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1.
Hum Vaccin Immunother ; 20(1): 2361500, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38904423

ABSTRACT

To assess the impact of vaccines on clinical outcomes among hospitalized COVID-19-infected patients requiring oxygen supplementation during the Beijing Omicron outbreak. We conducted a retrospective cohort study at Beijing Chaoyang Hospital, Capital Medical University, from November 15, 2022, to March 31, 2023. Vaccination statuses were categorized into 3 doses, 2 doses, and unvaccinated (0 dose). The primary outcome was 28-day all-cause mortality. Secondary outcomes included poor outcomes, intensive care unit admission, cardiovascular thromboembolism events, and hospital readmission. Among the included patients, 117 were 2 doses, 285 received booster doses, and 503 were unvaccinated. After propensity score inverse probability weighting, the 3 doses group showed a significantly lower 28-day all-cause mortality compared to the unvaccinated group (inverse probability of treatment weighting-adjusted HR: 0.64, 95% CI: 0.50-0.81). No significant difference was observed in all-cause mortality between the 2 doses and unvaccinated groups. No significant differences were observed in secondary outcome analyses when comparing the 3 doses or 2 doses group to the unvaccinated group. Subgroup analysis revealed significant benefits of booster vaccination in patients with shorter symptom duration, lower Charlson Comorbidity Index, and without immunosuppression status. Our study highlights the significant reduction in all-cause mortality among hospitalized Omicron-infected patients who received a third dose vaccine. These findings underscore the importance of prioritizing booster vaccinations, especially among the elderly. Further research is warranted to confirm and extend these observations.


Subject(s)
COVID-19 Vaccines , COVID-19 , Hospitalization , Immunization, Secondary , SARS-CoV-2 , Humans , COVID-19/prevention & control , COVID-19/mortality , COVID-19/immunology , Male , Retrospective Studies , Female , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/immunology , Middle Aged , Aged , SARS-CoV-2/immunology , Hospitalization/statistics & numerical data , Disease Outbreaks/prevention & control , Adult , Vaccination/methods
2.
Infect Drug Resist ; 17: 1367-1377, 2024.
Article in English | MEDLINE | ID: mdl-38618583

ABSTRACT

Objective: The efficacy of nirmatrelvir-ritonavir for hospitalized patients with COVID-19 has not been fully established. Methods: We conducted a retrospective analysis of hospitalized COVID-19 patients with high risk for disease progression at Beijing Chaoyang Hospital from October 15, 2022, to March 31, 2023. Patients ≥18 years old who were hospitalized with COVID-19 within 5 days of symptom onset were included. Baseline data were obtained from the routine electronic health record database of the hospital information system. Outcomes were monitored at 28 days via electronic medical record reviews or telephone interviews. Results: We identified 1120 patients hospitalized with COVID-19 during the study period. After exclusions, 167 nirmatrelvir-ritonavir users and 132 controls were included. 28-day all-cause mortality rate was 12.0% (20/167) in the nirmatrelvir-ritonavir group, versus 22.7% (30/132) in the control group (unadjusted log-rank p = 0.010; HR = 0.49, 95% confidence interval [CI] = 0.28-0.86, IPTW-adjusted HR = 0.58, 95% CI = 0.40-0.86). The 28-day disease progression rates did not differ between the two groups (unadjusted HR = 0.59, 95% CI = 0.34-1.02, IPTW-adjusted HR = 0.73, 95% CI = 0.50-1.06). Nirmatrelvir-ritonavir significantly reduced all-cause mortality and disease progression within 28 days among patients aged ≥65 years without ≥2 vaccine doses. Conclusion: We found significantly reduced all-cause mortality in the nirmatrelvir-ritonavir group, particularly in elderly patients who were incompletely vaccinated. Future randomized controlled studies are needed to validate our findings.

3.
Front Pharmacol ; 14: 1191608, 2023.
Article in English | MEDLINE | ID: mdl-37274098

ABSTRACT

Background: Azvudine (FNC) is a promising treatment candidate for managing coronavirus disease 2019 (COVID-19). However, drug interactions with azvudine have been poorly studied, especially with no reported cases of azvudine with anticoagulants such as warfarin and rivaroxaban. Case summary: The patient was diagnosed with lower limb venous thrombosis and took warfarin regularly. The international normalized ratio (INR) was stable (2.0-3.0). However, the INR increased to 7.52 after administering azvudine. The patient had no other factors justifying this change. This increase in INR occurred again with the administration of azvudine in combination with rivaroxaban, and the INR increased to 18.91. After azvudine administration was stopped, the INR did not increase when rivaroxaban was used alone. Conclusion: Azvudine, warfarin, and rivaroxaban might have previously unidentified drug interactions that increased the INR. Therefore, the INR must be closely monitored when they are concomitantly administered in COVID-19 patients.

