| Objective: In this study,a prospective randomized controlled trial was conducted to observe the Clincal effect of Yindan Zishen Fang on the treatment of blood-heat bleeding in children with Henoch-Schonlein purpura nephritis of hematuria type.The purpose of this study is to make clear its therapeutic effect and to make sufficient preparations for its popularization in clinical practice.Method: From February to December 2018,120 cases were collected from children diagnosed as HSPN(hematuria type-blood-heat bleeding)in outpatient department or in-patient ward of traditional Chinese medicine hospital in Shanxi province,which met the standard of traditional Chinese medicine and western medicine.According to the principle of randomized control,120 cases were divided into control group(n=60)and treatment group(n=60)(Yindan Zishen Fang group).The two groups were given general treatment.The treatment group were treated with Yindan Zishen Fang and The control group were treated with hematuria capsule on the basis of general treatment.At the end of the 12 th week,the changes of TCM syndrome scores and the indexes of curative effect between the two groups were compared.The indexes of curative effect in this clinical study were urine sediment red blood cell count and urine 24 hour protein quantity and safety index was blood routine and stool routine,liver and kidney function,Renal color Doppler ultrasound,electrocardiogram and so on.Results:(1)there was no significant difference between the two groups in weight,age,sex and other Demographic data,Observation index and TCM syndrome scores before treatment and the data were analyzed by statistical data software(p>0.05).(2)The count of urinary red blood cell of Yindan Zishen Fang group and control group was analyzed by data software before and after treatment and the difference was statistically significant(p<0.05),indicating that Urinary red blood cell count in both groups was significantly lower than that before treatment.After treatment,it is superior to pre-treatment.The difference of the count of urinary red blood cell between the two groups at the end of 12 weeks was statistically significant(p<0.05),which indicated that Yindan Zishen Fang had a stronger effect on reducing the count of urinary red blood cell than that in the control group.(3)the urine 24-hour protein quantity of the treatment group after 12 weeks of treatment was compared with that before treatment by the data software.The data software analysis showed that the difference was statistically significant(p<0.05),indicating that Yindan Zishen Fang group was effective for the treatment of urine 24-hour protein quantity.the urine 24-hour protein quantity of the control group after 12 weeks of treatment was compared with that before treatment by the data software.The data software analysis showed that the difference was no statistically significant(p>0.05).(4)After 12 weeks of treatment,an effective rate comparison in Clinical effect between the two groups shows that Yindan Zishen Fang group was 94.7% and the control group was 71.9%.The statistical software analysis showed that the difference was statistically significant(p<0.05).It can be considered that the total effective rate between the two groups is different,and Yindan Zishen Fang group is higher than the control group.(5)After 12 weeks of treatment,the scores in the treatment group were 7.67±2.393 before treatment and the scores were 1.23±1.982 after treatment.the scores in the control group were 6.86±2.216 and the scores were 2.07±2.404 after treatment.the statistical software analysis showed that the difference is statistically significant(p<0.05).It is believed that the total scores of TCM syndrome can be decreased in both Yindan Zishen Fang group and the control group,and the total scores of TCM syndrome after treatment is better than that before treatment.At the end of the 12 th week,compared with the control group,the total integral of TCM syndrome in Yindan Zishen Fang group was analyzed by data software and the difference was statistically significant(p<0.05).The results showed that Yindan Zishen Fang group had advantage over control group in lowering TCM syndrome scores.(6)After 12 weeks of treatment,an effective rate comparison in TCM syndromes between the two groups shows that Yindan Zishen Fang group was 93.0% and the control group was78.9%.The statistical software analysis showed that the difference was statistically significant(p<0.05).It can be concluded that the total effective rate of TCM syndromes between the two groups is different,and the treatment group is higher than the control group.It shows that Yindan Zishen Fang group has advantages over the control group in improving TCM syndrome.Conclusions:1.Yindan Zishen Fang can reduce the count of urine red blood cells,and it is superior to hematuria capsule in children with Henoch-Schonlein purpura nephritis(hematuria type-blood-heat bleeding syndrome).2.Yindan Zishen Fang can reduce the amount of 24-hour protein in urine.3.Yindan Zishen Fang obviously improve the clinical syndrome of TCM in children with Henoch-Schonlein purpura nephritis(Hematuria type),which belongs to the syndrome of blood-heat bleeding,and Yindan Zishen Fang Fang is superior to hematuria capsule in improving the TCM syndrome of Henoch-Schonlein purpura nephritis. |
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