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::The safety and efficacy of twice-daily applications of alclometasone dipropionate cream 0.05% were evaluated in 39 children with eczema during a three-week open study. Early-morning plasma cortisol levels were monitored at weekly intervals (visits 1, 2, and 3) for six children. For the remaining 33 children, levels we...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract::In this open-label, randomized, cross-over study, 12 healthy subjects received four doses of a new sustained-release formulation of diltiazem hydrochloride for six consecutive days. Blood samples were drawn on days 5 and 6 for determination of plasma diltiazem and desacetyldiltiazem levels. The peak concentrations aft...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1992-03-01 00:00:00
abstract:PURPOSE:Neglected tropical diseases (NTDs) impose a significant burden on public health, particularly in developing nations. Many can be treated cost-effectively with drugs donated or offered at or below marginal cost. In 2012, the World Health Organization published an NTD roadmap that outlined a strategy for the prev...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2016.02.031
更新日期:2016-05-01 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:BACKGROUND:In a previous study, we found that past medication use was associated with medication adherence in patients prescribed atypical antipsychotics. OBJECTIVE:The present study aimed to determine whether past medication experience was associated with adherence in patients prescribed selective serotonin reuptake ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2008.08.014
更新日期:2008-09-01 00:00:00
abstract:PURPOSE:Prostate cancer is the second most common cancer among men worldwide. In the past 10 years in Iran, prostate cancer has increased and become more common among hormone-related cancers. As the percentage of seniors in the population increases, the economic burden of this cancer will likely increase significantly....
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.11.001
更新日期:2019-01-01 00:00:00
abstract::The cost of induction and maintenance of anesthesia is analyzed in this article from the perspective of a health maintenance organization's (HMO) chief financial officer. While earlier economic studies tended to focus on the raw cost of anesthesia drugs, our model also includes the cost of the clinical labor involved ...
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:10.1016/0149-2918(95)80122-7
更新日期:1995-05-01 00:00:00
abstract::Zuclopenthixol acetate is a rapid-acting, injectable neuroleptic drug with a duration of action that allows for administration once every 2 to 3 days, in contrast to injectable haloperidol, which may require administration more than once daily. To assess the place of zuclopenthixol acetate in the treatment of acute ep...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(97)80120-8
更新日期:1997-03-01 00:00:00
abstract::The placenta is vital to the health and development of the fetus, serving to deliver oxygen and nutrients, facilitate the removal of waste products, and provide a barrier to pathogens and other harmful substances present in the maternal circulation. When these processes fail to operate normally, they can lead to compl...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.11.002
更新日期:2020-11-24 00:00:00
abstract::Long-term safety and efficacy of feprazone (4-prenyl-1,2-diphenyl-3,5-pyrazolidinedione), an antirheumatic drug that is well tolerated in the gastrointestinal tract, were assessed in a noncontrolled multicenter trial. Administered at a daily dosage of 600 mg for a mean duration of 114.1 days, feprazone was well tolera...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1981-01-01 00:00:00
abstract:BACKGROUND:Telbivudine (LdT) is an L-nucleoside that is structurally related to lamivudine. It is highly selective for hepatitis B virus (HBV) and inhibits viral DNA synthesis. LdT was approved by the US Food and Drug Administration on October 25, 2006, for the treatment of chronic HBV infection in adults who have acti...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.12.032
更新日期:2007-12-01 00:00:00
abstract:BACKGROUND:Asthma is a common chronic disorder of childhood, and it is frequently accompanied by dental and other oral abnormalities. As such, oral and dental effects of asthma medications have been investigated in several studies. However, the effect of combination therapy with a long-acting beta(2)-agonist and a cort...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/j.clinthera.2007.10.014
更新日期:2007-10-01 00:00:00
abstract:BACKGROUND:Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as "sinus' headache, while ignoring the possible diagnosis of migraine. OBJECTIVE:The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients wit...
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.2007.01.012
更新日期:2007-01-01 00:00:00
abstract::Flecainide, a new antiarrhythmic agent, was given to eight healthy men to ascertain plasma drug levels and to assess tolerance for the drug. Each subject received a single intravenous (IV) dose (0.5, 1, 1.5, or 2 mg/kg) of flecainide, and plasma levels of unchanged flecainide were measured by gas-liquid chromatography...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:BACKGROUND:The role of folate in pregnancy is well established, with most prenatal vitamins (PNVs) on the market containing at least 800 μg of folic acid. Folic acid must be converted in the body to L-methylfolate, the natural and biologically active form of folate. The role of vitamin B(12) in pregnancy is less charac...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2011.02.010
更新日期:2011-02-01 00:00:00
abstract::The management of patients with congestive heart failure (CHF) can place a significant economic burden on managed care organizations, leading providers to seek treatments that are cost-effective. Diuretics play a significant role in the treatment of edema associated with CHF. We evaluated the use of 2 loop diuretics, ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/s0149-2918(99)80007-1
更新日期:1999-05-01 00:00:00
abstract:PURPOSE:To evaluate the safety and efficacy of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute myocardial infarction (AMI) in the presence of intracoronary thrombus undergoing percutaneous coronary interventions. METHODS:This study, performed from January 1, 2004, to November 31, 2014, at 55 centers in ...
