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聚乙二醇化干扰素/利巴韦林联合疗法对“真实世界”慢性丙型肝炎病毒感染患者的疗效。

Effectiveness of pegylated interferon/ribavirin combination in 'real world' patients with chronic hepatitis C virus infection.

作者信息

Borroni G, Andreoletti M, Casiraghi M A, Ceriani R, Guerzoni P, Omazzi B, Terreni N, Salerno F

机构信息

Unità Organizzativa Alcoldipendenze, ASL Provincia di Milano 1, Abbiategrasso, Milan, Italy.

出版信息

Aliment Pharmacol Ther. 2008 May;27(9):790-7. doi: 10.1111/j.1365-2036.2008.03657.x. Epub 2008 Feb 21.

Abstract

BACKGROUND

Clinical trials have shown that the combination of pegylated interferon/ribavirin induces a sustained virological response in 54-63% of patients with chronic hepatitis C virus infection, but its effectiveness in day-to-day clinical practice is less clear.

AIM

To verify if the efficacy of pegylated interferon/ribavirin combination in 'real world' patients is comparable to that observed in trials. Methods The medical records of 397 consecutive naïve patients with chronic hepatitis C virus infection treated with pegylated interferon/ribavirin combination in nontertiary hospital settings were reviewed in order to assess the response to anti-viral treatment.

RESULTS

The sustained virological response rate achieved in this population was similar to that recorded in registration trials (total population: 64%; genotype 1: 46%; genotypes 2-3: 84%). Also, the premature discontinuation rate (15%) was similar to that observed in registration trials, but there were fewer dose reductions in one or both medications (26%). We confirmed the association between adherence and sustained virological response among the patients infected with hepatitis C virus genotype 1 who were treated for > or =80% of the planned duration of treatment.

CONCLUSION

The effectiveness of pegylated interferon/ribavirin therapy and factors predicting an sustained virological response in everyday clinical practice mirror those reported in randomized-controlled studies.

摘要

背景

临床试验表明,聚乙二醇化干扰素/利巴韦林联合用药可使54%至63%的慢性丙型肝炎病毒感染患者获得持续病毒学应答,但其在日常临床实践中的有效性尚不清楚。

目的

验证聚乙二醇化干扰素/利巴韦林联合用药在“现实世界”患者中的疗效是否与试验中观察到的疗效相当。方法回顾了在非三级医院环境中接受聚乙二醇化干扰素/利巴韦林联合治疗的397例初治慢性丙型肝炎病毒感染患者的病历,以评估抗病毒治疗的反应。

结果

该人群达到的持续病毒学应答率与注册试验中记录的相似(总体人群:64%;基因1型:46%;基因2 - 3型:84%)。此外,提前停药率(15%)与注册试验中观察到的相似,但一种或两种药物的剂量减少情况较少(26%)。我们证实了在接受治疗时间≥计划治疗时长80%的丙型肝炎病毒基因1型感染患者中,依从性与持续病毒学应答之间的关联。

结论

聚乙二醇化干扰素/利巴韦林治疗的有效性以及预测日常临床实践中持续病毒学应答的因素与随机对照研究中报告的情况相符。

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