| ObjectiveEvaluating the clinical efficacy and safety of Xiaoshi Tonglin Decoction by observing the changes of maximum stone diameter,TCM syndrome score,NRS score,urine RBC and other indicators of kidney stones of damp-heat mixed stasis treated by Xiaoshi Tonglin Decoction before and after treatment.Method58 outpatients with kidney stones of damp-heat mixed stasis in the nephrology department of Fuzhou hospital of traditional Chinese medicine from May 2020 to January2021 were collected.After signing the informed consent,they were randomly divided into test group and control group.The control group was treat-ed with Paishi granule(z20044192,Jiangxi Nanchang Jisheng pharmaceutical factory),and the test group was treated with Xiaoshi Tonglin Decoction.The period of treatment was thirty days.Observed and collected the changes of clinical symptoms and related indicators of the two groups.SPSS 23.0software was used to analyze and process all the collected data.Result1.58 outpatients were took part in this study.4 patients dropped out(2 in test group and 2in control group).1 outpatients in test group asked for western medicine surgical treatment to be excluded.Therefore,the number of effective cases in this study was 26 and 27 respectively.2.The sex and age of the two groups were no difference on statistics(P=0.630,0.431>0.05).Two groups were not statistically significant in stone size,NRS score,urinary RBC and TCM syndrome score,before treatment(P=0.554,0.634,0.262,0.786>0.05).3.TCM syndrome score and the efficacy of TCM symptom: After treatment,there was statistical difference in TCM syndrome score between the two groups(P=0.005<0.05).Compared with before treatment,there were significant differences in TCM symptom scores between the two groups after treatment(P=0.000,0.000<0.05).The reason may be related to the small number of cases and stone diameter.After treatment,both two can improve the condition of TCM,but the test group is better than the control group.After treatment,the efficacy of TCM symptom in the test groups was 84.62% and in the control group was62.96%.There was statistical difference between the two groups(P=0.009<0.05).The test group was better than the control group.4.Total effective rates: After treatment,the total effective rates of the two groups were88.46% and 70.73% respectively.There was statistical difference between the two groups(P=0.027<0.05).5.Stone size: After treatment,there was no statistical difference in the maximum diameter of stones between the two groups(P=0.079>0.05).The difference in the diameter of stones between the two groups before and after treatment was statistically significant(P=0.010<0.05).There was statistical difference in the maximum diameter of stones between the test group before and after treatment(P=0.000<0.05),but there was no statistical difference in the maximum diameter of stones between the control group before and after treatment(P=0.075>0.05).6.NRS score: After treatment,there was no significant difference in NRS score between the two groups(P=0.122>0.05).There was significant difference in NRS score between the two groups before and after treatment(P=0.009<0.05),and there was significant difference in NRS score between the two groups before and after treatment(P=0.000,0.004<0.05).Both groups could effectively reduce NRS score,but the improvement effect of the test group was better than that of the control group.7.Urinary RBC: There was statistical difference between the two groups after treatment(P=0.034<0.05),but there was no statistical difference between the two groups after treatment(P=0.756>0.05).There were significant differences between the experimental group and the control group before and after treatment(P=0.000,0.000<0.05).The two groups can effectively improve the urine red blood cells,and the experimental group is better than the control group in improving the urine red blood cell index.8.Safety index: There were no obvious adverse reactions in the two groups during the treatment.The safety indexes demonstrated no evident differences before and after the treatment(ALT,AST,BUN,Scr).There was no statistical difference between the two groups before treatment and after treatment(P>0.05).Conclusion1.Xiaoshi Tonglin Decoction is more effective than Paishi granule in the treatment of kidney stones of damp-heat mixed stasis.2.Xiaoshi Tonglin Decoction can significantly improve the TCM syndrome score of kidney stones of damp-heat mixed stasis.It has a certain effect of dissolving and expelling stones.3.There is no obvious adverse reactions were found in the treatment of 30 days with Xiaoshi Tonglin Decoction. |
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