Abstract:
INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT01790061, NCT02560727) for moderate-to-severe ulcerative colitis (Mayo score range 6-12) were performed from November 2012 to July 2017. Both studies were pooled for analysis on the safety and efficacy of fecal microbiota transplantation in patients with ulcerative colitis over a 1-year follow-up. The step-up fecal microbiota transplantation strategy included step 1: single fecal microbiota transplantation; step 2: two or more fecal microbiota transplantations; and step 3: fecal microbiota transplantations followed by immunosuppressants. Long-term clinical efficacy and adverse events were assessed, and multiple factors related to fecal microbiota transplantation were evaluated. RESULTS:Of 134 eligible patients in this real-word study, 81.3% (109/134) were included for analysis. The follow-up ranged from 1 to 5 years. Fecal microbiota transplantation-related adverse events were observed in 17.4% (43/247) of fecal microbiota transplantation procedures including one serious adverse event (myasthenia gravis) and 56 non-serious adverse events. Multivariable logistic regression analysis showed that both the method of preparation of microbiota from stool using the automatic system and the delivery method of colonic transendoscopic enteral tubing were associated with a lower rate of fecal microbiota transplantation-related adverse events (p = 0.023, p = 0.017, respectively). In total, 74.3% (81/109) and 51.4% (56/109) of patients achieved clinical response at 1 month and 3 months after step-up fecal microbiota transplantation, respectively. CONCLUSIONS:Fecal microbiota transplantation should be a safe and promising therapy for ulcerative colitis. The improved fecal microbiota preparation and colonic transendoscopic enteral tubing might reduce the rate of adverse events in ulcerative colitis. TRIAL REGISTRATION:ClinicalTrials.gov NCT01790061, NCT02560727.
journal_name
Drug Safjournal_title
Drug safetyauthors
Ding X,Li Q,Li P,Zhang T,Cui B,Ji G,Lu X,Zhang Fdoi
10.1007/s40264-019-00809-2subject
Has Abstractpub_date
2019-07-01 00:00:00pages
869-880issue
7eissn
0114-5916issn
1179-1942pii
10.1007/s40264-019-00809-2journal_volume
42pub_type
杂志文章相关文献
DRUG SAFETY文献大全abstract::Although travellers' diarrhoea can sometimes be associated with postinfectious complications, the condition is typically self-limiting. The infectious-diarrhoea guidelines subcommittees of the Infectious Disease Society of America and the American College of Gastroenterology recommend empirical antibacterial therapy f...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629030-00004
更新日期:2006-01-01 00:00:00
abstract::Recent evidence from animal studies has raised the possibility that immunisation by vaccines can influence the pathogenesis of type I (insulin-dependent) diabetes mellitus. In non-obese diabetic mice and biobreeding rats, complete Freund's adjuvant and bacillus Calmette-Guérin (BCG) vaccine have successfully been used...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199920030-00001
更新日期:1999-03-01 00:00:00
abstract::All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The eight available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure-lowering effects have been demonstrated whe...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-014-0239-7
更新日期:2015-01-01 00:00:00
abstract::Although inhaled and intranasal corticosteroids are first-line therapy for asthma and allergic rhinitis, there has recently been an increasing awareness of their propensity to produce systemic adverse effects. The availability of more potent and lipophilic corticosteroids and new chlorofluorocarbon (CFC)-free formulat...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200023010-00002
更新日期:2000-07-01 00:00:00
abstract::Antibiotic-associated pseudomembranous colitis is an uncommon but potentially serious adverse reaction, resulting in acute diarrhoea and characterised by colonic pseudomembranes. A direct relationship between the disease, recent antibiotic therapy and proliferation of Clostridium difficile in the colonic lumen was est...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199106050-00004
更新日期:1991-09-01 00:00:00
abstract:BACKGROUND:Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. OBJECTIVE:The aim of the study was to explore the...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/BF03261981
更新日期:2012-10-01 00:00:00
abstract::Insomnia is a heterogeneous, highly prevalent condition that is associated with a high level of psychiatric, physical, social and economic morbidity. The treatment of insomnia involves pharmacological and non-pharmacological interventions. The mainstay of pharmacological treatment of insomnia has been the benzodiazepi...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200528040-00003
更新日期:2005-01-01 00:00:00
abstract:INTRODUCTION:Adverse drug reactions (ADRs) are unintended reactions caused by a drug or combination of drugs taken by a patient. The current safety surveillance system relies on spontaneous reporting systems (SRSs) and more recently on observational health data; however, ADR detection may be delayed and lack geographic...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-020-00943-2
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200831020-00004
更新日期:2008-01-01 00:00:00
abstract:INTRODUCTION:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0502-1
更新日期:2017-05-01 00:00:00
abstract::Narcolepsy is a life-long central nervous system (CNS) syndrome characterised by excessive sleepiness, cataplexy, sleep paralysis, hypnagogic hallucinations and disturbed night-time sleep. Unsuccessfully treated narcolepsy confers increased risks on patients and on society due to the patient's increased chance of beco...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200225110-00004
