CN113730520B - A traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy - Google Patents
A traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy Download PDFInfo
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- CN113730520B CN113730520B CN202111157072.3A CN202111157072A CN113730520B CN 113730520 B CN113730520 B CN 113730520B CN 202111157072 A CN202111157072 A CN 202111157072A CN 113730520 B CN113730520 B CN 113730520B
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- urine
- proteinuria
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Abstract
本发明提供了一种治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪15份~60份、炒白术10份~30份、鬼箭羽15份~40份、僵蚕5份~15份、金雀根15份~40份、积雪草15份~40份、接骨木15份~40份、黄连3份~15份、土茯苓15份~40份、蛇舌草15份~40份。本发明在临床病例的应用中该方能够有效减少糖尿病肾病患者的蛋白尿,有较大的临床应用及研究价值。The invention provides a traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy. 5-15 parts, gorse root 15-40 parts, Centella asiatica 15-40 parts, elderberry 15-40 parts, Coptis chinensis 3-15 parts, Tuckahoe 15-40 parts, Hedyotis diffusa 15 to 40 servings. In the application of the present invention in clinical cases, the prescription can effectively reduce the proteinuria of diabetic nephropathy patients, and has great clinical application and research value.
Description
技术领域technical field
本发明属于中药技术领域,具体涉及一种治疗糖尿病肾病蛋白尿的中药组合。The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy.
背景技术Background technique
糖尿病目前已经成为我国慢性肾脏病的主要病因,其流行率高于肾小球肾炎导致的慢性肾脏病。糖尿病肾病(Diabetic nephropathy,DN)已成为终末期肾脏病(ESRD)的重要病因。糖尿病肾病患者一旦进入IV期,病情往往进行性发展,如不积极加以控制,肾小球滤过率(GFR)将平均每月下降1ml/min,其发展到ESRD的时间平均为7-10年。此期往往是糖尿病肾病肾功能进行性恶化的关键点,也是临床治疗难点,若治疗得当,病情得以控制,否则,病情加快发展为终末期肾脏病。糖尿病肾病的发生机制尚未明确,近期有研究显示,糖尿病肾病是一种炎症过程,免疫细胞可能参与到其发生和进展过程当中。糖尿病应激状态下,肾脏固有细胞通过DAMPs识别内源性损伤,可募集巨噬细胞、肥大细胞等固有免疫细胞,通过NF-κB、JNK、PKC、JAK/STAT等通路活化补体和募集细胞因子、黏附分子,放大固有免疫应答,促进炎症细胞和肥大细胞的肾组织浸润,导致糖尿病肾病肾脏损伤和肾功能下降。在糖尿病肾病时,患者补体系统被激活,C3沉积在肾小球,导致肾小球硬化,抑制补体C5,可以减少白蛋白尿和系膜扩张,阻断补体C3a受体可减少肾脏炎症、白蛋白尿,延缓糖尿病肾病肾脏组织的纤维化和肾功能丧失。此外,糖尿病肾病时患者的T淋巴细胞活化功能紊乱,影响T细胞激活过程,表现为CD8+降低以及CD4+/CD8+比例失调,CD8+抑制靶细胞分化及细胞毒性T细胞活性,造成自身免疫功能紊乱而导致糖尿病肾病发病获加剧病情发展。因此,免疫系统的激活在糖尿病肾病的发生和发展过程中发挥着重要作用,与临床表现差异、预后也密切相关,为糖尿病肾病的治疗提供了新的靶点。Diabetes has become the main cause of chronic kidney disease in my country, and its prevalence is higher than that of chronic kidney disease caused by glomerulonephritis. Diabetic nephropathy (DN) has become an important cause of end-stage renal disease (ESRD). Once diabetic nephropathy patients enter stage IV, the disease often develops progressively. If not actively controlled, the glomerular filtration rate (GFR) will decrease by an average of 1ml/min per month, and the average time to develop ESRD is 7-10 years. . This stage is often the key point of the progressive deterioration of renal function in diabetic nephropathy, and it is also a difficult point in clinical treatment. The pathogenesis of diabetic nephropathy is not yet clear. Recent studies have shown that diabetic nephropathy is an inflammatory process, and immune cells may be involved in its occurrence and progression. Under diabetic stress, renal innate cells recognize endogenous damage through DAMPs, recruit innate immune cells such as macrophages and mast cells, activate complement and recruit cytokines through NF-κB, JNK, PKC, JAK/STAT and other pathways , adhesion molecules, amplify the innate immune response, and promote the infiltration of inflammatory cells and mast cells in renal tissue, resulting in renal damage and decreased renal function in diabetic nephropathy. In diabetic nephropathy, the patient's complement system is activated, C3 is deposited in the glomeruli, leading to glomerulosclerosis, inhibition of complement C5 can reduce albuminuria and mesangial expansion, blocking complement C3a receptors can reduce renal inflammation, whitening Proteinuria, delays fibrosis and loss of renal function of renal tissue in diabetic nephropathy. In addition, in patients with diabetic nephropathy, the activation function of T lymphocytes in patients with diabetic nephropathy is disordered, which affects the activation process of T cells, manifested as a decrease in CD8+ and an imbalance in the ratio of CD4+/CD8+. CD8+ inhibits target cell differentiation and cytotoxic T cell activity, resulting in autoimmune dysfunction. The onset of diabetic nephropathy is exacerbated by the development of the disease. Therefore, the activation of the immune system plays an important role in the occurrence and development of diabetic nephropathy, and is closely related to differences in clinical manifestations and prognosis, providing a new target for the treatment of diabetic nephropathy.
