Abstract:
BACKGROUND:Oral 5-aminosalicylic (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs were more effective than placebo but had a statistically significant therapeutic inferiority relative to SASP. This updated review includes more recent studies and evaluates the effectiveness, dose-responsiveness, and safety of 5-ASA preparations used for maintenance of remission in quiescent ulcerative colitis. OBJECTIVES:The primary objectives were to assess the efficacy, dose-responsiveness and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators for maintenance of remission in quiescent ulcerative colitis. A secondary objective was to compare the efficacy and safety of once daily dosing of oral 5-ASA with conventional (two or three times daily) dosing regimens. SEARCH METHODS:A literature search for relevant studies (inception to January 20, 2012) was performed using MEDLINE, EMBASE and the Cochrane Library. Review articles and conference proceedings were also searched to identify additional studies. SELECTION CRITERIA:Studies were accepted for analysis if they were randomized controlled trials with a minimum treatment duration of six months. Studies of oral 5-ASA therapy for treatment of patients with quiescent ulcerative colitis compared with placebo, SASP or other 5-ASA formulations were considered for inclusion. Studies that compared once daily 5-ASA treatment with conventional dosing of 5-ASA and 5-ASA dose ranging studies were also considered for inclusion. DATA COLLECTION AND ANALYSIS:The primary outcome was the failure to maintain clinical or endoscopic remission. Secondary outcomes included adherence, adverse events, withdrawals due to adverse events, and withdrawals or exclusions after entry. Trials were separated into five comparison groups: 5-ASA versus placebo, 5-ASA versus sulfasalazine, once daily dosing versus conventional dosing, 5-ASA versus comparator 5-ASA formulation, and 5-ASA dose-ranging. Placebo-controlled trials were subgrouped by dosage. Once daily versus conventional dosing studies were subgrouped by formulation. 5-ASA-controlled trials were subgrouped by common 5-ASA comparators (e.g. Asacol and Salofalk). Dose-ranging studies were subgrouped by 5-ASA formulation. We calculated the relative risk (RR) and 95% confidence intervals (95% CI) for each outcome. Data were analyzed on an intention to treat basis. MAIN RESULTS:Thirty-eight studies (8127 patients) were included. The majority of included studies were rated as low risk of bias. Eight studies were rated at high risk of bias. Six of these studies were single-blind and two studies were open-label. However, the two open-label studies and four of the single-blind studies utilized investigator performed endoscopy as an endpoint, which may protect against bias. 5-ASA was significantly superior to placebo for maintenance of clinical or endoscopic remission. Forty-one per cent of 5-ASA patients relapsed compared to 58% of placebo patients (7 studies, 1298 patients; RR 0.69, 95% CI 0.62 to 0.77). There was a trend towards greater efficacy with higher doses of 5-ASA with a statistically significant benefit for the 1 to 1.9 g/day (RR 0.65; 95% CI 0.56 to 0.76) and the > 2 g/day subgroups (RR 0.73, 95% CI 0.60 to 0.89). SASP was significantly superior to 5-ASA for maintenance of remission. Forty-eight per cent of 5-ASA patients relapsed compared to 43% of SASP patients (12 studies, 1655 patients; RR 1.14, 95% CI 1.03 to 1.27). A GRADE analysis indicated that the overall quality of the evidence for the primary outcome for the placebo and SASP-controlled studies was high. No statistically significant differences in efficacy or adherence were found between once daily and conventionally dosed 5-ASA. Twenty-nine per cent of once daily patients relapsed over 12 months compared to 31% of conventionally dosed patients (7 studies, 2826 patients; RR 0.92, 95% CI 0.83 to 1.03). Fourteen per cent of patients in the once daily group failed to adhere to their medication regimen compared to 11% of patients in the conventional dosing group (5 studies, 1161 patients; RR 1.21, 95% CI 0.90 to 1.63). There does not appear to be any difference in efficacy among the various 5-ASA formulations. Thirty-eight per cent of patients in the 5-ASA group relapsed compared to 37% of patients in the 5-ASA comparator group (5 studies, 457 patients; RR 1.01, 95% CI 0.80 to 1.28). A pooled analysis of two studies showed no statistically significant difference in efficacy between Balsalazide 6 g and 3 g/day. Twenty-three per cent of patients in the 6 g/day group relapsed compared to 33% of patients in the 3 g/day group (216 patients; RR 0.72; 95% CI 0.46 to 1.13). One study found Balsalazide 4 g to be superior to 2 g/day. Thirty-seven per cent of patients in the 4 g/day Balsalazide group relapsed compared to 55% of patients in the 2 g/day group (133 patients; RR 0.66; 95% CI 0.45 to 0.97). One study found a statistically significant difference between Salofalk granules 3 g and 1.5 g/day. Twenty-five per cent of patients in the Salofalk 3 g/day group relapsed compared to 39% of patients in the 1.5 g/day group (429 patients; RR 0.65; 95% CI 0.49 to 0.86). Common adverse events included flatulence, abdominal pain, nausea, diarrhea, headache, dyspepsia, and nasopharyngitis. There were no statistically significant differences in the incidence of adverse events between 5-ASA and placebo, 5-ASA and SASP, once daily and conventionally dosed 5-ASA, 5-ASA and comparator 5-ASA formulations and 5-ASA dose ranging studies. The trials that compared 5-ASA and SASP may have been biased in favour of SASP because most trials enrolled patients known to be tolerant to SASP which may have minimized SASP-related adverse events. AUTHORS' CONCLUSIONS:5-ASA was superior to placebo for maintenance therapy in ulcerative colitis. However, 5-ASA had a statistically significant therapeutic inferiority relative to SASP. Oral 5-ASA administered once daily is as effective and safe as conventional dosing for maintenance of remission in quiescent ulcerative colitis. There does not appear to be any difference in efficacy or safety between the various formulations of 5-ASA. Patients with extensive ulcerative colitis or with frequent relapses may benefit from a higher dose of maintenance therapy. High dose therapy appears to be as safe as low dose and is not associated with a higher incidence of adverse events.
