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51.
Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH)
Marketing authorisations for medicines need to be based on the universal criteria quality, safety and efficacy, whilst taking into account local public health needs. With view to using resources efficiently and avoiding delay in access to medicines, scientific standards for investigating quality, safety and efficacy should be universal too. A major step to achieve this was taken in 1990 when the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established between authorities and industry in the European Union (EU), Japan and the United States. Since then more than 50 ICH Guidelines have been published, out of which six are specific to pharmacovigilance. They refer to management and expedited reporting of individual adverse drug reaction (ADR) cases, including electronic formats, periodic reporting of worldwide data and planning of pharmacovigilance. Their development has to be seen in the context of initiatives taken in the three ICH Regions to strengthen pharmacovigilance. Most recently this involves making use of risk management concepts, reflecting new thinking of proactivity in pharmacovigilance. Moreover, consideration is given to regional and international cooperation beyond the ICH Regions. 相似文献
52.
The effects of dopamine agonists on prepulse inhibition in healthy men depend on baseline PPI values
Rationale and objectives Dopamine (DA) agonists reliably disrupt prepulse inhibition (PPI) of the startle reflex in animals but less so in humans despite
cross-species similarities in the neural regulation of PPI. This study examines whether individual variation in baseline PPI
may account for the inconsistencies in DA agonist-induced PPI disruption in humans.
Methods Baseline PPI measures were obtained from 32 healthy adult men. Subjects were subsequently tested in three sessions after ingestion
of placebo or active drug in a balanced double-blind design. Seventeen subjects were given 0.05 and 0.1 mg of pergolide (a
direct DA agonist) and 15 subjects were given 100 and 200 mg of amantadine (an indirect DA agonist). In each treatment group,
subjects were assigned to “high” and “low” PPI subgroups based on the median split of their baseline PPI.
Results Amantadine and pergolide disrupted PPI in high- but not in low-PPI subjects. In contrast, low-PPI subjects showed a trend
towards PPI facilitation especially with pergolide.
Conclusions Our results suggest that baseline PPI is an important determinant of the effect of DA agonists on PPI. 相似文献
53.
Most cases are caused by a single mutation, paving the way for therapeutic advances for this fatal disease. 相似文献
54.
Catastrophic antiphospholipid syndrome in a 14-year-old child 总被引:2,自引:0,他引:2
Tsirpanlis G Moustakas G Sakka E Triantafyllis G Sotsiou F Liapis H Ziroyannis P 《Pediatric nephrology (Berlin, Germany)》2005,20(4):519-521
Antiphospholipid syndrome (APS) is an autoimmune disease. Less than 1% of patients with APS present with life-threatening catastrophic APS (CAPS). We report here a case of CAPS in a young girl with cardiac, gastrointestinal and renal involvement. Although the management was complicated, the outcome was better than expected. We suggest that CAPS be included in the differential diagnosis of acute renal failure in children with multi-organ involvement and prolonged phospholipid-dependent coagulation time and promptly treated with immunomodulating agents and anticoagulants. 相似文献
55.
