一贯煎加味治疗围绝经期妇女干眼的疗效观察

Curative effects of modified Yiguan Jian in treatment of perimenopausal xerophthalmia

目的探讨中药一贯煎加味治疗围绝经期妇女干眼的临床疗效。方法选取门诊确诊为干眼且中医辨证为阴虚肝郁证的围绝经期妇女90例(90只眼),采用前瞻性随机双盲对照研究方法分为两组,每组各45例。治疗组口服中药配方颗粒一贯煎加味,对照组口服维生素C,两组患者同时用0.1%玻璃酸钠滴眼液点眼,连续治疗4周。分别于治疗前和治疗4周后观察两组患者基础泪液分泌试验(SIT)、泪膜破裂时间(BUT)、角膜荧光素染色(FL)等客观指标的变化以及主观症状积分的情况。结果治疗4周后,两组患者的SIT、BUT、FL评分以及主观症状积分与治疗前比较,差异均具有统计学意义(P<0.01);治疗组以上各项指标改善情况明显优于对照组,差异均具有统计学意义(P<0.05);治疗组综合临床疗效与对照组比较也具有明显优势,差异具有统计学意义(P<0.05)。结论中药一贯煎加味参与治疗围绝经期妇女干眼临床疗效较好,能够显著改善干眼患者的症状和体征,提高患者生活质量,具有一定的临床应用价值。

OBJECTIVE To analyze the clinical efficacy of modified Yiguan Jian-a Traditional Chinese formula on xerophthalmia in perimenopausal women.METHODS Ninety perimenopausal female patients diagnosed with xerophthalmia and in yin deficiency and liver qi stagnation syndrome by TCM syndrome differentiation were divided into 2 groups according to the prospective,randomized,double-blind and placebo-controlled method,with 45 cases in each group.The Yiguan Jian group were treated with the TCM formula granule of modified Yiguan Jian.The placebo group were treated with oral vitamin C tablets.The two groups were both treated with 0.1%hyaluronic acid sodium eye drops for 4 weeks.Objective indexes as Schirmer I test(SIT),lacrimal film breakup time(BUT)and cornea fluorescent staining(FL)along with subjective symptom-oriented scores were applied to observe changes before and 4 weeks after treatment of patients in 2 groups respectively.RESULTS After 4 weeks of treatment,the results of SIT,BUT,FL and subjective symptom-oriented scores all changed significantly(P<0.01).The Yiguan Jian group had better and statistically significant improvements in the above indexes compared with the placebo group(P<0.05).The Yiguan Jian group also yielded significantly better total curative effects in contrast to placebo group(P<0.05).CONCLUSIONS The use of modified Yiguan Jian brought better effects in the treatment of xerophthalmia in perimenopausal women,it significantly relieved the symptoms and signs of patients and favorably improved their quality of life,thus it was of certain clinical application values.