Drug clinical comprehensive evaluation of tetrandrine in the treatment of pneumoconiosis / 中华劳动卫生职业病杂志

Objective: To analyze the safety, effectiveness, economics, innovation, suitability and accessibility of tetrandrine in the treatment of pneumoconiosis, and provide evidence-based basis for health policy decision-making and clinical practice. Methods: In July 2022, the system searched PubMed, Embase, the Cochrane Library, CNKI, Wanfang, SinoMed databases (the retrieval time was from the establishment of the database to June 30, 2022), screened the documents that meet the standards, extracted and evaluated the data, and used the "HTA checklist" developed by the International Network of Agencies for Health Technology Assessment (INAHTA) to evaluate the HTA report. AMSTAR-2 Scale was used to evaluate the quality of systematic evaluation/Meta analysis. CHEERS Scale was used to evaluate the quality of pharmacoeconomics research. The included cohort study or case-control study was evaluated with the Newcastle-Ottawa Scale. The included randomized controlled trial (RCT) studies were evaluated using the Cochrane Risk Bias Assessment Tool (Cochrane RCT) quality evaluation criteria. Comprehensive comparison and analysis based on the characteristics of the data included in the study. Results: A total of 882 related literatures were detected from the initial screening. According to relevant standards, 8 RCT studies were finally selected for analysis. Statistical results showed that basic treatment with tetrandrine could better improve FEV(1) (MD=0.13, 95%CI: 0.06-0.20, P<0.001), FEV(1)/FVC (MD=4.48, 95%CI: 0.61-8.35, P=0.02) and clinical treatment efficiency. Tetrandrine had a low incidence of adverse reactions. The affordability coefficient of tetrandrine tablets was 0.295-0.492. Conclusion: Tetrandrine can improve the clinical symptoms and pulmonary ventilation function of pneumoconiosis patients, most of the adverse reactions are mild, and the clinical application is safe.

Selecting and defining the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis / 北京大学学报(医学版)

OBJECTIVE@#To select and define the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis.@*METHODS@#A draft including clinical questions, which could be divided into foreground questions and background questions, and outcomes was drawn and revised by the secretary group for the guideline referring to the present guidelines with the guidance of a panel consisting of 7 experienced clinical medicine, pharmacy and nursing experts. Foreground questions and outcomes of the draft were voted into a final version after three rounds of counsels of 22 experienced medicine, pharmacy and nursing clinical experts using Delphi method including 3 rounds of inquiry. And the background questions were directly included in the guideline after the 22 experts' thorough revising. The research was carried out under the supervision of method ologists. Active coefficient, coefficient of variation and the frequencies of each score were calculated for quality control.@*RESULTS@#The draft of 34 foreground questions, 6 background questions and 6 outcomes was finally drawn up after thorough selecting and consulting. The 6 background questions revised by the clinical experts were all included. After three rounds of Delphi method, 28 pivotal clinical questions covering the diagnosis, preparation for the treatment, treatment and administration after the treatment, and 6 outcomes were defined and included for the guideline. The rest of the foreground questions, 4 of which were recognized as essential and 2 as important, were excluded from the guideline and left for further revising or updating. As for the outcomes, 4 of them were recognized as critical and the rest as important. The experts contributing to the research were active as the active coefficient reached 100%, and the degree of consensus was fine as the frequencies of the feedback scoring equal to or greater than 4 for all the 28 foreground questions included were greater than 75% and the result was settled in the first round. And 2 outcomes, fatality rate and severity, reached a higher degree of consensus with coefficient of variation less than 15%.@*CONCLUSION@#After thorough and rigorous selecting, the clinical questions and outcomes to be included in the Guideline for the Emergency Treatment of Anaphylaxis were finally selected and defined via Delphi method, guiding the future development of the guidelines.

Individualized vancomycin dosing for a patient diagnosed as severe acute pancreatitis with concurrent extracorporeal membrane oxygenation and continuous veno-venous hemofiltration therapy: a case report / 北京大学学报(医学版)

