1990~2020年我国冠心病中医证的流行病学调查研究概况

Research Situation of Traditional Chinese Medicine Clinical Epidemiological Investigation of Coronary Heart Disease in China from 1990 to 2020

目的:了解1990~2020年近30年来我国冠心病中医证的流行病学调查研究概况。方法:系统检索CNKI、VIP、WANFANG DATA、PubMed等数据库,纳入我国冠心病中医证的流行病学调查研究文献,对其调查目的、调查对象、调查方法及主要调查结果等进行描述统计。根据NICE推荐的研究质量评价标准以及STROBE声明第四版对纳入文献的方法学质量和报告质量进行评价。结果:①最终纳入139篇目标文献,最早发表于1992年,2007~2020年之间发表130篇(93.5%);调查地区涵盖全国28个省市自治区,主要集中在华北(44.6%)、中南(44.6%)、华东(33.8%)共纳入100546例冠心病患者,累计覆盖707个研究中心,住院或门诊患者占91.0%;②61.9%的调查采用横断面调查研究方法,其余分别采用队列研究方法(28.0%)、病例对照研究方法(10.1%);77.7%的调查主要研究证的分布特征,其余分别为研究证或临床表征的演变规律(28.8%),研究证与理化指标的关系(15.8%),明确辨证依据(10.8%)以及研究证对心血管事件的影响(5%);③主要调查结果显示,频数排名前四位的证为血瘀证(64.2%)、气虚证(57.3%)、痰浊(湿)证(37.8%)、阴虚证(26.7%),呈血瘀证>气虚证>痰浊(湿)证>阴虚证>阳虚证>气滞证>热证>水饮证>寒凝证>血虚证的趋势。不同阶段冠心病患者中医证分布结果显示,稳定性冠心病患者痰浊(湿)证(58.6%)和阳虚证(26.8%)比例高于其他阶段;至急性冠脉综合征阶段开始出现热证(2.8%);冠心病心力衰竭患者气虚证比例最高(81.2%),且近1/3(33.1%)患者出现水饮证。介入术后3个月内,血瘀证比例显著下降(术前68.3%→术后1 d 46.7%→术后1周44.7%→术后1个月35.1%→术后3个月26.2%),但术后6个月又升至42.6%,总体呈先降后升趋势。此外,气虚证成为介入术后各时间点最主要的单元证,且术后6个月比例最高达64.4%;气滞证比例于术后3个月、术后6个月呈上升趋势,热证、血虚证比例术后1 d最高,分别为9.0%、7.7%之后呈下降趋势;④方法学质量评价结果显示,有55.4%的文献是多中心研究,明确纳入排除标准的占81.3%,分别有100.0%、95.0%、99.3%的文献对研究目的、测量结局,以及研究的主要发现进行了明确说明,仅15.1%的文献对结局指标进行了分层分析,没有文献明确声明患者是否为连续招募。报告质量评价结果显示,所有文献均未“在论文中较早陈述研究设计的要素”“偏倚”“研究对象”(各阶段数量等)和“可推广性”;报告率为100%的内容有“结局资料”“主要结果”“重要结果”“解释”。结论:近30年我国冠心病中医证的流行病学调查研究已在证候分布等方面积累了一定基础,为今后的深入研究提供了有力支撑。但同时也存在缺乏冠心病全程中医证候演变规律研究,纵向研究样本量较少、地域代表性不足、缺乏随机抽样,以及中医辨证标准不规范、不统一、缺乏诊断权重等问题,研究质量及报告规范亟需进一步提升。

Objective:To understand the general situation of traditional Chinese medicine(TCM)clinical epidemiological investigation of coronary heart disease(CHD)in China from 1990 to 2020,the distribution characteristics of TCM syndromes of CHD,and the methodological problems affecting the research quality.Methods:CNKI,VIP,Wanfang,PubMed and other databases were searched systematically,and the literature of clinical epidemiological investigation of CHD in China was included.The investigation purpose,object,method and the main findings were described and counted.According to the research quality evaluation standard recommended by NICE and the STROBE statement,the methodological quality and report quality of the included literature were evaluated.Results:①139 target literatures were finally included,which were first published in 1992 and 130(93.5%)were published between 2007 and 2020.The survey area covers 28 provinces in China,mainly concentrated in North China(44.6%),Central South China(44.6%)and East China(33.8%).A total of 707 research centers were covered.A total of 10546 patients with CHD were included,of which 91.0%were hospitalized or outpatient.②61.9%of the investigations were conducted by cross-sectional investigation,while others were conducted by cohort study(28.0%)and case-control study(10.1%).77.7%of the investigations aim to explore the distribution characteristics of syndrome,28.8%to reveal the evolution law of syndrome or clinical representation,15.8%to explore the biological basis of syndrome,10.8%to clarify the basis of syndrome differentiation,and 5.0%to explore the influence of syndrome on cardiovascular events.③The main investigation results show that the top four frequency of unit syndrome of CHD are blood stasis(64.2%),Qi deficiency(57.3%),phlegm turbidity(dampness)(37.8%)and yin deficiency(26.7%),and the order is blood stasis>Qi deficiency>phlegm turbidity(dampness)>Yin deficiency>yang deficiency>Qi stagnation>heat syndrome>fluid retention>cold coagulation>blood deficiency.The analysis results of patients with CHD in different stages showed that the proportion of phlegm turbidity(dampness)syndrome(58.6%)and Yang deficiency syndrome(26.8%)in patients with stable CHD was higher than that in other stages.Heat syndrome appeared at the stage of acute coronary syndrome(2.8%).The highest proportion of patients with CHD and heart failure is Qi deficiency syndrome(81.2%),and 33.1%patients have fluid retention syndrome.Within 3 months after interventional therapy,the proportion of blood stasis syndrome decreased significantly(68.3%)before operation→46.7%1 day after operation→44.7%1 week after operation→35.1%1 month after operation→26.2%3 months after operation,but increased to 42.6%after 6 months.In addition,qi deficiency syndrome became the most important unit syndrome after interventional therapy,and the highest proportion was 64.4%after 6 months.The proportion of qi stagnation syndrome increased in 3 months and 6 months after operation.The proportions of heat syndrome and blood deficiency syndrome were the highest one day after interventional therapy,which were 9.0%and 7.7%,respectively,and then showed a downward trend.④55.4%of the literature are multi-center studies.81.3%were explicitly included in the exclusion criteria;100.0%,95.0%and 99.3%of the literature have clearly explained the research purpose,measurement result and main findings.Only 15.1%of the literature have analyzed the outcome indicators hierarchically.There is no literature clearly stating whether patients are continuously recruited.All the literature did not“state the elements of research design earlier in the paper”,“bias”,“research object”and“popularization”;The contents with a reporting rate of 100%include“outcome data”,“main results”,“important results”and“explanation”.Conclusion:In recent 30 years,the clinical epidemiological investigation of CHD in China has accumulated a certain foundation in the distribution and evolution of syndromes,which provides a strong support for further research.At the same time,there are some problems,such as lack of TCM syndrome evolution in the whole process of CHD,small sample size,insufficient regional representation,lack of random sampling and hierarchical analysis,nonstandard and inconsistent TCM syndrome differentiation standards,lack of diagnostic weight,etc.Also the research quality and reporting standards need to be further improved.