clinical observation of yinzhihuang oral liquid (茵栀黄口服液) on prevention of the premature...

7/27/2019 Clinical observation of Yinzhihuang Oral Liquid ( ) on prevention of the premature infantile jaundice

1/4

299 Chin J Integr Med 2009 Aug;15(4):299-302

Premature infants are prone to get jaundice,

bleeding, hard swelling, infection, apnea, and other

life-threatening complications due to their growth fac-

tors, among which premature infantile jaundice lasted

for a long time and more severe, often can cause

bilirubin encephalopathy, increasing mortality, and

morbidity for premature Infants. Therefore, in the pre-

mature infants, the early intervention to reduce no-

complicated bilirubin in body, and prevention of the

occurrence of bilirubin encephalopathy have positive

significance. This study used Yinzhihuang Oral Liquid

(YOL,) to prevent jaundice in premature

infants and the results were reported as follows.

METHODS

Inclusion Criteria

The included were premature infants except

hemolytic premature infants, with severe asphyxia

(1 min Apgar score < 7), serious infections, low birthweight, and blood diseases.

Exclusion Criteria

Excluded were premature infants with daily

percutaneous bilirubin > 257 mol/L, daily bilirubin

increasing equal, or more than 85 mol/L a day, or

complicated with infections or other serious diseases

of vital organs in the observation period.

Clinical Data

From September 2005 to April 2008, 242

premature infants from the Department of Obstetrics

and Gynecology, Xuanwu Hospital, Maternity Hospital,

Capital Medical University were enrolled and randomly

assigned to two groups. The completely random

sample of a large group was adopted, and each

premature infant took a three-digit random number,

according to Mantissa Single and Double to arrange

the treated group and the control group. Between the

two groups, the distribution of clinical data showed no

significant difference, and the data were showed in

the Table 1 (P>0.05).

Treatment

Both groups were taken conventional procedures,

such as warmth, feeding, and blood glucose

monitoring. In the treatment group, the parents signed

the informed consent, and the premature infants were

orally administered YOL (Beijing Shuanghe Gaoke

Natural Medicine Co., Ltd.), with a small soup spoonin the interval of two breast feedings, 5 mL each time,

twice daily for four consecutive days. The control group

recieved no treatment.

Observation Items

The body temperature, weight, stool frequency,

CLINICAL EXPERIENCE

Clinical Observation of Yinzhihuang Oral Liquid () onPrevention of the Premature Infantile Jaundice

CHEN Sheng-ping (), TIAN Li-li (), and LIU Feng-ling ()

Department of Obstetrics and Gynecology, Xuanwu Hospital,Capital Medical University, Beijing (100053), ChinaCorrespondence to: Dr. CHEN Sheng-ping, Tel: 13641116815,E-mail:[email protected]

DOI: 10.1007/s11655-009-0299-1

ABSTRACTABSTRACT Objective:Objective: To observe the clinical efficacy of Yinzhihuang Oral Liquid (YOL,) to pre-To observe the clinical efficacy of Yinzhihuang Oral Liquid (YOL,) to pre-vent the premature infantile jaundice.vent the premature infantile jaundice. Methods:Methods: After excluded hemolytic, suffocation, infection, and the very lowAfter excluded hemolytic, suffocation, infection, and the very lowbirth weight, 242 cases of premature infants were randomly assigned to two groups, the treatment group and thebirth weight, 242 cases of premature infants were randomly assigned to two groups, the treatment group and thecontrol group. Both groups were taken conventional procedures, such as warmth, feeding, and blood glucosecontrol group. Both groups were taken conventional procedures, such as warmth, feeding, and blood glucosemonitoring, and the treated group was administered YOL 5 mL each time, twice daily additionally, and the con-monitoring, and the treated group was administered YOL 5 mL each time, twice daily additionally, and the con-trol group without any treatment. The percutaneous bilirubin and blood cells were observed every day.trol group without any treatment. The percutaneous bilirubin and blood cells were observed every day. ResultsResults::Compared the two groups, the jaundice indices were more significantly different at 24-48 h, 48-72 h, and moreCompared the two groups, the jaundice indices were more significantly different at 24-48 h, 48-72 h, and morethan 72 h (than 72 h (P0.05). Hemoglobin, reticulocyte, platelets, and leu-cocyte were not significantly different between the two groups (cocyte were not significantly different between the two groups (P>0.05).>0.05). Conclusion:Conclusion: YOL as an early interven-YOL as an early interven-tion has positive significance to decrease the incidence of pathological jaundice in the premature infants, and notion has positive significance to decrease the incidence of pathological jaundice in the premature infants, and nosignificant impact on the blood cells.significant impact on the blood cells.KEY WORDSKEY WORDS premature infants, jaundice, early intervention, Yinzhihuang Oral Liquid, blood cellspremature infants, jaundice, early intervention, Yinzhihuang Oral Liquid, blood cells


