Abstract:
BACKGROUND:On February 3, 2006, the US Food and Drug Administration (FDA) approved a live, oral, pentavalent (G1-G4, P1[8]) human-bovine reassortant rotavirus vaccine for the prevention of rotavirus gastroenteritis (RVGE) in infants in the United States. The Advisory Committee of Immunization Practices of the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) recommended routine immunization of infants using 3 doses of the oral pentavalent rotavirus vaccine (PRV) at 8, 12, and 24 months of age, with the first dose administered between 6 and 12 weeks of age and subsequent doses administered at 4- to 10-week intervals. OBJECTIVE:This article reviews the composition, clinical efficacy, adverse events, and cost-effectiveness associated with its use. METHODS:Relevant literature was identified through searches of MEDLINE (1990-June 2007) and International Pharmaceutical Abstracts (1990-July 2007). Search terms included, but were not limited to, RotaTeq, PRV, intussusception, rotavirus infection, and cost-effectiveness. Further publications were selected from the reference lists of identified articles. Guidelines for use were identified from the Web sites of the CDC and the AAP. RESULTS:Two published Phase III clinical trials involving the PRV were identified. The Rotavirus Efficacy and Safety Trial (REST) and the Concomitant Use Study, a subanalysis of REST, found that PRV was efficacious and well tolerated. The vaccine was associated with preventing RVGE of any severity in 74% of patients and severe RVGE in 98%. The combined prevalence of hospitalizations and emergency department (ED) visits was reduced by 94.5% (95% CI, 91.2%-96.6%), including a decrease in hospitalizations of 95.8% (95% CI, 90.5%-98.2%) and a decrease in ED visits 93.7% (95% CI, 88.8%-96.5%), with vaccine administration compared with placebo. There were also reductions in physician's office visits of 86% (95% CI, 73.9%-92.5%) and the number of workdays lost for parents (65 vs 487). There were no confirmed cases of intussusception due to the vaccine. The prevalences of fever, diarrhea, and vomiting were not significantly different between the vaccine and placebo groups. Overall, the vaccine was well tolerated. The second study, a multicenter, randomized, placebo-controlled trial, found that PRV was efficacious, well tolerated, and immunogenic at the end of the vaccine's shelf-life. The vaccine was associated with preventing RVGE of any severity in 72.5% of cases and severe RVGE in 100% of cases. No cases of intussusception were reported. The Concomitant Use Study found that PRV could be administered concomitantly with other routine vaccinations during the first 24 weeks of life. Recently, the FDA's Vaccine Adverse Event Reporting System (VAERS) received 28 reports of cases that occurred after the first, second, and third doses. Approximately 50% of cases occurred 1 to 21 days after vaccination. Sixteen of the infants required hospitalization, while the remaining 12 required contrast or air enema intervention to reduce the intussusception. CONCLUSIONS:Based on the results from published studies, PRV appears effective in decreasing the prevalence of RVGE in the United States. Despite evidence from the large trial and no reported cases of intussusception, this event has been reported to VAERS. Continued postmarketing surveillance by the manufacturer, together with the VAERS and the CDC, will confirm whether use of the vaccine increases the risk for intussusception.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Tom-Revzon Cdoi
10.1016/j.clinthera.2007.12.018subject
Has Abstractpub_date
2007-12-01 00:00:00pages
2724-37issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(07)00406-7journal_volume
29pub_type
杂志文章,评审abstract:BACKGROUND:Ezetimibe (EZE) is a cholesterol-lowering drug that inhibits absorption of dietary and biliary cholesterol across the intestinal wall without affecting absorption of bile acids, fatty acids, fat-soluble vitamins, or triglycerides. It has a complementary mechanism of action to the statins, which inhibit chole...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2005.02.011
更新日期:2005-02-01 00:00:00
abstract::A recent report of two isolates of Streptococcus bovis resistant to killing by low levels of penicillin G prompted this study of the in vitro susceptibility of 100 clinical isolates of S bovis to six antibiotics. Using a microdilution method, we found the minimum bactericidal concentrations for 99% of the isolates to ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract::Recent pharmacotherapeutic advances in the treatment of depression have included the development of selective serotonin re-uptake inhibitors (SSRIs). The present study was designed to contrast direct health service expenditures for the treatment of depression among patients enrolled in a health maintenance organizatio...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0011-393x(05)80275-9
更新日期:1994-07-01 00:00:00