4.
Bioanalysis ; 15(5): 269-282, 2023 03.
Article in English | MEDLINE | ID: mdl-37083541

ABSTRACT

Background: Aimed to simultaneously measure linezolid, voriconazole, cefoperazone and fluconazole in human plasma suitable for therapeutic drug monitoring applications, a robust, rapid and easy-to-use HPLC-MS/MS approach was developed and validated. Materials & methods: Protein precipitation was used to prepare analytes from 100 µl plasma. HPLC was employed for analyte separation, and quantification was conducted via multiple-reaction monitoring in positive ion mode. The methodology was fully validated. Results & conclusion: All four antibiotics were found to be stable under the tested conditions, and accuracy values ranged from 90.96 to 113.25% and CV values were <14.0%. This HPLC-MS/MS method can be used for routine clinical therapeutic drug monitoring of linezolid, voriconazole, cefoperazone and fluconazole simultaneously.


Subject(s)
Anti-Bacterial Agents , Fluconazole , Humans , Chromatography, Liquid , Voriconazole , Tandem Mass Spectrometry/methods , Cefoperazone , Linezolid , Drug Monitoring/methods , Chromatography, High Pressure Liquid/methods , Reproducibility of Results
5.
Shanghai Kou Qiang Yi Xue ; 32(1): 47-51, 2023 Feb.
Article in Chinese | MEDLINE | ID: mdl-36973843

ABSTRACT

PURPOSE: To investigate the relationship between the levels of soluble intercellular adhesion molecule-1 (sICAM-1), interleukin-1ß (IL-1ß) and hypoxia-inducible factor-1α (HIF-1α) in gingival sulcus fluid and peri-implantitis (PI) in patients with implant restoration. METHODS: A total of 198 patients with implant restoration admitted to Fengcheng Hospital from January 2019 to December 2021 were selected, the patients were divided into PI and non-PI group according to whether the implant restoration was complicated by PI 3 months after restoration. The levels of sICAM-1, IL-1ß and HIF-1α in the gingival sulcus fluid prior to implant restoration were measured by enzyme-linked immunosorbent assay. Multi-factor logistic regression was used to analyze the factors influencing concurrent PI in patients with implant restoration. ROC curves were used to analyze the predictive value of sICAM-1, IL-1ß and HIF-1α levels in gingival sulcus fluid on concurrent PI in patients with implant restoration. SPSS 28.0 software package was used for statistical processing of the data. RESULTS: The incidence of PI in 198 patients with implant restoration was 17.68% (35/198) 3 months after implant restoration. The levels of sICAM-1, IL-1ß and HIF-1α in the gingival sulcus fluid were significantly higher in the PI group than in the non-PI group (P<0.05). Multi-factor logistic regression analysis showed that elevated sICAM-1(OR=1.135, 95%CI: 1.066-1.208), IL-1ß (OR=1.106, 95%CI: 1.054-1.161) and HIF-1α (OR=1.008, 95%CI: 1.004-1.012) were independent risk factors for complications of PI in prosthetic patients(P<0.05). ROC curve analysis showed that the area under the curve for sICAM-1, IL-1ß and HIF-1α levels in gingival sulcus fluid alone and in combination for the diagnosis of concurrent PI in patients with implantation was 0.787, 0.785, 0.794 and 0.930, respectively, with sensitivity of 80.00%, 74.29%, 62.86% and 88.57% and specificity of 66.87%, 74.85%, 78.53% and 85.28%, respectively. CONCLUSIONS: Elevated levels of sICAM-1, IL-1ß and HIF-1α in gingival sulcus fluid are independent risk factors for PI complications in patients with implant restoration and can be used as an auxiliary predictor of PI complications in patients with implant restoration.


Subject(s)
Dental Implants , Peri-Implantitis , Humans , Interleukin-1beta , Intercellular Adhesion Molecule-1/analysis , Hypoxia-Inducible Factor 1, alpha Subunit , Gingiva , Gingival Crevicular Fluid , Dental Implants/adverse effects
6.
Infect Drug Resist ; 16: 879-889, 2023.
Article in English | MEDLINE | ID: mdl-36820081

