Objective: To investigate whether Naoxueshu Oral Liquid(NXS) could promote hematoma absorption in post-craniotomy hematoma(PCH) patients. Methods: This is an open-label, multicenter, and randomized controlled trial co...Objective: To investigate whether Naoxueshu Oral Liquid(NXS) could promote hematoma absorption in post-craniotomy hematoma(PCH) patients. Methods: This is an open-label, multicenter, and randomized controlled trial conducted at 9 hospitals in China. Patients aged 18–80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS(10 m L thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage(ICH). Results: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients(60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set(FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median(Q1, Q3): 85%(71%, 97%) vs. 76%(53%, 93%), P<0.05]. The secondary outcomes showed no statistical significance between two groups, either in FAS or per-protocol set(P>0.05). Furthermore, no adverse events were reported during the study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups: male patients, patients younger than 65 years展开更多
目的探讨开颅术后危重患者急性肾损伤(AKI)的发病率、危险因素及其对预后的影响。方法本研究为单中心前瞻性队列研究,纳入2017年1月至2018年12月ICU住院时间≥24 h的成年患者(排除开颅术前合并AKI者)。收集患者基础资料、主要诊断、疾...目的探讨开颅术后危重患者急性肾损伤(AKI)的发病率、危险因素及其对预后的影响。方法本研究为单中心前瞻性队列研究,纳入2017年1月至2018年12月ICU住院时间≥24 h的成年患者(排除开颅术前合并AKI者)。收集患者基础资料、主要诊断、疾病严重程度评分、并发症以及AKI患者肾功能恢复等情况。所有患者随访至出院,并记录预后信息。采用多因素回归分析筛选AKI发生的危险因素。结果共纳入907例患者,其中143例(15.8%)出现AKI。多因素回归分析显示,低基础肾小球滤过率(eGFR)、高入住ICU第1天序贯器官衰竭评估(SOFA)评分、高钠血症及休克为AKI发生的独立危险因素。AKI患者ICU住院时间[10(5,19)d vs 5(3,12)d,Z=5.836,P<0.001]及机械通气时间更长[7(3,12)d vs 4(1,8)d,Z=1.193,P<0.001],住院病死率更高(30.8%vs 6.2%,χ^(2)=80.87,P<0.001),出院时格拉斯哥预后量表(GOS)评分更低[3(2,4)分vs 4(3,5)分,Z=1.181,P<0.001]。结论AKI在开颅术后危重患者中比较常见,低eGFR、高SOFA评分、高钠血症及休克是AKI的独立危险因素。合并AKI患者的预后更差。展开更多
Background: Post-craniotomy pain has been reported to be moderate to severe. Management of post-craniotomy pain is often inadequate, yet limited by the side effects of opioids. We aim to find out the efficacy of oral ...Background: Post-craniotomy pain has been reported to be moderate to severe. Management of post-craniotomy pain is often inadequate, yet limited by the side effects of opioids. We aim to find out the efficacy of oral oxycodone as compared to oral codeine for the treatment of post-craniotomy pain in our institution. Methods: A randomized, double-blinded controlled trial was used to evaluate the efficacy of oral oxycodone versus oral codeine. 40 patients were randomized to the control group of codeine (n = 20) or the experimental group receiving oxycodone (n = 20) in addition to regular oral paracetamol for both groups of patients. Results: There was no difference in the visual analogue scale scores at 24 hours (2.78 versus 1.85, p = 0.11) or side effects in the oxycodone group compared with the codeine group. Conclusions: Oral oxycodone had similar efficacy as oral codeine in the management of post-craniotomy pain.展开更多
In the present study, we aimed to develop a population pharmacokinetics(PPK) model of vancomycin(VCM) and propose the individualised dosage regimen for Chinese elderly patients. The data were collected prospectively f...In the present study, we aimed to develop a population pharmacokinetics(PPK) model of vancomycin(VCM) and propose the individualised dosage regimen for Chinese elderly patients. The data were collected prospectively from Chinese elderly patients receiving VCM therapy. Steady-state trough concentrations of VCM were determined using an enzyme-multiplied immunoassay. Patients’ sex, age, body weight, concomitant medications, infection type, and laboratory findings were recorded. The PPK model was developed using nonlinear mixed-effects model software. Moreover, we used Monte Carlo simulations to develop an initial dosage regimen targeting various VCM through concentration ranges based on the final model. We found that VCM clearance(CL) was significantly influenced by post-craniotomy meningitis(PCM) and glomerular filtration rate in elderly patients. Additionally, a new dosage regimen was proposed to individualise VCM regimen for PCM and non-PCM elderly patients. A PPK model was established to estimate the individual VCM CL for elderly patients, which could be applied for individualising doses in the target population.展开更多
