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口服胸腺提取物用于曾接受干扰素治疗的慢性丙型肝炎患者。一项随机、双盲、安慰剂对照试验。

Oral thymic extract for chronic hepatitis C in patients previously treated with interferon. A randomized, double-blind, placebo-controlled trial.

作者信息

Raymond R S, Fallon M B, Abrams G A

机构信息

University of Alabama at Birmingham, 35294-0007, USA.

出版信息

Ann Intern Med. 1998 Nov 15;129(10):797-800. doi: 10.7326/0003-4819-129-10-199811150-00009.

DOI:10.7326/0003-4819-129-10-199811150-00009
PMID:9841585
Abstract

BACKGROUND

Hepatitis C is an important cause of chronic liver disease. It is claimed that Complete Thymic Formula, an over-the-counter herbal dietary supplement, is beneficial for patients with hepatitis C.

OBJECTIVE

To evaluate the efficacy and safety of Complete Thymic Formula.

DESIGN

Randomized, double-blind, placebo-controlled trial.

SETTING

Tertiary referral center.

PATIENTS

38 patients with hepatitis C who did not respond to or were intolerant of interferon therapy.

INTERVENTION

Complete Thymic Formula for 3 to 6 months or placebo for 3 months.

MEASUREMENTS

Serial measurements of hepatitis C virus (HCV) RNA titers.

RESULTS

No differences were noted at 3 months between the placebo group (n = 13) and the treatment group (n = 19) in mean HCV RNA titers (4.06 +/- 1.52 x 10(6) copies/mL compared with 3.48 +/- 1.92 x 10(6) copies/mL; P > 0.2). The 19 patients who completed 6 months of treatment with Complete Thymic Formula remained positive for HCV, and their mean HCV RNA titers were similar at 6 months and at baseline (2.78 +/- 1.96 x 10(6) copies/mL compared with 3.12 +/- 1.94 x 10(6) copies/mL; P > 0.2).

CONCLUSIONS

Complete Thymic Formula did not benefit patients who had previously received interferon therapy. Patients should be advised about use of this over-the-counter compound.

摘要

背景

丙型肝炎是慢性肝病的一个重要病因。有一种非处方草本膳食补充剂——全胸腺配方,据称对丙型肝炎患者有益。

目的

评估全胸腺配方的疗效和安全性。

设计

随机、双盲、安慰剂对照试验。

地点

三级转诊中心。

患者

38例对干扰素治疗无反应或不耐受的丙型肝炎患者。

干预措施

服用全胸腺配方3至6个月或服用安慰剂3个月。

测量指标

连续测量丙型肝炎病毒(HCV)RNA滴度。

结果

安慰剂组(n = 13)和治疗组(n = 19)在3个月时的平均HCV RNA滴度无差异(分别为4.06 +/- 1.52 x 10(6)拷贝/毫升和3.48 +/- 1.92 x 10(6)拷贝/毫升;P > 0.2)。完成6个月全胸腺配方治疗的19例患者HCV仍为阳性,其6个月时的平均HCV RNA滴度与基线时相似(分别为2.78 +/- 1.96 x 10(6)拷贝/毫升和3.12 +/- 1.94 x 10(6)拷贝/毫升;P > 0.2)。

结论

全胸腺配方对先前接受过干扰素治疗的患者没有益处。应告知患者关于这种非处方化合物的使用情况。

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