稳心颗粒对围绝经期综合征患者神经症状的干预作用

Intervention Effect of Wenxin Granules on Neurologic Symptoms of Menopausal Syndrome

目的:探讨稳心颗粒对围绝经期综合征患者神经症状的干预作用及安全性评价。方法:将76例围绝经期综合征患者随机分为试验组和对照组。试验组口服稳心颗粒,每次1袋(5 g),1日早、中、晚、睡前各1次,1日共4次。对照组口服维生素B110 mg,谷维素10 mg,服用次数同试验组。两组均治疗4周。用药前后分别进行改良Kupperman评分、妇科检查、心电图检查,并进行生殖激素(FSH、LH、E2)、血尿常规、肝肾功能测定。对比用药前后主要症状缓解情况、改良Kupperman评分改善情况作为主要疗效判定标准。对比用药前后妇科检查、生殖激素(FSH、LH、E2)变化情况作为次要疗效判定标准。安全性方面包括治疗前后不良反应评估,用药后患者自觉不适症状,心电图检查、血尿常规、肝肾功能变化情况。结果:经治疗4周后,试验组疗效和安全性明显优于对照组,差异具有统计学意义(P<0.05)。结论:稳心颗粒能够改善围绝经期综合征患者神经症状,改善患者生活质量,值得广泛应用。

Objective： To investigate the intervention effect and evaluate safety of Wenxin Granules on neurologic symptoms of Menopausal Syndrome.Methods： A total of 76 patients with menopausal syndrome were divided to experimental group and control group.The experimental group took Wenxin Granules orally,4 times a day,i.e.in the morning,noon,afternoon and before bed,1 bag（5 g） each time.The control group was treated with vitamin B 1 10 mg,Oryzanol 10 mg.Two groups were treated for 4 weeks.Before and after treatment,performed Kupperman score test,gynecological examination,electrocardiogram inspection,and collected reproductive hormones（FSH,LH,E 2）,urine routine,liver and kidney function test.Main symptoms improvement and Kupperman score are the primary treatment endpoint,gynaecology examination,reproductive hormones（FSH,LH,E 2） as secondary treatment endpoint.Safety parameters includes adverse reactions during medical intervention;patients self-evaluation of symptoms,ECG examination,urine routine,liver and kidney function changes.Results： After 4 weeks treatment,the experimental group is obviously better than the control group in efficacy and safety,statistical significance（P 0.05）.Conclusion： Wenxin Granules can significantly improve neurologic symptoms,improve quality of life in patients with menopausal syndrome,is worth wide application.