基于AGREE Ⅱ的成人急性术后疼痛管理的指南评价及内容分析

Evaluation of guidelines for acute postoperative pain management in adults with AGREE Ⅱ: recommendations and controversies

目的:使用指南研究与评价工具Ⅱ(AGREE Ⅱ)评价国内外2008-2018年成人急性术后疼痛(POP)管理指南,总结并分析目前成人急性术后疼痛药物治疗的推荐意见。方法:制订POP指南的纳入与排除标准,系统地检索PubMed、Embase、SinoMed、英国国家临床优化研究所(NICE)、国际指南协作网(G-I-N)、苏格兰学院间指南网络(SIGN)等数据库,检索时限为建库至2018年6月9日。由2名研究者分别进行文献筛选、资料提取并根据AGREE Ⅱ进行质量评价。分析比较不同POP指南推荐意见的异同。结果:共纳入15篇指南,分别来自中国、美国、意大利、波兰、加纳、海湾地区和国际组织,发表年份从2008年至2018年。AGREE Ⅱ评价结果显示:大部分纳入指南均未清楚描述指南制订及更新的方法,缺少利益冲突声明,未充分考虑参与人员,且仍需完善临床可操作性。6个领域的评分中,仅范围和目的以及清晰性2个领域平均得分大于50%(67.0%和71.1%),参与人员、严谨性、应用性和独立性4个领域平均得分均小于50%(39.3%、34.2%、38.1%和32.2%);7篇中国指南仅范围和目的以及清晰性2个领域平均得分大于50%(52.4%和52.4%),参与人员、严谨性、应用性和独立性4个领域亟待加强(19.0%、7.1%、33.3%和16.7%)。达成共识的推荐意见主要包括:推荐采用多模式镇痛原则;推荐多模式镇痛方案为局麻药伤口局部浸润/外周神经阻滞联合非甾体类抗炎药(non-steroidal anti-inflammatory drugs,NSAIDs,包括非选择性NSAIDs和COX2抑制剂)和/或对乙酰氨基酚用于轻至中度疼痛,在此基础上联合阿片类药物用于中至重度疼痛等。目前尚未达成共识的部分主要围绕超前镇痛原则、NSAIDs的适应证与禁忌证,以及不同药物最佳的给药途径、剂量或时机等方面。结论:纳入POP指南整体的方法学质量和实用性均有待提高,中国指南在参与人员、严谨性和独立性方面比较欠缺,且指南在镇痛原则及具体药物选择方面均存在诸多差异。现有指南质量不高可能是POP管理现状不佳的原因之一,为改善国内POP管理现状,应当制订符合我国医疗卫生环境、基于系统评价结合会议共识的循证指南。

OBJECTIVE To evaluate guidelines for acute postoperative pain(POP) management in adults using the Appraisal of Guidelines for Research and Evaluation Ⅱ(AGREE Ⅱ), and to support application and development of the guidelines by comparing the basic consensus and differences between the guidelines.METHODS Inclusion and exclusion criteria was established prospectively. PubMed, Embase, SinoMed, National Institute for Clinical Excellence(NICE), International Guide Collaboration(GIN), and Scottish Inter-Academic Guide Network(SIGN) were researched from the establishment to 9 th June, 2018, for guidelines on acute POP management in adults. Two researchers independently screened studies, extracted data and assessed the quality using AGREE Ⅱ. The basic consensus and differences between the guidelines were compared and analyzed descriptively.RESULTS A total of 15 guidelines were eligible from China, the United States, Italy, Poland, Ghana, the Gulf region and international organizations. The guidelines were published from 2008 to 2018. Most of the included POP guidelines didn’t clearly describe the methods for developing and updating the guidelines, declare conflict of interest or fully consider participants involved. And the clinical practicality of included guidelines needed to be improved. The AGREE II instrument rated guidelines among 6 domains. "Scope and purpose" and "clarity and presentation" were averagely scored more than 50%(67.0% and 71.1%). "Stakeholder involvement", "rigor of development", "applicability" and "editorial independence" were scored less than 50%(39.3%, 34.2%, 38.1%, and 32.2%);particularly, for all the 7 guidelines from China, only "Scope and purpose" and "clarity and presentation" were averagely scored more than 50%(52.4% and 52.4%). Improvement was indispensable for "Stakeholder involvement", "rigor of development", "applicability" and "editorial independence"(scored only 19.0%, 7.1%, 33.3%, and 16.7%). Multimodal analgesia(MMA) was recommended for mild to moderate pain with local anesthetic wound local peripheral infiltration/peripheral nerve block in combination with NSAIDs(including non-selective NSAIDs and COX2 inhibitors) and/or paracetamol Phenol, on the basis of which opioids are used for moderate to severe pain;The existing controversy mainly focused on the efficacy and safety of preemptive analgesia, indications and contraindications of NSAIDs, and the optimal route of administration, dosage or timing of different kind of analgesic.CONCLUSION The overall methodological quality and practicality of the included POP guidelines need to be improved. In particular, the quality of guidelines from China are much lower. MMA principle and a basic regimen are recommended, but there is controversy regarding pre-emptive analgesia and the optimal route of administration, dosage and timing of the different drugs. Lacking high-quality POP guidelines may contribute to the poor management of POP, suggesting that developing domestic evidence-based POP guidelines of high quality is urgently needed.