摘要
目的评估福辛普利治疗慢性肾脏病患儿的安全性,为临床应用提供依据。方法以确诊为激素耐药型肾病综合征(SRNS)及IgA肾病的患儿为研究对象。分为福辛普利低剂量组、福辛普利中剂量组和对照组。3组均予甲泼尼龙或泼尼松的基础治疗,福辛普利低剂量组和中剂量组分别在基础治疗上加用福辛普利0.3和0.1mg·kg-1.d-1,对照组不予福辛普利治疗,3组均治疗24周。以开始治疗后2、4、8、12、16、20和24周为随访时点,测量患儿血压,行血常规、尿常规、SCr、肌酐清除率(CCr)、血K+和ALT检测;记录眩晕、干咳和水肿等不良事件的发生情况。结果 2008年2月至2009年8月广州市妇女儿童医疗中心肾内科住院诊断为SRNS患儿45例、IgA肾病患儿10例进入结果分析。福辛普利中剂量组22例、福辛普利低剂量组19例,对照组14例。①至观察终点,3组患儿无一例出现低血压。福辛普利中剂量组平均动脉压在治疗第8周时显著下降;福辛普利低剂量组在治疗第12周时平均动脉压明显下降;对照组在治疗期间平均动脉压无显著变化。②将福辛普利中、低剂量组患儿合并按治疗前基础血压分成正常血压组及高血压组,至观察终点正常血压组福辛普利治疗前后收缩压、舒张压和平均动脉压变化不明显;高血压组患儿治疗后收缩压、舒张压及平均动脉压较治疗前均显著降低。③至观察终点,福辛普利中、低剂量组、对照组治疗后24h尿蛋白均较治疗前显著降低,其中福辛普利中剂量组较治疗前下降更显著;3组患儿的SCr、CCr、血K+、WBC、HGB、PLT及ALT均在正常范围。④治疗过程中,福辛普利中剂量组有1例患儿出现轻微干咳。结论福辛普利0.3mg·kg-1.d-1在24周治疗期间未见明显不良反应,对慢性肾脏病患儿的安全性较好。
Objective To evaluate the safety of fosinopril treatment for chronic kidney disease（CKD）in children.Methods Cases with peadiatric CKD（SRNS and IgA nephropathy）whose proteinuria（DPL）was over 50 mg·kg^-1·d^-1were recruited from February,2008 to August,2009 in Guangzhou Children＇s Hospital.Subjects were divided into middle dose treatment group（group1）,lower dose treatment group（group 2）,and control group（group 3）.Group 1 was treated with basic therapies combined with 0.3 mg·kg^-1·d^-1Fos;Group 2 was treated with basic therapies combined with 0.1 mg·kg^-1·d^-1Fos;Group 3 was treated with basic therapies,respectively.Basic therapies were defined as prednisone oral administration combined with large-dose medrol ictus treatment.The patients were recorded regularly for DPL,potassium,Scr,Ccr,blood pressure,liver funtion and blood cell count at 0,2,4,8,12,16,20,24 week,then the data were analyzed by conventional methods.When adverse effect occurred,Fos treatment was stopped.Results After treatment,mean arterial pressure levels of middle dose group and low dose group decreased obviously compared with that before treatment（P〈0.05）.Compared with control group,the mean arterial pressure levels of group 1 and group 2 differed from each other significantly（P〈0.05）.The patients treated with Fos were divided into hypertension and normal blood presure groups at the start of the study.At ending point the mean arterial pressure dropped significantly from（73.9±2.8）mmHg to（79.7± 8.4）mmHg in hypertension group（P〈0.05）,and the normal blood pressure group did not change obviously（P〉0.05）.The potassium and SCr levels of groups 1 and 2 with fosinopril treatment were still normal at the end of study,whereas potassium levels of the two groups were elevated significantly than before treatment.SCr levels of group 1 was higher than the control group（P〈0.05）at the second week.Although the elevation of the CCr level appeared in the first two weeks,the difference was not statistically significant between pre-treatment and after treatment（P〈0.05）.During the study,the blood cell and liver function remained stable,and no case appeared cough and angioedema etc.Conclusions 0.3 mg·kg^-1·d^-1fosinopril is safe and tolerable treatment for children with CKD.
出处
《中国循证儿科杂志》
CSCD
2011年第2期110-114,共5页
Chinese Journal of Evidence Based Pediatrics
关键词
福辛普利
儿童
慢性肾脏病
安全性
Fosinopril
Children
Chronic kidney disease
Safety
