Objectives of Study:
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1.Through this study, the therapeutic effect of the method of tonifying qi, nourishing Yin, promoting blood circulation and benefiting water in the treatment of DME was further determined. Patients were collected, related indexes were observed and statistical data were collected, and academic exchanges were conducted to promote the clinical application and academic development of the method of tonifying qi, nourishing Yin, promoting blood circulation and benefiting water in the treatment of diabetic macular edema;
2.Through this study, we will further study the concentration of drug of aflibercept in patients' vitreous and the activity of VEGF factor in patients' vitreous, and explore the basis that the combination of traditional Chinese medicine and anti-VEGF vitreous administration can reduce the number of injections;
3.Through this study, the mechanism of tonifying qi, nourishing Yin, promoting blood circulation and improving water in the treatment of diabetic macular edema is explored, in order to provide scientific basis for clinical treatment.
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纳入标准:
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西医诊断标准参照《眼科学》和美国早期治疗糖尿病性视网膜病变研究组(early treatment diabetic retinopathy study, ETDRS)推荐的“临床有意义的黄斑水肿”的诊断标准制定:
1.有明确的糖尿病病史;
2.检眼镜下见视网膜黄斑水肿或合并下列病变,微血管瘤、视网膜内出血、硬性渗出、棉絮斑;
3.黄斑中心500um范围内有视网膜增厚, OCT示黄斑厚度>250um,眼底荧光血管造影(FFA)显示黄斑区荧光素渗漏;
4.同时根据ETDRS推荐的黄斑水肿类型标准进行分型。
(1)局部水肿型:FFA示荧光素渗漏主要来自黄斑区单个或成簇的微血管瘤, 或来自一小段扩张的毛细血管,晚期渗漏仅占据黄斑局部区域;
(2)弥漫水肿型:FFA示荧光素渗漏来自视网膜和/或脉络膜毛细血管,形成黄斑广泛荧光素渗漏,占据整个黄斑区;
(3)黄斑囊样水肿型:FFA示晚期黄斑形成花瓣状和/或蜂房样荧光素渗漏,常合并黄斑弥漫水肿, 也可单独发生,统计时归属于弥漫水肿型。
中医诊断标准参照《中医眼科学》消渴内障中气阴两虚证标准:症见视物昏矇,眼底见视网膜黄斑水肿,视网膜出血、渗出; 面色无华,神疲少气,咽干,五心烦热;舌淡,脉虚无力或涩。
1.符合上述西医和中医诊断标准;
2.血糖血压控制可,糖化血红蛋白<8.3%、空腹血糖<8.3mmol/L、餐后2h血糖<11.1mmol/L,血压<150/90mmHg;
3.能够至少完成5个月治疗与随访;
4.所有患者对本研究知情并签署同意书。
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Inclusion criteria
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Western medicine diagnostic criteria are made according to the diagnostic criteria of "clinically significant macular edema" recommended by <Ophthalmology> and the Early Treatment Diabetic Retinopathy Study (ETDRS) in the United States:
1.Having a clear history of diabetes;
2.Macular edema or associated with the following lesions, including microangioma, retinal hemorrhage, hard exudation, and cotton spots, were observed under ophthoscope;
3.There was retinal thickening in the area of 500um in the macular center, OCT showed macular thickness > 250um, and FFA showed luciferin leakage in the macular area;
4.At the same time, according to the standard of macular edema recommended by ETDRS, the classification was carried out.
(1)Local edema: FFA showed that lucilucin leakage mainly came from single or cluster microhemangiomas in macular area, or from a small segment of dilated capillaries, and late leakage only occupied local area of macular area;
(2)Diffuse edema type: FFA showed luciferin leakage from retinal and/or choroidal capillaries, forming extensive luciferin leakage, occupying the whole macular area;
(3)Macular cystic edema type: FFA showed that late macular formation of petal-like and/or beehive-like fluorescein leakage, often accompanied by diffuse macular edema, can also occur alone, statistically classified as diffuse edema type.
TCM diagnostic criteria refer to the standard of Qi and Yin deficiency syndrome in <Chinese Medicine Ophthalmology> : visual faintness, retinal macular edema, retinal bleeding and exudation can be seen in the fundus of the disease; Complexion, God tired little gas, dry pharynx, five upset hot; Light tongue, weak or astringent pulse.
1.Conform to the above-mentioned western and traditional Chinese medicine diagnostic criteria;
2.Control of blood glucose and blood pressure, HbA1c < 8.3%, fasting blood glucose. 8.3mmol/L, 2h postprandial blood glucose < 11.1mmol/L, blood pressure < 150/90 mmHg.
3.To complete treatment and follow-up for at least 5 months;
4.All patients were informed of the study and signed the consent form.
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Exclusion criteria:
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1.Systemic patients with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, or blood diseases;
2.Allergic to sodium fluorescein;
3.Pregnant or lactating women;
4.Psychopaths.
5.Local retinal pulling or detachment of the eye;
6.After the operation, the vitreous cavity was filled with gas or silicone oil.
7.History of vitreoretinal surgery;
8.DME secondary to non-diabetic retinopathy;
9.The opacity of the refractive interstitium affects the observer.
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