一项关于单独使用干扰素α-2b以及停用泼尼松后治疗慢性乙型肝炎的随机对照试验。肝炎介入治疗组。

A randomized, controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. The Hepatitis Interventional Therapy Group.

作者信息

Perrillo R P, Schiff E R, Davis G L, Bodenheimer H C, Lindsay K, Payne J, Dienstag J L, O'Brien C, Tamburro C, Jacobson I M, Sampliner R, Feit D, Lefkowitch J, Kuhns M, Meschievitz C, Sanghvi B, Albrecht J, Gibas A

机构信息

St. Louis Veterans Affairs Medical Center, MO 63106.

出版信息

N Engl J Med. 1990 Aug 2;323(5):295-301. doi: 10.1056/NEJM199008023230503.

DOI:10.1056/NEJM199008023230503

PMID:2195346

Abstract

BACKGROUND AND METHODS

Chronic hepatitis B is a common and often progressive liver disorder for which there is no accepted therapy. To assess the efficacy of treatment with interferon, we randomly assigned patients with chronic hepatitis B to one of the following regimens: prednisone for 6 weeks followed by 5 million units of recombinant interferon alfa-2b daily for 16 weeks; placebo followed by 5 million units of interferon daily for 16 weeks; placebo followed by 1 million units of interferon daily for 16 weeks; or observation with no treatment.

RESULTS

Hepatitis B e antigen and hepatitis B viral DNA disappeared from serum significantly more often in the patients given prednisone plus interferon (16 of 44 patients, or 36 percent) or 5 million units of interferon alone (15 of 41; 37 percent) than in the untreated controls (3 of 43; 7 percent; P less than 0.001); the difference between those given 1 million units of interferon (7 of 41; 17 percent) and the controls was not significant. The strongest independent predictor of a response to treatment was the amount of hepatitis B viral DNA in serum at entry (P less than 0.0001). Of the 38 patients who responded to interferon, 33 (87 percent) had normal serum aminotransferase levels after therapy; 11 patients who responded (29 percent), but no controls, lost the hepatitis B surface antigen. Blinded histologic assessment revealed a significant improvement in periportal necrosis in the treated patients (P = 0.03).

CONCLUSIONS

In chronic hepatitis B, treatment with interferon alfa-2b (5 million units per day for 16 weeks) was effective in inducing a sustained loss of viral replication and achieving remission, assessed biochemically and histologically, in over a third of patients. Moreover, in about 10 percent of the patients treated with interferon, hepatitis B surface antigen disappeared from serum.

摘要

背景与方法

慢性乙型肝炎是一种常见且往往会进展的肝脏疾病，目前尚无公认的治疗方法。为评估干扰素治疗的疗效，我们将慢性乙型肝炎患者随机分为以下治疗方案之一：泼尼松治疗6周，随后每日给予500万单位重组干扰素α-2b，共16周；安慰剂治疗，随后每日给予500万单位干扰素，共16周；安慰剂治疗，随后每日给予100万单位干扰素，共16周；或不治疗进行观察。

结果

给予泼尼松加干扰素的患者（44例中的16例，占36%）或仅给予500万单位干扰素的患者（41例中的15例，占37%）血清中乙肝e抗原和乙肝病毒DNA消失的频率显著高于未治疗的对照组（43例中的3例，占7%；P<0.001）；给予100万单位干扰素的患者（41例中的7例，占17%）与对照组之间的差异不显著。对治疗反应最强的独立预测因素是治疗开始时血清中乙肝病毒DNA的量（P<0.0001）。在38例对干扰素治疗有反应的患者中，33例（87%）治疗后血清转氨酶水平正常；11例有反应者（29%），但对照组中无此情况，失去了乙肝表面抗原。盲法组织学评估显示治疗患者的门周坏死有显著改善（P =0.03）。