| Observation of Ke Luo Xin Capsule in the treatment of diabetic nephropathy Ⅲ、 Ⅳ in patients with clinical efficacy and safety, and the possible role of machine production.Method:1. Consistent with diabetic nephropathy into standard60patients,randomly divided into Ke Luo Xin group30cases and control group30cases.2. The control group was given the low salt diet quality protein, protein quantification for every0.6-0.8g/kg, every day not more than40g, while giving the hypoglycemic, reducing proteinuria (ACEI or ARB drug) treatment, such as hypertension and electrolyte disorders and other complications, were given symptomatic treatment. Ke Luo Xin group was added with Ke Luo Xin Capsule (4,3/day), taking the time to8weeks.3. Detection of targets:Glycated haemoglobin, Quantitate of24hour urine protein, Urine albumin/Creatinine, creatinine, Glomerular filtration rate, Serum cystatin C, Urine beta2microglobulin, High Sensitivity C reactive protein, Angiotensin Ⅱ, Advanced glycation end products.Results:1. The total effective rate in Ke Luo Xin group68%, The control group always businesslike for50%, Ke Luo Xin group was superior to control group,P<0.05.2. In traditional Chinese medicine symptom integral, Ke Luo Xin group after treatment (22.36±1.89VS10.24±5.58, P<0.001), the difference was statistically significant; the control group after treatment (23.62±1.86VS13.34±5.87, P<0.001), the difference was statistically significant; two groups after the treatment contrast (10.24±5.58VS13.34±5.87, P <0.05), the difference was statistically significant.3. Two groups of patients after treatment in traditional Chinese medicine syndromes have different degrees of improvement. Improvement of fatigue, Palpitation and short of breath. Yaoxisuanruan, thirsty and like drinking symptoms in Ke Luo Xin group are better than the control group (P<0.05), other symptoms in contrast, no significant difference (P>0.05).4. In glycosylated hemoglobin, Ke Luo Xin group and the control group before and after treatment with contrast (8.992±2.261VS6.692±1.308, P<0.05;9.239±2.502VS7.762±1.877, P<0.05), the difference was statistically significant,between two groups after the treatment contrast (6.692±1.308VS7.762±1.877, P<0.05), differences there are stil statistically significant. 5. In24hour urine protein, Ke Luo Xin group and the control group before and after treatment with contrast (2.396±1.721VS1.071±0.764, P<0.05;2.002±1.463VS1.684±1.244, P<0.05), the differences were statistically significant, the two groups after treatment compared to (1.071±0.764VS1.684±1.244, P<0.05) similarly, difference has statistical significance. Urinary albumin/creatinine in aspect, Ke Luo Xin group and the control group before and after treatment with contrast (323.23±254.55VS127.52±108.09, P<0.05;305.81±254.47VS240.10±221.30, P<0.05), the differences were statistically significant, between two groups after the treatment contrast (127.52±108.09VS240.10±221.30, P<0.05), the differences are statistically significant.6. The creatinine, Ke Luo Xin group was compared before and after treatment with contrast (107.56±45.36VS107.56±48.62, P>0.05), the difference was not statistically significant; the control group before and after treatment with contrast (112.54±42.88VS146.08±72.33, P<0.05), the difference was statistically significant,after treatment in group two contrast (107.56±48.62VS146.08±72.33, P<0.05), the difference was statistically significant;In glomerular filtration rate, Ke Luo Xin group before and after contrast (61.70±35.34VS57.96±27.46, P>0.05), the difference was not statistically significant, the control group before and after treatment with contrast (63.86±30.68VS53.67±32.27, P<0.05), the difference was statistically significant, in two groups after the treatment compared (57.96±27.46VS53.67±32.27, P>0.05), the difference was not statistically significant.7. In the serum cystatin C, Ke Luo Xin group and control group before and after treatment with contrast (2.179±1.206VS1.398±0.837, P<0.05;2.105±1.315VS1.512±0.749, P<0.05), with significant differences, between two groups after the treatment compared (1.398±0.837VS1.512±0.749, P>0.05), the difference was not statistically significant;In urine beta2micro globulin Ke Luo Xin group and control group before and after treatment with contrast (2.581±3.449VS1.332±2.124, P<0.05;2.867±3.251VS1.814±0.366, P<0.05), with significant differences, between two groups after the treatment, compared (1.332±2.124VS1.814±0.366, P>0.05), the difference was not statistically significant.8. In high sensitive C reactive protein, Ke Luo Xin group and the control group before and after treatment with contrast (5.156±4.401VS3.041±2.511, P<0.05;6.183±3.782VS4.027±2.408, P<0.05), with significant differences, between two groups after the treatment compared (3.041±2.511VS4.027±2.408, P>0.05), the difference was not statistically significant;In angiotensin Ⅱ, Ke Luo Xin group and control group after treatment (104.527±23.915 VS92.686±14.124, P<0.05;105.782±20.904VS93.781±17.160, P<0.05), with significant differences, between two groups after the treatment compared (92.686±14.124VS93.781±17.160, P>0.05), no statistically significant difference.In advanced glycation end products, Ke Luo Xin group and control group before and after treatment with contrast (356.493±58.488VS291.022±62.239, P<0.05;368.612±84.224VS330.844±73.150, P<0.05), the differences were statistically significant; two groups after the treatment contrast (291.022±62.239VS330.844±73.150, P<0.05), there are still significant differences;9. The experiment included51patients, medication in patients with25cases, including1cases of taking Ke Luo Xin capsules during diarrhea symptoms improved after treatment, disabled, again after the occurrence of diarrhea. Exit test after discontinuing the medication, the symptoms improved, no significant adverse reactions, such as abnormal liver function, renal function, cardiac arrest and death exacerbated.Conclusion:1. Ke Luo Xin Capsule by supplementing qi and nourishing Yin, activating blood circulation to dissipate blood stasis, improve patient fatigue, Palpitation and short of breath,Yaoxisuanruan, thirsty and like drinking and other symptoms.2. Ke Luo Xin Capsule can reduce glycated hemoglobin,24hours to reduce urinary protein and urinary protein/creatinine excretion.3. Ke Luo Xin Capsule on glycosylated hemoglobin and advanced glycation end products to reduce, prompting Ke Luo Xin capsule may by reducing blood glucose, as well as the reduction of advanced glycation end products (AGES), to reduce urinary protein and urinary protein/creatinine excretion function. |
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