Abstract:
INTRODUCTION:Tubal ectopic pregnancy (tEP) is the most common life-threatening condition in gynaecology. tEPs with pretreatment serum human chorionic gonadotrophin (hCG) levels <1000 IU/L respond well to outpatient medical treatment with intramuscular methotrexate (MTX). TEPs with hCG >1000 IU/L take a significant time to resolve with MTX and require multiple outpatient monitoring visits. Gefitinib is an orally active epidermal growth factor receptor (EGFR) antagonist. In preclinical studies, we found that EP implantation sites express high levels of EGFR and that gefitinib augments MTX-induced regression of pregnancy-like tissue. We performed a phase I toxicity study administering oral gefitinib and intramuscular MTX to 12 women with tEPs. The combination therapy did not cause significant toxicities and was well tolerated. We noted that combination therapy resolved the tEPs faster than MTX alone. We now describe the protocol of a larger single arm trial to estimate the efficacy and side effects of combination gefitinib and MTX to treat stable tEPs with hCG 1000-10 000 IU/L METHODS AND ANALYSIS: We propose to undertake a single-arm multicentre open label trial (in Edinburgh and Melbourne) and recruit 28 women with tEPs (pretreatment serum hCG 1000-10 000 IU/L). We intend to give a single dose of intramuscular MTX (50 mg/m(2)) and oral gefitinib (250 mg) daily for 7 days. Our primary outcome is the resolution of EP to non-pregnant hCG levels <15 IU/L without requirement of surgery. Our secondary outcomes are comparison of time to resolution against historical controls given MTX only, and safety and tolerability as determined by clinical/biochemical assessment. ETHICS AND DISSEMINATION:Ethical approval has been obtained from Scotland A Research Ethics Committee (MREC 11/AL/0350), Southern Health Human Research Ethics Committee B (HREC 11180B) and the Mercy Health Human Research Ethics Committee (R12/25). Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12611001056987.
journal_name
BMJ Openjournal_title
BMJ openauthors
Horne AW,Skubisz MM,Doust A,Duncan WC,Wallace E,Critchley HO,Johns TG,Norman JE,Bhattacharya S,Mollison J,Rassmusen M,Tong Sdoi
10.1136/bmjopen-2013-002902subject
Has Abstractpub_date
2013-07-19 00:00:00issue
7issn
2044-6055pii
bmjopen-2013-002902journal_volume
3pub_type
杂志文章相关文献
BMJ Open文献大全abstract:INTRODUCTION:Premature infants are particularly vulnerable to brain injuries with associated cognitive and behavioural deficits. The worldwide first randomised interventional multicentre trial investigating the neuroprotective effects of erythropoietin (entitled 'Does erythropoietin improve outcome in very preterm infa...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-022157
更新日期:2018-04-24 00:00:00
abstract:OBJECTIVES:Identifying the issues and concerns that matter most to burns survivors can be challenging. For a number of reasons, but mainly relating to patient empowerment, some of the most pressing concerns patients may have during a clinical encounter may not naturally be the focal point of that encounter. The Patient...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2019-032785
更新日期:2019-12-30 00:00:00
abstract:OBJECTIVES:To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease (COPD) exacerbations, with home care provided by generic community nurses, compared with usual hospital care. DESIGN:Prospective, randomised controlled and multicentre trial with 3-month follow-up. SETTING:...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2012-001684
更新日期:2012-10-16 00:00:00
abstract:OBJECTIVE:To use newly available self-assigned ethnicity information to investigate variation in breast cancer screening uptake for women from the 16 specific ethnic groups within the broad Asian, Black and White groups that previous studies report. SETTING:National cancer screening programme services within London. ...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2014-005586
更新日期:2014-10-16 00:00:00
abstract:OBJECTIVE:The objective of this study is to assess the determinants of BCG vaccination in Ethiopia from 2016 Ethiopia Demographic and Health Survey (EDHS). SETTING:Since Ethiopia has nine regional states and two administrative cities, sample was taken from all the divisions. The population-based sample was intended to...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-023634
