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

OBJECTIVE: A large-scale prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants. Yinzhihuang oral solution is a herbal extract with the main c...

Ausführliche Beschreibung

Bibliographische Detailangaben
Veröffentlicht in:Zhonghua er ke za zhi = Chinese journal of pediatrics. - 1960. - 49(2011), 9 vom: 16. Sept., Seite 663-8
1. Verfasser: Clinical Research Collaborative Group of Yinzhihuang Oral Solution (VerfasserIn)
Weitere Verfasser: DU, Li-Zhong (BerichterstatterIn)
Format: Aufsatz
Sprache:Chinese
Veröffentlicht: 2011
Zugriff auf das übergeordnete Werk:Zhonghua er ke za zhi = Chinese journal of pediatrics
Schlagworte:English Abstract Journal Article Multicenter Study Randomized Controlled Trial Drugs, Chinese Herbal yin zhi huang Phenobarbital YQE403BP4D
LEADER 01000naa a22002652 4500
001 NLM213924358
003 DE-627
005 20231224022543.0
007 tu
008 231224s2011 xx ||||| 00| ||chi c
028 5 2 |a pubmed24n0713.xml 
035 |a (DE-627)NLM213924358 
035 |a (NLM)22176900 
040 |a DE-627  |b ger  |c DE-627  |e rakwb 
041 |a chi 
100 0 |a Clinical Research Collaborative Group of Yinzhihuang Oral Solution  |e verfasserin  |4 aut 
245 1 2 |a 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 
264 1 |c 2011 
336 |a Text  |b txt  |2 rdacontent 
337 |a ohne Hilfsmittel zu benutzen  |b n  |2 rdamedia 
338 |a Band  |b nc  |2 rdacarrier 
500 |a Date Completed 14.05.2012 
500 |a Date Revised 09.04.2022 
500 |a published: Print 
500 |a Citation Status MEDLINE 
520 |a OBJECTIVE: A large-scale prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants. Yinzhihuang oral solution is a herbal extract with the main components of Herba Artemisiae Scopariae, Scutellaria, Lonicera Japonica and Gardenia jasminoides 
520 |a METHODS: A total of 16 hospitals participated in this study. From March to September 2010, the term infants whose bilirubin level ≥ 40 th percentile for age in hours were enrolled, except for those who received exchange transfusion or had signs of bilirubin encephalopathy. All the 1177 cases were divided randomly into three groups: phototherapy group (409 cases), phenobarbital combined with phototherapy group (373 cases) and Yinzhihuang oral liquid combined with phototherapy group (395 cases). Phenobarbital and Yinzhihuang oral liquid was started once the infants participated the study, and persisted for 5 days. Phototherapy was added as soon as the bilirubin level reached the lowest threshold (the threshold for infants at higher risk). The demographic data of infants in each group were recorded, the serum bilirubin level before treatment, after treatment for 72 hours and after the treatment completion were checked. The reduction rate of serum bilirubin and the phototherapy rate in different groups were compared. The adverse events were assessed as well 
520 |a RESULTS: Of the total of 1177 cases, 707 (60.1%) were male, 1119 cases (95.1%) were of Han ethnicity. The average total bilirubin level before treatment was (282.0 ± 70.9) µmol/L and the highest level was 626 µmol/L. The severe hyperbilirubinemia (total bilirubin level at 342 µmol/L to 427 µmol/L) accounted for 15.8% (186 cases), and the extremely severe hyperbilirubinemia (total bilirubin > 427 µmol/L) accounted for 2.5% (30 cases). After treatment for 72 hours, the reduction of bilirubin was not significantly different among three groups (F = 2.89, P = 0.056). After completion of treatment, the reduction rate of bilirubin in Yinzhihuang group was higher than that of the other two groups (F = 5.55, P = 0.004). The rate of infants who did not receive phototherapy in Yinzhihuang group was higher than that in phenobarbital group (χ(2) = 47.38, P = 0.000). In Yinzhihuang group, more infants had bowel movements more than five times a day. The incidence of rashes was higher than that in phenobarbital group (P = 0.019), but no significant difference was found as compared with that in phototherapy group (P = 0.339) 
520 |a CONCLUSIONS: About 18% of the term infants who were admitted for jaundice had severe or extremely severe hyperbilirubinemia. Yinzhihuang oral solution combined with phototherapy is effective in bilirubin reduction. Early treatment with Yinzhihuang oral solution may inhibit further increase in bilirubin levels, reduce the phototherapy requirement 
650 4 |a English Abstract 
650 4 |a Journal Article 
650 4 |a Multicenter Study 
650 4 |a Randomized Controlled Trial 
650 7 |a Drugs, Chinese Herbal  |2 NLM 
650 7 |a yin zhi huang  |2 NLM 
650 7 |a Phenobarbital  |2 NLM 
650 7 |a YQE403BP4D  |2 NLM 
700 1 |a DU, Li-Zhong  |e investigator  |4 oth 
773 0 8 |i Enthalten in  |t Zhonghua er ke za zhi = Chinese journal of pediatrics  |d 1960  |g 49(2011), 9 vom: 16. Sept., Seite 663-8  |w (DE-627)NLM136249191  |x 0578-1310  |7 nnns 
773 1 8 |g volume:49  |g year:2011  |g number:9  |g day:16  |g month:09  |g pages:663-8 
912 |a GBV_USEFLAG_A 
912 |a SYSFLAG_A 
912 |a GBV_NLM 
912 |a GBV_ILN_11 
912 |a GBV_ILN_20 
912 |a GBV_ILN_22 
912 |a GBV_ILN_24 
912 |a GBV_ILN_31 
912 |a GBV_ILN_39 
912 |a GBV_ILN_40 
912 |a GBV_ILN_50 
912 |a GBV_ILN_61 
912 |a GBV_ILN_65 
912 |a GBV_ILN_69 
912 |a GBV_ILN_70 
912 |a GBV_ILN_72 
912 |a GBV_ILN_120 
912 |a GBV_ILN_130 
912 |a GBV_ILN_227 
912 |a GBV_ILN_244 
912 |a GBV_ILN_285 
912 |a GBV_ILN_294 
912 |a GBV_ILN_350 
912 |a GBV_ILN_665 
912 |a GBV_ILN_813 
951 |a AR 
952 |d 49  |j 2011  |e 9  |b 16  |c 09  |h 663-8