ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

IntroductionA study of the consumer's understanding of the product label instructions and the resulting product use were conducted to support the switch of a product from prescription to nonprescription status. H2receptor antagonists have recently been approved for nonprescription use. This study evaluated the consumer's understanding of the product label for ranitidine hydrochloride (Zantac 75) and the product usage pattern in the treatment of episodic heartburn.ObjectivesOur objectives were to evaluate each aspect of the communication of labeled indications, contraindications, and directions for use of two label formats (old and new) for a new nonprescription preparation of ranitidine (Zantac) and to evaluate nonprescription consumers' use of ranitidine 75-mg tablets (as Zantac 75) in a medically unsupervised, at-home setting to observe whether these consumers used the product appropriately and followed directions as written on the package label.MethodsAdult male and female consumers (n = 1405) in a shopping mall environment who were attracted to a poster asking, “Do you have stomach problems?” were recruited for the label comprehension phase (two different label formats) and the 3-week usage phase if after reading the Zantac 75 package label they decided the product was appropriate for them. No instructions regarding the use of Zantac 75 were provided beyond what was printed on the package label. Subjects recorded use in a diary and tablet counts were performed at the end of the study period. A medical history was also taken at this time and an assessment of product use was performed by a physician.ResultsIn at least 84% of all subjects, both formats were effective in the communication of label objectives for the contraindication against concurrent prescription stomach ulcer medication, maximum daily dose, and maximum duration of dosing at maximum daily doses. The direction to take one tablet per dose was adhered to by 90% of consumers, and 90% of consumers followed the instructions to take no more than two tablets in 24 hours. Ninety-six percent of consumers complied with the direction not to take the maximum daily dose for more than 14 consecutive days. Notably, the maximum daily dose was taken for ≤3 consecutive days by 79% of consumers. The most frequently reported adverse events were headache, acute nasopharyngitis, upper respiratory tract infection, diarrhea, nausea, and menstrual cramps.ConclusionThe study demonstrated that the vast majority of a large sample of unsupervised consumers understood the package label and fully complied with the package directions by not exceeding the maximum daily dosage and length of use. Nonprescription consumers safely used Zantac 75 without medical supervision.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

BackgroundMany Americans have heartburn or related symptoms monthly and >20% experience heartburn at least once per day. Although many self-treat episodic heartburn with nonprescription antacids, newer treatments that decrease gastric volume and increase the pH of refluxed material are proving effective and popular in relieving heartburn.AimTo evaluate the safety and efficacy of low-dose regimens of ranitidine for the relief of heartburn.MethodsAdults with at least a 3-month history of heartburn were eligible for this randomized, double-blind, parallel group, multicenter dose-ranging study. Following a 1-week, open-label run-in phase to document baseline heartburn frequency, subjects were randomly assigned to receive treatment with one tablet of either ranitidine, 75 mg (n = 537); ranitidine, 25 mg (n = 539); or placebo (n = 544), to be taken as needed up to four times daily for 2 weeks for the relief of heartburn.ResultsThe ranitidine 75-mg regimen was statistically (P< 0.05) and clinically (as defined a priori as ≥10% improvement) more effective than placebo in relieving episodic heartburn and in reducing antacid consumption. Ranitidine, 25 mg, was also statistically superior (P< 0.05) to placebo in providing heartburn relief. In addition, both regimens were superior to placebo in providing heartburn relief within 30 to 45 minutes of dosing. Ranitidine continued to be as effective over placebo in the treatment of the last heartburn episode as in the treatment of the first heartburn episode. Ranitidine was also equally effective over placebo in the treatment of mild, moderate, and severe episodes of heartburn. Ranitidine, 75 mg, was statistically superior to placebo for the relief of nocturnal heartburn episodes, whereas ranitidine, 25 mg, was not. All treatments were well tolerated and adverse events occurred no more frequently with the ranitidine regimens than with placebo.ConclusionsLow-dose ranitidine provides prompt and lasting relief of heartburn and has a safety profile comparable to that of placebo.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

Octreotide is a somatostatin analogue that has been suggested as a therapeutic agent in various diverse disease processes including gastrointestinal bleeding, pancreatitis, hypoglycemia related to hyperinsulin states, and chylous peritoneum/thorax. Despite successful use in the adult population, there is limited information concerning its use in pediatric patients. The authors retrospectively review their experience with octreotide in 10 infants and children ranging in age from 14 days to 17 years. Octreotide, administered by continuous intravenous infusion or intermittent bolus dosing, was used in the treatment of gastrointestinal bleeding in four patients, pancreatitis in three patients, chylous leaks in two patients, and hypoglycemia related to nesidioblastosis in one patient. The clinical course of these patients and the potential therapeutic impact of octreotide are evaluated. Additionally, previous experiences with octreotide in pediatric patients, dosing regimens, and the potential role of the drug in other disease processes are discussed.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

The authors investigated the effects of 2,4,6-trihydroxy-&agr;-p-methoxyphenylacetophenone (compound D-58), a potent inhibitor of protein tyrosine kinases SYK and Bruton's tyrosine kinase (BTK), on IgE receptor/FcϵRI-triggered mast cell–mediated acute allergic responses in vitro and in vivo. Compound D-58 abrogated IgE receptor/FcϵRI–mediated SYK and BTK activation as well as calcium mobilization in mast cells. Mast-cell degranulation and leukotriene (LT) C4release was inhibited by compound D-58 in a concentration-dependent fashion. Notably, compound D-58 prevented the mast cell mediator–induced vascular hyperpermeability in an in vivo murine model of passive cutaneous anaphylaxis as measured by the prevention of extravasation of systemically administered Evans blue dye. The results uniquely indicate that compound D-58 has potent antiallergic properties. Therefore, further development of compound D-58 may provide the basis for new and effective treatment programs for severe allergic disorders.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

