Comparison of conventional dosing versus continuous-infusion vancomycin therapy for patients with suspected or documented gram-positive infections.

1996 ◽  
Vol 40 (3) ◽  
pp. 696-700 ◽  
Author(s):  
J K James ◽  
S M Palmer ◽  
D P Levine ◽  
M J Rybak
Keyword(s):  
Continuous Infusion ◽  
Serum Drug Concentration ◽  
Vancomycin Therapy ◽  
Time Curve ◽  
Minimum Concentration ◽  
Dosing Interval ◽  
Significant Difference ◽  
The Mean ◽  
Ci Therapy ◽  
To Receive

Ten patients were treated with conventional dosing (CD) and continuous-infusion (CI) vancomycin therapy in this prospective, randomized, crossover study. Patients were randomized to receive either CD or CI therapy for 2 consecutive days and then crossed over to receive the opposite regimen for 2 days. CD therapy consisted of 1 g of vancomycin every 12 h. CI therapy consisted of a 500-mg loading dose followed by 2 g infused over 24 h. Ten serum samples were obtained on the second day of each therapy for pharmacokinetic and pharmacodynamic analyses. Two clinical isolates of Staphylococcus aureus, one methicillin sensitive (MSSA 1199) and one methicillin resistant (MRSA 494), were chosen for pharmacodynamic evaluation of both regimens. The patient demographics (means +/- standard deviations [SD]) were as follows: sex, six males, four females; age, 36 +/- 11 years; and serum creatinine, 0.72 +/- 0.18 mg/dl. Mean pharmacokinetic parameters +/- SD for CD therapy were as follows: elimination rate constant, 0.16 +/- 0.07 h-1; half-life, 5.6 +/- 3.5 h; volume of distribution, 33.7 +/- 25 liters, 0.5 +/- 0.2 liters/kg; maximum concentration in serum, 53.4 +/- 19.3 micrograms/ml; and minimum concentration, 8.4 +/- 5.9 micrograms/ml. The steady-state concentration for CI was 20.2 +/- 11.1 micrograms/ml. Overall, both regimens resulted in the MIC being exceeded 100% of the time. The mean CD trough serum bactericidal titer (SBT) was 1:8, and the average CI SBTs were 1:16 for both isolates. Even though there was no statistically significant difference between CD trough and CI SBTs, the CI SBTs remained > 1:8 for 100% of the time versus 60% of the time for CD therapy. During CI therapy, 20 and 40% of the patients maintained SBTs of > 1:32 throughout the dosing interval for MSSA 1199 and MRSA 494, respectively. During CD therapy, however, only 10% of patients maintained SBTs of > 1:32 during the entire dosing interval for both isolates. The mean areas under the bactericidal titer-time curve (AUBC24s) +/- SD for MSSA 1199 were 528 +/- 263 for CD therapy and 547 +/- 390 for CI therapy. The mean AUBC24s +/- SD against MRSA 494 were 531 +/- 247 for CD and 548 +/- 293 for CI therapy. Similar to the AUBC24, the mean area under the concentration-time curve for a 24-h dosing interval divided by the MIC (AUC/MIC24) ratios +/- SD were 550.0 +/- 265.7 for CD and 552.6 +/- 373.4 for CI therapy, respectively. No statistically significant differences were found between any of the pharmacodynamic parameters for CD and CI therapy. In addition, no adverse effects with either CD or CI therapy were observed during the study. We conclude that CI and CD vancomycin therapy demonstrated equivalent pharmacodynamic activities. Although CI therapy was more likely to result in SBTs that remained above 1:8 for the entire regimen, the clinical impact of this result is unknown. Serum drug concentration variability was observed with both treatment regimens but to a lesser extent with CI administration. CI administration of vancomycin should be further evaluated to determine the clinical utility of this method of administration.

scholarly journals Pharmacokinetics of Azithromycin Administered Alone and with Atovaquone in Human Immunodeficiency Virus-Infected Children

1999 ◽  
Vol 43 (6) ◽  
pp. 1516-1519 ◽  
Author(s):  
Leock Y. Ngo ◽  
Ram Yogev ◽  
Wayne M. Dankner ◽  
Walter T. Hughes ◽  
Sandra Burchett ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Steady State ◽  
Pharmacokinetic Parameters ◽  
Time Curve ◽  
Concentration Time ◽  
Significant Difference ◽  
Immunodeficiency Virus ◽  
The Mean ◽  
Clinically Significant ◽  
To Receive

