Abstract:
OBJECTIVE:Intragastric pH-metry is widely used to evaluate the efficacy of antisecretory drugs, but statistical interpretation of the measurements has not yet been standardised. METHODS:The effects of single morning (N = 9) or evening (N = 7) doses of the H2-receptor antagonist famotidine, 20 mg (QUAMATELR. Gedeon Richter, Hungary) were compared by 24-hour intragastric pH-metry in hyperacid patients, in a prospective, controlled clinicopharmacological study. Intragastric pH was repeatedly measured with or without administration of famotidine, and ¿1¿ the minute to minute median pH values were calculated. RESULTS:¿2¿ Both treatments significantly reduced gastric acidity according to the "traditional" parameters of the time at pH > or = 3, or median pH in the first 12 hours. Famotidine treatment in the evening was more effective than in the morning (634 vs 463 min or 5.22 vs 3.10). The morning and evening treatment groups did not differ from each other in these parameters when compared on the days without famotidine. ¿3¿ After demonstration of the significant differences between the treatment vs control days, and morning vs evening administrations we applied the Pattern Recognition by Independent Multicategory Analysis (PRIMA) method to select the most sensitive parameters for evaluation of the H2-receptor antagonist drug effect. The PRIMA method was developed to determine the sensitivity of each statistical parameter analysed in a comparison of different groups (discriminating power), and to determine the separability of groups using several parameters concomitantly (separation of groups). The mean pH, the period at pH > or = 3, and the duration of pH-increase > or = 1 on the day of treatment compared to the control day were found to be the most sensitive parameters both in demonstrating H2-receptor antagonist effect and in differentiation of morning and evening doses. ¿4¿ High separability of morning and evening treatment groups was achieved using these three parameters concomitantly according to the PRIMA method. CONCLUSION:This method may be of value in other clinical or clinicopharmacological trials to standardise the statistical analysis of data by selection of the most sensitive parameters for comparison of the patient groups. In subsequent studies it might also increase the sensitivity of discrimination by concomitant analysis of different parameters using the smallest appropriate number of patients.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Hunyady B,Juricskay I,Nagy L,Garamszegi M,Vincze A,Mózsik Gdoi
10.1007/s002280050139subject
Has Abstractpub_date
1996-01-01 00:00:00pages
449-56issue
6eissn
0031-6970issn
1432-1041journal_volume
50pub_type
临床试验,杂志文章abstract:OBJECTIVE:Pharmacokinetic parameters are important for dose adjustment of aminoglycosides, but they are highly variable in neonates. In this study the pharmacokinetics of a netilmicin loading dose was investigated on the first postnatal day in preterm neonates with very low gestational age (GA). METHODS:In an open pro...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-006-0153-8
更新日期:2006-09-01 00:00:00
abstract:PURPOSE:This study investigated the effects of clotrimazole troche on the risk of transplant rejection and the pharmacokinetics of tacrolimus. METHODS:The data mining approach was used to investigate whether the use of clotrimazole increased the risk of transplant rejection in patients receiving tacrolimus therapy. Pa...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-019-02770-6
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequenc...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-010-0987-y
更新日期:2011-06-01 00:00:00
abstract::Since 1988, the German Embryotox institute combines individual counselling of pregnant women and their health care providers (HCP) with research on drug safety in pregnancy. In addition, Embryotox offers web-based information which covers the most important and most frequently requested pharmaceutical substances. In c...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-017-2351-y
更新日期:2018-02-01 00:00:00
abstract::The kinetics of triamterene and its active phase II metabolite were studied in 32 patients with various degrees of impaired renal function; the creatinine clearances ranged from 135 to 10 ml/min. The area under the plasma concentration-time curves (AUC) for triamterene were not influenced by kidney function, but the A...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00609885
更新日期:1983-01-01 00:00:00
abstract::The presence of a possible correlation between changes in left ventricular mass of hypertensive patients and the degree of blood pressure reduction with different antihypertensive drugs has been investigated in 40 outpatients by M-mode echocardiography. Ten of these, with blood pressure in normal limits with different...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF00556886
