Therapeutic Effectiveness Evaluation Study On Chinese Medical Diagnosis And Treatment Scheme For Chronic Renal Failure (Non-dialysis)

BackgrooundTraditional Chinese Medicine (TCM) have good therapeutic effectiveness and unique advantages of prevention and treatment of Chronic Renal Failure (CRF), such as easing the symptoms, improving the quality of life (QOL), protecting residual renal function, slowing progress in early and medium stage, deferring to dialysis or renal transplantation.As the national first-rank key specialty of TCM and leading units of key disease entity study on CRF treatment scheme of State Chinese Medicine Administration Bureau in the Eleventh Five-year Plan Period, Nephropathy Key Specialty of Guangdong Provincail Hospital of TCM leaded 30 domestic hospitals to comb and summarize their current diagnosis and treatment scheme on CRF (Non-dialysis), and form a optimization scheme of diagnosis and treatment on CRF (Non-dialysis), with the characteristic and advantages of TCM.ObjectiveProspective and large samples clinic trial was used in our study to primarily evaluate the therapeutic efficiency of Chinese medical diagnosis and treatment scheme on CRF (Non-dialysis), in terms of symptoms, renal function, complications, quality of life (QOL), etc. The study will provide the foundation and evidence for the further multicenter clinic trial and popularization and application of the scheme. MethodsOne hundred and forty patients who were eligible for the inclusion criteria were enrolled in this prospective study. Two months was one period of treatment, and all patients were treated by Chinese Medical Diagnosis and Treatment Scheme on CRF(Non-dialysis) for 3 periods. The therapeutic effects were compared before and after treatment with the changes of symptom scores, serum creatinine (SCr), blood urea nitrogen (BUN), uric acid (UA), albumin (Alb), hemoglobin (Hb), serum total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), fibrinogen (Fib), serum calcium (Ca) and phosphorus (P). Therapeutic effectiveness evaluation criteria of renal function was decided by glomerular filtration rate (GFR), as the main index of effectiveness evaluation, estimated with CKD-EPI formula.Kidney Disease Quality of Life Short Form, Version 1.3 (KDQOL-SFTM1.3) questionnaire was translated and modified, and then used in the patients with CRF (Non-dialysis) to test the reliability and validity and evaluate the quality of life (QOL).Result①The TCM pathogenesis of CRF was attributive to primary deficiency and secondary excess. With respect to the primary deficiency syndrome, spleen and kidney Qi deficiency (SKQD) was the most common type, accounted for 52.90% of all the types; followed by both Qi and Yin deficiency (QYD) (18.84%), spleen and kidney Yang deficiency (SKYD) (13.77%), both Yin and Yang deficiency (YYD) (7.25%), liver and kidney Yin deficiency (LKYD) (7.25%). The secondary excess syndrome mostly emerged in form of several syndrome associatively, accounted for 55.80% of all the types. Blood stasis syndrome (BSS) and its accompanied syndromes were dominant in all excess syndrome types, accounted for 73.19%, followed by dampness heat syndrome (DHS) and its accompanied syndromes (37.68%). Age and stage of CKD had siginificant effect on the deficiency syndrome distribution, Stage of CKD had also siginificant effect on the excess syndrome distribution.②Chinese medical diagnosis and treatment scheme for CRF (Non-dialysis) could relieve clinical symptom of patients with CRF (Non-dialysis).The order of reduction rates of symptom scores was tiredness and inertia (38.60%), defecation (31.70%), abdominal distention (31.40%), aversion to cold and cold extremities (30.90%), edema (29.10%), ache of waist andknee (28.20%), nausea (26.90%), dizziness (23.40%), anorexia (23.30%), vomiting (21.40%), frequent Night urination (10.60%), from high to low. The total effective rate of improvement in clinical symptoms was 85.51%. The clinical symptom scores reduced markedly in different gender, each age phases, each primary diseases, stagesⅢ～Ⅴof CKD and each TCM syndrome types after treatment (P<0.05).In terms of the effective rate of improvement in clinical symptoms, SKQD was superior to YYD and SKYD, the single secondary excess syndrome was superior to the accompanied secondary excess syndrome, and DHS and dampness heat accompanied by blood stasis (DHABS) was superior to turbidity toxin accompanied by blood stasis (TTABS) (P<0.05).