2/4


blood sugar, and blood cells (hemoglobin, reticulocyte,

platelet, and leucocyte) were detected and recorded

every day.

The instrument models MNJ20 was used to

measure percutaneous biliary, photoelectric detector

(model M1K7222K, Japan) used for blood cells.

Preparatory work was adopted in full-term newborn

bilirubin values, the skin and vein blood bilirubin

values of newborn were measured and compared in

30 samples, including the results confidence interval

between the mean standard deviation, so the value

of percutaneous bilirubin could be substituted for

vein blood bilirubin in clinic. Percutaneous bilirubin

measuring equipment was put on the middle of the

premature infants' forehead every day after bathing in

the morning, three times consecutively, and then the

mean value was adopted. Blood sugar and blood cells

were also determined at the same time, and the side

effects were also observed.

Statistical Analysis

SPSS11.0 software was performed to conduct

statistical significance, and measurement data

was carried out by square analysis, counting data

by variance test and Fisher's exact probability.

All data were expressed as mean standard

deviation.

RESULTS

Comparison of the Results of Percutaneous

Bilirubin between the Two Groups

In the observation period, at 0-24 h, in each

group, one infant reached the pathological jaundice

value separately, at 48-72 h one, and at more than 72 h

two patients also reached a pathological jaundice

value in the control group. All of them withdrew from

the trial. Jaundice index at 24-48 h, 48-72 h, and more

than 72 h showed to be significantly different between

the two groups (P0.05, Table 2).

Comparison of Blood Cells between the TwoGroups

All changes of hemoglobin, reticulocyte, platelet,

and leucocyte between the two groups was not

Table 1. Distribution of Clinical Data Premature Infants

GroupGender ratio(Male:Female)

Gestationalage (week)

Weight (g) Post-delivery mode(cesarean:vaginal births)

Suffocation(%)

Complication(%)

Control 100:93.1 34.12.3 2601.2387.1 3169 2 32%

Treated 100:92.5 34.52.1 2620.1401.2 3466 3 34%

Notes: Square analysis, variance test, Fisher's exact; probability; Complications include pregnancy-induced

hypertension, gestational diabetes, hyperthyroidism, and systemic lupus erythematosus, etc.

Table 3. Comparison of Blood Cells of Premature Infants between the Two Groups ( s)

Group Time Case Hemoglobin (1012

g /L) Reticulocyte (%) Platelet (109g/L) Leucocyte (109g/L)

Treated 0-24 h 119 223.2021.54 4.832.04 234.5059.75 23.8021.12

24-48 h 119 221.5019.30 4.771.84 206.7099.07 21.2020.03

48-72 h 119 218.6018.34 3.271.53 210.1089.90 20.0020.47

>72 h 119 215.1016.87 2.610.96 203.3097.65 18.5017.42

Control 0-24 h 121 222.8018.25 4.822.09 236.5074.86 23.7022.04

24-48 h 121 220.1018.89 4.721.77 199.9098.56 21.1020.20

48-72 h 120 217.5018.07 3.241.63 208.4090.12 20.1020.00

>72 h 118 216.2017.11 2.631.03 196.7094.76 18.7017.01

Table 2. Comparison of Percutaneous Bilirubin Values between Two Groups ( s)

