A randomized controlled study of efficacy and safety of Yinzhihuang oral liquid for treatment of hyperbilirubinemia in preterm infants

doi:10.3877/cma.j.issn.1674-0785.2019.01.001

Abstract

Abstract:

Objective

To evaluate the efficacy and safety of Yinzhihuang oral liquid for the treatment of hyperbilirubinemia in preterm infants.

Methods

One hundred and thirty-six preterm infants with hyperbilirubinemia were enrolled from September 2016 to February 2018 at the Affiliated Xuzhou Hospital of Southeast University, and they were divided randomly into either a phototherapy group (67 cases, treated only with phototherapy) or a combination treatment group (69 cases, treated with phototherapy and Yinzhihuang oral liquid (2 mL/kg, q12h, for 5 days). Transcutaneous bilirubin (TcB) was measured at the marginal sternum covered by opaque material per 12 hours. The demographic data of infants in each group were compared by the Student′s t-test and chi-square test. TcB at 0 h , 60 h and 120 h after treatment and the reduction rates of TcB at 60 h and 120 h were compared by ANOVA of repeated measurement data. The correlation between the number of bowel movements and the reduction value of TcB during 120 h in the combination treatment group was analyzed by Pearson correlation analysis.

Results

The demographic data of infants in each group were not significantly different (P>0.05). TcB at 60 h after treatment was not significantly different between the two groups (P>0.05). TcB at 120 h in the combination treatment group was significantly lower than that in the phototherapy group (160.7±15.4 μmol/L vs 167.6±18.8 μmol/L, P=0.016). The reduction rates of TcB at 60 h and 120 h were not significantly different between the two groups (P>0.05). The incidence of diarrhea and rashes were not significantly different between the two groups (P>0.05). Serious diarrhea was not found in the phototherapy group, but two cases were found in the combination treatment group. Serious rashes were not found in either group. The number of bowel movements and the reduction value of TcB had a significant positive linear correlation during 120 h (r=0.709, P<0.001).

Conclusion

Yinzhihuang oral liquid as an adjuvant therapy has an appreciated curative effect for hyperbilirubinemia in preterm infants, but it functions slowly and has a weak effect. Compared with the phototherapy group, the incidence of adverse reaction such as diarrhea and rashes is not significantly different in the combination treatment group.

Key words: Yinzhihuang, Hyperbilirubinemia, Infant, Preterm

Dandan Zhao, Di Huang, Xiangyu Gao, Bo Yang, Yi Ren, Min Li, Jing Zhang. A randomized controlled study of efficacy and safety of Yinzhihuang oral liquid for treatment of hyperbilirubinemia in preterm infants[J]. Chinese Journal of Clinicians(Electronic Edition), 2019, 13(01): 1-6.

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Figures/Tables 6

References 22

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项目	光疗组（67例）	联合组（69例）	统计值	P值
男性［例（%）］	43（64.2）	38（55.1）	χ²=1.170	0.279
胎龄（周，±s）	33.9±1.1	34.1±1.4	t=-0.552	0.582
出生体质量（g，±s）	2137.2±429.5	2177.8±301.9	t=-0.640	0.523
5 min Apgar评分≤7分［例（%）］	4（6.0）	6（8.7）	χ²=0.371	0.543
生后24 h内发现黄疸［例（%）］	3（4.5）	3（4.3）	χ²=0.000	1.000^a
开始光疗时龄（h，±s）	85.3±14.0	85.2±16.7	t=0.014	0.989
入组前纯母乳喂养［例（%）］	5（7.5）	6（8.7）	χ²=0.070	0.792
同族免疫性溶血病［例（%）］	2（3.0）	2（2.9）	χ²=0.000	1.000^a
体温不稳定［例（%）］	9（13.4）	10（14.5）	χ²=0.032	0.859
显著萎靡［例（%）］	6（9.0）	7（10.1）	χ²=0.056	0.814
头颅血肿［例（%）］	7（10.4）	5（7.2）	χ²=0.433	0.510
血白蛋白＜30 g/L［例（%）］	6（9.0）	7（10.1）	χ²=0.056	0.814

项目	光疗组（67例）	联合组（69例）	统计值	P值
男性［例（%）］	43（64.2）	38（55.1）	χ²=1.170	0.279
胎龄（周，±s）	33.9±1.1	34.1±1.4	t=-0.552	0.582
出生体质量（g，±s）	2137.2±429.5	2177.8±301.9	t=-0.640	0.523
5 min Apgar评分≤7分［例（%）］	4（6.0）	6（8.7）	χ²=0.371	0.543
生后24 h内发现黄疸［例（%）］	3（4.5）	3（4.3）	χ²=0.000	1.000^a
开始光疗时龄（h，±s）	85.3±14.0	85.2±16.7	t=0.014	0.989
入组前纯母乳喂养［例（%）］	5（7.5）	6（8.7）	χ²=0.070	0.792
同族免疫性溶血病［例（%）］	2（3.0）	2（2.9）	χ²=0.000	1.000^a
体温不稳定［例（%）］	9（13.4）	10（14.5）	χ²=0.032	0.859
显著萎靡［例（%）］	6（9.0）	7（10.1）	χ²=0.056	0.814
头颅血肿［例（%）］	7（10.4）	5（7.2）	χ²=0.433	0.510
血白蛋白＜30 g/L［例（%）］	6（9.0）	7（10.1）	χ²=0.056	0.814

项目	光疗组（67例）	联合组（69例）	t值	P值
光疗第0小时TcB（μmol/L）	225.7±27.4	224.0±30.8	0.382	0.703
光疗第60小时TcB（μmol/L）	198.4±23.9	191.52±20.5	1.701	0.091
光疗第60小时TcB下降率（%）	11.3±11.2	12.9±12.1	-0.782	0.436
光疗第120小时TcB（μmol/L）	167.6±18.8	160.7±15.4	2.434	0.016
光疗第120小时TcB下降率（%）	24.9±10.1	27.1±10.5	-1.260	0.210

项目	光疗组（67例）	联合组（69例）	t值	P值
光疗第0小时TcB（μmol/L）	225.7±27.4	224.0±30.8	0.382	0.703
光疗第60小时TcB（μmol/L）	198.4±23.9	191.52±20.5	1.701	0.091
光疗第60小时TcB下降率（%）	11.3±11.2	12.9±12.1	-0.782	0.436
光疗第120小时TcB（μmol/L）	167.6±18.8	160.7±15.4	2.434	0.016
光疗第120小时TcB下降率（%）	24.9±10.1	27.1±10.5	-1.260	0.210

不良反应	光疗组（67例）	联合组（69例）	χ²值	P值
腹泻［例（%）］	10（14.9）	16（23.2）	1.501	0.221
皮疹［例（%）］	9（13.4）	11（15.9）	0.171	0.680

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