重组人干扰素α2b喷雾剂的抗病毒药效评价及临床观察  

Antivirus effects and clinical evaluation of recombinant human interferon α2b spray

作　　者：曹琳[1,2] 张磊[3] 田莉[4] 邓杰[4] 

机构地区：[1]大学化工学院制药工程系,天津300100 [2]诺和诺德(中国)制药有限公司 [3]细胞产品国家工程研究中心,天津300457 [4]天津华立达生物工程有限公司,300457

出　　处：《中国医药生物技术》2011年第5期336-340,共5页Chinese Medicinal Biotechnology

基　　金：天津市科技发展计划项目资金(033104611)

摘　　要：目的研究重组人干扰素α2b喷雾剂抑制单纯疱疹病毒、流感病毒、SARS冠状病毒有效浓度范围,为临床研究提供依据并进行治疗病毒性皮肤疾病临床验证。方法采用细胞病变抑制法研究重组人干扰素α2b喷雾剂抑制单纯疱疹病毒HSV-1及HSV-2攻击Vero细胞,抑制流感甲型及乙型病毒攻击人胚肾细胞,抑制SARS冠状病毒攻击Vero细胞的体外抗病毒作用。采用多中心、随机双盲临床试验评价重组人干扰素α2b喷雾剂对流感甲型及乙型病毒、尖锐湿疣的治疗效果。结果重组人干扰素α2b喷雾剂抑制单纯疱疹病毒HSV-1及HSV-2对Vero细胞的攻击的半数有效浓度(IC50)分别为81.2IU/ml和390.0IU/ml;重组人干扰素α2b喷雾剂抑制流感甲型及乙型病毒对人胚肾细胞攻击的IC50分别为534.1IU/ml和3645.5IU/ml;抑制SARS冠状病毒对Vero细胞攻击的IC50为11.77IU/ml。多中心、随机、双盲的临床研究表明,重组人干扰素α2b喷雾剂治疗单纯疱疹的有效率为89.09%,治疗尖锐湿疣有效率为22.0%,治愈率为17.0%,患者均未见明显不良反应。结论体外实验表明重组人干扰素α2b喷雾剂对单纯疱疹病毒、流感病毒、SARS冠状病毒有显著抑制作用,临床研究表明重组人干扰素α2b喷雾剂作为蛋白经皮给药制剂可用于单纯疱疹和尖锐湿疣的临床治疗。Objective Studies on antiviral effect of recombinant human interferon alpha 2b spray on herpes, influenza virus, SARS coronary virus, and providing basis for the treatment of viral Dermal Diseases. Methods The inhibitory effect of human interferon alpha 2b spray on herpes simplex virus HSV-1 and HSV-1 attacking Vero cells, influenza virus type I and type II attacking HEK human embryo kidney cells, and SARS coronary virus attacking Vero cells were tested with cytopathic effect inhibition assay in vitro. The therapeutic effect of recombinant human interferon-alpha 2b spray on herpes simplex and condyloma acuminatum were evaluated with multicenter, randomized, double-blind clinical trials. Results The half maximal inhibitory concentration （IC50） values of recombinant human interferon alpha 2b spray were assayed. The IC50 values on herpes simplex virus HSV-1 and HSV-1 attacking Vero cells were 81.2 IU/ml and 390.0 IU/ml respectively. The IC50 values on influenza virus type I and type II attacking HEK human embryo kidney cells were 534.1 IU/ml and 3645.5 IU/ml respectively. The IC50 value on SARS coronary virus attacking Vero cells was 11.77 IU/ml. The multicenter, randomized double-blind clinical studies on recombinant human interferon-alpha 2b spray have been accomplished. The total effective rate on treatment of herpes simplex was 89.09%. The total effective rate on treatment of condyloma acuminatum was 22.0%, and the curatives rate was 17.0%. No serious adverse reactions have been observed. Conclusions The CPE studies show that recombinant human interferon alpha 2b spray has significant antiviral effects on herpes simplex virus, influenza virus and SARS coronary virus. The clinical studies show that recombinant human interferon alpha 2b spray can be used for clinical treatment of herpes simplex and condyloma acuminatum as a new transdermal drug delivery protein preparation.

关 键 词：干扰素Α-2B 投药 皮肤 单纯疱疹病毒属 尖锐湿疣 

分 类 号：R97[医药卫生—药品]