Abstract:
:Mecapegfilgrastim (HHPG-19K) is a long-acting pegylated recombinant human granulocyte-colony stimulating factor (rhG-CSF) that is administered subcutaneously as prophylaxis once per chemotherapy cycle as a weight-adjusted dose of 100 µg/kg or as a 6 mg fixed dose. It is approved in China to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropenia. In phase III trials, once per cycle prophylaxis with mecapegfilgrastim was more effective than placebo in reducing the incidence of grade ≥ 3 neutropenia in cycle 1 in patients with advanced non-small cell lung cancer and was more effective than filgrastim at reducing the mean duration of grade ≥ 3 neutropenia in cycle 1 in patients with breast cancer. The tolerability and safety profiles of mecapegfilgrastim were similar to those of filgrastim, with no unexpected adverse events (AEs); most adverse reactions in cycle 1 were mild or moderate in severity. Thus, mecapegfilgrastim is an effective and generally well tolerated treatment option for patients with non-myeloid malignancies receiving myelosuppressive chemotherapy, and extends the options available for managing chemotherapy-induced neutropenia in China.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Al-Salama ZT,Keam SJdoi
10.1007/s40261-019-00836-ysubject
Has Abstractpub_date
2019-10-01 00:00:00pages
1009-1018issue
10eissn
1173-2563issn
1179-1918pii
10.1007/s40261-019-00836-yjournal_volume
39pub_type
杂志文章,评审abstract::Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. The minor manifestation of the condition is the most common and is characterised by small, shallow, round or oval lesions that are surrounded by a raised erythematous h...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525090-00001
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This real-world study assessed the prevalence, risk factors for, and incidence of seizures in patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS:Patients with mCRPC were selected from MarketScan Commercial and Medicare Supplemental Databases between 1 January 2009 a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0578-0
更新日期:2017-12-01 00:00:00
abstract::The role of postprandial hyperglycaemia in contributing to the risk of both micro- and macrovascular complications in patients with diabetes mellitus is being increasingly recognized. In type 2 diabetes, there is a progressive shift in the relative contributions of postprandial and fasting hyperglycaemia to the overal...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/00044011-200828040-00001
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Patients with schizophrenia or related disorders often switch antipsychotic therapy, most commonly due to lack of efficacy and side effects. The differences in anticipated efficacy and tolerability among atypical antipsychotics may drive switching behaviours. Switching to long-acting antipsychotics may impro...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/11599080-000000000-00000
更新日期:2012-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The time-course when changes in glycemic control and body weight were first manifest in patients with type 2 diabetes mellitus (T2DM) treated with a combination of insulin degludec and liraglutide (IDegLira) was assessed, comparing IDegLira to its individual components. METHODS:Data from week...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0376-0
更新日期:2016-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Interferon-alpha treatment is associated with a large number of adverse effects. Depressive symptoms are not unexpected, and potentially dangerous psychiatric adverse effects can induce life-threatening conditions. We compared the incidence of depressive symptoms in patients with chronic hepati...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200626110-00005
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Nonsteroidal anti-inflammatory drugs are effective analgesics but their use during tonsillectomy is controversial because of the risk of postoperative bleeding. The aim of this study was to compare the analgesic efficacy and safety of nimesulide, a preferential cyclo-oxygenase type-2 inhibitor,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323100-00004
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Vedolizumab, a humanized monoclonal antibody against the α4β7 integrin, is indicated for treatment of moderately to severely active ulcerative colitis or Crohn's disease. In this placebo-controlled, double-blind, randomized, single ascending-dose study, the pharmacokinetics, pharmacodynamics, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0437-4
更新日期:2016-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The optimal choice for first- and second-line antiseizure medications for pediatric patients with convulsive status epilepticus remains ambiguous. The present study aimed to estimate the comparative effect on the efficacy and safety of different antiseizure medications in pediatric patients wit...
