养阴剔络方干预老年代谢综合征（阴虚血瘀证）慢性肾损害的临床研究
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摘要
目的探讨养阴剔络方对老年代谢综合征患者慢性肾损害的影响,及对中医阴虚血瘀证疗效及安全性评价。
方法本实验共纳入49例符合代谢综合征西医诊断标准、慢性肾脏病(CKD) KDOQI诊断标准及阴虚血瘀证中医诊断标准的老年病人,其中男39人、女10人,年龄在68-87岁,随机分为观察组25人,对照组24人,观察组予养阴剔络方+西药基础治疗,对照组仅予西药基础治疗,观察时间四周,观察患者治疗前后Scr、BUN, c-aGFR、UA、24upr等指标,并评估中医症状积分疗效,统计分析两组治疗结果,作出疗效评价。
结果观察组与对照组的年龄、性别、体重指数、肥胖、高血压、血脂异常、血糖异常、心脑血管疾病分布、治疗前中医症状积分均无显著统计学差异(P值均>0.05),两组具有可比性。中医症状积分疗效结果提示,观察组治疗后积分低于对照组,疗效指数(54.2±10.83)高于对照组(38.31±7.69),观察组中显效2例、有效22例、无效1例,对照组中有效18例、无效6例,观察组疗效明显优于对照组(P<0.05)。两组治疗后Scr、24upr、BUN、UA值均明显下降(P<0.01),c-aGFR较前提高(P<0.01),且观察组治疗后Scr、U-pro较对照组下降更为明显(P<0.05),观察组疗效优于对照组。降BUN、UA、c-aGFR两组疗效相当。而两组综合疗效比较：观察组显效12例(48%)、有效9例(36%)、稳定3例(12%),无效1例(4%),总有效率84%;对照组显效0例、有效10例(41.67%)、稳定11例(45.83%)、无效3例(12.5%),总有效率41.76%。观察组总体疗效优于对照组(P<0.05)。
结论1、养阴剔络方以养阴药与和化瘀药相配伍,切合老年代谢综合征患者肝肾阴虚、久病入络、瘀毒互结的基本病机,临床上能有效的改善患者阴虚血瘀证症状体征；2、养阴剔络方治疗老年代谢综合征是安全有效的；3、养阴剔络方能降低老年代谢综合征慢性肾损害患者的血肌酐、尿酸及尿蛋白水平,可增加患者肾小球滤过率,对肾功能有改善作用,可防治和延缓肾损害的进一步发展,且对防治代谢综合征及其靶器官损害的发生发展有重要的意义。
Objective To evaluate the safety and clinical effect of improving the renal function in elderly patients with metabolic syndrome typed in Yin deficiency blood stasis treating by the Nourishing-Yin-and-Dredging-Collateral formula.
Methods The study includes 49 elderly patients in accordance with western medicine diagnosis standard of MS、CKD and TCM diagnosis standard of yin deficiency blood stasis,among which male 39, female 10, age between 60 and 87, randomly being divided,25into the observation group and 24 into the control group. The observation group is treated by the nourishing-Yin-and-Dredging-Collateral Formula and common western medicine. The control group was treated only by common western medicine. We carry out lab tests of chronic kidney disease such as SCr、BUN、UA and UPro before and after treatment, and make appraisal of the effect of the total points of TCM symptoms, finally conduct the statistic analysis then evaluate curative effect.The treatment course is 4 weeks。
Results There is no evident statistic difference(P>0.05) between the two groups about the distribution of age, gender, BMI, obesity, hypertension, blood lipid disorder, diabates, cardio-cerebral vascular disease,and the total scores of the TCM symptoms. So they have comparability.The result of the total scores of TCM symptoms showed that after treatment the total scores of the observation group is lower than the control group, and the efficacy index is higher (54.2±10.83) than the control group (38.31±7.69).There is 2 cases of obvious effect,22 cases of common effect,1 cases of non-effect in the observation group. There is 18 cases of common effect,6 cases of non-effect in the control group. The effect of the observation group is much better than the control group (P<0.05). The results of the lab test about renal function: the level of Scr、24hupr greatly decreased in the observation group after treatment as well as compared with the control group, the effect of observation group is better than control group; the level of BUN、UA dereased and GFR increased in both groups, but there is no obvious difference between the two; The two groups of integrated effect comparison:There is 12 cases of obvious effect,9 cases of common effect,3 cases of stable,1 cases of non-effect in the observation group, with the total effective 84%; There is 10 cases of common effect,11 cases of stable,3 cases of non-effect in the control group,with the total effective 41.76%. The effect of the observation group is superior to the control group (P<0.05).
Conclusion 1. The formula is combinated by the Nourishing-Yin herbs and Dredging-Collateral herbs.This compatibility fit the basic pathogenic principle of Asthenia of Hepatonephric Yin and Chronic Diseases Transforming to Collaterals for elderly patients with MS. It can improve the clinic TCM symptoms; 2.It's safe and effective towards elderly MS by the between the contract Nourishing-Yin-and-Dredging-Collateral formula; 3.The formula dereased the level of SCr、BUN、UA and UPro,and improved glomerular filtration rate.lt can ameliorate the renal function and played an important roal in delaying renal damage further development.Furthermore, it has great significance of preventing from the onset and development of MS and its related cardio-cerebral vascular diseases.
