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目的探索聚乙二醇干扰素α-2a在中国健康受试者中的安全性与耐受性。方法选择10名健康受试者,每名受试者皮下注射聚乙二醇干扰素α-2a 180μg,然后进行14 d的安全性观察。结果有9名受试者完成试验,共报告45次不良事件,其中包括发热7次,头痛8次,中性粒细胞降低7次,白细胞降低4次,恶心2次,头晕2次,肌肉酸痛2次,尿蛋白异常2次,尿酮体异常2次,乏力1次,纳差1次,发冷1次,腹部隐痛1次,腰痛1次,双眼刺痛1次,ALP异常1次,血钾异常1次,其中发热、头痛、恶心、头晕、肌肉酸痛、乏力、纳差、发冷、腰痛、白细胞降低、中性粒细胞降低均判断为与用药肯定有关,腹部隐痛、尿蛋白异常、双眼刺痛、ALP异常、血钾异常均判断为与用药可能有关,尿酮体异常被判断为与用药可能无关。结论发热、头痛、中性粒细胞降低及白细胞降低是聚乙二醇干扰素α-2a的常见不良反应,即使在短期给药中也可以明显观察到。
Objective To explore the safety and tolerability of pegylated interferon α-2a in Chinese healthy subjects. Methods Ten healthy subjects were selected. Subjects were injected subcutaneously with 180 μg peginterferon alfa-2a and then observed for safety for 14 days. RESULTS Nine subjects completed the trial and reported a total of 45 adverse events, including 7 episodes of fever, 8 headaches, 7 fewer neutrophils, 4 leukopenia, 2 nausea, 2 dizziness, 2 muscle aches 2 times, urinary protein abnormalities 2 times, urine ketone body abnormalities 2 times, weakness 1 times, anorexia 1 times, chills 1 times, abdomen pain 1 times, back pain 1 times, eyes irritation 1 times, ALP abnormality 1 times, serum potassium Abnormal 1 times, of which fever, headache, nausea, dizziness, muscle soreness, fatigue, anorexia, chills, back pain, leukopenia, neutropenia were determined to be related to medication affirmation, abdominal pain, urinary protein abnormalities, eyes Stinging, abnormal ALP, abnormal serum potassium are judged to be related to the medication, and urine ketone abnormalities may be judged as having nothing to do with medication. Conclusions Fever, headache, neutropenia, and leukopenia are common side effects of peginterferon alfa-2a, which can be clearly observed even in short-term administration.