重组人干扰素α2b栓剂的检定及其临床疗效

Quality Control and Clinical Effect of Recombinant Human Interferon α2b Suppository

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 control the quality and study the clinical effect of recombinant human interferon（rhlFN） α2b suppository. Methods Prepare three serial batches of rhIFN α2b suppository. Perform control tests on the suppository and observe its curative effect on cervical erosion in clinical trial,using the commercial rbIFN α2b suppository as control. Results All the quality indexes of rhIFN α2b suppository met the relevant requirements. The effective rate of the suppository in cervical erosion was 74.8% ,which was significantly higher than that of control（60.0% ）. The incidence rates of adverse reactions in test and control groups were 9.1% and 8.3% respectively. Conclusion The prepared rhIFN α2b suppository was of good stability and safety and definite curative effect.