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目的探讨波生坦治疗3月龄以下小婴儿先天性心脏病相关性肺动脉高压(CHD-PAH)有效性及安全性。方法选择2012年1月至2013年12月在山东大学齐鲁医院和齐鲁儿童医院治疗的3月龄以下CHD-PAH患儿60例,随机分为波生坦组和卡托普利组,每组30例;同期选择年龄3个月以下健康查体婴儿30例(正常对照组)。采用ELISA法、超声心动图检测波生坦组、卡托普利组和对照组治疗前、治疗后4、8周血浆内皮素-1(ET-1)水平及平均肺动脉压(m PAP)的变化;检测波生坦组和卡托普利组治疗前、后肝酶变化;通过60 m L奶液喂养时间的变化评估患儿运动耐量。结果波生坦组和卡托普利组治疗前血浆ET-1含量、m PAP较正常对照组明显升高(P<0.05);波生坦组治疗后4、8周m PAP及血浆ET-1水平较治疗前明显下降(P<0.01),卡托普利组治疗后m PAP较治疗前下降(P<0.05),血浆ET-1水平无明显变化;波生坦组与卡托普利组治疗后4、8周血浆ET-1含量及m PAP比较明显下降(P<0.05);波生坦组治疗前后肝酶差异无统计学意义(P>0.05);波生坦组治疗后4周60 m L奶液喂养时间较治疗前明显缩短(P<0.01)。结论波生坦可有效降低先心病患儿平均肺动脉压,提高运动耐量。短期应用波生坦治疗小婴儿先天性心脏病相关性肺动脉高压安全、有效。
Objective To investigate the efficacy and safety of bosentan in the treatment of congenital heart disease-associated pulmonary hypertension (CHD-PAH) in infants younger than 3 months. Methods Sixty children with CHD-PAH under 3 months of age treated at Qilu Hospital and Qilu Children’s Hospital of Shandong University from January 2012 to December 2013 were randomly divided into bosentan group and captopril group, and each group 30 cases; the same period, select the age of 3 months following 30 healthy babies (normal control group). The levels of endothelin-1 (ET-1) and mean pulmonary arterial pressure (mPa) in Bosentan group, Captopril group and control group before and after treatment were detected by ELISA and echocardiography at 4 and 8 weeks after treatment The changes of liver enzymes in bosentan group and captopril group before and after treatment were detected. The exercise tolerance of children was evaluated by the change of 60 m L feeding time. Results The plasma levels of ET-1 and mPAP in bosentan group and captopril group were significantly higher than those in normal control group (P <0.05). The PAP and plasma ET- (P <0.01). The mPAP in captopril group was lower than that before treatment (P <0.05), but there was no significant change in plasma ET-1 level. Bosentan group and captopril The levels of plasma ET-1 and m-PAP in the bosentan group were significantly lower than those in the bosentan group 4 and 8 weeks after treatment (P <0.05) Week 60 m L milk feeding time was significantly shorter than before treatment (P <0.01). Conclusion Bosentan can effectively reduce the average pulmonary artery pressure in children with congenital heart disease, improve exercise tolerance. Short-term use of bosentan in infants with congenital heart disease associated with pulmonary hypertension is safe and effective.