Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
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：

 1. Full-term newborns with jaundice after 3-7 days of birth, total bilirubin in serum or
 transcutaneous bilirubin is between 100umol/L and 257umol/L, and start taking
 Yinzhihuang oral liquid, dose: 3ml per each time, 3 times per each day, during the
 period, measuring bilirubin from skin one time every 24 hours;

 2. Gestational age≥37 weeks, birth weight≥2.5Kg, Apgar scores≥8;

 3. lineal consanguinity are all the native residents from Guangdong or Guangxi;

 4. The enzyme activity of G-6-PD will be detected and collected from all the neonates
 subjects;

 5. Informed consents of all the neonates subjects are needed. Exclusion Criteria： (1)
 Neonates with inherited metabolic diseases; (2) Neonates with congenital malformation of
 liver and gallbladder; (3) Neonates with asphyxia, hypoxia, acidosis, sepsis, high
 fever, low temperature, low protein, low blood sugar, etc. which may lead to bilirubin
 encephalopathy; (4)History of oxidation drug exposure(e.g. honeysuckle bath) Study
 procedures： Outpatient and inpatient neonates (mainly for cesarean section newborns),
 with jaundice after 3-7 days of birth, total bilirubin in serum or measuring bilirubin
 from skin is between 100umol/L and 257umol/L, will be selected. On the first day of
 jaundice, the G-6-PD enzyme activity will be detected by checking arterial blood, and
 then start taking Yinzhihuang oral liquid, dose: 3ml each time, 3 times every day,
 during the period, measuring bilirubin from skin one time every 24 hours.

 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.
Inclusion Criteria:

 1. Full-term newborns with jaundice after 3-7 days of birth, total bilirubin in serum or
 transcutaneous bilirubin is between 100umol/L and 257umol/L, and start taking
 Yinzhihuang oral liquid, dose: 3ml per each time, 3 times per each day, during the
 period, measuring bilirubin from skin one time every 24 hours;

 2. Gestational age≥37 weeks, birth weight≥2.5Kg, Apgar scores≥8;

 3. lineal consanguinity are all the native residents from Guangdong or Guangxi;

 4. The enzyme activity of G-6-PD will be detected and collected from all the neonates
 subjects;

 5. Informed consents of all the neonates subjects are needed.

 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:

 1. Neonates with inherited metabolic diseases;

 2. Neonates with congenital malformation of liver and gallbladder;

 3. Neonates with asphyxia, hypoxia, acidosis, sepsis, high fever, low temperature, low
 protein, low blood sugar, etc. which may lead to bilirubin encephalopathy;

 4. History of oxidation drug exposure(e.g. honeysuckle bath)