慢性肾病3期肾气阴（血）虚证的临床研究
摘要
目的研究慢性肾脏病3期(简称CKD3期)肾气阴(血)虚证(简称肾虚证)患者的证候特点,及其与临床、肾病理的相关性；并观察益肾养血为主的中药配伍组方治疗CKD3期肾虚证患者的临床疗效。
方法①收集观察411例CKD3期肾虚证患者的证候分布规律和特点,并进一步分析肾虚证证候积分与临床、理化指标间的相关性;
②分析具有完善肾病理资料的97例CKD3期肾虚证患者证候积分与肾病理小球、小管间质、血管及与活动、慢性病变积分的相关性;
③CKD3期肾虚证患者随机分三组,分别给予中药(益肾养血方为基础的组方)、西药(ACEI)及中西药治疗24周,共完成治疗187例,观察三组患者的证候和实验室指标的改变情况。
结果①95.13%CKD3期患者存存肾虚证,88.98%的肾虚证与风湿证、肾络瘀痹证呈二、三联合并存在;肾虚证患者24小时尿蛋白定量、血肌酐水平较非肾虚证患者高,eGFR较非虚证患者低；多联证患者24小时尿蛋白定量、血肌酐水平较单纯肾虚证患者高,eGFR、血浆白蛋白较单纯肾虚证患者低。
②肾虚证重度患者肾病理katafuchi评分总积分高于轻证患者、Andreoli评分硬化小球评分高于轻组患者、Andreoli评分细胞新月体的积分高于轻、中度组患者；二联证(肾虚+瘀痹)、三联证(肾虚+瘀痹+风湿)Andreoli评分的活动性指数总积分及间质炎细胞积分明显高于单纯肾虚证患者：三联证的活动性指数总积分尚高于二联证(肾虚+风湿);三联证(肾虚+瘀痹+风湿)的Andreoli评分慢性化指数总积分和纤维新月体的积分均明显高于单纯肾虚证组,二联证(肾虚+瘀痹)的纤维化积分高于单纯肾虚证组。
③中药、西药、中西药三组治疗均能改善CKD3期患者证候总积分,但中药组和中西药组优于西药组,其中中西药组疗效更明显；治疗前后比较中西药组尿蛋白量下降明显,中药组、中西药组治疗后eGFR水平上升,尤其中药组差异更明显,中药组治疗后血红蛋白较前上升,上述结果均存在统计学差异。
结论①肾虚证是CKD3期最主要证候,并多与风湿证、肾络瘀痹证呈二、三联存在,肾虚证的严重程度和多联证的存在与尿蛋白定量及肾功能密切相关。
②肾虚证的严重程度与肾病理慢性化指数相关,多联证患者肾病理相对重,且呈慢性、活动性病变的多样性表现。
③中药益肾养血方酌情配伍祛风除湿、活血祛瘀方治疗CKD3期肾虚证及其兼挟证对改善症状、提升血色素、保护肾功能疗效显著,与西药ACEI联用效果更佳。
Objective To explore the characteristics of the syndrome of deficiency of Kidney-Qiand Yin (Blood) which can also be recognized as the syndrome of kidney, in patients with Chronic kidney disease-3stage(CKD-3stage). approach the relationship between the clinical manifestations and renal pathology with it, and observe the effect of the TCM treating patients with CKD-3stage.
Methods①To investigate the correlation between the score of the deficiency syndrome and the clinical and chemical index, by observing the distribution and the characteristics with the deficiency syndrome in the period of CKD3.
②To analyze the relationship between the score of the deficiency syndrome and renal pathology in CKD-3stage patients.
③To randomize187patients into three groups including TCM group.ACEl group and TCM integrated with ACEI group which being treated with TCM decoction,benazepril and combtination of two medcines respectively. Observe the changes in the syndrome scores and indices from the laboratory, after24weeks' treatment.
Results①95.15%of the patients with CKD-3stage have deficiency syndrome, meanwhile88.98%of the patients have the deficiency syndrome together with wind-dampness syndrome and/or blood stasis syndrome; the patients with deficiency syndrome have a higher level in the24h proteinuria. serum creatinine. and oppositely a lower level in eGFR compared with the patients in non-deficiency syndrome. The patients with multiple syndrome have a higher level in24hour urine quantitative protein. serum creatinine than the patients in isolated deficiency syndrome. Conversely, they exhibited a lower level in eGFR and plasma albumin, compared with the isolated decifiency patients.
②The patients who have seriously deficiency syndrome have higher score in pathological total score (katafuchi score), Glomerular sclerosis score(Andreoli score) and cellular crescentic's score. The patients who have two or three syndromes have higher score in many aspects, including activity index total scores Interstitial inflammatory cell score、chronicity index totalscore and fiber crescentic score (Andreoli score) than the isolated deficiency patients.
③All of the three groups make benefit to the syndrome total score, but TCM group and the combination of TCM and ACEI is superior to ACEI group;the amount of urinary protein in the the combination of TCM and ACEI decreased obviously than before;the eGFR level of the TCM group and the combination of TCM and ACEI group rise obviously after the treatment;Similarly, hemoglobin is improved in the TCM group.the results all have statistically significant.
Conclusion①Deficiency syndrome is the main syndrome in the CKD-3stage, it always exists with blood stasis or/and wind-dampness syndrome. the severity of deficiency syndrome and the combination of syndromes are closely related to urinary protein excretion and renal function.
②The severity of deficiency syndrome is related to the chronicity index of the renal pathology, and proves more varieties of manifestations in chronic and acute disease.
