A Randomized,Double-Blind,Placebo-Controlled Study of Fentanyl Buccal Tablets for Breakthrough Pain: Efficacy and Safety in Japanese Cancer Patients

ContextRapid-onset opioids for treating breakthrough pain (BTP) in patients with cancer are needed in the Japanese care setting.ObjectivesTo examine the efficacy and safety of fentanyl buccal tablets (FBTs) for treating BTP in Japanese cancer patients.MethodsThis was a randomized, double-blinded, placebo-controlled study. In subjects receiving around-the-clock (ATC) opioids at doses of 30 mg or more to less than 60 mg or 60–1000 mg of oral morphine equivalents (low and high ATC groups), dose titration was started from 50 to 100 μg FBT, respectively. Subjects whose effective dose was identified were randomly allocated to a prearranged administration order of nine tablets (six FBTs and three placebos), one tablet each for nine episodes of BTP (double blinded). Efficacy and safety of FBT were assessed for patients overall, and also for the low and high ATC groups.ResultsA significant difference was observed between FBT and placebo for the primary endpoint of pain intensity difference at 30 minutes. The analgesic onset of FBT was observed from 15 minutes in several secondary variables (e.g., pain relief). Adverse events were somnolence and other events associated with opioids were mostly mild or moderate. Of the low and high ATC group subjects, an effective FBT dose was identified in 72.2% and 73.1%, respectively.ConclusionThe safety of FBT and its analgesic effect on BTP were confirmed in Japanese cancer patients receiving opioids. Our findings suggest that analgesic onset may occur from 15 minutes after FBT, and that FBT can be administered to patients with low doses of ATC opioids.     

芬太尼透皮贴剂用于烧伤切痂植皮术后镇痛的效果观察

[目的]探讨芬太尼透皮贴剂用于烧伤切痂植皮术后镇痛的临床效果及不良反应。[方法]将80例Ⅱ度～Ⅲ度烧伤切痂植皮面积(10±3)%的病人随机分为芬太尼透皮贴剂组(A组)和安慰贴剂组(B组)各40例。A组病人术前2h给予芬太尼透皮贴剂镇痛;B组病人术前2h予贴1片邦迪创可贴作安慰剂,不用预防性镇痛药,仅在术后出现疼痛时再予处理。[结果]手术后2h、4h、8h、16h、24h、48h、72h各时间点的视觉模拟评分(VAS),A组显著低于B组(P<0.01);术毕、术后第1天血糖值A组显著低于B组(P<0.01);A组恶心、呕吐、嗜睡发生率显著高于B组(P<0.05),头晕、便秘、皮肤瘙痒、尿潴留发生率,两组差异无统计学意义(P>0.05);两组均未发现呼吸抑制及呼吸困难。[结论]25μg/h芬太尼透皮贴剂应用于烧伤切痂植皮术后能达到有效镇痛。     

Intranasal Fentanyl Versus Fentanyl Pectin Nasal Spray for the Management of Breakthrough Cancer Pain in Doses Proportional to Basal Opioid Regimen

The aim of this randomized, crossover, comparison study was to assess the analgesic and adverse effects of 2 nasal preparations, intranasal fentanyl (INFS) and fentanyl pectin nasal spray (FPNS), for breakthrough pain, given in doses proportional to opioid basal regimen. Each patient randomly received INFS or FPNS in doses proportional to opioid dosages used for background analgesia for 2 pairs of episodes. For each episode of breakthrough pain, pain intensity and adverse effects intensity were recorded just before starting the INFS or FPNS (T0) and 5 minutes (T5), 10 minutes (T10), and 20 minutes (T20) after the administration of the nasal drugs. Sixty-nine patients were studied. The mean age was 63.4 years, and 37 patients were males. For the present analysis, 188 episodes were considered. A statistical decrease in pain intensity was observed with both nasal drugs after 5, 10, and 20 minutes. A decrease in pain intensity of >33% was observed in 16, 102, and 159 treated episodes at T5, T10, and T20, respectively. Adverse effects were of mild nature in most cases or were preexistent because of basal opioid therapy. No differences were found in summed pain intensity difference 20 minutes after dosing. Most of patients did not find substantial preferences. INFS and FPNS were effective and well-tolerated treatments for breakthrough pain management. Both delivery systems, in doses proportional to the basal opioid regimen, provided significant analgesia within 10 minutes, without producing relevant adverse effects.PerspectiveThis article showed that INFS and FPNS in doses proportional to basal opioid regimen are equally safe and effective for the management of breakthrough pain in cancer patients. These data provide new insights on the use of nasal preparations of fentanyl.     

