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目的对重组人干扰素α2b栓剂进行质量检定及临床疗效观察。方法连续试制3批样品,进行各项质控指标的检定及宫颈糜烂的临床疗效观察。结果本品各项检定指标均符合质量要求。治疗组宫颈糜烂的有效率为74·8%,对照组的有效率为60·0%。治疗组和对照组的副反应发生率分别为9·1%和8·3%。结论重组人干扰素α2b栓剂质量稳定,安全性好,疗效确切。
Objective To evaluate the quality of recombinant human interferon α2b suppository and its clinical efficacy. Methods Three batches of samples were continuously prepared and tested for quality control indexes and clinical efficacy of cervical erosion. Results The test items are in line with the quality requirements. The effective rate of cervical erosion was 74.8% in the treatment group and 60.0% in the control group. The incidence of side effects in the treatment and control groups was 9.1% and 8.3%, respectively. Conclusion Recombinant human interferon α2b suppository has stable quality, good safety and definite curative effect.