③Traditional Chinese medicine is proven to have an excellent curative effect in lightening the symptoms of the deficiency syndrome and protecting renal function. and if it is used in combination with ACEI, a much better efficacy can be achieved.
方法①收集观察411例CKD3期肾虚证患者的证候分布规律和特点,并进一步分析肾虚证证候积分与临床、理化指标间的相关性;
②分析具有完善肾病理资料的97例CKD3期肾虚证患者证候积分与肾病理小球、小管间质、血管及与活动、慢性病变积分的相关性;
③CKD3期肾虚证患者随机分三组,分别给予中药(益肾养血方为基础的组方)、西药(ACEI)及中西药治疗24周,共完成治疗187例,观察三组患者的证候和实验室指标的改变情况。
结果①95.13%CKD3期患者存存肾虚证,88.98%的肾虚证与风湿证、肾络瘀痹证呈二、三联合并存在;肾虚证患者24小时尿蛋白定量、血肌酐水平较非肾虚证患者高,eGFR较非虚证患者低；多联证患者24小时尿蛋白定量、血肌酐水平较单纯肾虚证患者高,eGFR、血浆白蛋白较单纯肾虚证患者低。
②肾虚证重度患者肾病理katafuchi评分总积分高于轻证患者、Andreoli评分硬化小球评分高于轻组患者、Andreoli评分细胞新月体的积分高于轻、中度组患者；二联证(肾虚+瘀痹)、三联证(肾虚+瘀痹+风湿)Andreoli评分的活动性指数总积分及间质炎细胞积分明显高于单纯肾虚证患者：三联证的活动性指数总积分尚高于二联证(肾虚+风湿);三联证(肾虚+瘀痹+风湿)的Andreoli评分慢性化指数总积分和纤维新月体的积分均明显高于单纯肾虚证组,二联证(肾虚+瘀痹)的纤维化积分高于单纯肾虚证组。
③中药、西药、中西药三组治疗均能改善CKD3期患者证候总积分,但中药组和中西药组优于西药组,其中中西药组疗效更明显；治疗前后比较中西药组尿蛋白量下降明显,中药组、中西药组治疗后eGFR水平上升,尤其中药组差异更明显,中药组治疗后血红蛋白较前上升,上述结果均存在统计学差异。
结论①肾虚证是CKD3期最主要证候,并多与风湿证、肾络瘀痹证呈二、三联存在,肾虚证的严重程度和多联证的存在与尿蛋白定量及肾功能密切相关。
②肾虚证的严重程度与肾病理慢性化指数相关,多联证患者肾病理相对重,且呈慢性、活动性病变的多样性表现。
③中药益肾养血方酌情配伍祛风除湿、活血祛瘀方治疗CKD3期肾虚证及其兼挟证对改善症状、提升血色素、保护肾功能疗效显著,与西药ACEI联用效果更佳。
Objective To explore the characteristics of the syndrome of deficiency of Kidney-Qiand Yin (Blood) which can also be recognized as the syndrome of kidney, in patients with Chronic kidney disease-3stage(CKD-3stage). approach the relationship between the clinical manifestations and renal pathology with it, and observe the effect of the TCM treating patients with CKD-3stage.
Methods①To investigate the correlation between the score of the deficiency syndrome and the clinical and chemical index, by observing the distribution and the characteristics with the deficiency syndrome in the period of CKD3.
②To analyze the relationship between the score of the deficiency syndrome and renal pathology in CKD-3stage patients.
③To randomize187patients into three groups including TCM group.ACEl group and TCM integrated with ACEI group which being treated with TCM decoction,benazepril and combtination of two medcines respectively. Observe the changes in the syndrome scores and indices from the laboratory, after24weeks' treatment.
Results①95.15%of the patients with CKD-3stage have deficiency syndrome, meanwhile88.98%of the patients have the deficiency syndrome together with wind-dampness syndrome and/or blood stasis syndrome; the patients with deficiency syndrome have a higher level in the24h proteinuria. serum creatinine. and oppositely a lower level in eGFR compared with the patients in non-deficiency syndrome. The patients with multiple syndrome have a higher level in24hour urine quantitative protein. serum creatinine than the patients in isolated deficiency syndrome. Conversely, they exhibited a lower level in eGFR and plasma albumin, compared with the isolated decifiency patients.
②The patients who have seriously deficiency syndrome have higher score in pathological total score (katafuchi score), Glomerular sclerosis score(Andreoli score) and cellular crescentic's score. The patients who have two or three syndromes have higher score in many aspects, including activity index total scores Interstitial inflammatory cell score、chronicity index totalscore and fiber crescentic score (Andreoli score) than the isolated deficiency patients.
③All of the three groups make benefit to the syndrome total score, but TCM group and the combination of TCM and ACEI is superior to ACEI group;the amount of urinary protein in the the combination of TCM and ACEI decreased obviously than before;the eGFR level of the TCM group and the combination of TCM and ACEI group rise obviously after the treatment;Similarly, hemoglobin is improved in the TCM group.the results all have statistically significant.
Conclusion①Deficiency syndrome is the main syndrome in the CKD-3stage, it always exists with blood stasis or/and wind-dampness syndrome. the severity of deficiency syndrome and the combination of syndromes are closely related to urinary protein excretion and renal function.
②The severity of deficiency syndrome is related to the chronicity index of the renal pathology, and proves more varieties of manifestations in chronic and acute disease.
③Traditional Chinese medicine is proven to have an excellent curative effect in lightening the symptoms of the deficiency syndrome and protecting renal function. and if it is used in combination with ACEI, a much better efficacy can be achieved.
引文
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