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目的:探讨紫竹爱维(国产替勃龙)控制绝经症状的最小用药剂量以及患子宫内膜癌与血栓的风险。方法:将自然绝经因身体不适就诊并确诊为更年期综合征、自愿接受激素替代补充疗法的患者随机分为两组:A组103例,予替勃龙1.25 mg;B组100例,予替勃龙2.5 mg,治疗1～4年,定期观察两组治疗前后Kupperman评分变化、血常规、凝血项、D-二聚体、肝功、血脂、血Ca、雌二醇(E2)、促卵泡素(FSH),超声检查子宫附件及双下肢静脉,乳腺检查,子宫内膜采集以及双下肢周径变化等情况。结果:两组治疗后,Kupperman评分2个月后下降,4个月后明显下降;激素水平及血E2水平上升,血FSH水平下降,与治疗前比较差异有统计学意义(P<0.01);治疗3年后血总胆固醇(TC)、低密度脂蛋白(LDL)与治疗前比较差异有统计学意义(P<0.05或P<0.01),甘油三酯(TG)、高密度脂蛋白(HDC-L)治疗后有降低,但差异无统计学意义;子宫内膜厚度A组治疗前后无明显差异,B组有差异,主要为用药3年以上者,但差异无统计学意义(P>0.05)。结论:紫竹爱维能有效改善绝经后妇女的更年期症状,最安全剂量为1.25 mg,副作用少,患子宫内膜癌和血栓病风险小,值得临床进一步研究和探讨。
Objective: To investigate the minimum dose of Zizhu Aizi (domestic tibolone) for controlling menopausal symptoms and the risk of endometrial cancer and thrombus. Methods: The patients who were diagnosed as climacteric syndrome due to physical discomfort due to physical discomfort were randomly divided into two groups: group A (n = 103) and tibolone 1.25 mg (group B: n = 100) Long 2.5 mg for 1 to 4 years. The changes of Kupperman score, blood routine, blood coagulation, D-dimer, liver function, blood lipid, blood Ca, estradiol, FSH ), Ultrasound examination of uterine appendages and lower extremity veins, breast examination, endometrial acquisition and changes in both lower extremities circumference and so on. Results: Kupperman score decreased after 2 months and decreased significantly after 4 months. Hormone level, E2 level and FSH level were decreased in both groups (P <0.01). After 3 years of treatment, the levels of total cholesterol (TC) and low density lipoprotein (LDL) were significantly different from those before treatment (P <0.05 or P <0.01), triglyceride (TG), high density lipoprotein L), but the difference was not statistically significant. There was no significant difference in the thickness of endometrium between before and after treatment in group A, there was a difference in group B, mainly for more than 3 years, but the difference was not statistically significant (P> 0.05 ). Conclusion: Zizhu Aloe can effectively improve menopausal symptoms of menopausal women, the safest dose of 1.25 mg, fewer side effects, risk of endometrial cancer and thrombosis is small, worth further clinical study and discussion.