比较患者自控和医师控制丙泊酚镇痛的效果：系统评价和试验序贯的meta分析
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Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses
背景与目的
丙泊酚镇静常用于诊断和治疗过程中。给药途径分为患者自控（患者自控镇静[PCS]）和医师控制（医师控制镇静[CCS]）。本研究的目的为比较这两种方法的效果。
方 法
我们检索了PubMed, Embase, CENTRAL和试验注册截止2017年10月的有关比较丙泊酚PCS和CCS的随机对照试验。主要终点是至少出现1次氧饱和度降低，动脉血压降低和心动过缓的风险，以及需要进行镇静相关不良事件的抢救干预（药物或物理治疗）的风险。次要终点是丙泊酚的给药剂量，操作者和患者的满意度以及过度使用的风险。采用随机效应模型和α为0.02来进行多重分析。对主要结果进行了试验顺序分析。根据推荐、评价、发展和评估系统对证据质量进行分析。
结 果
纳入了13项试验（1103名患者;年龄中位数为47岁;ASA I-III），描述了丙泊酚镇静的各种诊断和治疗过程。PCS对氧饱和度降低的风险没有影响（11项试验，31/448例患者[6.9％]使用PCS而46/481 [9.6％]采用CCS;RR：0.74 [98％CI，0.35-1.56]），但降低了因不良事件需要抢救干预的风险（11项试验，29/449例患者[6.5％]使用PCS而74/48 [15.4％]采用CCS;RR：0.45 [98％CI，0.25-0.81]）。对于这两种结果，试验序贯分析表明，尽管所有主要结果的证据质量都非常低，但进一步的试验不太可能改变结果。对于动脉血压降低和心动过缓的风险，尚未达到明确结论所需的样本量。对次要结果的分析表明，PCS降低了过度使用丙泊酚的风险，并且对丙泊酚的给药剂量、操作者或患者满意度没有影响。
结 论
与丙泊酚CCS相比，PCS对氧饱和度下降的风险没有影响，但显著降低了镇静相关不良事件的抢救干预风险。需要进一步对高质量试验分析来评估PCS的风险和益处
原始文献摘要
Kreienbühl L, Elia N, Pfeilbeun E, et al. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses.[J]. Anesthesia & Analgesia, 2018.
BACKGROUND:
Sedation with propofol is frequently used to facilitate diagnostic and therapeutic procedures. Propofol can be administrated by the patient (patient-controlled sedation [PCS]) or by a clinician (clinician-controlled sedation [CCS]). We aimed to compare these 2 techniques.
METHODS:
PubMed, Embase, CENTRAL, and trial registries were searched up to October 2017 for randomized controlled trials comparing PCS with CCS with propofol. The primary end points were the risks of presenting at least 1 episode of oxygen desaturation, arterial hypotension, and bradycardia, and the risk of requiring a rescue intervention (pharmacologic therapies or physical maneuvers) for sedation-related adverse events. Secondary end points were the dose of propofol administrated, operator and patient satisfaction, and the risk of oversedation. A random-effects model and an α level of .02 to adjust for multiple analyses were used throughout. Trial sequential analyses were performed for primary outcomes. Quality of evidence was assessed according to the Grades of Recommendation, Assessment, Development, and Evaluation system.
RESULTS:
Thirteen trials (1103 patients; median age, 47 years; American Society of Anesthesiologists physical status I-III) describing various diagnostic and therapeutic procedures with propofol sedation were included. PCS had no impact on the risk of oxygen desaturation (11 trials, 31/448 patients [6.9%] with PCS versus 46/481 [9.6%] with CCS; risk ratio, 0.74 [98% confidence interval, 0.35-1.56]) but decreased the risk of requiring a rescue intervention for adverse events (11 trials, 29/449 patients [6.5%] with PCS versus74/482 [15.4%] with CCS; risk ratio, 0.45 [98% confidence interval, 0.25-0.81]). For both outcomes, Trial sequential analysessuggested that further trials were unlikely to change the results, although the quality of evidence was graded very low for all primary outcomes. For the risk of arterial hypotension and bradycardia, the required sample size for a definitive conclusion had not been reached. Analysis of secondary outcomes suggested that PCS decreased the risk of oversedation and had no impact on propofoldose administrated, or on operator or patient satisfaction.
CONCLUSIONS:
PCS with propofol, compared with CCS with propofol, had no impact on the risk of oxygen desaturation, but significantly decreased the risk of rescue interventions for sedation-related adverse events. Further high-quality trials are required to assess the risks and benefits of PCS.
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