Abstract:
BACKGROUND:Mucositis can be a serious complication of cancer treatment. Palifermin reduces mucositis when given in multiple doses to patients undergoing hematopoietic stem-cell transplantation. OBJECTIVE:To evaluate the efficacy of palifermin given as a single dose before each cycle in patients receiving multicycle chemotherapy. DESIGN:Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00267046) SETTING:The University of Texas M.D. Anderson Cancer Center, Houston, Texas. PATIENTS:48 patients with sarcoma were randomly assigned in a 2:1 ratio to receive palifermin or placebo. All patients received doxorubicin-based chemotherapy (90 mg per m(2) of body surface area over 3 days, by infusion). INTERVENTION:Palifermin (180 µg per kg of body weight) or placebo was administered intravenously as a single dose 3 days before each chemotherapy cycle (maximum, 6 cycles). Patients who had severe mucositis received open-label palifermin in subsequent cycles. MEASUREMENTS:Oral assessment of mucositis by using World Health Organization (WHO) oral toxicity scale (grades 0 to 4), with moderate to severe mucositis (grades 2 to 4) as the main outcomes; patient-reported outcome questionnaire; and daily symptom record diary. RESULTS:A median of 6 blinded cycles (range, 1 to 6) were completed by the palifermin group and 2 (range, 1 to 6) by the placebo group. Compared with placebo, palifermin reduced the cumulative incidence of moderate to severe (grade 2 or higher) mucositis (44% vs. 88%; P < 0.001; difference, -44 percentage points [95% CI, -71 to -16 percentage points) and severe (grade 3 or 4) mucositis (13% vs. 51%; P = 0.002; difference, -38 percentage points [CI, -67 to -9 percentage points]). The main adverse effects were thickening of oral mucosa (72% in the palifermin group vs. 31% in the placebo group; P = 0.007) and altered taste. Seven of the 8 patients who had severe mucositis in the placebo group received open-label palifermin. None of these patients had severe mucositis in the subsequent cycles (a total of 17) with open-label palifermin. LIMITATIONS:Study limitations include smaller sample size for the control group, inclusion of only patients with sarcoma, and perceived unblinding of the treatment because of notable differences between the biologic effects of palifermin and placebo. CONCLUSION:A single dose of palifermin before each cycle reduced the incidence and severity of mucositis. The drug was generally well tolerated, but most patients experienced thickening of oral mucosa. Further investigation is needed to determine whether palifermin use will facilitate greater adherence to chemotherapy regimens by reducing mucositis.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Vadhan-Raj S,Trent J,Patel S,Zhou X,Johnson MM,Araujo D,Ludwig JA,O'Roark S,Gillenwater AM,Bueso-Ramos C,El-Naggar AK,Benjamin RSdoi
10.7326/0003-4819-153-6-201009210-00003subject
Has Abstractpub_date
2010-09-21 00:00:00pages
358-67issue
6eissn
0003-4819issn
1539-3704pii
153/6/358journal_volume
153pub_type
杂志文章,随机对照试验abstract:STUDY OBJECTIVE:To assess respiratory muscle fatigue in acute respiratory failure in patients with chronic obstructive pulmonary disease and evaluate its influence on weaning patients from mechanical ventilation. DESIGN AND PATIENTS:We studied the time course of tracheal occlusion pressure (P0.1) and high-to-low ratio...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-108-6-800
更新日期:1988-06-01 00:00:00
abstract::During the past quarter century, general internal medicine has emerged as a vital discipline. In the realm of patient care, it is the integrating discipline par excellence. Ironically, as general internists face the challenge of integrating advances of dizzying speed and complexity, and as their clinical practice beco...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-134-10-200105150-00013
更新日期:2001-05-15 00:00:00
abstract:Background:High-risk human papillomavirus (hrHPV) testing to triage women with minor cervical lesions generates many referrals. Purpose:To evaluate the accuracy of genotyping for HPV types 16 and 18 and its utility as a second triage step after hrHPV testing in women with minor cervical lesions. Data Sources:Searches...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析,评审
doi:10.7326/M15-2735
更新日期:2017-01-17 00:00:00
abstract::Position statements opposing legalization of physician-assisted suicide by organizations such as the American College of Physicians-American Society of Internal Medicine rightly emphasize that palliative care should be the standard of care for the dying, and that the inadequacies that exist in its delivery should be r...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-138-3-200302040-00013
更新日期:2003-02-04 00:00:00
abstract:OBJECTIVE:To determine whether the quality of care for common ambulatory conditions is adversely affected when physicians are provided with incentives to limit the use of health services. DESIGN:Retrospective cohort study over a 2-year period. SETTING:Four group practices that cared for both fee-for-service patients ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-115-5-394
更新日期:1991-09-01 00:00:00
abstract:BACKGROUND:Markers are needed for assessing response to antiretroviral therapy over time. The CD4+ lymphocyte count is one such surrogate, but it is relatively weak. OBJECTIVE:To assess the association of changes in plasma human immunodeficiency virus (HIV) RNA level and CD4+ lymphocyte count with progression to the a...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-126-12-199706150-00002