abstract:PURPOSE:The aim of this study was to assess the pharmacokinetic (PK) and pharmacodynamic (PD) properties and safety of single and multiple doses of cinacalcet in Chinese healthy volunteers (HVs) for the purposes of a New Drug Application package for the Chinese Food and Drug Administration. METHODS:In this randomized,...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2015.12.015
更新日期:2016-02-01 00:00:00
abstract:BACKGROUND:Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE:This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS:This was a mult...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.clinthera.2006.06.006
更新日期:2006-06-01 00:00:00
abstract::Hyaluronic acid is the most abundant mucopolysaccharide in connective tissue. Because of its high viscous elasticity, it lubricates joints and can hold cells together in the intercellular spaces in connective tissue. The administration of exogenous hyaluronic acid can increase the repair potential of damaged tissue. A...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1989-11-01 00:00:00
abstract::One hundred sixteen children between 2 and 15 years of age entered a clinical trial of albendazole after examination of their stools revealed ova of one or more intestinal helminths. The drug was administered as a single 400-mg dose (20 ml of 2% suspension) to all the patients except those having Hymenolepis nana infe...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1985-01-01 00:00:00
abstract:PURPOSE:Rosuvastatin, a hydroxy methylglutaryl coenzyme A reductase inhibitor; telmisartan, an angiotensin receptor blocker; and amlodipine, a calcium channel inhibitor, are commonly prescribed together for the treatment of hypertension nonresponsive to monotherapy and accompanied by dyslipidemia. However, the pharmaco...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2016.06.011
更新日期:2016-08-01 00:00:00
abstract::The efficacy and tolerability of a twice-daily dose of 5 mg of nisoldipine versus 40 mg of sustained-release isosorbide dinitrate (ISDN) were compared in a randomized, double-masked study in 91 patients. During the 21-day treatment period, the mean time taken during bicycle ergometry to the appearance of an ST segment...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(96)80025-7
更新日期:1996-05-01 00:00:00
abstract:PURPOSE:The formulary inclusion of proton pump inhibitors (PPIs) in the government hospital health services in Qatar is not comparative or restricted. Requests to include a PPI in the formulary are typically accepted if evidence of efficacy and tolerability is presented. There are no literature reports of a PPI scoring...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2016.03.004
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:Hypersensitivity reactions consist of a variable group of clinical findings and have been described for a wide variety of chemical compounds. OBJECTIVE:This review characterizes the clinical profile of hypersensitivity to the nucleoside reverse transcriptase inhibitor abacavir sulfate. METHODS:We performed...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(01)80132-6
更新日期:2001-10-01 00:00:00
abstract:PURPOSE:Interruptions in opioid use have the potential to cause pain relapse and withdrawal symptoms. The objectives of this study were to observe patterns of opioid interruption during acute illness in nursing home residents and examine associations between interruptions and pain and withdrawal symptoms. METHODS:Pati...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.10.013
更新日期:2014-11-01 00:00:00
abstract:PURPOSE:Respiratory syncytial virus (RSV) and influenza are important viral pathogens worldwide. Children, in particular, bear considerable burdens of morbidity and mortality associated with these viruses. There are limited therapeutic options for children infected with RSV or influenza. This review focuses on therapeu...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.06.014
更新日期:2018-08-01 00:00:00
abstract::The pharmacokinetics of cimetidine were studied in three newborn infants with reflux esophagitis or stress ulcer. One infant was given 5 mg/kg intravenously (IV), one was given 10 mg/kg IV, and one was given 10 mg orally. Serum concentrations 30 minutes after administration were 1.2 micrograms/ml, 5 micrograms/ml, and...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1985-01-01 00:00:00
abstract::The effects of treatment with epalrestat, an aldose reductase inhibitor, on peripheral neuropathy were studied in 45 patients with non-insulin-dependent diabetes mellitus (NIDDM). Epalrestat 150 mg three times daily was given for 24 weeks. Subjective symptoms, such as spontaneous pain in the lower extremities and numb...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/0149-2918(95)80111-1
更新日期:1995-05-01 00:00:00
abstract::This study was designed to determine changes in the number of beta-adrenergic receptors of circulating lymphocytes in patients with varying degrees of congestive heart failure. Thirty-seven patients with congestive heart failure were classified into four groups according to the functional classifications of the New Yo...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1989-05-01 00:00:00
