Clinical effectiveness of high dose versus standard dose of meropenem in ventilator-associated pneumonia caused by multidrug-resistant bacteria: a randomized single-blind clinical trial

2020 ◽  
Vol 20 ◽  
Author(s):  
Mahila Monajati ◽  
Shahram Ala ◽  
Masoud Aliyali ◽  
Roya Ghasemian ◽  
Fatemeh Heidari ◽  
...  
Keyword(s):  
Success Rate ◽  
Sofa Score ◽  
Dose Group ◽  
Clinical Success ◽  
Standard Dose ◽  
Clinical Success Rate ◽  
High Dose Group ◽  
Resistant Bacteria ◽  
High Dose ◽  
Ventilator Associated Pneumonia

Background: Meropenem standard doses are based on the minimum inhibitory concentration of sensitive pathogens and the pharmacokinetic parameter of not critically ill patients. We compared the efficacy of high versus standard dose of meropenem in ventilator-associated pneumonia (VAP). Methods: 24 out of 34 eligible patients were randomized to receive meropenem 3 g q8h (high dose group, 11 patients) or 2 g q8h (standard dose group, 13 patients) as a 3h infusion. Primary outcome was considered as clinical success that was defined as stable hemodynamic, improved sequential organ failure assessment (SOFA) score, stable or improved PaO2/FiO2 after 7 days. A sputum culture was taken before intervention. Results: Clinical success rate was not significantly different between the high and standard dose group (54.5% vs. 38.5%, P= 0.431). There was a significant difference in reduction of clinical pulmonary infection score (CPIS) compared to high dose with standard group (P=0.038). SOFA score declined significantly in high dose group through the study (P=0.006). A shorter duration of VAP treatment was recorded in high dose group (P=0.061). We did not observe any significant adverse event related to meropenem. Acinetobacter spp. (34.8%), Klebsiella spp. (32.6%) and, Pseudomonas aeruginosa (19.5%) isolated more frequently from sputum cultures. Conclusion: Treatment with high dose of meropenem seems to be safe. However, it did not provide significantly higher clinical success rate in comparison with the standard dose, but could be considered as an appropriate empirical treatment in patients with severe infection due to reducing in SOFA and CPIS.

scholarly journals Efficacy of a High-Dose Proton Pump Inhibitor in Patients with Gastroesophageal Reflux Disease: A Single Center, Randomized, Open-Label Trial

2020 ◽  
Author(s):  
Jae Ho Cho ◽  
Cheol Min Shin ◽  
Hyuk Yoon ◽  
Young Soo Park ◽  
Nayoung Kim ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Proton Pump ◽  
Dose Group ◽  
Standard Dose ◽  
High Dose Group ◽  
High Dose ◽  
Single Center ◽  
Open Label ◽  
Atypical Symptoms

Abstract Background: The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established.Methods: In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥ 50% reduction from the initial questionnaire score.Results: Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.Conclusions: High-dose rabeprazole is more effective for relieving typical GERD symptoms and some atypical symptoms such as cough and globus than a standard-dose regimen.Trial registration: This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health (ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400). This study was registered on June 26, 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04001400.

scholarly journals Efficacy of a High-Dose Proton Pump Inhibitor in Patients with Extraesophageal Symptoms of Gastroesophageal Reflux Disease: A Single Center, Randomized, Open-Label Trial

2020 ◽  
Author(s):  
Jae Ho Cho ◽  
Cheol Min Shin ◽  
Hyuk Yoon ◽  
Young Soo Park ◽  
Nayoung Kim ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Proton Pump ◽  
Dose Group ◽  
Standard Dose ◽  
High Dose Group ◽  
High Dose ◽  
Single Center ◽  
Open Label ◽  
Atypical Symptoms

Abstract Background The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established. Methods In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥ 50% reduction from the initial questionnaire score. Results Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes. Conclusions High-dose rabeprazole may be more effective for relieving atypical symptoms as well as typical GERD symptoms than a standard-dose regimen. Trial registration: This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health (ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400). This study was registered on June 26, 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04001400.

scholarly journals A meta-analysis on the curative effect and safety of high-dose flurbiprofen axetil for pain management after general surgery

2019 ◽  
Author(s):  
Tingting Hou ◽  
Dandan Cheng ◽  
Huang Nie
Keyword(s):  
Postoperative Pain ◽  
Dose Group ◽  
Standard Dose ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
High Dose Group ◽  
High Dose ◽  
Standard Group ◽  
Curative Effect ◽  
Vas Scores

