超低剂量雌孕激素连续联合方案治疗绝经综合征的疗效初探

Preliminary study on efficacy of continuous combination regimen of ultra-low dose estrogen and progesterone in treatment of menopausal syndrome

目的评价低于标准剂量雌孕激素连续联合方案在绝经激素治疗中的疗效及安全性。方法选择2019年1月至2020年5月在新疆医科大学第一附属医院门诊就诊有意愿进行绝经激素治疗(MHT)的女性共110例作为研究对象。按随机数字表法随机分组,共入组110例。A组37例口服雌二醇地屈孕酮片2/10 mg黄色片1片,B组35例口服雌二醇地屈孕酮片1/10 mg灰色片1片,C组38例口服雌二醇地屈孕酮片1/10 mg灰色片半片。记录并比较治疗前、治疗后第4、24、48周改良Kupperman评分和治疗前、治疗后第48周MENQOL评分;治疗48周后,比较3组的完全缓解率、显效率、有效率以及子宫内膜厚度变化、不良反应发生情况等。结果用药第4周超低剂量组改良Kupperman评分高于其他两组,差异有统计学意义(P<0.05)。第24周与第48周,超低剂量组改良Kupperman评分略高于其他两组,差异无统计学意义(P>0.05)。经过48周治疗,3组MENQOL评分均较治疗前显著下降,差异有统计学意义(P<0.05);标准剂量组总有效率(82.3%)高于低剂量组(71.8%)和超低剂量组(60.6%)(P=0.015、0.023),低剂量组与超低剂量组总有效率,差异无统计学意义(P=0.21)。治疗前、治疗后48周3组子宫内膜的厚度无显著变化,差异无统计学意义(P>0.05)。标准剂量组乳房胀痛发生率(29.4%)高于超低剂量组(15.1%)(P<0.05)。标准剂量组非预期阴道出血率(14.7%)高于低剂量组(6.2%)和超低剂量组(3.0%),差异有统计学意义(P<0.05)。标准剂量组体重增加发生率(14.7%)与低剂量组(12.5%)和超低剂量组(12.1%)相比,差异无统计学意义(P>0.05)。结论绝经激素治疗除标准方案以外,超低剂量、低剂量方案也可有效缓解围绝经期低雌激素症状,不良反应发生率相对低,患者依从性及耐受性更好。

Objective To investigate the efficacy and safety of ultra low dose and low dose continuous combined Estrin regimen in the treatment of climacteric.Methods A total of 110 women were willing to undergo menopausal hormone therapy(MHT)in the hospital from January 2019 to May 2020 were selected as the research subjects.A total of 110 cases were randomly grouped according to random number table.37 patients in group A took didrogesterone estradiol tablets 2/10mg yellow tablets 1 tablet;35 patients in group B took didrogesterone estradiol tablets 1/10mg gray tablets 1 tablet;38 patients in group C took didrogesterone estradiol tablets 1/10mg gray tablets 1/2 tablets.The modified Kupperman score before the treatment and MENQOL score at 4,24 and 48 weeks after the treatment were recorded and compared.After 48 weeks of the treatment,the complete response rate,significant efficiency,effective rate,changes in endometrial thickness and occurrence of adverse reactions among the three groups were compared.Results The modified Kupperman score in the ultra-low dose group at week 4 was higher than that in the other two groups,and the difference was statistically significant(P<0.05).At week 24 and 48,the modified Kupperman score in the ultra-low dose group was slightly higher than that in the other two groups,with no statistical significance(P>0.05).After 48 weeks of the treatment,MENQOL scores in 3 groups were significantly decreased compared with before the treatment,the difference was statistically significant(P<0.05).The total effective rate of standard dose group(82.3%)was higher than that of low dose group(71.8%)and low dose group(60.6%)(P=0.015,0.023),the total effective rate of low-dose group and ultra-low-dose group was not statistically significant(P=0.21).There was no significant difference in endometrial thickness between the three groups beforethe treatment and 48 weeks after the treatment(P>0.05).The incidence of breast tenderness in standard dose group(29.4%)was higher than that in ultra-low dose group(15.1%)(P<0.05).The rate of unexpected vaginal bleeding in standard dose group(14.7%)was higher than that in low dose group(6.2%)and low dose group(3.0%),and the difference was statistically significant(P<0.05).There was no significant difference in the incidence of weight gain in the standard dose group(14.7%)compared with the low dose group(12.5%)and the ultra-low dose group(12.1%)(P>0.05).Conclusion The continuous combination of ultra-low dose and low-dose group can effectively alleviate menopausal symptoms caused by low estrogen,and the tolerance is good,the occurrence of adverse reactions is low.