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伏诺拉生治疗胃食管反流有效性和安全性的Meta分析
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| 篇名： | 伏诺拉生治疗胃食管反流有效性和安全性的Meta分析 |
| TITLE： | Efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease：a meta-analysis |
| 摘要： | 目的 评价伏诺拉生治疗胃食管反流（GERD）的有效性和安全性，为临床用药提供循证依据。方法计算机检索PubMed、theCochraneLibrary、WebofScience、中国知网、万方数据、维普网和中国生物医学文献数据库，收集伏诺拉生（试验组）对比安慰剂或质子泵抑制剂（对照组）的随机对照试验（RCT），检索时限为建库起至2022年6月。筛选文献、提取资料后采用Co‐chrane系统评价员手册5.1.0推荐的偏倚评估工具对纳入文献质量进行评价；采用RevMan5.4软件进行Meta分析、敏感性分析和发表偏倚分析。结果共纳入9项RCT，共计1882例患者。Meta分析结果显示，试验组患者的总体有效率[OR＝1.94，95%CI（1.45，2.58），P＜0.00001]、治愈率[OR＝2.27，95%CI（1.33，3.86），P＝0.003]、缓解率[OR＝1.81，95%CI（1.28，2.55），P＝0.0007]均显著高于对照组；两组患者的药物不良事件发生率及腹泻、鼻咽炎、上呼吸道感染、碱性磷酸酶升高发生率比较，差异均无统计学意义（P＞0.05）。亚组分析结果显示，治疗2周时，试验组患者的治愈率显著高于对照组（P＜0.05）；治疗4、8周时，两组患者的治愈率比较，差异均无统计学意义（P＞0.05）。洛杉矶分级A/B级患者中，两组患者治疗2、4、8周时的治愈率比较，差异均无统计学意义（P＞0.05）；洛杉矶分级C/D级患者中，试验组患者治疗2、4、8周时的治愈率均显著高于对照组（P＜0.05）。敏感性分析和发表偏倚分析结果显示，本研究所得结果稳健且存在发表偏倚的可能性较小。结论伏诺拉生治疗GERD的有效性和安全性均较好。 |
| ABSTRACT： | OBJECTIVE To systematically evaluate the efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease， and to provide evidence-based reference for clinical drug use. METHODS Randomized controlled trials （RCTs） about vonoprazan （trial group） versus placebo or proton pump inhibitor （control group） were searched in PubMed， the Cochrane Library， Web of Science， CNKI， Wanfang， VIP and CBM databases from the inception to June， 2022. After literature screening and data extraction， the qualities of included literature were evaluated with bias assessment tool recommended by Cochrane system evaluator manual 5.1.0. Meta-analysis， sensitivity analysis and publication bias analysis were conducted by using RevMan 5.4 software. RESULTS A total of 9 RCTs were included， involving 1 882 patients. The results of meta-analysis showed that： total response rate [OR＝1.94，95%CI（1.45，2.58），P＜0.000 01]， cure rate [OR＝2.27，95%CI（1.33，3.86），P＝0.003] and remission rate [OR＝1.81，95%CI（1.28， 2.55）， P＝0.000 7] of trial group were significantly higher than control group； there was no significant difference in the incidence of adverse drug events， diarrhea， nasopharyngitis， upper respiratory tract infection and alkaline phosphatase elevation between two groups （P＞0.05）. The results of subgroup analysis showed that cure rate of trial group was significantly higher than control group at 2 weeks of treatment （P＜0.05）； at 4 and 8 weeks of treatment， there was no significant difference in the cure rate between two groups （P＞0.05）. There was no statistically significant difference in the cure rate between two groups at 2， 4 and 8 weeks of treatment among the patients with Los Angeles grade A/B （P＞0.05）； among the patients with Los Angeles grade C/D， the cure rate of patients in the trial group was significantly higher than control group at 2， 4 and 8 weeks of treatment （P＜0.05）. The results of sensitivity analysis and publication bias analysis showed that the results of this study were robust and the possibility of publication bias was small. CONCLUSIONS Vonoprazan has a considerable effectiveness and safety in the treatment of gastroesophageal reflux disease. |
| 期刊： | 2023年第34卷第06期 |
| 作者： | 唐嘉曦；国梦然；樊天斐；王治丹；占美；郑明琳；樊萍 |
| AUTHORS： | TANG Jiaxi，GUO Mengran，FAN Tianfei，WANG Zhidan，ZHAN Mei，ZHENG Minglin，FAN Ping |
| 关键字： | 伏诺拉生；胃食管反流；有效性；安全性；Meta分析 |
| KEYWORDS： | vonoprazan； gastroesophageal reflux disease； |
| 阅读数： | 163 次 |
| 本月下载数： | 6 次 |
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