不同劑量大黃治療慢性腎衰竭（脾腎氣虛濁毒證）的臨床療效觀察
發(fā)布時間：2019-06-27 17:41
【摘要】：目的：目前大黃已被廣泛運用于治療早中期慢性腎衰竭。諸多動物與臨床實驗均證實大黃具有保護腎臟功能、延緩慢性腎臟病發(fā)展等臨床功效。本文旨在觀察不同劑量大黃中藥復方治療慢性腎衰竭(脾腎氣虛濁毒證)的臨床療效變化趨勢,進行綜合療效性和安全性評價,以探討不同體質更有效、副作用較小的合理大黃劑量,進而提高臨床療效。方法：依據(jù)本試驗的納排標準,對符合條件的60例受試者采取隨機、對照的臨床試驗方法,分為對照組、治療組(低、中、高劑量),觀察患者治療前后療效評價指標：腎功能、血紅蛋白量、血紅細胞數(shù)、24h尿蛋白定量、血漿白蛋白、中醫(yī)癥狀及體征等,記錄安全性指標：肝功能、電解質、凝血功能、心電圖、大便情況等及相關不良反應,并根據(jù)試驗所得數(shù)據(jù),做出初步的療效及安全性評價。結果：本研究對照組的臨床有效率為33.33%,低劑量治療組的臨床有效率為37.50%,中劑量治療組的臨床有效率為43.75%,高劑量治療組的臨床有效率為46.15%,不同劑量大黃組綜合療效差別無統(tǒng)計學意義。組間療效呈現(xiàn)量效關系趨勢,因受試者樣本量較小,差異統(tǒng)計學無意義。對照組與低、中、高劑量治療組可明顯改善CRF(脾腎氣虛濁毒證)的中醫(yī)癥狀。治療過程中部分受試者出現(xiàn)了以不同程度腹瀉為主的相關不良反應,與使用的大黃劑量呈現(xiàn)正相關。除高劑量組2名受試者因不能耐受相關腹瀉要求退出研究之外,其它受試者均可耐受主要因大黃引起的腹瀉,故大黃中藥復方的臨床安全性比較好。結論：1.不同劑量大黃組對CRF(脾腎氣虛濁毒證)有較好臨床療效,可改善中醫(yī)癥狀。隨大黃劑量變化,臨床療效呈現(xiàn)量效關系趨勢,因樣本量少,差異無統(tǒng)計學意義。2.不同劑量大黃組血肌酐均有不同程度的降低,但因樣本量少,統(tǒng)計學無意義。3.根據(jù)綜合臨床療效趨勢及副作用情況,臨床推薦有效而副作用較小的酒大黃劑量為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).
【學位授予單位】：成都中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2016
【分類號】：R277.5
本文編號：2507001
[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).
【學位授予單位】：成都中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2016
【分類號】：R277.5
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