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Cochrane系统评价:聚乙二醇化干扰素联合利巴韦林与干扰素联合利巴韦林治疗慢性丙型肝炎的比较

Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C.

作者信息

Simin M, Brok J, Stimac D, Gluud C, Gluud L L

机构信息

The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

出版信息

Aliment Pharmacol Ther. 2007 May 15;25(10):1153-62. doi: 10.1111/j.1365-2036.2007.03294.x.

Abstract

BACKGROUND

About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy.

AIM

To evaluate the beneficial and harmful effects of pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection.

METHODS

We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, Science Citation Index Expanded and contacted pharmaceutical companies and authors of trials (to March 2005).

RESULTS

We included 18 randomized clinical trials with 4811 patients. Eleven trials (61%) had allocation bias risks and all had assessment bias risk because of lack of blinding. Compared with interferon plus ribavirin, pegylated interferon plus ribavirin had significant beneficial effects on sustained virological response [risk ratio (RR): 0.80; 95% CI: 0.74-0.88]. Data were insufficient to determine impact on long-term outcomes. Pegylated interferon plus ribavirin significantly increased dose reductions (RR: 1.44; 95% CI: 1.14-1.82) and adverse events including neutropenia (RR: 2.25; 95% CI: 1.58-3.21), thrombocytopenia (RR: 2.28; 95% CI: 1.14-4.54), arthralgia (RR: 1.19; 95% CI: 1.05-1.35), and injection-site reaction (RR: 2.56; 95% CI: 1.06-6.22).

CONCLUSIONS

Pegylated interferon plus ribavirin compared with interferon plus ribavirin increased the proportion of patients with sustained virological response, but at the cost of more adverse events.

摘要

背景

全球约有1.7亿患者患有慢性丙型肝炎。聚乙二醇化干扰素联合利巴韦林是目前推荐的治疗方法。

目的

评估聚乙二醇化干扰素联合利巴韦林与干扰素联合利巴韦林治疗慢性丙型肝炎感染的利弊。

方法

我们检索了考克兰图书馆、医学期刊数据库、荷兰医学文摘数据库、拉丁美洲和加勒比卫生科学数据库、科学引文索引扩展版,并联系了制药公司和试验作者(截至2005年3月)。

结果

我们纳入了18项随机临床试验,共4811名患者。11项试验(61%)存在分配偏倚风险,且由于缺乏盲法,所有试验均存在评估偏倚风险。与干扰素联合利巴韦林相比,聚乙二醇化干扰素联合利巴韦林对持续病毒学应答有显著益处[风险比(RR):0.80;95%可信区间(CI):0.74 - 0.88]。数据不足以确定对长期结局的影响。聚乙二醇化干扰素联合利巴韦林显著增加了剂量减少率(RR:1.4

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