不同剂量大黄治疗慢性肾衰竭（脾肾气虚浊毒证）的临床疗效观察

发布时间：2019-06-27 17:41

【摘要】：目的：目前大黄已被广泛运用于治疗早中期慢性肾衰竭。诸多动物与临床实验均证实大黄具有保护肾脏功能、延缓慢性肾脏病发展等临床功效。本文旨在观察不同剂量大黄中药复方治疗慢性肾衰竭(脾肾气虚浊毒证)的临床疗效变化趋势,进行综合疗效性和安全性评价,以探讨不同体质更有效、副作用较小的合理大黄剂量,进而提高临床疗效。方法：依据本试验的纳排标准,对符合条件的60例受试者采取随机、对照的临床试验方法,分为对照组、治疗组(低、中、高剂量),观察患者治疗前后疗效评价指标：肾功能、血红蛋白量、血红细胞数、24h尿蛋白定量、血浆白蛋白、中医症状及体征等,记录安全性指标：肝功能、电解质、凝血功能、心电图、大便情况等及相关不良反应,并根据试验所得数据,做出初步的疗效及安全性评价。结果：本研究对照组的临床有效率为33.33%,低剂量治疗组的临床有效率为37.50%,中剂量治疗组的临床有效率为43.75%,高剂量治疗组的临床有效率为46.15%,不同剂量大黄组综合疗效差别无统计学意义。组间疗效呈现量效关系趋势,因受试者样本量较小,差异统计学无意义。对照组与低、中、高剂量治疗组可明显改善CRF(脾肾气虚浊毒证)的中医症状。治疗过程中部分受试者出现了以不同程度腹泻为主的相关不良反应,与使用的大黄剂量呈现正相关。除高剂量组2名受试者因不能耐受相关腹泻要求退出研究之外,其它受试者均可耐受主要因大黄引起的腹泻,故大黄中药复方的临床安全性比较好。结论：1.不同剂量大黄组对CRF(脾肾气虚浊毒证)有较好临床疗效,可改善中医症状。随大黄剂量变化,临床疗效呈现量效关系趋势,因样本量少,差异无统计学意义。2.不同剂量大黄组血肌酐均有不同程度的降低,但因样本量少,统计学无意义。3.根据综合临床疗效趋势及副作用情况,临床推荐有效而副作用较小的酒大黄剂量为10g。
[Abstract]:Objective: rhubarb has been widely used in the treatment of early and middle chronic renal failure. Many animals and clinical experiments have confirmed that rhubarb has the clinical effect of protecting kidney function and delaying the development of chronic kidney disease. The purpose of this paper was to observe the changing trend of clinical efficacy of different doses of rhubarb in the treatment of chronic renal failure (syndrome of spleen and kidney qi deficiency and turbid poison), and to evaluate the efficacy and safety of rhubarb, so as to explore the reasonable dosage of rhubarb with different physique and less side effects, so as to improve the clinical curative effect. Methods: according to the standard of admission, 60 subjects were randomly divided into control group, treatment group (low, medium and high dose). The evaluation indexes of curative effect before and after treatment were observed: renal function, hemoglobin content, blood red blood cell count, 24 h urine protein quantity, plasma albumin, TCM symptoms and signs, and the safety indexes were recorded: liver function, electrolyte, Coagulation function, electrocardiogram, stool and other related adverse reactions, and according to the test data, make a preliminary efficacy and safety evaluation. Results: the clinical effective rate was 33.33% in the control group, 37.50% in the low dose treatment group, 43.75% in the middle dose treatment group and 46.15% in the high dose treatment group. There was no significant difference in the comprehensive curative effect among different doses of rhubarb. There was a dose-effect relationship between the two groups, because the sample size of the subjects was small, and the difference was not statistically significant. Control group and low, middle and high dose treatment group could significantly improve the TCM symptoms of CRF (spleen and kidney qi deficiency turbid toxin syndrome). During the treatment, some subjects developed adverse reactions with different degrees of diarrhea, which were positively correlated with the dose of rhubarb used. Except for 2 subjects in the high dose group who could not tolerate related diarrhea, the other subjects could tolerate diarrhea mainly caused by rhubarb, so the clinical safety of rhubarb traditional Chinese medicine compound was better. Conclusion: 1. Different doses of rhubarb group have good clinical effect on CRF (syndrome of spleen and kidney qi deficiency and turbid poison), and can improve the symptoms of traditional Chinese medicine. With the change of rhubarb dose, the clinical efficacy showed a dose-effect relationship trend, because of the small sample size, the difference was not statistically significant. 2. Serum creatinine was decreased in different doses of rhubarb group, but it was not statistically significant because of the small sample size. According to the trend of comprehensive clinical efficacy and side effects, it is recommended that the dose of rhubarb with effective and less side effects is 10 g 路L ~ (- 1).
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.5

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