ABSTRACT To evaluate if atovaquone (ATQ) interacts pharmacokinetically with azithromycin (AZ) in human immunodeficiency virus-infected children, 10 subjects (ages, 4 to 13 years) were randomized in a crossover study to receive AZ (5 mg/kg/day) alone (ALONE) or AZ (5 mg/kg/day) and ATQ (30 mg/kg/day) simultaneously (SIM) prior to receiving AZ and ATQ staggered by 12 h. Despite a lack of significant difference in the mean AZ pharmacokinetic parameters, the steady-state values of AZ’s area under the concentration-time curve from 0 to 24 h and maximum concentration in serum were consistently lower (n = 7 of 7) for the SIM regimen than they were for the ALONE regimen. A larger study will be required to determine if ATQ affects AZ pharmacokinetics and efficacy in a clinically significant manner.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

scholarly journals Pharmacokinetics of Nelfinavir and Efavirenz in Antiretroviral-Naïve, Human Immunodeficiency Virus-Infected Subjects when Administered Alone or in Combination with Nucleoside Analog Reverse Transcriptase Inhibitors

2005 ◽  
Vol 49 (8) ◽  
pp. 3558-3561 ◽  
Author(s):  
Patrick F. Smith ◽  
Gregory K. Robbins ◽  
Robert W. Shafer ◽  
Hulin Wu ◽  
Song Yu ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Reverse Transcriptase ◽  
Half Life ◽  
Pharmacokinetic Studies ◽  
Reverse Transcriptase Inhibitors ◽  
Time Curve ◽  
Minimum Concentration ◽  
Concentration Time ◽  
Immunodeficiency Virus ◽  
The Mean

ABSTRACT Pharmacokinetic studies were conducted with human immunodeficiency virus-infected patients receiving efavirenz, nelfinavir, or both agents at weeks 4 and 32. Reductions of 25% and 45% were observed in the mean nelfinavir area under the concentration-time curve and minimum concentration of the drug in serum, and there was a 31% more rapid half-life for patients receiving both drugs compared to patients receiving nelfinavir alone. There were no significant differences in efavirenz pharmacokinetics.

scholarly journals Pharmacokinetics of Ritonavir and Delavirdine in Human Immunodeficiency Virus-Infected Patients

2003 ◽  
Vol 47 (5) ◽  
pp. 1694-1699 ◽  
Author(s):  
Mark J. Shelton ◽  
Ross G. Hewitt ◽  
John Adams ◽  
Andrew Della-Coletta ◽  
Steven Cox ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Systemic Exposure ◽  
Pharmacokinetic Parameters ◽  
Time Curve ◽  
Minimum Concentration ◽  
Mean Values ◽  
Immunodeficiency Virus ◽  
The Mean ◽  
Full Dosage ◽  
Delavirdine Mesylate

ABSTRACT To evaluate the pharmacokinetic effect of adding delavirdine mesylate to the antiretroviral regimens of human immunodeficiency virus (HIV)-infected patients stabilized on a full dosage of ritonavir (600 mg every 12 h), 12 HIV-1-infected subjects had delavirdine mesylate (400 mg every 8 h) added to their current antiretroviral regimens for 21 days. Ritonavir pharmacokinetics were evaluated before (day 7) and after (day 28) the addition of delavirdine, and delavirdine pharmacokinetics were evaluated on day 28. The mean values (± standard deviations) for the maximum concentration in serum (C max) of ritonavir, the area under the concentration-time curve from 0 to 12 h (AUC0-12), and the minimum concentration in serum (C min) of ritonavir before the addition of delavirdine were 14.8 ± 6.7 μM, 94 ± 36 μM · h, and 3.6 ± 2.1 μM, respectively. These same parameters were increased to 24.6 ± 13.9 μM, 154 ± 83 μM · h, and 6.52 ± 4.85 μM, respectively, after the addition of delavirdine (P is <0.05 for all comparisons). Delavirdine pharmacokinetic parameters in the presence of ritonavir included a C max of 23 ± 16 μM, an AUC0-8 of 114 ± 75 μM · h, and a C min of 9.1 ± 7.5 μM. Therefore, delavirdine increases systemic exposure to ritonavir by 50 to 80% when the drugs are coadministered.

scholarly journals Induction of theophylline clearance by rifampin and rifabutin in healthy male volunteers.

