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Dyloject®, a novel injectable diclofenac solubilised with cyclodextrin: Reduced incidence of thrombophlebitis compared to injectable diclofenac solubilised with polyethylene glycol and benzyl alcohol Dyloject®,一种新型可注射双氯芬酸与环糊精溶解:与可注射双氯芬酸与聚乙二醇和苯甲醇溶解相比,可降低血栓性静脉炎的发生率
Pub Date : 2009-03-01 DOI: 10.1016/j.acpain.2008.11.001
Robert D. Colucci, Curtis Wright IV, Fred H. Mermelstein, Daniel G. Gawarecki, Daniel B. Carr

Background

Thrombophlebitis is a common complication of a widely used formulation of injectable diclofenac that employs propylene glycol and benzyl alcohol (PG–BA) as solvents. Initial studies of Dyloject®, a novel injectable diclofenac solubilised with hydroxypropyl-β-cyclodextrin (HPβCD), suggested that this complication occurred less frequently and with lower severity with the newer formulation.

Methods

We conducted a safety analysis of seven single-dose clinical trials that enrolled 531 patients receiving either a rapid intravenous (IV) bolus of Dyloject® or a 30 min IV infusion of PG–BA diclofenac.

Results

The incidence of thrombophlebitis observed as an adverse event following Dyloject® treatment was 1.2% (5 of 423) versus 6.5% (7 of 108) following PG–BA diclofenac (p < 0.01). In a subset of clinical studies that included an observer-rated thrombophlebitis assessment, the incidence of mild irritation was similar for both products (5.4% for Dyloject® and 4.9% for PG–BA diclofenac). Differences between the formulations were most evident in the higher incidence of moderate to severe thrombophlebitis after PG–BA diclofenac (2.4% incidence) compared to Dyloject® (0% incidence).

Conclusion

HPβCD, the solubilising agent in Dyloject®, may be less irritating and result in less clinical thrombophlebitis than the cosolvents propylene glycol and benzyl alcohol used in PG–BA diclofenac.

血栓性静脉炎是广泛使用的以丙二醇和苯甲醇(PG-BA)为溶剂的注射用双氯芬酸制剂的常见并发症。Dyloject®是一种新型可注射双氯芬酸与羟丙基-β-环糊精(HPβCD)溶解的药物,初步研究表明,使用新制剂时,这种并发症发生的频率更低,严重程度更低。方法:我们对7项单剂量临床试验进行了安全性分析,纳入了531例接受快速静脉注射(IV) Dyloject®或静脉输注PG-BA双氯芬酸30分钟的患者。结果:Dyloject®治疗后血栓性静脉炎的不良事件发生率为1.2%(423人中的5人),而PG-BA双氯芬酸治疗后的不良事件发生率为6.5%(108人中的7人)。0.01)。在包括观察者评价血栓性静脉炎评估的临床研究子集中,两种产品的轻度刺激发生率相似(Dyloject®为5.4%,双氯芬酸PG-BA为4.9%)。两种制剂之间的差异最明显的是PG-BA双氯芬酸治疗后中至重度血栓性静脉炎的发生率(2.4%)高于Dyloject®(0%)。结论与PG-BA双氯芬酸中使用的共溶剂丙二醇和苯甲醇相比,Dyloject®中的增溶剂hp β cd可能具有更小的刺激性和更少的临床血栓性静脉炎。
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引用次数: 14
Acute and chronic pain following breast surgery 乳房手术后的急性和慢性疼痛
Pub Date : 2009-03-01 DOI: 10.1016/j.acpain.2009.01.001
Serene H. Chang, Vivek Mehta, Richard M. Langford

Background

Successful acute pain management after breast surgery remains challenging, and if not achieved, may increase the likelihood of subsequent chronic pain.

Aims

This article aimed to evaluate the evidence for varied techniques described for peri-operative pain management in breast surgery, and to review the literature on chronic pain after breast surgery and particularly ‘post-mastectomy pain syndrome’.

Method

A Pubmed search was performed, with the key words “mastectomy” and “pain” for articles in the English language in the adult human population (age > 19 years), looking specifically for different analgesic techniques that have been evaluated.

Results

Thirty-three peer-reviewed publications with pain outcome data were included, ranging from 15 to 289 patients per study (total n = 2104). Twenty three were randomised controlled trials and the rest were prospective or retrospective audits and case series. Inconsistent trial methodology precluded a meta-analysis. Paravertebral local anaesthetic nerve blockade resulted in lower pain scores and fewer side effects than opioid-based regimens. Three risk factors emerged predicting chronic pain post-mastectomy: higher post-operative pain scores, age <65 years and inclusion of major reconstructive surgery.

Conclusion

Paravertebral block should be considered for use in major breast surgery. Pain control should be optimised/a priority for both acute care and to potentially reduce chronic pain.