方法本实验共纳入49例符合代谢综合征西医诊断标准、慢性肾脏病(CKD) KDOQI诊断标准及阴虚血瘀证中医诊断标准的老年病人,其中男39人、女10人,年龄在68-87岁,随机分为观察组25人,对照组24人,观察组予养阴剔络方+西药基础治疗,对照组仅予西药基础治疗,观察时间四周,观察患者治疗前后Scr、BUN, c-aGFR、UA、24upr等指标,并评估中医症状积分疗效,统计分析两组治疗结果,作出疗效评价。
结果观察组与对照组的年龄、性别、体重指数、肥胖、高血压、血脂异常、血糖异常、心脑血管疾病分布、治疗前中医症状积分均无显著统计学差异(P值均>0.05),两组具有可比性。中医症状积分疗效结果提示,观察组治疗后积分低于对照组,疗效指数(54.2±10.83)高于对照组(38.31±7.69),观察组中显效2例、有效22例、无效1例,对照组中有效18例、无效6例,观察组疗效明显优于对照组(P<0.05)。两组治疗后Scr、24upr、BUN、UA值均明显下降(P<0.01),c-aGFR较前提高(P<0.01),且观察组治疗后Scr、U-pro较对照组下降更为明显(P<0.05),观察组疗效优于对照组。降BUN、UA、c-aGFR两组疗效相当。而两组综合疗效比较：观察组显效12例(48%)、有效9例(36%)、稳定3例(12%),无效1例(4%),总有效率84%;对照组显效0例、有效10例(41.67%)、稳定11例(45.83%)、无效3例(12.5%),总有效率41.76%。观察组总体疗效优于对照组(P<0.05)。
结论1、养阴剔络方以养阴药与和化瘀药相配伍,切合老年代谢综合征患者肝肾阴虚、久病入络、瘀毒互结的基本病机,临床上能有效的改善患者阴虚血瘀证症状体征；2、养阴剔络方治疗老年代谢综合征是安全有效的；3、养阴剔络方能降低老年代谢综合征慢性肾损害患者的血肌酐、尿酸及尿蛋白水平,可增加患者肾小球滤过率,对肾功能有改善作用,可防治和延缓肾损害的进一步发展,且对防治代谢综合征及其靶器官损害的发生发展有重要的意义。
Objective To evaluate the safety and clinical effect of improving the renal function in elderly patients with metabolic syndrome typed in Yin deficiency blood stasis treating by the Nourishing-Yin-and-Dredging-Collateral formula.
Methods The study includes 49 elderly patients in accordance with western medicine diagnosis standard of MS、CKD and TCM diagnosis standard of yin deficiency blood stasis,among which male 39, female 10, age between 60 and 87, randomly being divided,25into the observation group and 24 into the control group. The observation group is treated by the nourishing-Yin-and-Dredging-Collateral Formula and common western medicine. The control group was treated only by common western medicine. We carry out lab tests of chronic kidney disease such as SCr、BUN、UA and UPro before and after treatment, and make appraisal of the effect of the total points of TCM symptoms, finally conduct the statistic analysis then evaluate curative effect.The treatment course is 4 weeks。
Results There is no evident statistic difference(P>0.05) between the two groups about the distribution of age, gender, BMI, obesity, hypertension, blood lipid disorder, diabates, cardio-cerebral vascular disease,and the total scores of the TCM symptoms. So they have comparability.The result of the total scores of TCM symptoms showed that after treatment the total scores of the observation group is lower than the control group, and the efficacy index is higher (54.2±10.83) than the control group (38.31±7.69).There is 2 cases of obvious effect,22 cases of common effect,1 cases of non-effect in the observation group. There is 18 cases of common effect,6 cases of non-effect in the control group. The effect of the observation group is much better than the control group (P<0.05). The results of the lab test about renal function: the level of Scr、24hupr greatly decreased in the observation group after treatment as well as compared with the control group, the effect of observation group is better than control group; the level of BUN、UA dereased and GFR increased in both groups, but there is no obvious difference between the two; The two groups of integrated effect comparison:There is 12 cases of obvious effect,9 cases of common effect,3 cases of stable,1 cases of non-effect in the observation group, with the total effective 84%; There is 10 cases of common effect,11 cases of stable,3 cases of non-effect in the control group,with the total effective 41.76%. The effect of the observation group is superior to the control group (P<0.05).
Conclusion 1. The formula is combinated by the Nourishing-Yin herbs and Dredging-Collateral herbs.This compatibility fit the basic pathogenic principle of Asthenia of Hepatonephric Yin and Chronic Diseases Transforming to Collaterals for elderly patients with MS. It can improve the clinic TCM symptoms; 2.It's safe and effective towards elderly MS by the between the contract Nourishing-Yin-and-Dredging-Collateral formula; 3.The formula dereased the level of SCr、BUN、UA and UPro,and improved glomerular filtration rate.lt can ameliorate the renal function and played an important roal in delaying renal damage further development.Furthermore, it has great significance of preventing from the onset and development of MS and its related cardio-cerebral vascular diseases.
引文
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