GroupPercutaneous bilirubin (mol/L)

0-24 h 24-48 h 48-72 h >72 h

Treated (n=120) 77.321.2 (n=119) 127.82.3 (n=119) 201.650.4 (n=119) 235.854.0 (n=119)

Control (n=122) 78.123.6 (n=121) 149.155.8 (n=121) 230.462.5 (n=120) 257.457.6 (n=118)

P value >0.05


3/4


significantly different (P>0.05, Table 3).

Adverse Reactions

Adverse reactions included nausea, vomiting,

abdominal distention, constipation, diarrhea, and

increasing of stool frequency. Five cases in the treated

group had diarrhea, and two cases lost weight of 10%.

All these were improved after infusion treatment. No

side effects were observed in the control group.

DISCUSSION

Premature infants are prone to get jaundice,

bleeding, hard swel l ing, infect ion, and other

complications due to their weak constitutions, in

which premature infant jaundice appears earlier, lasts

longer, and often more severe. Because of immature

blood-brain barrier in premature infants, bilirubin

blood easily accesses the brain and causes bilirubin

encephalopathy, which increases premature mortality

and disability. Since the hyperbilirubinemia of the

nervous system can lead to short-term and long-term

permanent damage to premature infants and cause

bilirubin encephalopathy, so more attention has been

paid to premature infants with hyperbilirubinemia

clinically in recent years. The study showed that in

the first week, 40%-65% of the normal newborns

have jaundice, but 80% of the premature infants

have various degrees of jaundice. On the causeof hyperbilirubinemia, in addition to clear neonatal

perinatal diseases, perinatal obstetric factors is also

an important factor in inducing hyperbilirubilirubine-

mia. The exact cause for morbidity cannot be found

in hyperbilirubinemia cases(1)

. The research showed

that small gestational age, premature, amniotic fluid

pollution, fetal distress, premature rupture of fetal

membranes, gestational disease, cesarean section,

the use of oxytocic hormone, old primiparity, multiple

births, and the use of sedatives may potentially cause

high serum bilirubin levels to increase.

The high level of serum bi l i rubin is one

of impor tant reasons for e levat ing b i l i rubin

encephalopathy, but it is not the only reason. Other

reasons may be premature birth, asphyxia, infections,

and hypoproteinemia, premature infants themselves

is a risk factor for neonatal jaundice and more liable

to suffer from bilirubin encephalopathy than full-

term infants(2). It has been reported that neonates

have a high rate of the nervous system sequelae

of hyperbilirubinemia; in addition to severe high

bilirubin, mild to moderate high bilirubin can also

have permanent nerve damage to a newborn baby,

resulting in abnormal development of the spirit, only

by serum total bilirubin level cannot predict the exact

outcome, all newborns with high bilirubin should be

given positive treatment to minimize the occurrence of

sequelae(3)

.

In the causes of premature infants wi th

hyperbilirubinemia, jaundice can be physical and

pathological, internal and external(4). The internal

factors include erythropoietin, short life, quick damage,

and liver cells intake functioning. The external

causes include (1) Infection factors, in relation with

humoral and cellular immune function immaturity of

premature infants. (2) Hypoxia and acidosis, due to

premature infants immaturity of the respiratory center,

and the lack of carbonic anhydrase in red blood

cells, resulting in the amount reduction of carbon

dioxide decomposition of carbonate, so it cannot

be effectively formed stimulation on the respiratory

center, easily cause apnea and cyanose(5), leading to

hypoxia and aggravating jaundice. Premature infants

are vulnerable to the impact of acidosis, because

of the poor regulatory function of premature infants

in the acid-base balance; within a few days after

birth, about two-thirds premature infants showed

metabolic acidosis, and one-third showed respiratoryacidosis or respiratory alkalosis(5). Aacidosis may