ABSTRACT

Purpose: Tigecycline, the first glycylcycline antibiotic, which was widely used for off-label indications because of its broad-spectrum antibacterial activity. This study evaluated the indications for clinical use of tigecycline, clinical and microbiological effectiveness, factors associated with in hospital mortality, and bacterial resistance. Methods: This retrospective study evaluated all inpatients who received tigecycline treatment for >72 hours between January 2018 and December 2021 in a comprehensive teaching hospital in China. The evaluation included indications, administration regimen, etiology, efficacy and so on. Univariate and multivariate analyses were used to evaluate the risk factors for all-cause mortality. Results: There were 203 patients treated with tigecycline. Tigecycline was commonly prescribed for off-label indications (83.25%, 169/203), and hospital-acquired pneumonia ranked first (79.29%, 134/169). The most common pathogen was Acinetobacter baumannii. Clinical and microbiological success was 57.14% (116/203) and 32.28% (41/127), respectively. Fifty-four patients died and all-cause mortality was 26.60%. Univariate and multivariate analyses showed no significant difference in age, gender, off-label indication, duration of treatment, combination with other drugs, multidrug-resistant or extensively drug-resistant infections and tigecycline application scoring with respect to mortality. Conclusion: Although detection of A. baumannii has decreased in the past 4 years in our hospital, resistance to tigecycline has increased. For clinical application, physicians attach importance to detection of pathogenic microorganisms, but there is still empirical medication without bacterial culture reports. Therefore, an antibiotic stewardship program oriented toward tigecycline should be strengthened to curb bacterial resistance.

7.
Cancer Med ; 12(3): 2227-2237, 2023 02.
Article in English | MEDLINE | ID: mdl-35986570

ABSTRACT

BACKGROUND: Cutaneous adverse effects (AEs) are common following the phosphoinositide-3-kinase (PI3K) inhibitors treatment. We aim to estimate the incidence and risk of PI3K inhibitor-related cutaneous AEs. METHODS: The protocol was submitted to the PROSPERO registry. We searched ClinicalTrials.gov and international databases up to July 29, 2022. Meta-analysis was conducted by using risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: Fourteen randomized controlled trials (RCTs) comprising 3877 patients were analyzed in this study. Compared with control arms, PI3K inhibitors showed a significant increase in the risk of all-grade rash, high-grade rash, and serious rash events (RR 2.29, 95% CI 1.58-3.31, p < 0.00001; RR 9.34, 95% CI 4.21-20.69, p < 0.00001; RR 5.11, 95% CI 2.11-12.36, p = 0.0003). The overall incidences of all-grade rash and high-grade rash were 26.2% (592/2257) and 4.4% (66/1487). Subgroup analyses of all-grade rash according to cancer types and PI3K inhibitor assignations identified the significant associations. PI3K inhibitors also significantly increased the risk of pruritus and dry skin (RR 1.63, 95% CI 1.14-2.33, p = 0.007; RR 3.34, 95% CI 2.30-4.85, p < 0.00001), with incidences of 13.4% (284/2115) and 9.8% (141/1436) in the treatment group. CONCLUSION: There is a significantly increased risk of some cutaneous AEs in patients using PI3K inhibitors. Advance intervention is recommended in case of severe and life-threatening events. Further research is required to investigate the risk factors and pathogenesis.


Subject(s)
Exanthema , Neoplasms , Humans , Randomized Controlled Trials as Topic , Phosphoinositide-3 Kinase Inhibitors , Phosphatidylinositol 3-Kinases , Phosphatidylinositols
8.
Surg Obes Relat Dis ; 18(8): 1074-1086, 2022 08.
Article in English | MEDLINE | ID: mdl-35717432

ABSTRACT

This meta-analysis aimed to compare the effects of bariatric surgery and nonsurgery on cardiovascular outcomes in patients with obesity. A systematic literature search of the Medline (via PubMed), Embase, and Cochrane Central Register of Controlled Trials databases was performed until August 18th, 2021. Population-based cohort studies comparing long-term cardiovascular outcomes for patients with obesity undergoing bariatric surgery or not were included. A meta-analysis of relative risks (RRs) was performed for all outcomes. We conducted subgroup analyses and meta-regression to explore sources of heterogeneity and the stability of the results. Twenty-one population-based cohort studies involving 2,857,016 participants were identified. The major adverse cardiovascular event (MACE) RR in the bariatric surgery group was .53 (95% confidence interval [CI] = .45-.62, P < .001) relative to the nonsurgical group. Relative to the nonsurgical group, the risk of myocardial infarction (MI) (RR = .40, 95% CI = .30-.52, P < .001), stroke (RR = .60, 95% CI = .46-.79, P < .001), cardiovascular death (RR = .43, 95% CI = .35-.54, P < .001), and all-cause death (RR = .44, 95% CI = .32-.59, P < .001) was significantly reduced for patients who underwent bariatric surgery. In subgroup analyses, as the proportion of patients with diabetes mellitus increased, lower RRs for MACE, MI, and stroke were observed in the surgery group relative to the nonsurgical group. The decreased risk of MACE was also observed in the subgroup with median follow-up duration ≥5 years.Bariatric surgery improves cardiovascular outcomes in patients with obesity, especially providing long-term benefits, and this effect is more pronounced in patients with comorbid diabetes.