中医目前普遍认为糖尿病肾病是一种本虚标实之证,本虚为脾肾亏虚,标实为瘀血、湿浊阻滞。肾为先天之本,脾为后天之本。肾中精气依赖于脾胃运化的水谷精微的培补,一旦脾气亏虚,水谷精微生化无源,则肾气亏虚,肾精匮乏。糖尿病肾病源于消渴病,如《灵枢·本脏》所云:“脾脆则善病消瘅”,脾气亏虚是消渴病主要病因之一,因此糖尿病肾病基础就是脾气亏虚。到了消渴病后期,伤及肾气,出现了肾虚不足,内生燥热,阴津亏耗,阴损及阳,继而阴阳俱伤。蛋白属于人体的精微物质,由脾气生化而得,其封藏依赖于脾气的升清与肾气的固摄。脾肾亏虚后,脾不升清,肾失封藏,蛋白从尿中流失。到了糖尿病肾病中晚期,肾失气化而致水湿、痰浊内生,或阻滞三焦,或泛溢全身,或郁而化火可见浮肿、倦态、大便粘腻或便秘。水谷精微生化无源,气血亏耗,脏腑失养,症见乏力纳呆;津液不得输布,水湿停聚,水肿可见;水气凌心,可见气喘心慌;水湿浊毒壅塞中焦,阻滞气机,可见恶心呕吐;肾气匮乏,固摄无力,精微外流,可见肾病综合征范围内的大量蛋白尿;肾虚气化无力,膀胱尿闭,症见少尿、浮肿等等,总之是脾肾衰败,诸症生焉。此外,瘀血穿插在糖尿病肾病发展的全过程。《圣济总录》云“消渴者,……久不治,则经治雍涩”。消渴病阴虚燥热,煎耗津血,久之成痰成瘀,堵塞肾络,影响肾脏气化功能,不能升清降浊,湿浊溺毒内停,而见糖肾诸证。结合现代研究,高血糖直接刺激蛋白激酶C,增加血管紧张素的作用,引起血管舒张物质水平升高,从而导致肾小球高压力、高灌注、高滤过的“三高”产生,另外糖尿病肾病血浆纤维蛋白原升高、血小板功能亢进、低蛋白血症等导致血液高凝,而糖基化产物的蓄积、炎症因子的释放,又导致内皮细胞及系膜细胞的增殖,使肾小球逐渐硬化,这些都与中医瘀血阻滞相关。Traditional Chinese medicine generally believes that diabetic nephropathy is a kind of syndrome of deficiency and excess. The kidney is the innate foundation, and the spleen is the acquired foundation. The essence and qi in the kidney depend on the nourishing and nourishing of the water and grain essence that is transported and transformed by the spleen and stomach. Once the spleen is deficient and the water grain essence has no biochemical source, the kidney qi will be deficient and the kidney essence will be deficient. Diabetic nephropathy originates from diabetes, as stated in "Lingshu · Ben Zang": "If the spleen is brittle, it is good for the disease to disappear." Deficiency of spleen spleen is one of the main causes of diabetes. Therefore, the foundation of diabetic nephropathy is deficiency of spleen spleen. In the late stage of diabetes mellitus, the kidney qi is damaged, resulting in deficiency of kidney, endogenous dryness and heat, depletion of yin and body fluids, damage to yin and yang, and then damage to both yin and yang. Protein belongs to the subtle substances of the human body, which are biochemically obtained from the spleen, and its storage depends on the improvement of the spleen and the fixation of the kidney qi. When the spleen and kidney are deficient, the spleen does not raise the spleen, the kidney loses its sealing and storage, and the protein is lost from the urine. In the middle and late stages of diabetic nephropathy, the kidney loses qi and turns into water and dampness, phlegm and phlegm endogenous, or block the triple burner, or overflow the whole body, or stagnate and turn into fire, which can show edema, tiredness, sticky stool or constipation. The microbiological changes of the water and grains are passive, the qi and blood are depleted, the viscera is dystrophic, the symptoms are manifested as fatigue and anorexia; the body fluid cannot be transported, the water and dampness stop gathering, and edema can be seen; , block qi movement, nausea and vomiting can be seen; deficiency of kidney qi, inability to fixate, and outflow of fines, a large amount of proteinuria in the range of nephrotic syndrome can be seen; deficiency of kidney qi is weak, urinary bladder closed, symptoms such as oliguria, edema, etc. In short, the spleen and kidneys fail, and various symptoms arise. In addition, blood stasis is interspersed in the whole process of the development of diabetic nephropathy. "Saint Ji Zonglu" says, "Those who quench their thirst... if they are not cured for a long time, they will be cured by treatment." Diabetes disease: yin deficiency and dryness heat, decoction consumes body fluid, phlegm and blood stasis are formed over a long period of time, blocking kidney collaterals, affecting the function of kidney qi transformation, unable to raise clearness and lowering turbidity, dampness and turbidity, drowning toxins and stopping within, and various syndromes of sugar and kidney can be seen. Combined with modern research, high blood sugar directly stimulates protein kinase C, increases the effect of angiotensin, and causes an increase in the level of vasodilatory substances, which leads to the "three highs" of glomerular high pressure, high perfusion, and high filtration. In addition, diabetes Nephropathy plasma fibrinogen elevation, platelet hyperfunction, hypoalbuminemia, etc. lead to blood hypercoagulation, and the accumulation of glycosylation products and the release of inflammatory factors lead to the proliferation of endothelial cells and mesangial cells, which makes glomerular Gradual sclerosis, these are related to TCM blood stasis block.
