| Objective: Through the clinical study of Yishen Tonglin Xiaoshi Recipe in the treatment of urinary calculi(kidney deficiency damp-heat type),its clinical efficacy and safety were discussed,thereby opening up a new way for traditional Chinese medicine to treat urinary calculi.Methods: In this study,66 patients who met the inclusion criteria were divided into the experimental group and the control group by random number table method,with 33 cases in each group.The control group was treated with Paishi Granules orally,and the experimental group was treated with Yishen Tonglin Xiaoshi Decoction orally,and the observation time was 4 weeks.The clinical comprehensive efficacy,traditional Chinese medicine syndrome score,stone expulsion rate,stone size,pain score,laboratory indicators(urinary red blood cells,urinary white blood cells)and safety indicators were observed and compared before and after treatment in the two groups of patients,so as to preliminarily explore its efficacy and safety.Results: A total of 66 patients were included in this trial.During the research process,2 patients were excluded from the control group,and 1patient was excluded from the experimental group.The actual control group completed a total of 31 investigators,and the experimental group completed a total of 32 investigators.The results before and after treatment were compared.The following conclusions:(1)The total effective rate of the experimental group was 81.25%;the total effective rate of the control group was 54.84%.The difference between the two groups was statistically significant(P<0.05);(2)The total effective rate of traditional Chinese medicine syndromes in the experimental group was 84.38%,and the total effective rate of traditional Chinese medicine syndromes in the control group was 61.29%,with significant statistical significance compared between the two groups(P<0.01);(3)The stone expulsion rate in the experimental group was 40.63%;the stone expulsion rate in the control group was 16.13%,and the difference was statistically significant(P<0.05);the maximum stone diameters of both groups were reduced compared with those before treatment,the difference was statistically significant(P<0.01);compared between groups,the reduction of the maximum diameter of stones in the experimental group was better than that in the control group,and the difference was statistically significant(P<0.05);(4)After treatment Compared with those before the test,there were significant statistical differences in white blood cells(P<0.01);compared between the groups,the levels of urinary red blood cells and white blood cells in the test group were significantly higher than those in the control group(P<0.05);(5)The two groups of patients There were significant differences in pain scores before and after treatment(P<0.01);there was no significant difference between the groups after treatment(P>0.05);(6)Safety evaluation: the blood routine,electrocardiogram,etc.of the two groups were significantly different from those before treatment.There was no obvious abnormality in comparison;there was no significant difference in liver function(ALT,AST)and renal function(Scr,BUN)before and after treatment(P>0.05).During the test,1 patient in the control group developed mild diarrhea,and the symptoms disappeared after oral administration of berberine,and the remaining patients did not have obvious adverse reactions.Conclusion: Yishen Tonglin Xiaoshi Recipe can promote the excretion of urinary calculi,relieve the clinical symptoms of traditional Chinese medicine in patients with kidney deficiency and damp-heat type,and improve the hematuria and inflammation of the urinary system.It is safe and worthy of promotion. |