Abstract Background To compare the curative efficiency or tolerability of flurbiprofen axetil(FA) in a high dose with that in a standard dose for postoperative pain of general surgery. Methods Relevant RCTs were retrieved from PubMed, Ovid, EMBASE, the Cochrane library, CBM, and CNKI from their inceptions to July 2019. The included studies were selected according to eligibility criteria. The study design, participant characteristics, interventions, and outcomes were abstracted after assessingmethodological quality of the trials. All data were analyzed by Review Manager 5.3. Results 10 studies were identified, which compared the curative effect or tolerability of FA between high and standard dose group. 500 patients were involved in this meta-analysis, with 250 patients in high dose group and 250 patients in standard dose group, respectively. Pooled analysis of VAS scores at 1, 2, 4, 6, 8, 12, and 24h showed that VAS scores at 1h(P <0.00001), at 2h (P=0.003), at 4h (P = 0.0007), at 6h (P=0.0002), at 8h (P= 0.0002), at 12h (P = 0.0001), and at 24h (P = 0.0004) in the high dose group were significantly lower than that in the standard group. Pooled analysis of BCS scores at 1, 2, 4, 6, 8, 12, and 24h showed that BCS scores at 1h (P < 0.00001), at 6h (P < 0.00001), at 12h(P=0.03), and at 24h (P=0.01) in the high dose group were significantly higher than that in the standard group. Pooled analysis showed that there was no difference in the incidence of adverse events or administrating rate of analgesics after FA treatment between high and standard dose groups (P>0.05). Conclusions In our meta-analysis, we found that FA with high dose (≥1.25 mg/kg or 100 mg) was more effective than that with standard dose in postoperative pain control after general operation,while the incidence of adverse effects with high or standard dose showed no significant difference.

scholarly journals PERALIHAN (KONVERSI) SPUTUM BTA ANTARA PEMBERIAN DOSIS BAKU (STANDAR) DAN TINGGI RIFAMPICIN PADA PENGOBATAN (TERAPI) ANTI TUBERKULOSIS KELOMPOK (KATEGORI) I

2018 ◽  
Vol 14 (1) ◽  
pp. 1
Author(s):  
Yani Triyani ◽  
Ida Parwati ◽  
I. Sjahid ◽  
J. E. Gunawan
Keyword(s):  
Pulmonary Tuberculosis ◽  
Dose Group ◽  
Standard Dose ◽  
High Dose Group ◽  
High Dose ◽  
Intensive Phase ◽  
Pulmonary Tb ◽  
Antituberculous Treatment ◽  
Sputum Microscopy ◽  
Sputum Conversion

Acid fast bacilli (AFB) sputum microscopy is used as a diagnostic tool of pulmonary tuberculosis (TB) in TB eradication program with directly observed treatment short course (DOTS) strategy. The AFB sputum microscopy should be performed before treatment,two months after intensive phase and four months after advance phase treatment. This study is a part of a research to compare thestandard (450 mg) and high (600 mg) rifampicin dose in patients with pulmonary tuberculosis in Indonesia. The aim of this studywas to detect the sputum conversion time of AFB in pulmonary TB patients who obtained category I antituberculous treatment with standard dose compared to one who received high dose of rifampicin at the beginning and at the end of the intensive phase. This AFB sputum microscopy have been performed from September 2003 until August 2005 from 85 pulmonary TB patients every two weeksusing Ziehl Neelsen and read by means of International Union Against Tuberculosis and Lung Diseases (IUATLD) scale, in PoliklinikParu Balai Pengobatan Penyakit Paru-paru and Department of Internal Medicine RS. Dr. Hasan Sadikin. Patients with pulmonary TBwho obtained category I antituberculous treatment of the intensive phase were divided randomly double blind into two groups, usingstatistical analysis by Page test for order alternative and Mann Whitney test. After randomization, there were 52 patients who receivedstandard dose and 33 patients who had high dose of rifampicin. Sputum conversions of AFB on week 2, 4, 6, and 8 were 36.1%, 63.9%,75%, and 91.7% for standard dose group. Sputum conversions of AFB on week 2, 4, 6, and 8 were 46.2%, 80.8%, 80.8%, and 84.6%for high dose group. Sputum conversion of AFB for high dose group were faster than standard dose group (p=0.030). Dropout (DO)patients were 5.9% (5/85) and no sputum conversion of AFB on week 8 was 8.3% and 15.4% for standard dose group and high dosegroup of rifampicin, respectively. Sputum conversions of AFB for high dose group were found significant more quickly than standarddose group of rifampicin statistically.