1996 ◽  
Vol 40 (8) ◽  
pp. 1866-1869 ◽  
Author(s):  
J G Gillum ◽  
J M Sesler ◽  
V L Bruzzese ◽  
D S Israel ◽  
R E Polk
Keyword(s):  
Treatment Phase ◽  
Pharmacokinetic Parameters ◽  
Theophylline Clearance ◽  
Healthy Male ◽  
Time Curve ◽  
Concentration Time ◽  
Male Volunteers ◽  
Hepatic Microsomal Enzyme ◽  
The Mean ◽  
To Receive

Rifampin and rifabutin induce the metabolism of many drugs, which may result in subtherapeutic concentrations and failure of therapy. However, differences between rifabutin and rifampin in potency of induction, and the specific enzymes which are altered, are not clear. This study, involving 12 adult male volunteers, compared the effects of 14-day courses of rifampin and rifabutin on clearance of theophylline, a substrate for the hepatic microsomal enzyme CYP1A2. Subjects were given oral theophylline solution (5 mg/kg of body weight) on day 1 and then randomized to receive daily rifampin (300 mg) or rifabutin (300 mg) on days 3 to 16. Theophylline was readministered as described above on day 15. The first treatment sequence was followed by a 2-week washout period; subjects then received the alternative treatment. Theophylline concentrations were determined for 46 h after each dose, and pharmacokinetic parameters were determined. One subject developed flu-like symptoms while taking rifabutin and withdrew voluntarily. Results from the remaining 11 subjects are reported. Compared with the baseline, the mean area under the concentration-time curve (AUC) (+/- standard deviation) for theophylline declined significantly following rifampin treatment (from 140 +/- 37 to 100 +/- 24 micrograms . h/ml, P <0.001); there was no significant change following rifabutin treatment (136 +/- 48 to 128 +/- 45 micrograms.h/ml). Baseline theophylline AUCs before each treatment phase were not different. A comparison of equal doses of rifampin and rifabutin administered to healthy volunteers for 2 weeks indicates that induction of CYP1A2, as measured by theophylline clearance, is significantly less following rifabutin treatment than it is following rifampin treatment. However, the relative induction potency for other metabolic enzymes remains to be investigated.

scholarly journals Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial

2021 ◽  
Author(s):  
Jayne Joo ◽  
Aunna Pourang ◽  
Catherine N. Tchanque-Fossuo ◽  
April W. Armstrong ◽  
Danielle M. Tartar ◽  
...  
Keyword(s):  
Comparative Effectiveness ◽  
Wound Closure ◽  
Anatomic Site ◽  
Randomized Controlled ◽  
Scar Assessment ◽  
Significant Difference ◽  
The Mean ◽  
To Receive ◽  
Component Scores

AbstractUndermining is thought to improve wound outcomes; however, randomized controlled data regarding its efficacy are lacking in humans. The objective of this randomized clinical trial was to determine whether undermining low to moderate tension wounds improves scar cosmesis compared to wound closure without undermining. Fifty-four patients, 18 years or older, undergoing primary linear closure of a cutaneous defect with predicted postoperative closure length of ≥ 3 cm on any anatomic site were screened. Four patients were excluded, 50 patients were enrolled, and 48 patients were seen in follow-up. Wounds were divided in half and one side was randomized to receive either no undermining or 2 cm of undermining. The other side received the unselected intervention. Three months, patients and 2 masked observers evaluated each scar using the Patient and Observer Scar Assessment Scale (POSAS). A total of 50 patients [mean (SD) age, 67.6 (11.5) years; 31 (64.6%) male; 48 (100%) white] were enrolled in the study. The mean (SD) sum of the POSAS observer component scores was 12.0 (6.05) for the undermined side and 11.1 (4.68) for the non-undermined side (P = .60). No statistically significant difference was found in the mean (SD) sum of the patient component for the POSAS score between the undermined side [15.9 (9.07)] and the non-undermined side [13.33 (6.20)] at 3 months. For wounds under low to moderate perceived tension, no statistically significant differences in scar outcome or total complications were noted between undermined wound halves and non-undermined halves.Trail Registry: Clinical trials.gov Identifier NCT02289859. https://clinicaltrials.gov/ct2/show/NCT02289859.

scholarly journals Comparative outcomes of foot cast and short leg cast in pseudo-Jones avulsion fracture: a single blinded randomized controlled trial

