Point-of-care testing of C-reactive protein (CRP) may be a way to reduce unnecessary use of antibiotics without harming patients who have acute exacerbations of chronic obstructive pulmonary disease (COPD).
床旁C反應蛋白(CRP)檢測可能減少COPD急性加重(AECOPD)患者不必要的抗生素使用，同時也不造成危害
METHODS 方法We performed a multicenter, open-label, randomized, controlled trial involving patients with a diagnosis of COPD in their primary care clinical record who consulted a clinician at 1 of 86 general medical practices in England and Wales for an acute exacerbation of COPD. The patients were assigned to receive usual care guided by CRP point-of-care testing (CRP-guided group) or usual care alone (usual-care group). The primary outcomes were patient-reported use of antibiotics for acute exacerbations of COPD within 4 weeks after randomization (to show superiority) and COPD-related health status at 2 weeks after randomization, as measured by the Clinical COPD Questionnaire, a 10-item scale with scores ranging from 0 (very good COPD health status) to 6 (extremely poor COPD health status) (to show noninferiority).
我們進行了一項多中心、開放標籤、隨機對照試驗，在英格蘭和威爾斯的86個全科醫療中心納入診斷為AECOPD的患者。患者接受隨機分組，分別接受床旁CRP檢測指導的常規治療（CRP指導組）或常規治療（常規治療組）。主要預後指標為隨機分組後4周內患者報告的因AECOPD的抗生素使用情況（優效）以及隨機分組後2周時COPD相關健康狀況（非劣效），後者通過臨床COPD問卷評價，這是一個包括10項問題的評分，分值從0分（COPD健康狀況極佳）到6分（COPD健康狀況極差）。
RESULTS 結果A total of 653 patients underwent randomization. Fewer patients in the CRP-guided group reported antibiotic use than in the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31; 95% confidence interval [CI], 0.20 to 0.47). The adjusted mean difference in the total score on the Clinical COPD Questionnaire at 2 weeks was −0.19 points (two-sided 90% CI, −0.33 to −0.05) in favor of the CRP-guided group. The antibiotic prescribing decisions made by clinicians at the initial consultation were ascertained for all but 1 patient, and antibiotic prescriptions issued over the first 4 weeks of follow-up were ascertained for 96.9% of the patients. A lower percentage of patients in the CRP-guided group than in the usual-care group received an antibiotic prescription at the initial consultation (47.7% vs. 69.7%, for a difference of 22.0 percentage points; adjusted odds ratio, 0.31; 95% CI, 0.21 to 0.45) and during the first 4 weeks of follow-up (59.1% vs. 79.7%, for a difference of 20.6 percentage points; adjusted odds ratio, 0.30; 95% CI, 0.20 to 0.46). Two patients in the usual-care group died within 4 weeks after randomization from causes considered by the investigators to be unrelated to trial participation.
共有653名患者接受隨機分組。與常規治療組相比，CRP指導組更少患者報告使用抗生素（57.0% vs. 77.4%；校正後比數比，0.31; 95%可信區間[CI], 0.20 to 0.47）。2周時，兩組患者臨床COPD問卷總分校正後平均差為−0.19分（雙側90% CI, −0.33 to −0.05），CRP指導組更低。除1名患者外，所有患者在最初就診時，臨床醫生處方抗生素的情況均已明確，96.9%的患者最初4周隨訪期間的抗生素處方情況也已明確。與常規治療組相比，最初就診時（47.7% vs. 69.7%，差異為22.0個百分點；校正後比數比，0.31；95% CI, 0.21 to 0.45）以及最初4周隨訪期間（59.1% vs. 79.7%，差異為20.6個百分點；校正後比數比，0.30; 95% CI, 0.20 to 0.46），CRP指導組更少患者使用抗生素。隨機分組後4周內，常規治療組2名患者死亡，研究者判斷死因與參加臨床試驗無關。
CONCLUSIONS 結論CRP-guided prescribing of antibiotics for exacerbations of COPD in primary care clinics resulted in a lower percentage of patients who reported antibiotic use and who received antibiotic prescriptions from clinicians, with no evidence of harm.
在全科醫療診所採用CRP指導抗生素處方，能夠減少AECOPD患者報告的抗生素使用，同時減少使用臨床醫生處方抗生素的患者比例，且沒有造成危害的證據。
(Funded by the National Institute for Health Research Health Technology Assessment Program; PACE Current Controlled Trials number, ISRCTN24346473.)
這不是針對危重病患者的研究，但對我們或許有一些提示。受這個研究的啟發，是否會有研究者針對可疑感染的ICU患者，比較CRP和PCT指導抗生素治療的差異？
需要回答的臨床問題可能包括：
目前臨床PCT檢測是否過濫？
生物標誌物（PCT，CRP）真的能夠指導抗生素治療嗎？
在指導抗生素治療方面，PCT真的優於CRP嗎？PCT真的優於臨床判斷嗎？
在社區獲得性下呼吸道感染患者得到的結論能否適用於危重病患者？
--北京協和醫院 杜斌
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