背景:成功的乳房手术后急性疼痛管理仍然具有挑战性,如果不能实现,可能会增加后续慢性疼痛的可能性。本文旨在评估各种乳房手术围手术期疼痛管理技术的证据,并回顾关于乳房手术后慢性疼痛的文献,特别是“乳房切除术后疼痛综合征”。方法在Pubmed上检索成人(年龄>19年),专门寻找已经评估过的不同镇痛技术。结果纳入33篇同行评议的疼痛结局数据出版物,每项研究15至289例患者(总n = 2104)。23项是随机对照试验,其余是前瞻性或回顾性审计和病例系列。不一致的试验方法学排除了荟萃分析。与基于阿片类药物的治疗方案相比,椎旁局部麻醉神经阻断导致较低的疼痛评分和较少的副作用。预测乳房切除术后慢性疼痛的三个危险因素:较高的术后疼痛评分、年龄(65岁)和包括重大重建手术。结论在乳房大手术中应考虑椎旁阻滞。对于急性护理和潜在地减少慢性疼痛,应优先优化疼痛控制。
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引用次数: 30
Timing of intraoperative parecoxib analgesia in colorectal surgery 结直肠手术术中帕瑞昔布镇痛的时机选择
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.07.002
L.H. Lee , M.G. Irwin , T.J. Yao , M.K. Yuen , C.W. Cheung

Objective

The aim of this study was to determine the analgesic effect of parecoxib when administered either before or at the end of surgery in patients undergoing colorectal laparotomy.

Methods

Sixty patients were randomised to three groups of 20. The PS group received intravenous parecoxib 40 mg before skin incision and normal saline at skin closure. The SP group received saline before skin incision and intravenous parecoxib 40 mg at skin closure. A control group (SS) received saline at both time points.

Results

In both SP and PS groups, morphine consumption was smaller. There was a 40–55% reduction in cumulative morphine consumption in both treatment groups at all time points up to 48 h after anaesthesia finished. The greatest reduction was from 12 h to 24 h which showed a 66% reduction for the SP group and a 55% reduction for the PS group compared to control (p = 0.0003 and 0.0049, respectively, with an adjusted significance value = 0.0167). For SP and PS groups, the time to first post-operative analgesic request tended to be longer and the number of patients requesting morphine in the recovery room was less.

Conclusion

Parecoxib administration at the end of surgery is as effective as at the beginning with regard to analgesic and opioid-sparing effects.

目的本研究的目的是确定在结肠剖腹手术患者术前或术后给予帕瑞昔布的镇痛效果。方法60例患者随机分为3组,每组20例。PS组患者在皮肤切开前静脉注射帕瑞昔布40 mg,皮肤闭合时静脉注射生理盐水。SP组在皮肤切开前给予生理盐水,皮肤闭合时静脉注射帕瑞昔布40 mg。对照组(SS)在两个时间点均给予生理盐水。结果SP组和PS组吗啡用量均小于对照组。在麻醉结束后48小时内,两个治疗组的累积吗啡用量均减少40-55%。最大的减少是从12小时到24小时,与对照组相比,SP组减少了66%,PS组减少了55% (p分别= 0.0003和0.0049,调整后的显著性值= 0.0167)。SP组和PS组术后首次请求镇痛时间更长,恢复室中请求吗啡的患者数量较少。结论手术结束时给予帕瑞昔布与手术开始时给予帕瑞昔布的镇痛和阿片类药物节约效果相同。
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引用次数: 5
When to think about chronic pain, to avoid progression of acute pain to chronic pain 当考虑慢性疼痛时,要避免急性疼痛发展为慢性疼痛
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.012
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引用次数: 0
Managing acute pain in patients with a substance abuse or dependence disorder 药物滥用或依赖障碍患者的急性疼痛管理
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.007
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引用次数: 0
Progression of acute to chronic pain: How to prevent it 急性到慢性疼痛的进展:如何预防
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.011
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引用次数: 0
Burns pain 烧伤疼痛
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.005
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引用次数: 0
Selective and non-selective inhibitors of cyclooxygenases: The state of the art 环加氧酶的选择性和非选择性抑制剂:最新进展
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.016
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引用次数: 0
Local infiltration analgesia in total knee arthroplasty and hip resurfacing: A methodological study 全膝关节置换术和髋关节表面置换术中的局部浸润镇痛:一项方法学研究
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.001
Kristian S. Otte , Henrik Husted , Lasse Ø. Andersen , Billy B. Kristensen , Henrik Kehlet

Effective pain management is essential for early recovery and rehabilitation after total hip and knee arthroplasty. Current methods include a multimodal regimen of oral analgesics combined with either continuous epidural analgesia or continuous peripheral nerve blockade both of which have risk of side effects and demand expertise. A simple and effective local infiltration technique with local anaesthetic, epinephrine and NSAID has been developed by D. Kerr and L. Kohan in Sydney, but with variable results reported from others. Since there is no detailed description of the technique we herein present the method in detail as developed by the inventors.

有效的疼痛管理对于全髋关节和膝关节置换术后的早期恢复和康复至关重要。目前的方法包括口服镇痛药联合持续硬膜外镇痛或持续周围神经阻滞的多模式方案,这两种方法都有副作用的风险,需要专业知识。悉尼的D. Kerr和L. Kohan开发了一种简单有效的局部浸润技术,使用局部麻醉剂、肾上腺素和非甾体抗炎药,但其他人报道的结果不一。由于没有对该技术的详细描述,我们在此详细介绍由发明人开发的方法。
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引用次数: 22
New options of non-opioids in acute pain management: The view of a pharmacologist 非阿片类药物在急性疼痛管理中的新选择:药理学家的观点
Pub Date : 2008-12-01 DOI: 10.1016/j.acpain.2008.08.014
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Acute Pain
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