传统观点认为糖尿病肾病的发展与遗传、高血压、糖尿病、血流动力学、血管活性物质代谢紊乱等有关,在治疗上注重控制血压、血糖,以及ACEI/ARB药物的应用。近年来发现氧化应激、免疫炎症损伤在糖尿病肾病的发生发展中起着重要的作用,为糖尿病肾病的研究指出了新的方向。相对应的是中医近年来在治疗糖尿病肾病的理论及用药也有了新的发展。中医论治糖尿病肾病传统的着眼点在于健脾益肾、活血祛湿,尤其是吕仁和教授等提出了糖尿病肾病肾络“微型癥瘕”的瘀血致病理论后,中医界大力研究活血化瘀在糖尿病肾病中的应用,有一定的突破。近年来“风邪致病”理论的提出,从祛风角度论治糖尿病肾病,其科学性及有效性在糖尿病肾病免疫炎症损伤机制上得到了印证,丰富了中医论治糖尿病肾病的理论,以及治疗手段。The traditional view holds that the development of diabetic nephropathy is related to heredity, hypertension, diabetes, hemodynamics, and vasoactive substance metabolism disorders. In the treatment, emphasis is placed on the control of blood pressure, blood sugar, and the application of ACEI/ARB drugs. In recent years, it has been found that oxidative stress and immune-inflammatory damage play an important role in the occurrence and development of diabetic nephropathy, which points out a new direction for the research of diabetic nephropathy. Correspondingly, there have been new developments in the theory and medication of traditional Chinese medicine in the treatment of diabetic nephropathy in recent years. The traditional focus of traditional Chinese medicine on the treatment of diabetic nephropathy is to invigorate the spleen and kidney, invigorate blood and remove dampness, especially after Professor Lu Renhe and others put forward the theory of blood stasis pathogenicity of "miniature syndrome" in the kidneys and collaterals of diabetic nephropathy, the TCM community has vigorously researched on promoting blood circulation and removing dampness. There are certain breakthroughs in the application of blood stasis in diabetic nephropathy. In recent years, the theory of "pathogenicity caused by wind" has been put forward to treat diabetic nephropathy from the perspective of expelling wind. treatment approach.
发明内容SUMMARY OF THE INVENTION
本发明所要解决的技术问题在于针对上述现有技术的不足,提供一种治疗糖尿病肾病蛋白尿的中药组合,该中药组合在临床病例的应用中该方能够有效减少糖尿病肾病患者的蛋白尿,有较大的临床应用及研究价值。The technical problem to be solved by the present invention is to provide a traditional Chinese medicine combination for the treatment of diabetic nephropathy proteinuria in view of the above-mentioned deficiencies in the prior art. Great clinical application and research value.
为解决上述技术问题,本发明采用的技术方案是:一种治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪15份~60份、炒白术10份~30份、鬼箭羽15份~40份、僵蚕5份~15份、金雀根15份~40份、积雪草15份~40份、接骨木15份~40份、黄连3份~15份、土茯苓15份~40份、蛇舌草15份~40份。In order to solve the above-mentioned technical problems, the technical scheme adopted in the present invention is: a traditional Chinese medicine combination for the treatment of diabetic nephropathy proteinuria, which is composed of the following raw materials by weight: 15 to 60 parts of raw astragalus, 10 to 30 parts of fried Atractylodes, 15-40 parts of arrow feathers, 5-15 parts of silkworm, 15-40 parts of gorse root, 15-40 parts of Centella asiatica, 15-40 parts of elderberry, 3-15 parts of coptis, soil Poria cocos 15-40 parts, Hedyotis diffusa 15-40 parts.
优选地,由以下重量份的原料组成:生黄芪20份~40份、炒白术12份~18份、鬼箭羽20份~40份、僵蚕8份~12份、金雀根20份~35份、积雪草20份~35份、接骨木25份~35份、黄连5份~12份、土茯苓25份~40份、蛇舌草25份~35份。Preferably, it is composed of the following raw materials in parts by weight: 20-40 parts of raw astragalus, 12-18 parts of fried Atractylodes Rhizoma, 20-40 parts of ghost arrow feather, 8-12 parts of silkworm, 20-18 parts of gorse root 35 parts, 20 to 35 parts of Centella asiatica, 25 to 35 parts of elderberry, 5 to 12 parts of Coptis chinensis, 25 to 40 parts of Tuckahoe, and 25 to 35 parts of Hedyotis diffusa.
优选地,由以下重量份的原料组成:生黄芪30份、炒白术15份、鬼箭羽30份、僵蚕10份、金雀根30份、积雪草30份、接骨木30份、黄连6份、土茯苓30份、蛇舌草30份。Preferably, it is composed of the following raw materials by weight: 30 parts of raw astragalus, 15 parts of fried Atractylodes, 30 parts of ghost arrow feathers, 10 parts of silkworm, 30 parts of gorse root, 30 parts of Centella asiatica, 30 parts of elderberry, Coptis chinensis 6 parts, 30 parts of Tuckahoe, 30 parts of Hedyotis diffusa.
本发明与现有技术相比具有以下优点:Compared with the prior art, the present invention has the following advantages:
1、本发明以生黄芪、炒白术益气健脾为君药,鬼箭羽祛风活血,僵蚕、接骨木、金雀根、土茯苓祛风、活血、除湿,黄连、蛇舌草解毒、祛湿,全方以益气健脾扶正为主,辅以活血、祛风、除湿,符合糖尿病肾病本虚标实的病机,方中尤其注重风药的使用,选用了祛风兼有活血或除湿功效的金雀根、接骨木、土茯苓,以及有较强祛风搜剃入络的虫类药僵蚕,对于久消不除的蛋白尿会有事半功倍之效,在临床病例的应用中该方能够有效减少糖尿病肾病患者的蛋白尿,能够有效减少早中期糖尿病肾病(临床糖尿病肾病II-III期)微量蛋白尿及24小时蛋白尿;能够降低部分临床糖尿病肾病IV期患者的肌酐水平,有较大的临床应用及研究价值。1, the present invention takes raw Astragalus, fried Atractylodes, invigorating qi and invigorating spleen as monarch medicine, ghost arrow feather dispels wind and activates blood, silkworm, elderberry, gorse root, soil Poria dispels wind, promotes blood circulation, dehumidifies, coptis chinensis, Hedyotis diffusa detoxify , to remove dampness, the whole recipe focuses on nourishing qi, invigorating the spleen and strengthening the body, supplemented by blood circulation, expelling wind, and dehumidification, which is in line with the pathogenesis of diabetic nephropathy. The gorse root, elderberry, tuckahoe, which have the effect of promoting blood circulation or dehumidification, and the worm-like silkworm with strong expelling wind and shaving into the network, will have twice the result with half the effort for the long-term elimination of proteinuria. In application, the prescription can effectively reduce the proteinuria of patients with diabetic nephropathy, can effectively reduce the microalbuminuria and 24-hour proteinuria of early and mid-stage diabetic nephropathy (clinical diabetic nephropathy stage II-III); can reduce the creatinine of some clinical diabetic nephropathy stage IV patients. It has great clinical application and research value.
