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。
关键词： 功能性消化不良；阿考替胺；系统评价
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.
Key words： Functional dyspepsia; Acotiamide; Systematic review
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