Efficacy and safety of propranolol for treatment of temporomandibular disorder pain: a randomized, placebo-controlled clinical trial.
Efficacy and safety of propranolol for treatment of temporomandibular disorder pain: a randomized, placebo-controlled clinical trial.
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普萘洛尔治疗颞下颌关节紊乱疼痛的功效和安全性：一项随机、安慰剂对照临床试验。
DOI：
10.1097/j.pain.0000000000001882
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发表时间：
2020
期刊：
影响因子：
7.4
通讯作者：
Slade,GaryD
中科院分区：
文献类型：
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作者：
Tchivileva,InnaE;Hadgraft,Holly;Lim,PeiFeng;DiGiosia,Massimiliano;Ribeiro-Dasilva,Margarete;Campbell,JohnH;Willis,Janet;James,Robert;Herman-Giddens,Marcus;Fillingim,RogerB;Ohrbach,Richard;ArbesJr,SamuelJ;Slade,GaryD
普萘洛尔是一种非选择性β-肾上腺素能受体拮抗剂。一项多中心、随机、双盲、安慰剂对照、平行组、2b期临床试验招募了年龄在18至65岁的颞下颌关节紊乱病肌痛患者，以评估普萘洛尔与安慰剂相比在减轻面部疼痛方面的疗效和安全性。参与者以1：1的比例随机分配至盐酸普萘洛尔缓释片（60 mg，BID）或安慰剂组。主要终点是面部疼痛指数的变化（FPI 5面部疼痛强度乘以面部疼痛持续时间，除以100）。疗效分析为从随机化至第9周FPI的平均变化，以及第9周FPI降低30%或50%的受试者比例。检验回归模型，以校正随机化时研究中心、性别、人种和FPI的治疗组差异。在筛选的299名参与者中，200名被随机化; 199名至少有一次随机化后FPI测量，并被纳入意向治疗分析。第9周时，治疗组间模型校正的平均FPI降低无显著差异（21. 8，95% CL：26. 2，2. 6; P 5 0. 41）。然而，普萘洛尔组FPI降低30%的比例（69.0%）显著高于安慰剂组（52.6%），相关的需要治疗的人数为6.1（P <0.03）。普萘洛尔同样有效，FPI减少50%（需要治疗的人数5 6.1，P 5 0.03）。两个治疗组的不良事件发生率相似，除了普萘洛尔组更常见的疲劳、头晕和睡眠障碍。普萘洛尔在降低平均FPI方面与安慰剂没有差异，但在颞下颌关节紊乱病受试者中，治疗9周后，普萘洛尔有效地使FPI降低了30%和50%。
Propranolol is a nonselective beta-adrenergic receptor antagonist. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b trial enrolled participants aged 18 to 65 years with temporomandibular disorder myalgia to evaluate efficacy and safety of propranolol compared with placebo in reducing facial pain. Participants were randomized 1: 1 to either extended-release propranolol hydrochloride (60 mg, BID) or placebo. The primary endpoint was change in facial pain index (FPI 5 facial pain intensity multiplied by facial pain duration, divided by 100). Efficacy was analyzed as a mean change in FPI from randomization to week 9 and as the proportion of participants with $30% or $50% reductions in FPI at week 9. Regression models tested for treatment-group differences adjusting for study site, sex, race, and FPI at randomization. Of 299 participants screened, 200 were randomized; 199 had at least one postrandomization FPI measurement and were included in intention-to-treat analysis. At week 9, model-adjusted reductions in mean FPI did not differ significantly between treatment groups (21.8, 95% CL: 26.2, 2.6; P 5 0.41). However, the proportion with a $30% reduction in FPI was significantly greater for propranolol (69.0%) than placebo (52.6%), and the associated number-needed-to-treat was 6.1 (P 5 0.03). Propranolol was likewise efficacious for a $50% reduction in FPI (number-needed-totreat 5 6.1, P 5 0.03). Adverse event rates were similar between treatment groups, except for more frequent fatigue, dizziness, and sleep disorder in the propranolol group. Propranolol was not different from placebo in reducing mean FPI but was efficacious in achieving $30% and $50% FPI reductions after 9 weeks of treatment among temporomandibular disorder participants.