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1.
《Vaccine》2016,34(51):6626-6633
BackgroundSafety signal detection in spontaneous reporting system databases and electronic healthcare records is key to detection of previously unknown adverse events following immunization. Various statistical methods for signal detection in these different datasources have been developed, however none are geared to the pediatric population and none specifically to vaccines. A reference set comprising pediatric vaccine-adverse event pairs is required for reliable performance testing of statistical methods within and across data sources.MethodsThe study was conducted within the context of the Global Research in Paediatrics (GRiP) project, as part of the seventh framework programme (FP7) of the European Commission. Criteria for the selection of vaccines considered in the reference set were routine and global use in the pediatric population. Adverse events were primarily selected based on importance. Outcome based systematic literature searches were performed for all identified vaccine-adverse event pairs and complemented by expert committee reports, evidence based decision support systems (e.g. Micromedex), and summaries of product characteristics. Classification into positive (PC) and negative control (NC) pairs was performed by two independent reviewers according to a pre-defined algorithm and discussed for consensus in case of disagreement.ResultsWe selected 13 vaccines and 14 adverse events to be included in the reference set. From a total of 182 vaccine-adverse event pairs, we classified 18 as PC, 113 as NC and 51 as unclassifiable. Most classifications (91) were based on literature review, 45 were based on expert committee reports, and for 46 vaccine-adverse event pairs, an underlying pathomechanism was not plausible classifying the association as NC.ConclusionA reference set of vaccine-adverse event pairs was developed. We propose its use for comparing signal detection methods and systems in the pediatric population. 相似文献
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《Vaccine》2016,34(20):2349-2353
BackgroundIn October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine.ObjectivesWe characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011–2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005–2010).MethodsWe searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011–6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005–06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation.ResultsWe found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5–2.8%) and injection site reactions/arm pain (4.5–11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7–1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports.ConclusionsNo new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester. 相似文献
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目的 探讨丙泊酚复合瑞芬太尼喉罩全身麻醉(全麻)的效果。方法 62例腹腔镜、泌尿科、骨科、肛肠科、妇科等手术治疗的患者,随机分为实验组和对照组,每组31例。对照组采用常规气管插管静脉复合全麻,实验组给予靶控输注丙泊酚复合瑞芬太尼喉罩全麻。比较两组患者插入喉罩(插管)、插管1 min、插管3 min、拔出喉罩(拔管)1 min、拔管3 min时心率(HR)和平均动脉压(MAP)水平;不良反应发生情况、麻醉效果;全麻起效时间、维持全麻时间、术后苏醒时间。结果 实验组插管时、插管1 min、插管3 min、拔管1 min、拔管3 min的HR水平分别为(77.52±6.36)、(73.26±5.56)、(72.01±4.69)、(75.35±7.63)、(72.34±6.79)次/min,均低于对照组的(92.34±7.85)、(87.97±5.25)、(78.85±5.20)、(95.69±9.21)、(85.63±7.43)次/min,差异均具有统计学意义(P<0.05)。实验组插管时、插管1 min、插管3 min、拔管1 min、拔管3 min的MAP水平分别为(90.25±6.73)、(87.65±7.98)、(88.79±7.65)、(88.09±5.61)、(88.52±5.16)mm Hg(1 mm Hg=0.133 kPa),均低于对照组的(109.51±7.85)、(103.27±12.43)、(102.52±8.21)、(106.74±7.68)、(104.62±7.71)mm Hg,差异均具有统计学意义(P<0.05)。实验组不良反应发生率3.23%低于对照组的19.35%,差异具有统计学意义(P<0.05)。实验组麻醉总有效率96.77%均高于对照组的80.65%,差异均具有统计学意义(P<0.05)。实验组全麻起效、维持全麻、术后苏醒时间分别为(1.61±0.23)、(100.59±6.72)、(17.99±3.52)min,均短于对照组的(2.93±0.41)、(123.61±7.85)、(36.87±4.16)min,差异均具有统计学意义(P<0.05)。结论 针对腹腔镜等手术患者应用丙泊酚复合瑞芬太尼喉罩全麻对血液动力学影响小,不良反应发生率低,麻醉效果良好,降低对机体损伤,值得推广应用。 相似文献
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T. L. Naneishvili M. G. Dashniani G. I. Machavariani 《Neuroscience and behavioral physiology》1987,17(1):49-55