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Peerapong Piyapittayanun ◽  
Kanakij Mutthakalin ◽  
Alisara Arirachakaran ◽  
Jatupon Kongtharvonskul
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Randomized Controlled ◽  
Metatarsal Bones ◽  
Significant Difference ◽  
Metatarsal Fractures ◽  
The Mean ◽  
Foot Fractures ◽  
To Receive

Abstract Background Fractures of the metatarsal bones account for 35% of all foot fractures. Conservative management of fractures proximal to the metaphyseal-diaphyseal junction of the fifth metatarsal bone (pseudo-Jones) is by protected weight bearing. The methods of protected weight bearing include short-leg casting and splinting (boot cast, Jones’s bandage and elastic bandage). However, currently there is no consensus as to which method is the most suitable. Method We have conducted a randomized controlled trial to compare outcomes of foot casting (FC) and short leg casting (SLC) to assess pain, function and complication outcomes for the treatment of pseudo-jones metatarsal fractures. This single-center, single blind,randomized controlled trial was conducted between 1 June 2016–1 July 2018 at Police General Hospital, Bangkok, Thailand. Result A total of 72 pseudo-jones metatarsal fracture participants were randomly allocated to treatment by foot cast or short leg cast. The primary outcomes were pain VAS, AOFAS and complications measured at 2, 4, 6 and 8 weeks after receiving the treatment. Seventy-two patients (36 paticipants per group) were enrolled to receive either FC or SLC. The mean VAS measured at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks were 7.36, 1.97, 0.58, 0.17 and 0.08 respectively in the FC group; and 6.09, 2.91, 1.23, 0.37 and 0.11 respectively in the SLC group. The mean AOFAS at baseline, 2, 4, 6 and 8 weeks were 33.60, 68.22, 82.72, 91.75 and 98.11 respectively in the FC group; and 32.60, 60.20, 70.20, 92.24 and 99.13 in the SLC group. The estimated mean difference of pain VAS and AOFAS at 2 weeks and 4 weeks were − 0.94 (95% CI: − 1.53, − 0.34), − 0.65 (95%CI: − 1.24, − 0.05), 8.02 (95%CI: 3.74, 12.10) and 12.52 (95%CI: 8.27, 16.78), which were statistically significantly better in the FC groups when compared to the SLC groups. However, there were no statistically significant difference between the two groups at 6 and 8 weeks. Conclusion This study demonstrated that the application of foot casting can improve pain VAS and AOFAS function at 2 and 4 weeks in the treatment of pseudo-jones metatarsal fractures when compared to short leg casting. However, at 6 and 8 weeks, there were no statistically significantly different between the two groups.

scholarly journals The efficacy of suppository versus oral ibuprofen for reducing fever in children

2016 ◽  
Vol 45 (5) ◽  
pp. 211
Author(s):  
Suhesti Handayani ◽  
Sri Rezeki Hadinegoro ◽  
Sudigdo Sastroasmoro
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Maximum Temperature ◽  
Duration Of Effect ◽  
Significant Difference ◽  
Oral Group ◽  
Oral Ibuprofen ◽  
The Mean ◽  
To Receive ◽  
Mean Time

Background Ibuprofen suppository is used to reduce fever inchildren who are unable to receive it orally. The effectiveness ofibuprofen suppository compared to that of oral ibuprofen has notbeen documented in Indonesian children.Objective The aim of this study was to compare the efficacy ofibuprofen suppository with that of oral ibuprofen for reducingfever in children.Methods This study was a randomized clinical trial without blind-ing on children aged 2-5 years with body weight of 12.5 to 16 kgwho had fever. Subjects received ibuprofen in either oral (7.5mg/kg) or suppository (125 mg) form. The temperature was mea-sured prior to ibuprofen administration, 30 minutes afterwards,and every subsequent half hour until the end of the sixth hour.Any observed adverse effects were recorded.Results Mean time needed for fever reduction was 2.72 (SD 1.1)hours in the suppository group, compared to 3.43 (SD 0.9) hoursin the oral group (P=0.004). The mean rate of fever reduction inthe suppository group was 0.90 (SD 0.4) °C/hour, while in theoral group it was 0.61 (SD 0.3) °C/hour. However, mean maxi-mum temperature lowering ability did not differ significantly [2.11(SD 0.7) °C for the suppository group and 1.99 (SD 0.7) °C, forthe oral group (P=0.489)]. There was no significant difference inmean duration of effect [220.8 (SD 83.0) hours for the supposi-tory group and 196.6 (SD 92.7) hours for the oral group (p=0.231)].Conclusions There was no significant difference between bothpreparations in maximum temperature lowering ability and dura-tion of effect. Temperature reduction was significantly fasterwith the administration of ibuprofen suppository

scholarly journals Registry-Based Incidence of Multiple Sclerosis in Southwestern Iran, 2001-2014