journal_name
Cochrane Database Syst Revjournal_title
The Cochrane database of systematic reviewsauthors
Feagan BG,Macdonald JKdoi
10.1002/14651858.CD000544.pub3subject
Has Abstractpub_date
2012-10-17 00:00:00pages
CD000544issn
1469-493Xjournal_volume
10pub_type
杂志文章,meta分析,评审abstract:BACKGROUND:Global high rates of unplanned pregnancy and abortion among young women demonstrate the need for increased access to modern contraceptive services. In sub-Saharan Africa, the birth rate for those aged 15 to 19 years is 121 per 1000. In the USA, 6% of teens aged 15 to 19 years became pregnant in 2010. Most pr...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD012025.pub2
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abstract:BACKGROUND:Neuropathic pain may be caused by nerve damage, and is often followed by changes to the central nervous system. Uncertainty remains regarding the effectiveness and safety of acupuncture treatments for neuropathic pain, despite a number of clinical trials being undertaken. OBJECTIVES:To assess the analgesic ...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD012057.pub2
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abstract:BACKGROUND:The need for sedation for neonates undergoing uncomfortable procedures in the neonatal intensive care unit (NICU) has often been overlooked. Proper sedation may reduce stress and avoid complications during procedures such as mechanical ventilation. Midazolam is a short acting benzodiazepine that has been inc...
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doi:10.1002/14651858.CD002052
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abstract:BACKGROUND:Oral analgesia is a convenient and widely used form of pain relief following caesarean section. It includes various medications used at different doses alone or in adjunction to other form of analgesia. OBJECTIVES:To determine the effectiveness, safety and cost-effectiveness of oral analgesia for post-caesa...
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doi:10.1002/14651858.CD010450.pub2
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abstract:BACKGROUND:Occupational exposure to hazardous drugs can decrease fertility and result in miscarriages, stillbirths, and cancers in healthcare staff. Several recommended practices aim to reduce this exposure, including protective clothing, gloves, and biological safety cabinets ('safe handling'). There is significant un...
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pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD012860.pub2
更新日期:2018-03-27 00:00:00
abstract:BACKGROUND:Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. OBJECTIVES:To assess the effectiveness and safety of using an opiate compared to a sedative or non-pharmacological...
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doi:10.1002/14651858.CD002059.pub3
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abstract:BACKGROUND:Over the last two decades, a long protocol of Gonadotrophin-releasing hormone agonist (GnRHa) to prevent premature LH surges has been the standard treatment for ovarian stimulation in assisted reproduction. In the long protocols (with GnRHa started either in the mid luteal phase or in the early follicular ph...
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doi:10.1002/14651858.CD000184.pub4
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doi:10.1002/14651858.CD004929.pub3
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doi:10.1002/14651858.CD004502.pub2
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doi:10.1002/14651858.CD002924
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doi:10.1002/14651858.CD012389.pub2
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doi:10.1002/14651858.CD006358.pub2
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abstract:BACKGROUND:Prayer is an ancient and widely used intervention for alleviating illness and promoting good health. This review focuses specifically on intercessory prayer, which is organised, regular and committed, and those who practise it will almost inevitably hold some committed belief that they are praying to God. Wh...
journal_title:The Cochrane database of systematic reviews
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更新日期:2000-01-01 00:00:00
abstract:BACKGROUND:Resilience can be defined as the maintenance or quick recovery of mental health during or after periods of stressor exposure, which may result from a potentially traumatising event, challenging life circumstances, a critical life transition phase, or physical illness. Healthcare professionals, such as nurses...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析
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更新日期:2020-07-05 00:00:00
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更新日期:2005-04-18 00:00:00
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更新日期:2019-05-15 00:00:00
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journal_title:The Cochrane database of systematic reviews
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journal_title:The Cochrane database of systematic reviews
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abstract:BACKGROUND:A patent ductus arteriosus (PDA) complicates the clinical course of preterm infants, increasing their risks of developing chronic lung disease (CLD), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH). Indomethacin is used as standard therapy to close a PDA, but is associated with reduced...
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