Meta-analysis: mortality and serious adverse events of peginterferon plus ribavirin therapy for chronic hepatitis C.
Meta-analysis: mortality and serious adverse events of peginterferon plus ribavirin therapy for chronic hepatitis C.
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荟萃分析：聚乙二醇干扰素联合利巴韦林治疗慢性丙型肝炎的死亡率和严重不良事件。
DOI：
10.1007/s00535-012-0631-y
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发表时间：
2013
期刊：
影响因子：
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通讯作者：
Yoshida H et al. (6人中5番目)
中科院分区：
文献类型：
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作者：
Nakagawa M;Sakamoto N;Watanabe T;Nishimura-Sakurai Y;Onozuka I;Azuma S;Kakinuma S;Nitta S;Kiyohashi K,Kusano-Kitazume A;Murakawa M;Yoshino K;Itsui Y;Tanaka Y;Mizokami M,Watanabe M;Ochanomizu Liver Conference Study Group;Yoshida H et al. (6人中5番目)
聚乙二醇化干扰素（PEG-IFN）加利巴韦林（RBV）治疗是目前慢性丙型肝炎患者的标准治疗方案。由于严重不良事件发生的频率较低，因此从单一研究中精确确定严重不良事件（SAEs）的风险和死亡率相当困难。本系统综述的目的是在汇总的大样本中评估PEG-IFN/RBV治疗的SAEs发生率和死亡率，并评估SAEs与死亡率和治疗特征之间的关系。方法采用MEDLINE、EMBASE和Cochrane文库进行文献检索，筛选评价PEG-IFN/RBV治疗疗效和安全性的随机对照试验。我们以95%的置信区间（ci）计算粗死亡率和SAE率。结果共纳入80项研究，153个治疗组，27569例患者（14401例患者接受Peg-IFN α -2a/RBV治疗，13168例患者接受Peg-IFN α -2b/RBV治疗）。全因死亡和治疗相关死亡分别为50例（0.18%；95%可信区间[CI] 0.13 - 0.24%）和16例（0.058%;95% CI 0.033 - 0.094%）。原油SAE率为7.08% （95% CI 6.75 - 7.41%）。亚组分析显示，接受PEG-IFN α -2a治疗的患者SAE发生率高于接受PEG-IFN α -2b治疗的患者（7.45% vs. 6.74%），高剂量的患者SAE发生率高于低剂量的PEG-IFN-2a和2b（分别为11.94 vs. 6.99%, 7.10 vs. 5.05%），延长PEG-IFN α -2a治疗的持续时间（bb0 48周）高于标准持续时间（48周）（15.5 vs. 6.67%）。结论PEG-IFN/RBV治疗期间的死亡率可接受，但对于良性疾病的治疗，SAEs的发生率不可忽视，并且受治疗方案的影响。
BackgroundPegylated interferon (PEG-IFN) plus ribavirin (RBV) therapy is the current standard of care for patients with chronic hepatitis C. Determining precisely the risk of serious adverse events (SAEs) and mortality from a single study is rather difficult because of the infrequency of such events. The aim of this systematic review was to assess the rates of SAEs and the mortality of PEG-IFN/RBV therapy in a pooled large sample, and to assess the relationship between SAEs and mortality rates and therapeutic characteristics.MethodsA literature search was conducted using MEDLINE, EMBASE, and the Cochrane Library to identify randomized controlled trials evaluating the efficacy and safety of PEG-IFN/RBV therapy. We calculated the crude mortality and SAE rates with 95 % confidence intervals (CIs).ResultsEighty studies with 153 treatment arms that included 27569 patients were enrolled (14401 patients treated with Peg-IFN alpha-2a/RBV and 13168 with Peg-IFN alpha-2b/RBV). All-cause and treatment-related deaths were observed in 50 (0.18 %; 95 % confidence interval [CI] 0.13–0.24 %) and sixteen (0.058 %; 95 % CI 0.033–0.094 %) patients, respectively. The crude SAE rate was 7.08 % (95 % CI 6.75–7.41 %). Subgroup analysis revealed higher SAE rates in patients receiving PEG-IFN alpha-2a than in those with PEG-IFN alpha-2b (7.45 vs. 6.74 %), and higher SAE rates with higher doses than with the lower doses in PEG-IFN-2a and 2b (11.94 vs. 6.99 %, 7.10 vs. 5.05 %, respectively), and with extended duration (>48 weeks) than with standard duration (48 weeks) (15.5 vs. 6.67 %) in PEG-IFN alpha-2a.ConclusionThe mortality rate during PEG-IFN/RBV therapy was acceptably low, but the rate of SAEs was not negligible in a treatment for a benign disease, and the rate was affected by treatment regimens.