Manios EG Kallergis EM Kanoupakis EM Mavrakis HE Kambouraki DC Arfanakis DA Vardas PE 《Chest》2005,128(4):2604-2610
STUDY OBJECTIVES: Even in high-risk population groups, not all patients have the same risk of sudden cardiac death (SCD). Given the emerging data about the amino-terminal fragment of the brain natriuretic peptide prohormone (NT-proBNP) value in heart failure, we planned to evaluate the importance of NT-proBNP levels in predicting the occurrence of malignant arrhythmias in patients with ischemic cardiomyopathy and implantable cardioverter-defibrillators (ICDs). DESIGN: Prospective study. SETTING: Tertiary referral center. PATIENTS: Thirty five ambulatory patients with previous myocardial infarction, left ventricular ejection fraction < 35%, and ICDs for primary prevention of SCD according to Multicenter Automatic Defibrillator Implantation Trial I criteria. INTERVENTIONS: Venous blood samples for plasma NT-proBNP measurement were obtained after 30 min of supine rest from all patients at the beginning of the study. Patients were evaluated every 2 months, or sooner in cases of device discharges, during a 1-year follow-up period. Data concerning arrhythmias and device therapy were stored at the time of device interrogation on each follow-up visit. MEASUREMENTS AND RESULTS: During 1-year follow-up, 11 of 35 patients (31.4%) received 18 antiarrhythmic device therapies for ventricular tachyarrhythmia (VT). Patients who experienced such arrhythmias had NT-proBNP levels of 997.27 +/- 335.14 pmol/L (mean +/- SD), whereas those without VT had NT-proBNP levels of 654.87 +/- 237.87 pmol/L (p = 0.001). An NT-proBNP cutoff value of 880 pmol/L had a sensitivity of 73%, a specificity of 88%, a positive predictive value of 80%, and a negative predictive value of 88% for the prediction of occurrence-sustained VT events. CONCLUSION: To achieve the maximum benefit by ICD therapy, more precise risk stratification is required, even in high-risk, post-myocardial infarction patients. Plasma NT-proBNP levels comprise a promising method that could help in the better identification of a patient group with an even higher risk of sudden death. 相似文献
56.
The aim of this study was to evaluate the short-term impact of a group crisis intervention for children aged 9-15 years from five refugee camps in the Gaza Strip during ongoing war conflict. Children were selected if they reported moderate to severe posttraumatic stress reactions, and were allocated to group intervention (N=47) encouraging expression of experiences and emotions through storytelling, drawing, free play and role-play; education about symptoms (N=22); or no intervention (N=42). Children completed the CPTSD-RI and the CDI pre- and post-intervention. No significant impact of the group intervention was established on children's posttraumatic or depressive symptoms. Possible explanations of the findings are discussed, including the continuing exposure to trauma and the non-active nature of the intervention. 相似文献
57.
Surgical and radiological management of uterine fibroids--a UK survey of current consultant practice
Taylor A Sharma M Tsirkas P Arora R Di Spiezio Sardo A Mastrogamvrakis G Buck L Oak M Magos A 《Acta obstetricia et gynecologica Scandinavica》2005,84(5):478-482
BACKGROUND: The aim of this study was to determine the current surgical and radiological management of uterine fibroids by consultants working in the UK. METHODS: A structured questionnaire was posted to all 1439 UK consultants. Non-responders were sent one reminder. The main outcome measures were surgical route and technique used for myomectomy, and the use and availability of uterine artery embolization (UAE). RESULTS: Eight hundred fifty-two (59%) consultants replied. Seven hundred thirty-five (86%) admitted to regular sessions of gynecologic surgery, and 75% of this group performed open myomectomy, 16% laparoscopic myomectomy, and 66% hysteroscopic myomectomy. Open myomectomy: Forty-one percent of consultants performed open surgery on uteri equivalent to 12-week gestational age or less, 87% prescribed preoperative gonadotrophin-releasing hormone agonists (GnRHa) in order to reduce surgical bleeding, with 35% using myomectomy clamps, 23% tourniquets, and 19% vasoconstrictors. Laparoscopic myomectomy: The largest uterine size the majority would attempt was equivalent to a 12-week gestation, 58.6% used preoperative GnRHa, 21% used intraoperative vasoconstrictors, and 1.4% tourniquets in order to minimize bleeding. Hysteroscopic myomectomy: As with laparoscopic myomectomy, the largest uterine size the majority would attempt was equivalent to a 12-week pregnancy. Blood transfusion: Twenty per cent, 10%, and 7% reported the need for blood transfusion in up to 10% of patients undergoing open, laparoscopic, or hysteroscopic myomectomy, respectively. UAE: Fifty-one percent have access to UAE and 40% have referred at least one patient in 2001. CONCLUSIONS: Open and hysteroscopic myomectomy are frequently utilized in contrast to laparoscopic myomectomy. The reported rate of blood transfusion appears low. Although UAE is widely available, the majority of patients are still managed surgically. 相似文献
58.
59.