更新日期:2019-02-21 00:00:00
abstract:INTRODUCTION:The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less inte...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2017-020294
更新日期:2018-05-26 00:00:00
abstract:INTRODUCTION:Smell and taste of milk are not generally considered when tube feeding preterm infants. Preterm infants have rapid growth, particularly of the brain, and high caloric needs. Enteral feeding is often poorly tolerated which may lead to growth failure and long-term neurodevelopmental impairment. Smell and tas...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-027805
更新日期:2019-07-17 00:00:00
abstract:OBJECTIVES:Hospitals devoted to maternal and child health represent unique healthcare institutions in China. Healthcare professionals in these hospitals attend to health services for women and children, and also provide technical services and support for district maternal and children's healthcare as well as family pla...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-024205
更新日期:2019-01-25 00:00:00
abstract:INTRODUCTION:Young people with drug and alcohol problems are likely to have poorer health and other psychosocial outcomes than other young people. Residential treatment programmes have been shown to lead to improved health and related outcomes for young people in the short term. There is very little robust research sho...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2015-010824
更新日期:2016-05-25 00:00:00
abstract:OBJECTIVE:To examine newspaper coverage of maternal health in three countries that have made varying progress towards Millennium Development Goal 5 (MDG 5): Bangladesh (on track), Rwanda (making progress, but not on track) and South Africa (no progress). DESIGN:We analysed each country's leading national English-langu...
journal_title:BMJ open
pub_type: 杂志文章,多中心研究
doi:10.1136/bmjopen-2015-008837
更新日期:2016-01-13 00:00:00
abstract:INTRODUCTION:Global multidrug-resistant tuberculosis (MDR-TB) treatment success rates remain suboptimal. Highly active WHO group A drugs moxifloxacin and levofloxacin show intraindividual and interindividual pharmacokinetic variability which can cause low drug exposure. Therefore, therapeutic drug monitoring (TDM) of f...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2019-035350
更新日期:2020-06-16 00:00:00
abstract:INTRODUCTION:A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim...
journal_title:BMJ open
pub_type: 杂志文章,随机对照试验
doi:10.1136/bmjopen-2017-018906
更新日期:2018-01-23 00:00:00
abstract:OBJECTIVES:We investigated associations of officially recorded crime and perceived neighbourhood safety with physical health, evaluating potential effect modification by gender. SETTING:Nationally representative population-based survey in New Zealand. PARTICIPANTS:Individual-level data from 6995 New Zealand General S...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2013-004058
更新日期:2014-03-10 00:00:00
abstract:OBJECTIVES:Current research on the perceptions of overdiagnosis or overdetection of breast cancer has largely been conducted outside of the USA and with women younger than 70 years.Therefore, we explored older women's perceptions about the concept of overdetection of breast cancer and its influence on future screening ...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-022138
更新日期:2018-06-14 00:00:00
abstract:INTRODUCTION:Frailty is a common condition affecting older adults and is associated with increased mortality and adverse outcomes. Identification of older adults at risk of adverse outcomes is central to subsequent resource planning and targeted interventions. This systematic review and meta-analysis will examine the: ...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2020-040765
更新日期:2021-01-20 00:00:00
abstract:OBJECTIVES:Physicians are a commonly targeted group in health research surveys, but their response rates are often relatively low. The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates. DESIGN:Following 13 key informant inte...
journal_title:BMJ open
pub_type: 杂志文章,随机对照试验
doi:10.1136/bmjopen-2014-007166
更新日期:2015-02-18 00:00:00
abstract:OBJECTIVE:To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. DESIGN:Single-study economic evaluation of a cluster-controlled trial (Food Choic...
