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OBJECTIVE To optimize the pre-audit rules for anesthesia prescriptions， improve the audit quality and rational drug use. METHODS The inpatient medical orders of anesthesia department from prescription pre-audit system of the Affiliated Hospital of Qingdao University （hereinafter referred to as “our hospital”） were analyzed from April 1 to 30， 2023. The classification statistics and evidence-based inquiry were carried out for irrational drug use issues； combined with our hospital’s current implementation of the Anesthesiology Clinical Pathway Medication Standards， the audit rules were set in details， and audit management and communication feedback processes were established. The total number of monthly audited orders， the number of pre-audit pop ups， system interception rate， physician modification rate after system audit， pharmacist audit rate， and reasonable rate of medical orders after refined setting of rules （May-December in 2023） were compared with before setting （April in 2023）； the average medication cost per anesthesia session after refined setting of rules was also compared with before setting （May- December in 2022）. RESULTS Irrational drug use in the anesthesia department mainly included inappropriate indications， inappropriate administration routes， inappropriate usage and dosage， inappropriate compatibility， medication problems in special populations， and improper medication during the perioperative period. After the refinement of the rules， the number of pre-audit pop ups in the anesthesia department significantly decreased over time， and gradually reached a stable state after continuous improvement. Compared with before setting， the system interception rate after the refinement of rules （P＜0.001）， physician modification rate after system audit （P＜0.001） both increased significantly， while the pharmacist audit rate significantly decreased （P＜0.001）. There was a linear trend between the reasonable rate of medical orders and the month from May to December in 2023 （P＜0.05）. Compared with before the setting， the average medication cost of anesthesia per session decreased from 720.72 yuan to 528.21 yuan， with a decrease of 26.71%. CONCLUSIONS Based on evidence-based reference， refining pre-audit rules for anesthesia prescriptions can significantly improve the quality of prescription examination， promote rational drug use， and save patient’s medical expenses.
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Objective:To investigate the antibody-dependent cell-mediated cytotoxicity (ADCC) in plasma samples from patients with SARS-CoV-2 infection and to evaluate its correlation with antibody titer and neutralizing activity.Methods:A simple method for ADCC detection was established using HEK293T cells expressing SARS-CoV-2 spike (S) protein as target cells and FcγRⅢa-V158-expressing Jurkat cells as effector cells. It was used to analyze the ADCC activity in 38 plasma samples after the ratio of effector cells to target cells was optimized. Plasma-specific antibody was detected by capturing ELISA, which was to capture the C-terminal-tagged recombinant SARS-CoV-2 S protein with an anti-tag antibody. The neutralizing activity in plasma samples was detected using a pseudovirus neutralization assay. Mann-Whitney U test was used for comparison between different groups and non-parametric Spearman correlation test was performed for correlation analysis. Results:The seroconversion rates for antibodies specific for S protein, S1 protein and RBD were all 97.4% (37/38), and the dynamic changes in antibody titers with recovery time showed that antibody titers peaked at 3-4 weeks. Among the plasma samples with neutralizing activity, those with antibody titers >1∶320 had stronger neutralizing activity than the plasma samples with antibody titers <1∶320 [IC 50: 749.6 (396.5-3 772.0) vs 81.4 (11.6-228.4), P<0.01]. ADCC activity was detectable in 86.8% (33/38) of the plasma samples, and its dynamic change with recovery time were consistent with that of specific antibody titer with a peak at 3-4 weeks. Correlation analysis showed ADCC was positively correlated with the titers of antibodies specific for S protein, S1 protein and RBD ( r=0.686, 0.535 and 0.471, all P<0.01). A positive correlation was also found between ADCC and neutralizing activity ( r=0.573, P<0.01). Conclusions:This study established a simple method for the detection of ADCC. Results of this study suggested that SARS-CoV-2 could induce specific ADCC in plasma and the ADCC might be associated with non-neutralizing antibodies. Besides, the activity of ADCC peaked at 3-4 weeks. These findings would be of reference value for clinical treatment with convalescent plasma.
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OBJECTIVE To explore and establish a long-term mechanism for rational control of intravenous fluids in hospitals. METHODS On the basis of the establishment of rules and regulations， through the exploration and implementation of the core technical strategy of “six-step method”， a new mode of intravenous infusion control was established. The contents of the “six-step method” were as follows： the first step was to sort out the diseases that did not require intravenous infusion； the second step was to sort out the alternative drugs/dosage forms； the third step was to sort out the alternative routes of infusion； the fourth step was to develop drug specifications； the fifth step was to explore the personalized medication needs of clinical departments； the sixth step was to develop a department-specific integrated infusion regimen. The utilization rate of intravenous fluids in inpatients and the average daily amount of intravenous fluids per bed in inpatients were used as the main indicators to evaluate the control effect. RESULTS The comparison of the average values of three months before and after the implementation of the “six-step” management mode in the department of thoracic surgery of our hospital showed that after management and control， the average utilization rate of intravenous fluids in inpatients decreased by 1.74%， the average daily use of intravenous fluids in inpatients per bed decreased by 0.30 bags/bottle， and the per capita use of infusion drugs under key control gradually decreased. CONCLUSIONS The “six-step” management mode can reduce the utilization rate of intravenous fluids in inpatients， and this management mode is practical and feasible.
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The technological level of medical device trials researchers directly affects the validity and risk of trials,but now almost all the research programs and informed consents don't have designate researchers.The analyses of the contents of three informed consents suggested that "researcher information" was that the subjects paid great attention to and had the right to know;in order to respect the subject autonomy,maintain the justice of research,reduce the harm and maintain social harmony,the information of researchers of medical device clinical trials with significant risk involved operation should be informed to subjects.In this regard,policy and ethical review should make clear requirements in practice.
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From the interest of subjects in clinical trials,this paper analyzed the ethical issues of the following cases.It included that the standard operating procedures of the clinical trial were contrary to the programs;the clinical trials failed because of statistical problems;unnecessary duplication blood increased the damage to subjects.It is recommend that relative researchers of the clinical trials of in vitro diagnostic reagent should grasp the scientificity and ethicality,improve the quality of clinical trials and effectively protect the rights and interests of subjects.