affect the combination of unconjugate bilirubin to

albumin and aggravate jaundice. (3) The delay of

feeding the excretion of meconium all can increase

the circulation of the gut-liver and the absorption of

bilirubin, so timely milking and promoting the excretion

of meconium, can effectively reduce the gut-liver

circulation and reduce bilirubin absorption. (4) Due to

preterm infant's immaturity of the heat center, there

is less subcutaneous fat and large body surface

area, and heat dissipation increases, which is liable

to cause hypothermia. Premature infants have a low

function of translating the glycogen into the blood

sugar, so it easily results in lowering of blood sugar so

as to increase premature infant jaundice.

YOL, a Chinese medicine, mainly composed

of siphonostiga herb, cape jasmine fruit, scutellaria

baicalin, and honeysuckle flower. It has the effects

of anti-pathogenic microorganism antibacterial and

sterilization, inhibiting the body allergic reaction to

reduce destruction of red blood cells, reducing red


4/4


blood cells hemolysis, and lowering serum bilirubin

levels. YOL may reduce the damage to the liver,

promote bile secretion and excretion, participate as

compositions of enzyme, and regulate the activity

of enzymes. It can be directly involved in the body

nucleic acid, sugar, fat and protein metabolism and

promote liver regeneration and protect the integrity

of liver cells, thus avoiding the injury of fat peroxides,

promoting enterokinesia and being conducive to

the excretion of bile and reducing bilirubin gut-liver

cycle(6).

For their special physiological characteristics of

premature infants, under the condition of warming,

feeding, and monitoring of blood sugar, maintaining

the stability of body temperature and blood sugar, and

ruling out the external interference factors, premature

infants were fed with YOL for four consecutive days.

The results showed that jaundice indices were significantly

different between the two groups at 24-48 h, 48-72 h,

and >72 h but not at 0-24 h. Therefore, the authors

considered that the prevention of the premature

infants could start from the second day. In this study,

some premature infants in the control group withdrawn

from the trial at 48-72 h and more than 72 h, because

of bilirubin values reaching infants pathological

jaundice (7). The level of serum bilirubin reaching

257 mol/L or a daily increment of more than 85 mol/L occurred in the control group, which did not

occur in the treated group; the results showed that

preventive medication for delaying the increase of

premature infant jaundice indices has a positive effect.

The blood cell tests including hemoglobin, reticulocyte,

platelet, and leucocyte were not significantly different

between the two groups after four days of treatment,

which showed that YOL was safe to blood cells and

had few side effects. This suggested that it might be

used clinically.

REFERENCES

Li QP, Feng ZC. The latest guideline for neonatal jaundice

produced by American Academic of Pediatrics. J Appl Clin

Pediatr (Chin) 2006;21:958-959.

Cashore WJ. Bilirubin and jaundice in the micropremie. Clin

Perinatal 2000;27:171-179.

Dong SL, Hua Q, Yu AH, Yang YY, Zhang YY. A long-term

follow-up of newborn infants with hyperbilirubinemia. Chin J

Pract Pediatr (Chin) 1999;14(2):23-24.

Yang XQ, Yi ZW, eds. Pediatrics. 6th ed. Beijing: People's

Medical Publishing House; 2004:134.

Jin HZ, Huang DM, Guan XJ. Practical neonatology. 3rd ed.

Beijing: People's Medical Publishing House; 2004:194-196.

Heng XH, Tang ZZ. Observation on efficacy of Yinzhihuang

Oral Liquid in the prevention and treatment of 388 cases of

neonate jaundice. Maternal Child Healthcare Chin (Chin)

2007;32;4617.

Wang Y, He NH. Analysis of high risk factors in 210

neonates with hyperbilirubinemia. Chongqing Med (Chin)2006;35:1932-1934.

(Received August 15, 2008)

Edited by ZHANG Wen

1.

2.

3.

4.

5.

6.

7.

clinical observation of yinzhihuang oral liquid (茵栀黄口服液) on prevention of the premature...

Documents