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.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.
3.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.
4.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.
5.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.
6.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.
7.Systemic review and Meta -analysis of nephrotoxicity caused by vancomycin combines drugs influence renal function
Qian-Ru DONG ; Ken CHEN ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2015;(13):1341-1343
Objective To systematic evaluate whether combining drugs influence renal function could increases the risk of nephrotoxicity caused by vancomycin. Methods Electronic databases such as PubMed , EMBase, the Cochrane library and Chinese database (CNKI, WanFang, CBM) were searched from establishment dates of databases to January 2014.The clinical observational studies which include vancomycin com-bines other drugs which could influence renal function was identified . The studies were screened according to the inclusion and exclusion crite-ria, the data were extracted, the quality of the included studies was as-sessed , and Meta-analysis was performed using RevMan 5.3 software. Results A total of six cohort studies were included , containing 1312 pa-tients, 791 patients of them using vancomycin alone , the other 521 patients combining other renal influence drugs .Compare with singly using vancomy-cin, combining renal influence drugs could increase nephrotoxicity signifi-cantly(P<0.01), but the heterogeneity is huge(P<0.05).After the sensi-tivity analysis , nephrotoxicity increasing still significantly ( P <0.01 ) . Conclusion Combining drugs which influence renal function could increase nephrotoxicity caused by vancomycin , so we should avoid combining drugs in clinical practice , or focus on monitoring when combining .
8.Systemic review and Meta -analysis of therapeutic drug monitoring in cancer patients
Qian-Ru DONG ; Xi-Lan ZHAO ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2015;(13):1344-1347
Objective To systematic evaluate the necessity of vancomy-cin therapeutic drug monitoring in cancer patients .Methods Electronic databases such as PubMed , EMBase, Cochrane library and Chinese data-base (CNKI, WanFang, CBM) were searched from establishment dates of databases to January 2014.The clinical observational studies which in-clude cancer patients using vancomycin intravenously was identified .The studies were screened according to the inclusion and exclusion criteria , the data were extracted , the quality of the included studies was assessed , and Meta -analysis was performed using Rev Man 5.3 software. Results Six cohort studies were identified .Compared with no -cancer patients, infectious treatment failure increases significantly (P<0.05), the target concentration rate of vancomycin decrease significantly (P<0.05).Conclusion As the decrease of target concentration rate and increase of treatment failure , cancer patients need therapeutic drug monitoring ( TDM) to adjust the dose of vancomycin .
9.Relationship between individualized vancomycin regimens and clinical outcomes:systematic review and Meta analysis
Rui JIAO ; Ran XIE ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2015;(13):1353-1357
Objective To systematically assess the relationship between individualized vancomycin regimens and clinical outcomes .Methods Electronic databases such as PubMed , EMbase, CNKI were searched. The clinical studies which focus on individualized vancomycin regimens was identified.Meta-analysis was conducted by Revmen 5.3 software. Results A total of 6 studies were included ,involving 797 patients.The results of Meta -analysis revealed that compared with conventional group, there was a significant differences in attainment of target concen-tration and microbiological eradicated rates of patient -tailored group (P<0.05), but no significant differences in mortality , clinical cure rates and nephrotoxicity ( P>0.05 ) .There was a significant differences in attainment of target concentration between therapeutic drug monitoring ( TDM) and non -TDM groups ( P<0.05 ) .Conclusion A patient -tailored initial dosing regimens may increases the attainment of target con-centration and microbiological eradicated rates .Adjust dosing regimen with TDM may increases the attainment of target concentration .
10.Systemic review and Meta-analysis of therapeutic drug monitoring of vancomycin in intensive care unit patients
Qian-Ru DONG ; Xi-Lan ZHAO ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2015;(13):1358-1360
Objective To systematic evaluate the necessity of vancomy-cin therapeutic drug monitoring in intensive care unit ( ICU ) patients compare with general ward patients . Methods Electronic databases such as PubMed , Embase , the Cochrane library and Chinese database (CNKI, WanFang, CBM) were searched from establishment dates of databases to January 2014.The clinical observational studies which in-clude ICU patients using vancomycin intravenously was identified .The studies were screened according to the inclusion and exclusion criteria , the data were extracted , the quality of the included studies was assessed , and Meta-analysis was performed using Rev Man 5.3 software. Results Three cohort studies were identified . One study shows no difference in the rate of treatment failure of ICU compare with general ward patients ( P>0.05 ) .Two studies shows nephrotoxicity increased significantly of ICU patients compare with general ward patients (P<0.05).Conclusion As the increase of nephrotoxicity and large individual difference , ICU patients need vancomycin TDM more .Due to the low methodological quality of the included studies , more high -quality clinical studies need to be conducted to verify this conclusion .