2017 ◽  
Vol 42 (1) ◽  
pp. 08-13
Author(s):  
Mohammad Khammarnia ◽  
Aziz Kassani ◽  
Elham Izadi ◽  
Fatemeh Setoodehzadeh
Keyword(s):  
Multiple Sclerosis ◽  
Age Group ◽  
Newly Diagnosed ◽  
Medical Sciences ◽  
Significant Difference ◽  
The Mean ◽  
Receive Treatment ◽  
Southwestern Iran ◽  
Study Participants ◽  
To Receive

Multiple Sclerosis (MS) is the most common cause of neurological disability in young adults. It is estimated that more than two million people have MS worldwide. This study aimed to assess the incidence of MS and its associated factors in Shiraz, Southwestern Iran. Data related to the inci-dence of MS were obtained from the MS center of Shiraz University of Medical Sciences from 2001 to 2014. The study participants were all residents of Shiraz. The subjects were diagnosed with MS by neurologists (all newly diagnosed patients from 2001-2014) and were registered in MS center to receive treatment. Descriptive statistics and univariate and multivariate Poisson re-gression analysis were done. During the study period, 2637 eligible patients were identified. The highest incidence of MS occurred in 2011 and 2012 (17.62, 95% CI: 8.02-38.72 and 16.92, 95% CI: 6.23-45.88 per 100,000 respectively). Besides, the female to male ratio was 2.95 and 44.71% of the MS patients (1070 cases) were in the 20-30 years’ age group. In addition, the mean age of the patients was 30.18±8.86 years. The results showed a significant difference among different age and sex groups regarding the incidence of MS (p=0.01). Moreover, a significant relationship was observed between education level and incidence of MS (p=0.03). The incidence of MS has in-creased in the south of Iran more than other regions.

scholarly journals A study of vaginal misoprostol tablet versus intra cervical dinoprostone gel for the induction of labour

2017 ◽  
Vol 6 (4) ◽  
pp. 1404
Author(s):  
Chandni N. Badlani ◽  
Shraddha S. Shastri ◽  
Neelesh S. Risbud
Keyword(s):  
Cost Effective ◽  
Induction Of Labor ◽  
Significant Difference ◽  
Misoprostol Group ◽  
Group A ◽  
The Mean ◽  
Nicu Admission ◽  
Vaginal Misoprostol ◽  
Group B ◽  
To Receive

Background: This was a comparative study conducted to compare the effectiveness of 25 microgram of intravaginal misoprostol with intracervical dinoprostone gel in terms of efficacy of drug, feto-maternal outcome, side effects and complications of drugs.Methods: 400 nulliparas at term, admitted for induction of labor were included in this study. They were randomly selected to receive either intravaginal misoprostol or intracervical dinoprostone gel. Group A (200 women) recieved tablet misoprostol 25 micrograms vaginally 4 hrly to a maximum of 3 doses and Group B (200 women) received dinoprostone gel 0.5mg intracervically 6 hrly to a maximum of 3 doses. Comparison was done in terms of Induction to delivery interval, need for augmentation, LSCS and instrumentation rate, need for NICU admissions and cost effectiveness.Results: The mean induction to delivery interval was less in the misoprostol group than dinoprostone group (12.5 hrs vs. 20 hrs). 78% patients delivered in the first 24 hrs in misoprostol group compared to 52 % patients in dinoprostone group. Group A had a higher success rate (81% vs.76%) and also required less augmentation of labor ( 30% vs. 60%) compared to group B. Need for LSCS was also lower in misoprostol group (11% vs. 16%). Need for instrumentation and incidence of NICU admission was similar in both groups. Misoprostol was more cost effective compared to dinoprostone.Conclusions: The misoprostol group had a shorter induction to delivery interval, more number of deliveries in the first 24 hrs of induction and a reduced need of augmentation of labor with oxytocin. There was no significant difference in the rate of caesarean section, hyper-stimulation syndrome, neonatal and maternal morbidity between the two groups. Thus, misoprosol appears to be safer, cheaper and more efficacious alternative for induction of labor especially for non-fetal indications as compared to dinoprostone gel.

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