阿考替胺治疗功能性消化不良有效性与安全性的系统评价和Meta分析-国际临床研究杂志-CSCIED科技核心评价数据库-手机版

阿考替胺治疗功能性消化不良有效性与安全性的系统评价和Meta分析

The efficacy and safety of acotiamide in the treatment of functional dyspepsia：Systematic review and meta analysis

ES评分 0 浏览量：263 下载量：0

DOI	10.12208/j.ijcr.20250071
刊名	国际临床研究杂志 International Journal of Clinical Research
年，卷(期)	2025, 9(2)
作者	吕游¹,时庆伟¹,陆荣华²*,
作者单位	¹扬州东方医院消化内科江苏扬州,²南通市海门区人民医院消化内科江苏南通
摘要	目的系统评价阿考替胺治疗功能性消化不良的有效性与安全性。方法计算机通过使用检索词“功能性消化不良、阿考替胺、Functional dyspepsia、acotiamide”等，检索PubMed、Embase、web of science、CBM、CNKI、VIP、Wanfang、Cochrane library数据库，搜集与阿考替胺治疗功能性消化不良的相关文献。检索时间为各数据库建库至2024年4月24日。由2名研究员根据纳入与排除标准进行筛选文献、提取资料并评价纳入研究的偏倚风险，采用 RevMan 5. 3 软件Meta 分析。结果共6项随机对照试验纳入定性分析，其中3项纳入定量meta分析，共1360例患者，其中试验组（阿考替胺）681例（总有效例数356例），对照组（安慰剂）679例（总有效例数255例）。在缓解FD总体症状方面，显示阿考替胺治疗组和安慰剂对照组的差异有统计学意义（RR=1.40，95% CI 1.24 ~ 1.57，P<0.05）。在不良反应方面，试验组与对照组的不良反应发生率无明显差别。结论阿考替胺能有效改善功能性消化不良的总体症状，其疗效优于安慰剂，不良反应较少。然而需要更多高质量的随机对照试验来检验。
Abstract	Objective To systematically evaluate the efficacy and safety of acotiamide in the treatment of functional dyspepsia. Methods The computer conducted searches in the PubMed, Embse, web of science, CBM, CNKI, VIP, Wanfang, Cochrane library database by using the key words "functional dyspepsia, acotiamide", etc., to collect the relevant literature on the treatment of functional dyspepsia with acotiamide. The retrieval time is from the establishment of each database to March 24, 2024. According to the inclusion and exclusion criteria, two researchers screened the literature, extracted data and evaluated the risk of bias of the included studies. Revman 5.3 software was used for meta analysis. Results A total of RCTs were included in the qualitative analysis, 3 of which were included in the quantitative meta-analysis, with a total of 1360 patients, including 681 cases in the experimental group (acotiamide) (356 total effective cases) and 679 cases in the control group (placebo) (255 total effective cases). In terms of alleviating the overall symptoms of FD ,it showed that there was a statistically significant difference between the acotiamide treatment group and the placebo control group (RR=1.40, 95% CI 1.24 ~ 1.57, P<0.05). In terms of adverse reactions, there was no significant difference in the incidence of adverse reactions between the experimental group and the control group. Conclusion Acotiamide can effectively improve the overall symptoms of functional dyspepsia, and its curative effect is better than that of placebo, with fewer adverse reactions. However, more high-quality randomized controlled trials are needed to test.
关键词	功能性消化不良；阿考替胺；系统评价
KeyWord	Functional dyspepsia; Acotiamide; Systematic review
基金项目
页码	46-54