2、本发明以益气健脾,祛风活血除湿立论,组方严谨,既符合糖尿病肾病脾肾亏虚、湿瘀阻滞的传统观点,又体现了风邪致病的新进展,无论在理论及治则上均是一种突破,且在临床病例的应用中发现其能有效减少早中期糖尿病肾病患者蛋白尿,因此具有独创性以及疗效的肯定性。本方特点在于风药的应用,选用祛风兼有活血或除湿功效的金雀根、接骨木、土茯苓,以及有较强祛风搜剃入络的虫类药僵蚕,对于久消不除的蛋白尿会有事半功倍之效。2. The present invention is based on the theory of invigorating qi and spleen, dispelling wind, activating blood and removing dampness, and the formula is rigorous, which not only conforms to the traditional viewpoint of spleen and kidney deficiency and damp stasis block in diabetic nephropathy, but also reflects the new progress of pathogenic wind pathogens. It is a breakthrough in theory and treatment, and it has been found in clinical cases that it can effectively reduce proteinuria in patients with early and mid-stage diabetic nephropathy, so it has originality and certainty of efficacy. The feature of this recipe lies in the application of wind medicine. It uses gorse root, elderberry, and tuckahoe, which have both the functions of expelling wind and promoting blood circulation or dehumidification. In addition to proteinuria will be more effective.
下面结合实施例对本发明作进一步详细说明。The present invention will be described in further detail below in conjunction with the embodiments.
具体实施方式Detailed ways
实施例1Example 1
本实施例的治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪30份、炒白术15份、鬼箭羽30份、僵蚕10份、金雀根30份、积雪草30份、接骨木30份、黄连6份、土茯苓30份、蛇舌草30份。The Chinese medicine combination for the treatment of proteinuria in diabetic nephropathy of the present embodiment is composed of the following raw materials by weight: 30 parts of raw astragalus, 15 parts of fried Atractylodes, 30 parts of ghost arrow feathers, 10 parts of silkworm, 30 parts of gorse root, 30 parts of grass, 30 parts of elderberry, 6 parts of Coptis chinensis, 30 parts of Tuckahoe, and 30 parts of Hedyotis diffusa.
患者黄某,女性,48周岁,于2020.11初诊,主诉泡沫尿2年,伴双下肢浮肿1周。现病史:有糖尿病病史10年,目前使用胰岛素治疗。2年前出现泡沫尿,尿微量白蛋白阳性,具体不详,1周前出现双下肢浮肿,在我院就诊,查24小时尿蛋白2.13g,尿微量白蛋白提示959.1mg/l,尿蛋白/尿肌酐270.57mg/mmol,空腹血糖9mmol/l,糖化血红蛋白7.9%,拟糖尿病肾病收治入院。既往有高血压病史10年余,目前服用厄贝沙坦控制血压,血压在140/90mmhg左右。入院后予调整胰岛素控制血糖治疗,肾康活血化瘀,并予本实施例的治疗糖尿病肾病蛋白尿的中药组合治疗,水煎服,每日两次,每次150ml;住院两周,出院前复查24小时尿蛋白1.93g,微量白蛋白提示765.2mg/l,尿蛋白/尿肌酐211.93mg/mmol。出院后在门诊治疗,2021年3月复诊,双下肢不肿,尿微量白蛋白提示496.2mg/l,尿蛋白/尿肌酐171.22mg/mmol。治疗期间血常规、肝肾功能正常。The patient Huang, female, 48 years old, was first diagnosed on November 2020 and complained of foamy urine for 2 years and edema of both lower extremities for 1 week. History of present illness: 10-year history of diabetes mellitus, currently on insulin therapy. Foamy urine appeared 2 years ago, and the urine microalbumin was positive, the details were unknown, and edema of both lower extremities occurred 1 week ago. He was treated in our hospital, and the 24-hour urine protein was 2.13g. Urine creatinine was 270.57 mg/mmol, fasting blood glucose was 9 mmol/l, glycosylated hemoglobin was 7.9%, and he was admitted to hospital for pseudodiabetic nephropathy. He has a history of hypertension for more than 10 years. He is currently taking irbesartan to control his blood pressure, and his blood pressure is around 140/90 mmhg. After admission, he was given the treatment of adjusting insulin to control blood sugar, Shenkang, promoting blood circulation and removing blood stasis, and given the Chinese medicine combination treatment for the treatment of proteinuria in diabetic nephropathy in the present embodiment, decoct in water, twice a day, 150ml each time; hospitalized for two weeks, before discharge The 24-hour urine protein was 1.93g, the microalbumin level was 765.2mg/l, and the urine protein/urine creatinine was 211.93mg/mmol. After being discharged from the hospital, he was treated in an outpatient clinic, and he was re-examined in March 2021. The lower extremities were not swollen, the urine microalbumin was 496.2 mg/l, and the urine protein/urine creatinine was 171.22 mg/mmol. During the treatment, blood routine, liver and kidney function were normal.
实施例2Example 2
本实施例的治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪40份、炒白术12份、鬼箭羽40份、僵蚕8份、金雀根35份、积雪草20份、接骨木25份、黄连12份、土茯苓25份、蛇舌草25份。The Chinese medicine combination for the treatment of proteinuria in diabetic nephropathy of the present embodiment is composed of the following raw materials by weight: 40 parts of raw astragalus, 12 parts of fried Atractylodes, 40 parts of ghost arrow feather, 8 parts of silkworm, 35 parts of gorse root, 20 parts of grass, 25 parts of elderberry, 12 parts of coptis, 25 parts of tuckahoe, and 25 parts of Hedyotis diffusa.