journal_title:Clinical drug investigation
pub_type:
doi:10.1007/s40261-020-00975-7
更新日期:2021-01-01 00:00:00
abstract:OBJECTIVE:To compare the real-life treatment of acute exacerbations of chronic bronchitis (AECBs) using moxifloxacin tablets or one of the oral macrolides azithromycin, clarithromycin or roxithromycin in terms of symptom relief, time until improvement and cure, overall efficacy and tolerability. METHODS:This prospecti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.2165/00044011-200626120-00007
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Icosapent ethyl is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved as an adjunct to diet to reduce triglyceride levels in adult patients with triglyceride levels ≥500 mg/dL (≥5.65 mmol/L). The objective of this open-label, drug-drug interaction study was to examine...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0252-8
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Pegylated interferon (peg-IFN)-α2a and -α2b show different pharmacokinetic properties but are used interchangeably for hepatitis C treatment in traditional dual combinations and with newer agents. We assessed whether peg-IFN antiviral effects vary with peg-IFN subtype, affecting viral response...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0241-y
更新日期:2014-12-01 00:00:00
abstract::Sublingual buprenorphine [Subutex(R)] is used to treat opioid dependence. However, illicit intravenous (IV) injection of buprenorphine is a widespread problem. This survey investigated the IV misuse of buprenorphine among patients receiving drug replacement therapy at the Drug Addiction Centre in Udine, Italy. All pat...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11536020-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Overactive bladder is a prevalent condition worldwide that is associated with a considerable burden, both on the patient and on society. OBJECTIVE:Our objective was to assess the economic value of fesoterodine compared with tolterodine extended release (ER) for the treatment of overactive bladder (OAB) with...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-014-0178-1
更新日期:2014-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL and the generic Kl...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929040-00005
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Currently evidence about clinical and demographic predictors of response to newer antidepressants such as duloxetine is limited. This study aimed to investigate whether a number of predictors, particularly co-morbid anxiety disorders and anxious depression, are associated with clinical improve...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11588800-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Bilastine is a novel second-generation antihistamine for the symptomatic treatment of allergic rhinitis and urticaria. The objective of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of bilastine following single and multiple oral doses in healthy Japanese ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0447-2
更新日期:2016-12-01 00:00:00
abstract::Doravirine (MK-1439) is a novel non-nucleoside reverse transcriptase inhibitor indicated for the combination treatment of human immunodeficiency virus type-1 (HIV-1) infection. The recommended dose is 100 mg once daily. This review summarizes the pharmacokinetics of doravirine, the influence of intrinsic factors, and ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-020-00934-2
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:NSAIDs are widely used to treat fever and pain in children, but their possible role in the progression of some bacterial infections is controversial. OBJECTIVE:This study was performed to analyse reported cases of severe bacterial infection associated with NSAID exposure in children admitted for this reason...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11532890-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:For patients with hypertension, effective 24-hour blood pressure (BP) control is vital to ensure protection against the early morning surge in BP and the associated increased risk of cardiovascular events. The aim of this analysis was to assess the 24-hour antihypertensive efficacy of olmesartan medoxomil (2...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626040-00002
更新日期:2006-01-01 00:00:00
abstract::We performed a prospective, randomised, investigator-masked and parallel-group study to compare topical lomefloxacin 0.3% instilled twice daily with topical chloramphenicol instilled five times daily in the treatment of acute bacterial conjunctivitis. 191 patients (lomefloxacin 96, chloramphenicol 95) were enrolled in...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815040-00001
更新日期:1998-01-01 00:00:00
abstract::The Editor-in-Chief has retracted this article because two of the three studies [1, 2] included in the meta-analysis (cited as references 11 and 12) have been retracted due to fabrication of the data, which has rendered the results of this meta-analysis invalid. ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,撤回出版物
doi:10.1007/s40261-018-0643-3
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a risk that disturbances of activities of daily living (ADL) due to rheumatoid arthritis (RA) are increased by the occurrence of fractures, including vertebral compression fractures and femoral neck fractures, in RA patients receiving oral corticosteroid therapy. Bisphosphonates are mo...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200828030-00002
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-tre...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0742-1
更新日期:2019-04-01 00:00:00
abstract:OBJECTIVE:To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model. METHODS:Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 y...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323090-00003
更新日期:2003-01-01 00:00:00
abstract::Lung infections caused by invasive filamentous fungi are very rare conditions in AIDS, but must be considered in patients with profound immune suppression especially in the presence of additional risk factors, such as hematologic malignancies, corticosteroid therapy, neutropenia, and chemotherapy. The authors report a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0017-1
更新日期:2013-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0556-6
更新日期:2017-10-01 00:00:00
abstract::We report the long-term effects of deferasirox 10-30 mg/kg/day on cardiac iron overload in a case series of five patients with transfusion-dependent beta-thalassaemia major who underwent up to 5 years of chelation therapy. Iron overload was monitored by multislice multi-echo T2* magnetic resonance imaging (MRI). Overa...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11534480-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Propofol is approved both for anaesthesia and sedation during intensive care. Serious adverse reactions with propofol have recently been reported, but patient exposure to the drug is unknown. OBJECTIVE:To investigate the consumption of propofol in Finnish hospitals and to develop a denominator to estimate p...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323010-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Following oral administration of abiraterone acetate, the parent compound abiraterone acetate is rapidly metabolized to abiraterone. To our knowledge, bioanalytical methods to date have not been able to detect the parent compound in human plasma, and bioassay was only performed on the metabolit...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00752-1
更新日期:2019-03-01 00:00:00