目的：评价国产７－甲基异炔诺酮治疗绝经期征候群的安全性、有效性和药物不良反应以及调脂作用。方法：１００例绝经期妇女随机分入实验组和对照组，另外５０例为开放实验。实验组口服国产７－甲基异炔诺酮２．５ｍｇ·ｄ~（－１），对照组口服进口 ７－甲基异炔诺酮２．５ｍ·ｄ~（－１），两组连续治疗１６周。用药前及用药１６周观察绝经期征候群，测血清Ｅ２、ＦＳＨ、脂蛋白，Ｂ超测量子宫内膜厚度，并观察安全性指标及药物不良反应。结果：两组绝经期征候群均有极显著改善，实验组潮热改善较对照组明显。两组ＦＳＨ、 ＴＣ、 ＴＧ、 ＨＤＬ均有显著性下降，实验组ＬＤＬ明显下降；两组Ｅ２明显上升。实验组和对照组药物不良反应率分别为３９．３％与３８．３％；实验组用药后子宫内膜增厚明显，但内膜活检无异常提示。实验组阴道出血率３０．８５％，对照组为１７％，两组间有显著差异。其他安全性指标无显著变化。结论：国产７－甲基异炔诺酮用于治疗更年期综合征是安全、有效的。 OBJECTIVE: To evaluate the safety, efficacy, adverse drug reactions and lipid-lowering effect of domestic 7-methyl-norethindrone in the treatment of menopausal syndrome. Methods: 100 cases of menopausal women were randomly divided into experimental group and control group, the other 50 cases were open experiment. In the experimental group, 2.5mg · d -1 of domestic 7-methyl-norethindrone was orally administered, and 2.5m · d -1 of 7-methyl-norethynodrel was orally administered to the control group. The two groups of continuous treatment 16 weeks. Before treatment and 16 weeks after treatment, the menopausal syndromes were observed, serum E2, FSH, lipoprotein, B-ultrasound were measured for endometrial thickness, and safety indicators and adverse drug reactions were observed. Results: Two groups of menopausal symptoms were significantly improved, the experimental group improved hot flashes than the control group. The levels of FSH, TC, TG and HDL decreased significantly in both groups, and the LDL in the experimental group decreased significantly. The E2 in both groups increased significantly. Adverse drug reaction rates in the experimental and control groups were 39.3% and 38.3%, respectively. The endometrial thickening in the experimental group was obvious, but there was no abnormality in the endometrial biopsy. The vaginal bleeding rate was 30.85% in the experimental group and 17% in the control group, with significant differences between the two groups. Other safety indicators did not change significantly. Conclusion: Domestic 7-methyl-norethindrone is safe and effective for the treatment of climacteric syndrome.