Pharmacokinetic parameters can be significantly altered for acute kidney injury (AKI), extracorporeal membrane oxygenation (ECMO) and continuous veno-venous hemofiltration therapy (CVVH). Here we reported a case of individualized vancomycin dosing for a patient diagnosed as severe acute pancreatitis treated with concurrent ECMO and CVVH. A 65 kg 32-year-old woman was admitted to hospital presented with severe acute pancreatitis (SAP), respiratory failure, metabotropic acidosis and hyperkalemia. She was admitted to intensive care unit (ICU) on hospital day 1 and was initiated on CVVH. She progressed to multiple organ dysfunction syndrome (MODS) and acute respiratory distress syndrome (ARDS) on ICU day 2, and veno-venous ECMO was instituted. Several catheters were inserted into the body to support ECMO, CVVH and pulse indicator continuous cardiac output (PiCCO), so vancomycin was prescribed empirically on ICU day 3 for prevention of catheter-related infection. Given the residual renal function and continuous hemofiltration intensity on day 3, vancomycin bolus of 1 000 mg was prescribed, followed by a maintenance dose of 500 mg every 8 hours. On ICU day 4, a vancomycin trough serum concentration of 14.1 mg/L was obtained before the fourth dose, which was within the target range of 10-20 mg/L. By ICU day 7, vancomycin dosage was elevated to 1.0 g every 12 hours because of aggravated infection and improved kidney function. On ICU day 14, a vancomycin trough serum concentration of 17 mg/L was obtained. Her white blood cell (WBC) and neutrophil percentage (Neut%) dropped to the normal level by ICU day 19. This vancomycin regimen was successful in providing a target attainment of trough serum concentration ranging from 10-20 mg/L quickly and in controlling infection-related symptoms and signs properly. With the help of this case report we want to call attention to the clinically significant alteration in vancomycin pharmacokinetics among critically ill patients. Individualized vancomycin dosing regimens and therapeutic drug monitoring are necessary for critically ill patients receiving CVVH and ECMO to ensure that the target serum vancomycin levels are reached to adequately treat the infection and avoid nephrotoxicity.

A protocol for developing a clinical practice guideline for therapeutic drug monitoring of vancomycin / 华中科技大学学报（医学）（英德文版）

This study aimed to develop a guideline for therapeutic drug monitoring (TDM) of vancomycin. We adopted the new guideline definition from the Institute of Medicine (IOM), adhered closely to the six domains of the Appraisal of Guidelines for Research & Evaluation II (AGREE II), and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome (PICO) and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation (GRADE).

Risk of cardiovascular disease and all-cause mortality among diabetic patients prescribed rosiglitazone or pioglitazone: a meta-analysis of retrospective cohort studies / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The difference of cardiovascular effects between rosiglitazone and pioglitazone treatment for diabetic patients has not been thoroughly studied. We performed a meta-analysis to compare the risk of cardiovascular adverse effects in patients with type 2 diabetes treated with rosiglitazone compared to pioglitazone.</p><p><b>METHODS</b>The Cochrane Library, PubMed, and Embase were searched to identify retrospective cohort studies assessing cardiovascular outcomes with rosiglitazone and pioglitazone. Meta-analysis of retrospective cohort studies was conducted using RevMan 5.0 software to calculate risk ratios.</p><p><b>RESULTS</b>Of the 74 references identified, eight studies involving 945 286 patients fit the inclusion criteria for the analysis. The results of meta-analyses showed that, compared with pioglitazone, rosiglitazone therapy significantly increased the risk of myocardial infarction (risk ratios (RR) 1.17, 95% confidence interval (CI) 1.04 - 1.32; P = 0.01), the risk of heart failure (RR 1.18, 95%CI 1.02 - 1.36; P = 0.03), and total mortality (RR 1.13, 95%CI 1.08 - 1.20; P < 0.000 01).</p><p><b>CONCLUSION</b>Compared with pioglitazone, rosiglitazone was associated with an increased risk of myocardial infarction, heart failure, and all-cause mortality in diabetic patients.</p>

Population pharmacokinetics of remifentanil in patients undergoing orthotopic liver transplantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Little is known about the influence of liver transplantation on the pharmacokinetics of most anesthetic drugs. The goal of this study was to study the population pharmacokinetics of remifentanil in the different phases of orthotopic liver transplantation (OLT) and the influence of relevant factors.</p><p><b>METHODS</b>Thirteen adult patients undergoing OLT were enrolled. A single bolus infusion of remifentanil 5 microg/kg was administered during the preanhepatic, anhepatic and neohepatic phases of OLT. Arterial blood samples of 1.5 ml were collected at 0 (baseline), 1, 2, 3, 5, 7, 10, 15, 20, 25, 30, 45, 60 and 90 minutes after drug administration. Remifentanil concentration was assayed by high-performance liquid chromatography/mass spectrometry/mass spectrometry (HPLC/MS/MS). Population pharmacokinetic modeling was performed using nonlinear mixed-effects modeling (NONMEM).</p><p><b>RESULTS</b>The pharmacokinetics of remifentanil in patients undergoing OLT was best described by a two-compartment open model. The pharmacokinetic parameters were not influenced by age, gender, operative phase, blood temperature, rehydration volume, or blood loss volume during sampling. The volume of distribution in the central compartment (V(1)) and the volume of distribution in the peripheral compartment (V(2)) were influenced by body weight.</p><p><b>CONCLUSIONS</b>The population pharmacokinetics of remifentanil in patients undergoing OLT can be well described by a two-compartment open model. The functional status of the liver does not significantly affect the pharmacokinetics of remifentanil, but the body weight is an influential factor of V(1) and V(2).</p>