消瘤丸治疗气滞血瘀证子宫肌瘤55例临床分析

Clinical Analysis of Xiaoliu Pills in Treating 55 Patients with Uterus Myoma of Qi Stagnation and Blood Stasis Syndrome

目的:评价消瘤丸治疗气滞血瘀证子宫肌瘤的临床疗效及作用机制的探讨。方法:将110例患者采用随机、对照方法,按数字表法分为对照组和观察组各55例。对照组口服米非司酮片,25 mg/次,1次/d。观察组服用消瘤丸,9 g/次,2次/d。两组疗程均为12周。进行治疗前后肌瘤、子宫体积测量;进行气滞血瘀证评分;检测治疗前后包括促卵泡刺激素(FSH),促黄体生成素(LH),催乳素(PRL),雌二醇(E2)和孕激素(P)和血流变学指标。结果:观察组临床疗效总有效率为94.55%,对照组为78.18%,观察组优于对照组(P<0.05);治疗后观察组肌瘤和子宫体积均小于对照组(P<0.01);观察组在治疗后第8,12周气滞血瘀证评分低于对照组(P<0.01),治疗后观察组气滞血瘀证评分下降幅度多于对照组(P<0.01);治疗后观察组全血黏度(高切、低切)、血浆黏度、纤维蛋白原、红细胞聚集指数均比治疗前下降,并低于治疗后对照组(P<0.01);治疗后观察组FSH,LH,E2水平低于对照组(P<0.01),治疗后两组PRL和P水平组间差异无统计学意义。结论:消瘤丸在缩小肌瘤体积、子宫体积、减轻气滞血瘀证评分方面均优于米非司酮片,并能改善血液流变学指标,调节女性激素,其临床疗效优于米非司酮片,值得临床使用。

Objective： To discuss the clinical effect of Xiaoliu pills in treating uterus myoma of qi stagnation and blood stasis syndrome,and to explore its mechanism of action. Method： One hundred and ten patients were randomly divided into the control group（ 55 cases） and the observation group（ 55 cases） by a random number table. Patients in the control group received 25 mg mifepristone once daily. Patients in the observation group received 9 g Xiaoliu pills twice daily. All patients received 12 weeks of treatment. Before and after treatment,volume of fibroid and uterine was detected. Scores of qi stagnation and blood stasis were graded.Levels of follicle-stimulating hormone（ FSH）,luteinizing hormone（ LH）,prolactin（ PRL）,estrogen（ E2）,progesterone（ P） and indexes of hemorrheology were detected. Result： The total clinical efficiency in the observation group was 94. 55%,which was superior to that of 78. 18% in the control group（ P〈0. 05）. After therapy,volume of fibroid and uterine in the observation group was smaller than that in the control group（ P〈0. 01）. At the eighth and twelfth week after treatment,scores of qi stagnation and blood stasis in the observation group were lower（ P〈0. 01）,falling range was larger than those in the control group（ P〈0. 01）. After therapy,levels of whole blood viscosity（ high shear,low shear）,plasmatic viscosity,fibrinogen and erythro-agglutation index decreased,and the results were lower in the control group（ P〈0. 01）. Levels of FSH,LH and E2 in observation group were lower than those in the control group（ P〈0. 01）,while,there was no statistically significant difference for the levels of PRL and P between two groups. Conclusion： The clinical effect of Xiaoliu pills on reducing volume of fibroid and uterine and decreasing scores of qi stagnation and blood stasis was superior to mifepristone. Moreover,it could ameliorate hemorrheology and regulate female sex hormone,so it is worthy to be used in clinic.