Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tear secretion
研究概览
简要总结
This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women
详细描述
This project aims to: 1. Evaluate the possible relationship between MGD and HRT in perimenopausal women; 2. To explore the mechanism of HRT treatment on MGD through clinical trials;3. Optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for MDG patients in the perimenopausal period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Perimenopausal women who did not undergo HRT
排除标准
- •(1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ① Unable or unwilling to sign a consent form, or unable to follow study procedures.
- •(2) Have worn contact lenses in the past month, have had anterior segment surgery in the past 3 months, have a history of corneal refractive surgery, and have eye diseases other than dry eyes.Use of topical medicines other than eye lubricants in the past 3 months.Use of total body immunomodulators, tetracycline, or glucocorticoids in the past 3 months.Occlusion of lacrimal dots or eye trauma in the past 3 months.③ is pregnant, nursing or breastfeeding, or has received HRT treatment.
- •④ All patients with DE related diseases, such as diabetes mellitus, Sjogren syndrome, Stevens-Johnson syndrome.All participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.Women who used anticoagulants, corticosteroids or vitamin A, vitamin E or beta-carotene were also excluded.
研究组 & 干预措施
Perimenopausal women who did not undergo HRT
Perimenopausal women who did not undergo HRT at baseline. And they did not receive any other drugs
干预措施: Hormone replacement therapy (Drug)
Perimenopausal women who did undergo HRT
Perimenopausal women who did undergo HRT received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV. Weesp, The Netherlands).Take this medicine once a day. A course of treatment was defined as 28 days of continuous treatment.
干预措施: Hormone replacement therapy (Drug)
结局指标
主要结局
Tear secretion
时间窗: 3 months
After local anesthesia, a 35mm×5mm filter paper strip was placed longitudinally into the conjunctival sac of the lower eyelid. After 5 minutes, the length of the moist part was recorded. Less than 10mm was considered abnormal.
次要结局
- The scoring of corneal fluorescein staining(3 months)
- Noninvasive tear break-up time test (NITBUT)(3 months)