journal_title:BMJ open
pub_type: 杂志文章,多中心研究
doi:10.1136/bmjopen-2017-019182
更新日期:2018-03-03 00:00:00
abstract:OBJECTIVE:To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression. DESIGN:The model was based on several strands of ev...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2014-006448
更新日期:2015-02-06 00:00:00
abstract:OBJECTIVES:Explore the function of three specific modes of talk (discourse types) in decision-making processes. DESIGN:Ten real-life admissions of patients with critical illness were audio/video recorded and transcribed. Activity-type analysis (a qualitative discourse analytical method) was applied. SETTING:Interdisc...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-023749
更新日期:2018-11-03 00:00:00
abstract:INTRODUCTION:With almost 50% of cases preventable and the Australian National Bowel Cancer Screening Program in place, colorectal cancer (CRC) is a prime candidate for investment to reduce the cancer burden. The challenge is determining effective ways to reduce morbidity and mortality and their implementation through p...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2019-036475
更新日期:2020-06-21 00:00:00
abstract:BACKGROUND:Specialist Lifestyle Management (SLiM) is a structured patient education and self-management group weight management programme. Each session is run monthly over a 6-month period providing a less intensive long-term approach. The groups are patient-centred incorporating educational, motivational, behavioural ...
journal_title:BMJ open
pub_type: 历史文章,杂志文章
doi:10.1136/bmjopen-2014-007217
更新日期:2015-04-08 00:00:00
abstract:INTRODUCTION:Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder affecting approximately 10% to 25% of the adult population. A large number of clinical trials have been conducted to evaluate the efficacy of probiotics for IBS but the results were inconsistent. Previous meta-analyses ...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-027376
更新日期:2019-12-02 00:00:00
abstract:INTRODUCTION:Partners and children of individuals with alcohol use disorder (AUD) present with impaired quality of life and mental health, yet seldom seek or participate in traditional supportive interventions. Engaging the parent/partner without AUD in treatment is a promising way of supporting behavioural change in b...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2017-020879
更新日期:2018-08-10 00:00:00
abstract:INTRODUCTION:Exercise and physical activity (PA) are established and effective treatment options for various side effects of cancer treatments such as surgery, chemotherapy and radiotherapy. The advent of eHealth brings new opportunities to influence healthy behaviours, using interactive and novel approaches. Influenci...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-024999
更新日期:2019-03-08 00:00:00
abstract:OBJECTIVE:The standard data-collection procedure in the Norwegian national patient experience survey programme is post-discharge mail surveys, which include a pen-and-paper questionnaire with the option to answer electronically. A purely electronic protocol has not previously been explored in Norway. The aim of this st...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2019-036533
更新日期:2020-10-13 00:00:00
abstract:INTRODUCTION:The ongoing opioid epidemic has necessitated increasing prescriptions of buprenorphine, which is an evidence-based treatment for opioid use disorder, and also shown to reduce harms associated with unsafe opioid administration. A systematic review of perioperative management strategies for patients taking b...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-027374
更新日期:2019-05-22 00:00:00
abstract:INTRODUCTION:Drug-related problems (DRPs) are a major cause of unplanned hospital admissions among elderly people, and transitions of care have been emphasised as a key area for improving patient safety. We have designed a complex clinical pharmacist intervention that targets people ≥75 years of age undergoing transiti...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2019-036650
更新日期:2020-04-27 00:00:00
abstract:OBJECTIVES:To examine the association between multisite musculoskeletal pain in adolescence and mental health disorders in young adulthood. DESIGN AND SETTING:Data were obtained from a linkage between the Norwegian Patient Registry (2008-2012) and the Norwegian Arctic Adolescent Health Study, a school-based survey con...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2016-012035
更新日期:2017-02-10 00:00:00
abstract:OBJECTIVE:To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet. DESIGN:A ...
journal_title:BMJ open
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1136/bmjopen-2019-030884
更新日期:2019-11-11 00:00:00
abstract:OBJECTIVES:The local care and treatment of liver disease (LOCATE) intervention embedded specialist liver nurses in general practitioner (GP) practices to improve the identification of progressive liver disease, enabling earlier intervention. This current process evaluation examines GP practice staffs' perceptions of th...
journal_title:BMJ open
pub_type: 杂志文章
doi:10.1136/bmjopen-2018-028591
更新日期:2019-05-22 00:00:00