地屈孕酮片治疗更年期综合征的临床研究

Clinical trial of dydrogesterone tablets in the treatment of climacteric syndrome

目的观察地屈孕酮片治疗更年期综合征的临床疗效及安全性。方法将86例更年期综合征妇女随机分为对照组43例和试验组43例。对照组予以安慰剂每次10 mg,qd,口服;试验组予以地屈孕酮每次10 mg,qd,口服。2组患者均治疗1个月。比较2组患者的临床疗效、性激素和血脂水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.02%(40例/43例)和72.09%(31例/43例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的促黄体生成素分别为(11.70±1.13)和(28.36±4.48)U·L^(-1),促卵泡生长激素分别为(36.31±4.24)和(60.77±7.75)U·L^(-1),雌二醇分别为(71.76±9.37)和(45.43±5.21)pmol·L^(-1),三酰甘油分别为(1.23±0.24)和(1.72±0.20)mmol·L^(-1),总胆固醇分别为(4.94±0.66)和(5.82±0.58)mmol·L^(-1),低密度脂蛋白胆固醇分别为(2.64±0.36)和(3.25±0.31)mmol·L^(-1),高密度脂蛋白胆固醇分别为(1.66±0.21)和(1.38±0.13)mmol·L^(-1),差异均有统计学意义(均P<0.05)。试验组出现失眠及头痛各2例次,对照组未发生药物不良反应。试验组和对照组的总药物不良反应发生率分别为9.30%和0,差异无统计学意义(P>0.05)。结论地屈孕酮片治疗更年期综合征妇女的临床疗效确切,其能够有效调节血脂和性激素水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of deprogesterone tablets in the treatment of climacteric syndrome.Methods A total of 86 women with climacteric syndrome were randomly divided into control group and treatment group with 43 cases per group.Control group received placebo 10 mg per time,qd,orally. Treatment group was treated with deprogesterone 10 per time,qd,orally. Two groups were treated for one month. The clinical efficacy,the levels of sex hormone and blood lipid,adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 93. 02%（ 40 cases/43 cases） and72. 09%（ 31 cases/43 cases） with statistically significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： luteinizing hormone were（ 11. 70 ± 1. 13） and（ 28. 36 ± 4. 48） U · L-1, follicle stimulating hormone were（ 36. 31 ± 4. 24） and（ 60. 77 ± 7. 75） U·L-1, estradiol were（ 71. 76 ± 9. 37） and（ 45. 43 ± 5. 21） pmol · L-1,triglyceride were（ 1. 23 ± 0. 24） and（ 1. 72 ± 0. 20） mmol·L-1,total cholesterol were（ 4. 94 ± 0. 66） and（ 5. 82 ± 0. 58） mmol · L-1,low density lipoprotein cholesterol were（ 2. 64 ± 0. 36） and（ 3. 25 ± 0. 31） mmol·L-1,high density lipoprotein cholesterol were（ 1. 66 ± 0. 21） and（ 1. 38 ± 0. 13） mmol·L-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions in treatment group were based on insomnia（ 2 cases） and headache（ 2 cases）. And there was no adverse drug reaction in the control group. The incidences of adverse drug reactions in treatment and control groups were 9. 30% and 0 without significant difference（ P〈0. 05）. Conclusion Deprogesterone tablets have a definitive clinical efficacy in the treatment of climacteric syndrome,which can effectively adjust the levels of sex hormone and blood lipid,without increasing the incidence of adverse drug reactions.