Prognostic Value of the Delivery Dialysis Dose on Twice-Weekly Hemodialysis Patients

2017 ◽  
Vol 45 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Qichen Fan ◽  
Yucheng Yan ◽  
Leyi Gu ◽  
Liqun He ◽  
Nan Chen ◽  
...  
Keyword(s):  
Physical Function ◽  
Prognostic Value ◽  
Dose Group ◽  
Standard Dose ◽  
High Dose Group ◽  
High Dose ◽  
Dialysis Dose ◽  
Free Survival ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial

Background: Few studies have evaluated the prognostic value of dialysis dose in twice-weekly hemodialysis (HD). A single-pool Kt/V (spKt/V) over 1.70 may benefit patients receiving twice-weekly maintenance HD. Methods: This is a multicenter randomized controlled trial performed on 163 patients from 17 dialysis centers in Shanghai who were allocated to high- (n = 98) and standard-dose groups (n = 65) and followed through 96 weeks of study period. Therapeutic approaches were given to increase spKt/V to over 1.70 in the high-dose group. Data were collected every 12-24 weeks. The primary outcomes were all-cause mortality and major adverse cardio-cerebrovascular events (MACEs) occurrence, and secondary outcomes included residual kidney function (RKF) and health-related quality of life (HR-QOL). Results: The spKt/V in high-dose and standard-dose groups were 1.80 ± 0.23 and 1.55 ± 0.19, respectively, after an 8-week intervention (p < 0.001). At the end of the study, SF-36 physical function and total score in high-dose group were 82 (69-90) and 74 (47-84), respectively, both of which were higher than those in the standard-dose group. Decline in urine volume was observed in both groups with no significant difference (p = 0.431). No difference was found in overall survival between the 2 groups (p = 0.580). The 1-year MACE-free survival for high-dose group was 84.49%, better than 76.72% for standard-dose group (p = 0.029). Conclusions: Higher spKt/V is also associated with MACE-free survival and better HR-QOL, especially in physical function aspect for twice-weekly dialysis patients. Increasing spKt/V over 1.70 in twice-weekly HD population does not cause loss of RKF.

Ferric sulfate as pulpotomy agent in primary teeth: twenty month clinical follow-up

2000 ◽  
Vol 24 (4) ◽  
pp. 269-272 ◽  
Author(s):  
Hamijeta Ibricevic ◽  
Qumasha Al-Jame
Keyword(s):  
Success Rate ◽  
Primary Teeth ◽  
Root Resorption ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Ferric Sulfate ◽  
Primary Molar ◽  
Molar Teeth ◽  
The Moment

Seventy primary molar teeth, carious exposed, symptom free, without any sign of root resorption in children aged from 3 to 6 years (main age 4.3yr) were treated with conventional pulpotomy procedures. Ferric sulfate 15.5% solution (applied for 15 second for 35 teeth) and formocresol solution (five minute procedure of Buckley's formula for next 35 teeth) have been used as pulpotomy agents. In both groups, pulp stumps were covered with zinc-oxide eugenol paste. Permanent restorations were stainless steel crowns. Clinical check up was every three-months and radiographic follow-up time was six and twenty months after treatment. Our results within this period revealed 100% clinical success rate in both groups. Radiographic success rate was in both groups 97.2%, while in 2.8% cases has shown internal root resorption. On the basis of these results, we can recommend ferric sulfate as a pulpotomy agent in primary teeth in substitution for formocresol at the moment.

scholarly journals Newly Developed Recombinant Antithrombin Protects the Endothelial Glycocalyx in an Endotoxin-Induced Rat Model of Sepsis

2020 ◽  
Vol 22 (1) ◽  
pp. 176
Author(s):  
Toshiaki Iba ◽  
Jerrold H. Levy ◽  
Koichiro Aihara ◽  
Katsuhiko Kadota ◽  
Hiroshi Tanaka ◽  
...  
Keyword(s):  
Dose Group ◽  
Low Dose ◽  
Leukocyte Adhesion ◽  
Endothelial Glycocalyx ◽  
High Dose Group ◽  
Control Group ◽  
High Dose ◽  
Protective Effects ◽  
Circulating Levels

