注射用重组人干扰素α-1b滴鼻治疗小儿病毒性上呼吸道感染的耐受性及安全性研究  

Tolerance and Safety of Intranasal Injection of Recombinant Human Interferon α-1b in the Treatment of Viral Upper Respiratory Tract Infection in Children

作　　者：孙薇[1] 王君霞[1] 郭林梅[1] 徐丽婷 景临林[1] 杜慧[1] 文爱东 

机构地区：[1]兰州军区兰州总医院,兰州730050 [2]第四军医大学第一附属医院药剂科,西安710032

出　　处：《中国药房》2015年第3期325-328,共4页China Pharmacy

摘　　要：目的：观察注射用重组人干扰素α-1b滴鼻治疗小儿病毒性上呼吸道感染的耐受性及安全性。方法：将24例病毒性上呼吸道感染患儿分为单次给药组（18例）和多次给药组（6例）,再随机将单次给药组分为A组（2例）、B组（2例）、C组（6例）、D组（6例）和E组（2例）5个亚组。单次给药A、B、C、D、E组患儿分别给予注射用重组人干扰素α-1b 0.3、0.6、1.0、1.5、2.0μg/kg,5组均给药1次;多次给药组患儿给予注射用重组人干扰素α-1b 1.5μg/kg,每日3次,连用5 d10观察所有患儿给药前后体温、收缩压、舒张压、心率、呼吸频率、白细胞（WBC）、嗜碱性粒细胞绝对值（BASO）、中性粒细胞绝对值（NEUT）、淋巴细胞绝对值（LYMPH）、红细胞（RBC）、血红蛋白（HGB）、丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、总蛋白（TP）、白蛋白（ALB）、尿素氮（BUN）、肌酐（Cr）、尿常规、大便常规检查及不良反应。结果：所有患儿给药前后体温、收缩压、舒张压、心率、呼吸频率、WBC、BASO、NEUT、LYMPH、RBC、HGB、ALT、AST、TP、ALB、BUN、Cr均在正常值范围内,差异均无统计学意义（P〉0.05）;尿常规、大便常规检查均未见异常,且未见严重不良反应发生。结论：注射用重组人干扰素α-1b在0.3~2.0μg/kg范围内滴鼻治疗小儿病毒性上呼吸道感染的耐受性及安全性均较好。推荐以1.5μg/kg为治疗剂量作Ⅱ期临床研究。OBJECTIVE： To observe the tolerance and safety of Recombinant human interferon α-1b for injection in the treatment of viral upper respiratory tract infection in children. METHODS： 24 children with viral upper respiratory tract infection were divided into single administration group （18 cases） and multiple administration group （6 cases）. Single administration group was randomly divided into 5 sub-groups as groups A （2 cases）, B （2 cases）, C （6 cases）, D （6 cases） and E （2 cases） again. Group A, B, C, D, E was given Recombinant human interferon α-1b for injection 0.3 μg/kg, 0.6μg/kg, 1.0 μg/kg, 1.5 μg/kg, 2.0 μg/kg; all of them were given relevant drug one time. Multiple administration group received Recombinant human interferon α-1b for injection 1.5 μg/kg 3 times a day for consecutive 5 days. Body temperature, systolic pressure, diastolic pressure, heart rate, respiratory frequency, white blood cell （WBC）, basophil absolute value （BASO） , neutrophil absolute count （NEUT）, lymphocyte absolute counts （LYMPH）, red blood cell （RBC） , hemoglobin （HGB） , alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, total protein （TP）, albumin （ALB）, blood urea nitrogen （BUN）, creatinine （Cr）, urine routine, stool routine and ADR were observed before and after treatment. RESULTS： Body temperature, systolic pressure, diastolic pressure, heart rate, respirato- ry frequency, WBC, BASO, NEUT, LYMPH, RBC, HGB, ALT, AST, TP, ALB, BUN and Cr of all groups were within the normal range before and after treatment. Both urine routine and stool routine were in normal level. No serious ADR was observed. CONCLUSIONS： Intranasal injection of recombinant human interferon α-1b for injection 0.3-2.0 μg/kg is safe and tolerable in the treatment of viral upper respiratory tract infection in children. The recommended dose for phase Ⅱ clinical trial is 1.5 μg/kg.

关 键 词：注射用重组人干扰素α-1b 儿童 滴鼻治疗 病毒性上呼吸道感染 

分 类 号：R725.6[医药卫生—儿科]