Purpose: To assess the safety and effectiveness of ketorolac tromethamine 0.5% (Acular(R)) as a cost-efficient single agent to prevent intraoperative miosis and postoperative inflammation in cataract surgery. Methods:...
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Purpose: To assess the safety and effectiveness of ketorolac tromethamine 0.5% (Acular(R)) as a cost-efficient single agent to prevent intraoperative miosis and postoperative inflammation in cataract surgery. Methods: Both eyes of 26 patients were randomized to receive Acular preoperatively and postoperatively or flurbiprofen sodium (Ocufen(R)) preoperatively and prednisolone acetate 1% (Pred Forte(R)) postoperatively. Time scheduled between procedures was from 2 weeks to 1 month. Pupil dilation was measured preoperatively, intraoperatively, and at the end of surgery. Cell and flare were measured 1 day, 1 week, and 1 month postoperatively. Results: A comparison of the Acular and the Ocufen/Pred Forte groups (n=22) showed no statistically significant differences in dilation (preoperative versus postpostoperative) or cell and flare postoperatively. Conclusion: Using Acular as a single agent was as effective as the combination Of preoperative Ocufen and postoperative Pred Forte in preventing intraoperative miosis and postoperative inflammation in cataract surgery. The use of Acular as a single agent could save the expense of using separate anti-inflammatory and antimiotic preparations preoperatively and postoperatively, enhancing convenience for the surgeon and surgical facility. J Cataract Refract Surg 2000;26:1225-1227 (C) 2000 ASCRS and ESCRS.
In a prospective, single-blind trial, we randomized 150 consecutive symptomatic patients with acute (less than or equal to 48 hours' duration) atrial fibrillation to receive intravenous flecainide, propafenone, or...
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In a prospective, single-blind trial, we randomized 150 consecutive symptomatic patients with acute (less than or equal to 48 hours' duration) atrial fibrillation to receive intravenous flecainide, propafenone, or amiodarone. Flecainide and propafenone were administered as a bolus dose of 2 mg/kg in 20 minutes. A second bolus dose of 1 mg/kg in 20 minutes was administered if conversion to sinus rhythm was not achieved after 8 hours. Amiodarone was administered as a bolus of 5 mg/kg in 20 minutes followed by a continuous infusion of 50 mg/hour. By the end of a 12-hour observation period, conversion to sines rhythm was achieved in 45 patients (90%) in the flecainide group, 36 (72%) in the propafenone group, and 32 (64%) in the amiodarone group (p = 0.008 for the overall comparison, p = 0.002 for flecainide vs amiodarone, p = 0.022 for flecainide vs propafenone, and p 0.39 for propafenone vs amiodarone). When compared with amiodarone, this higher reversion rate with flecainide was present from the first hour of the study period. However, only after administering the second bolus was there a significant difference between flecainide and propafenone. Median time to conversion to sinus rhythm was different among groups (p <0.001), and it was lower in the flecainide (25 minutes;range 4 to 660) and propafenone (30 minutes;range 10 to 660) groups than in the amiodarone group (333 minutes;range 15 to 710;p <0.001 for both comparisons). Flecainide, at the doses administered in this study, is more effective than propafenone and amiodarone for conversion of acute atrial fibrillation to sinus rhythm. Propafenone and amiodarone have similar conversion rates, although propafenone was faster in achieving the conversion to sinus rhythm. (C)2000 by Excerpta Medica, Inc.
Background: Budesonide is a glucocorticosteroid used in the treatment of, for example, inflammatory bowel diseases, with a recommended once-daily morning dosing regimen. Ketoconazole is a potent inhibitor of the cytoc...
