1.Drug clinical comprehensive evaluation of tetrandrine in the treatment of pneumoconiosis.
Zhi Ling ZHANG ; Na HE ; Xiao Han XU ; Peng MEN ; Li GUAN ; De Hong LI ; Suo Di ZHAI
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(3):217-221
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.
Humans
;
Pneumoconiosis/drug therapy*
;
Benzylisoquinolines/therapeutic use*
;
Drugs, Chinese Herbal
;
Case-Control Studies
2.Selecting and defining the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis.
Hang Ci ZHENG ; Xiao Tong LI ; Peng MEN ; Xiang MA ; Qiang WANG ; Yao Long CHEN ; Suo Di ZHAI
Journal of Peking University(Health Sciences) 2020;52(4):715-718
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.
Anaphylaxis/therapy*
;
Consensus
;
Delphi Technique
;
Emergency Treatment
;
Humans
;
Research Design
3.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.
Na HE ; Ying Ying YAN ; Ying Qiu YING ; Min YI ; Gai Qi YAO ; Qing Gang GE ; Suo Di ZHAI
Journal of Peking University(Health Sciences) 2018;50(5):915-920
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.
Adult
;
Anti-Bacterial Agents/administration & dosage*
;
Critical Illness
;
Extracorporeal Membrane Oxygenation
;
Female
;
Hemofiltration
;
Humans
;
Pancreatitis/drug therapy*
;
Vancomycin/administration & dosage*
4.Pilot study of the effect of WeChat medication education on patients using warfarin
Zai-Wei SONG ; Zhi-Yuan TAN ; Shu-Jie DONG ; Rong-Sheng ZHAO ; Rui TIAN ; Suo-Di ZHAI ; Li YANG
The Chinese Journal of Clinical Pharmacology 2018;34(1):60-62
Objective To explore the method of WeChat medication education for patients used by pharmacists,and to investigate the effect of WeChat medication education at Peking university third hospital.Methods Totally 30 patients who used warfarin at Peking university third hospital were enrolled.A series of subscriptions concerning warfarin medication education were sent to patients and/or their caregivers by WeChat regularly.The medication knowledge score after/before the intervention were assessed.Results The score of patients' warfarin medication knowledge before intervention was (14.20 ± 1.97) points,and after that the score was (16.63 ± 1.74) points,showing an improvenent with significance (P < 0.001).Questions about adverse events of warfarin were most likely to be answered by mistake and the score of relevant questions was only (0.97 ± 0.80) points and (1.07 ± 0.81) points,respectively (P > 0.05) before and after intervention.Conclusion It is of great significance for pharmacists to provide warfarin medication education.It is proved effective to improve patients' recognition of warfarin medication by means of WeChat subscriptions.
5.Current situation of individualized vancomycin dosing via pharmacokinetic tool
Na HE ; Ying-Ying YAN ; Shan SU ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2018;34(1):63-65,69
Vancomycin (VCM) is the first-line therapy for invasive multi-resistant gram-positive bacterial infections involving Methicillinresistant Staphylococcus aureus.The therapeutic range of VCM is narrow,and its use is associated with nephrotoxicity.The pharmacokinetic characteristics of VCM vary greatly with renal function.Therapeutic drug monitoring and pharmacokinetic (PK) monitoring are required for maximizing its efficacy and minimizing adverse effect.Several studies focused on vancomycin individualized dosing have been published recently.The advances of vancomycin individualized dosing via PK tool are reviewed in this study.
6.Review of association between high-dose tigecycline and clinical outcome
Shu-Yao LIANG ; Chen-Xiao WANG ; Wei LIU ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2018;34(3):362-364
Objective To evaluate the efficacy and safety of the usage of high-dose tigecycline.Methods Databases including PubMed,EmBase,The Cochrane Library,CNKI,Wanfang data and Clinical Tirals.gov were searched to select randomized controlled trials (RCTs) and observational studies that met the inclusion criteria from inception to May 2017.Two reviewers independently screened literature,extracted data,and evaluated the risk of bias of included studies.Risk ratio and 95% confidence interval were used to present results.Meta-analysis was performed using RevMan 5.3 software to analyze patients' all-cause mortality,micro-biological clearance rate,clinical effective rate and clinical cure rate.Result A total of 5 observational studies were included,which involved 348 patients.The results of meta-analysis indicated that compared with the regular-dose group(50 mg,q12 h),the high-dose group(>50 mg,q12 h) could significantly decrease all-cause mortality (RR =0.65,95% CI =0.50-0.84,P < 0.01),increase micro-biological clearance rate(RR =1.71,95% CI =1.22-2.41,P < 0.01),clinical effective rate (RR =1.46,95% CI =1.13-1.87,P < 0.01) and clinical cure rate (RR =1.71,95% CI =1.71-2.48,P < 0.01).Conclusion Compared with regular-dose tigecycline (50 mg,q12 h),the usage of high-dose tigecycline (> 50 mg,q12 h) showed superiority.