患者邹某,男性,75岁,于2021.6.1就诊,主诉反复泡沫尿6年,加重1周伴双下肢轻度浮肿。现病史:患者有糖尿病病史12年,2015年因泡沫尿就诊,查尿微量蛋白43.2mg/l,肾功能正常,诊断为糖尿病肾病,开始服用金水宝、可元治疗,3月后复查尿微量白蛋白正常,遂自行停药,1年后发现泡沫尿再次增多,未就诊,自行服用金水宝、可元,自觉泡沫尿减少后停药,6年来反复如此,1周前因泡沫尿增多,伴有双下肢轻度浮肿,在家人陪同下就诊,查尿微量白蛋白提示200.1mg/l,尿蛋白/尿肌酐54.05mg/mmol,尿素氮6.65umol/l,肌酐103.2umol/l。予本实施例的治疗糖尿病肾病蛋白尿的中药组合治疗,水煎服,每日两次,每次150ml,连续服用1月。2021.6.29复查出院前复查微量白蛋白提示206.4mg/l,尿蛋白/尿肌酐31.91mg/mmol,原方续服1月。2021.7.27复查微量白蛋白提示151.2mg/l,尿蛋白/尿肌酐29.88mg/mmol,尿素氮7.86umol/l,肌酐87.9umol/l。Patient Zou, male, 75 years old, visited the doctor on June 1, 2021, and complained of repeated foamy urine for 6 years, aggravated for 1 week, and mild edema of both lower extremities. History of present illness: The patient has a history of diabetes for 12 years. In 2015, he went to the doctor because of foamy urine. The urine trace protein was 43.2 mg/l, and the renal function was normal. Diabetic nephropathy was diagnosed. He started taking Jinshuibao and Keyuan treatment. The albumin was normal, and the drug was stopped by himself. One year later, the foamy urine increased again. He did not seek medical attention. He took Jinshuibao and Keyuan by himself. After consciously the foamy urine decreased, the drug was stopped. This happened repeatedly for 6 years. One week ago, the foamy urine increased. Accompanied by mild edema of both lower extremities, he was accompanied by his family. The urine microalbumin test showed 200.1 mg/l, urine protein/urine creatinine 54.05 mg/mmol, blood urea nitrogen 6.65 umol/l, and creatinine 103.2 umol/l. The Chinese medicine combination therapy for the treatment of proteinuria in diabetic nephropathy in this example was given, decocted in water, twice a day, 150 ml each time, for one month. On June 29, 2021, the re-examination before discharge showed that the microalbumin level was 206.4 mg/l, and the urine protein/urine creatinine was 31.91 mg/mmol. The original prescription was continued for 1 month. On July 27, 2021, the re-examination of microalbumin showed 151.2 mg/l, urine protein/urine creatinine 29.88 mg/mmol, urea nitrogen 7.86 umol/l, and creatinine 87.9 umol/l.
实施例3Example 3
本实施例的治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪20份、炒白术18份、鬼箭羽20份、僵蚕12份、金雀根20份、积雪草35份、接骨木35份、黄连5份、土茯苓40份、蛇舌草35份。The traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy of the present embodiment is composed of the following raw materials in parts by weight: 20 parts of raw astragalus, 18 parts of fried Atractylodes, 20 parts of ghost arrow feather, 12 parts of silkworm, 20 parts of gorse root, 35 parts of grass, 35 parts of elderberry, 5 parts of Coptis chinensis, 40 parts of Tuckahoe, and 35 parts of Hedyotis diffusa.
患者张某,女性,67岁,2021.3.9就诊。主诉反复泡沫尿3年伴双下肢浮肿1年加重2周。患者由糖尿病病史8年,脑梗塞病史3年,遗留左上肢活动不利。3年前出现泡沫尿,尿蛋白+,未治疗,1年前双下肢浮肿,予速尿后浮肿能消退。2周前双下肢浮肿加重就诊,查微量白蛋白提示893.4mg/l,尿蛋白/尿肌酐173.73mg/mmol,尿素氮16.53umol/l,肌酐269.5umol/l,予速尿片每日1粒口服,同时予本实施例的治疗糖尿病肾病蛋白尿的中药组合治疗,水煎服,每日两次,每次150ml,连续服用1月。2021.4.6复诊,双下肢浮肿消退,查微量白蛋白提示738.5mg/l,尿蛋白/尿肌酐131.93mg/mmol,尿素氮18.43umol/l,肌酐311.1umol/l,停用速尿,原方续服。2021.6.25复诊时复查微量白蛋白提示569.1mg/l,尿蛋白/尿肌酐192.96mg/mmol,尿素氮13.11umol/l,肌酐206.7umol/l,继续服用原方。2021.8.12复诊,自诉无明显不适,血压血糖控制较好,查微量白蛋白提示311.3mg/l,尿蛋白/尿肌酐156.33mg/mmol,尿素氮10.87umol/l,肌酐187.7umol/l。The patient Zhang, female, 67 years old, visited the doctor on March 9, 2021. Complaints of repeated foamy urine for 3 years and bilateral lower extremity edema aggravated for 2 weeks in 1 year. The patient had an 8-year history of diabetes mellitus and a 3-year history of cerebral infarction, and the left upper extremity was left unfavorable. Foamy urine appeared 3 years ago, protein in urine +, without treatment, edema of both lower extremities 1 year ago, and the edema subsided after furosemide. Two weeks ago, the edema of both lower extremities worsened and he went to the doctor. The microalbumin test showed 893.4 mg/l, urine protein/creatinine 173.73 mg/mmol, blood urea nitrogen 16.53 umol/l, and creatinine 269.5 umol/l. One fast diaper was taken orally every day, At the same time, the Chinese medicine combination therapy for the treatment of diabetic nephropathy proteinuria of the present embodiment was given, decocted in water, twice a day, 150 ml each time, and taken continuously for 1 month. 2021.4.6 follow-up, edema of both lower extremities subsided, microalbumin check showed 738.5mg/l, urine protein/urine creatinine 131.93mg/mmol, blood urea nitrogen 18.43umol/l, creatinine 311.1umol/l, furosemide was discontinued, original prescription Continue serving. On June 25, 2021, the re-examination of microalbumin showed 569.1 mg/l, urine protein/urine creatinine 192.96 mg/mmol, blood urea nitrogen 13.11 umol/l, and creatinine 206.7 umol/l, and continued taking the original prescription. On August 12, 2021, he returned to the consultation and complained that he had no obvious discomfort, and his blood pressure and blood sugar were well controlled. The microalbumin check showed 311.3 mg/l, urine protein/urine creatinine 156.33 mg/mmol, urea nitrogen 10.87 umol/l, and creatinine 187.7 umol/l.
