| 刘春姿,韩红波.六味地黄丸内服联合熏蒸治疗原发性干燥综合征干眼的临床研究[J].浙江中医药大学学报,2021,45(6):618-624. |
| 六味地黄丸内服联合熏蒸治疗原发性干燥综合征干眼的临床研究 |
| Clinical Study of Oral Administration and Fumigation of Liuwei Dihuang Pills for Treating Primary Sjogren's Syndrome-dry Eye Disease |
| DOI：10.16466/j.issn1005-5509.2021.06.009 |
| 中文关键词: 原发性干燥综合征 干眼症 白涩症 六味地黄丸 内服 眼部熏蒸 人工泪液 临床研究 |
| 英文关键词: primary Sjogren's syndrome dry eye disease white dry eye Liuwei Dihuang pill take orally eye fumigation artificial tears clinical study |
| 基金项目:浙江省中医药科技计划项目(2017ZB036) |
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| 中文摘要: |
| [目的]研究六味地黄丸内服结合六味地黄丸煎液眼部熏蒸治疗原发性干燥综合征干眼(primary Sjogren's syndrome-dry eye disease，pSS-DED)的临床疗效。[方法]选取2016年10月至2019年2月就诊于浙江中医药大学附属第一医院眼科的pSS-DED患者120例，采用随机对照法分为4组，每组各30例。对照组用0.1%玻璃酸钠滴眼液滴眼，1滴/次，4次/d；试验组1在对照组基础上口服六味地黄丸，8丸/次，3次/d；试验组2在对照组基础上加用六味地黄丸煎液熏蒸双眼，20min/次，2次/d；试验组3在对照组基础上加用六味地黄丸口服8丸/次，3次/d，并取六味地黄丸煎液熏蒸双眼20min/次，2次/d。各组均以6个月为1个疗程，共治疗3个疗程。全部疗程结束后，比较各组患者的临床疗效、中医症候积分、泪液分泌试验(SchirmerⅠtest，SIT)、泪膜破裂时间(break-up time，BUT)和角膜荧光素钠染色(corneal fluorescence staining，CFS)评分，并观察不良反应。[结果]治疗后三个试验组和对照组中医症候积分、SIT、BUT、CFS评分较治疗前有明显好转，差异均有统计学意义(P＜0.05，P＜0.001)；治疗后试验组3临床疗效优于对照组、试验组1和试验组2，差异有统计学意义(P＜0.05)。组间两两比较显示，试验组3与对照组、试验组1、试验组2比较症状和体征明显好转，差异均有统计学意义(P＜0.05)，对照组、试验组1、试验组2三组间两两比较，差异均无统计学意义(P＞0.05)。治疗期间各组均未见明显不良反应。[结论]人工泪液基础上联合六味地黄丸内服加六味地黄丸煎液眼部熏蒸综合治疗，可以有效改善pSS-DED患者的症状和体征，且无明显副作用。 |
| 英文摘要: |
| [Objective]To observe the effect of oral administration and fumigation of Liuwei Dihuang pills on the treatment of primary Sjogren's syndrome-dry eye disease(pSS-DED). [Methods] A total of 120 patients with pSS-DED in the Ophthalmology Department of the First Affiliated Hospital of Zhejiang Chinese Medical University from October 2016 to February 2019 were selected and randomly divided into four groups， with 30 cases in each. In control group， 0.1% sodium hyaluronate eye drops were applied to both eyes，1 drop each time， 4 times a day; in treatment group 1， Liuwei Dihuang pill was added orally(8 pills/time，3 times a day) on the basis of control group; in treatment group 2， Liuwei Dihuang pill decoction was taken to fumigate the eyes(20mins/time，2 times a day) on the basis of control group; in treatment group 3， Liuwei Dihuang pill was added orally(8 pills/time，3 times a day) and Liuwei Dihuang pill decoction was taken to fumigate the eyes(20mins/time，2 times a day) on the basis of control group.Each group took 6 months as a course of treatment， and the treatment lasted for a total of 3 courses.At the end of the whole course of treatment，traditional Chinese medicine(TCM) syndrome score， tear secretion test SchirmerⅠtest(SIT) without surface anesthesia， tear film break-up time(BUT) and corneal fluorescence staining(CFS) score were compared between the four groups， and the adverse reactions were observed.[Results] After treatment， the scores of TCM syndrome， SIT， BUT and CFS score of the three treatment groups and control group were better than that before treatment， and the differences were statistically significant(P＜0.05，P＜0.001).The clinical efficacy of treatment group 3 was better than that of control group， treatment group 1 and treatment group 2， and the differences were statistically significant(P＜0.05). Pairwise comparison showed that the symptoms and signs of treatment group 3 were slighter than that of control group， treatment group 1，and treatment group 2， and the differences were statistically significant(P＜0.05). Pairwise comparison showed that there is no statistical differences among control group， treatment group 1 and treatment group 2(P＞0.05). There were no obvious adverse reactions in each group during treatment. [Conclusion] Artificial tears combined with oral administration and fumigation of Liuwei Dihuang pills can effectively relieve symptoms and signs of pSS-DED， which is safe without significant side effects. |
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