McNicol Ewan D, Ferguson McKenzie C, Hudcova Jana
Departments of Anesthesiology and Pharmacy, Tufts Medical Center, Box #420, 800 Washington Street, Boston, Massachusetts, USA, 02111.
Cochrane Database Syst Rev. 2015 Jun 2;2015(6):CD003348. doi: 10.1002/14651858.CD003348.pub3.
This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia.
To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief.
We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles.
We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain.
Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events.
Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay.
AUTHORS' CONCLUSIONS: Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.
这是2006年第4期发表的原始Cochrane综述的更新版本。患者可使用为此目的设计的设备自行静脉注射阿片类药物来控制术后疼痛(患者自控镇痛或PCA)。1992年Ballantyne等人的一项荟萃分析发现,与非患者自控镇痛相比,患者对PCA有强烈的偏好,但未发现镇痛药物消耗量或术后住院时间有差异。尽管Ballantyne的荟萃分析发现PCA对疼痛强度确实有微小但具有统计学意义的益处,但2001年Walder等人的一项综述未发现PCA与非患者自控镇痛治疗组在疼痛强度或疼痛缓解方面有统计学意义的差异。
评估患者自控静脉注射阿片类镇痛(本综述中称为PCA)与按需使用阿片类镇痛的非患者自控阿片类镇痛在缓解术后疼痛方面的疗效和安全性。
我们在2004年11月进行了上次综述的检索。对于本次更新,我们检索了Cochrane对照试验中央注册库(CENTRAL 2014年第12期)、MEDLINE(1966年至2015年1月28日)和EMBASE(1980年至2015年1月28日),以查找任何语言的随机对照试验(RCT)以及综述和检索文章的参考文献列表。
我们选择将疼痛强度评估作为主要或次要结局的RCT。这些研究比较了无持续背景输注的PCA与非患者自控阿片类镇痛方案。我们排除了明确声明涉及慢性疼痛患者的研究。
两位综述作者独立提取数据,包括人口统计学变量、手术类型、干预措施、疗效和不良事件。我们通过评估偏倚风险对每项纳入研究的方法学质量进行分级,并采用GRADE方法评估证据的整体质量。我们对包括通过0至100视觉模拟量表(VAS)评估的疼痛强度、阿片类药物消耗量、患者满意度、住院时间和不良事件等结局进行了荟萃分析。
49项研究符合纳入标准,其中1725名参与者接受PCA,1687名参与者被分配到对照组。原始综述包括55项研究,2023名患者接受PCA,1838名患者被分配到对照组。由于修订了排除标准,我们更新后的综述中纳入的研究较少。对于主要结局,在大多数时间段内,接受PCA的参与者的VAS疼痛强度评分低于非患者自控镇痛,例如,0至24小时的评分低9分(95%置信区间(CI)-13至-5,中等质量证据),0至48小时的评分低10分(95%CI -12至-7,低质量证据)。在次要结局中,参与者对PCA更满意(81%对61%,P值=0.002),且比对照组消耗的阿片类药物量更多(0至24小时,静脉注射吗啡等效物多7毫克,95%CI 1毫克至13毫克)。接受PCA的患者瘙痒发生率较高(15%对8%,P值=0.01),但其他不良事件的发生率相似。住院时间没有差异。
自本综述的上一版本以来,我们发现了提供更多信息的新研究。我们重新分析了数据,但结果并未实质性改变我们之前发表的任何结论。本综述提供了中等至低质量的证据,表明PCA是用于术后疼痛控制的非患者自控全身镇痛的有效替代方法。