中国临床药学杂志

目的探讨口服酪酸梭菌活菌散剂辅助治疗足月新生儿高胆红素血症的疗效及安全性。方法将236例高胆红素血症的足月新生儿随机分为观察组(n=127)和对照组(n=109)。2组均采用双面兰光治疗等综合措施。观察组在此基础上口服酪酸梭菌活菌散剂500 mg,bid,连用5 d,每日测经皮胆红素(TCB)值。结果治疗2 d TCB下降值、5 d内TCB下降值观察组为(41.38±25.31)、(30.10±9.75)μmol.L-1,明显高于对照组的(33.00±29.58)、(25.31±9.92)μmol.L-1(t=2.34、3.73,P<0.05、<0.01);TCB降至171μmol.L-1以下所需的时间观察组为(7.37±1.27)d,明显短于对照组的(9.19±1.78)d(P<0.01)。治疗5 d总有效率观察组为79.53%,明显高于对照组的58.72%(P<0.01)。观察组10例(7.87%)发生发热、腹泻等一过性不良反应,无严重不良反应发生。结论口服酪酸梭菌活菌散剂辅助治疗足月新生儿高胆红素血症是一种安全有效的措施。

AIM To explore the efficacy and safety of clostridium butyricum powder in adjuvant treatment of neonatal hyperbilirubinemia.METHODS A total of 236 term infants with hyperbilirubinemia were randomly assigned into 2 groups,127 infants as control group and 109 infants as observation group.All infants in 2 groups were given general care(phototherapy) and treatment.At the same time,clostridium butyricum powder was admininstered orally to infants in observation group.All the infants were assessed by measurement of transcutaneous bilirubin(TCB).RESULTS TCB decreased value after 2 d treatment,the average value within 5 d treatment in the observation group[(41.38±25.31) and(30.10±9.75)μmol·L-1] were significantly higher than those in the control group [(33.00±29.58) and(25.31±9.92)μmol·L-1](t=2.34,3.73;P<0.05,<0.01).The time to decrease TCB values < 171 μmol·L-1 was shorter in observation group(7.31±1.27)d than in control group(9.19±1.78)d(t=9.13,P<0.01).The total effective rate of 5 d in the observation group(79.53%,101/127) was significantly higher than in the control group(58.72%,64/109)(χ2=12.08,P<0.01).Ten infants in observation group produced fever,diarrhea,etc.CONCLUSION Clostridium butyricum powder,as a adjuvant treatment of newborn with hyperbilirabinemia,is safe and effective.