共查询到20条相似文献,搜索用时 15 毫秒
1.
2.
3.
Almeida L Kashdan TB Nunes T Coelho R Albino-Teixeira A Soares-da-Silva P 《European journal of clinical pharmacology》2008,64(6):575-582
Objective
To investigate the influence of anxiety, social anxiety and depressive symptoms on the willingness of healthy subjects to volunteer for phase I studies and to report adverse events.Materials and methods
A group of healthy subjects who had never participated in a clinical trial (“Naïve Subjects”) were invited to participate in a phase I study. All subjects were assessed for trait anxiety (State-Trait Anxiety Inventory, STAI-T), social anxiety (Social Avoidance and Distress, SAD, and Fear of Negative Evaluation, FNE) and depressive symptomatology (Beck Depression Inventory, BDI-II). Subjects who accepted the invitation to participate were compared with those who refused. The personality traits of a group of “Actual Participants” were examined, and the relation of these traits to adverse events reported during participation was evaluated.Results
A significant inverse correlation was found between the STAI-T (R?=??0.203, p?0.05) and SAD (R?=??0.204, p?0.05) scores and the willingness to participate. Naïve Subjects who refused the invitation to participate showed higher scores on STAI-T (Z?=??2.600, p?0.01) and SAD (Z?=?2.524, p?0.05) inventories. Logistic regression using BDI-II, STAI-T, SAD and FNE as covariates also showed that the only unique predictors of participation were the STAI-T (p?0.05) and SAD (p?0.01) scores. Significant positive correlations were found between trait anxiety and reporting of adverse events.Conclusion
Participants in phase I studies are a self-selected sample defined by low trait-anxiety and social avoidance behaviors. This self-selection bias may affect the study results because less anxious subjects tend to report fewer adverse events. The characterization of a participant’s personality traits may be important in phase I studies.4.
van Geffen EC van der Wal SW van Hulten R de Groot MC Egberts AC Heerdink ER 《European journal of clinical pharmacology》2007,63(12):1193-1199
Objective To assess experiences related to antidepressant use reported to an internet-based medicine reporting system and to compare
the nature of the side effects reported by patients with those reported by health care professionals (HCPs).
Methods All reports submitted from May 2004 to May 2005 to an internet-based medicine reporting system in The Netherlands related
to the use of antidepressants were analysed. Spontaneous reports of adverse drug reactions on antidepressants from HCPs received
by The Netherlands Pharmacovigilance Centre Lareb from May 2004 to May 2005 were included for comparison.
Results Of the 2232 individuals who submitted a report to the internet-based medicine reporting system, 258 submitted a report on
antidepressants. Of these, 92 individuals (36%) reported on effectiveness, 40 (16%) of whom reported on ineffectiveness, and
217 (84%) submitted a report on side effects, with 202 (78%) reporting a total of 630 side effects that were experienced as
negative. Fourteen individuals (5%) reported a practical issue and four (2%) reported a reimbursement issue. Of all 630 side
effects reported, 48% resulted in the patient discontinuing the antidepressant therapy; of these 29% did not inform their
HCP. Of all the side effects reported, 52% were perceived as “very negative”. In comparison to the side effects reported by
HCPs, patients more often reported apathy, excessive sweating, ineffectiveness, somnolence, insomnia, sexual problems and
weight increase.
Conclusion Patients report the ineffectiveness and side effects of antidepressant therapy as negative and leading to discontinuation
of the therapy. Patients and HCPs differ in the nature of the reported side effects. Patient experiences should be included
in the evaluation of antidepressant treatment in clinical practice. 相似文献
5.
