杞菊地黄丸联合氟米龙滴眼液治疗肝肾阴亏型干眼症的疗效观察

doi:10.11958/20250411

摘要/Abstract

摘要：

目的探讨杞菊地黄丸联合氟米龙滴眼液治疗肝肾阴亏型干眼症（DED）的疗效及对患者眼表功能的影响。方法选取2021年4月—2024年5月在本院收治的92例DED患者，依照随机数字表法分成常规组和联合组，每组46例。常规组给予氟米龙滴眼液治疗，联合组在常规组基础上口服杞菊地黄丸治疗。比较2组DED患者治疗疗效、泪膜破裂时间（TBUT）、泪液分泌功能、角膜荧光色素染色（FLS）、干眼症眼表疾病指数（OSDI），并对不良反应进行评估。结果 2组治疗后TBUT、泪液浸润的长度均明显升高（P<0.05），OSDI及FLS评分均明显降低（P<0.05），且联合组变化更明显（P<0.05）；2组不良反应总发生率比较差异无统计学意义（P>0.05）；联合组总有效率为91.30%（42/46），高于常规组的76.09%（35/46），差异有统计学意义（P<0.05）。结论杞菊地黄丸联合氟米龙滴眼液治疗肝肾阴亏型DED具有良好的效果。

关键词: 干眼病, 杞菊地黄丸, 氟米龙, 眼表功能

Abstract:

Objective To investigate the efficacy of Qiju Dihuang pill combined with fluorometholone eye drops on dry eye disease (DED) due to Yin deficiency of liver and kidney and its impact on the ocular surface function of patients. Methods Ninety-two patients with DED admitted to our hospital from April 2021 to May 2024 were gathered and assigned into two groups using a random number table method, with 46 patients in each group. The conventional group was treated with fluorometholone eye drops, while the combination group was treated with Qiju Dihuang pills on the basis of the conventional group. The efficacy, tear film break up time (TBUT), length of tear infiltration, corneal fluorescein staining (FLS) and ocular surface disease index (OSDI) of DED patients were compared between the two groups, and adverse reactions were evaluated. Results After treatment, the length of TBUT and tear infiltration were significantly increased in the two groups（P<0.05), OSDI and FLS scores were significantly decreased (P<0.05), and changes were more significant in the combined group (P<0.05). There was no significant difference in the total incidence of adverse reactions between the two groups (P>0.05). The efficacy of the combination group was 91.30% (42/46), which was higher than that of the conventional group, 76.09% (35/46) (P<0.05). Conclusion The combination of Qiju Dihuang pill and flumilone eye drops has good therapeutic effect for patients with DED of Yin deficiency of liver and kidney.

Key words: xerophthalmia, Qi Ju Di Huang pill, fluorometholone, ocular surface function

中图分类号:

R777.3

图/表 5

参考文献 21

[1]	HU J, YAO Y, HUANG J, et al. Erxian decoction modulates Th17/Treg cells differentiation through LFA-1/ICAM-1/STAT3 pathway in menopausal dry eye disease[J]. Exp Eye Res, 2022, 215:108890. doi:10.1016/j.exer.2021.108890.
[2]	MOHAMED H B, ABD EL-HAMID B N, FATHALLA D. et al. Current trends in pharmaceutical treatment of dry eye disease:a review[J]. Eur J Pharm Sci, 2022, 175:106206. doi:10.1016/j.ejps.2022.106206.
[3]	陈均浩, 吴苗琴. 小牛血去蛋白提取物联合氟米龙治疗儿童干眼症的临床效果及对Th1/Th17介导的免疫炎症的影响[J]. 中国妇幼保健, 2022, 37(15):2798-2801.
	CHEN J H, WU M Q. Clinical efficacy of deproteinized calf blood extract combined with fluorometholone in the treatment of childhood dry eye disease and its impact on Th1/Th17-mediated immune inflammation[J]. Maternal and Child Health Care of China, 2022, 37(15):2798-2801. doi:10.19829/j.zgfybj.issn.1001-4411.2022.15.023.
[4]	邓洁, 庞媛. 普拉洛芬联合氟米龙滴眼液治疗中重度干眼症的临床疗效研究[J]. 中国处方药, 2023, 21(12):119-121.
	DENG J, PANG Y. Clinical efficacy of pranoprofen combined with fluorometholone eye drops in the treatment of moderate to severe dry eye disease[J]. Journal of China Prescription Drug, 2023, 21(12):119-121. doi:10.3969/j.issn.1671-945X.2023.12.032.
[5]	要博, 冯炜, 辛志坤. 双氯芬酸钠滴眼液联合玻璃酸钠滴眼液治疗干眼症的效果[J]. 中国医药指南, 2025, 23(5):80-82.
	YAO B, FENG W, XIN Z K. Diclofenac sodium eye drops combined with sodium hyaluronate eye drops for the treatment of dry eye[J]. Guide of China Medicine, 2025, 23(5):80-82. doi:10.15912/j.issn.1671-8194.2025.05.023.
[6]	田小辉, 胡鹿梅, 易湘龙, 等. 0.05%环孢素A治疗干眼有效性和安全性Meta分析[J]. 国际眼科杂志, 2023, 23(2):248-255.
	TIAN X H, HU L M, YI X L, et al. Meta-analysis of the efficacy and safety of 0.05% cyclosporine A in the treatment of dry eye[J]. International Eye Science, 2023, 23(2):248-255. doi:10.3980/j.issn.1672-5123.2023.2.14.
[7]	于曼, 张大卫, 安艳辰, 等. 中药熏蒸对肝肾阴虚型干眼症的疗效研究[J]. 辽宁中医杂志, 2024, 51(2):103-106.
	YU M, ZHANG D W, AN Y C, et al. Study on curative effect of Chinese herbal fumigation on xerophthalmia of liver-kidney yin deficiency type[J]. Liaoning Journal of Traditional Chinese Medicine, 2024, 51(2):103-106. doi:10.13192/j.issn.1000-1719.2024.02.025.
[8]	李锡谦, 王冬梅. 杞菊地黄丸联合普拉洛芬和玻璃酸钠滴眼液对干眼症患者泪膜稳定性及血清STRA6-TGF-β1水平的影响[J]. 药物流行病学杂志, 2022, 31(8):530-533,543.
	LI X Q, WANG D M. Effects of Qiju Dihuang Pills combined with pranoprofen and sodium hyaluronate eye drops on tear film stability and serum STRA6 and TGF-β1 levels in patients with dry eye syndrome[J]. Chinese Journal of Pharmacoepidemiology, 2022, 31(8):530-533,543. doi:10.19960/j.cnki.issn1005-0698.2022.08.004.
[9]	亚洲干眼协会中国分会, 海峡两岸医药卫生交流协会眼科学专业委员会眼表与泪液病学组, 中国医师协会眼科医师分会眼表与干眼学组. 中国干眼专家共识:检查和诊断(2020年)[J]. 中华眼科杂志, 2020, 56(10):741-747.
	Chinese Chapter of the Asian Dry Eye Society, Ocular Surface and Tear Disease Study Group(Ophthalmology Professional Committee,Cross-Strait Medical and Health Exchange Association), Ocular Surface and Dry Eye Study Group(Ophthalmologist Branch,Chinese Medical Doctor Association).Chinese Expert Consensus on Dry Eye:Investigation and Diagnosis (2020)[J]. China J Ophthalmol, 2020, 56(10):741-747. doi:10.3760/cma.j.cn112142-20200714-00477.
[10]	彭清华. 中医眼科学[M]. 上海: 上海科学技术出版社,2019:44-47.
	PENG Q H. Ophthalmology of Traditional Chinese Medicine[M]. Shanghai: Shanghai Scientific & Technical Publishers, 2019:44-47.
[11]	中华医学会眼科学分会角膜病学组, 中国医师协会眼科医师分会角膜病学组. 中国干眼临床诊疗专家共识(2024年)[J]. 中华眼科杂志, 2024, 60(12):968-976.
	Cornea Group of Ophthalmology, Branch of Chinese Medical Association. Chinese expert consensus on the diagnosis and treatment of dry eye (2024)[J]. Chin J Ophthalmol, 2024, 60(12):968-976. doi:10.3760/cma.j.cn112142-20240517-00227.
[12]	中华医学会. 临床诊疗指南眼科学分册[M]. 北京: 人民卫生出版社, 2012:132-135.
	Chinese Medical Association. Clinical Diagnosis and Treatment Guidelines:Ophthalmology Volume[M]. Beijing: People's Medical Publishing House, 2012:132-135.
[13]	MITTAL R, PATEL S, GALOR A. Alternative therapies for dry eye disease[J]. Curr Opin Ophthalmol, 2021, 32(4):348-361. doi:10.1097/ICU.00000000000000768.
[14]	许行艳, 潘可生. 曲安奈德联合氟米龙滴眼液治疗过敏性结膜炎的临床研究[J]. 现代药物与临床, 2023, 38(7):1742-1745.
	XU X Y, PAN K S. Clinical study on fluorometholone combined with triamcinolone acetonide in treatment of allergic conjunctivitis[J]. Drugs & Clinic, 2023, 38(7):1742-1745. doi:10.7501/j.issn.1674-5515.2023.07.033.
[15]	王江维, 刘茂雄, 洪利, 等. 不同浓度氟米龙滴眼液治疗儿童重度混合型春季角结膜炎[J]. 国际眼科杂志, 2023, 23(12):2092-2095.
	WANG J W, LIU M X, HONG L, et al. Different concentrations of fluorometholone eye drops on the treatment of children with severe mixed vernal keratoconjunctivitis[J]. International Eye Science, 2023, 23(12):2092-2095. doi:10.3980/j.issn.1672-5123.2023.12.29.
[16]	DANG D H, RIAZ K M, KARAMICHOS D. Treatment of non-infectious corneal injury: review of diagnostic agents,therapeutic medications,and future targets[J]. Drugs, 2022, 82(2):145-167. doi:10.1007/s40265-021-01660-5.
[17]	晏林伟, 程静, 王亚峰, 等. 急性高眼压发作后眼后节的变化[J]. 国际眼科杂志, 2024, 24(4):551-555.
	YAN L W, CHENG J, WANG Y F, et al. Changes in the posterior segment of the eye after an episode of acute ocular hypertension[J]. International Eye Science, 2024, 24(4):551-555. doi:10.3980/j.issn.1672-5123.2024.4.10.
[18]	李澍才, 王颖. 杞菊地黄丸HPLC指纹图谱的建立及特征峰的归属分析[J]. 中国现代应用药学, 2021, 38(18):2222-2226.
	LI S C, WANG Y. Establishment of HPLC fingerprint of Qiju Dihuang Pill and the attribution analysis of characteristic peaks[J]. Chinese Journal of Modern Applied Pharmacy, 2021, 38(18):2222-2226. doi:10.13748/j.cnki.issn1007-7693.2021.18.005.
[19]	康泽林, 陈虹, 连曙光. 杞菊地黄丸治疗睑板腺功能障碍所致蒸发过强型干眼症临床研究[J]. 新中医, 2023, 55(14):29-32.
	KANG Z L, CHEN H, LIAN S G. Clinical study of Qiju Dihuang Pills for evaporative dry eye due to meibomian gland dysfunction[J]. New Chinese Medicine, 2023, 55(14):29-32. doi:10.13457/j.cnki.jncm.2023.14.006.
[20]	王宗, 吴安黛, 李俊. 羟糖甘滴眼液联合氟米龙滴眼液对干眼症患儿胸腺基质淋巴细胞生成素和泪液分泌试验的影响[J]. 中国妇幼保健, 2024, 39(19):3730-3734.
	WANG Z, WU A D, LI J. Effects of Hypromellose 2910,Dextran 70 and Glycerol eye drops combined with fluorometholone on thymic stromal lymphopoietin and tear secretion test in children with dry eye[J]. Maternal and Child Health Care of China, 2024, 39(19):3730-3734. doi:10.19829/j.zgfybj.issn.1001-4411.2024.19.013.
[21]	叶小婉. 普拉洛芬滴眼液对干眼症治疗的临床效果分析[J]. 中国眼镜科技杂志, 2024(10):119-122.
	YE X W. Clinical effect analysis of pranoprofen eye drops in the treatment of dry eye[J]. China Glasses Sciecse-Technology Magazine, 2024(10):119-122. doi:10.3969/j.issn.1004-6615.2024.10.046.

