参芪降糖颗粒治疗早期糖尿病肾病的临床疗效观察
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摘要
背景
据美国、日本、及许多西欧国家统计资料表明,糖尿病肾病(DN)已经升为终末期肾脏病(ESRD)首位病因,目前,在我国DN发病率亦呈上升趋势,也是目前糖尿病患者的主要死因之一。糖尿病肾病(DN)是糖尿病最典型的微血管并发症之一,又称糖尿病性肾小球硬化症。临床特征为蛋白尿、渐进性肾功能损害、高血压、水肿,晚期出现严重肾功能衰竭。在糖尿病肾病早期,尚可通过正确的治疗使之逆转,随着病情进展,患者一旦出现尿微量白蛋白排泄率增加,病情就将持续加重,进一步可表现为蛋白尿、水肿等,直至发生终末期肾衰尿毒症。因此糖尿病肾病的早期诊断和防治是其治疗的关键。目前被循证医学证明有效的治疗糖尿病肾病的途径主要是控制血糖糖、血压、调脂、抗凝、限制蛋白质摄入等西医对症治疗方案仍存在一定的局限性,难以从根本上改变DN的进程。所以如何有效地治疗、预防DN已成为国内外学者共同关注的问题。而中医药治疗DN在改善临床症状、降低各项生化指标、保护肾脏等方面已取得较好的疗效,目前中医药对糖尿病肾病的防治存在着巨大的潜力和前景,研究中西医结合治疗DN对早期防治、延缓DN的发生、发展具有重要临床及科研意义。
目的
通过临床研究,观察以益气养阴,健脾补肾为治法组成的中成药参芪降糖颗粒对早期糖尿病肾病的临床疗效。
方法
将符合纳入标准的早期糖尿病肾病患者共63例采用随机开放对照的原则分为对照组、观察治疗组各治疗3个月。同时以治疗前、治疗后血糖、糖化血红蛋白、血脂、24小时尿微量白蛋白定量等指标及中医症候疗效为观察指标,进行总体疗效评价估及作出安全性评价,综合评价参芪降糖颗粒治疗早期糖尿病肾病的临床疗效。
结果
经统计分析,治疗前两组患者基线资料无显著性差异,具有可比性。
临床研究表明对照组、治疗组两组患者的临床症状均有不同程度的改善,两组患者治疗后血糖、糖化血红蛋白、血脂、24小时尿微量白蛋白定量均较治疗前明显下降,但加用中成药参芪降糖颗粒的治疗组在改善临床症状及24小时尿微量白蛋白定量、血糖、糖化血红蛋白生化指标效果优于对照组。两组患者在治疗过程中均未出现不良反应。
结论
治疗后两组患者的血糖、糖化血红蛋白、血脂、24小时尿微量白蛋白定量均有下降,但加用中成药参芪降糖颗粒的观察治疗组在改善症状、24尿微量白蛋白定量、糖代谢等综合疗效更优于单纯西药的对照组。
Background
According to the United States, Japan and many Western European countries study, diabetic nephropathy (DN) has been promoted to the first cause of end-stage renal disease (ESRD). At present, the incidence trend of DN in China is rising, and it is one of the most leading causes of death in diabetic patients. Diabetic nephropathy (DN) is one of the most typical diabetic microangiopathy complications, also known as diabetic glomerulosclerosis. The clinical features of DN are albuminuria, progressive renal dysfunction, hypertension, edema, and severe renal failure in the late stages. It can be reversed the diabetic nephropathy In early stage under the right treatment. But once patients increased the urinary albumin excretion rate, the disease will be progressively, and following proteinuria, edema and so on, until the end stage renal failure in uremia. Therefore, the key to treat DN is early diagnosis and prevention diabetic nephropathy. Up till now, evidence-based medicine proves the effective treatment of diabetic nephropathy mainly through hypoglycemic, antihypertensive, regulating lipid, anticoagulation, limiting protein intake, and other Western symptomatic treatment. But there are still have some limitations. It is difficult to change the DN process fundamentally. So how to treat and prevent the DN effectively have become issues of common concern all over the world. Chinese medicine treatment of DN have effect on improving clinical symptoms, reduce the biochemical indicators, and to protect the kidneys. Therefore Chinese medicine prevention and treatment of diabetic nephropathy have huge potential and prospects. It is clinical and scientific important to do some research prevention or delay the occurrence of DN.
