Clinical trial of dydrogesterone tablets in the treatment of climacteric syndrome
10.13699/j.cnki.1001-6821.2017.23.015
- VernacularTitle:地屈孕酮片治疗更年期综合征的临床研究
- Author:
Li-Fei TANG
1
;
You-Chun YE
;
Yin-Fang LI
Author Information
1. 宁波鄞州人民医院妇产科,浙江 宁波315040
- Keywords:
dydrogesterone tablet;
climacteric syndrome;
sex hormone;
blood liquid;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(23):2378-2380
- CountryChina
- Language:Chinese
-
Abstract:
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) and 72.09％ (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.