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:We investigated whether interindividual differences in the pharmacokinetic disposition of lansoprazole are attributed to the genetic polymorphism of CYP2C19 which occurred by two mutations. CYP2C19m1 and CYP2C19m2, in 20 Japanese subjects. METHODS:Polymerase chain reaction (PCR) restriction fragment length p...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280050307
更新日期:1997-01-01 00:00:00
abstract:PURPOSE:Intravenous (IV) magnesium sulfate (MgSO4) is used as adjunct therapy to treat acute asthma exacerbations. Despite its clinical use, there is a limited understanding of the disposition of magnesium in children. METHODS:To explore the pharmacokinetics (PK) of IV MgSO4 in this population, we collected retrospect...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-016-2165-3
更新日期:2017-03-01 00:00:00
abstract:OBJECTIVES:Designing a safe medication process requires the ability to model its reliability using methods such as probabilistic risk assessment (PRA). However, lack of data, especially on human-error probabilities (HEPs), limits its use. To assess whether small-scale simulations could help generate HEP data, a pilot s...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-007-0319-z
更新日期:2007-08-01 00:00:00
abstract::In a double-blind, placebo-controlled study nasal saline and histamine provocation tests were performed in patients with perennial allergic rhinitis in order to assess changes in eosinophil influx and non-specific nasal reactivity after 8 days of treatment with ipratropium bromide. A "nasal pool" method was used to tr...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/BF02440856
更新日期:1993-01-01 00:00:00
abstract:OBJECTIVE:To study the effects of possible interactions between levosimendan and warfarin on pharmacokinetics and pharmacodynamics. Furthermore, the effects of levosimendan on blood coagulation were investigated. METHODS:Open, randomised cross-over design with two treatment phases was used. During one phase, levosimen...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/s002280000204
更新日期:2000-12-01 00:00:00
abstract:PURPOSE:The use of melatonin is increasing among Swedish children and adolescents despite deficient knowledge of usage in these groups. The aim of this study was to investigate the use of melatonin in Swedish children and adolescents according to age, gender, dosage, treatment duration, and use of attention deficit hyp...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-015-1866-3
更新日期:2015-07-01 00:00:00
abstract:PURPOSE:To investigate possible differences in the time course of vasodilating effects of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) in humans. METHODS:We measured forearm blood flow (FBF) by strain gauge plethymography and cyclic GMP spillover during and after intra-arterial infusions of BNP...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-008-0516-4
更新日期:2008-09-01 00:00:00
abstract:OBJECTIVES:To study the frequency of corticosteroid therapy and the use of inpatient care for preschool children with wheezing in two regions in Finland. METHODS:The Finnish Social Insurance Institution database on refundable asthma medication indicated that 1.18% of children in Tampere and 2.37% in Turku used inhaled...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280000199
更新日期:2000-11-01 00:00:00
abstract::The disposition of oral metoprolol was studied in 5 women during the last trimester of pregnancy and 3 to 5 months after delivery. After a single oral dose of 100 mg the individual peak plasma concentration in the pregnant state was only 20-40% of that after pregnancy. The plasma half-lives of metoprolol were about th...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00613820
更新日期:1983-01-01 00:00:00
abstract::Ten healthy subjects took single oral doses of placebo, 8.8 +/- 1.8 mg motapizone, 40 +/- 13 mg captopril, 25 mg dihydralazine, 20 mg nifedipine and 4.5 +/- 1.1 mg prazosin in random order, and, as the last preparation 500 mg acetylsalicylic acid. Thrombocyte aggregation induced "ex-vivo" with collagen, ADP and adrena...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF00613515
更新日期:1986-01-01 00:00:00
abstract:PURPOSE:This exploratory study was aimed at elucidating the pharmacogenetics of regulatory nuclear receptors (PXR, CAR, RXRα and HNF4α) and their implications on docetaxel pharmacokinetics and pharmacodynamics in local Chinese nasopharyngeal cancer patients. METHODS:A total of 59 single nucleotide polymorphisms (SNPs)...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-013-1596-3
更新日期:2014-02-01 00:00:00
abstract::Drug shortages in developed countries pose a serious public health problem and have far-reaching implications for healthcare providers and their patients. Given the current state of the market, with the limited number of manufacturers and the array of manufacturing quality issues, drug shortages have become a global c...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1007/s00228-014-1747-1
更新日期:2014-12-01 00:00:00
