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目的采用循证医学的方法评估尿胰蛋白酶原-2(TPS-2)和尿液淀粉酶(UAmy)早期诊断急性胰腺炎(AP)的诊断价值与诊断效能,为临床医生和检验人员选择AP生化标志物提供最佳临床决策证据。方法检索MEDLINE、EMBASE、中国生物医学文献数据库(CBMDISC)、中国生物医学期刊文献数据库(CMCC)、中文期刊全文数据库(CNKI)等数据库,按照纳入标准收集TPS-2与UAmy诊断AP的研究文献,采用QUADAS量表进行严格的文献质量评价,利用MetaDisc软件进行异质性分析及定量合成,绘制SROC曲线,计算相应的验后概率。结果39篇TPS-2与UAmy诊断AP的研究结果异质性分析,前者无明显异质性(P=0.5641,I2=0%);后者有中等程度的异质性(P=0.0086,I2=38.5%)。合并敏感度Sen分别为93%(95%CI:92%～94%)与81%(95%CI:79%～83%);合并特异度Spe分别为94%(95%CI:94%～95%)与82.0%(95%CI:81%～83%);SROCAUC分别为0.9788(SE=0.0024)与0.8680(SE=0.0084),差异有统计学意义,前者的综合诊断效能优于后者。TPS-2与UAmy结果阳性时诊断AP的验后概率分别约为56.88%与26.62%,阴性验后概率分别为0.69%与2.38%。结论检测尿液TPS-2诊断AP比UAmy具有更高的诊断价值,可作为AP诊断的过筛试验,阴性结果有99.31%的概率可排除AP的可能性。
Objective To evaluate the diagnostic value and diagnostic efficacy of early diagnosis of acute pancreatitis (AP) by urinary trypsinogen-2 (TPS-2) and urine amylase (UAmy) by evidence-based medicine. Biochemical markers provide the best evidence of clinical decision-making. Methods The databases of MEDLINE, EMBASE, CBMDISC, CMCC and CNKI were searched. According to the inclusion criteria, the research articles of TPS-2 and UAmy in diagnosing AP were collected. The QUADAS scale was used to evaluate the quality of literatures. MetaDisc software was used to carry out heterogeneity analysis and quantitative synthesis. The SROC curve was drawn and the corresponding posterior probability was calculated. Results There was no significant heterogeneity in the study results of 39 TPS-2 and UAmy APs (P = 0.5641, I2 = 0%); the latter had a moderate degree of heterogeneity (P = 0.0086, I2 = 38.5%). The combined sensitivity (Sen) was 93% (95% CI: 92% ~ 94%) and 81% (95% CI: 79% ~ 83% 95%) and 82.0% (95% CI: 81% -83%). The SROCAUC was 0.9788 (SE = 0.0024) and 0.8680 (SE = 0.0084) respectively. The difference was statistically significant . The posterior probability of diagnosing AP was about 56.88% and 26.62% when TPS-2 and UAmy were positive, respectively, and 0.69% and 2.38% respectively after negative test. Conclusion The diagnostic value of urine TPS-2 in diagnosis of AP is higher than that of UAmy and can be used as a screening test for AP diagnosis. The negative result is 99.31% probability of excluding AP.