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Background: Budesonide is a glucocorticosteroid used in the treatment of, for example, inflammatory bowel diseases, with a recommended once-daily morning dosing regimen. Ketoconazole is a potent inhibitor of the cytochrome P450 3A (CYP3A) activities and known to inhibit the elimination of drugs metabolized by CYP3A, including budesonide. It is of therapeutic interest to know whether the influence of ketoconazole can be reduced by administration on an occasion different in time to CYP3A substrates. Methods: Eight healthy men completed this randomized, open crossover study that comprised three different periods. In period 1, a single oral dose of 3 mg budesonide was given in the morning. In period 2, a 200-mg ketoconazole tablet was administered once daily in the morning on 4 consecutive days. On the fourth day, 3 mg budesonide was administered at the same time as the ketoconazole. In period 3, 200 mg ketoconazole was administered once daily in the evening on 4 consecutive days. On the fourth day, 3 mg budesonide was administered 12 hours before the ketoconazole. One-week washout periods separated the budesonide administrations. Results: The mean area under the plasma drug concentration-time curve [AUC(0-24)] for budesonide was increased by 6.5 times when it was given simultaneously with ketoconazole. When the administrations of the two drugs were separated by 12 hours, the mean AUC(0-24) for budesonide was increased by only 3.8 times. Conclusion: This study shows that the capability of ketoconazole to inhibit the elimination of budesonide is significantly reduced (by 50%) by a 12-hour separation of the administration times.
‘Hold the Mayo’: Solid facts or pulp fiction? C. J. A. Punt Search for other works by this author on: Oxford Academic PubMed Google Scholar C. J. A. Punt Annals of Oncology, Volume 11, Issue 8, 1 August 2000, Pages ...
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‘Hold the Mayo’: Solid facts or pulp fiction? C. J. A. Punt Search for other works by this author on: Oxford Academic PubMed Google Scholar C. J. A. Punt Annals of Oncology, Volume 11, Issue 8, 1 August 2000, Pages 919–920, https://***/10.1023/A:1008324221450 Published: 01 August 2000
The uniqueness of carboplatin as a chemotherapy drug is in the fact that the systemic drug exposure produced by any dose in a patient can be reasonably estimated on the basis of his or her renal function. Calvert'...
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The uniqueness of carboplatin as a chemotherapy drug is in the fact that the systemic drug exposure produced by any dose in a patient can be reasonably estimated on the basis of his or her renal function. Calvert's formula (1) of delivering a calculated dose in terms of target carboplatin area under the time–concentration curve (AUC) and a measured or estimated glomerular filtration rate (GFR) has been widely used. Here, we describe the derivation of Calvert's formula and point out some limitations in its development, including violation of an underlying assumption of linear regression theory. We also discuss the related published literature and recommend practicing caution in its use for a high-dose setting. Calvert et al. (1) derived the dosage formula in three stages. Analysis at stage I involved a retrospective look at data from pharmacokinetic studies and produced a preliminary dosing relationship as \[{dose}/{AUC}\ {=}\ {[}1.21({\pm}0.19)\ {\times}\ GFR\ {+}\ 23{(}{\pm}16{)}{]}.\] The error terms given in the parentheses represent the standard errors of estimates of slope (i.e., 1.21) and the intercept (i.e., 23). The correlation between dose/AUC and GFR was high (r = .851; two-sided P<.00001, t test). The formula is simplified in the equation as: \[dose\ {=}\ AUC\ {\times}\ {(}{[}1.2\ {\times}\ GFR{]}\ {+}\ 20{)}.\] In stage II, the authors used this formula to dose 31 patients for target AUCs of 3–8 mg/mL per minute. The model was reported to underpredict AUC by about 20% (1). In stage III, the authors attempted to improve on the underprediction by using the data from stage II and revising the dosing formula as follows (with the error terms given in the parentheses representing the standard errors of estimates of slope [i.e., 0.93] and the intercept [i.e., 26] given below): \[dose\ {=}\ AUC\ {\times}\ {[}0.93{(}{\pm}0.08{)}\ {\times}\ GFR\ {+}\ 26{(}{\pm}6{)}{]}.\ \] The formula was then simplified to \[dose\ {=}\ AUC\ {\times}\ {(}GFR\ {+}\ 25{)}\] and was
Purpose. The aim of this study was to investigate the toxicity and efficacy of a more convenient topotecan administration schedule tin contrast to the "standard" 1.5 mg/m(2)/day x 5 days q 21 days) in the ma...
