CCERW：一种预测中老年人社区获得性肺炎临床无效结局的工具

CCERW： a new rule to predict treatment failure in patients with community-acquired pneumonia in middle aged and elderly people

目的 建立一种预测中国中老年人社区获得性肺炎（CAP）临床无效结局的工具,并与其他工具进行对比.方法 前瞻性收集2006年12月17日至2008年12月22日3所高校教学医院呼吸内科住院部收治的年龄≥45岁并确诊为CAP患者的数据,按随机数字表法将其中75%的患者数据用于工具的建立（推导组）,25%的患者数据用于工具内部真实性的检验（内部组）.同期收集另外一所高校教学医院的患者数据用于工具外部真实性的检验（外部组）.结局定义为患者入院14 d或未满14 d出院时的临床无效状态.观测指标包括社会人口学特征、基础疾病和既往情况、并发症、症状、体征、辅助检查结果共6个方面58个因素.采用单因素分析、多因素分析和受试者工作特征曲线（ROC曲线）分析结合的方法进行工具的建立和评价,并与肺炎严重度指数（PSI）、英国胸科协会评估标准（CURB65）及其修订版（CRB65）等预测工具对临床结局的判断能力进行比较.结果 3个中心共纳入539例CAP患者的资料用于数据分析,其中推导组400例,内部组139例;外部组159例.以推导组400例数据进行单因素分析显示,共6个方面33个变量在痊愈和临床无效两组间差异有统计学意义;并以此进行多因素分析显示,精神混乱（C）、肌酐（Cr）＜60 μmol/L、电解质紊乱（E）、呼吸衰竭（R）、白细胞计数（WBC）＞7.5×109/L 5个因素差异有统计学意义.以此5个变量建立预后工具,即CCERW,将患者分为3个危险级别：得0～1分者无效率为5.5%～9.1%,得2分者无效率为12.8%～20.0%,得3～6分者无效率为31.0%～40.5%.ROC曲线分析显示,CCERW对推导组、内部组和外部组临床无效结局的预测能力分别为0.709[95%可信区间（95%CI）0.638～0.780]、0.725（95%CI 0.613～0.838）、0.686（95%CI 0.590～0.782）.CCERW对全部698例患者的临床结局判断能力为0.710（95%CI 0.659～0.761）,而PSI、CURB65、CRB65的判断能力分别为0.667（95%CI 0.614～0.719）、0.648（95%CI 0.592～0.705）和0.584（95%CI 0.530～0.638）.结论 CCERW可帮助临床医师快速区分出中国中老年CAP患者的临床无效结局,且其对临床结局的判断能力优于PSI、CURB65、CRB65等预测工具,谨慎推荐将其在中国大陆地区汉族中老年CAP患者中使用.

Objective To develop and validate a clinical rule to predict treatment failure in middleaged and elderly patients suffering from community-acquired pneumonia （CAP） in China, and to compare it with other prognostic rules. Methods Data of 58 variables affiliated to 6 aspects, including demographics,underlaying diseases, previous status, complications, symptoms, signs and laboratory examination results from the CAP patients aged ≥ 45 years admitted to the respiratory departments in three university affiliated hospitals between December 17, 2006 and December 22, 2008 were enrolled prospectively and then validated in two groups to create a derivation cohort with 75% of the patients for rule development and an internal validation cohort with the other 25% for internal test. An external validation cohort was formed at the same time with patients admitted to the other university affiliated hospital for external test. The single outcome was treatment failure at the time of 14 days after admitted or at discharge from hospital. Univariate analysis, multivariate analysis and receiver operating characteristics （ROC） curve were used for the rule establishment, assessment and comparison among the pneumonia severity index （PSI）, CURB65 [confusion,blood urea nitrogen〉6.8 mmol/L, respiratory rate （RR）≥30 breaths per minute, systolic blood pressure （SBP）〈90 mm Hg （1 mm Hg=0. 133 kPa） or diastolic blood pressure （DBP）≤60 mm Hg, age≥65 years]and CRB65 （confusion, RR ≥ 30 breaths per minute, SBP 〈 90 mm Hg or DBP ≤ 60 mm Hg,age≥65 years）. Results The data of a total of 539 patients in three hospitals were enrolled for analysis. Ofthose, 400 and 139 patients were randomly allocated into the derivation cohort or internal validation cohort respectively. Meanwhile, 159 patients were enrolled in the external validation cohort. Analyzing the data from 400 patients in the derivation cohort, 33 variables of 6 aspects had significant difference between cure and treatment failure outcome in the univariate analysis. Then, in the multivariate analyses, five independent predictive factors showed significant difference, including confusion （C）, creatinine 〈60 μmol/L, electrolyte disturbances （E）, respiratory failure （R）, white blood cell （WBC）〉7.5× 109/L. A clinical prediction rule CCERW based on these variables showed that the treatment failure outcome increased directly with increasing scores ： 5.5%- 9. 1 %, 12.8 %- 20. 0% and 31.0 %- 40. 5% for scores of 0 - 1, 2 and 3 - 6, respectively. ROC curve analysis yielded an area under the curve （AUC） for CCERW of 0. 709 [95% confidence intervals （95%CI） 0.638 - 0.780], 0.725 （95%CI 0.613 - 0.838） and 0.686 （95%CI 0.590 - 0.782） in the derivation, internal and external validation cohorts respectively; and in the same manner, of 0.710（95%CI 0. 659 - 0. 761） for total 698 patients, which was better than PSI, CURB65 and CRB65, at 0. 667（95%CI 0. 614 - 0. 719）, 0. 648 （95%CI0. 592 - 0. 705）, and 0. 584 （95%CI 0.530 - 0.638）, respectively.Conclusion CCERW can help physicians to distinguish high and low risk leading to treatment failure in middle-aged and elder patients with CAP, and has better predictable capability than PSI, CURB65 and CRB65. We prudent recommend the simple rule can be used in the middle-aged and elder patients with CAP of Han race people in China.