abstract::Ten patients with moderate to severe Raynaud's syndrome were recruited into a four week randomised double blind crossover study to compare the efficacy of UK-38,485 50 mg, a new thromboxane synthetase inhibitor with that of placebo. With the doses used there was no significant difference between the two treatment peri...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1984-01-01 00:00:00
abstract:PURPOSE:It is well known that CPT-11 (irinotecan) is biotransformed to its active metabolite, SN-38, by carboxylesterase in the liver and other tissues. However, little is known about its pharmacokinetics (PK) when administered intraperitoneally. The aim of our study was to develop a population pharmacokinetic model fo...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-010-0885-3
更新日期:2010-12-01 00:00:00
abstract::We have assessed the effect of omeprazole on various endocrine functions in man. Eight healthy subjects took 60 mg omeprazole or placebo daily for 1 week in a double-blind, randomized, cross-over study. On Day 7 basal concentrations of follicle-stimulating hormone (FSH), luteinising hormone (LH), prolactin, testostero...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF00543980
更新日期:1987-01-01 00:00:00
abstract::The kinetics of mefloquine were studied in 12 healthy Thai male and 12 healthy Thai female volunteers. Mefloquine (MQ) was administered either alone (750 mg orally) or in combination (MSP) with sulphadoxine (1.5 g) and pyrimethamine (75 mg) to each of 6 male and 6 female subjects. Plasma concentrations of MQ were meas...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00542191
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:Psychosis is a common complication of the drug treatment of Parkinson's disease (PD). Treatment of this complication is difficult as most antipsychotic drugs worsen motor symptoms of PD. Only the atypical antipsychotic clozapine improves psychosis without worsening of parkinsonism. The aim of the present stud...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-002-0441-x
更新日期:2002-05-01 00:00:00
abstract::As a target group, geriataric patients were selected for pharmacokinetic studies with terodiline (Mictrol), an anticholinergic and calcium antagonist drug effective in the treatment of urinary incontinence. The single-dose kinetics in the geriatric patients (mean age 82 years) differed significantly from that previous...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00540958
更新日期:1988-01-01 00:00:00
abstract::In a model of mental stress the influence of nifedipine and hydrochlorothiazide on stress-induced changes in blood pressure, heart rate, and plasma catecholamines was studied in normal persons. The drugs were used to investigate whether substances with antihypertensive but no particular sympatholytic properties were c...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00544008
更新日期:1983-01-01 00:00:00
abstract:OBJECTIVE:The extrapolated area under the concentration-time curve (AUC0-infinity) for any drug is considered by operating guidelines as the primary parameter related to the extent of absorption in single-dose bioavailability and bioequivalence trials. Not more than 20% should be added to the experimental AUC (AUC0-t) ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280050684
更新日期:1999-11-01 00:00:00
abstract::Atenolol 100 mg and penbutolol 40 mg given once a day were both effective in controlling moderate hypertension, as judged by a randomised controlled, double-blind trial in 45 patients treated for six weeks. Both drugs significantly reduced the resting supine and erect blood pressures. No serious adverse effects could ...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF00637507
更新日期:1981-01-01 00:00:00
abstract::Blood levels of racemic chloroquine and its main metabolites desethylchloroquine and bisdesethylchloroquine were measured in 29 patients treated chronically for rheumatoid arthritis. In six patients, the concentrations were followed during a one day dosage interval. There was considerable intersubject variability in t...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00280130
更新日期:1992-01-01 00:00:00
abstract:PURPOSE:The use of surgical antibiotic prophylaxis (SAP) in children is poorly characterized. Our aim was to evaluate the effectiveness of a quality improvement (QI) intervention targeting SAP in children, by means of a multicenter prospective intervention study, with a before and after design. METHODS:We prospectivel...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/s00228-017-2270-y
更新日期:2017-09-01 00:00:00
abstract::The pharmacokinetics, hypotensive effect and tolerability of a new vasodilator, tolmesoxide (T), have been studied in 6 uncontrolled hypertensive patients receiving atenolol and diuretic. After a 50 mg oral dose mean (+/- SD) peak plasma concentration of T was 1.13 +/- 0.29 micrograms/ml-1 and occurred 0.79 +/- 0.40 h...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00568397
更新日期:1981-01-01 00:00:00