7.Population pharmacokinetics of combined ethinylestradiol/gestodene transdermal contraceptive tablets and patches in Chinese healthy volunteers
Yang LIU ; Chao ZHANG ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2018;34(7):870-874,880
Objective To evaluate the population pharmacokinetics (PPK) of combined gestodene (GSD)/ethinylestradiol (EE) oral tablet and transdermal contraceptive patch in Chinese healthy volunteers,and provide theoretic supports for personalized medication.Methods An open-label,two-period comparative study was conducted in 12 healthy women volunteers.A single dose of combined GSD/EE oral tablet and transdermal contraceptive patch were administered.Blood samples at different time points after dose were collected,and concentrations were analyzed.A reliable,highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry assay method was developed in this study to determine the plasma concentrations of GSD and EE.The population pharmacokinetic parameters were estimated by nonlinear mixed effect model (NONMEM).Results A two -compartment model with first-order absorption and first-order elimination process was built as the structural model for GSD and EE of the tablet,respectively.Meanwhile,a one-compartment model with zero-order input and first-order elimination best described the GSD plasma concentrations after a single dose administration of the patch,and a one -compartment model with first-order absorption and first-order elimination for EE of the patch adequately described the data.When covariates were tested,none were found to adequately explain the changes of GSD and EE pharmacokinetic parameters in the PPK model for each route.Conclusion The established PPK models are capable of depicting pharmacokinetics of combined GSD/EE oral tablet and transdermal contraceptive patch in Chinese healthy volunteers.The final models are stable,and further research is warranted to study the effect of the potential covariates on GSD and EE pharmacokinetic parameters to improve the predictive performance.
8.Drug use research of patients with coronary heart disease and methodological evaluation
Ming-Yang SUN ; Ying-Ying YAN ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2018;34(10):1243-1245
Objective To report the preliminary results of drug use in patients with coronary heart disease,and to compare the differences of research results and methodologies between literature research and database research.Methods PubMed,EMbase,Cochrane Library,Wanfang data base,CNKI and CBM,were searched to collect all related literatures from beginning to November 28,2015.Data extracted from each individual study were analyzed using Excel 2011;patients with coronary heart disease from the database of a real word study were screened,and the drug use of patients with coronary heart disease was analyzed using SPSS 21.0 and Excel 2011.Results The literature research showed that the utilization rates of antiplatelet drugs,β-blocker,statins,angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blocker (ARB) were 90.62%,65.38%,73.94%,43.56% and 19.95% respectively;the database analysis showed that the utilization rate of antiplatelet drugs,β-blocker,statins,ACEI and ARB were 77.40%,53.60%,68.60%,27.00% and 26.00%,respectively.Compared with database research,literature research has the characteristics of large sample size,low cost and fast acquisition.Conclusion There are both advantages and disadvantages in all the research methods of drug epidemiology,and literature researches can be used for pharmacoepidemiological study if there is enough original researches.
9.Discussion of development of Chinese Practice Guideline for Individualized Medication of Voriconazole
Ken CHEN ; Shu-Yao LIANG ; Zai-Wei SONG ; Xiang-Lin ZHANG ; Guan-Hua DU ; Xiao-Yan KE ; Ke-Hu YANG ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2017;33(3):265-266,270
Collection and rating of evidence,survey of patients' preference and value and economic evaluation of the Practice Guideline for Therapeutic Drug Monitoring of Voriconazole have been finished.The Guideline Consensus Panel reached consensus of the recommendations by 3 rounds Delphi and Grading of Recommendations Assessment,Development and Evaluation grid method.Consensus of 38 recommendations was reached,with a consensus percentage of 50.7%.Twenty seven recommendations were finalized and approved by the Guideline Steering Committee.Draft recommendations were generated.
10.Efficacy and safety of indobufen for prevention and treatment of ischemic cardiovascular and cerebrovascular diseases: a Meta-analysis
Xia YANG ; Wei LIU ; Ken CHEN ; Shu-Jie DONG ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2017;33(4):359-362
Objective To evaluate the efficacy and safety of indobufen in the prevention and treatment of ischemic cardiovascular and cerebrovascular diseases or thrombosis.Methods PubMed,EmBase,Cochrane Library,Web of Science,Clinical Trials.gov,CNKI,CBM and WANFANG database were systematically searched until May 2016.All randomized controlled trials (RCTs) of indobufen therapy in patients with ischemic cardiovascular and cerebrovascular disease or thromboembolic disease were selected.Meta-analysis was carried out by using RevMan 5.3 software.The incidence of cardiovascular death,all-cause mortality,stroke,myocardial infarction,embolism,gastrointestinal reactions and bleeding after the treatment were compared and the results were presented with risk ratio (RR) with 95% confidence interval (CI).Results Nineteen RCTs of 5304 cases were included in this study,including 2668 cases received indobufen (treatment group),other 2636 cases received other drugs (control group).The results of Meta-analysis were as follows.The incidence of bleeding in the indobufen group was lower than that in the warfarin group (P < 0.01).The incidence of bleeding,gastrointestinal reactions and total adverse effects in the indobufen group were lower than those in aspirin group (P < 0.05).The incidence of bleeding and gastrointestinal reactions in the indobufen group were lower than those in the other antiplatelet drugs group (P < 0.05).The incidence of embolism in the indobufen group was significantly lower than that in the placebo or blank group (P < 0.01).Conclusion Although the clinical application of indobufen is relatively few,it is an efficacious and safe choice for ischemic cardiac and cerebral vascular diseases and thrombosis treatment.There should be more large-scale original researches to explore its clinical value.

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