Efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease： a meta-analysis

TANG Jiaxi; GUO Mengran; FAN Tianfei; WANG Zhidan; ZHAN Mei; ZHENG Minglin; FAN Ping

doi:10.6039/j.issn.1001-0408.2023.06.18

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Efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease： a meta-analysis

更新时间：2023-03-24

- Efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease： a meta-analysis
- ZHONGGUO YAOFANG Vol. 34, Issue 6, Pages: 735-739(2023)
- 作者机构：
  
  四川大学华西医院临床药学部，成都　610041
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.06.18
  CLC： R975
- Published：30 March 2023，
  
  Received：26 July 2022，
  
  Revised：06 February 2023，
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唐嘉曦,国梦然,樊天斐等.伏诺拉生治疗胃食管反流有效性和安全性的Meta分析 ^Δ[J].中国药房,2023,34(06):735-739.

TANG Jiaxi,GUO Mengran,FAN Tianfei,et al.Efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease： a meta-analysis[J].ZHONGGUO YAOFANG,2023,34(06):735-739.
唐嘉曦,国梦然,樊天斐等.伏诺拉生治疗胃食管反流有效性和安全性的Meta分析 ^Δ[J].中国药房,2023,34(06):735-739. DOI： 10.6039/j.issn.1001-0408.2023.06.18.

TANG Jiaxi,GUO Mengran,FAN Tianfei,et al.Efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease： a meta-analysis[J].ZHONGGUO YAOFANG,2023,34(06):735-739. DOI： 10.6039/j.issn.1001-0408.2023.06.18.

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、the Cochrane Library、Web of Science、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Cochrane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RevMan 5.4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1 882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），

＜0.000 01]、治愈率[OR＝2.27，95%CI（1.33，3.86），

＝0.003]、缓解率[OR＝1.81，95%CI（1.28，2.55），

＝0.000 7]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（

＞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（

＜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（

＞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（

＞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（

＜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），

＜0.000 01]， cure rate [OR＝2.27，95%CI（1.33，3.86），

＝0.003] and remission rate [OR＝1.81，95%CI（1.28， 2.55），

＝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 （

＞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 （

＜0.05）； at 4 and 8 weeks of treatment， there was no significant difference in the cure rate between two groups （

＞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 （

＞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 （

＜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.

关键词

伏诺拉生胃食管反流有效性安全性Meta分析

Keywords

gastroesophageal reflux diseaseeffectivenesssafetymeta-analysis

references

梁笑楠，战蓉蓉，张晓岚. 《2020年中国胃食管反流病专家共识》解读[J]. 河北医科大学学报，2021，42（8）：869-871，925.

NIRWAN J S，HASAN S S，BABAR Z U，et al. Global prevalence and risk factors of gastro-oesophageal reflux disease（GORD）：systematic review with meta-analysis[J]. Sci Rep，2020，10（1）：5814.

ASHIDA K，IWAKIRI K，HIRAMATSU N，et al. Maintenance for healed erosive esophagitis：phase Ⅲ comparison of vonoprazan with lansoprazole[J]. World J Gastroenterol，2018，24（14）：1550-1561.

中华医学会消化病学分会. 2020年中国胃食管反流病专家共识[J]. 中华消化杂志，2020，40（10）：649-663.

李卉，张宏亮，黄振光. 伏诺拉生治疗酸相关性疾病的研究进展[J]. 中国新药与临床杂志，2022，41（8）：459-465.

SUGANO K. Vonoprazan fumarate，a novel potassium-competitive acid blocker，in the management of gastroesophageal reflux disease：safety and clinical evidence to date[J]. Therap Adv Gastroenterol，2018，11：1756283X17745776.

KAWAMI N，HOSHINO S，HOSHIKAWA Y，et al. Pathogenesis of potassium-competitive acid blocker-resistant non-erosive reflux disease[J]. Digestion，2018，98（3）：194-200.

IWAKIRI K，SAKURAI Y，SHIINO M，et al. A rando-mized，double-blind study to evaluate the acid-inhibitory effect of vonoprazan（20 mg and 40 mg）in patients with proton-pump inhibitor-resistant erosive esophagitis[J]. Therap Adv Gastroenterol，2017，10（6）：439-451.

SAKURAI Y，MORI Y，OKAMOTO H，et al. Acid-inhibitory effects of vonoprazan 20 mg compared with esomeprazole 20 mg or rabeprazole 10 mg in healthy adult male subjects：a randomised open-label cross-over study[J]. Aliment Pharmacol Ther，2015，42（6）：719-730.