更新日期:1997-06-15 00:00:00
abstract:Background:Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT). Objective:To determine the safety and efficacy of Triplex. Design:First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933). Setting:3...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/M19-2511
更新日期:2020-03-03 00:00:00
abstract:OBJECTIVE:To determine the efficacy of ciprofloxacin therapy in eradicating convalescent fecal excretion of salmonellae after acute salmonellosis. DESIGN:Randomized, placebo-controlled, double-blind trial of ciprofloxacin, with prospective follow-up of nonparticipants. SETTING:An acute care community hospital experie...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-114-3-195
更新日期:1991-02-01 00:00:00
abstract::The Hospital Readmissions Reduction Program (HRRP) has penalized hospitals with higher 30-day readmission rates more than $3 billion to date. Clinicians and policy experts have raised concerns that the 30-day readmission measure used in this program provides an incomplete picture of performance because it does not cap...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M20-3486
更新日期:2021-01-01 00:00:00
abstract::Wilson's disease is an inherited disorder of copper accumulation that is fatal if untreated. Because penicillamine, the established treatment, is toxic in a substantial number of patients, we studied the efficacy of zinc treatment. We induced a negative or neutral copper balance in five out of five patients with Wilso...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-99-3-314
更新日期:1983-09-01 00:00:00
abstract:OBJECTIVE:To determine whether prolonging the duration of tamoxifen administration beyond the cessation of a combined chemotherapy regimen benefits patients with primary breast cancer with positive findings in axillary nodes who benefit initially from the combined regimen. DESIGN:Nonrandomized, nonconcurrent cohort st...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-106-5-649
更新日期:1987-05-01 00:00:00
abstract:BACKGROUND:The number of very elderly persons who are candidates for implantation of a permanent pacemaker is increasing, but the effect of cardiac pacing on long-term survival and functional variables has not been determined. OBJECTIVE:To determine long-term survival after implantation of a permanent pacemaker in oct...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-125-6-199609150-00008
更新日期:1996-09-15 00:00:00
abstract::As more people with mild hypertension are treated, non-drug therapies should be used more frequently and effectively. These therapies include weight reduction; sodium restriction; potassium, calcium, and magnesium supplementation; other dietary changes; exercise; relaxation; and moderation of alcohol use. Such therapi...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,评审
doi:10.7326/0003-4819-102-3-359
更新日期:1985-03-01 00:00:00
abstract::Relapsing polychondritis, an uncommon, chronic, multisystem disorder characterized by recurrent episodes of inflammation of cartilaginous tissues, can be life-threatening, debilitating, and difficult to diagnose. This review is based on the authors' experience with 36 patients with relapsing polychondritis who were fo...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-129-2-199807150-00011
更新日期:1998-07-15 00:00:00
abstract:OBJECTIVE:To develop criteria for interpreting results of the metyrapone test for the differential diagnosis of the adrenocorticotropin (ACTH)-dependent Cushing syndrome and to compare its diagnostic accuracy with that of the high-dose dexamethasone suppression test. DESIGN:Retrospective cohort study. SETTING:Inpatie...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-121-5-199409010-00002
更新日期:1994-09-01 00:00:00
abstract:OBJECTIVE:To determine whether self-assessment of purified protein derivative of tuberculin (PPD) skin test reactions, done using a simple two-choice approach, is an effective screening method for tuberculosis. DESIGN:Double-blind comparison between self-assessments and trained professional readings of PPD skin test r...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-125-4-199608150-00004
更新日期:1996-08-15 00:00:00
abstract:OBJECTIVE:To evaluate the incidence and symptoms of and risk factors for biliary sludge and gallstones during pregnancy and to assess the natural history of these conditions in the first year after delivery. DESIGN:Cohort study. PATIENTS:A total of 272 pregnant women recruited in the first trimester. MEASUREMENTS:Bi...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-119-2-199307150-00004
更新日期:1993-07-15 00:00:00
abstract:BACKGROUND:Several studies show an inverse association between self-reported physical activity and type 2 diabetes. It is not known whether physical activity or cardiorespiratory fitness is associated with the onset of objectively determined impaired fasting glucose and type 2 diabetes. OBJECTIVE:To determine whether ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-130-2-199901190-00002
更新日期:1999-01-19 00:00:00
abstract:SOURCE CITATION:Liu J, Li L, Li S, et al. Sodium-glucose co-transporter-2 inhibitors and the risk of diabetic ketoacidosis in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2020;22:1619-27. 32364674. ...
