1.Risk of cardiovascular disease and all-cause mortality among diabetic patients prescribed rosiglitazone or pioglitazone: a meta-analysis of retrospective cohort studies.
Xin CHEN ; Li YANG ; Suo-di ZHAI
Chinese Medical Journal 2012;125(23):4301-4306
BACKGROUNDThe 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.
METHODSThe 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.
RESULTSOf 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).
CONCLUSIONCompared with pioglitazone, rosiglitazone was associated with an increased risk of myocardial infarction, heart failure, and all-cause mortality in diabetic patients.
Cardiovascular Diseases ; epidemiology ; Diabetes Mellitus ; drug therapy ; epidemiology ; mortality ; Humans ; Hypoglycemic Agents ; therapeutic use ; Retrospective Studies ; Thiazolidinediones ; therapeutic use
2.Optimal voriconazole dosing regimens for obese patients:A systematic review
Ken CHEN ; Meng-Jia GE ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2016;32(5):459-461
Objective To assess the optimal voriconazole dosing regimens for obese patients.Methods PubMed, EmBase, the Cochrane Library, Clinicaltriasl.gov and three Chinese databases ( CNKI, CBM, and Wan-Fang ) were searched through March 2015.Clinical trials or observational studies comparing the clinical and pharmacokinetic outcomes of different dosing regimens in obese patients or healthy subjects were included.Results Three cohort studies involving 237 subjects were included in the review.There were no statistical difference among actual body weight ( ABW) , ideal body weight ( IBW) , adjusted body weight ( AdjBW) and normal body weight ( NBW) groups on rates of hepatotoxicity and neuro-toxicity.No studies reported clinical response of treatment.Attainment of target concentration in AdjBW group was significantly higher than ABW and NBW group , respectively.Random plasma concentration in ABW group was significantly higher than NBW group when using intravenous administration (Median 6.4 vs 2.8μg· mL-1 ).Trough concentration in ABW group was significantly higher than NBW ( MD=2.70μg· mL-1 ) , IBW ( MD=2.25μg· mL-1 ) and AdjBW ( MD =2.90 μg · mL-1 ) groups , respectively.Conclusion Voriconazole AdjBW and IBW dosing regimens are recommended for obese patients.Drug monitoring may be necessary for obese patients to ensure the safety of voriconazole.
3.Salvianolate for treatment of angina:An overview of systematic reviews
Yue LIU ; Ying-Ying YAN ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2016;32(6):560-562
Objective To evaluate the efficacy and safety of salvianolate injection for angina by overview of systematic reviews( SRs).Methods The Cochrane library, PubMed, EMbase, CBM, CNKI and Wanfang da-ta were searched from the inception to July 2015.According to the inclu-sion and exclusion criteria, articles for systematic reviews and Meta -analysis were selected.Extracted the trials of systematic reviews and then RevMan 5.3 was used to undertake Meta analysis.Results A total of 7 articles were included, and the scores of AMSTAR tool in 67 percent of articles were above 7.A total of 18 outcomes were included, the results of grading showed that 15 outcomes ( 83 percent ) were graded as low quality.A total of 33 trials involving 3126 patients were overviewed.The results showed that:compared with the control group, salvianolate signifi-cantly increased the clinical efficacy ( P <0.001 ) and improved of electrocardiograph ( P<0.001 ) in treating unstable angina;and lowered the adverse drug reaction ( P <0.001 ).Conclusion Salvianolate is effective and safe for angina pectoris.Because of the poor methodological quality on the whole studies, high quality randomized controlled trials are required to provide reliable evidence.
4.Efficacy and safety of rivaroxaban for thromboprophylaxis after orthopedic surgery: a Meta-analysis
Xia YANG ; Shu-Jie DONG ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2017;33(14):1366-1370
Objective To further evaluate the efficacy and safety of rivaroxaban in the thromboprophylaxis after orthopedic surgery.Methods PubMed,EmBase,Cochrane Library,Web of Science,Clinical Trials,CNKI,CBM and Wanfang database were systematically searched.All databases had been searched from established up to August 2016.All randomized controlled trials (RCTs) of rivaroxaban therapy in patients after orthopedic surgery were selected.Meta-analysis was carried out by using RevMan 5.3 software.The incidence of total venous thromboembolism (VTE),major VTE,deep vein thrombosis (DVT),pulmonary embolism (PE),all-cause mortality,symptomatic VTE,bleeding,major bleeding,clinical relevant non-major bleeding (CRNMB),minor bleeding and wound complication were compared and the results were presented with risk ratio (RR) with 95% confidence interval (CI).Results Totally 32 RCTs of 17061 cases were included in this study,including 9167 cases accepted rivaroxaban (treatment group),other of 7894 cases accepted other drugs (control group).The results of Meta-analysis were as follows.The incidence of symptomatic VTE,total VTE,major VTE and DVT in the rivaroxaban group was lower than that in the low molecular heparin group (P < 0.05).The incidence of total VTE,and DVT in rivaroxaban group was lower than that in aspirin group (P < 0.05).There was no significant difference in the efficacy and safety between the rivaroxaban and apixaban group (P > 0.05).Conclusion In the thromboprophylaxis after orthopedic surgery,efiicacy of rivaroxban is better than that of traditional anticoagulant therapy and it will not increase the risk of adverse events such as bleeding and wound complication.
