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Neonatal Glucose-6-phosphate Dehydrogenase(G6PD) Deficiency is one of the significant reason for neonatal hyperbilirubinemia and even irreversible bilirubin encephalopathy.The neonates may be attacked due to acute infection, eating beans or exposure to oxidative drugs, etc.
The main clinical manifestations are hemolytic anemia, and the resulting hyperbilirubinemia. When bilirubin is pretty high in body, bilirubin may spread into brain, and thus cause nervous system damage, and severely affect the prognosis of neonates. Therefore, monitoring and early intervention of jaundice has important significance to prevent further aggravation of jaundice and certain sequelae. Phototherapy and exchange transfusion are mainly suitable methods for severe hyperbilirubinemia, however, patients need to be hospitalized. Yinzhihuang Oral Liquid is a kind of traditional Chinese medicine for jaundice. Many large sample and multicenter clinical studies show that the positive efficacy of Yinzhihuang Oral Liquid in the treatment of neonatal hyperbilirubinemia is exactly confirmed.
The purpose of this study is try to detect the treatment effect of Yinzhihuang Oral Liquid on indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia. Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.
The primary objective is to detect the treatment effect of Yinzhihuang Oral Liquid on indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia. Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.
Study subjects includes neonates with hyperbilirubinemia from five hospitals, who are willing to take Yinzhihuang oral liquid.
Five hospitals are South Hospital of Southern Medical University (primary institute), The Third Affiliated Hospital of Guangzhou medical university, Shenzhen maternal and child health hospital, First Affiliated Hospital of Guangxi Medical University, The maternal and child health hospital of Guangxi Zhuang Autonomous Region Inclusion criteria:
When the transcutaneous bilirubin is below 100umol/L, stop taking the medication. When bilirubin increases to match the phototherapy indications, the neonates will be transferred to the neonatal department, and continue the Yinzhihuang oral liquid treatment until bilirubin decreasing to normal level.
after the transfer to the ICU still needs to continue to use until the jaundice decreased to normal level.
The neonates 's families have to sign the informed consents before entering the study.
G-6-PD <10.37U /g.H b was diagnosed as a lack of G-6-PD activity. Subgroup: according to the severity of the lack of the activity of the enzyme, it will be divided into 3 groups: mild deficiency: 6.93-10.37U/g.H b; moderate deficiency: 3.47-6.92U/g. Hb; severe deficiency: 0-3.46U/g.H b.
Note: the above criteria can be modified according to the test methods of those five hospitals, and will be uniformed by same final standards.
The normal value of G-6-PD enzyme activity is 2.5-5.8KU/L in our hospital, <2.5KU/L can be diagnosed as lack of G-6-PD enzyme activity. However, there is no certain standards for the definition of mild deficiency, moderate deficiency and severe deficiency in our hospital. It was reported that activity is less than 10% of normal is severe deficiency, less than 10%-60% of normal is moderate deficiency, less than 60% of normal is mild deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-6-PD normal group | Experimental | Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours. |
|
| G-6-PD mild deficiency group | Experimental | Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours. |
|
| G-6-PD moderate deficiency group | Experimental | Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours. |
|
| G-6-PD sever deficiency group | Experimental | Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yinzhihuang Oral Liquid | Drug | All the four groups will be given same treatment as being described in arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized | Value of the total bilirubin in serum(umol/L) will be collected and calculated. | Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change(%) from baseline of total bilirubin(umol/L) will be calculated and finalized | Value of the total bilirubin in serum(umol/L) will be collected and calculated. | Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L) |
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Inclusion Criteria:
Note: Icterus testers are Minolta 105 type. Measurements of bilirubin are from three location, inluding forehead, chest and abdomen. The value of bilirubin will use the average value from the three location, and the unit is umol / L.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weimin Huang, Ph.D | Contact | +8613900261113 | drhwm2003@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Weimin Huang, Ph.D | The South Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The South Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19942489 | Background | Kaplan M, Hammerman C. Glucose-6-phosphate dehydrogenase deficiency and severe neonatal hyperbilirubinemia: a complexity of interactions between genes and environment. Semin Fetal Neonatal Med. 2010 Jun;15(3):148-56. doi: 10.1016/j.siny.2009.10.007. Epub 2009 Nov 26. | |
| 19233695 | Background | Nkhoma ET, Poole C, Vannappagari V, Hall SA, Beutler E. The global prevalence of glucose-6-phosphate dehydrogenase deficiency: a systematic review and meta-analysis. Blood Cells Mol Dis. 2009 May-Jun;42(3):267-78. doi: 10.1016/j.bcmd.2008.12.005. Epub 2009 Feb 23. |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| 22176900 | Background | Clinical Research Collaborative Group of Yinzhihuang Oral Solution. [A multicenter randomized controlled study on the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants]. Zhonghua Er Ke Za Zhi. 2011 Sep;49(9):663-8. Chinese. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |