Interferon alfa with or without ribavirin for chronic hepatitis C: systematic review of randomised trials
Interferon alfa with or without ribavirin for chronic hepatitis C: systematic review of randomised trials
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DOI：
10.1136/bmj.323.7322.1151
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发表时间：
2001-11-17
影响因子：
105.7
通讯作者：
Gluud, C
中科院分区：
文献类型：
--
作者：
Kjaergard, LL;Krogsgaard, K;Gluud, C
目的评价干扰素α联合利巴韦林治疗慢性丙型肝炎的疗效和安全性。设计干扰素阿尔塔联合利巴韦林与干扰素α联合治疗慢性丙型肝炎随机对照试验的系统评价。患者是初治（以前没有用干扰素治疗），复发者（暂时响应以前的干扰素治疗），或无应答者（没有响应以前的干扰素治疗）。研究回顾1155参考确定，48个试验6585例患者符合纳入标准。在20项试验中，患者随访至治疗结束，在28项试验中，治疗后随访12-96周。主要结果测量病毒学应答和发病率加死亡率。结果与干扰素相比，联合治疗使初治患者6个月内无持续病毒学应答的风险降低了26（相对危险度0.74，95%置信区间0.70至0.78），复发者33%（0.67，0.57至0.78），无应答者11%（0.89，0.83至0.96）。发病率和死亡率显示出有利于联合治疗的非显著趋势（Peto比值比0.45，0.19至1.06）。联合治疗显著降低了组织学结果未改善的风险，初治患者降低了17%（0.83，0.74至0.93），复发者和无应答者降低了27%（0.73，0.66至0.82）。结论干扰素α联合利巴韦林治疗慢性丙型肝炎患者，无论既往是否接受过治疗，均能显著改善患者的病毒学和组织学应答。因此，联合治疗也可被认为适用于复发者和无应答者。
Objective To assess the efficacy and safety of interferon alfa with or without ribavirin for treatment of chronic hepatitis C.Design Systematic review of randomised trials on interferon alta plus ribavirin combination therapy versus interferon alfa. Patients were naive (not previously treated with interferon), relapsers (transient response to previous interferon therapy), or non-responders (no response to previous interferon therapy).Studies reviewed Of 1155 references identified, 48 trials with 6585 patients met the inclusion criteria. Patients were followed to the end of treatment in 20 trials and in 28 trials for 12-96 weeks after treatment.Main outcome measures Virological response and morbidity plus mortality.Results Compared with interferon, combination therapy reduced the risk of not having a sustained virological response for 6 months by 26% in naive patients (relative risk 0.74, 95% confidence interval 0.70 to 0.78), 33% in relapsers (0.67, 0.57 to 0.78), and 11% in non-responders (0.89, 0.83 to 0.96). Morbidity and mortality showed a non-significant trend in favour of combination therapy (Peto odds ratio 0.45, 0.19 to 1.06). Combination therapy significantly, reduced the risk of not having improvement in results of histology by 17% in naive patients (0.83, 0.74 to 0.93) and by 27% in relapsers and non-responders (0.73, 0.66 to 0.82). The risk of treatment discontinuations was significantly higher after combination therapy (1.28,1.07 to 1.52).Conclusion Treatment with interferon alfa plus ribavirin has a significant beneficial effect on the virological and histological responses of patients with chronic hepatitis C, irrespective of previous treatment. Combination therapy may therefore also be considered appropriate for relapsers and non-responders.