International journal of clinical pharmacology research最新文献

{"title":"Kineret: efficacy and safety in daily clinical practice: an interim analysis of the Kineret response assessment initiative (kreative) protocol.","authors":"H E Langer,&nbsp;B Missler-Karger","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Data from 166 patients who had completed 6 months of anakinra (Kineret, r-metHuIL-1Ra) therapy under the conditions of daily clinical practice showed an efficacy and safety profile comparable to the data known from clinical trials. Patients significantly responded as early as 1 month following initiation of therapy. The data suggest that anakinra may also be effective in patients who have failed tumor necrosis factor (TNF)-blocking agents. Injection-site reactions were reported less frequently than in clinical trials, indicating that these reactions seem to require less therapeutic attention under non-clinical trial conditions.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 4","pages":"119-28"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24590447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Calcipotriol ointment versus cream in psoriasis vulgaris.","authors":"G Duweb,&nbsp;S Aldebani,&nbsp;A Elzorghany,&nbsp;M Benghazil,&nbsp;J Alhaddar","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Psoriasis is a multifactorial, chronically relapsing, inflammatory skin disease occurring in 1-3% of the world's population. Vitamin D3 analogs have effects on proliferation and differentiation, as well as on the infiltration and activation of neutrophils and immunocytes in psoriatic skin lesions. This study aims to assess the efficacy and safety of topical calcipotriol and to compare ointment and cream formulations in the treatment of psoriasis vulgaris. A total of 41 patients with mild to moderate psoriasis vulgaris (18 men and 23 women aged between 5 and 63 years) were enrolled in the study. Each patient was instructed to apply the treatment twice daily over the psoriatic lesions. Routine blood tests and serum calcium were performed prior to and at the end of treatment. Treatment assessment was carried out on weeks 2, 4 and 6 and was based on the Psoriasis Area and Severity Index (PASI) score. Of the 41 patients included in our study, only 29 completed the treatment course. Their PASI before treatment ranged from 1.2 to 43 (mean: 12.1). Both groups, calcipotriol 50 microg/g ointment (11 patients) and calcipotriol 50 microg/g cream (18 patients) showed time-dependent improvement and after 6 weeks there was excellent improvement with a marked reduction in the total mean PASI from 12.1 to 1.02. There was a significant reduction of PASI in the ointment group in comparison with the cream group (mean PASI from 12.7 to 0.8 and 11.1 to 1.15, respectively). No significant adverse effects were observed in either group, except for mild irritation in a few patients in the calcipotriol cream group. In conclusion, calcipotriol was effective, safe and well tolerated in the treatment of psoriasis vulgaris and better results were observed with the ointment formulation. Longer treatment courses could be advised.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 2-3","pages":"47-51"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40838962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The acute effect of orlistat on endothelial function in young obese women.","authors":"C Sekuri,&nbsp;T Tavli,&nbsp;A Avsar,&nbsp;H Sozcuer,&nbsp;B S Uyanik,&nbsp;Z Ari","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Recent studies indicate that abdominal fat accumulation is related to impaired endothelial function in young healthy volunteers. The aim of this study was to determine the acute effect of gastrointestinal lipase inhibitor on brachial flow-mediated vasodilatation and hemodynamic parameters in young obese women. The study population was composed of 42 female obese patients (mean age 29 +/- 4 years, age range between 18 and 34 years). Flow-mediated endothelial-dependent vasodilatation was assessed in the brachial artery in response to reactive hyperemia using high-resolution ultrasound. Brachial artery diameter (3.46 +/- 0.72 mm to 3.82 +/- 0.84 mm) and flow-mediated vasodilation (7.6 +/- 0.8% to 9.8 +/- 1.6%) changed significantly after 12 weeks of therapy (p < 0.001). Brachial artery flow was not changed (124 +/- 92 ml/min to 148 +/- 14 ml/min, p > 0.05). The results of this study demonstrate that orlistat improved endothelial function, weight, body mass index and systolic and diastolic blood pressure in young women.