可塞风加芬太尼对脊柱术后PCIA血皮质醇的影响

目的:对比可塞风加芬太尼、芬太尼加氟哌啶术后静脉自控镇痛术后24h、48h血中皮质醇浓度,同时观察其镇痛效果、镇痛药用量、不良反应等。方法:90例脊柱手术后病人,随机分为三组,每组30例,Ⅰ组芬太尼1mg加氟哌啶10mg,Ⅱ组可塞风16mg加芬太尼0.5mg,Ⅲ组可塞风24mg加芬太尼0.5mg,3组药液均配制为100ml,镇痛持续48-72h。结果:①血中皮质醇浓度(nmol/L):术后24h,Ⅰ组113.92±85.04;Ⅱ组56.06±28.77;Ⅲ组51.23±30.01,Ⅱ、Ⅲ组与Ⅰ组比较P<0.01,48小时各组间比较无差异P>0.01。②镇痛优良率(VAS<3分):Ⅱ组(90％)、Ⅲ组(93.3％)与Ⅰ组(60％)比较P<0.01。③芬太尼用量(ug/h):Ⅱ组7.75±1.52、Ⅲ组6.92±1.73、Ⅰ组18.24±7.44,Ⅱ、Ⅲ组与Ⅰ组比较P<0.01。④不良反应:恶心呕吐:Ⅰ、Ⅱ组无病例,Ⅲ组1例;头晕:Ⅰ组5例,Ⅱ、Ⅲ组无病例;腹涨:Ⅰ组1例,Ⅱ、Ⅲ组无病例。结论:可塞风在治疗剂量范围内(<16mg/24h)复合芬太尼用于PCIA可显著减少芬太尼用量,减轻病人术后应激反应,同时降低阿片类镇痛药的副作用。     

Oral transmucosal fentanyl citrate for the treatment of migraine headache pain in outpatients: a case series

BACKGROUND: Migraine headache pain that does not respond to traditional antimigraine medications frequently requires treatment in the emergency department (ED) with parenteral opioids. Rapid onset of pain relief in an outpatient setting for migraine headache is the primary objective of patients and clinicians. Oral transmucosal fentanyl citrate (OTFC; ACTIQ) is a novel opioid product designed to deliver rapid analgesia to patients who experience breakthrough pain (BTP). OBJECTIVE: To evaluate the effectiveness, tolerability, and patient satisfaction with OTFC for the outpatient treatment of acute, refractory migraine headache pain. PATIENTS AND METHODS: Twenty patients with recurrent acute, refractory migraine headaches who had been referred to this headache clinic are reported in this case series. All patients had a history of tolerating parenteral opioids in the ED when experiencing refractory migraine pain and had been treated with outpatient opioid therapies in attempts to manage their migraine pain. Patients were prescribed OTFC (400 microg) as rescue treatment for moderate or severe migraine headache pain as outpatients. Patients were instructed to self-administer OTFC at home and complete a diary recording: pain intensity (11-point scale; 10 = worst pain imaginable to 0 = no pain) before and 15, 30, 60, and 120 minutes after OTFC; satisfaction with the effectiveness of OTFC (selecting 1 of 7 categories ranging from "very dissatisfied" through "very satisfied") rated at 120 minutes; and adverse events. RESULTS: Eighteen patients (13 female) experienced a migraine and self-administered OTFC. OTFC successfully treated migraine episodes in all 18 outpatients; no patient went to an ED. OTFC rapidly reduced pain intensity, with significant improvement at 15 minutes that was sustained and provided progressively more pain relief at 30, 60, and 120 minutes (all P <.01). Mean (SEM) pain intensity significantly declined from 8.83 (0.35) pretreatment to 2.28 (0.67) at 120 minutes, an average reduction of 75% (P <.01). Patients' satisfaction ratings with OTFC were overwhelmingly positive, with 94% being satisfied and more than half (56%) being "very satisfied." Three (17%) patients experienced nausea, two (11%) somnolence, and one (6%) each itching, vomiting, and dry mouth. All adverse events were mild or moderate in severity. CONCLUSIONS: OTFC rapidly and significantly relieved acute, refractory migraine pain in outpatients, prevented the need for an ED visit, and was associated with high patient satisfaction ratings. The rapid onset of migraine headache pain relief in this case series is consistent with the analgesic effect reported with the use of OTFC in patients with BTP. OTFC was well tolerated in these patients who had a history of tolerating parenteral opioids in the ED when experiencing refractory migraine pain and had been treated with outpatient opioid therapies in attempts to manage their migraine pain. OTFC may be effective for outpatient treatment of acute, refractory migraine headache pain. Further controlled studies are warranted.     