journal_title:Annals of internal medicine
pub_type: 评论,杂志文章
doi:10.7326/ACPJ202010200-040
更新日期:2020-10-20 00:00:00
abstract::Fifteen patients with chronic type B hepatitis were treated with corticosteroids in a randomized, double-blind, placebo-controlled trial lasting 28 days. Ten patients received prednisolone, 60 mg/d for 2 weeks, then 30 mg/d for another 2 weeks; 5 patients received placebo. Serum aminotransferase levels decreased signi...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-104-1-12
更新日期:1986-01-01 00:00:00
abstract::Twenty-one juvenile-onset diabetic patients with azotemic nephropathy underwent coronary angiography and left ventriculography before renal transplantation or chronic hemodialysis. Two-year survival of 12 patients with no coronary artery disease (group A) was 88% compared to 22% for nine patients with coronary artery ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-88-3-346
更新日期:1978-03-01 00:00:00
abstract::A 53-year-old librarian had recurrent palpable purpura on her ankles and legs that was found to be caused by the fumes released from heat-activated photocopy paper at her place of employment. Behenic acid was identified as the responsible chemical component through a series of challenge studies that simulated her work...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-98-3-320
更新日期:1983-03-01 00:00:00
abstract:PURPOSE:To evaluate the possibility that fibrinogen represents a cardiovascular risk factor. DATA IDENTIFICATION:A computerized literature search (1980 to 1992) identified all published epidemiologic studies on fibrinogen and cardiovascular disease. Clinical and basic research data were found by separate searches. Ref...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/0003-4819-118-12-199306150-00008
更新日期:1993-06-15 00:00:00
abstract:Description:Recommendation on screening for urinary incontinence in women by the Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient representatives. The WPSI's recommendations are intended to guide clinical practice and coverage of services for t...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:10.7326/M18-0595
更新日期:2018-09-04 00:00:00
abstract:BACKGROUND:No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). OBJECTIVE:To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. DESIGN:Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/M20-4207
更新日期:2020-10-20 00:00:00
abstract:Background:High-sensitivity assays for cardiac troponin T (hs-cTnT) are sometimes used to rapidly rule out acute myocardial infarction (AMI). Purpose:To estimate the ability of a single hs-cTnT concentration below the limit of detection (<0.005 µg/L) and a nonischemic electrocardiogram (ECG) to rule out AMI in adults ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/M16-2562
更新日期:2017-05-16 00:00:00
abstract:BACKGROUND:Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. OBJECTIVE:To compare the effectiveness and...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究
doi:10.7326/M14-2070
更新日期:2016-04-05 00:00:00
abstract::We recently implemented a full-featured electronic health record in our independent, 4-internist, community-based practice of general internal medicine. We encountered various challenges, some unexpected, in moving from paper to computer. This article describes the effects that use of electronic health records has had...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-143-3-200508020-00008
更新日期:2005-08-02 00:00:00
abstract::Population screening for hemochromatosis done by using the transferrin saturation test has been advocated by experts to permit the initiation of therapeutic phlebotomy before the onset of clinical disease. The discovery of a gene associated with hemochromatosis has made DNA testing another option for screening and dia...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-129-11_part_2-199812011-00008
更新日期:1998-12-01 00:00:00
abstract:BACKGROUND:The long-term risk for fatal pulmonary embolism (PE) after treatment of venous thromboembolism (VTE) may be an important factor in the decision to discontinue this treatment. OBJECTIVE:To provide reliable and precise estimates of the annual risk for fatal PE and the case-fatality rate of disease recurrence ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-147-11-200712040-00007
更新日期:2007-12-04 00:00:00