加味五苓散联合康柏西普治疗肝郁脾虚型糖尿病性黄斑水肿的临床研究

周娜; 姜凤; 刘瑞宝

doi:10.16766/j.cnki.issn.1674-4152.003729

加味五苓散联合康柏西普治疗肝郁脾虚型糖尿病性黄斑水肿的临床研究

doi: 10.16766/j.cnki.issn.1674-4152.003729

周娜^{1, 2, ,},
姜凤³,
刘瑞宝¹

1.
河南中医药大学第一附属医院眼科，河南郑州 471000
2.
河南中医药大学第一临床医学院，河南郑州 471000
3.
重庆市合川区中医院眼科, 四川重庆 401520

基金项目:

河南省中医药科学研究专项课题 2022ZY1010

详细信息

通讯作者:
周娜，E-mail：Zhou5339@163.com

中图分类号: R587.2
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出版历程
- 收稿日期: 2024-03-19
- 网络出版日期: 2024-12-28

The clinical study of modified Wuling Powder Combined with conbercept in the treatment of diabetic macular edema of liver depression and spleen deficiency

ZHOU Na^{1, 2
, ,},
JIANG Feng³,
LIU Ruibao¹

1.
Ophthalmology Department, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan 471000, China

摘要

摘要: 目的研究加味五苓散联合康柏西普治疗肝郁脾虚型糖尿病性黄斑水肿(DME)的临床效果。方法选取2020年12月—2023年5月在河南中医药大学第一附属医院眼科治疗的肝郁脾虚型DME患者86例(86眼)，以随机数字表法分为观察组(43例，采用加味五苓散联合康柏西普治疗)及对照组(43例，采用康柏西普治疗)，比较2组患者的临床疗效、中医证候积分、视力水平、黄斑厚度、血清因子水平及不良反应发生率，运用SPSS 22.0统计学软件进行分析。结果治疗3个月后，观察组治疗总有效率(95.35%，41/43)高于对照组(81.40%，35/43，χ²=4.074，P=0.044)；2组患者中医证候积分、视力水平、黄斑厚度、白细胞介素-6及血管内皮生长因子均降低，且观察组较对照组低(P＜0.05)；2组患者一氧化氮合酶水平均升高，且观察组较对照组高(P＜0.05)；2组患者不良反应总发生率分别为9.30%(4/43)、11.63%(5/43)，差异无统计学意义(P＞0.05)。结论加味五苓散联合康柏西普治疗肝郁脾虚型DME具有较好的疗效，可显著改善患者临床症状、血管内皮功能及视力，降低黄斑厚度，减轻炎症反应，安全性高。
- 加味五苓散 /
- 康柏西普 /
- 肝郁脾虚型糖尿病性黄斑水肿
Abstract: Objective To examine the clinical impact of a modified Wuling Powder combined with Conbercept on diabetic macular edema (DME) in patients with liver depression and spleen deficiency. Methods The study subjects were 86 patients (86 eyes) with DME of liver depression and spleen deficiency treated in the Department of Ophthalmology at the First Affiliated Hospital of Henan University of Chinese Medicine between December 2020 and May 2023. The subjects were randomly assigned to either the observation group (n=43, modified Wuling Powder combined with Conbercept) and the control group (n=43, Conbercept) using a random number table method. A comparison was made of the clinical efficacy, traditional Chinese medicine (TCM) syndrome score, visual acuity level, macular thickness, serum factor level and incidence of adverse reactions in the two groups. The statistical analysis was conducted using SPSS 22.0 software. Results The observation group exhibited higher total effective rate [95.35% (43/43) vs. 81.40% (35/43)] 3 months following treatment (χ²=4.074, P=0.044). The TCM syndrome scores, visual acuity levels, macular thickness indexes, interleukin-6 and vascular endothelial growth factor levels in both groups decreased, with the observation group exhibiting lower levels (P < 0.05), conversely, the nitric oxide synthase levels increased in both groups, with the observation group demonstrating higher levels (P < 0.05). With regard to adverse reactions, no statistically significant difference was observed between the two groups [9.30% (4/43) vs. 11.63% (5/43), P>0.05]. Conclusion The combination of modified Wuling Powder with Conbercept has been demonstrated to be an effective treatment for DME caused by hepatic depression and splenic deficiency. It has the capacity to significantly improve the clinical symptoms of patients, enhance their visual acuity, reduce macular thickness, alleviate inflammatory response, and improve vascular endothelial function. Furthermore, it has been shown to be a safe treatment option.
- Modified Wuling Powder /
- Conbercept /
- Diabetic macular edema of liver depression and spleen deficiency

