Giaccari Luca G, Coppolino Francesco, Aurilio Caterina, Esposito Valentina, Pace Maria Caterina, Paladini Antonella, Passavanti Maria Beatrice, Pota Vincenzo, Sansone Pasquale
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of MESVA, University of L'Aquila, Aquila, Italy.
Pain Ther. 2020 Jun;9(1):217-230. doi: 10.1007/s40122-020-00166-4. Epub 2020 Apr 17.
Pain is commonly experienced among patients after surgical procedures. Clinical pain management after surgery is far from being successful. Patients may control postoperative pain by self-administration of intravenous opioids using devices designed for this purpose (patient-controlled analgesia or PCA). PCA devices have been developed including the sufentanil sublingual tablet system (SSTS). A systematic review of the use of SSTS for postoperative pain is needed to identify an alternative method of pain management.
To systematically review literature to establish the efficacy and the safety of PCA with SSTS used in the treatment of moderate-to-severe acute post-operative pain in a hospital setting.
Embase, MEDLINE, Google Scholar, and Cochrane Central Trials Register were systematically searched in December 2019 for studies examining SSTS for pain in adult after surgical procedures. The methodological quality of the studies and their results were appraised using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist and specific measurement properties criteria, respectively.
Sixteen studies evaluating SSTS were included for a total of 2311 patients. All participants in the SSTS group reported NRS ≤ 4 within 24 h after surgery. Patient satisfaction was high, with a minimum of 70% satisfaction among patients treated with SSTS. The most common adverse events (AEs) overall for SSTS 15 and 30 mcg were nausea, vomiting, and headache. AEs observed in the studies were generally consistent with those associated with opioids and the postsurgical setting.
SSTS is an important system for the management of moderate-to-severe acute pain in a hospital setting. SSTS is well tolerated, with no unexpected adverse events (AEs) and no clinically meaningful vital sign changes. These data confirm the safety and tolerability of the SSTS. Successful pain management resulted in a high level of acceptance of the SSTS by patients with high satisfaction for the method of pain control.
手术后患者普遍会经历疼痛。术后的临床疼痛管理远未成功。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）。已开发出包括舒芬太尼舌下片系统（SSTS）在内的PCA设备。需要对SSTS用于术后疼痛的情况进行系统评价，以确定一种替代的疼痛管理方法。
系统评价文献，以确定在医院环境中使用SSTS进行PCA治疗中重度急性术后疼痛的疗效和安全性。
2019年12月，对Embase、MEDLINE、谷歌学术和Cochrane中心试验注册库进行了系统检索，以查找关于SSTS用于成人手术后疼痛的研究。分别使用基于共识的健康测量工具选择标准（COSMIN）清单和特定测量属性标准对研究的方法学质量及其结果进行评估。
纳入了16项评估SSTS的研究，共2311例患者。SSTS组的所有参与者在术后24小时内报告数字评分量表（NRS）≤4。患者满意度较高，接受SSTS治疗的患者中至少70%满意。SSTS 15微克和30微克总体上最常见的不良事件是恶心、呕吐和头痛。研究中观察到的不良事件通常与阿片类药物及术后情况相关。
SSTS是医院环境中管理中重度急性疼痛的重要系统。SSTS耐受性良好，没有意外不良事件，也没有具有临床意义的生命体征变化。这些数据证实了SSTS的安全性和耐受性。成功的疼痛管理使患者对SSTS的接受度很高，对疼痛控制方法满意度也很高。