The absorption of dietary calcium (Ca) may in part be determined by the formation in the intestinal lumen of soluble Ca complexes and insoluble Ca salts. This study was undertaken to test the assumption that ionic Ca concentration (Ca2+) is the only species of Ca that is available for absorption. Bidirectional steady-state Ca fluxes were measured in vitro under short-circuit conditions across segments of the proximal duodenum and the cecum in the presence and absence of varying concentrations of soluble Ca citrate complexes. The presence of 5.0 mmol/L medium citrate reduced medium Ca2+and cecal Ca mucosal-to-serosal fluxes (Jms) (29 ± 18 versus 108 ± 7 nmol Ca/cm2/h,P< .001), but did not reduce duodenal Ca Jms (31 ± 5 versus 23 ± 9,Pnot significant). Duodenal Ca Jms increased 106% as medium Ca citrate complex increased to 1.018 mmol/L and Ca2+remained constant; cecal Jms increased by 48% under the same conditions. The formation of soluble Ca organic anion complexes with lactate, malate, and fumarate reduced medium Ca2+and cecal Ca Jms decreased with the reduction of medium Ca2+. The results of this study indicate that Ca2+is the form of Ca most readily absorbed by the small intestine and the colon. Soluble Ca citrate complexes are absorbed by the duodenum and, to a much lesser extent, by the cecum. The reduction of Ca Jms by citrate is caused by the reduction of medium Ca2+through formation of Ca citrate complexes and not caused by a direct interaction of the anion with the intestinal epithelium.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

Pain of multiple etiologies remains a substantial problem for many patients presenting in the clinical setting. Improved pain relief can be demonstrated, and adverse effects minimized, by multimodal analgesic combinations as the method to improve pain treatment. Substantial evidence supports combining analgesics for the management of pain and, in some instances, they have a heterogenous pharmacologic sparing effect. Fixed-dose combination analgesics with demonstrated efficacy and safety are widely useful for pain management. However, work needs to continue to further explore which analgesics at which doses can be combined with a coanalgesic in a patient-specific manner to achieve additive, if not synergistic, multimodal pain relief with the fewest possible adverse consequences. Unsupervised consumption of over-the-counter drugs that contain acetaminophen, aspirin, or ibuprofen offers clinical challenges to both the patient and health care providers. Couple this often undisclosed over-the-counter medication consumption event with prescription medications, which many contain similar combination ingredients, and the potential for a therapeutic misadventure may precipitate. This article will address the safety and efficacy of acetaminophen, aspirin, and ibuprofen independently and in combination with currently available prescription dosage forms with a focus on pharmacology, pharmacotherapeutics, pharmacodynamics, and pharmacokinetics, including drug interactions at the CYP450 system. Patient-specific cautions are presented for opiate/opioid combinations, codeine, hydrocodone, oxycodone, and propoxyphene, and there is a discussion of COX I/COX II agents.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

摘要:

Despite undisputed clinical benefit of platelet inhibitors in an acute interventional setting, chronic antiplatelet treatment with aspirin and clopidogrel have shown a moderate reduction of approximately 18% in the prevention of myocardial infarction and stroke. More recent data on the effect of combining the two compounds leading to an irreversible blockade of cyclooxygenase as well as the adenosine diphosphate receptor showed increased protection from cardiac events in patients with unstable angina and no significant protection from stroke. This improvement did come with the price of a significant increase in major bleeding, requiring hospitalization or transfusion. Furthermore, the most potent inhibition of platelet aggregation by blocking the binding of fibrinogen to activated platelets did not further improve the clinical outcome. All major clinical investigations of the effect of chronic administration have been recently terminated owing to an overall increased mortality rate for the entire class of drugs of orally active fibrinogen receptor antagonists. This poses the question of whether measuring platelet aggregation in vitro and ex vivo can serve as an adequate surrogate parameter to select antithrombotic therapy, particularly in the chronic setting. When evaluating the importance of other endogenous antithrombotic defense systems, the test for inhibition of platelet aggregation must fail. The importance of the endogenous defense systems is easily demonstrated by in vivo studies of thrombus formation in smaller vessels. The rapid and well-balanced interaction of local prothrombotic as well as antithrombotic factors is key in keeping the process confined. By carefully shifting this balance with antiplatelet therapy in combination with therapy to amplify the endogenous antithrombotic defense systems, a far more pronounced overall antithrombotic therapeutic effect can be demonstrated. By employing more complex antithrombotic tests performed in vivo, this balance can be studied. These studies confirm the importance of the ratio of two independent antithrombotic treatments when given together, which was not reflected in in vitro tests but was found to correlate with clinical outcome data. The attention in selecting antithrombotic treatment is to be shifted from approaches only directed toward the inhibition of platelets to an antithrombotic treatment, which includes amplification of the local therapeutic effects often mediated through the vessel wall.

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID

ISSN:1075-2765    

出版商:OVID    

年代:2001

数据来源: OVID