参考文献
相关文献

[1] Tack, J., et al., Functional gastroduodenal disorders. Gastroenterology, 2006. 130(5): p. 1466-79.
[2] Ford, A.C., et al., Global prevalence of, and risk factors for, uninvestigated dyspepsia: a meta-analysis. Gut, 2015. 64(7): p. 1049-57.
[3] Aziz, I., et al., Epidemiology, clinical characteristics, and associations for symptom-based Rome IV functional dyspepsia in adults in the USA, Canada, and the UK: a cross-sectional population-based study. Lancet Gastroenterol Hepatol, 2018. 3(4): p. 252-262.
[4] Oshima, T., Functional Dyspepsia: Current Understanding and Future Perspective. DIGESTION, 2024. 105(1): p. 26-33.
[5] Kindt, S. and J. Tack, Impaired gastric accommodation and its role in dyspepsia. Gut, 2006. 55(12): p. 1685-91.
[6] Nowlan, M.L. and L.J. Scott, Acotiamide: first global approval. Drugs, 2013. 73(12): p. 1377-83.
[7] Shrestha, D.B., et al., Acotiamide and Functional Dyspepsia: A Systematic Review and Meta-Analysis. Cureus, 2021. 13(12): p. e20532.
[8] Sterne, J.A.C., et al., RoB 2: a revised tool for assessing risk of bias in randomised trials. Bmj, 2019. 366: p. l4898.
[9] Tack, J., et al., A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterology and motility, 2009. 21(3): p. 272‐280.
[10] Matsueda, K., et al., A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut, 2012. 61(6): p. 821-828.
[11] Kusunoki, H., et al., Therapeutic efficacy of acotiamide in patients with functional dyspepsia based on enhanced postprandial gastric accommodation and emptying: Randomized controlled study evaluation by real-time ultrasonography. Neurogastroenterology and Motility, 2012. 24(6): p. 540-e251.
[12] Talley, N.J., et al., A novel acetylcholine esterase inhibitor acotiamide hydrochloride (YM443) in functional dyspepsia: Efficacy in a randomized, double-blind, placebo-controlled dose ranging trial. GASTROENTEROLOGY, 2008. 134(4): p. A157-A158.
[13] Nakamura, K., et al., A double-blind placebo controlled study of acotiamide hydrochloride for efficacy on gastrointestinal motility of patients with functional dyspepsia. Journal of Gastroenterology, 2017. 52(5): p. 602-610.
[14] Matsueda, K., et al., Clinical trial: dose-dependent therapeutic efficacy of acotiamide hydrochloride (Z-338) in patients with functional dyspepsia - 100 mg t.i.d. is an optimal dosage. Neurogastroenterology and motility, 2010. 22(6): p. 618‐e173.
[15] Nakamura, K., et al., A double-blind placebo controlled study of acotiamide hydrochloride for efficacy on gastrointestinal motility of patients with functional dyspepsia (vol 52, pg 602, 2017). JOURNAL OF GASTROENTEROLOGY, 2021. 56(2): p. 191-191.
[16] Ogishima, M., et al., Z-338 facilitates acetylcholine release from enteric neurons due to blockade of muscarinic autoreceptors in guinea pig stomach. J Pharmacol Exp Ther, 2000. 294(1): p. 33-7.
[17] Xiao, G., et al., Efficacy and safety of acotiamide for the treatment of functional dyspepsia: systematic review and meta-analysis. ScientificWorldJournal, 2014. 2014: p. 541950.
[18] Masuy, I., et al., Acotiamide affects antral motility, but has no effect on fundic motility, gastric emptying or symptom perception in healthy participants. Neurogastroenterology and Motility, 2019. 31(4).
[19] Matsunaga, Y., et al., Acotiamide hydrochloride (Z-338), a new selective acetylcholinesterase inhibitor, enhances gastric motility without prolonging QT interval in dogs: Comparison with cisapride, itopride, and mosapride. Journal of Pharmacology and Experimental Therapeutics, 2011. 336(3): p. 791-800.
[20] Sinha, S., et al., Efficacy and Safety of Acotiamide Versus Mosapride in Patients With Functional Dyspepsia Associated With Meal-Induced Postprandial Distress Syndrome: A Phase III Randomized Clinical Trial. CUREUS JOURNAL OF MEDICAL SCIENCE, 2021. 13(9).
[21] Ctri, A Study to Evaluate Efficacy and Safety of fixed dose of Acotiamide plus Pantoprazole Capsule Compared to Pantoprazole tablet in patients with Acid reflux and Functional Dyspepsia. https://trialsearch.who.int/Trial2.aspx? TrialID=CTRI/2023/04/051516, 2023.
[22] Shinozaki, S., et al., Vonoprazan Therapy is as Effective for Functional Dyspepsia without Heartburn as Acotiamide Therapy. J Gastrointestin Liver Dis, 2023. 32(1): p. 23-29.
[23] Tack, J., et al., Long-term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open-label safety trial. Neurogastroenterology and Motility, 2018. 30(6).

引用本文

吕游,时庆伟,陆荣华*. 阿考替胺治疗功能性消化不良有效性与安全性的系统评价和Meta分析 [J]. 国际临床研究杂志. 2025; 9; (2). 46 - 54.

文献评论

相关学者

相关机构