KINOSHITA Y，SAKURAI Y，TAKABAYASHI N，et al. Efficacy and safety of vonoprazan in patients with nonerosive gastroesophageal reflux disease：a randomized，placebo-controlled，phase 3 study[J]. Clin Transl Gastroenterol，2019，10（11）：e00101.

张爱玲，孟海阳，杨莉萍，等. 托法替布治疗中、重度银屑病的疗效及安全性的系统评价和Meta分析[J]. 中国药学杂志，2019，54（8）：665-670.

OSHIMA T，ARAI E，TAKI M，et al. Randomised clinical trial：vonoprazan versus lansoprazole for the initial relief of heartburn in patients with erosive oesophagitis[J]. Aliment Pharmacol Ther，2019，49（2）：140-146.

XIAO Y L，ZHANG S T，DAI N，et al. Phase Ⅲ，randomised，double-blind，multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis[J]. Gut，2020，69（2）：224-230.

ASHIDA K，SAKURAI Y，NISHIMURA A，et al. Randomised clinical trial：a dose-ranging study of vonoprazan，a novel potassium-competitive acid blocker，vs. lansoprazole for the treatment of erosive oesophagitis[J]. Aliment Pharmacol Ther，2015，42（6）：685-695.

ASHIDA K，SAKURAI Y，HORI T，et al. Randomised clinical trial：vonoprazan，a novel potassium-competitive acid blocker，vs. lansoprazole for the healing of erosive oesophagitis[J]. Aliment Pharmacol Ther，2016，43（2）：240-251.

SAKURAI K，SUDA H，FUJIE S，et al. Short-term symptomatic relief in gastroesophageal reflux disease：a comparative study of esomeprazole and vonoprazan[J]. Dig Dis Sci，2019，64（3）：815-822.

杜明阳，韩宇，张彩凤. 伏诺拉生与雷贝拉唑治疗反流性食管炎的临床疗效比较[J]. 广西医学，2022，44（5）：484-486，495.

黄博，崔德军，赵寻，等. 伏诺拉生治疗难治性反流性食管炎的临床疗效及安全性[J]. 临床合理用药杂志，2021，14（25）：18-20.

吴明方，杨娟，杨江平. 反流性食管炎老年患者使用伏诺拉生片治疗的疗效分析[J]. 医学美学美容，2021，30（2）：82-83.

汪忠镐，吴继敏，胡志伟，等. 中国胃食管反流病多学科诊疗共识[J/OL]. 中华胃食管反流病电子杂志，2020，7（1）：1-28[2022-06-30]. https：//kns.cnki.net/kcms2/article/abstract?v=3uoqIhG8C44YLTlOAiTRKibYlV5Vjs7iy_Rp-https://kns.cnki.net/kcms2/article/abstract?v=3uoqIhG8C44YLTlOAiTRKibYlV5Vjs7iy_Rp-

ms2pqwbFRRUtoUImHRnLiR5NHSRFNbPhTquU8t5wt-3rkvYC_HUdwmXOFFZMr&uniplatform=NZKPT. DOI：10.3877/cma.j.issn.2095-8765.2020.01.001http://dx.doi.org/10.3877/cma.j.issn.2095-8765.2020.01.001.

张苑，朱晏，刘治恺，等. 新型抑酸药物伏诺拉生在幽门螺杆菌治疗中的应用进展[J]. 实用医学杂志，2021，37（24）：3218-3222.

JENKINS H，SAKURAI Y，NISHIMURA A，et al. Randomised clinical trial：safety，tolerability，pharmacokine-tics and pharmacodynamics of repeated doses of TAK-438（vonoprazan），a novel potassium-competitive acid blocker，in healthy male subjects[J]. Aliment Pharmacol Ther，2015，41（7）：636-648.

RICHTER J E，KAHRILAS P J，JOHANSON J，et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis：a randomized controlled trial[J]. Am J Gastroenterol，2001，96（3）：656-665.

CASTELL D O，KAHRILAS P J，RICHTER J E，et al. Esomeprazole（40 mg）compared with lansoprazole（30 mg）in the treatment of erosive esophagitis[J]. Am J Gastroenterol，2002，97（3）：575-583.

LABENZ J，ARMSTRONG D，LAURITSEN K，et al. A randomized comparative study of esomeprazole 40 mg versus pantoprazole 40 mg for healing erosive oesopha-gitis：the EXPO study[J]. Aliment Pharmacol Ther，2005，21（6）：739-746.

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