Andriolo Brenda Ng, Andriolo Regis B, Salomão Reinaldo, Atallah Álvaro N
Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, São Paulo, Brazil, 04038-000.
Department of Public Health, Universidade do Estado do Pará, Travessa Perebebuí, 2623, Belém, Pará, Brazil, 66087-670.
Cochrane Database Syst Rev. 2017 Jan 18;1(1):CD010959. doi: 10.1002/14651858.CD010959.pub2.
Serum procalcitonin (PCT) evaluation has been proposed for early diagnosis and accurate staging and to guide decisions regarding patients with sepsis, severe sepsis and septic shock, with possible reduction in mortality.
To assess the effectiveness and safety of serum PCT evaluation for reducing mortality and duration of antimicrobial therapy in adults with sepsis, severe sepsis or septic shock.
We searched the Central Register of Controlled Trials (CENTRAL; 2015, Issue 7); MEDLINE (1950 to July 2015); Embase (Ovid SP, 1980 to July 2015); Latin American Caribbean Health Sciences Literature (LILACS via BIREME, 1982 to July 2015); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO host, 1982 to July 2015), and trial registers (ISRCTN registry, ClinicalTrials.gov and CenterWatch, to July 2015). We reran the search in October 2016. We added three studies of interest to a list of 'Studies awaiting classification' and will incorporate these into formal review findings during the review update.
We included only randomized controlled trials (RCTs) testing PCT-guided decisions in at least one of the comparison arms for adults (≥ 18 years old) with sepsis, severe sepsis or septic shock, according to international definitions and irrespective of the setting.
Two review authors extracted study data and assessed the methodological quality of included studies. We conducted meta-analysis with random-effects models for the following primary outcomes: mortality and time spent receiving antimicrobial therapy in hospital and in the intensive care unit (ICU), as well as time spent on mechanical ventilation and change in antimicrobial regimen from a broad to a narrower spectrum.
We included 10 trials with 1215 participants. Low-quality evidence showed no significant differences in mortality at longest follow-up (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.65 to 1.01; I = 10%; 10 trials; N = 1156), at 28 days (RR 0.89, 95% CI 0.61 to 1.31; I = 0%; four trials; N = 316), at ICU discharge (RR 1.03, 95% CI 0.50 to 2.11; I = 49%; three trials; N = 506) and at hospital discharge (RR 0.98, 95% CI 0.75 to 1.27; I = 0%; seven trials; N = 805; moderate-quality evidence). However, mean time receiving antimicrobial therapy in the intervention groups was -1.28 days (95% CI to -1.95 to -0.61; I = 86%; four trials; N = 313; very low-quality evidence). No primary study has analysed the change in antimicrobial regimen from a broad to a narrower spectrum.
AUTHORS' CONCLUSIONS: Up-to-date evidence of very low to moderate quality, with insufficient sample power per outcome, does not clearly support the use of procalcitonin-guided antimicrobial therapy to minimize mortality, mechanical ventilation, clinical severity, reinfection or duration of antimicrobial therapy of patients with septic conditions.
血清降钙素原（PCT）评估已被用于脓毒症、严重脓毒症和脓毒性休克患者的早期诊断、准确分期及指导决策，可能降低死亡率。
评估血清PCT评估对降低脓毒症、严重脓毒症或脓毒性休克成年患者死亡率及抗菌治疗疗程的有效性和安全性。
我们检索了Cochrane对照试验中心注册库（CENTRAL；2015年第7期）；MEDLINE（1950年至2015年7月）；Embase（Ovid SP，1980年至2015年7月）；拉丁美洲及加勒比地区健康科学文献数据库（LILACS via BIREME，1982年至2015年7月）；护理学与健康照护相关文献累积索引（CINAHL；EBSCO host，1982年至2015年7月），以及试验注册库（ISRCTN注册库、ClinicalTrials.gov和CenterWatch，截至2015年7月）。我们于2016年10月再次进行检索。我们将三项感兴趣的研究添加到“待分类研究”列表中，并将在更新综述时将其纳入正式的综述结果。
我们仅纳入了随机对照试验（RCT），这些试验根据国际定义，在至少一个比较组中对脓毒症、严重脓毒症或脓毒性休克的成年人（≥18岁）进行PCT指导的决策，且不考虑研究背景。
两位综述作者提取研究数据并评估纳入研究的方法学质量。我们采用随机效应模型对以下主要结局进行荟萃分析：死亡率、在医院和重症监护病房（ICU）接受抗菌治疗的时间、机械通气时间以及抗菌治疗方案从广谱到窄谱的变化。
我们纳入了10项试验，共1215名参与者。低质量证据表明，在最长随访期（风险比（RR）0.81，95%置信区间（CI）0.65至1.01；I² = 10%；10项试验；N = 1156）、28天（RR 0.89，95% CI 0.61至1.31；I² = 0%；4项试验；N = 316）、ICU出院时（RR 1.03，95% CI 0.50至2.11；I² = 49%；3项试验；N = 506）和医院出院时（RR 0.98，95% CI 0.75至1.27；I² = 0%；7项试验；N = 805；中等质量证据），死亡率无显著差异。然而，干预组接受抗菌治疗的平均时间为 -1.28天（95% CI -1.95至 -0.61；I² = 86%；4项试验；N = 313；极低质量证据）。没有一项原始研究分析了抗菌治疗方案从广谱到窄谱的变化。
现有证据质量极低至中等，每个结局的样本量不足，不能明确支持使用降钙素原指导的抗菌治疗来降低脓毒症患者的死亡率、机械通气时间、临床严重程度、再感染率或抗菌治疗疗程。