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 4","pages":"111-7"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24590446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Salmeterol decreases eosinophilic cationic protein and rescue medication in patients inhaling beclomethasone dipropionate: preliminary study in mild and moderate asthma in Trinidad, West Indies.","authors":"L M Pinto Pereira,&nbsp;Y Clement,&nbsp;J Rouse,&nbsp;J Matthew,&nbsp;Z Asgarali,&nbsp;D Ramoutar,&nbsp;S Teelucksingh","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Activated eosinophils play a critical role in asthma pathogenesis, and eosinophil cationic protein (ECP) is a useful indicator of inflammation. Inhaled corticosteroids and long-acting beta2-agonists (LABA) effectively control asthma symptoms and improve airway function. Salmeterol's anti-inflammatory efficacy as add-on therapy to inhaled corticosteroids has not been evaluated in Caribbean populations. We investigated nine non-smoking subjects (three men and six women; mean age: +/- SE, 50.7 +/- 3.82 years) with stable mild and moderate persistent asthma who were inhaling > or = 500 microg beclomethasone dipropionate (BDP) daily. This was a with-in-patient controlled laboratory blind study performed over 8 weeks. Patients received BDP for 2 weeks, add-on salmeterol 100 microg in weeks 3-6 and BDP alone in weeks 7-8. Patients recorded daily morning and night symptoms. Morning peak expiratory flow rate was measured on entry to the study and with sputum ECP at the end of weeks 2, 4, 6 and 8. Salmeterol together with BDP decreased sputum ECP from a pretreatment median value of 897.84 microg/l to 628.38 microg/l after 4 weeks, and ECP continued to decrease even after salmeterol withdrawal. Both drugs decreased the frequency of rescue medication use by approximately 50% and increased the median number of days per week without rescue salbutamol from 0 to 3 days. Salmeterol's bronchoprotective effect was maximal after 4 weeks and was sustained after its withdrawal. In conclusion, this study, performed in Trinidadian asthmatics, used ECP as a surrogate marker of bronchial inflammation and supports the recent Salmeterol Multi-center Asthma Research Trial (SMART) data recommending add-on salmeterol therapy to adequate anti-inflammatory medication such as inhaled corticosteroids for optimal asthma management. Further studies are required to evaluate the anti-inflammatory efficacy and possible tolerance to salmeterol in Caribbean patients.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 2-3","pages":"69-74"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40844262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of raloxifene on lowering lipid parameters in patients with osteoporosis.","authors":"B Miskić,&nbsp;D Bistrović,&nbsp;V Cosić,&nbsp;N Leko,&nbsp;M Balen-Jandrić,&nbsp;I Balen,&nbsp;P Samardzić,&nbsp;D Miskić","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of this study was to show the effect of raloxifene on the lowering of lipid parameters in patients with osteoporosis. New investigations introduced selective estrogen receptor modulators (SERMs), such as raloxifene, as a potent drug in the lowering of lipid parameters. Raloxifene is known as a substance that works well in preventing and treating osteoporosis. We investigated the effect of raloxifene on the lowering of lipid parameters (cholesterol and triglycerides) in 94 women who took 60 mg/day of raloxifene for the treatment of osteoporosis. We performed three measurements of cholesterol and triglycerides, at the beginning of the study and at 3 and 12 months. Bone mineral density (BMD) was measured at the begining and at 12 months; spine BMD increased 2.7%. The mean value of cholesterol was 6.6961 mmol/l at the beginning, 6.060 mmol/l at 3 months and 5.826 mmol/l at 12 months. The difference between mean values was statistically significant at p < 0.01. Mean values of triglycerides were 2.153 mmol/l at the beginning, 1.970 mmol/l at 3 months and 1.680 mmol/l at 12 months. The difference between mean values at 3 months was statistically significant at p < 0.05 and at 12 months at p < 0.01. We concluded that raloxifene had significant effects on lowering cholesterol and triglycerides in postmenopausal women and that raloxifene is the best choice in the treatment of osteoporosis and moderate lipid disorders.