Ringold Forrest G, Minkowitz Harold S, Gan Tong Joo, Aqua Keith A, Chiang Yu-Kun, Evashenk Mark A, Palmer Pamela P
From the *Mobile Infirmary Medical Center, Mobile, AL; †Memorial Hermann-Memorial City Medical Center, Houston, TX; ‡Duke University Medical Center, Durham, NC; §Visions Clinical Research, Boyton Beach, FL; ║Essence Sciences, San Jose, CA; and **AcelRx Pharmaceuticals, Redwood City, CA.
Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152.
This study evaluates the efficacy and safety of a sufentanil sublingual tablet system (SSTS) for the management of postoperative pain following open abdominal surgery.
At 13 hospital sites in the United States, patients following surgery with pain intensity of greater than 4 on an 11-point numerical rating scale were randomized to receive SSTS dispensing a 15-μg sufentanil tablet sublingually with a 20-minute lockout or an identical system dispensing a placebo tablet sublingually. Pain intensity scores were recorded at baseline and for up to 72 hours after starting study drug. The primary end point was time-weighted summed pain intensity difference (SPID) over 48 hours. Secondary end points included SPID and total pain relief (TOTPAR) for up to 72 hours and patient and health care provider global assessments of the method of pain control.
Summed pain intensity difference over 48 hours was significantly higher in the SSTS group than in the placebo group (least squares mean [SEM], 105.60 [10.14] vs 55.58 [13.11]; P = 0.001). Mean SPID and TOTPAR scores were significantly higher in the SSTS group at all time points from 1 hour (SPID) or 2 hours (TOTPAR) until 72 hours (P < 0.05). In the SSTS group, patient global assessment and health care provider global assessment ratings of good or excellent were greater than placebo at all time points (P < 0.01). Safety parameters, including adverse events and vital signs, were similar for SSTS and placebo.
These results suggest that SSTS is effective and safe for the management of postoperative pain in patients following open abdominal surgery.
本研究评估了舒芬太尼舌下片系统（SSTS）用于开放性腹部手术后疼痛管理的有效性和安全性。
在美国的13个医院站点，将手术疼痛强度在11分数字评分量表上大于4分的患者随机分组，分别接受舌下含服15μg舒芬太尼片且锁定时间为20分钟的SSTS，或接受舌下含服安慰剂片的相同系统。在基线以及开始研究药物后长达72小时记录疼痛强度评分。主要终点是48小时内的时间加权疼痛强度总和差值（SPID）。次要终点包括长达72小时的SPID和完全缓解疼痛（TOTPAR），以及患者和医护人员对疼痛控制方法的总体评估。
SSTS组48小时内的疼痛强度总和差值显著高于安慰剂组（最小二乘均值[SEM]，105.60[10.14]对55.58[13.11]；P = 0.001）。从1小时（SPID）或2小时（TOTPAR）直至72小时的所有时间点，SSTS组的平均SPID和TOTPAR评分均显著更高（P < 0.05）。在SSTS组中，所有时间点患者总体评估和医护人员总体评估为良好或优秀的比例均高于安慰剂组（P < 0.01）。包括不良事件和生命体征在内的安全性参数，SSTS组和安慰剂组相似。
这些结果表明，SSTS用于开放性腹部手术后患者的疼痛管理有效且安全。
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