治疗组总有效率是95.24%，显著高于对照组的80.95%（P＜0.05）。治疗后，两组患者改良KMI、SCL-90和MENQOL评分都低于同组治疗前（P＜0.05）；治疗后，治疗组改良KMI、SCL-90和MENQOL评分都低于对照组（P＜0.05）。治疗后，两组血清促黄体生成素（LH）、卵泡刺激素（FSH）水平都低于同组治疗前，雌二醇（E₂）水平显著升高（P＜0.05）；治疗后，治疗组LH、FSH水平低于对照组，治疗组血清E₂水平高于对照组（P＜0.05）。治疗后，两组血清IL-1β、IL-8水平都低于同组治疗前，两组血清SOD水平都显著上升（P＜0.05）；治疗后，治疗组血清IL-1β、IL-8水平低于对照组，血清SOD水平高于治疗组（P＜0.05）。结论 坤宝丸联合替勃龙治疗围绝经期综合征具有较好的疗效，能有效调节机体性激素水平、减轻患者症状，并能明显抑制机体炎症及自由基损害，改善患者身心状态及生存质量。

Objective To explore the clinical efficacy of Kunbao Pills combined with tibolone in treatment of perimenopausal syndrome. Methods A total of 84 patients with perimenopausal syndrome admitted to Beijing Rehabilitation Hospital Affiliated to Capital Medical University from October 2021 to August 2024 were selected and divided into control group and treatment group according to random number table method, with 42 cases in each group. Patients in control group were po administered with Tibolone Tablets, 1 tablet/time, once daily. Patients in treatment group were po administered with Kunbao Pills on the basis of the control group, 50 pills/time, twice daily. The treatment course of both groups was 3 months. The clinical effects of two groups were observed, and the modified Kupperman Menopause index (KMI), Symptom Checklist 90 (SCL-90), Menopause Quality of Life Scale (MENQOL) scores, serum sex hormone levels, IL-1β, IL-8, and superoxide dismutase (SOD) levels were compared between two groups before and after treatment. Results After treatment, the total effective rate of the treatment group was 95.24%, which was significantly higher than that of the control group (80.95%, P < 0.05). After treatment, the improved KMI, SCL-90 and MENQOL scores in two groups were lower than before treatment (P < 0.05). After treatment, the improved KMI, SCL-90 and MENQOL scores in treatment group were lower than those in control group (P < 0.05). After treatment, serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in two groups were lower than before treatment, and estradiol (E₂) levels were significantly increased (P < 0.05). After treatment, the level of LH and FSH in treatment group was lower than that in control group, and the level of serum E₂ in treatment group was higher than that in control group (P < 0.05). After treatment, serum IL-1β and IL-8 levels in two groups were lower than before treatment, and serum SOD levels in two groups were significantly increased (P< 0.05). After treatment, the serum levels of IL-1β and IL-8 in treatment group were lower than those in control group, and the serum level of SOD was higher than that in treatment group (P < 0.05). Conclusion Kunbao Pills combined with tibolone has good curative effect in treatment of perimenopausal syndrome, and can effectively regulate the body sex hormone level, reduce the symptoms of patients, and significantly inhibit the body inflammation and free radical damage, which can improve the physical and mental state and life quality of patients.

R984

首都医科大学附属北京康复医院科研发展专项资助项目（2020-057）