| Objective:This study through the use of reinforcing kidney and spleen recipe and Losartan in the treatment of stage CKD4 spleen and kidney Qi deficiency and blood stasis in patients with turbid damp, to observe its efficacy and safety, to provide clinical evidence for the treatment of stage CKD4. Methods:This study used a double-blind, randomized controlled trial, in 2012 November to 2013 December were selected from the Department of nephropathy of Hubei Provincial Traditional Chinese Medical Hospital outpatient or hospitalization of 31 patients, divided into treatment group and control group, patients in CKD4 stage were in line with spleen and kidney qi dampness stasis diagnosis. The control group: Losartan plus traditional Chinese medicine granule placebo plus basic treatment of Western medicine, specifically as follows: the spleen and kidney qi deficiency, dampness stasis to losartan 100 mg, once a day, invigorating the spleen and tonifying the kidney side placebo every 1 bag, three times a day, with warm water after oral administration of 150 ml melt and damp heat syndrome; when: with the hot side placebo every 1 bags on the basis of the above, three times a day, with warm water after oral administration of 150 ml. Drug treatment group: placebo plus losartan Granule plus Western medicine foundation treatment, specifically as follows: the spleen and kidney qi deficiency, dampness stasis placebo to losartan 100 mg, once a day, each time the spleen and kidney 1 bag, three times a day, with warm water after oral administration of 150 ml melt and damp heat syndrome; when added: heat 1 party each pouch on the basis of the above, three times a day, with warm water after oral administration of 150 ml. Two groups of observation period is one year. Two groups were observed before and after treatment of clinical symptoms, signs and glomerular filtration rate, end event rate and serum creatinine, blood urea nitrogen, urinary protein / creatinine ratio, blood lipid(TG, TC, HDL, LDL) and other laboratory indexes, blood routine, urine routine, stool routine, liver function and so on as the safety index. This study is a multi-center clinical trial, this center included a total of 31 cases, among them, 1 cases of loss, because the research has not yet entered the unblind stage, so the overall effect on the center of 30 cases were analyzed. Results:1.The main symptoms of third months, sixth months, Ninth months,twelfth months and zeroth months of TCM integral comparison, results showed that there were statistically significant differences between the reduced integration(P<0.05); The main symptoms of Chinese medicine of other months in comparison, there were no significant differences(P>0.05).2.Urinary protein / creatinine ratio comparison before and after treatment : third months, sixth months, Ninth months and twelfth months of urinary protein / creatinine ratio compared with before treatment, the difference was not statistically significant(P>0.05).3. Comparative analysis of serum creatinine and blood urea nitrogen: a comparison between third and sixth months, Ninth months and twelfth months, the serum creatinine, the differences were statistically significant(P<0.05); compared with other months serum creatinine, differences were not statistically significant(P>0.05). Comparison of zeroth month and twelfth month, Ninth months and twelfth months of blood urea nitrogen, the differences were statistically significant(P<0.05); compared with other months of blood urea nitrogen, there were no significant differences(P>0.05).4. In the course of the study, the event was 8 cases, the incidence rate was 26.67%.5.Comparison of glomerular filtration rate: in addition to the ninth and twelfth months were statistically significant difference(e GFR P<0.05), the rest of the e GFR, there were no significant differences.6 In the aspect of the main symptoms of traditional Chinese medicine in total curative effect, 0 cases were cured, 4 cases markedly effective, effective 16 cases, invalid 10 cases, the main symptoms of traditional Chinese medicine curative effect the total effective rate was 66.67%.7. On the clinical efficacy, the total effective rate was 36.67%, of which 4 cases were cured, effective in 2 cases, 5 cases, and invalid in 19 cases.8. In the aspect of safety, adverse events occurred 29 times, including mild adverse events 19 times, 4 times of moderate adverse events, serious adverse events 6 times. Conclusion:This study confirmed that the spleen and kidney invigorating recipe and losartan can make 66.67% phase CKD4 spleen kidney qi deficiency and blood stasis of dampness and turbid in patients with clinical symptoms alleviated, 36.67% patients with renal function and related laboratory indicators improved; but it happened 26 times in hyperkalemia, were relieved by symptomatic treatment. |
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