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Sofosbuvir联合Velpatasvir治疗1~6基因型慢性丙型肝炎和丙型肝炎肝硬化患者疗效及安全性Meta分析
作者:庄立伟  纪世博  张雨  赵莹莹  全敏  李炜  李贲  程丹颖  段英  欧蔚妮  邢卉春  王笑梅 
单位:首都医科大学附属北京地坛医院 肝三科 北京 100015 
关键词:Sofosbuvir Velpatasvir 肝炎病毒 丙型 疗效 安全性 
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出版年,卷(期):页码:2019,11(2):30-36
摘要:
摘要:目的 探讨Sofosbuvir联合Velpatasvir治疗1~6基因型慢性丙型肝炎和丙型肝炎肝硬化患者的 疗效及安全性。方法 以“Sofosbuvir”、“Velpatasvir”及“HCV”等为检索词,检索2015年1月至 2018年8月在Medline、PubMed、CNKI全文数据库及万方数据库等公开发表的中、英文文献。采用Q 检验法分析研究间的异质性,对纳入文献进行质量评价及数据提取,采用STATA 15.1统计软件进行 Meta分析。结果 依据标准共纳入文献8篇,共计患者2040例。Sofosbuvir联合Velpatasvir治疗1~6基 因型HCV感染(包括失代偿期肝硬化患者、初/经治患者)效果较好,总SVR12为96.35%(95%CI: 94.43%~98.26%)。因不良反应终止治疗者9例(0.3%,95%CI:0.0%~0.6%),发生严重不良 反应60例(2.4%,95%CI:1.2%~3.6%),病死6例(1.5%,95%CI:0.2%~2.8%)。普通不良 反应中常见头痛 [515例(23.1%),95%CI:19.1%~27.1%]、乏力 [443例(21.7%),95%CI: 19.4%~24.0%]、恶心 [243例(11.5%),95%CI:9.1%~13.8%]、鼻咽炎 [140例(8.7%),95%CI: 5.7%~11.7%]及腹泻 [119例(7.0%),95%CI:5.7%~8.2%]等。实验室指标异常发生率较低,主要 为高胆红素血症 [9例(3.4%),95%CI:0.1%~10.6%]、淋巴细胞减少 [24例(1.0%),95%CI: 0.1%~1.9%]、血红蛋白降低 [15例(1.0%),95%CI:0.2%~2.1%]及高血糖 [8例(1.0%), 95%CI:0.1%~2.0%]。结论 Sofosbuvir联合Velpatasvir抗HCV治疗具有泛基因活性,可覆盖1~6基因 型患者,SVR12较高,不良反应较少。
Abstract: Objective To investigate the efficacy and safety of Sofosbuvir combined with Velpatasvir in treatment of chronic hepatitis C and hepatitis C related liver cirrhosis patients with genotype 1~6. Methods A literature search with terms of “Sofosbuvir and Velpatasvir, HCV” was performed across Medline, PubMed, CNKI and WanFang Data from January 2015 to August 2018. Q test was used to analyze the heterogeneity between the studies. The quality evaluation and data extraction of the included literature were carried out and STATA 15.1 was used to perform a Meta-analysis. Results According to the criteria, a total of 8 articles were included in the literature, with a total of 2040 patients. Sofosbuvir combined with Velpatasvir was effective in the treatment of HCV infection with genotype 1~6 (including decompensated cirrhotic patients, initial/menstrual patients). The total rate of sustained virologic response at week 12 (SVR12) was 96.35% (95%CI: 94.43%~98.26%). There were 9 cases (0.3%, 95%CI: 0.0%~0.6%) who discontinued treatment due to adverse events, 60 cases (2.4%, 95%CI: 1.2%~3.6%) had serious adverse events and 6 cases (1.5%, 95%CI: 0.2%~2.8%) died. The most common adverse events were headache [515 cases (23.1%), 95%CI: 19.1%~27.1%], fatigue [443 cases (21.7%), 95%CI: 19.4%~24.0%], nausea [243 cases (11.5%), 95%CI: 9.1%~13.8%], nasopharyngitis [140 cases (8.7%), 95%CI: 5.7%~11.7%] and diarrhea [119 cases (7.0%), 95%CI: 5.7%~8.2%]. The rate of hematologic events was low, mainly including hyperbilirubinemia [9 cases (3.4%), 95%CI: 0.1%~10.6%], lymphocytes [24 cases (1.0%), 95%CI: 0.1%~1.9%), hemoglobin decrease [15 cases (1.0%), 95%CI: 0.2%~2.1%) and hyperglycemia [8 cases (1.0%), 95%CI: 0.1%~2.0%)]. Conclusions Sofosbuvir combined with Velpatasvir anti-HCV therapy had pan-genic antiviral ability in treatment of hepatitis C and hepatitis C related liver cirrhosis patients , which could achieve genotype 1~6 achieved a high rate of SVR12 and a little adverse events.
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