重组人干扰素α-2b喷雾剂人群试验的安全性评价  

A field trial for evaluating the safety of recombinant human interferon α-2b for nasal spray

作　　者：陈清[1] 张丽兰 于德宪[1] 喻志爱 刘翼[1] 张丽萍 李志锋[1] 段招军[3] 王斌会[1] 卫学军 胡贵方[1] 刘玉清 楚心唯[1] 韩艳红 吴敏[1] 江晓玲[1] 李建栋[1] 戴迎春[1] 聂军[1] 龙军[1] 朱利[1] 孙素霞[1] 芮勇宇[1] 张定康[1] 俞守义[1] 侯云德[3] 

机构地区：[1]南方医科大学流行病学教研室,广州510515 [2]北京远策药业有限责任公司 [3]病毒生物技术国家工程研究中心北京金迪克生物技术研究所

出　　处：《中华实验和临床病毒学杂志》2005年第3期211-215,共5页Chinese Journal of Experimental and Clinical Virology

基　　金：国家863计划资助(2003AA208206;2003AA208209)

摘　　要：目的评价重组人干扰素α2b喷雾剂(远策素喷雾剂)人群应用预防SARS等呼吸道病毒感染的安全性。方法采用随机、同期平行对照的现场流行病学实验方法进行评价,用药5d,随访10d。结果用药期间,与对照组比较,用药组体温未见异常;用药期间用药组出现的不良反应有头痛(4.83%～7.09%)、头晕(7.17%～11.63%)、乏力(8.55%～15.06%)、肌肉酸痛(4.43%～7.09%)、咽干(12.10%～17.85%)、咽痛(6.25%～8.72%)、腹痛(2.30%～5.50%)、腹泻(2.45%～5.66%)等,不良反应的发生率均高于对照组(P<0.05);不良反应主要出现在用药的前3天;除咽干和乏力外,其他症状在停药后显著下降,其发生率甚至显著低于对照组;用药期间鼻塞、咳嗽和咯痰发生率两组差异无统计学意义;对照组的皮疹发生率显著高于用药组。在整个用药过程中未发现国外志愿者试验发生的血涕现象。结论应用远策素喷雾剂可引起一些较轻的流感样不良反应,但所有症状均为可逆性反应,停药后可消失;未见有其他严重不良反应的发生,在人群中应用是安全的。Objective To evaluate the safety of recombinant human interferon α-2b for nasal spray for the prevention of SARS and other upper respiratory viral infections. Methods Field epidemiologie evaluation was conducted, the design was randomized and had a synchronously parallel control group. In the study, the drugs were given for five days and all subjects were followed up for ten days. Results During the period of using interferon, body temperature of the experimental group was normal compared to the control group. Experimental group had more influenza-like symptoms than the control group （ P 〈 0. 05 ） , such as headache （ 4. 83% -7.09% ） , dizziness （ 7. 17%-11.63% ） , lassitude （ 8.55% -15.06% ） , muscular soreness （4.43%-7.09%） , pharynx dryness （ 12. 10% -17. 85% ） , angina （6. 25% -8. 72% ） , abdominal pain （2. 30%-5.50% ） and diarrhea （2.45% -5.66% ）. Most of side effects reached their peak with in the first 3 days. Except for pharynx dryness, the incidences of all other side effects declined after completion of the use of the trial drug, and incidences of some symptoms in experimental group were lower than those of the control group. There were no significant differences in the symptoms of cough and expectoration between the experimental group and the control group. The incidence of exanthem in the control group was significantly higher than that in the experimental group. The side effect of bloody nasal mucus was not observed in experimental group, which had been reported by other authors in several volunteer studies. Conclusions Using recombinant human interferon α-2b for nasal spray could lead to some influenza-like symptoms, however, all those symptoms were mild , reversible, and relieved after completion of the use of the trial drug. No serious side effects were found during the period of following up. The authors conclude that the drug is safe.

关 键 词：干扰素Α 安全 重组人干扰素Α-2B喷雾剂 安全性评价 人群试验 严重不良反应 呼吸道病毒感染 用药期间 现场流行病学 对照组 

分 类 号：R96[医药卫生—药理学]