基于“目标试验模拟”框架开展方氏头针治疗卒中后认知功能障碍的真实世界研究探索  

Exploring RWS on Fang's Scalp Acupuncture for PSCI Based on a TTE Framework

作　　者：武纹帆 童艳杰 安军明[2] 雷欢 曹坤 马阿利 WU Wenfan;TONG Yanjie;An Junming;LEI Huan;CAO Kun;MA Ali(Shaanxi University of Chinese Medicine,Xianyang 712046,China;The Fifth Clinical Medical College of Shaanxi University of Chinese Medicine,Xi'an 710021,China)

机构地区：[1]陕西中医药大学,陕西咸阳712046 [2]陕西中医药大学第五临床医学院,陕西西安710021

出　　处：《针灸临床杂志》2025年第3期5-10,共6页Journal of Clinical Acupuncture and Moxibustion

基　　金：国家自然科学基金,编号:11974237;陕西省中医药管理局重点科学研究项目,编号:2021-01-22-007;陕西省中医药管理局方氏头针重点研究室项目,编号:[2018]32号;西安市科技计划项目,编号:23YXYJ0007;西安英才计划项目,编号:XAYC200048;西安市卫生健康委员会卫生科研人才项目,编号:2021yb02。

摘　　要：随着医疗大数据的不断普及,真实世界研究(RWS)已成为临床研究的大趋势,方氏头针作为中国独有的特色头针流派之一,前期研究表明对卒中后认知功能障碍(PSCI)有着显著的改善作用。但现有研究存在外部真实性较差、证据不充分等问题,因此推广性并不强,RWS为此提供了契机,但也存在诸多局限,如混杂偏倚及设计缺陷等。近年来,“目标试验模拟(TTE)”作为一种极具前景的新型真实世界框架被正式确立,其突出优势是具有高度的透明性,正确模拟时能得到与随机对照试验(RCT)相似的估计值,最大限度上解决RWS中的研究设计及分析数据产生的偏倚问题,备受国内外研究者的青睐。采用TTE真实世界研究框架或许可以为方氏头针治疗PSCI的有效性、安全性和卫生经济学价值提供新的试验角度,从而提供更多真实世界证据,进一步充实、验证前期RCT得到的证据。Objective:With the increasing availability of medical big data,real-world study(RWS)has become a major trend in clinical studies.Fang's scalp acupuncture,a distinctive school of scalp acupuncture unique to China,has demonstrated a significant efficacy in improving post-stroke cognitive impairment(PSCI)in previous studies.However,existing research suffers from limitations such as poor external validity and insufficient evidence,which reduces its generalizability.RWS offers an opportunity to address theses issues but also presents challenges,including confounding bias and design flaws.In recent years,target trial emulation(TTE)has emerged as a promising new framework for RWS.Its key advantage lies in its high degree of transparency and its ability to provide estimates comparable to those from randomized controlled trials(RCTs)when properly implemented.This approach minimizes biases arising from study design and data analysis in RWS,making it highly regarded by researchers worldwide.Adopting the TTE framework for RWS may offer a new perspective on evaluating the effectiveness,safety,and health-economic value of Fang's scalp acupuncture in treating PSCI.By doing so,it could provide more robust real-world evidence,further substantiating and validating findings from earlier RCTs.

关 键 词：卒中 认知功能障碍 方氏头针 真实世界研究 目标试验模拟研究 

分 类 号：R246.6[医药卫生—针灸推拿学]