Several types of neurons were differentiated on the basis of a study of neuronal activity in various parts of the cortex near the sulcus principalis during the execution of spatial delayed reactions by monkeys. It was established that the different types of neurons are represented in different numbers in. different parts of the cortex near the sulcus principalis. The determination of several factors influencing the activity of these neurons and the comparison of data on their quantitative representation in the anterior, middle, and posterior parts of the cortex near the sulcus principalis with the existing behavioral data obtained after local ablations of identical regions of the brain made it possible to postulate that neurons belonging to the different types are involved in the analysis of different processes and represent different functional units.Translated from Fiziologicheskii. Zhurnal SSSR imeni I. M. Sechenova, Vol. 71, No. 12, pp. 1488–1494, December, 1985. 相似文献
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Clinical Efficacy of New Antiepileptic Drugs in Refractory Partial Epilepsy: Experience in the United States With Three Novel Drugs 总被引:1,自引:1,他引:0
Jacqueline A. French 《Epilepsia》1996,37(S2):S23-S26
Summary: A number of new antiepileptic drugs (AEDs), including topiramate (TPM), felbamate (FBM), and gabapentin (GBP), are approved or believed to be close to approval for marketing in the United States. Key efficacy findings for these AEDs in refractory partial epilepsy were reviewed. Large and significant drug-placebo differences were observed with TPM in two large dose-finding trials conducted in the United States. The minimal effective dose of TPM in the population studied was determined to be approximately 200 mg/day, and doses above 600 mg/day produced good efficacy but little incremental benefit versus the lower dosages for the overall study population. FBM is active in partial epilepsy, although seizure reduction is less marked and drug interactions complicate the findings. GBP is also active in this population, but only the 1,800 mg/day dosage was significantly better than placebo with respect to percent re-sponders. It may be useful to explore higher dosage ranges for both FBM and GBP if they can be well tolerated. 相似文献
9.
Drug related hospital admissions 总被引:13,自引:0,他引:13
J. Hallas B. Harvald J. Worm J. Beck-Nielsen L. F. Gram E. Grodum N. Damsbo J. Schou H. Kromann-Andersen F. Frølund 《European journal of clinical pharmacology》1993,45(3):199-203
Summary As part of a high-intensity monitoring study of drug events as the cause of admission to departments of internal medicine, the effect of an educational intervention programme was studied. Two departments were included, one specialising in geriatrics and one that received patients by non-selected referral. The series consisted of 607 consecutive admissions studied before and 703 after the intervention. The drug events considered were adverse drug reactions and dose-related therapeutic failures, mainly due to non-compliance.A modest, statistically non-significant decrease in drug related hospital admissions (DRH) was seen, from 14% before to 13% after the intervention period. However, DRHs classified as definitely avoidable showed the significant decrease of 83%.There was no apparent relationship between the topics selected for the intervention programme and changes in the pattern of DRHs. No relationship between alterations in sales data and hospital admissions caused by a given drug could be demonstrated. A blinded external evaluation of case abstracts did not disclose any significant shift in the investigators' assessments.The intervention may have had an non-specific effect on avoidable DRHs. 相似文献
10.
Thilo Klindert Isabel Stroetmann Gunther Seitz Georg Hfner Klaus Th. Wanner Gerlinde Frenzen Brigitta Eckhoff 《Archiv der Pharmazie》1997,330(6):163-168
A number of novel pyridazinomorphinans have been synthesized by the inverse electron demand Diels-Alder reaction of various 3,6-disubstituted 1,2,4,5-tetrazines with enamines derived from dihydrocodeinone and with codeinone. Reduction of some of the pyridazinomorphinans did not furnish the expected pyrroloepoxymorphinans; in all cases investigated reductive cleavage of the epoxybridge was observed to yield dihydropyridazino- or pyrrolomorphinans. The structures of all new compounds were assigned by the spectral data, that of the cycloadduct of codeinone was additionally verified by X-ray crystallography. Compounds 5a, 8, 11a , and 16 have been evaluated for their affinity at μ and κ opioid receptors in radioligand binding assays. Their ability to inhibit [3H]DAMGO binding at μ and [3H]U 69.593 binding at κ receptors, respectively as compared to codeine has been found to be lower. 相似文献