摘要
目的探讨小儿病毒性肺炎的临床治疗方法,旨在提升临床治疗效果。方法予以患儿重组人干扰素α1b治疗,依据其临床资料确定初始剂量及最大剂量,随机选择病毒性肺炎恢复期患儿30例,分别采用单次、连续多次肌内注射的方法给药,动态观测用药后的临床症状、体征并严密观察记录实验期间发生的不良事件。结果所有患儿在给药前后体温、呼吸、心率、收缩压、舒张压、肌酐(Cr)、尿素氮(BUN)、血清白蛋白(ALB)、总蛋白(TP)、谷草转氨酶(AST)、丙氨酸氨基转移酶(ALT)均在正常值范围,差异无统计学意义(P〉0.05);尿常规、大便常规均无异常,且无严重不良反应。结论注射重组人干扰素α1b在0.2~2.0μg/kg范围内耐受性良好,临床II期研究剂量可参考使用1.5μg/kg。
Objective To explore the clinical treatment of infantile viral pneumonia,designed to improve the clinical therapeutic effect. Methods Give children with recombinant human interferon alpha 1b for treatment,on the basis of the preclinical safety data to determine the initial dose and maxima dose,randomly selected 30 cases of children with viral pneumonia at recovery stage,a single or continuous multiple intramuscular injection method was used. Dynamically observe the clinical symptoms, signs and adverse events during the test.Results Body temperature,respiration,heart rate,systolic blood pressure,diastolic blood pressure,serum creatinine( CR),blood urea nitrogen( BUN),serum albumin( ALB),total protein( TP),aspartate amino-transferase( AST),and alanine amino transfer enzyme( alt) were in the normal range both before and after administration,the differences were not statistically significant( P 〉0. 05). Urine routine,stool routine showed no abnormality,and no serious adverse reactions occurred. Conclusions The injection of recombinant human interferon alpha 1B in the range of 0. 2 ~ 2. 0 g / kg is well tolerated,the clinical phase II study dose can be referred to 1. 5g / kg.
出处
《齐齐哈尔医学院学报》
2016年第7期852-854,共3页
Journal of Qiqihar Medical University