基于临床流行病学调查的充血性心力衰竭气虚血瘀证诊断标准

Diagnostic criteria of congestive heart failure qi-deficiency-blood-stasis syndrome based on clinical epidemiological survey

目的探讨充血性心力衰竭气虚血瘀证的中医诊断标准。方法应用充血性心力衰竭中医证候量表于多中心收集病例750份（2012年12月至2013年12月）,综合筛选证候相关条目与主、次症;应用条件概率换算方法为相关条目赋值;结合ROC曲线确定本病证的临床诊断界值,应用四分位数间距法确定证候轻中重程度;运用均值描述脑钠肽（BNP）参考范围,完善其临床诊断标准。结果根据充血性心力衰竭中医证候量表、条目赋值表以及百分制换算,本病气虚血瘀证的临床诊断界值为52分,52~58分为轻证,59~70分为中等程度证候,71~100分为重证。BNP参考值为209.33~316.57 pg/ml;量化诊断标准的回顾性与前瞻性临床考核灵敏度、特异度、准确度基本都在90%以上,阳性似然比基本均〉10。结论充血性心力衰竭气虚血瘀证的临床诊断标准,将临床症状、体征分为主要依据、次要依据,并参考BNP的变化,灵敏度、特异度、准确度均较高,具有较好的临床适用性。

Objective To improve the TCM diagnosis criteria of qi-deficiency-blood-stasis syndrome of congestive heart failure.Methods 750 CHF cases from multicenter were collected by TCM syndrome scale of congestive heart failure. Related items,primary and secondary symptoms of syndromes were screened by Logistic regression. The assignment of items related to the syndromes was by means of conditional probability conversion method. The threshold values in clinic diagnosis of qi-deficiency-blood-stasis syndrome got determined combined with ROC curve. The degree of this syndrome was weighed by interquartile range method. Results Based on TCM syndrome scale of congestive heart failure,items assignment table,and conversion by centesimal system,the diagnosis dividing value of CHF qi-deficiency-bloodstasis syndrome was 52 points. Patients with 52 to 58 points were considered as the mild pattern of this syndrome,from 59 to 70 points as the medium pattern,and 71 to 100 points as the severe one. The reference range of BNP was from 209. 33 to 316. 57 pg / ml. Besides,the results of retrospective and prospective clinical assess showed all of the sensitivity,specificity and accuracy degree were above 90%,and positive likelihood ratio was almost greater than 10. Conclusions The clinical diagnosis criteria of qi-deficiency-blood-stasis syndrome divide symptoms and signs into major and minor defining characteristics,by considering the variation of BNP. It has higher sensitivity,specificity and accuracy,which could be better applied in clinical practice.