布比卡因锭剂对口腔粘膜炎疼痛的影响：随机对照多中心II期研究
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Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study
背景与目的
本研究主要通过干预组（Lozenge组）和对照组在口腔或咽部日平均疼痛评分（以较高者为准）之间的差异，从而探讨重复给予布比卡因锭剂（25mg）作为头颈部癌症患者的口腔粘膜炎疼痛的疼痛管理的有效性和耐受性。
方 法
本研究为非盲、随机、对照试验，共纳入来自丹麦2家医院的50例患者，随机接受布比卡因锭剂（每2小时服用，洛赛格组）及标准疼痛治疗（包括局部利多卡因，对照组），疗程1至7天；由于研究设计和数据缺失，12名受试者被排除在外。
结 果
在服用锭剂后35分钟（n = 22），口腔或咽部的平均疼痛评分明显低于对照组（51mm， [n = 16]；组间差异-16 mm；95％CI：-26至-6，P = 0.0032）。试验组（18mm）与对照组（36mm，P = 0.0002）相比，口腔的疼痛评分也显着降低。两组间咽部粘膜炎疼痛无显着差异（试验组：37mm 、对照组：48mm，P = 0.0630）。无严重的不良事件发生。
结 论
布比卡因锭剂作为标准疼痛治疗的药物在口腔粘膜炎患者中具有临床显着的疼痛缓解作用，且安全性极高。
原始文献摘要
Mogensen, Stine, Treldal, et al. Effect of bupivacaine lozenges on oral mucositis pain:, a randomized controlled multicenter phase II study[J]. Pain Reports, 2017, 2(5):1.
INTRODUCTION:
A nonblinded parallel-group randomized controlled study investigated the efficacy and tolerability of repeated administration of a bupivacaine lozenge (25 mg) as pain management for oral mucositis pain in head and neck cancer patients as add-on to standard systemic pain management.
OBJECTIVE:
The primary end point was the difference between the intervention group (Lozenge group) and the Control group in daily mean pain scores in the oral cavity or pharynx (whichever was higher).
METHOD:
Fifty patients from 2 hospitals in Denmark were randomized 1:1 to 7 days of treatment with bupivacaine lozenges (taken up to every 2 hours) plus standard pain treatment minus topical lidocaine (Lozenge group) or standard pain treatment including topical lidocaine (Control group). The efficacy analysis included 38 patients, as 12 patients were excluded because of changes in study design and missing data.
RESULTS:
Mean pain in the oral cavity or pharynx (whichever was higher) was significantly lower 60 minutes after taking lozenges (35 mm [n = 22]) than for the Control group (51 mm [n = 16]) (difference between groups -16 mm, 95% confidence interval: -26 to -6, P = 0.0032). Pain in the oral cavity was also significantly lower in the Lozenge group (18 mm) vs the Control group (36 mm, P = 0.0002). Pharyngeal mucositis pain did not differ significantly (37 mm [Lozenge group] vs 48 mm [Control group], P = 0.0630). No serious adverse events were reported.
CONCLUSION:
These results show that the bupivacaine lozenge as an add-on to standard pain treatment had a clinically significant pain-relieving effect in patients with oral mucositis.
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