5.Analysis of off-indication use of voriconazole
Shu-Yao LIANG ; Ken CHEN ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2017;33(17):1706-1709
Objective To provide evidence for the off-indication use of voriconazole.Methods PubMed,EmBase,the CochraneLibrary and three Chinese databases (CNKI,SinoMed and WangFang) were searched through January 2016.The indications,pathogens,route of administration,cure rate and type of study were inclu-ded in the statistical analysis.All thestudies about the off-indication use of voriconazole were included,according to the established criteria.Results Thirty-nine case reports and case series involving the off-indication use and research advance of voriconazole on ocular infections,skin and soft tissue infections,bone and joint infections,abdominal infections,cardiac infection,and histoplasmosiswere included in the review.Conclusion We provided support for the treatment of fungal infections in rare sites with a low incidence rate and no clear antifungal treatment regimen.
6.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.
7.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.
8.Advance of the study on anesthesia and analgesia of pentazocine
The Chinese Journal of Clinical Pharmacology 2015;(2):158-160
This review collected the recent clinical application of pen-tazocine in preoperative anesthesia , acute pain and chronic pain.Data of pharmacodynamics , pharmacokinetics and safety evaluation related to pentazocine were retrieved and analyzed.Pentazocin can decrease the in-cidence of adverse drug reactions when as additional analgesics adminis-trated either before anesthesia or during anesthesia induction and main -tenance.The clinical efficacy of pentazocine in postoperative acute pain has been confirmed , with a low incidence of adverse reaction.Prolonged injection of pentazocine may cause drug dependence leading to lesions in skin and soft tissue.
9.Systematic review on effects of CYP3A4*1G genetic polymorphism on daily dose of tacrolimus and drug concentration in renal transplant recipients
Wei-Long SHI ; Hui-Lin TANG ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2015;(4):292-296
Objective To systematically assess the effects of CYP3A4*1G genetic polymorphism on daily dose of tacrolimus, tacrolimus trough concentration and dose-adjusted trough concentration.Methods The EmBase, PubMed, Cochrane Library, CNKI, WanFang and SinoMed databases were searched, and related literature were manually searched focused on the influence of CYP3A4*1G genetic polymorphism on daily dose of tacrolimus and drug concentrations.The Meta-analysis was per-formed by Revman 5.2 software.Results A total of seven studies ( five papers in Chinese and two papers in English ) were included, involving 750 adult renal transplant recipients.The results of meta -analysis re-vealed that the CYP3A4*1G carriers need higher weight-adjusted daily dose of tacrolimus than the patients carried CYP3A4 * 1/* 1 ( P<0.05) .A subgroup analysis revealed that there was no significant diffe-rence between the two groups two weeks after renal transplant, but at one month and two three months after transplant, the CYP3A4*1G carriers required higher weight-adjusted daily dose of tacrolimus than the patients carried CYP3 A4*1/*1 . Besides, CYP3 A4 *1 G carriers showed a lower tacrolimus trough concentration and dose-ad-justed trough concentration compared with CYP3 A4*1/*1 carriers ( P <0.05 ) . Conclusion CYP3 A4*1 G genetic polymorphism significantly influences the daily dose of tacrolimus and drug concentration in adult renal transplant recipients.
10.Evaluation of comparative effectiveness and safety of bisphosphonates
Jun-Wen ZHOU ; Xiang MA ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2015;(12):1197-1201
Objective To evaluate the comparative effectiveness and safety of bisphosphonates.Methods PubMed and Cochrane Database of Systematic Review were electronically searched for Meta -analysis and network Meta-analysis about the effectiveness and safety of bisphospho-nates.The randomized controlled trials ( RCTs ) comparing different bi-sphosphonates were manually searched.We then complete the descriptive analysis about the direct and indirect comparison between bisphospho-nates.Results Seventeen Meta-analyses were included, including 1 Meta-analysis comparing different bisphosphonates, 10 Meta-analyses comparing bisphosphonates and placebo, and 6 network Meta-analyses. The results of direct comparison showed that there was no significant difference between different bisphosphonates in effectiveness and safety. The results of indirect comparison showed that zoledronic acid, alendr-onate or zoledronic acid, alendronate, risedronate ranked first in preven-ting vertebral fracture, hip fracture, wrist, non -hip -non -vertebral fracture among different bisphosphonates, respectively.Zoledronic acid, zoledronic acid, etidronate ranked highest in causing any gastrointestinal adverse events, nausea, and discontinuation due to adverse drug reactions among different bisphosphonates, respective-ly.Conclusion Bisphosphonates are effective and safe medications for treating osteoporosis.Although zoledronic acid ranked highest in preventing fracture, it was also more likely to cause gastrointestinal adverse events.However, the quality of a body of evidence comparing different bisphosphonates is low.More well -designed clinical studies are needed to support above conclusion.