T2 relaxation time analysis in patients with multiple sclerosis: correlation with magnetization transfer ratio 总被引:1,自引:0,他引:1
Papanikolaou N Papadaki E Karampekios S Spilioti M Maris T Prassopoulos P Gourtsoyiannis N 《European radiology》2004,14(1):115-122
The aim of the current study was to perform T2 relaxation time measurements in multiple sclerosis (MS) patients and correlate them with magnetization transfer ratio (MTR) measurements, in order to investigate in more detail the various histopathological changes that occur in lesions and normal-appearing white matter (NAWM). A total number of 291 measurements of MTR and T2 relaxation times were performed in 13 MS patients and 10 age-matched healthy volunteers. Measurements concerned MS plaques (105), NAWM (80), and dirty white matter (DWM; 30), evenly divided between the MS patients, and normal white matter (NWM; 76) in the healthy volunteers. Biexponential T2 relaxation-time analysis was performed, and also possible linearity between MTR and mean T2 relaxation times was evaluated using linear regression analysis in all subgroups. Biexponential relaxation was more pronounced in black-hole lesions (16.6%) and homogeneous enhancing plaques (10%), whereas DWM, NAWM, and mildly hypointense lesions presented biexponential behavior with a lower frequency(6.6, 5, and 3.1%, respectively). Non-enhancing isointense lesions and normal white matter did not reveal any biexponentional behavior. Linear regression analysis between monoexponential T2 relaxation time and MTR measurements demonstrated excellent correlation for DWM(r=–0.78, p<0.0001), very good correlation for black-hole lesions(r=-0.71, p=0.002), good correlation for isointense lesions(r=–0.60, p=0.005), moderate correlation for mildly hypointense lesions(r=–0.34, p=0.007), and non-significant correlation for homogeneous enhancing plaques, NAWM, and NWM. Biexponential T2 relaxation-time behavior is seen in only very few lesions (mainly on plaques with high degree of demyelination and axonal loss). A strong correlation between MTR and monoexponential T2 values was found in regions where either inflammation or demyelination predominates; however, when both pathological conditions coexist, this linear relationship is lost. 相似文献
60.
Genetic variation near the hepatocyte nuclear factor-4 alpha gene predicts susceptibility to type 2 diabetes 总被引:15,自引:0,他引:15
Silander K Mohlke KL Scott LJ Peck EC Hollstein P Skol AD Jackson AU Deloukas P Hunt S Stavrides G Chines PS Erdos MR Narisu N Conneely KN Li C Fingerlin TE Dhanjal SK Valle TT Bergman RN Tuomilehto J Watanabe RM Boehnke M Collins FS 《Diabetes》2004,53(4):1141-1149
The Finland-United States Investigation Of NIDDM Genetics (FUSION) study aims to identify genetic variants that predispose to type 2 diabetes by studying affected sibling pair families from Finland. Chromosome 20 showed our strongest initial evidence for linkage. It currently has a maximum logarithm of odds (LOD) score of 2.48 at 70 cM in a set of 495 families. In this study, we searched for diabetes susceptibility variant(s) at 20q13 by genotyping single nucleotide polymorphism (SNP) markers in case and control DNA pools. Of 291 SNPs successfully typed in a 7.5-Mb interval, the strongest association confirmed by individual genotyping was with SNP rs2144908, located 1.3 kb downstream of the primary beta-cell promoter P2 of hepatocyte nuclear factor-4 alpha (HNF4A). This SNP showed association with diabetes disease status (odds ratio [OR] 1.33, 95% CI 1.06-1.65, P = 0.011) and with several diabetes-related traits. Most of the evidence for linkage at 20q13 could be attributed to the families carrying the risk allele. We subsequently found nine additional associated SNPs spanning a 64-kb region, including the P2 and P1 promoters and exons 1-3. Our results and the independent observation of association of SNPs near the P2 promoter with diabetes in a separate study population of Ashkenazi Jewish origin suggests that variant(s) located near or within HNF4A increases susceptibility to type 2 diabetes. 相似文献