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Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy
Naser Honar1, Elham Ghashghaei Saadi, Forough Saki
1*Pediatric Gastroenterology and Hepatology Department †Pediatrics Department ‡Shiraz Endocrinology and Metabolism Research Center §Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz ||Hormozgan University of Medical Science, Bandar Abbas, Iran.
Insights
Ursodeoxycholic acid effectively reduces indirect hyperbilirubinemia in newborns when used with phototherapy. This treatment shortens phototherapy duration and hospital stays for jaundiced infants.
Area of Science:
- Neonatal Medicine
- Pediatric Gastroenterology
- Pharmacology
Background:
- Neonatal hyperbilirubinemia is a prevalent clinical issue.
- Indirect hyperbilirubinemia frequently necessitates phototherapy in newborns.
- Investigating adjunct therapies to phototherapy is crucial for improving infant outcomes.
Purpose of the Study:
- To evaluate the efficacy of ursodeoxycholic acid in conjunction with phototherapy for treating indirect hyperbilirubinemia in neonates.
- To determine if ursodeoxycholic acid can accelerate bilirubin level reduction compared to phototherapy alone.
Main Methods:
- A double-blind, randomized clinical trial involving 80 neonates with indirect hyperbilirubinemia.
- Infants received either phototherapy plus ursodeoxycholic acid or phototherapy alone.
- Total bilirubin levels were monitored every 12 hours, and phototherapy duration was recorded.
Main Results:
- The intervention group (ursodeoxycholic acid + phototherapy) showed significantly lower total bilirubin levels at 12, 24, and 48 hours compared to the control group (P < 0.05).
- The mean duration of phototherapy required to reach bilirubin levels below 10 mg/dL was significantly shorter in the intervention group (15.5 hours) versus the control group (44.6 hours) (P = 0.001).
Conclusions:
- Ursodeoxycholic acid demonstrates an additive therapeutic effect when combined with phototherapy in neonates suffering from indirect hyperbilirubinemia.
- The addition of ursodeoxycholic acid significantly reduces the required duration of phototherapy.
- This reduction in phototherapy time consequently leads to shorter hospitalization periods for affected infants.
Background:
Hyperbilirubinemia is a common neonatal problem. The present study aimed to investigate the effect of ursodeoxycholic acid in reducing indirect hyperbilirubinemia of infants under phototherapy.
Methods:
This double-blind randomized clinical trial was conducted on neonates with jaundice, who had received phototherapy in the hospitals affiliated with the Shiraz University of Medical Sciences in 2013. A total of 80 neonates were enrolled in the study and were randomly divided into 2 groups. The intervention group (n = 0) with indirect hyperbilirubinemia received 10 mg · kg(-1) · day(-1) divided every 12 hours Ursobil (capsule 300 mg) in addition to phototherapy, whereas the control group (n = 0) received only phototherapy. Total bilirubin levels were measured every 12 hours until reaching <10 mg/dL, and then phototherapy was disrupted. The duration of phototherapy was measured. The 2 groups were compared regarding total bilirubin levels at different time points and duration of phototherapy using the generalized estimating equation (GEE) test.
Results:
The mean of total bilirubin in the intervention group was 12 ± 1.6, 10 ± 1.1, and 9.8 ± 0.2 mg/dL 12, 24, and 48 hours after the beginning of phototherapy, respectively. On the contrary, these measures were 14.4 ± 1.3, 12.5 ± 1.4, and 10.1 ± 1.1 mg/dL in the control group, respectively, (P < 0.05). The mean time required for phototherapy to decrease the bilirubin level to < 10 mg/dL was 15.5 ± 6 and 44.6 ± 13.3 hours in the case and the control group, respectively, (P = 0.001).
Conclusions:
Ursodeoxycholic acid had additive effect with phototherapy in neonates with indirect hyperbilirubinemia. This drug also reduced the time period needed for phototherapy and, consequently, decreased the hospitalization period.
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