重组人干扰素α-2b喷雾剂(远策素)在新兵中应用的安全性评价

Safety evaluation of recombinant human interferon α-2b for spray using in recruits

目的评价重组人干扰素α-2b喷雾剂(远策素)在新兵中应用的安全性。方法采用现场流行病学实验方法进行评价,用药5d(喷鼻、咽,180万I U/d),随访10d。以班为单位,整群抽样分为用药组和安慰剂组。结果用药期间用药组出现的不良反应如咳嗽、咳痰、肌肉酸痛、鼻塞、打喷嚏、咽痛、咽干和腹泻症状发生率均高于安慰剂组,其中最高的为鼻塞;而头痛、乏力症状发生率则低于安慰剂组;头晕、腹痛和皮疹症状两组发生率相似,10d内差异均无显著性(P<0.05)。大多数症状的不良反应发生率前5天(用药期)明显高于后5天,多数症状在第一天就达到高峰,而后逐渐下降,用药期过后趋于平稳。结论应用重组人干扰素α-2b喷雾剂(远策素)可增加流感样症状和腹泻症状的发生率,均为可逆性反应,停药后消失。未见其他严重的不良反应发生,在人群中应用是安全的。

Objective To evaluate the safety of recombinant human interferon α- 2b for spray using in recruits. Methods Field survey was conducted to evaluate the safety. The drugs were given for five days （1.8 × 10^6 IU/d） and all subjects were followed up for ten days. Cluster sampling was used to divide all recruits into experimental group and placebo-controlled group. Results During the period of using interferon, the incidence rate of influenza-like symptoms, such as cough, expectoration, muscular ache, snuffle, sneeze, angina, pharynx dryness and diarrhea were higher in experimental group than in placebo group （ P〈0.05）, and the highest was snuffle; but the incidence rates of headache and inertia were lower in experimental group; there were no significant differences in the symptoms of dizziness, abdominal pain and exanthem between experimental group and placebo group （P〈0.05）. Most side effects came to their peak in the first day, then dropped to mild after using interferon. Conclusions Using recombinant human interferon α - 2b for spray could bring influenza-like symptoms and diarrhea which disappeared after withdrawal. It was safe to use human interfernon α - 2b for spay.