(1) Background: The endothelial glycocalyx is a primary target during the early phase of sepsis. We previously reported a newly developed recombinant non-fucosylated antithrombin has protective effects in vitro. We further evaluated the effects of this recombinant antithrombin on the glycocalyx damage in an animal model of sepsis. (2) Methods: Following endotoxin injection, in Wistar rats, circulating levels of hyaluronan, syndecan-1 and other biomarkers were evaluated in low-dose or high-dose recombinant antithrombin-treated animals and a control group (n = 7 per group). Leukocyte adhesion and blood flow were evaluated with intravital microscopy. The glycocalyx was also examined using side-stream dark-field imaging. (3) Results: The activation of coagulation was inhibited by recombinant antithrombin, leukocyte adhesion was significantly decreased, and flow was better maintained in the high-dose group (both p < 0.05). Circulating levels of syndecan-1 (p < 0.01, high-dose group) and hyaluronan (p < 0.05, low-dose group; p < 0.01, high-dose group) were significantly reduced by recombinant antithrombin treatment. Increases in lactate and decreases in albumin levels were significantly attenuated in the high-dose group (p < 0.05, respectively). The glycocalyx thickness was reduced over time in control animals, but the derangement was attenuated and microvascular perfusion was better maintained in the high-dose group recombinant antithrombin group (p < 0.05). (4) Conclusions: Recombinant antithrombin maintained vascular integrity and the microcirculation by preserving the glycocalyx in this sepsis model, effects that were more prominent with high-dose therapy.

scholarly journals Recombinant Human Thyrotropin-Stimulated Radioiodine Therapy in Patients with Multinodular Goiters: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 52 (12) ◽  
pp. 841-849
Author(s):  
Chunmei Xu ◽  
Ping Wang ◽  
Huikai Miao ◽  
Tianyue Xie ◽  
Xiaojun Zhou ◽  
...  
Keyword(s):  
Fixed Effects ◽  
Dose Group ◽  
Low Dose ◽  
Radioiodine Therapy ◽  
Meta Analysis ◽  
High Dose Group ◽  
High Dose ◽  
Fixed Effects Model ◽  
Recombinant Human Thyrotropin

AbstractA potential reduction of goiter volume (GV) of recombinant human thyrotropin (rhTSH) on multinodular goiters (MNG) was previously reported but controversial. Hence we conducted a meta-analysis to estimate the effect of rhTSH-stimulated radioiodine therapy in patients with MNG. PubMed, Cochrane, CNKI, VIP, and Wanfang databases were searched. Mean difference (MD) and odds ratios with 95% confidence intervals (95% CI) were derived by using an inverse variance random-effects model and fixed-effects model, respectively. Six studies (n=237) were involved in the analysis. For 12 months follow up, high dose (>0.1 mg) of rhTSH significantly reduced GV (MD=17.61; 95% CI=12.17 to 23.04; p<0.00001) compared with placebo. No effective pooled results of low dose of rhTSH (<0.1 mg) were applicable for only one study included. For 6 months follow up, the source of heterogeneity was determined by subgroup and sensitivity analysis. High dose group showed vast improvement in GV reduction (MD=16.62; 95% CI=1.34 to 31.90; p=0.03). The reduction of low dose group compared with placebo was inferior to high dose group. No available data were obtained to assess the influence of rhTSH after 36 months follow up for the only included study. Hypothyroidism incidence was higher for rhTSH group. No publication bias was seen. High dose of rhTSH treatment-stimulated radioactive 131I therapy after 6 months and 12 months follow up had a better effect in reducing GV, but with higher incidence of hypothyroidism. Owing to the limited methodological quality, more clinical researches are warranted in the future.