abstract::General health-status questionnaires such as the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) are frequently used to measure health-related quality of life. The SF-36, in its current form, cannot be used to measure individuals' utilities or preferences for their health state. Recently, several inves...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/S0149-2918(00)86747-8
更新日期:1999-11-01 00:00:00
abstract:BACKGROUND:Patients newly diagnosed with type 2 diabetes mellitus generally initiate therapy with either metformin [Met] or a sulfonylurea [SU] drug, followed by the addition of a second agent (Met, an SU drug, or a thiazolidinedione [TZD] drug) if the diabetes is not well controlled. If necessary, the usual third line...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2011.10.018
更新日期:2011-12-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to determine the time to onset of pain relief from a single dose of a tablet formulation of paracetamol (acetaminophen) containing sodium bicarbonate (PSC). METHODS:A single oral dose of PSC or placebo was randomly administered to patients with acute sore throat under double-blind c...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2006.09.009
更新日期:2006-09-01 00:00:00
abstract:BACKGROUND:Besifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2010.12.004
更新日期:2011-01-01 00:00:00
abstract::The effects on corneal tissue of three marketed beta-blocker eye drops, carteolol 1% and 2%, befunolol 0.5% and 1%, and timolol 0.25% and 0.5%, were studied by instilling these drops into the eyes of rabbits twice daily for two consecutive months. The corneal sections were examined under a scanning electron microscope...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract:BACKGROUND:Glucagon-like peptide (GLP-1) is a neuroendocrine hormone that increases blood glucose and is a drug target for treatment of type 2 diabetes. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for w...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.06.004
更新日期:2011-07-01 00:00:00
abstract:PURPOSE:This observational study of oncologic clinical practices was designed to describe real-world patterns of use of emerging therapies (abiraterone acetate, cabazitaxel, enzalutamide, radium-223, sipuleucel-T) in patients with castration-resistant prostate cancer and to characterize their concomitant use with denos...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.12.015
更新日期:2018-04-01 00:00:00
abstract:PURPOSE:We assessed the effects of coadministration of metformin and teneligliptin on their pharmacokinetics in steady-state conditions relative to the administration of either drug alone. METHODS:This was a Phase I, single-center, open-label, 2-way parallel-group study in healthy male and female subjects. Subjects in...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.06.012
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Antimicrobial prophylaxis in select neutropenic patients has reduced fever, infection rates, hospital length of stay, and hospitalization rates. Guidelines from the Infectious Diseases Society of America recommend the consideration of prophylaxis with a fluoroquinolone in patients at high risk for infection ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.04.013
更新日期:2014-06-01 00:00:00
abstract::This study categorizes the types of inappropriate intravenous prescriptions in hospitalized patients in China. Prescription data from 2016 were retrospectively analyzed based on predefined categories of inappropriateness. Of the 123,521 patients included, 89.2% received intravenous medications, contributing to 80% of ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2019.05.009
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND:Mycophenolate mofetil (MMF) is an immunosuppressant indicated for prophylaxis of acute organ transplant rejection. Generic MMF is less costly than the branded product, but European regulatory authorities require bioequivalence studies for the marketing of generics. OBJECTIVES:The aims of the 2 studies repor...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2011.04.003
更新日期:2011-03-01 00:00:00
abstract:BACKGROUND:The median time to approval of new drugs in Canada decreased considerably in the mid-1990s, although it continued to be longer than in such countries as Australia, Sweden, the United Kingdom, and the United States. Ongoing concern about approval times pointed to a need for a further international comparison....
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(03)80080-2
更新日期:2003-04-01 00:00:00
abstract:PURPOSE:Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] to blue [Pha...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2017.08.022
更新日期:2017-11-01 00:00:00
abstract:PURPOSE:We undertook a preliminary assessment of the efficacy of administering intravenous dexamethasone (DEX) for relieving the nausea and dizziness accompanying vestibular neuritis (VN). METHODS:Between November 2013 and October 2014, 26 patients with VN were prospectively enrolled in this study. The patients were r...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2015.09.010
更新日期:2015-11-01 00:00:00