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基因工程干扰素α1b治疗慢性乙型肝炎Ⅲ期临床研究报告 被引量:3

Clinical Phage Ⅲ Observasion of Ricombinant Human Intcrfcron α1b in the Treatment of Chronic Hepatitis B
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摘要 应用赛若金基因工程干扰素α1b治疗慢性乙型肝炎514例,分为400万IU(每日注射)、400万IU(隔日注射)、300万IU(隔日注射)和100万IU加聚肌胞等四组治疗,经3个月治疗,HBeAg阴转率分别为51.4%、42.4%、53.9%和74.1%,HBV DNA阴转率分别为65.8%、61.4%、57.8%和42.9%,ALT复常率分别为57.7%、62.5%、63.3%和72.9%,与Ⅱ期结果相似(P>0.05)。停药3个月~1年随访HBVM结果与疗程结束时亦无显著差异(P>0.05),提示干扰素α1b疗效可以重复,且较稳定。大多数情况下,300万IU隔日用药可取得与400万IU相似疗效,且可大大减轻患者经济负担。100万IU干扰素α1b加聚肌胞等药物联合应用,可能是进一步减少干扰素用量,提高疗效和适合我国目前国情的一种方法,但尚待进一步扩大探讨。其不良反应少而轻,未发现严重毒副反应,易为患者所接受。主要不良反应是一过性发热(34.2%),伴“流感样”症状(18.5%),其他副反应有WBC下降(9.1%),BPC下降(5.4%),少见副反应有轻度脱发(0.6%),皮疹(2.1%),嗜睡(1.4%)和消化道反应(0.4%)。其疗效不逊于国外同类药物,且不良反应较轻,rhIFNα1b可作为乙型肝炎治疗药物之一。 The present study was to investigate the ricombinant human interferon a-1b (rhIFNu-1b) in the treatment of 514 patients with chronic hepatits B.The drug was given at doses of 4Mu(qd), 4Mu(qod).3Mu (qod) and IMu conbined with poly : 1C (qd).respectively.for each group.After 3 mon therapy, the conversion rates from HBeAg positivity to anti-HBe positivity were 51.1% , 42.4% , 53.9% , 74.1 % ; and the HBV DNA negativity rates were 65.8% , 61.4%.57.8%.42.9% ; and the normality rates of serum alanine aminotransferase levels were 57.7% , 62.5%.63.3%and 72.9% , respectively.The states of the former two HBV markers sustained not significantly changed during 3~12 mon follow-up periods, suggestting that the effective effect of rhIFNu-Ib was stable.Our results also showed that the capicity of rhIFNu-1b at a dose of 3Mu(qod) was similar to that of 4Mu(qod).which means less costs.The authers recommended the regimen of IMu of rhIFNu-Ib Combined with poly:IC for the treatment of hepatitis B under the economical consideration.The side effects included-fever (34.2%).common cold-like symptoms (18.5%),leukothrombopenia (7.3% ) ,mild alopecia (0.6 % ).rash ( 2.1% ) ,lethargy(1.4 % ) and gastrointestinal disorders (0.4%).It is indicated that the domestic rhTFNa-be adminstered for the therapy of hepatitis B and its efficacy is parallel to imported ones.
出处 《实用肝脏病杂志》 CAS 1997年第1期10-13,共4页 Journal of Practical Hepatology
关键词 基因工程干扰素α1b 慢性乙型肝炎 临床研究 Hepatitis B Interferon Therapy
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