不同剂量芬太尼复合丙泊酚用于人工流产术的比较

目的丙泊酚剂量相同，对不同配伍芬太尼用于人工流产术的观察。方法50例（ASAT级）手术病例随机分成两组，Ⅰ组（n=25）给予1.5μg／kg芬太尼＋2mg／kg丙泊酚：Ⅱ组（n=25）给予2、0pg／kg芬太尼＋2mg／kg丙泊酚进行对比观察。结果术中呼吸抑制Ⅱ组明显大于T组，Ⅰ组4例辅助呼吸，Ⅱ组13例辅助呼吸。苏醒时间Ⅰ组于停药后6～7rain唤醒，Ⅱ组7—10min后唤醒。两组均无恶心呕吐和术中知晓，且两组均能提供较满意的麻醉效果。结论小剂量芬太尼复合丙泊酚用于人流术时，其效果相同，更为安全。     

曲马多与芬太尼对全麻苏醒期镇痛效果的研究

目的探讨术中应用曲马多、芬太尼对全麻苏醒期镇痛效果的影响。方法 2009年10月2010年4月将80例静脉麻醉下行胃癌根治术的患者随机分为4组：Q1组曲马多1mg/kg、F1组芬太尼1μg/kg、Q2组曲马多2mg/kg、F2组芬太尼2μg/kg。各组分别于术毕前30min静注给药。手术结束后送恢复室,比较4组的呼唤睁眼时间、拔管时间、拔管后即刻疼痛评分（VAS评分）、术前术后平均动脉压（MAP）、心率（HR）、脉搏血氧饱和度（SpO2）的变化以及不良反应的发生情况。结果 4组患者呼唤睁眼时间差异无统计学意义（P〉0.05）,F2组的拔管时间明显长于其他3组（P〈0.05）,Q1组和F1组的疼痛评分明显高于Q2组和F2组（P〈0.05）,在T2时点,Q2组和F2组的MAP值明显低于Q1组和F1组（P〈0.05）。结论曲马多2mg/kg与芬太尼2μg/kg的镇痛效果的效果相当,但安全性更高,更加适合全麻苏醒期的镇痛治疗。     

右美托咪定联合芬太尼镇静在内镜下食管胃底静脉套扎术中的应用

目的探讨右美托咪定联合芬太尼镇静用于内镜下食管胃底静脉套扎术(EVL)的有效性与安全性。方法拟行EVL术的肝硬化患者80例,随机分成右美托咪定联合芬太尼组DF组和芬太尼组F组,每组各40例,两组患者术前10 min口服利多卡因胶浆10 ml表面麻醉,DF组术前10 min始匀速静脉泵入0.5μg/kg右美托咪定,术前2 min缓慢静脉推注芬太尼0.5μg/kg,F组术前2 min缓慢静脉推注芬太尼0.5μg/kg,记录两组患者Ramsay镇静评分、术中不良反应、患者的术中反应程度、患者满意度和操作医生的满意度,操作时间。结果 DF组的Ramsay镇静评分大于F组,患者的满意度、操作医生的满意度均优于F组,手术时间DF组小于F组,不良反应两组相似。结论右美托咪定联合芬太尼清醒镇静用于EVL安全有效,优于单用芬太尼。     

氯诺昔康与芬太尼用于下腹部术后患者自控镇痛疗效比较

目的:评价非甾体类抗炎药氯诺昔康用于下腹部手术术后患者自控镇痛(PCA)的疗效。方法:选择40例下腹部手术的患者.通过相同的麻醉方法,术后随机分为A组(n=20)和B组(n=20),进行PCA治疗。A组静脉应用氯诺昔康(2ml/h.holus为3.5ml),B组静脉应用芬太尼(2ml/h,bolus为3.5ml)。结果:下腹部手术患者术后PCA镇痛,A组(氯诺昔康组)与B组(芬太尼组)在疼痛程度(PI)、病人对镇痛治疗总体印象评分、疼痛缓解度(PAR)、用药量等方面无显著差异(P>0.05);A组总体睡眠质量略逊于B组(P<0.05);呼吸频率、皮肤瘙痒及恶心、呕吐等类似于B组。结论:氯诺昔康不失为阿片类镇痛药术后PCA的较好的替代药。     

不同剂量芬太尼联合咪达唑仑在支气管镜检查中的应用效果比较

目的 探讨不同剂量芬太尼联合咪达唑仑在支气管镜检查中的舒适性和安全性.方法 选取入住该院呼吸内科且需要行电子支气管镜检查的住院患者共136例,分为试验组101例和对照组35例,试验组分为3个亚组,即:单用咪达唑仑组(A组)、25μg芬太尼联合咪达唑仑组(B组)、50μg芬太尼联合咪达唑仑组(C组).记录4组患者行支气管...     