更新日期:2002-01-01 00:00:00
abstract::Absolute and functional iron deficiency is the most common cause of epoetin (recombinant human erythropoietin) hyporesponsiveness in renal failure patients. Diagnostic procedures for determining iron deficiency include measurement of serum iron levels, serum ferritin levels, saturation of transferrin and percentage of...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199717040-00004
更新日期:1997-10-01 00:00:00
abstract::The main goal of pharmacological research in the field of topical corticosteroids (TCs) is to dissociate efficacy and adverse effects as much as possible. The optimal use of TCs, i.e. the careful evaluation of the benefit/risk ratio, depends on: (i) the chemical structure of the TC; (ii) the type of vehicle; (iii) the...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199410050-00005
更新日期:1994-05-01 00:00:00
abstract::Current antiretroviral therapy has lead to longer survival in patients infected with HIV, but it is also associated with new and important problems. Body fat redistribution and metabolic abnormalities, the so-called lipodystrophy syndrome, are among the most prevalent and worrisome ones. While an increasing number of ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200124030-00001
更新日期:2001-01-01 00:00:00
abstract::Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199207040-00004
更新日期:1992-07-01 00:00:00
abstract:INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0424-y
更新日期:2016-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Rosuvastatin is a lipid-lowering drug, the newest of a class of drugs called HMG-CoA reductase inhibitors, or 'statins', launched in the UK in March 2003. Our objective was to monitor the post-marketing safety of this drug, prescribed in primary care in England, using prescription-event monitor...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200730020-00005
更新日期:2007-01-01 00:00:00
abstract::The US FDA has issued safety alerts and required manufacturers of leukotriene-modifying agents (LTMAs), including montelukast, zafirlukast and zileuton, to include suicide and neuropsychiatric events as a precaution in the drug label. This paper reviews the existing evidence on the potential association between the LT...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/11587260-000000000-00000
更新日期:2011-07-01 00:00:00
abstract:BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/0002018-200831120-00009
更新日期:2008-01-01 00:00:00
abstract::The WHO World Alliance on Patient Safety is a new, all encompassing project to improve medical care. Individual patients are the focus and all countries are encouraged to develop systems in which medical error, therapeutic accidents and failures are minimised. The potential for adverse events is present at all levels ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200528050-00002
更新日期:2005-01-01 00:00:00
abstract::Since the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heteroge...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-018-0782-8
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving. OBJECTIVE:The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-0737-0
更新日期:2019-03-01 00:00:00
abstract::Older people in the UK receive a disproportionate amount of medication. They comprise 18% of the population but receive 45% of all prescription items. Not surprisingly they experience drug-related illnesses - in 1980, 1 in 10 admissions to acute geriatric units were wholly or partly due to adverse drug reactions. Drug...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199819040-00001
更新日期:1998-10-01 00:00:00
abstract:INTRODUCTION:While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. AIM:The aim of this study was to describe the landscape of technolo...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-019-00838-x
更新日期:2019-09-01 00:00:00
abstract:BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200730070-00004
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:The case-population approach or population-based case-cohort approach is derived from the case-control design and consists of comparing past exposure to a given risk factor in subjects presenting a given disease or symptom (cases) with the exposure rate to this factor in the whole cohort or in the source pop...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11592140-000000000-00000
更新日期:2011-10-01 00:00:00
abstract::Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-018-0773-9
更新日期:2019-02-01 00:00:00
abstract::Methylphenidate is the most widely use psychotropic medication in children in the US. It is both well tolerated and efficacious in the treatment of attention deficit hyperactivity disorder, and is associated with few serious adverse effects. However, the abuse of methylphenidate for the purpose of experiencing a 'high...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199717030-00001
更新日期:1997-09-01 00:00:00
abstract::Several recent case control studies have shown an excess rate of venous thromboembolism in women using third generation progestogen-containing combined contraceptive pills compared to second generation combined contraceptive pills. This excess is about 1 in 10,000 women per year of use. It is likely that second and th...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-199716020-00001
更新日期:1997-02-01 00:00:00
abstract::The term 'benefit-risk ratio' is often used as a general term linked to the use of a medicine. To balance risk and benefit is, however, a very complex exercise. For most medicines the benefits are limited to a few indications and for an individual patient there is usually only a single benefit sought but the potential...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-199615010-00001
更新日期:1996-07-01 00:00:00