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表 1 2组肝郁脾虚型DME患者临床总有效率比较[例(%)]

Table 1. Comparison of clinical efficacy of DME patients with liver-stagnation and spleen-deficiency between the two groups[cases (%)]

组别	例数	显效	有效	无效	总有效
观察组	43	26(60.47)	15(34.88)	2(4.65)	41(95.35)
对照组	43	12(27.91)	23(53.49)	8(18.60)	35(81.40)
统计量			3.210^a		4.074^b
P值			0.001		0.044
注：^a为Z值，^b为χ²值。

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表 2 2组肝郁脾虚型DME患者中医证候积分比较(x±s，分)

Table 2. Comparison of TCM syndrome scores between the two groups of liver-stagnation and spleen-deficiency DME patients (x±s, points)

组别	例数	视物昏花		眼部干涩		气短懒言		面色晦暗		五心烦热		乏力
组别	例数	治疗前	治疗3个月后	治疗前	治疗3个月后	治疗前	治疗3个月后	治疗前	治疗3个月后	治疗前	治疗3个月后	治疗前	治疗3个月后
观察组	43	4.35±0.78	1.69±0.47	4.62±0.51	2.01±0.54	4.49±0.62	1.76±0.52	2.24±0.41	1.08±0.31	2.16±0.48	0.97±0.29	2.07±0.54	0.83±0.24
对照组	43	4.11±0.83	1.98±0.43	4.49±0.63	2.45±0.48	4.34±0.66	2.08±0.49	2.09±0.43	1.26±0.28	2.04±0.53	1.13±0.27	2.01±0.56	0.99±0.22
统计量		1.382^a	2.985^b	1.052^a	3.993^b	1.086^a	2.937^b	1.656^a	2.826^b	1.100^a	2.648^b	0.506^a	3.223^b
P值		0.171	0.004	0.296	＜0.001	0.281	0.004	0.102	0.006	0.274	0.010	0.614	0.002
注：^a为t值，^b为F值。

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表 3 2组肝郁脾虚型DME患者视力水平、黄斑厚度比较(x±s)

Table 3. Comparison of visual acuity level and macular thickness between the two groups of liver-stagnation and spleen-deficiency DME patients(x±s)

组别	例数	最佳矫正视力(LogMAR)		黄斑中心凹下脉络膜厚度(μm)		黄斑中心凹下视网膜厚度(μm)
组别	例数	治疗前	治疗3个月后	治疗前	治疗3个月后	治疗前	治疗3个月后
观察组	43	0.84±0.21	0.43±0.13	194.69±9.64	156.34±3.52	487.38±12.04	303.42±5.29
对照组	43	0.79±0.23	0.52±0.11	192.83±9.97	158.73±3.28	485.89±13.12	308.15±5.72
统计量		1.053^a	3.466^b	0.879^a	3.257^b	0.549^a	3.981^b
P值		0.296	0.001	0.382	0.002	0.585	＜0.001
注：^a为t值，^b为F值。

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表 4 2组肝郁脾虚型DME患者血清因子水平比较(x±s)

Table 4. Comparison of serum factor levels in liver depression and spleen deficiency DME patients between the two groups(x±s)

组别	例数	IL-6(ng/L)		VEGF(mg/L)		NOS(IU/mL)
组别	例数	治疗前	治疗3个月后	治疗前	治疗3个月后	治疗前	治疗3个月后
观察组	43	35.46±2.58	18.33±2.26	218.43±9.64	115.18±3.95	46.71±3.48	89.45±2.73
对照组	43	34.67±2.72	20.28±2.13	216.79±9.78	118.41±3.63	45.56±3.59	87.16±2.88
统计量		1.382^a	4.117^b	0.783^a	3.948^b	1.508^a	3.784^b
P值		0.171	＜0.001	0.436	＜0.001	0.135	＜0.001
注：^a为t值，^b为F值。

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表 5 2组肝郁脾虚型DME患者不良反应发生率比较[例(%)]

Table 5. Incidence of adverse reactions in 2 groups[cases (%)]

组别	例数	结膜出血	干眼症	玻璃体出血	高眼压	总发生
观察组	43	0	2(4.65)	1(2.33)	1(2.33)	4(9.30)
对照组	43	2(4.65)	0	1(2.33)	2(4.65)	5(11.63)
注：2组不良反应总发生率比较，χ²=0.124，P=0.725。

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