Description for medicine or protocol of treatment in detail:
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Research content and design scheme
This study used a prospective research method to observe the effect of Xiaodian Tongluo Recipe on the clinical efficacy and adverse reactions of HSP children.
Outpatients and inpatients aged 2 ~ 18 years old with recurrent HSP of non nephritic type with syndrome differentiation of blood heat syndrome in the pediatric ward of the First Affiliated Hospital and the Second Affiliated Hospital of Henan University of traditional Chinese medicine and Zhengzhou people's hospital were selected as the research objects. They were randomly divided into traditional Chinese Medicine group and Western medicine group. The traditional Chinese medicine group was treated with Xiaodian Tongluo formula, and the western medicine group was treated with loratadine + prednisone. The children in the two groups were treated for 4 weeks and followed up for 3 months, The efficacy of rash and the remission of systemic symptoms were evaluated every week, the adverse reactions were observed, the recurrence rate and the incidence of renal damage were counted, and the six index levels of hematuria routine, 24-hour urinary protein, liver and kidney function and immunity at 0 and 4 weeks were detected for statistical analysis.
Experimental methods and steps
(1) Subject recruitment and grouping
Using the screening method of outpatient and inpatient medical records, 60 HSP children with syndrome differentiation of wind heat injuring collaterals and blood heat reckless behavior were recruited. They were randomly divided into Xiaodian Tongluo group (30 cases) and Western medicine group (15 cases of light and 15 cases of heavy), registered the subject information, signed the informed consent and entered the clinical study.
(2) Clinical treatment of subjects
1) The treatment scheme of TCM group: Xiaodian Tongluo formula, which is composed of buffalo horn, Rehmannia glutinosa, red peony, peony bark, Arnebia, Scutellaria baicalensis, Forsythia suspensa, black plum, raw licorice and Tripterygium wilfordii. According to the scoring standard of rash, it was divided into light and heavy. Different doses of Tripterygium wilfordii granules were used for intervention. The total course of treatment was 4 weeks.
A. Mild: the rash score was 0 ~ 29. The intervention was carried out with Tripterygium wilfordii granule 0.3mg/kg ? D, and the maximum amount was no more than 50g;
B. Severe: rash score ≥ 30, intervention with Tripterygium wilfordii granule 0.5mg/kg ? D, the maximum amount shall not exceed 50g;
Tripterygium wilfordii formula granules: Jiangyin Tianjiang Pharmaceutical Co., Ltd., 0.5g per bag (equivalent to 10mg of traditional Chinese medicine decoction pieces), code 11081443. They were divided into light and heavy groups and treated with 0.3mg/kg and 0.5mg/kg respectively for a total course of 4 weeks.
2) Western medicine group: loratadine + vitamin C (or + prednisone), the course of treatment was 4 weeks.
A. Mild: rash score was 0 ~ 29, and loratadine + vitamin C was used for intervention;
B. Severe: rash score ≥ 30, with loratadine + vitamin C + prednisone acetate tablets for intervention
① Loratadine Tablets (kairuitan, specification: 10mg / tablet) × 6 tablets, Bayer pharmaceutical Shanghai Co., Ltd., gyzz h10970410). Usage and dosage: children over 12 years old, 10mg each time, once a day; Children aged 2 ~ 12 years old, weight > 30kg, 10mg each time, once a day; Weight ≤ 30kg, 5mg each time, once a day.
② Vitamin C tablets (specification: 100mg / tablet) × 100 tablets, South China Pharmaceutical Co., Ltd., gyzz h44020774). Usage and dosage: 100mg ~ 300mg / kg ? D.
③ Prednisone acetate tablets: Zhejiang Xianju Pharmaceutical Co., Ltd., 5mg per tablet, in line with GMP standard, national drug approval No. h33021207. The severe patients in the western medicine group (rash score 40 and above) were given prednisone tablets 1mg / kg / D orally, divided into three times, changed to take it in the morning after three days, reduced 5mg in two days until it was reduced and stopped, and the maximum amount was no more than 80mg.
(3) Collection of specimens
With the informed consent of the subjects, the routine blood and urine, 24-hour urinary protein, liver and kidney function and treatment of the enrolled children were collected
Six immune results were obtained after 0 and 4 weeks of treatment.
(4) Statistical analysis
Results spss23.0 software was used for statistical analysis. Counting data are expressed in frequency and percentage; The measurement data shall be expressed as mean ± standard deviation (x ± s); For counting data χ 2 test and Fisher exact probability statistics; When the measurement data conform to the normal distribution and homogeneity of variance, two independent sample t-test is selected between the two groups, one-way ANOVA is selected between multiple groups, and LSD-t test is selected for pairwise comparison between multiple groups; When the measurement data do not conform to the normal distribution and homogeneity of variance, Mann Whitney U rank sum test is used between the two groups, Kruskal Wallis h rank sum test is used between multiple groups, and Dunn or Dunn Bonferroni post hoc method is used for pairwise comparison between multiple groups.
(5) Outcome indicators
1) Efficacy indicators: ① main efficacy indicators: rash efficacy (including rash regression time, rash regression number and rash recurrence times); ② Secondary efficacy indicators: remission of systemic symptoms (quantitative score of TCM symptoms), recorded once every 0 ~ 4 weeks.
2) Examination indexes: blood routine examination, urine routine examination, 24-hour examination and liver and kidney function were detected in 0 ~ 4 weeks; Six immune levels were observed at 0 and 4 weeks after treatment.
3) Safety indicators: observe the children's leukocytes, liver enzymes, gastrointestinal symptoms (abdominal pain, nausea, vomiting, diarrhea, etc.) and reproductive system symptoms (menstruation of female children) every week.
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