胃肠安丸临床研究现状及应用特点分析

Analysis of the clinical research status and application characteristics of Weichang’an pill

关键词:  胃肠安丸  临床研究  应用特点  可视化分析

Key words:  Weichang’an pill  clinical research  application characteristics  visual analysis

摘要:

[目的] 系统分析胃肠安丸临床研究现状，为该药的临床研究设计及临床价值定位提供参考。[方法] 系统检索胃肠安丸的临床研究，采用文献计量学等方法对发表信息、研究人群、干预措施、合并用药、结局指标等进行分析。使用Citespace 6.3.R1软件绘制可视化图谱。[结果] 共纳入50篇随机对照试验，共包括51个实施单位，以河北省内三级医疗机构为主；涉及71个关键词，主要围绕其适应病症（功能性消化不良、抗生素相关性腹泻、溃疡性结肠炎、肠系膜淋巴结炎）；治疗组干预方式以西医常规加载治疗为主；研究人群包括成人及儿童；临床结局主要关注临床总有效率、安全性事件、临床症状体征积分、中医症候评分以及血清相关胃肠激素水平、胃肠道功能动力学指标等理化指标。[结论] 胃肠安丸相关临床研究已初具规模，能够支撑其主要适应症的疗效评价，并在一定程度上反映了该药的临床应用特点。但仍存在缺乏系统规划，研究质量较低等问题。

Abstract:

[Objective] To systematically analyze the clinical research status of Weichang’an Pill to provide reference for the clinical research design and clinical value positioning of the drug. [Methods] Clinical studies of Weichang’an Pill were systematically searched，and bibliometrics was used to analyze the publication information， study population，interventions，concomitant medication，and outcome measures. The visualization map was drawn using the CiteSpace 6.3. R1 software. [Results] The study incorporated 50 randomized controlled trials（RCTs）， encompassing 51 implementation units，mainly from tertiary medical institutions in Hebei Province；involving 71 keywords，mainly focusing on its adaptive diseases（functional dyspepsia，antibiotic-associated diarrhea，ulcerative colitis，mesenteric lymphadenitis）；the intervention in the treatment group mainly consisted of conventional Western medicine therapy plus Weichang’an Pill；the study population included adults and children；clinical outcomes mainly focused on the clinical total effective rate，safety events，clinical symptom and sign scores，Traditional Chinese Medicine（TCM） syndrome scores，as well as physico-chemical indicators such as serum-related gastrointestinal hormone levels and gastrointestinal functional motility indices. [Conclusion] The relevant clinical studies of Weichang’an Pill have begun to take shape，which can support the efficacy evaluation of its main indications，and reflect the clinical application characteristics of the drug to a certain extent. However，there are still issues such as a lack of systematic planning and low research quality.