曲马多复合芬太尼应用于清醒气管内插管的探索

[目的]探讨曲马多复合芬太尼用于清醒气管内插管的可行性及其合适的剂量.[方法]采用up-and-down序贯设计方法分别探讨20～49岁组、50～69岁组和70岁以上组患者曲马多复合芬太尼用于纤维支气管镜引导下经鼻腔清醒气管内插管的可行性及其合适的剂量并进行验证.[结果]20～49岁组患者应用2.2 μg/kg芬太尼+2.0 mg/kg曲马多、50～69岁组患者应用1.6ug/kg芬太尼+1.9 mg/kg曲马多、70岁以上组患者应用1.0 ug/kg芬太尼+1.8 mg/kg曲马多后患者神志清楚,没有明显呼吸抑制;同时在该剂量下患者容易接受环甲膜穿刺气道表面麻醉和经鼻纤维支气管镜引导的气管内插管,术后随访大多数患者对插管过程有记忆但无明显不适,未发现清醒气管内插管相关后遗效应.[结论]曲马多复合芬太尼可以安全用于纤维支气管镜引导的经鼻腔清醒气管内插管,但具体用药剂量在不同年龄组患者稍有差异.     

丙泊酚、芬太尼联合米索前列醇在无痛人工流产中的应用效果

目的观察丙泊酚、芬太尼联合米索前列醇在无痛人工流产中的麻醉效果。方法92例行无痛人工流产的健康妇女随机分为两组,观察组46例采用丙泊酚、芬太尼联合米索前列醇,对照组46例仅采用丙泊酚、芬太尼,比较两组的麻醉效果以及术中、术后效果。结果两组麻醉总有效率比较,差异无统计学意义(P>0.05),但观察组的显效率明显高于对照组(P<0.05)。观察组手术时间、术后出血时间明显短于对照组(P<0.05),术中出血量明显少于对照组(P<0.05),宫缩幅度大于对照组(P<0.05)。结论丙泊酚、芬太尼联合米索前列醇在无痛人工流产中,麻醉效果显著,并且能缩短手术时间、术后出血时间,减少术中出血量,加强宫缩幅度,值得临床推广应用。     

人流术中随机双盲用芬太尼、曲马多镇痛的对比研究

减少人流术中终止妊娠病人的痛苦和并发症。方法：２０例病随机双盲用０．０５ｍｇ芬太尼或５０ｍｇ曲马多＋生理盐水４ｍｌ,２分钟左右静脉缓推完,推药后３－５分钟进行吸宫术。结果：在人流术中芬太尼的镇痛效果优于曲马多;在对宫颈松驰度,并发症和出血的影响方面的两种药物无差异;胆用曲马多镇痛的病人术后自动离院的时间早于用芬太尼者。结论芬太尼的镇痛效果好,价值便宜,值推广。     

癌痛患者芬太尼透皮贴剂处方剂量影响因素的研究

目的 了解癌痛患者使用芬太尼透皮贴剂处方剂量的影响因素,为居家宁养护理中正确给予镇痛治疗提供依据.方法 对居家宁养的100例中、重度疼痛的癌症患者使用芬太尼透皮贴剂镇痛,以患者不感觉疼痛为准,观察疼痛程度、疼痛部位、性别、年龄与用药剂量的关系.结果 重度疼痛患者的维持剂量高于中度疼痛患者,而不同疼痛部位、性别、年龄患者的维持剂量差异无统计学意义.结论 疼痛程度是唯一影响芬太尼透皮贴剂处方剂量的因素,实施镇痛治疗时应首先加以考虑.     