基金Supported by the Technology Platform Construction Project of Fujian Province (No. 2021Y2001 and 2020Y2003)。
文摘Objective: To investigate whether Naoxueshu Oral Liquid(NXS) could promote hematoma absorption in post-craniotomy hematoma(PCH) patients. Methods: This is an open-label, multicenter, and randomized controlled trial conducted at 9 hospitals in China. Patients aged 18–80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS(10 m L thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage(ICH). Results: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients(60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set(FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median(Q1, Q3): 85%(71%, 97%) vs. 76%(53%, 93%), P<0.05]. The secondary outcomes showed no statistical significance between two groups, either in FAS or per-protocol set(P>0.05). Furthermore, no adverse events were reported during the study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups: male patients, patients younger than 65 years
文摘目的探讨开颅术后危重患者急性肾损伤(AKI)的发病率、危险因素及其对预后的影响。方法本研究为单中心前瞻性队列研究,纳入2017年1月至2018年12月ICU住院时间≥24 h的成年患者(排除开颅术前合并AKI者)。收集患者基础资料、主要诊断、疾病严重程度评分、并发症以及AKI患者肾功能恢复等情况。所有患者随访至出院,并记录预后信息。采用多因素回归分析筛选AKI发生的危险因素。结果共纳入907例患者,其中143例(15.8%)出现AKI。多因素回归分析显示,低基础肾小球滤过率(eGFR)、高入住ICU第1天序贯器官衰竭评估(SOFA)评分、高钠血症及休克为AKI发生的独立危险因素。AKI患者ICU住院时间[10(5,19)d vs 5(3,12)d,Z=5.836,P<0.001]及机械通气时间更长[7(3,12)d vs 4(1,8)d,Z=1.193,P<0.001],住院病死率更高(30.8%vs 6.2%,χ^(2)=80.87,P<0.001),出院时格拉斯哥预后量表(GOS)评分更低[3(2,4)分vs 4(3,5)分,Z=1.181,P<0.001]。结论AKI在开颅术后危重患者中比较常见,低eGFR、高SOFA评分、高钠血症及休克是AKI的独立危险因素。合并AKI患者的预后更差。
文摘Background: Post-craniotomy pain has been reported to be moderate to severe. Management of post-craniotomy pain is often inadequate, yet limited by the side effects of opioids. We aim to find out the efficacy of oral oxycodone as compared to oral codeine for the treatment of post-craniotomy pain in our institution. Methods: A randomized, double-blinded controlled trial was used to evaluate the efficacy of oral oxycodone versus oral codeine. 40 patients were randomized to the control group of codeine (n = 20) or the experimental group receiving oxycodone (n = 20) in addition to regular oral paracetamol for both groups of patients. Results: There was no difference in the visual analogue scale scores at 24 hours (2.78 versus 1.85, p = 0.11) or side effects in the oxycodone group compared with the codeine group. Conclusions: Oral oxycodone had similar efficacy as oral codeine in the management of post-craniotomy pain.
基金Guidance Project of Fujian Science and Technology Department(Grant No.2017Y0033)Fujian Medical Innovation Project(Grant No.2017-CX-31)+1 种基金Sail Project of Fujian Medical University(Grant No.2017XQ1068)“Weak Discipline Construction Project” of Shanghai Municipal Commission of Health and Family Planning(Grant No.2016ZB0301-01).
文摘In the present study, we aimed to develop a population pharmacokinetics(PPK) model of vancomycin(VCM) and propose the individualised dosage regimen for Chinese elderly patients. The data were collected prospectively from Chinese elderly patients receiving VCM therapy. Steady-state trough concentrations of VCM were determined using an enzyme-multiplied immunoassay. Patients’ sex, age, body weight, concomitant medications, infection type, and laboratory findings were recorded. The PPK model was developed using nonlinear mixed-effects model software. Moreover, we used Monte Carlo simulations to develop an initial dosage regimen targeting various VCM through concentration ranges based on the final model. We found that VCM clearance(CL) was significantly influenced by post-craniotomy meningitis(PCM) and glomerular filtration rate in elderly patients. Additionally, a new dosage regimen was proposed to individualise VCM regimen for PCM and non-PCM elderly patients. A PPK model was established to estimate the individual VCM CL for elderly patients, which could be applied for individualising doses in the target population.
