ObjectiveTo observe and analyse the effects of Qingli Tongbi Decoction on the clinical manifestations and auxiliary test results of patients with chronic uric acid nephropathy with internal stasis of dampness and heat,so as to evaluate its clinical efficacy and safety,in an effort to provide clinical evidences for the TCM treatment of this disorder.MethodsSeventy-two patients with chronic uric acid nephropathy with internal stasis of dampness and heat meeting the inclusion criteria were randomly assigned to the treatment or control group each including 36 patients.The control group received conventional Western medicine treatment,in addition to which the treatment group received Qingli Tongbi Decoction;both groups were observed continuously for 12 weeks.The TCM symptoms scores,vital signs,urinalysis,24-hour urine protein,?2-microglobulin,renal function,as well as routine blood tests,routine stool tests,hepatic function,ECG,and urinary ultrasoundB,etc.,were recorded pre-treatment and post-treatment for statistical analysis to evaluate the clinical efficacy and safety of Qingli Tongbi Decoction.Results(1)Before treatment,there were no statistically significant differences between the two groups in age,disease duration,sex,TCM symptoms scores,routine blood tests,urine occult blood,urine protein,24-hour urine protein,renal function,or ?2-microglobulin,etc.(P>0.05).(2)The total effective rate was 93.55% in the treatment group and 78.13% in the control group,with difference statistically significant at the 0.01 level between the two groups.(P<0.01).In the treatment group,there were improvements in the laboratory indicators including uric acid,blood urea nitrogen,etc.,from pre-treatment to post-treatment,with statistically significant differences.(P<0.05).In the treatment group,there were improvements in the laboratory indicators including urine occult blood,urine protein,24-hour urine protein,serum creatinine,and ?2-microglobulin,etc.,from pre-treatment to posttreatment,with difference statistically significant at the 0.01 level.(P<0.01).Compared to the control group,there were greater post-treatment improvements in the laboratory indicators including urine protein,24-hour urine protein,and serum creatinine,etc.,in the treatment group,with statistically significant differences.(P<0.05).Compared to the control group,there were greater post-treatment improvements in the laboratory indicators including urine occult blood,uric acid,blood urea nitrogen,and ?2-microglobulin,etc.,in the treatment group,with difference statistically significant at the 0.01 level.(P<0.01).(3)The total curative effect of syndrome score of TCM was 83.87% in the treatment group and 68.75% in the control group,with statistically significant difference between the two groups.(P<0.05).In the treatment group,there were improvements in TCM symptoms scores such as swollen face or lower limbs,sore throat,burning or astringent pain in urine,sticky stool,and constipation,etc.,from pre-treatment to post-treatment,with statistically significant differences.(P<0.05).In the treatment group,there were improvements in TCM symptoms scores such as heavy limbs,joint swelling,joint pain,skin furuncle and swelling,or skin sores and ulcers,etc.,from pre-treatment to post-treatment,with difference statistically significant at the 0.01 level.(P<0.01).Compared to the control group,there were greater post-treatment improvements in TCM symptoms scores such as joint swelling,fecal viscosity and constipation,etc.,in the treatment group,with statistically significant differences.(P<0.05).Compared to the control group,there were greater post-treatment improvements in TCM symptoms scores such as heavy limbs and sore throat,in the treatment group,with difference statistically significant at the 0.01 level.(P<0.01).(4)No adverse reactions were reported in either group.There were no statistically significant intra-group or inter-group differences in vital signs,routine blood tests,hepatic function pre-treatment and post-treatment in either group.(P>0.05).ConclusionFor patients with chronic uric acid nephropathy with internal stasis of dampness and heat,Qingli Tongbi Decoction can effectively alleviate the symptoms,reduce the urine protein,and improve the renal function as well as the laboratory indicators including ?2-microglobulin;its combined used with conventional Western medicine treatment provided additional efficacy,with good safety and reliability,supporting its further clinical application. |