恩再适预镇痛对芬太尼用于术后静脉镇痛的临床效应

目的比较术前预用恩再适对不同剂量芬太尼用于子宫全切术后患者自控静脉镇痛的影响。方法选择全麻下子宫全切术的患者120例，术后采用芬太尼经生理盐水稀释后行患者自控静脉镇痛（PCIA），并根据不同的用药方法随机分为四组：A组，芬太尼1mg＋0．9％NaCl共100ml；B组，芬太尼0．5mg＋0．9％NaCl共100ml；C组，术前晚、麻醉前、术毕各经静脉注射恩再适3．6U，芬太尼0．7mg＋0．9％NaCl共100ml；D组，术前晚、麻醉前、术毕各经静脉注射恩再适7．2U，芬太尼0．5mg＋0．9％NaCl共100ml，每组30例。术后24h内采用视觉模拟评分（VAS）、PCA按压次数来观察各组镇痛效应及恶心呕吐、嗜睡等不良反应的发生率。结果B组术后2h时的VAS评分显著高于A、C和D组（P〈0．05），而2h后的VAS四组间差异无统计学意义（P〉0．05）。24h内的PCA按压次数B组显著多于A、C和D组（P〈0．05）。B、C和D组中恶心、呕吐、皮肤瘙痒及嗜睡等不良反应的发生率显著低于A组（P〈0．05）。镇痛期间无呼吸抑制、异常出血等严重并发症的发生。结论术前预用恩再适复合小剂量芬太尼用于子宫全切术后静脉镇痛可取得满意的镇痛效果，并能减少芬太尼的用量及不良反应的发生率。     

无痛内镜下十二指肠乳头括约肌切开术应用丙泊酚复合芬太尼的麻醉效果及安全性评价

目的探讨丙泊酚复合芬太尼用于无痛内镜下十二指肠乳头括约肌切开术（EST）的麻醉效果及其安全性。方法 60例拟行EST的患者被分为A、B两组各30例,A组采用无痛EST,B组行常规EST。观察比较两组患者手术期间的生命体征的变化,不良反应以及术后感受,并记录两组手术操作时间、手术成功率。结果 A组术中平均动脉压（MAP）、心率（HR）及血氧饱和度（SpO2）呈一过性下降,B组术中HR及MAP升高,与术前及A组术中相比差异有统计学意义（P〈0.05）;A组手术成功率高,不良反应低,患者满意率高;两组操作时间比较,差异无统计学意义（P〉0.05）。结论丙泊酚复合芬太尼用于无痛EST安全舒适有效、清醒快、不良反应少、患者更满意,值得临床推广应用。     

地佐辛与芬太尼患者自控静脉镇痛的比较

目的比较地佐辛与芬太尼自控静脉镇痛(PCIA)的镇痛效果和不良反应。方法将120例胆囊切除术患者随机均分为A、B 2组,每组60例。术后A组PCIA采用地佐辛1 mg/Kg、氟哌利多5 mg,B组PCIA采用芬太尼18μg/Kg、氟哌利多5 mg,分别于术后4、8、12、24 h采用视觉模拟评分法(VAS)评定镇痛效果,并记录不良反应情况。结果 2组患者术后镇痛效果无显著性差异;2组均未见血压心率的波动及呼吸抑制等严重并发症发生;A组镇静评分为Ⅰ~Ⅳ级的比例显著低于B组,其余不良反应发生率与B组均无统计学差异。结论地佐辛PCIA镇痛效果可靠,不失为一种比较好的PCIA方法。     

地佐辛与芬太尼患者自控静脉镇痛的比较

目的比较地佐辛与芬太尼自控静脉镇痛(PCIA)的镇痛效果和不良反应。方法 120例胆囊切除术患者,年龄39~52岁,随机均分为2组,术后A组PCIA采用地佐辛1 mg/kg+氟哌啶5 mg,B组PCIA采用芬太尼18μg/kg+氟哌啶5mg,分别于术后4、8、12、24 h采用视觉模拟评分法(VAS)评定镇痛效果及不良反应。结果 2组患者术后镇痛效果及不良反应均无显著性差异。结论地佐辛PCIA镇痛效果可靠,不失为一种比较好的PCIA方法。     

术后芬太尼皮下镇痛及对胃肠功能影响的研究

目的 比较术后芬太尼皮下镇痛(PCSA)与硬膜外镇痛(PCEA)的临床效果,以及对胃肠功能的影响.方法 2009年1-6月间观察择期硬膜外麻醉下经腹子宫切除术患者120例,术后分别实施PCSA与PCEA,观察术后第4、8、12、24、48 h的镇痛、镇静情况,呼吸循环、恶心呕吐及其他不良事件,记录术后首次肛门排气时间,...