Clinical trial of drospirenone and ethinylestradiol tablets and gonadotropin-releasing hormone agonistin in the treatment of patients with uterine muscular glands
10.13699/j.cnki.1001-6821.2017.12.013
- VernacularTitle:屈螺酮炔雌醇片联合促性腺激素释放激素激动剂治疗子宫肌腺症的临床研究
- Author:
Fu-Zhu CEN
1
;
Guang-Ping TAN
;
Jing-Jing LI
;
Jun MENG
;
Sai-Qiong CHEN
Author Information
1. 广西医科大学第四附属医院妇产科
- Keywords:
drospirenone and ethinylestradiol tablets;
uterine muscular glands;
ovarian cancer antigen;
human epididymis protein
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(12):1116-1119
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical efficacy of drospirenone and ethinylestradiol tablets combined with gonadotropin-releasing hormone agonistin(GnRH-a) in treatment of patients with uterine muscular glands and its effect on serum ovarian cancer antigen (CA125) and human epididymis protein (HE4).Methods A total of 96 patients with adenomyosis were randomly divided into control group and treatment group,each group 48 cases.Control group was given levonorgestrel intrauterine birth control system,placed levonorgestrel intrauterine system,given drospirenone ethinyl estradiol tablets (ethinyl estradiol 0.03 mg and drospirenone 3 mg),once a day,orally given for 21 d,and stopped for 7 d,then continue for 3 months after discontinuation of oral,according to this method for 3 consecutive months medication.Treatment group was given GnRH-a 3.75 mg every 4 weeks a time before treatment,subcutaneous injection for 3 times.The clinical effect,cancer antigen-125 (CA125),human epididymis protein 4 (HE4),B lymphocyte tumor-2 (Bcl-2),Bcl-2 relative X protein (Bax),caspase-3 and adverse drug reactions in two groups were observed.Results After treatment,the clinical efficacy in control group was 81.25％ (39/48 cases),had significant difference with that in treatment group,which was 95.83％ (46/48 cases,P ＜0.05).The levels of serum CA125,HE4 and Bcl-2 and uterine volume in treatment group were (27.22 ±0.35) U · L-1,(20.67 ±0.52) pmol · L-1,(3.62 ±0.43) μg · mL-1,(95.11 ± 10.29)cm2,had significant difference with those in control group,which were (41.42 ± 0.43) U · L-1,(36.67 ± 0.38) pmol · L-1,(4.76 ± 0.52) μg · mL-1,(120.02 ± 13.92) cm2 (P ＜0.05).The levels of Bax and caspase-3 in treatment group had significant difference with control group (P ＜ 0.05).The adverse drug reactions in treatment group were agitation,nausea,intermenstrual bleeding,total incidence rate of adverse drug reactions was 6.25％ (3/48 cases).The adverse drug reactions in control group were nausea,intermenstrual bleeding,skin rash,total incidence rate of adverse drug reactions was 14.58％ (7/48 cases,P ＞ 0.05).Conclusion Drospirenone and ethinylestradiol tablets in the treatment of adenomyosis was effective with high safety.