Cleophas RC Cleophas TJ 《International journal of clinical pharmacology and therapeutics》1999,37(1):1-7
BACKGROUND: Studies that do not confirm their prior hypotheses, otherwise called "negative" studies, receive less interest from different parties including authors, editors and sponsors, and so, not to publish such studies is a common phenomenon. Opinions differ on whether or not this phenomenon introduces imprecision into the assessment of health research and care. OBJECTIVE: The current paper gives arguments against and in favor of publishing "negative" trials, and tries to give suggestions for a more balanced approach to this problem. RESULTS: Arguments against publishing "negative" trials include: we need not publish erroneously "negative" trials; we need not publish a "negative" study out of worry that the favored treatment is inferior; full-length reports of "negative" trials devaluate the quality of literature, because the data are usually not so important, and generally receive little interest from readers, and so, not to publish them is a more or less "natural" matter of course. Arguments in favor of publishing "negative" trials include: no report reduces the flow of information because "negative" trials provide at least some evidence and balance against the overwhelming power of positive data readily accepted for publication; no report violates the promise to patient participants; studies that do not confirm prior hypotheses are especially important; not-publishing leads to unnecessary repetition of research. Initially, trials were frequently "negative" not only due to lack of power but also due to inappropriate hypotheses and poor designs. Currently, this is less so, and the issue of selective reporting, therefore, needs to be reassessed. Suggestions for a more balanced approach to the problem of selective reporting might include: careful planning before the trial begins, reduces the chance of biased and erroneously "negative" trials; any trial, "positive" or "negative", provides probabilities rather than truths; this notion does not explain away publication bias but does make it less of a problem; "negative" trials may not be appropriate for general journals but very relevant to specialist journals as well as other organs of specialist groups; ethical committees and trial review boards should address the issue of publishing as part of their function. CONCLUSION: Data from properly executed trials should routinely be made available. However, we should not forget that the empirical observations provided by clinical trials, are statistically tested, and that statistics are based merely on probabilities. It means that we must consider a more philosophical attitude to clinical trial evidence in terms of acceptance that scientific truths are rarely absolute. 相似文献
6.
Pierfitte C Bégaud B Lagnaoui R Moore ND 《British journal of clinical pharmacology》1999,47(3):329-331
AIMS: Uncertainty as to relative under-reporting plagues the comparisons of spontaneous reporting rates as a tool for decision-making in pharmacovigilance. However, it is generally accepted that under-reporting should be reasonably similar for similar drugs sharing the same indication, country and period of marketing. To test this, we compared the adverse drug reaction reporting rates to the French regional pharmacovigilance centres for six pairs of identical drug marketed at the same time by different companies under different brand names (co-marketing). METHODS: All reaction reports were related to sales, to compute reporting rate; within each pair, the reporting rate ratio and its confidence interval were calculated. RESULTS: The rate ratios were all between 0.76 and 1.33. Two of them were significantly different from 1 (1.28; 95% C.I. [1.01; 1.60] and 1.33; 95% C.I. [1.06; 1.74]). CONCLUSIONS: These small differences in reporting rates would not warrant regulatory action and support the usual assumption of similar reporting for similar drugs. 相似文献
7.
Tubert-Bitter P Haramburu F Begaud B Chaslerie A Abraham E Hagry C 《Pharmacoepidemiology and drug safety》1998,7(5):323-329
A survey among Bordeaux pharmacovigilance centre 'users' and 'non-users' was conducted in Aquitaine, France. Two hundred physicians having reported to the centre at least one adverse drug reaction (ADR) during the past 3 years were matched to a randomly selected sample of 400 physicians who did not report. They were asked to anonymously fill out a postal questionnaire collecting data on their individual characteristics, including their practice mode, and on ADRs that they observed and reported during the past 12 months. The number of questionnaires returned was 151 (25%), of which 76 were from users (38%) and 75 from non-users (19%). The two groups had very close individual characteristics. All but three responders had observed at least one ADR during the past 12 months. For the different types of ADRs defined in terms of seriousness and labelling, more users had seen ADRs than non-users but among those who observed them, the numbers of ADRs seen were similar in both groups. In any case, the more recent the drug, the more prone to report were the physicians. 相似文献
8.
9.
10.
Kang-Nee Ting Dane Michael Stratton-Powell Claire Anderson 《Pharmacy World & Science》2010,32(3):339-342
Objectives To investigate community pharmacists’ knowledge, attitudes and views on adverse drug reaction (ADR) reporting. Setting Seven community pharmacies in Malaysia. Method Structured interviews with community pharmacists. Informed consent was obtained and interviews were audio-recorded and transcribed
verbatim. Main Outcome Measures Content analysis of themes on awareness of ADR reporting, reporting activities, attitudes and views on patient reporting.
Results All pharmacists claimed to have some knowledge of a reporting system but only one had submitted a report directly to the
regulatory authority. Despite the low level of reporting activities, all participants agreed that it was part of their professional
obligation to report an ADR. Most participants were not aware of the direct patient reporting scheme and were skeptical about
its success. Lack of awareness and patients’ limited knowledge about their medications were viewed as barriers to patient
reporting. Local attitudinal issues including pharmacists’ attitude towards ADR reporting were described as possible contributing
factors. Conclusion Community pharmacists have an important role in reporting ADRs. Many Malaysian patients are still perceived to be ill-informed
of their medications, an important determinant to the success of patient reporting. There is a need for further training about
ADRs and ADR reporting for health professionals and further education for patients. 相似文献
11.
