Research
True 99th centile of high sensitivity cardiac troponin for hospital patients: prospective, observational cohort study
Mark Mariathas, Rick Allan, Sanjay Ramamoorthy, et al
BMJ 2019;364:l729
Abstract
Objective 目的
To determine the distribution, and specifically the true 99th centile, of high sensitivity cardiac troponin I (hs-cTnI) for a whole hospital population by applying the hs-cTnI assay currently used routinely at a large teaching hospital.
采用大型教学医院目前使用的高敏心脏肌钙蛋白I (hs-cTnI)分析方法，确定全部住院人群hs-cTnI的分布及真正的99百分位。
Design 设计
Prospective, observational cohort study.
前瞻、观察性队列研究
Setting 场景
University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, between 29 June 2017 and 24 August 2017.
英国南安普顿NHS Foundation Trust南安普顿大学医院2017年6月29日至8月24日。
Participants 研究对象
20 000 consecutive inpatients and outpatients undergoing blood tests for any clinical reason. Hs-cTnI concentrations were measured in all study participants and nested for analysis except when the supervising doctor had requested hs-cTnI for clinical reasons.
因任何临床原因接受血液检查的20000名连续的住院及门诊患者。对所有研究对象测定hs-cTnI水平，除临床医生由于临床原因要求检查hs-cTnI之外，其余结果均纳入分析。
Main outcome measures 主要研究结局
Distribution of hs-cTnI concentrations of all study participants and specifically the 99th centile.
所有研究对象hs-cTnI水平分布及其99百分位。
Results 结果
The 99th centile of hs-cTnI for the whole population was 296 ng/L compared with the manufacturer’s quoted level of 40 ng/L (currently used clinically as the upper limit of normal; ULN). Hs-cTnI concentrations were greater than 40 ng/L in one in 20 (5.4%, n=1080) of the total population. After excluding participants diagnosed as having acute myocardial infarction (n=122) and those in whom hs-cTnI was requested for clinical reasons (n=1707), the 99th centile was 189 ng/L for the remainder (n=18 171). The 99th centile was 563 ng/L for inpatients (n=4759) and 65 ng/L for outpatients (n=9280). Patients from the emergency department (n=3706) had a 99th centile of 215 ng/L, with 6.07% (n=225) greater than the recommended ULN. 39.02% (n=48) of all patients from the critical care units (n=123) and 14.16% (n=67) of all medical inpatients had an hs-cTnI concentration greater than the recommended ULN.
全部人群hs-cTnI的99百分位为296 ng/L，厂家建议的参考值为40 ng/L（即目前临床使用的正常值上限；ULN）。全部人群中约1/20 (5.4%, n = 1080)的hs-cTnI水平超过40 ng/L。排除诊断为急性心肌梗死(n=122)及其他临床原因测定hs-cTnI (n=1707)的患者后，其余人群(n=18 171)的99百分位数为189 ng/L。住院患者 (n=4759)的99百分位数为563 ng/L，门诊患者(n=9280)的99百分位数为65 ng/L。急诊科患者(n=3706)的99百分位数为215 ng/L，6.07%的患者(n=225)超过推荐的ULN。监护病房39.02%的患者(n=48)以及14.16%的内科住院患者(n=67)其hs-cTnI水平超过推荐的ULN。
Table 1Baseline characteristics stratified by hs-cTnI levels (ng/L) less than or greater than ULN
| Hs-cTnI <ULN (n=18 915) | Hs-cTnI >ULN (n=1085) | P value | |
|---|---|---|---|
| Age (years) | 57.4 | 74.2 | <0.001 |
| Male sex (No, %) | 8796 (46.5) | 622 (57.3) | 0.005 |
| eGFR(mL/min/1.73 m2) | 79.1 | 59.6 | <0.001 |
| Sodium (mmol/L) | 137.2 | 136 | <0.001 |
| Inpatients (No, %) | 4540 (24.0) | 405(37.3) | <0.001 |
| Outpatients (No, %) | 9155(48.4) | 189(17.4) | <0.001 |
eGFR=estimated glomerular filtration rate; hs-cTnI=high sensitivity cardiac troponin I; ULN=upper limit of normal (40 ng/L).
Conclusions 结论
Of 20 000 consecutive patients undergoing a blood test for any clinical reason at our hospital, one in 20 had an hs-cTnI greater than the recommended ULN. These data highlight the need for clinical staff to interpret hs-cTnI concentrations carefully, particularly when applying the recommended ULN to diagnose acute myocardial infarction, in order to avoid misdiagnosis in the absence of an appropriate clinical presentation.
在我们医院因任何临床原因接受血液检查的20000名连续患者中，1/20的hs-cTnI水平超过推荐的UNL。这些数据表明，在没有相应临床表现时，为避免误诊，临床医生需要仔细解读hs-cTnI的检查结果，尤其是使用推荐的ULN诊断急性心肌梗塞时。
Trial registration 试验注册
Clinicaltrials.gov NCT03047785.
