Abstract:
CONTEXT:This article presents the results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine. In this randomized, placebo-controlled study with an enriched enrollment design, the buprenorphine transdermal system (BTDS) was found to be efficacious and generally well tolerated. OBJECTIVES:This enriched, multicenter, randomized, double-blind study evaluated the efficacy, tolerability, and safety of BTDS in opioid-naïve patients who had moderate to severe chronic low back pain. METHODS:Patients who tolerated and responded to BTDS (10 or 20 mcg/hour) during an open-label run-in period were randomized to continue BTDS 10 or 20 mcg/hour or receive matching placebo. The primary outcome was "average pain over the last 24 hours" at the end of the 12-week double-blind phase, collected on an 11-point scale (0=no pain, 10=pain as bad as you can imagine). Sleep disturbance (Medical Outcomes Study subscale) and total number of supplemental analgesic tablets used were secondary efficacy variables. RESULTS:Fifty-three percent of patients receiving open-label BTDS (541 of 1024) were randomized to receive BTDS (n=257) or placebo (n=284). Patients receiving BTDS reported statistically significantly lower pain scores at Week 12 compared with placebo (least square mean treatment difference: -0.58, P=0.010). Sensitivity analyses of the primary efficacy variable and results of the analysis of secondary efficacy variables supported the efficacy of BTDS relative to placebo. During the double-blind phase, the incidence of treatment-emergent adverse events was 55% for the BTDS treatment group and 52% for the placebo treatment group. Laboratory, vital sign, and electrocardiogram evaluations did not reveal unanticipated safety findings. CONCLUSION:BTDS was efficacious in the treatment of opioid-naïve patients with moderate to severe chronic low back pain. Most treatment-emergent adverse events observed were consistent with those associated with the use of opioid agonists and transdermal patches.
journal_name
J Pain Symptom Managejournal_title
Journal of pain and symptom managementauthors
Steiner DJ,Sitar S,Wen W,Sawyerr G,Munera C,Ripa SR,Landau Cdoi
10.1016/j.jpainsymman.2011.04.006subject
Has Abstractpub_date
2011-12-01 00:00:00pages
903-17issue
6eissn
0885-3924issn
1873-6513pii
S0885-3924(11)00369-1journal_volume
42pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:The objective of this study was to assess the characteristics of breakthrough cancer pain (BTcP) in patients with abdominal cancer pain, and the eventual factors associated with its presentation. METHODS:Patients with abdominal visceral cancer presenting BTcP were included in the analysis. Pain intensity, cu...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jpainsymman.2019.02.014
更新日期:2019-05-01 00:00:00
abstract:CONTEXT:Efforts in developing useful tools to properly identify the end-of-life trajectory of patients with advanced medical diseases have been made, but the calibration and/or discriminative power of these tools has not been optimal. OBJECTIVES:Our objective was to develop a new, reliable prognostic tool to identify ...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jpainsymman.2013.04.011
更新日期:2014-03-01 00:00:00
abstract::The technology of telemedicine has been used for over 20 years, involving different areas of medicine, providing medical care for the geographically isolated patients, and uniting geographically isolated clinicians. Today audio-visual technology may be useful in palliative care for the patients lacking access to medic...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/s0885-3924(01)00402-x
更新日期:2002-02-01 00:00:00
abstract::Headache is a common and disabling aspect of pituitary disease. Chronic and episodic migraine are the most common clinical syndromes of headaches related to pituitary tumors, although other types of headache, such as trigeminal autonomic cephalalgias (TACs), can also be present. TACs include short-lasting, unilateral ...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2008.02.013
更新日期:2009-02-01 00:00:00
abstract::Indwelling subcutaneous cannula for the administration of intermittent morphine boluses postoperatively have been used in several centers as an alternative to intramuscular (IM) injections. We introduced this technique to our hospital, assessed it for complications in 220 children, and conducted a survey to see if nur...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/s0885-3924(96)00200-x
更新日期:1997-01-01 00:00:00
abstract:CONTEXT:Although many family members who make surrogate decisions report problems with communication, there is no validated instrument to accurately measure surrogate/clinician communication for older adults in the acute hospital setting. OBJECTIVES:The objective of this study was to validate a survey of surrogate-rat...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2016.08.010
更新日期:2017-01-01 00:00:00
abstract:CONTEXT:Cancer pain has a severe impact on quality of life and is associated with numerous psychosocial responses. Recent studies suggest that treatment of cancer pain has improved during the last decade. OBJECTIVES:The aim of this review was to examine the present status of pain prevalence and pain severity in patien...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.jpainsymman.2015.12.340
更新日期:2016-06-01 00:00:00
abstract::To explore the factors that patients with malignant and nonmalignant pain consider when deciding whether to enroll in pain research studies, determine whether their views are different, and determine whether willingness to enroll in research is associated with pain severity, semi-structured interviews were conducted w...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/s0885-3924(02)00527-4
更新日期:2002-11-01 00:00:00
abstract::To define changes in sleep and subjective fatigue associated with localized radiation treatment, and to determine their relationship to interleukin-1B (IL-1), we prospectively followed 15 men, none of whom were depressed during 8 wk of radiation treatment for localized prostate cancer. Each patient rated fatigue daily...