12.
13.
Iavicoli LG 《The Mount Sinai journal of medicine, New York》2005,72(4):228-231
Should physicians be mandated to report domestic violence involving a competent adult patient regardless of whether or not he or she consents to the report? This is a complex ethical and moral issue; in some states such as California, Colorado, Kentucky, New Hampshire, Rhode Island and New Mexico it has become a legal one as well. The Federal health privacy regulation instituted in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses issues of privacy protection for survivors of domestic violence, but it does not preempt those state laws that are less (or more) protective of patient privacy. In the above states, physicians and/or health care providers are mandated to report acts of domestic violence to an agency, under their own circumstances, regardless of whether the physician or health care worker believes that reporting the violence is in the patient's best interest or not. But is mandatory reporting truly "good" or "bad" for the patient, the physician or society as a whole? This article explores the laws and the evidence (including evidence-based research) surrounding the issue of mandatory reporting of domestic violence when it pertains to a competent adult. 相似文献
14.
《中国药理学与毒理学杂志》1991,(4)
<正> It was suggested that adriamycin (ADM) may have at least two mechanisms of tissue damage. One, which involves lipid peroxidation, is blocked by the free radical scavenger, appears to play a major role in the development of cardiomyopathy. The other, which may involve binding of ADM to DNA, appears to be the major determinant of ADM toxicity for tumor cells. So the antitumor efficiency of ADM may be dissociated from its side effect of 相似文献
15.
16.
17.
SONG Yu JIANG Feng WANG Da-cheng ZHU Tong-fei HAN Xiao-hu ZHAO Wen-jie DENG Xu-ming 《中国临床药理学与治疗学》2007,12(10):1189-1189
华蟾毒精对小鼠免疫功能影响的体外研究@宋宇$College of Animal Science and Veterinary Medicine,Jilin University!Changchun 130062,Jilin,China;National Standard Laboratory of Pharmacology for Traditional Chinese Medicine, Jilin Natural Pharmatech Co.Ltd, Chang 相似文献
18.
《Saudi Pharmaceutical Journal》2022,30(12):1725-1735
BackgroundVaccine adverse event reporting system (VAERS) was established in the United States (U.S.) as an early warning system with a main purpose of collecting post-marketing Adverse events following immunizations (AEFIs) reports to monitor the vaccine safety and to mitigate the risks from vaccines. During the coronavirus diseases 2019 (COVID-19) pandemic, VAERS got more attention as its important role in monitoring the safety of the vaccines. The aim of this study was to investigate VAERS patterns, reported AEFI, vaccines, and impact of different pandemics since its inception.MethodsThis was an observational study using VARES data from 2/7/1990 to 12/11/2021. Patterns of reports over years were first described, followed by a comparison of reports statistics per year. Furthermore, a comparison of incidents (death, ER visits, etc.) statistics over years, in addition to statistics of each vaccine were calculated. Moreover, each incident's statistics for each vaccine were calculated and top vaccines were reported. All analyses were conducted using R (Version 1.4.1717) and Excel for Microsoft 365.ResultsThere were 1,396,280 domestic and 346,210 non-domestic reports during 1990–2021, including 228 vaccines. For both domestic and non-domestic reports, year of 2021 had the highest reporting rate (48.52 % and 70.33 %), in addition a notable change in AEFIs patterns were recorded during 1991, 1998, 2000, 2006, 2009, 2011, and 2017. AEFIs were as follow: deaths (1.00 % and 4.08 %), ER or doctor visits (13.37 % and 2.27 %), hospitalizations (5.84 % and 27.78 %), lethal threat (1.42 % and 4.38 %), and disabilities (1.4 % and 7.96 %). Pyrexia was the top reported symptom during the past 31 years, except for 2021 where headache was the top one. COVID-19 vaccines namely Moderna, Pfizer-Biontech, and Janssen were the top 3 reported vaccines with headache, pyrexia, and fatigue as the top associated AEFIs. Followed by Zoster, Seasonal Influenza, Pneumococcal, and Human papillomavirus vaccines.ConclusionsThe large data available in VARES make it a useful tool for detecting and monitoring vaccine AEFIs. However, its usability relies on understating the limitations of this surveillance system, the impact of governmental regulations, availability of vaccines, and public health recommendations on the reporting rate. 相似文献
19.
20.