journal_title:Clinical therapeutics
pub_type: 信件,多中心研究
doi:10.1016/j.clinthera.2020.02.022
更新日期:2020-05-01 00:00:00
abstract:BACKGROUND:Patients with glaucoma or ocular hypertension may have inadequately controlled intraocular pressure (IOP) or experience adverse effects with their current medication regimens. OBJECTIVE:This post hoc reanalysis determined the effectiveness and tolerability of brimonidine used as replacement therapy in a rea...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/s0149-2918(00)87977-1
更新日期:2000-01-01 00:00:00
abstract::Phenytoin has a wide range of pharmacologic effects other than its anticonvulsant activity. It has been the subject of more than 8,000 published papers, which include clinical reports of its usefulness in approximately 100 diseases and symptoms. In the United States the only indications for use in the official labelin...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,评审
doi:
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:This meta-analysis was performed to assess the possible prophylactic benefit of prolonged treatment with oral N-acetylcysteine (NAC) in chronic bronchitis (CB) based on qualifying clinical trials. Treatment of acute exacerbations with NAC was not investigated. BACKGROUND:Prolonged treatment with oral NAC has...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/S0149-2918(00)88479-9
更新日期:2000-02-01 00:00:00
abstract::This paper describes a study of drug use and drug-related problems in community-dwelling elderly (> or =65 years) Medicaid recipients in Maryland, Iowa, and Washington from 1989 through 1996. A claim-by-claim review of Medicaid prescriptions was conducted to detect 5 types of prescribing problems (dose, duration of th...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(00)87245-8
更新日期:1999-12-01 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:PURPOSE:The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS:A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertens...
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.2017.10.013
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND:Drug treatment can defer surgical intervention in benign prostatic hyperplasia (BPH), a common disorder in elderly men, and is widely practiced. Various herbal formulations have been used for the treatment of BPH, but few have been compared with established modern medicines in head-to-head clinical trials. ...
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.2011.11.005
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:Previous evaluations of the Southwestern Ontario (SSWO) cohort have reported that hypertension (HTN) and dyslipidemia (DYS) are undertreated illnesses; however, concomitant treatment is unknown. OBJECTIVES:The objectives of this study were to assess the prevalence and associated treatment of HTN and DYS in ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2008.06.004
更新日期:2008-06-01 00:00:00
abstract:PURPOSE:Current data suggest potential benefits with β-lactam plus macrolide combination therapy for empiric treatment of intensive care unit (ICU) patients with severe community-acquired pneumonia (CAP). However, it is unclear whether deescalation to β-lactam monotherapy in the absence of positive results on diagnosti...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2019.10.005
更新日期:2019-12-01 00:00:00
abstract::Prolonged, repeated use of nasal decongestants for symptomatic relief of allergic rhinitis often results in rhinitis medicamentosa (RM), a condition involving "rebound swelling" and additional congestion. Most decongestant sprays contain the preservative benzalkonium chloride (BKC), which causes toxic reactions in the...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/S0149-2918(99)80053-8
更新日期:1999-10-01 00:00:00
abstract::The efficacy and safety of Naprelan (naproxen sodium) 1000 mg once daily (QD) and nabumetone 1500 mg QD were compared in a multicenter, randomized, parallel-group, placebo-controlled, double-masked, 4-week study of adult outpatients with active osteoarthritis (OA) of the knee. Nabumetone 1500 mg was chosen for compari...
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/s0149-2918(97)80090-2
更新日期:1997-07-01 00:00:00
abstract::This paper presents a state-of-the-art review of oral contraceptives (OCs), termed one of the epochal developments of modern times. OCs have had both direct and indirect influences on moral, social, and cultural values and on the interaction of population resources and the environment. In recent years there has been...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1985-01-01 00:00:00
abstract:PURPOSE:Restless legs syndrome (RLS) is a commonly occurring neurologic disorder that affects up to one third of women during pregnancy. RLS has been associated with increased sympathetic tone in the nonpregnant population. We examined whether a RLS surrogate is associated with a higher prevalence of pregnancy and neon...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.11.021
更新日期:2016-02-01 00:00:00