journal_title:Journal of pain and symptom management
pub_type: 临床试验,杂志文章
doi:10.1016/0885-3924(93)90127-h
更新日期:1993-05-01 00:00:00
abstract::Assessing for the presence of addiction in the chronic pain patient receiving chronic opioid analgesia is a challenging clinical task. This paper presents a recently developed screening tool for addictive disease in chronic pain patients, and pilot efficacy data describing its ability to do so. In a small sample of pa...
journal_title:Journal of pain and symptom management
pub_type: 临床试验,杂志文章
doi:10.1016/s0885-3924(98)00110-9
更新日期:1998-12-01 00:00:00
abstract::Despite decades of research, national mandates, and widespread implementation of guidelines, recent reports suggest that the quality of pain assessment and management in hospitalized children remains suboptimal. The mismatch between what is advocated and what is done in practice has led experts to argue for a conceptu...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,评审
doi:10.1016/j.jpainsymman.2011.09.005
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:Dying patients whose implantable cardioverter defibrillators (ICDs) continue to deliver shocks may experience significant pain, and the National Quality Forum has endorsed routine deactivation of ICDs when patients near the end of life. The overarching goal of this quality improvement project was to increase...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2013.09.010
更新日期:2014-09-01 00:00:00
abstract:CONTEXT:Improving quality of death (QOD) is a key goal in palliative care (PC). To our knowledge, no instruments to measure QOD have been validated in Spanish. OBJECTIVES:The goals of this study were to validate the Spanish version of the quality of dying and death (QODD) questionnaire and to develop and validate a sh...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2017.02.005
更新日期:2017-06-01 00:00:00
abstract:CONTEXT:The Eastern Cooperative Oncology Group performance status (ECOG PS) is one of the most commonly used assessments in oncology and palliative care (PC). However, the interobserver differences between medical oncologists and PC specialists have never been reported. OBJECTIVES:To determine the interobserver differ...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2014.10.015
更新日期:2015-06-01 00:00:00
abstract:CONTEXT:Palliative care for the older person is often limited, resulting in poor quality of dying. Pharmacological management can be one of the components to achieve better symptom control. OBJECTIVES:To describe the anticipatory prescription of medication for symptomatic treatment and the deprescription of potentiall...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jpainsymman.2015.12.325
更新日期:2016-06-01 00:00:00
abstract:CONTEXT:Spirituality is a distinctive subject within palliative care practice and literature, but research to date is relatively undeveloped in this field and studies often throw more light on conceptual and methodological issues than producing reliable data for clinical practice. OBJECTIVES:To determine what is known...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,评审
doi:10.1016/j.jpainsymman.2011.06.017
更新日期:2012-06-01 00:00:00
abstract:CONTEXT:Because of the increasing body of literature on neuropathic cancer pain (NCP), an accurate estimate of its prevalence requires recurring updates. OBJECTIVES:To provide this estimate using information from a systematic review and a survey. METHODS:Using MEDLINE, Embase, and a previous review, we searched for s...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,meta分析,多中心研究,评审
doi:10.1016/j.jpainsymman.2015.12.336
更新日期:2016-06-01 00:00:00
abstract:CONTEXT:Nursing home (NH) residents with advanced dementia are commonly suspected of having infections. Most episodes are treated with antimicrobials, although evidence supporting bacterial infections is often lacking. The extent to which other interventions are used in managing suspected infections is unknown. OBJECT...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2015.06.011
更新日期:2015-12-01 00:00:00
abstract:CONTEXT:Challenges experienced by patients with the left ventricular assist device (LVAD) and their caregivers during the early period after LVAD implantation are well documented. However, little is known about long-term challenges, supportive care needs, and views toward supportive care of Asian LVAD patients and care...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2020.03.022
更新日期:2020-09-01 00:00:00
abstract:CONTEXT:Longitudinal studies that have described the trajectory of familial caregiving and bereavement outcomes have often failed to include a comprehensive range of carer and caregiving variables or any patient assessments, and only a few have used a recognized structured interview for psychiatric disorders. OBJECTIV...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2010.03.014
更新日期:2010-12-01 00:00:00
abstract::The objective of this study was to compare the efficacy and tolerability of gabapentin and amitriptyline monotherapy in painful diabetic neuropathy. This was a 12-week, open-label, prospective, randomized trial. Twenty-five type-II diabetic patients with pain attributed to diabetic neuropathy and a minimum score of 2 ...