实施例4Example 4
本实施例的治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪15份、炒白术10份、鬼箭羽15份、僵蚕5份、金雀根15份、积雪草40份、接骨木40份、黄连15份、土茯苓15份、蛇舌草40份。The traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy of the present embodiment is composed of the following raw materials by weight: 15 parts of raw astragalus, 10 parts of fried Atractylodes, 15 parts of ghost arrow feather, 5 parts of silkworm, 15 parts of gorse root, 40 parts of grass, 40 parts of elderberry, 15 parts of Coptis chinensis, 15 parts of Tuckahoe, and 40 parts of Hedyotis diffusa.
患者凌某,男性,71岁,于2021.7.29就诊。主诉发现双下肢浮肿1月加重3天。患者有糖尿病病史7年,发现蛋白尿1年,平素服用黄葵胶囊,尿蛋白在+-至+之间。就诊时患者双下肢轻度浮肿,朝轻暮重,查微量白蛋白提示57.1mg/l,尿蛋白/尿肌酐10.76mg/mmol,予本实施例的治疗糖尿病肾病蛋白尿的中药组合治疗,水煎服,每日两次,每次150ml。2021.8.19复诊,查微量白蛋白提示5.4mg/l,尿蛋白/尿肌酐3.72mg/mmol,继续原方服用。The patient Ling, male, 71 years old, saw a doctor on July 29, 2021. The chief complaint found that the edema of both lower extremities increased for 3 days in January. The patient had a history of diabetes for 7 years, and was found to have proteinuria for 1 year. He usually took Huangkui capsules, and the urine protein was between +- and +. At the time of consultation, the patient's lower extremities were slightly edematous, and the symptoms were severe. The microalbumin test showed 57.1 mg/l, and the urine protein/urine creatinine was 10.76 mg/mmol. The Chinese medicine combination treatment for the treatment of proteinuria in diabetic nephropathy in this example was given. Decoction, twice a day, 150ml each time. On August 19, 2021, the patient was re-examined, and the microalbumin level was found to be 5.4 mg/l, and the urine protein/urine creatinine was 3.72 mg/mmol. Continue to take the original prescription.
实施例5Example 5
本实施例的治疗糖尿病肾病蛋白尿的中药组合,由以下重量份的原料组成:生黄芪60份、炒白术30份、鬼箭羽40份、僵蚕15份、金雀根40份、积雪草15份、接骨木15份、黄连3份、土茯苓40份、蛇舌草15份。The traditional Chinese medicine combination for treating proteinuria in diabetic nephropathy of the present embodiment is composed of the following raw materials by weight: 60 parts of raw astragalus, 30 parts of fried Atractylodes, 40 parts of ghost arrow feathers, 15 parts of silkworm, 40 parts of gorse root, 15 parts of grass, 15 parts of elderberry, 3 parts of Coptis chinensis, 40 parts of Tuckahoe, and 15 parts of Hedyotis diffusa.
患者肖某,女性,46岁,于2021.3.2就诊。主诉泡沫尿1年。患者发现糖尿病3年余,1年前因大量泡沫尿就诊诊断为糖尿病肾病,服用科素亚、雷公藤降尿蛋白,1年来泡沫尿反复出现,尿蛋白在+至++之间。就诊时患者自觉乏力,双下肢轻度浮肿,查谷丙转氨酶70.1u/l,微量白蛋白提示941.7mg/l,尿蛋白/尿肌酐97.34mg/mmol,考虑雷公藤引起肝损,予停用雷公藤,继续服用科素亚,同时予本实施例的治疗糖尿病肾病蛋白尿的中药组合治疗,水煎服,每日两次,每次150ml。2021.3.18查肝功能正常,尿常规提示尿蛋白+,继续服用本方,科素亚剂量不变。2021.6.4复诊时查肝功能正常,微量白蛋白提示532.1mg/l,尿蛋白/尿肌酐60.32mg/mmol,继续服用原方。2021.7.2复诊,查微量白蛋白提示509.3mg/l,尿蛋白/尿肌酐55.2mg/mmol。The patient Xiao Mou, female, 46 years old, saw a doctor on March 2, 2021. Complaint of foamy urine for 1 year. The patient was diagnosed with diabetes for more than 3 years. One year ago, he was diagnosed with diabetic nephropathy due to a large amount of foamy urine. Taking Cozaia and Tripterygium wilfordii to reduce urine protein, foamy urine appeared repeatedly in the past year, and the urine protein was between + and ++. At the time of consultation, the patient felt fatigued, mild edema of both lower extremities, alanine aminotransferase 70.1u/l, microalbumin 941.7mg/l, urine protein/urine creatinine 97.34mg/mmol, considering that Tripterygium wilfordii caused liver damage, it was discontinued Tripterygium wilfordii, continue to take Cozaia, and at the same time give the Chinese medicine combination treatment for the treatment of diabetic nephropathy proteinuria in this embodiment, decoct in water, twice a day, 150ml each time. On March 18, 2021, the liver function was normal, and the urine routine showed that the urine protein +, continue to take this prescription, the sub-dose of Kesu remains unchanged. On June 4, 2021, the liver function was normal, and the microalbumin level was 532.1 mg/l, and the urine protein/urine creatinine was 60.32 mg/mmol. The original prescription was continued. On July 2, 2021, the follow-up examination showed that the microalbumin level was 509.3 mg/l, and the urine protein/urine creatinine was 55.2 mg/mmol.
