芬太尼颊片突破opioid-tolerant疼痛的缓解成人慢性神经性疼痛患者:一项多中心、随机、双盲、安慰剂对照研究。

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辛普森DM,墨西拿J,黑尔谢F M

芬太尼颊片突破opioid-tolerant疼痛的缓解成人慢性神经性疼痛患者:一项多中心、随机、双盲、安慰剂对照研究。

4月。2007;29 (4):588 - 601。

PubMed ID

17617282 (在PubMed

]

文摘

背景:慢性疼痛患者,包括神经性疼痛,可能会有短暂的发作的疼痛(平均持续时间60分钟),称为突破痛苦(BTP),可能在几分钟内达到峰值强度。典型的短效口服阿片类药物可能无法提供足够的快速救援(30到60分钟出现镇痛)。芬太尼颊片(FBT)提供了一个快速的镇痛(10 - 15分钟)通过提高芬太尼在颊粘膜吸收。目的:本研究评估疗效和耐受性的炉膛温度opioid-tolerant BTP患者慢性神经性疼痛。方法:这是一个多中心、随机、双盲、安慰剂对照研究在18岁到80岁的男性和女性谁是阿片类宽容;> / = 3个月历史的慢性神经性疼痛与糖尿病周围神经病变有关,postherpetic神经痛,创伤性损伤,或复杂区域疼痛综合征;和报告BTP集。后一项滴定时间确定一个有效的FBT剂量(病人的剂量报告后30分钟内收到足够的疼痛管理一个平板电脑的剂量期间至少2 3 BTP集),患者被随机分配到治疗连续9集BTP在接下来的21天的1 3双盲剂量的炉膛温度序列和安慰剂药片。疼痛强度(π)(额定11个疼痛量表,从0 =没有疼痛10 =严重疼痛)和其他结果评估在剂量和给药后2小时。主要疗效测量是π的总和差异(pid)第一60分钟(SPID (60)。 Secondary efficacy measures included the proportion of BTP episodes with >/= 33% and >/= 50% improvement in PI from baseline; PID at other time points (5, 10, 15, 30, 45, 60, 90, and 120 minutes after dosing); pain relief (PR) at the same time points (rated on a 5-point Likert scale from 0 = none to 4 = complete); proportion of BTP episodes with meaningful PR; time to meaningful PR; and proportion of BTP episodes in which supplemental medication was required after administration of study drug. Adverse events (AEs) spontaneously reported by the patient or elicited by the investigator were recorded throughout the study. RESULTS: Of 102 patients in the open-label titration period, 80 identified an effective dose of FBT and 79 entered the double-blind phase. Of these 79 patients, 77 (97%) completed the study and 75 (95%) were evaluable for efficacy. Of the 79 patients who entered the double-blind phase, 63% were women and 92% were white; their mean (SD) age was 48.3 (10.42) years, and their mean weight was 96.8 (33.42) kg. Baseline demographic and pain characteristics were similar between the overall population and the double-blind population. SPID(60) was significantly greater for BTP episodes treated with FBT compared with those in which placebo was administered (mean [SE], 9.63 [0.75] vs 5.73 [0.72], respectively; P < 0.001). Significant differences between FBT and placebo were seen beginning at 10 minutes for PID (mean, 0.740 [0.149] vs 0.427 [0.081]; P < 0.047) and PR (mean, 0.561 [0.087] vs 0.324 [0.056]; P < 0.001). A >/= 33% improvement in PI from baseline was seen in a greater proportion of BTP episodes treated with FBT compared with placebo from 10 minutes (9% vs 3%; P = 0.008) through 2 hours (66% vs 37%; P < 0.001). Patients were almost 4 times less likely to require supplemental opioids when BTP episodes were treated with FBT compared with placebo (odds ratio = 0.28; 95% Cl, 0.18-0.42). AEs were reported by 64 (63%) of 102 patients. The most commonly reported AEs were those typical of opioids (nausea [13%], dizziness [13%], somnolence [10%], and vomiting [5%]) and occurred more often during the dose-titration phase (55/102 [54%]) than during the double-blind phase (22/79 [28%]). CONCLUSION: In these opioid-tolerant patients with chronic neuropathic pain who identified an effective FBT dose, FBT had a rapid onset of action and was effective and well tolerated in the treatment of BTP.

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药物

芬太尼