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 4","pages":"107-10"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24590443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polyamine levels and ornithine decarboxylase activity in blood and erythrocytes in human diseases.","authors":"G Stabellini,&nbsp;C Calastrini,&nbsp;N Gagliano,&nbsp;C Dellavia,&nbsp;C Moscheni,&nbsp;L Vizzotto,&nbsp;S Occhionorelli,&nbsp;M Gioia","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Serum and erythrocyte levels of the polyamines spermine, spermidine and putrescine, as well as ornithine decarboxylase in erythrocytes, were studied in patients with different neoplasms (breast, lung and colon cancer) and in those with a nonmalignant proliferative disease (familial polyposis). The blood levels of polyamines and the spermine/putrescine ratio were significantly higher in all tumors and in nonmalignant colon polyposis. In erythrocyte ornithine decarboxylase activity, spermine and spermidine levels, as well as spermidine/putrescine and spermine/putrescine ratios showed a significant decrease after surgery and chemotherapy. Our data suggest that high levels of blood polyamines and erythrocyte ornithine decarboxylase activity are related to cell proliferation and cancer treatment, but that levels of polyamines in serum and erythrocytes are still significantly high after cancer treatment and are similar to those in polyposis disease. Polyamines are related to nuclear activity during differentiation; therefore, the altered turnover of polyamines could be a sign of abnormal nuclear function. Since polyamines stimulate protooncogene expression, their high levels could be considered an important cofactor in malignant cell transformation.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 1","pages":"17-22"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24079195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interindividual variation in the ratio between plasma morphine and its metabolites in cancer patients.","authors":"M Tateishi,&nbsp;K Ohashi,&nbsp;K Kobayashi,&nbsp;T Hashimoto,&nbsp;J Yamaguchi,&nbsp;H Fujioka,&nbsp;K Izawa,&nbsp;M Masada","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In 25 cancer patients treated with slow-release oral morphine and in 10 cancer patients treated with continuous infusion of morphine, plasma steady-state concentrations of morphine (M), morphine-3-glucuronide (M-3-G) and morphine-6-glucuronide (M-6-G) were determined by high-performance liquid chromatography. Blood samples were withdrawn at 0, 2 and 6 h after oral administration in patients treated with slow-release oral morphine and once or twice a day in patients treated with continuous infusion of morphine. In four cancer patients treated with continuous infusion of morphine, in order to analyze chronopharmacokinetic variability, the M-3-G/M ratio was observed at 12:00 h and 24:00 h. No significant changes were observed in M-3-G/M ratios and M-6-G ratios at 0, 2, and 6 h after oral administration of morphine. The M-3-G/M ratio (38.6 +/- 25.7) in the oral morphine group was significantly higher than that (15.3 +/- 12.9) in the continuous infusion group (p < 0.01). There was an approximately 10-fold interindividual variation in the M-3-G/M ratio both in the continuous infusion group and in the oral morphine group. These results suggest that the activity of UDP glucuronosyltransferase 2B7 in the intestinal metabolism of morphine may play an active part in a large interindividual variation in the ratio of metabolites to morphine. Further studies are needed to clarify this hypothesis.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 2-3","pages":"75-82"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40839502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacoeconomic analysis of osteoporosis treatment with risedronate.","authors":"J G Brecht,&nbsp;H P Kruse,&nbsp;D Felsenberg,&nbsp;W Möhrke,&nbsp;A Oestreich,&nbsp;E Huppertz","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Hip fracture is an important and costly problem. Therapy with the bisphosphonate risedronate effectively prevents hip and other fractures among women with established osteoporosis. Risedronate is a first-choice therapy option in the German Guidelines of the Dachverband Osteologie for Osteoporosis according to evidence-based medicine criteria for the treatment of postmenopausal osteoporosis, osteoporosis of the elderly (women aged > 75 years) and glucocorticoid-induced osteoporosis. There are few published economic evaluations of bisphosphonates in Germany. Therefore, an assessment of the cost-effectiveness of risedronate utilizing a state transition Markov model of established postmenopausal osteoporosis based on randomized clinical trial data was developed. Uncertainty underlying model parameters and outcomes was dealt with using traditional sensitivity analysis and stochastic sensitivity analysis to produce quasi-95% Cls. We focused on patients aged 70 years, since this population most closely matches the randomized controlled trial and is typical of osteoporosis patients in Germany. The baseline model was a cohort of 1,000 70-year-old women, who received risedronate for 3 years and were followed up for an overall observation period of 10 years, modelling transitions through