米非司酮联合桂枝茯苓对子宫肌瘤的临床研究  

Clinical trial of mifepristone combined with Guizhifuling in patients with uterine fibroid

作　　者：陈燕娥[1] 闫雪[1] 钟业超[2] 温云花 唐海妹[1] 

机构地区：[1]海口市妇幼保健院妇产科,海口570203 [2]海南医学院附属医院妇产科,海口570102

出　　处：《中国临床药理学杂志》2016年第15期1374-1377,共4页The Chinese Journal of Clinical Pharmacology

基　　金：海南省自然科学基金资助项目(20158312)

摘　　要：目的观察米非司酮联合桂枝茯苓胶囊治疗子宫肌瘤的临床疗效及其对患者血清人附睾分泌蛋白(HE4)、糖类抗原125(CA125)水平的影响。方法 122例子宫肌瘤患者随机分为对照组61例和试验组61例。对照组自患者月经来潮第2天开始口服米非司酮片10 mg,每天1次;试验组在对照组的基础上,口服桂枝茯苓胶囊1.24 mg,每日3次。2组患者均治疗24周。比较2组患者的临床疗效、治疗前后子宫大小、子宫肌瘤大小、雌二醇(E_2)、黄体生成素(LH)、卵泡刺激素(FSH)、HE4、CA125水平变化及药物不良反应发生情况。结果治疗后,试验组的总有效率为91.80%(56/61例),对照组为75.41%(46/61例,P<0.05)。治疗后,试验组E2为(4.89±1.03)pmol·L^(-1),LH为(10.46±1.87)U·L^(-1),FSH为(16.78±2.83)U·L^(-1),对照组E_2为(7.49±2.14)pmol·L^(-1),LH为(14.26±2.18)U·L^(-1),FSH为(20.18±3.14)U·L^(-1),2组差异有统计学意义(P<0.05)。治疗后,试验组血清HE4为(51.29±6.24)pmol·L^(-1),血清CA125为(15.32±1.87)U·m L^(-1),对照组HE4为(66.59±8.79)pmol·L^(-1),CA125为(18.98±2.13)U·m L^(-1)(P<0.05)。药物不良反应主要表现为食欲下降、恶心、呕吐,试验组药物不良反应发生率为6.56%(4/61例),对照组为31.15%(19/61例,P<0.05)。结论米非司酮联合桂枝茯苓胶囊治疗子宫肌瘤的临床疗效显著,且药物不良反应发生率低。Objective To evaluate the clinical efficacy of mifepristone combined with Guizhifuling capsule in the treatment of uterine fibroid and their effects on the levels of human epididymis protein 4 （HE4） and carbohydrate antigen 125 （CA125）. Methods A total of 122 cases of patients with uterine fibroid were randomly divided into control group （n =61 ） and treatment group （n = 61 ）. The control group was orally given mifepristone 10 mg since day 2 of menstrual cramps, one time a day, and the treatment group was orally given Guizhifuling capsule 1.24 mg, three times per day on the basis of control group. The course of treatment was 24 weeks. The clinical efficacy, changes of the size of uterus, size of uterine fibroid, estradiol （ E2 ） , luteinizing hormone （LH）, follicle- stimulating hormone（FSH）, HFA and CA125 levels before and after treatment were compared. The adverse drug reactions were observed. Results Total effective rate in treatment group was 91.80% （56/61）, had significant difference with 75.41% （46/61） in control group（P 〈 0. 05 ）. After treatment, the levels of E2, LH and FSHin treatment group were（4. 89 ± 1.03） pmol · L^-1 , （ 10. 46± 1.87） U · L^-1, （ 16. 78 ±2. 83） U · L^-1, had significant difference with （ 7. 49± 2.14 ） pmol · L^-1,（14.26 ±2.18） U · L^-1,（20.18±3.14） U · L^-1 in control group （P 〈0. 05）. The levels of HE4 and CA125 in treatment group were（51.29 ＋ 6.24） pmol · L^-1, （ 15.32 ＋ 1.87） U· mL^-1, had significant difference with （66. 59 ± 8.79） pmol· L^-1, （18.98±2. 13）U · mL^-1 in control group. The main adverse drug reactions were loss of appetite, nausea, and vomiting. The incidence of adverse drug reactions in treatment group had significant difference with control group （P 〈 0. 05 ）. Conclusions Mifepristone combined with Guizhifuling capsule in treatment of uterine fibroid had significant efficacy and less adverse reactions.

关 键 词：桂枝茯苓胶囊 米非司酮 子宫肌瘤 人附睾分泌蛋白 糖类抗原125 

分 类 号：R97[医药卫生—药品]