实施例6Example 6
本实施例为使用本发明的治疗糖尿病肾病蛋白尿的中药组合的临床试验:The present embodiment is a clinical trial using the Chinese medicine combination for the treatment of diabetic nephropathy proteinuria of the present invention:
1、研究对象1. Research objects
(1)入选病例:2018-2020年在上海市第七人民医院门诊及病房就诊的糖尿病肾病(糖尿病肾病)患者共120例。(1) Selected cases: A total of 120 patients with diabetic nephropathy (diabetic nephropathy) were treated in the outpatient and ward of Shanghai Seventh People's Hospital from 2018 to 2020.
(2)糖尿病肾病临床诊断标准:参照2007年KDOQI糖尿病肾病指南诊断标准:存在大量蛋白尿或以下情况存在微量白蛋白尿:存在糖尿病视网膜病变,糖尿病病程超过10年。(2) Clinical diagnostic criteria for diabetic nephropathy: refer to the 2007 KDOQI Diabetic Nephropathy Guidelines Diagnostic Criteria: presence of macroalbuminuria or microalbuminuria in the following conditions: presence of diabetic retinopathy, duration of diabetes more than 10 years.
(3)脾虚、血瘀、湿浊证诊断标准:根据国家中医药管理局2002年版《中药新药临床研究指导原则》。脾虚主要症状:倦怠乏力,口干,腰腿酸软或面色晄白,自汗畏风。脾虚次症:少气懒言,心悸气短,舌淡,苔薄白,脉细。具备主症2项,次症1项即可辨证为脾虚证。血瘀主要症状:手足麻木,胸痛,腰痛,入夜尤甚。次症:面部瘀斑,口唇暗,失眠健忘,舌暗甚至有瘀斑,舌下脉络青紫迂曲,脉沉涩。具备主症2项,次症1项即可辨证为血瘀证。湿浊主要症状:恶心呕吐,肢体困重,食少纳呆,口干口苦。次症:脘腹胀满,口中粘腻,水肿,舌苔厚腻;脉滑。具备主症2项,次症1项即可辨证为湿浊证。同时具备脾虚证、血瘀证和湿浊证,诊断标准者为脾虚血瘀湿浊证。(3) Diagnostic criteria for spleen deficiency, blood stasis, and damp turbidity syndrome: According to the 2002 edition of the "Guidelines for Clinical Research on New Chinese Medicines" issued by the State Administration of Traditional Chinese Medicine. Main symptoms of spleen deficiency: fatigue, dry mouth, soreness of waist and legs or pale complexion, spontaneous sweating and fear of wind. Secondary symptoms of spleen deficiency: sluggish speech, palpitations, shortness of breath, pale tongue, thin white coating, and thin pulse. With 2 main symptoms and 1 secondary symptom, the syndrome can be differentiated as spleen deficiency syndrome. Main symptoms of blood stasis: numbness of hands and feet, chest pain, low back pain, especially at night. Secondary symptoms: facial ecchymosis, dark lips, insomnia and forgetfulness, dark tongue and even ecchymosis, bruising and tortuous sublingual veins, and astringent pulse. With 2 main symptoms and 1 secondary symptom, the syndrome can be differentiated as blood stasis syndrome. Main symptoms of wet turbidity: nausea and vomiting, heavy limbs, poor appetite, dry mouth and bitter taste. Secondary symptoms: abdominal distention, sticky mouth, edema, thick and greasy tongue coating; slippery pulse. With 2 main symptoms and 1 secondary symptom, the syndrome can be differentiated as damp-turbid syndrome. At the same time, there are spleen deficiency syndrome, blood stasis syndrome and damp turbidity syndrome, and the diagnostic criteria are spleen deficiency and blood stasis damp turbidity syndrome.
(4)入选标准:我院住院及门诊患者,符合上述糖尿病肾病诊断标准及中医脾气亏虚、湿瘀阻滞诊断标准,且尿微量白蛋白在30-3500mg/d(临床糖尿病肾病II-III期),eGFR大于60ml/min/1.73m2(慢性肾脏病II-III期),年龄18-75岁。(4) Inclusion criteria: Inpatients and outpatients in our hospital meet the above diagnostic criteria for diabetic nephropathy and the TCM diagnostic criteria for spleen deficiency and damp stasis block, and the urine microalbumin level is 30-3500 mg/d (Clinical Diabetic Nephropathy II-III). stage), eGFR greater than 60ml/min/1.73m2 (chronic kidney disease II-III stage), age 18-75 years old.
(5)排除标准:①1型糖尿病;②妊娠糖尿病、甲亢等其他疾病所致的高血糖患者;伴有精神病、老年性痴呆等不能配合者;③严重的心、脑、肝等并发症者;恶性肿瘤,严重心功能不全,妊娠,免疫系统疾病或其他并发症,存在急慢性感染患者;④已知对所用药物过敏的患者;正在参加其它药物临床试验者或3个月内参加过其它临床试验者。⑤eGFR小于60ml/min/1.73m2;⑥年龄小于18岁或年龄大于75岁。(5) Exclusion criteria: ①Type 1 diabetes; ②Patients with hyperglycemia caused by gestational diabetes, hyperthyroidism and other diseases; patients with mental illness, senile dementia, etc. who cannot cooperate; ③Patients with serious heart, brain, liver and other complications; Malignant tumor, severe cardiac insufficiency, pregnancy, immune system disease or other complications, patients with acute or chronic infection; ④ patients known to be allergic to the drugs used; those who are participating in clinical trials of other drugs or have participated in other clinical trials within 3 months tester. ⑤ eGFR less than 60ml/min/1.73m2; ⑥ less than 18 years old or more than 75 years old.