Objective
Clinical Observation on the Treatment of early diabetic nephropathy by Shenqi Jiangtang Particles, which is supplementd qi and nourishing yin nourished spleen and kidney.
Methods
63cases which meet the inclusion criteria were divided into three groups(control group, Observation groupn treatment group) by randomized, after3months of treatment. Testing the blood glucose, glycosylated hemoglobin, lipids, urinary albumin excretion rate, serum creatinine and effective of TCM syndromes etc. pre and post treatment. Evaluate its safety and efficacy, comprehensive evaluation the henqi Jiangtang Particles clinical effect in early diabetic nephropathy.
Results
Statistical analysis shows that it was no significant difference in comparable baseline data before treatment.
Clinical studies have shown that the control group, treatment group, two groups of patients with clinical symptoms were improved to varying degrees, After treatment, blood glucose, glycosylated hemoglobin, lipids, and24-hour urine albumin quantitative than before treatment decreased, but the addition ofsugar granule of Chinese patent medicines Shenqi treatment group to improve the clinical symptoms and24-hour urinary albumin quantitative, blood glucose, glycosylated hemoglobin biochemical indicators better than the control group. There were no obvious adverse reactions during treatment.
Conclusion
After treatment, blood glucose, glycosylated hemoglobin, lipids,24-hour urine albumin quantitative were decreased in both groups. However, increasing the shenqi Jiangtang Particles in improving symptoms,24urinary albumin quantitative glucose, glucose metabolism showed better efficacy than western medicine only in the control group.
据美国、日本、及许多西欧国家统计资料表明,糖尿病肾病(DN)已经升为终末期肾脏病(ESRD)首位病因,目前,在我国DN发病率亦呈上升趋势,也是目前糖尿病患者的主要死因之一。糖尿病肾病(DN)是糖尿病最典型的微血管并发症之一,又称糖尿病性肾小球硬化症。临床特征为蛋白尿、渐进性肾功能损害、高血压、水肿,晚期出现严重肾功能衰竭。在糖尿病肾病早期,尚可通过正确的治疗使之逆转,随着病情进展,患者一旦出现尿微量白蛋白排泄率增加,病情就将持续加重,进一步可表现为蛋白尿、水肿等,直至发生终末期肾衰尿毒症。因此糖尿病肾病的早期诊断和防治是其治疗的关键。目前被循证医学证明有效的治疗糖尿病肾病的途径主要是控制血糖糖、血压、调脂、抗凝、限制蛋白质摄入等西医对症治疗方案仍存在一定的局限性,难以从根本上改变DN的进程。所以如何有效地治疗、预防DN已成为国内外学者共同关注的问题。而中医药治疗DN在改善临床症状、降低各项生化指标、保护肾脏等方面已取得较好的疗效,目前中医药对糖尿病肾病的防治存在着巨大的潜力和前景,研究中西医结合治疗DN对早期防治、延缓DN的发生、发展具有重要临床及科研意义。
目的
通过临床研究,观察以益气养阴,健脾补肾为治法组成的中成药参芪降糖颗粒对早期糖尿病肾病的临床疗效。
方法
将符合纳入标准的早期糖尿病肾病患者共63例采用随机开放对照的原则分为对照组、观察治疗组各治疗3个月。同时以治疗前、治疗后血糖、糖化血红蛋白、血脂、24小时尿微量白蛋白定量等指标及中医症候疗效为观察指标,进行总体疗效评价估及作出安全性评价,综合评价参芪降糖颗粒治疗早期糖尿病肾病的临床疗效。
结果
经统计分析,治疗前两组患者基线资料无显著性差异,具有可比性。
临床研究表明对照组、治疗组两组患者的临床症状均有不同程度的改善,两组患者治疗后血糖、糖化血红蛋白、血脂、24小时尿微量白蛋白定量均较治疗前明显下降,但加用中成药参芪降糖颗粒的治疗组在改善临床症状及24小时尿微量白蛋白定量、血糖、糖化血红蛋白生化指标效果优于对照组。两组患者在治疗过程中均未出现不良反应。
结论
治疗后两组患者的血糖、糖化血红蛋白、血脂、24小时尿微量白蛋白定量均有下降,但加用中成药参芪降糖颗粒的观察治疗组在改善症状、24尿微量白蛋白定量、糖代谢等综合疗效更优于单纯西药的对照组。
Background