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Purpose. The aim of this study was to investigate the toxicity and efficacy of a more convenient topotecan administration schedule tin contrast to the "standard" 1.5 mg/m(2)/day x 5 days q 21 days) in the management of platinum- and paclitaxel-refractory ovarian cancer. Methods. Patients with clinically defined platinum- and paclitaxel-refractory ovarian cancer participating in this phase 2 trial conducted by the Gynecologic Cancer Program of the Cleveland Clinic Taussig Cancer Center received topotecan at a dose of 1.5 mg/m(2)/day x 3 days on a 21-day schedule. Both dose escalations and reductions were permitted in the protocol design. Results. A total of 29 patients (median age: 61;range: 43-80) were treated with this modified topotecan schedule. These individuals had received a median of two prior regimens (range: 1-4) (retreatment with a platinum agent or palcitaxel considered a single regimen). The median number of topotecan courses delivered was 3 (range: 1-7). Major toxicity included grade 4 neutropenia (24% of patients);neutropenic fever (10%);grade 3 thrombocytopenia (10%);and requirement for blood transfusion (14%). Dose escalation was possible, and dose reductions required, in 14 and 28% of patients, respectively. Two patients exhibited evidence of a clinically relevant response to treatment. Conclusion. This 3-day topotecan program is more convenient and less toxic than the standard 5-day regimen. The limited level of activity observed is not inconsistent with that previously reported for the 5-day topotecan infusion schedule in platinum/paclitaxel-refractory ovarian cancer. Further investigation will be required to document the clinical utility of a 3-day topotecan schedule in a less heavily pretreated and more chemosensitive patient population. (C) 2000 Academic Press.
The goal of treatment for idiopathic (immune) thrombocytopenic purpura (ITP) is to prevent serious bleeding. Traditionally, corticosteroids have been used as first-line therapy followed by splenectomy. Experience with...
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The goal of treatment for idiopathic (immune) thrombocytopenic purpura (ITP) is to prevent serious bleeding. Traditionally, corticosteroids have been used as first-line therapy followed by splenectomy. Experience with splenectomy over 60 years shows that approximately two thirds of patients achieve normal platelet counts during the initial observation, but that thrombocytopenia often recurs with longer follow-up. We know that long-term use of corticosteroids can lead to significant morbidities; there is no consensus regarding the appropriate timing or indications for splenectomy. To address the issue of appropriate use of splenectomy, we designed a multicenter clinical trial that will randomize patients to either standard care, involving prednisone followed by splenectomy, or to a novel regimen of limited prednisone treatment followed by WinRho SDF™ (Nabi, Boca Raton, FL) (anti-D) therapy to maintain the platelet count in a safe range for 1 year. Anti-D can be administered easily in an outpatient setting with few side effects and can provide predictable, transient increases in platelet count. The hypothesis is that prolonged maintenance therapy with a nontoxic regimen may increase the percentage of patients who will experience a spontaneous remission from thrombocytopenia, thereby avoiding an invasive and permanent surgical procedure, splenectomy, and its potentially life-threatening sequelae.
OBJECTIVE: The outcomes of pregnancies after maternal use of 6-mercaptopurine (6-MP) for inflammatory bowel disease (IBD) during pregnancy have been reported, but data are lacking for outcomes when the fathers use thi...
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OBJECTIVE: The outcomes of pregnancies after maternal use of 6-mercaptopurine (6-MP) for inflammatory bowel disease (IBD) during pregnancy have been reported, but data are lacking for outcomes when the fathers use this drug. METHODS: Subjects were male patients with IBD seen at one center between 1970 and 1997. Patients and their wives were interviewed. Group I comprised pregnancies fathered by men who were taking 6-MP. This group was further subdivided into those conceived within 3 months of 6-MP use and those conceived at least 3 months after 6-MP was stopped. Group 2 comprised pregnancies fathered by men with IBD, similar in characteristics to group 1, who had not taken 6-MP before fertilization. Information was collected regarding the fathers, the mothers, and the pregnancies, as well as the health of the children, in a historical cohort study. RESULTS: There were 50 pregnancies in group 1 (13 in 1A and 37 in 1B) and 90 pregnancies in group 2. Four of the 13 pregnancies in group 1A were associated with complications. There were two spontaneous abortions, and two congenital anomalies including a missing thumb in one and acrania with multiple digital and limb abnormalities in the other. Risk of complications was significantly increased when compared with group 1B (p < 0.013) and group 2 (p < 0.002). CONCLUSION: The incidence of pregnancy-related complications was significantly increased when the fathers used 6-MP within 3 months of conception. (Am J Gastroenterol 2000;95:684-688. (C) 2000 by Am. Coll. of Gastroenterology).
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