(6)脱落/剔除标准:①不符合入选标准者;②资料不全影响疗效和安全性的判断;③观察中病人依从性有问题;(4)中途因出现严重并发症而合并使用其他药物治疗者;④中途终止治疗或出现不良反应而中途停药者。(6) Dropout/exclusion criteria: ① Those who do not meet the inclusion criteria; ② Incomplete data affect the judgment of efficacy and safety; ③ There is a problem with the patient’s compliance during the observation; (4) Combined with other drug treatment due to serious complications ④ Those who discontinued the treatment halfway or had adverse reactions and discontinued the medicine halfway.
2、试验分组:按上述标准入选患者共120例,采用统计软件生成随机数字表,受试者按照1:1比例随机分为健脾活血祛风方联合氯沙坦钾治疗组及单用氯沙坦钾治疗组,每组60例。在签署知情同意书后开始进行临床试验。2. Trial grouping: A total of 120 patients were selected according to the above criteria, and statistical software was used to generate a random number table. The subjects were randomly divided into the treatment group of Jianpi Huoxue Qufeng formula combined with losartan potassium treatment group and chlorine single treatment group according to the ratio of 1:1. Sartan potassium treatment group, 60 cases in each group. Clinical trials were started after the informed consent was signed.
3、治疗方案及疗程:3. Treatment plan and course of treatment:
两组患者均接受糖尿病教育、糖尿病饮食,内科口服降糖药物或者皮下注射胰岛素治疗,在此基础上:(1)中西医结合治疗组:予本发明的治疗糖尿病肾病蛋白尿的中药组合物联合氯沙坦钾(科素亚)治疗,水煎服,每日两次,每次150ml;氯沙坦钾(科素亚)剂量为每日一次,每次100mg口服。(2)西药(氯沙坦钾)治疗组:予氯沙坦钾(科素亚)每日一次,每次100mg口服。上述两组用药总疗程均为6个月。Both groups of patients received diabetes education, diabetes diet, oral hypoglycemic drugs or subcutaneous injection of insulin treatment in internal medicine, on this basis: (1) integrated traditional Chinese and Western medicine treatment group: combined with the Chinese medicine composition for the treatment of diabetic nephropathy proteinuria of the present invention Losartan potassium (Kesaya) treatment, decoction in water, twice a day, 150ml each time; Losartan potassium (Kesaya) dose is once a day, 100mg orally each time. (2) Western medicine (losartan potassium) treatment group: 100 mg of losartan potassium (Cosiya) was administered orally once a day. The total course of treatment in both groups was 6 months.
4、临床观察指标:24小时尿蛋白定量、尿微量白蛋白定量及尿白蛋白/肌酐比值(ACR)4. Clinical observation indicators: 24-hour urine protein quantification, urine microalbumin quantification and urine albumin/creatinine ratio (ACR)
5、试验结果5. Test results
表1两组治疗前后24h蛋白尿定量、尿微量白蛋白定量及尿白蛋白/肌酐比值比较Table 1 Comparison of 24h proteinuria quantification, urine microalbumin quantification and urine albumin/creatinine ratio before and after treatment between the two groups
注:治疗前,治疗组和对照组比较,*P>0.05,无统计学意义;治疗后,治疗组和对照组比较,#P<0.01,有统计学意义。Note: Before treatment, the comparison between the treatment group and the control group, *P>0.05, with no statistical significance; after treatment, the comparison between the treatment group and the control group, #P<0.01, with statistical significance.
目前公认的治疗糖尿病肾病蛋白尿有确切疗效的西药是ACEI/ARB类药物,而中药汤剂作为传统剂型,由于其组方的多样性、便捷性、辨证论治完整性,更能筛选出治疗糖尿病肾病的临床药物组合。本试验采用健脾活血祛风方联合科素亚治疗糖尿病肾病蛋白尿,6个月后的结果显示,与单用科素亚治疗相比较,两组均能减少24小时尿蛋白、尿微量白蛋白,尿白蛋白/肌酐比值上,但明显健脾活血祛风方联合科素亚组对于24小时尿蛋白、尿微量白蛋白,尿白蛋白/肌酐比值的减轻程度优于科素亚组,且有统计学意义。Currently recognized western medicines with definite curative effect in the treatment of diabetic nephropathy proteinuria are ACEI/ARB drugs, and traditional Chinese medicine decoction, as a traditional dosage form, can better screen out the treatment of diabetic nephropathy due to its diversity, convenience, and completeness of syndrome differentiation and treatment. clinical drug combination. In this trial, Jianpi Huoxue Qufeng Recipe combined with Kesuya was used to treat proteinuria in diabetic nephropathy. The results after 6 months showed that compared with treatment with Kesuya alone, both groups could reduce 24-hour urine protein and urinary trace whiteness. Protein, urine albumin/creatinine ratio, but obviously Jianpi Huoxue Qufeng formula combined with Kesu subgroup was better than the Kesu subgroup in reducing 24-hour urine protein, urine microalbumin, and urine albumin/creatinine ratio. and statistically significant.
以上所述,仅是本发明的较佳实施例,并非对本发明作任何限制。凡是根据发明技术实质对以上实施例所作的任何简单修改、变更以及等效变化,均仍属于本发明技术方案的保护范围内。The above descriptions are only preferred embodiments of the present invention, and do not limit the present invention in any way. Any simple modifications, changes and equivalent changes made to the above embodiments according to the technical essence of the invention still fall within the protection scope of the technical solutions of the present invention.
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