Anticoagulation profile of high-dose vs. standard-dose enoxaparin for percutaneous coronary intervention

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Z Liu ◽  
Q Chen ◽  
J Li ◽  
X Zhu ◽  
L Xu ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Single Dose ◽  
Dose Group ◽  
Standard Dose ◽  
Coronary Intervention ◽  
High Dose ◽  
Funding Source ◽  
Minor Bleeding ◽  
Therapeutic Anticoagulation ◽  
Percutaneous Coronary

Abstract Background Although enoxaparin 0.5 mg/kg is a recommended anticoagulation regimen for percutaneous coronary intervention (PCI), a randomized study demonstrated that more patients receiving enoxaparin 0.75 mg/kg compared to those receiving 0.5 mg/kg achieved therapeutic anticoagulation without increase of major bleeding. However, no detailed data regarding the anticoagulation profile of enoxaparin 0.75 mg/kg was reported in the study. Purpose This study prospectively assessed the anticoagulation profile of enoxaparin 0.75 mg/kg vs. 0.5 mg/kg in troponin-negative patients undergoing elective trans-radial coronary angiography (CAG). Methods Eligible patients were randomly assigned to the Planned Single-dose group (0.75 mg/kg) or the Planned Staged-dose group (0.5±0.25 mg/kg). In the Planned Single-dose group, all patients received enoxaparin 0.75 mg/kg before CAG irrespective of their indication for subsequent PCI. In the Planned Staged-dose group, enoxaparin 0.5 mg/kg was administered to all patients before CAG and additional 0.25 mg/kg was given only to those undergoing subsequent PCI immediately before PCI. Patients without indication for subsequent PCI in each group were defined as High-dose (0.75 mg/kg) and Standard-dose (0.5 mg/kg) groups, respectively. Anti-Xa levels were assessed at 0 min (immediately before), 10 min, and 90 min after enoxaparin administration. Therapeutic anticoagulation was defined as anti-Xa level of 0.5–1.8 IU/ml. Bleeding was according to the thrombolysis in myocardial infarction (TIMI) criteria. Results In 170 randomized patients, 48 of 85 patients in the Planned Single-dose group and 47 of 85 patients in the Planned Staged-dose group were included in the High-dose and Standard-dose groups, respectively. The baseline characteristics were well balanced between the two groups. The anti-Xa levels were higher in the High-dose vs. Standard-dose group both at 10 min (1.354±0.228 IU/ml vs. 0.976±0.213 IU/ml, p&lt;0.001) and 90 min (0.827±0.195 IU/ml vs. 0.583±0.169 IU/ml, p&lt;0.001) (Figure 1). The percentages of patients with therapeutic anticoagulation were similar at 10 min (100% [46/46] vs. 100% [46/46], p=1.000) but higher at 90 min (100% [41/41] vs. 75% [33/44], p=0.001) in the High-dose vs. Standard-dose group. No TIMI major or minor bleeding occurred within 24 h of randomization in both groups. Conclusions Enoxaparin 0.75 mg/kg compared to 0.5 mg/kg provided higher anticoagulation which was adequate for up to 90 min of administration. Enoxaparin 0.75 mg/kg would be a superior anticoagulation regimen for PCI, especially when the procedure duration is long. Figure 1. High-dose vs. Standard-dose Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): 2016 Peking Union Medical College Hospital (PUMCH) Science Fund for Junior Faculty

Effects of piperonyl butoxide on spontaneous behavior in F1-generation mice

2009 ◽  
Vol 25 (7) ◽  
pp. 489-497 ◽  
Author(s):  
Toyohito Tanaka ◽  
Osamu Takahashi ◽  
Shinshi Oishi ◽  
Akio Ogata
Keyword(s):  
Dose Group ◽  
Female Offspring ◽  
Piperonyl Butoxide ◽  
High Dose Group ◽  
High Dose ◽  
Adult Females ◽  
Developmental Parameters ◽  
Spontaneous Behavior ◽  
Dose Levels ◽  
F1 Generation

Piperonyl butoxide was given in the diet to provide levels of 0 (control), 0.02%, 0.06%, and 0.18% from 5 weeks of age of the F0 generation to 12 weeks of age of the F1 generation in mice. Select reproductive and neurobehavioral parameters were then measured. In exploratory behavior in the F0 generation, vertical time of adult females increased significantly in a dose-related manner. In behavioral developmental parameters, cliff avoidance was delayed significantly in the high-dose group in male offspring, and this effect was significantly dose-related. In female offspring, surface righting was significantly delayed in the high-dose group, and this effect was significantly dose-related. In spontaneous behavior in the F1 generation, females showed more activities in some variables in the high-dose group. Dose levels of piperonyl butoxide used in the present study produced several adverse effects in neurobehavioral parameters in mice.

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