③The scheme could noticeably raise eGFR, and reduce SCr, UA in CRF patients (Non-dialysis). According to the criteria for evaluating therapeutic effect of kidney function with GFR droping less than 2 ml/(min·1.73m2) per year, the total effective rate of improvement in kidney function by the scheme was 76.92%. There were significant increases of eGFR in male and female, patients under 65 years old, chronic glomerulonephritis, stagesⅢandⅣof CKD, QYD, LKYD, DHS, BSS after treatment (P<0.05).In terms of the effective rate of improvement in kidney function, female was markedly higher than male, patients less 45 years old than patients over 65 years old, chronic glomerulonephritis (CGN) than diabetic nephropathy (DN), patients in stage III of CKD than stage V of CKD, SKQD than YYD and SKYD, QYD than SKYD, the single secondary excess syndrome than the accompanied secondary excess syndrome, DHS than TTABS (P<0.05).④The scheme could significantly raise ALB and Hb in CRF patients (Non-dialysis) after treatment (P<0.05), especially in male, patients under 45 years old, chronic glomerulonephritis (CGN), SKQD, DHABS and TTABS, with overall improvement of the nutritional status both in Hb and ALB.⑤The scheme could obviously reduce TC and LDL in CRF patients (Non-dialysis) after treatment (P<0.05), especially in patients of CGN, SKQD and DHABS, with better adjustment of the hyperlipidemia both in LDL and TC.⑥The scheme could significantly drop Fib level after treatment in CRF patients (Non-dialysis) of different gender, over 45 years old, each primary diseases, stagesⅢ～Ⅴof CKD, SKQD, SKYD, QYD, DHABS, DHABS and TTABS (P <0.05).⑦The scheme could distinctly decrease serum P and increase serum Ca in CRF patients (Non-dialysis) after treatment (P<0.05), especially in patients under 65 years old, SKQD, with overall improvement of calcium- phosphorus metabolic disorder. Serum P can lower in stagesⅢ～Ⅴof CKD mainly, while serum Ca can rise in stages V of CKD.⑧The translated and modified KDQOL-SFTM1.3 showed good reliability and validity. Cronbach's alpha coefficient of full scale was 0.954, spilit reliability was 0.899; Each item in the scale had significant correlation with its belonged dimension (P<0.05), and the correlation coefficient of 70 items were over 0.5, account for 88.61 percentage of all 79 items (70/79). Eleven common factors were extracted from KDTA scale through exploratory principal component analysis and explaining 72.73% variance. The structure of the scale after varimax rotation was similar to the theory construction.⑨The single factor analysis showed that the factors influencing the overall quality of life (QOL) in CRF patients (Non-dialysis) involved gender, age, primary diseases, stages of CKD, syndrome of TCM (primary deficiency syndrome and secondary excess syndrome), educational level, working condition, medical payment and so on. The multiple regressive analysis revealed that the factors influencing the QOL of Physical Component Summary (PCS) of SF-36 scale included symptom scores, Hb, stages of CKD, gender; the factors influencing the QOL of Mental Component Summary (MCS) of SF-36 scale included symptom scores, medical payment; the factors influencing the QOL of Kidney Disease Targeted Areas (KDTA) included eGFR, working condition, educational level, Hb.⑩The scheme could significantly improve quality of life (QOL) of CRF patients (Non-dialysis) (P<0.05), which might not completely depend on the improvement of renal function; Some patients with poor improvement in kidney function could also have improvement in clinical symptoms and enhancement in QOL through the treatment based on syndrome differentiation and overall adjustment of TCM. The QOL of patients in different gender, age phases, primary diseases, stagesⅢ～Ⅴof CKD, SKQD, QYD, each of the secondary excess syndromes (excepting TTABS) could have overall improvement in PCS and MCS of SF-36 scale as well as in KDTA scale (P<0.05). ConclusionChinese medical diagnosis and treatment scheme for CRF (Non-dialysis) could effectively relieve the clinical symptoms; protect residual renal function with postponing the CRF rapid process; improve the nutritional status, the metabolism of lipid and calcium-phosphorus, and the hypercoagulant state, thus decreasing the occurance and development of some complications; but safely and without severe side-effects. The scheme could also improve the QOL all sidedly, involving PCS and MCS of SF-36 scale as well as KDTA scale. The translated and modified KDQOL-SFTM1.3 showed good reliability and validity in individuals with CRF (Non-dialysis), as a result, it could be used to evaluate the quality of life in domestic CRF (Non-dialysis) patients initially.