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目的探讨激素替代疗法联合坤泰胶囊治疗围绝经期综合征患者的疗效及安全性。方法选取2016年1-12月天津市滨海新区大港妇女儿童保健中心妇科收治的300例围绝经期综合征患者为研究对象,采用随机数表法分为对照组(150例)和观察组(150例)。对照组给予口服戊酸雌二醇片/雌二醇环丙孕酮片治疗,观察组给予口服戊酸雌二醇片联合坤泰胶囊治疗,1个月为1个疗程,连续服用3个疗程。对比两组患者临床疗效,治疗前后症状改善情况、血清激素水平、子宫内膜厚度及不良反应。结果对照组患者总有效率低于观察组,差异有统计学意义(P<0.05)。治疗前,两组KI评分比较,差异无统计学意义(P>0.05);治疗3个月后,两组KI评分均显著降低,组内比较,差异有统计学意义(P<0.05),组间比较,差异无统计学意义(P>0.05)。治疗前,两组患者各项激素水平、子宫内膜厚度比较,差异无统计学意义(P>0.05);治疗后,两组各项血清激素水平均有显著变化,组内和组间比较,差异均有统计学意义(P<0.05)。两组子宫内膜厚度治疗前后比较,差异均无统计学意义(P>0.05)。对照组不良反应发生率高于观察组,差异有统计学意义(P<0.05),但不良反应均在停药后自行消失。结论激素替代疗法联合坤泰胶囊治疗围绝经期综合征安全有效,不良反应轻微,可有效改善患者临床症状及激素水平。
Objective To investigate the efficacy and safety of hormone replacement therapy combined with kuntai capsule in the treatment of patients with perimenopausal syndrome. Methods From January to December in 2016, 300 cases of perimenopausal syndrome treated by gynecology in Dagang Women and Children’s Health Center of Tianjin Binhai New Area were enrolled. The patients were divided into control group (150 cases) and observation group (150 cases) by random number table example). The control group was given oral administration of estradiol valerate tablets / estradiol cyproterone tablets. The observation group was given orally administered estradiol valerate tablets together with kuntai capsule. One month was a course of treatment and three courses of continuous treatment . The clinical efficacy, the improvement of symptoms before and after treatment, serum hormone levels, endometrial thickness and adverse reactions were compared between the two groups. Results The total effective rate of the control group was lower than that of the observation group, the difference was statistically significant (P <0.05). Before treatment, there was no significant difference in KI between the two groups (P> 0.05). After 3 months of treatment, the KI scores of both groups were significantly decreased, and the difference was statistically significant (P <0.05) Between the two groups, the difference was not statistically significant (P> 0.05). Before treatment, there was no significant difference in the levels of hormones and endometrial thickness between the two groups (P> 0.05). After treatment, the levels of serum hormone in both groups changed significantly. The differences were statistically significant (P <0.05). The two groups of endometrial thickness before and after treatment, the difference was not statistically significant (P> 0.05). The incidence of adverse reactions in the control group was higher than that in the observation group, with significant difference (P <0.05), but the side effects disappeared after discontinuation. Conclusion Hormone replacement therapy combined with kuntai capsule in the treatment of perimenopausal syndrome is safe and effective with minor adverse reactions, which can effectively improve the clinical symptoms and hormone levels of patients.