Department of Anesthesiology, Gunma University Graduate School of Medicine, Maebashi-shi, Gunma, Japan.
Department of Oral and Maxillofacial Surgery, Gunma University Graduate School of Medicine, Maebashi-shi, Gunma, Japan.
PLoS One. 2018 Jul 2;13(7):e0200059. doi: 10.1371/journal.pone.0200059. eCollection 2018.
We have synthesized a sustained-release lidocaine sheet (SRLS) using biodegradable polymers and previously demonstrated its safety and long-term analgesic effect in the normal mucous membrane of healthy human volunteers.
The aim of this clinical study was to evaluate the efficacy, safety, and appropriate dose of the SRLS for pain following tooth extraction.
Randomized, single-blind, dose-response, controlled, clinical study (Phase 1/2).
The patients in this trial were enrolled between January 2014 and December 2016. A total of 99 patients were randomly divided into 5 groups as follows: the Non-administration group received the conventional extraction; the Poly Lactic-co-Glycolic Acid (PLGA) 100 mg control group received the PLGA matrix without lidocaine; the SRLS 100 mg group received a single sheet of SRLS 100 mg; the SRLS 200 mg group received double sheets of SRLS 100 mg; and the SRLS 400 mg administration group received four sheets of SRLS 100 mg. A study drug was inserted into the defect socket after the extraction, and postoperative pain intensity, satisfaction with postoperative pain relief, adverse events, and postoperative supplemental analgesic rescue use (time, dose) were investigated by patient self-report.
In total, 94 (94.9%) patients completed the study. There were no significant differences in postoperative pain intensity, satisfaction with postoperative pain relief, and postoperative supplemental analgesic rescue use among the 5 groups. There were no serious side effects, including a plasma concentration increase of lidocaine, attributable to the SRLS.
Administration of the SRLS at 100 mg may have clinical therapeutic potential for pain relief following tooth extraction. The safety of the SRLS for patients undergoing tooth extraction was demonstrated.
The University Hospital Medical Information Network UMIN000011945.
我们使用可生物降解聚合物合成了一种缓释利多卡因贴剂（SRLS），并在健康志愿者的正常黏膜中进行了安全性和长期镇痛效果的前期研究。
本临床研究旨在评估 SRLS 用于拔牙后疼痛的疗效、安全性和适宜剂量。
随机、单盲、剂量反应、对照的临床研究（1/2 期）。
该试验于 2014 年 1 月至 2016 年 12 月期间招募患者。共 99 例患者随机分为 5 组：非给药组接受常规拔牙；聚丙交酯-乙交酯（PLGA）100mg 对照组给予不含利多卡因的 PLGA 基质；SRLS 100mg 组给予 1 片 SRLS 100mg；SRLS 200mg 组给予 2 片 SRLS 100mg；SRLS 400mg 给药组给予 4 片 SRLS 100mg。拔牙后将研究药物插入拔牙窝，通过患者自我报告调查术后疼痛强度、对术后疼痛缓解的满意度、不良事件以及术后补充性镇痛药物的使用（时间、剂量）。
共 94 例（94.9%）患者完成了研究。5 组间术后疼痛强度、对术后疼痛缓解的满意度和术后补充性镇痛药物的使用无显著差异。SRLS 无严重副作用，包括血浆利多卡因浓度升高。
SRLS 给药 100mg 可能具有缓解拔牙后疼痛的临床治疗潜力。SRLS 用于拔牙患者的安全性得到了证实。
日本大学医院医疗信息网络 UMIN000011945。