journal_title:Journal of pain and symptom management
pub_type: 临床试验,杂志文章
doi:10.1016/s0885-3924(00)00181-0
更新日期:2000-10-01 00:00:00
abstract:CONTEXT:Previous surveys have suggested that pain in hospitalized patients remains undertreated. However, little is known about those with persistently high pain scores. OBJECTIVES:To document the distribution of scores and analyze the clinical characteristics of outliers with persistently high pain scores. METHODS:W...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2014.01.006
更新日期:2014-11-01 00:00:00
abstract::Assessing quality of care at the end of life involves measurements in several domains-use of evidence-based guidelines, patient and family satisfaction, quality of life, and incidence of adverse events, among others. There are several different data sources from which to calculate quality measures. Each data source ha...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/s0885-3924(01)00329-3
更新日期:2001-09-01 00:00:00
abstract::The management of pain in the patient with advanced cancer requires comprehensive assessment and expertise in the application of many therapeutic techniques. Given the complexity of the problems posed by these patients, it is not surprising that most aspects of palliative care derive from personal anecdote and clinica...
journal_title:Journal of pain and symptom management
pub_type: 指南,杂志文章,评审
doi:10.1016/0885-3924(90)90047-n
更新日期:1990-10-01 00:00:00
abstract::Stercoral perforation of the colon is a rare complication of constipation, and there have only been a few reported cases of stercoral perforation of the colon secondary to opioid-induced constipation. This article describes such a case in a cancer survivor with chronic cancer-related pain and reviews the medical/surgi...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2015.02.019
更新日期:2015-08-01 00:00:00
abstract::The aim of this study was to examine the relationship of changes in hemoglobin levels to changes in fatigue and cognitive functioning in cancer patients undergoing chemotherapy treatment. Seventy-seven (77) patients completed a self-administered measure of fatigue and a battery of psychometrician-administered measures...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2003.11.002
更新日期:2004-07-01 00:00:00
abstract::In a randomized, double-blind, crossover study, we evaluated the effect of intravenous lidocaine (5 mg/kg body weight over 30 min) on the neuropathic pain of advanced cancer patients. Pain intensity, assessed by a visual analogue scale, did not show any significant difference between lidocaine and placebo infusion. Th...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,随机对照试验
doi:10.1016/s0885-3924(06)80004-7
更新日期:1992-04-01 00:00:00
abstract::The rising prevalence of neuropathic pain and the multifaceted sequelae of pain particularly within older adults are part of the increasing challenges in providing good geriatric pain management. Aging can lead to a higher sensitivity to pain within older adults, whereas physiological changes modify the absorption, bi...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章,评审
doi:10.1016/j.jpainsymman.2009.05.002
更新日期:2009-08-01 00:00:00
abstract::Rational drug treatment of chronic musculoskeletal pain remains a challenge. Although commonly prescribed, the true efficacy of opioid analgesics or of nonsteroidal antiinflammatory drugs remains to be established. Using an N-of 1 design, eight patients with regional cervicobrachial pain received ibuprofen 800 mg/day,...
journal_title:Journal of pain and symptom management
pub_type: 临床试验,杂志文章
doi:10.1016/s0885-3924(98)00369-8
更新日期:1998-04-01 00:00:00
abstract:CONTEXT:Limited studies have identified symptom clusters (SCs) and their risk factors and the relationships with inflammatory biomarkers in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). OBJECTIVES:In this study, we aimed to investigate SCs in patients with AECOPD and explore their...
journal_title:Journal of pain and symptom management
pub_type: 杂志文章
doi:10.1016/j.jpainsymman.2020.03.037
更新日期:2020-09-01 00:00:00