组别	性别		年龄/岁	病程/年
组别	男	女	年龄/岁	病程/年
常规组	21	25	52.61±9.64	1.89±0.53
联合组	17	29	52.97±9.87	1.87±0.49
χ²或t	0.717		0.171	0.188

组别	性别		年龄/岁	病程/年
组别	男	女	年龄/岁	病程/年
常规组	21	25	52.61±9.64	1.89±0.53
联合组	17	29	52.97±9.87	1.87±0.49
χ²或t	0.717		0.171	0.188

组别	TBUT/s
组别	治疗前		治疗后		t
常规组	2.63±0.72		7.29±1.75		16.702^＊＊
联合组	2.82±0.64		8.57±2.31		16.270^＊＊
t	1.338		2.996^＊
组别		泪液浸润的长度/（mm/5 min）
组别		治疗前		治疗后		t
常规组		5.32±1.61		8.17±2.52		6.464^＊＊
联合组		5.89±1.78		9.89±2.47		8.911^＊＊
t		1.611		3.306^＊

组别	TBUT/s
组别	治疗前		治疗后		t
常规组	2.63±0.72		7.29±1.75		16.702^＊＊
联合组	2.82±0.64		8.57±2.31		16.270^＊＊
t	1.338		2.996^＊
组别		泪液浸润的长度/（mm/5 min）
组别		治疗前		治疗后		t
常规组		5.32±1.61		8.17±2.52		6.464^＊＊
联合组		5.89±1.78		9.89±2.47		8.911^＊＊
t		1.611		3.306^＊

组别	OSDI/分
组别	治疗前		治疗后		t
常规组	47.46±11.69		35.16±9.51		5.536^＊＊
联合组	48.51±11.75		28.32±7.30		9.899^＊＊
t	0.430		3.870^＊＊
组别		FLS/分
组别		治疗前		治疗后		t
常规组		7.57±1.09		4.26±0.84		16.314^＊＊
联合组		7.64±1.21		3.51±0.56		21.009^＊＊
t		1.123		4.085^＊＊