estimated health states and evaluating outcomes. Over the 3-year treatment period and 10-year observation period, risedronate dominated the current average basic treatment in Germany. In the risedronate group 33 hip fractures were averted and 32 quality-adjusted life years (QALYs) were gained (discounted values). Risedronate treatment saves costs for German social insurance: the present net value of the associated costs from the perspective of German social insurance is [symbol: see text]10.66 million if risedronate treatment is used versus [symbol: see text]11 million if basic treatment is used. Thus, net savings of [symbol: see text]340,000 for the treatment group per 1,000 treated women were calculated. Furthermore, risedronate treatment is cost effective from the perspective of the statutory health insurance with costs per averted hip fracture in the analyzed population of [symbol: see text]33,856 and cost per QALY gained of [symbol: see text]35,690. Both results demonstrate cost-effectiveness and are far below the accepted threshold level of [symbol: see text]50,000. Based on this analysis, risedronate is a cost-effective treatment for postmenopausal osteoporosis within the German health care system, offering benefits for osteoporotic patients and for budget decision-makers.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 4","pages":"93-105"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24590441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The acute effects of cilazapril on pulmonary function tests and arterial blood gas changes in patients with pulmonary hypertension.","authors":"T Tavli,&nbsp;C Sekuri,&nbsp;T Goktalay,&nbsp;B S Uyanik,&nbsp;Z Ari","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of the present study was to evaluate pulmonary function tests and arterial oxygen transport in patients with pulmonary hypertension due to congestive heart failure before and after cilazapril treatment. Thirty patients (16 men and 14 women, mean age, 65 +/- 18 years) with congestive heart failure and 30 healthy volunteers (20 men and 10 women, mean age 59 +/- 12 years, p > 0.05) were included in the study. All patients underwent evaluation of pulmonary function by spirometry and arterial blood gas analysis. Arterial oxygen saturation and arterial oxygen transport changed significantly after treatment (81 +/- 7 to 87 +/- 8 and 317 +/- 74 to 392 +/- 8, respectively). Forced expiration volume in 1 second, vital capacity and total lung capacity were increased after cilazapril treatment (2.55 +/- 0.7 to 2.61 +/- 0.8, 3.2 +/- 0.9 to 3.3 +/- 1.0 and 3.6 +/- 0.9 to 4.1 +/- 1.1, respectively, p < 0.05). In conclusion, short-term cilazapril administration improved pulmonary function and arterial oxygen transport because it increased cardiac output, produced pulmonary vasodilatation, improved the pulmonary hemodynamics and removed interstitial fluid.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 2-3","pages":"53-9"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40839500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Docetaxel-ifosfamide combination chemotherapy in patients with metastatic hormone-refractory prostate cancer: a phase I pharmacokinetic study.","authors":"P Hervonen,&nbsp;A Jekunen,&nbsp;P Lefebvre,&nbsp;P Kellokumpu-Lehtinen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This phase I study was designed to evaluate the activity toxicity and pharmacokinetics of docetaxel combined with ifosfamide in the treatment of hormone-refractory prostate cancer. Ten patients received a median of 4.6 treatment cycles. Docetaxel was administered at a dose of 40 mg/m2 in a 1-hour infusion followed by ifosfamide 3,000 mg/m2 in a 24-hour infusion every 3 weeks. The optimal sequence of chemotherapeutic agents was investigated by reversing the order of administration in the second cycle and by collecting a total of six pharmacokinetic blood samples per cycle from all patients during the first and second cycles. The sequence of administration did not influence the pharmacokinetics of docetaxel. Prostate-specific antigen (PSA) responses were observed in four out of nine patients, with a PSA response rate of 44.4% (complete response + partial response). The treatment was well tolerated. No grade IV toxicities were recorded and grade III leucopenia resulted in dose-reductions in 6 cycles (13.3%). The pharmacokinetic parameters of docetaxel were similar in both sequences. Our recommendation for further phase II studies is ifosfamide followed by low-dose docetaxel. Further phase II efficacy studies are warranted.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"23 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24079279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}