Henoch-Schönlein Purpura Nephritis
Conditions
Keywords
Children，, Henoch-Schönlein Purpura Nephritis, Integrated and Stepped Treatment in TCM
Brief summary
The purpose of this study is to determine the optimum dosage and application method of Glycosides Of Tripterygium Wilfordii Hook(GTW) for Henoch-Schönlein Purpura Nephritis(HSPN) in children, and develop into the normal treatment protocols for Henoch-Schönlein Purpura Nephritis in children.
Detailed description
Based on Chinese Eleventh Five-year Plan for Science and Technology Program, this study follows a large-sample multicenter centerrandom open-label controlled perspective method, enrolls HSPN children with hematuria associated with proteinuria and isolated proteinuria from 2 to 18 years of age, classifys five traditional Chinese medicine patterns of syndrome: wind-heat complicated with blood stasis, blood-heat complicated with blood stasis, yin deficiency complicated with blood stasis, both qi and yin deficiency complicated with blood stasis,damp-heat complicated with blood stasis. For TCM group,according to the severity of HSPN, stepped treatment should be taken. The initial dosage of GTW for severe HSPN is 2mg/kg/d, continued with 1.5mg/kg/d and 1mg/kg/d; The initial dosage of GTW for light HSPN is 1.5mg/kg/d, continued with 1mg/kg/d. On the above base, the comprehensive treatment are taken combined with TCM syndrome differentiation, medicated with Sulfotanshinone Sodium Injection.For controlled group,the treatment for severe HSPN is prednisone combined with heparin plus lotensin and dipyridamole tablets;for light HSPN is heparin plus lotensin and dipyridamole tablets.12 weeks after treatment, the third-party statistics evaluate the efficacy and effect,and a follow-up lasting 36 weeks will go on.
Interventions
DRUGGlycosides Of Tripterygium Wilfordii Hook(GTW)
For severe HSPN GTW is 2mg/kg/d for the first 2 weeks , continued with 1.5mg/kg/d (maximum to 90mg/d) for another 2 weeks; For light HSPN GTW is 1.5mg/kg/d(maximum to 90mg/d) for 4 weeks. Both the 2 types are continued with 1mg/kg/d of GTW for another 4 weeks . Besides,Sulfotanshinone Sodium Injection,Qingrezhixue graunles,Chinese herbs by syndrome differentiation are plused at the same time
DRUGSulfotanshinone Sodium Injection
Intravenous drip of Sulfotanshinone Sodium Injection with the dosage of 1mg/kg/d(maximum to 50mg), combined with 100-250ml 5% Glucose Solution (G.S) for 2 weeks in both the light and serious type of TCM group.
DRUGChinese herbs based on syndrome differentiation
For both the light and serious type of HSPN in TCM group,five traditional Chinese medicine patterns of syndrome are classified on the main pathogenesis Blood Stasis: based on Qingre Zhixue granule,for wind-heat complicated with blood stasis, add Forsythia, Honeysuckle,;for blood-heat complicated with blood stasis,add Buffalo horn,Comfrey; for yin deficiency complicated with blood stasis, add Rhizoma anemarrhenae,Cortex phellodendri;for both qi and yin deficiency complicated with blood stasis,add Astragalus, Heterophylla;for damp-heat complicated with blood stasis,add Scutellaria baicalensis,Lalang Grass Rhizome.
Prednisone Acetate Tablets are necessary for serious HSPN in controlled group,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinued（Reduce the dosage at the rate of 5mg every other day in 4-8 weeks，then reduce the dosage at the rate of 5-10mg per week in 8-12weeks）
DRUGBenazepril Hydrochloride Tablets
In controlled group, Benazepril Hydrochloride Tablets are used for both the light and serious type with the dosage of 5-10mg/d(10mg/d for children with weight above 30kg) ,12 weeks in total.
DRUGLow Molecular Weight Heparin Calcium Injection
In controlled group,Low Molecular Weight Heparin Calcium Injection are used for both the light and serious type with the dosage of 100u/kg/d by hypodermic injection for 2 weeks
DRUGDipyridamole Tab 25 MG
In controlled group,Dipyridamole Tab 25 MG are used for both the light and serious type of HSPN with the dosage of 3mg/kg/d ,3 times a day,12 weeks in total.
DRUGChinese medicine placebo
In controlled group,take a potential necessary for patients who come to the hospital of TCM to take traditional Chinese medicine in consideration, we add the traditional Chinese medicine placebo in controlled group.
Sponsors
Peking University First Hospital
Children's Hospital of Fudan University
Shanghai Children's Hospital
Chengdu University of Traditional Chinese Medicine
Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of Henoch-Schönlein Purpura Nephritis Disease * Age form 2-18 years old * Disease onset within 2 months
Exclusion criteria
* Nephritis not causing by HSPN * Being alergic to the medicine in the treatment * No compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urinary protein quantity | Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline | 24-hour urinary protein is the most important and direct indicators of therapeutic effect,so this clinical lab index should be reccord at every point during treatment and follow-up,17 times in total. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine red blood cells | Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline | Compared to 24-hour urinary protein,urine red blood cells count is a secondary indicator to reflect therapeutic effect because urine red blood cells recede more slowly than protein,this clinical lab index should also be reccorded at every point during treatment and follow-up,17 times in total. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glutamate alanine transferase(ALT) in the blood | Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase | There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of ALT should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein. |
| Glutamate aspartate transferase(AST) in the blood | Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase | There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of AST should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein. |
| The white blood cell count(WBC) in the blood | Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase | There is a potential risk of abnormality in the blood system in terms of leukocyte counts after taking immunosuppressor or prednison. Leukocyte count should be recorded in total of 17 times during and after treatment through routine blood tests. |
| Blood Urea Nitrogen(BUN) | Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase | There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage，the test of BUN should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein. |
| Serum Creatinine(Scr) | Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase | There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage,the test of Cr should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein. |
| The platelet count(PLT) in the blood | Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase | There is a potential risk of abnormality in the blood system in terms of platelet counts after taking immunosuppressor or prednison. Platelet count should be recorded in total of 17 times during and after treatment through routine blood tests. |
Countries
China
Contacts
Primary ContactYing Ding, professor
Backup ContactGuizhen Zheng, Lecturer
Outcome results
None listed