According to the United States, Japan and many Western European countries study, diabetic nephropathy (DN) has been promoted to the first cause of end-stage renal disease (ESRD). At present, the incidence trend of DN in China is rising, and it is one of the most leading causes of death in diabetic patients. Diabetic nephropathy (DN) is one of the most typical diabetic microangiopathy complications, also known as diabetic glomerulosclerosis. The clinical features of DN are albuminuria, progressive renal dysfunction, hypertension, edema, and severe renal failure in the late stages. It can be reversed the diabetic nephropathy In early stage under the right treatment. But once patients increased the urinary albumin excretion rate, the disease will be progressively, and following proteinuria, edema and so on, until the end stage renal failure in uremia. Therefore, the key to treat DN is early diagnosis and prevention diabetic nephropathy. Up till now, evidence-based medicine proves the effective treatment of diabetic nephropathy mainly through hypoglycemic, antihypertensive, regulating lipid, anticoagulation, limiting protein intake, and other Western symptomatic treatment. But there are still have some limitations. It is difficult to change the DN process fundamentally. So how to treat and prevent the DN effectively have become issues of common concern all over the world. Chinese medicine treatment of DN have effect on improving clinical symptoms, reduce the biochemical indicators, and to protect the kidneys. Therefore Chinese medicine prevention and treatment of diabetic nephropathy have huge potential and prospects. It is clinical and scientific important to do some research prevention or delay the occurrence of DN.
Objective
Clinical Observation on the Treatment of early diabetic nephropathy by Shenqi Jiangtang Particles, which is supplementd qi and nourishing yin nourished spleen and kidney.
Methods
63cases which meet the inclusion criteria were divided into three groups(control group, Observation groupn treatment group) by randomized, after3months of treatment. Testing the blood glucose, glycosylated hemoglobin, lipids, urinary albumin excretion rate, serum creatinine and effective of TCM syndromes etc. pre and post treatment. Evaluate its safety and efficacy, comprehensive evaluation the henqi Jiangtang Particles clinical effect in early diabetic nephropathy.
Results
Statistical analysis shows that it was no significant difference in comparable baseline data before treatment.
Clinical studies have shown that the control group, treatment group, two groups of patients with clinical symptoms were improved to varying degrees, After treatment, blood glucose, glycosylated hemoglobin, lipids, and24-hour urine albumin quantitative than before treatment decreased, but the addition ofsugar granule of Chinese patent medicines Shenqi treatment group to improve the clinical symptoms and24-hour urinary albumin quantitative, blood glucose, glycosylated hemoglobin biochemical indicators better than the control group. There were no obvious adverse reactions during treatment.
Conclusion
After treatment, blood glucose, glycosylated hemoglobin, lipids,24-hour urine albumin quantitative were decreased in both groups. However, increasing the shenqi Jiangtang Particles in improving symptoms,24urinary albumin quantitative glucose, glucose metabolism showed better efficacy than western medicine only in the control group.
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