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干扰素治疗对丙型肝炎病毒相关性肝硬化自然史的影响。

Impact of interferon therapy on the natural history of hepatitis C virus related cirrhosis.

作者信息

Gramenzi A, Andreone P, Fiorino S, Cammà C, Giunta M, Magalotti D, Cursaro C, Calabrese C, Arienti V, Rossi C, Di Febo G, Zoli M, Craxì A, Gasbarrini G, Bernardi M

机构信息

Dipartimento di Medicina Interna, Cardioangiologia ed Epatologia, Università di Bologna, Bologna, Italy.

出版信息

Gut. 2001 Jun;48(6):843-8. doi: 10.1136/gut.48.6.843.

Abstract

BACKGROUND

The role of interferon treatment on the natural history of hepatitis C virus related cirrhosis is under debate.

AIM

To evaluate the effect of interferon on the clinical course of compensated hepatitis C virus related cirrhosis.

PATIENTS AND METHODS

Seventy two cirrhotic patients treated with interferon and 72 untreated controls matched treated patients with for quinquennia of age, sex, and Child-Pugh's score were enrolled in a prospective non-randomised controlled trial. Treated patients received leucocytic interferon alfa, with an escalating schedule for 12 months. The incidence and risk (Cox regression analysis) of clinical complications (hepatocellular carcinoma, ascites, jaundice, variceal bleeding, and encephalopathy) and death were calculated.

RESULTS

Over median follow up periods of 55 months for treated and 58 for untreated subjects, seven and nine patients, respectively, died, and 20 and 32, respectively, developed at least one clinical complication (ns). Hepatocellular carcinoma developed in six treated and 19 untreated patients (p=0.018). Seven treated patients showed sustained aminotranferase normalisation and none died or developed complications. Clinical complications were significantly associated with low albumin, bilirubin, and prothrombin activity while hepatocellular carcinoma was significantly related to no treatment with interferon, oesophageal varices, and high alpha fetoprotein levels. By stratified analysis, the beneficial effect of interferon was statistically evident only in patients with baseline alpha fetoprotein levels > or =20 ng/ml.

CONCLUSIONS

Interferon does not seem to affect overall or event free survival of patients with hepatitis C virus related cirrhosis while it seems to prevent the development of hepatocellular carcinoma. Patients who achieved sustained aminotransferase normalisation survived and did not develop any complications during follow up.

摘要

背景

干扰素治疗对丙型肝炎病毒相关性肝硬化自然病程的作用仍存在争议。

目的

评估干扰素对代偿期丙型肝炎病毒相关性肝硬化临床病程的影响。

患者与方法

一项前瞻性非随机对照试验纳入了72例接受干扰素治疗的肝硬化患者以及72例未接受治疗的对照患者,后者在年龄、性别和Child-Pugh评分方面与治疗组患者匹配。治疗组患者接受白细胞干扰素α治疗,采用递增方案,疗程为12个月。计算临床并发症(肝细胞癌、腹水、黄疸、静脉曲张出血和肝性脑病)的发生率和风险(Cox回归分析)以及死亡率。

结果

治疗组和未治疗组的中位随访期分别为55个月和58个月,分别有7例和9例患者死亡,分别有20例和32例患者发生至少一种临床并发症(无显著性差异)。6例接受治疗的患者和19例未接受治疗的患者发生了肝细胞癌(p=0.018)。7例接受治疗的患者转氨酶持续正常,无死亡或发生并发症。临床并发症与低白蛋白、胆红素和凝血酶原活性显著相关,而肝细胞癌与未接受干扰素治疗、食管静脉曲张和高甲胎蛋白水平显著相关。通过分层分析,干扰素的有益作用仅在基线甲胎蛋白水平≥20 ng/ml的患者中具有统计学意义。

结论

干扰素似乎不影响丙型肝炎病毒相关性肝硬化患者的总体生存或无事件生存,而似乎可预防肝细胞癌的发生。转氨酶持续正常的患者在随访期间存活且未发生任何并发症。

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