Subject(s)
Bariatric Surgery , Diabetes Mellitus , Myocardial Infarction , Stroke , Cohort Studies , Humans , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Obesity/surgery
9.
Int J Gen Med ; 15: 4937-4948, 2022.
Article in English | MEDLINE | ID: mdl-35592536

ABSTRACT

Background: Cervical cancer is the fourth most frequent malignancy among women globally, with approximately 604,000 new cases and 341,000 deaths per year. Necroptosis is a newly discovered mechanism of cell death involved in biological behaviors of cancer. Methods: LASSO Cox regression analysis was conducted to construct a prognostic necroptosis-related signature. lncRNA-miRNA-mRNA regulatory axis was constructed with a ceRNA network. qRT-PCR was performed to verify our result. Results: A total of 54 necroptosis-related genes were differentially expressed in cervical cancer (all p < 0.05). We also summarized genetic mutation landscape of necroptosis-related genes in cervical cancer. We then developed a necroptosis-related prognostic signature including 13 necroptosis-related genes (ATRX, AXL, DDX58, IDH1, ITPK1, MAP3K7, SLC39A7, TARDBP, TNF, TNFRSF1A, TNFRSF1B, TNFSF10, TRIM11) for cervical cancer. Cervical cancer patients with high riskscore had a poor overall survival (HR = 2.128, p = 0.00194) with an AUC of 0.725, 0.763 and 0.637 in 3-year, 5-year, and 10-year ROC curve. Consensus clustering analysis revealed that all cervical cancer cohort could be divided into three subtypes, which was correlated with different prognosis and immune infiltration (p < 0.05). A PPI network revealed TNF as the hub gene and TNF expression was correlated with immune infiltration (all p < 0.05), microsatellite instability (p < 0.012) and drug sensitivity (p < 0.05). The ceRNA network was performed and identified a lncRNA NUTM2B-AS1/miR-361-5p/TNF regulatory axis for cervical cancer. qRT-PCR result also suggested that TNF was upregulated in cervical cancer (p < 0.001) and associated with a poor overall survival (p = 0.007). Univariate and multivariate analysis demonstrated TNF expression, lymph node metastasis and clinical stage were prognosis factors of cervical cancer patients (p < 0.05). Conclusion: We developed a necroptosis-related prognostic signature including 13 necroptosis-related genes for cervical cancer. Moreover, we also identified a lncRNA NUTM2B-AS1/miR-361-5p/TNF regulatory axis, which may play a vital role in the progression of cervical cancer. Further studies should be conducted to verify these results.

10.
Medicine (Baltimore) ; 100(52): e28458, 2021 Dec 30.
Article in English | MEDLINE | ID: mdl-34967386

ABSTRACT

ABSTRACT: This study aimed to assess the impact of the pharmacist-led intervention on perioperative antibiotic prophylaxis by standardizing the cephalosporin intradermal skin test in the orthopedic department.A pre-and postintervention study was conducted among patients in the Orthopedics Department at the Beijing Chao-Yang Hospital in China. Use of intradermal skin test, perioperative antibacterial prophylaxis, and cost of care were compared between the preintervention population (admitted from 6/1/2018 to 8/31/2018) and postintervention population (admitted from 1/1/2019 to 3/31/2019). Logistic regression and generalized linear regression were used to assess the intervention impact.425 patients from the preintervention period and 448 patients from the postintervention period were included in the study. After the implementation of the pharmacist intervention program, there was a decrease in the utilization of intradermal skin tests, from 95.8% to 16.5% (P < .001). Patients were more likely to have cephalosporin as prophylactic antimicrobials (OR = 5.28, P < .001) after the implementation. The cost of antimicrobials was significantly reduced by $150.21 (P < .001) for each patient.Pharmacist-involved intervention can reduce the utilization of cephalosporins skin tests and decrease the prescription of unnecessary high-cost antimicrobials.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis/methods , Antimicrobial Stewardship/standards , Cephalosporins/therapeutic use , Intradermal Tests/standards , Orthopedic Procedures , Pharmacists , China , Hospitals , Humans , Middle Aged , Orthopedics
11.
J Pharm Pharm Sci ; 24: 292-307, 2021.
Article in English | MEDLINE | ID: mdl-34107240

ABSTRACT

PURPOSE: To evaluate the effect of hyperuricemia on clinical outcomes of renal transplant recipients (RTRs). METHODS: A literature search of PubMed, Cochrane, Embase was conducted up to March 20, 2020. The primary outcome was the estimated glomerular filtration rate (eGFR). The second outcomes were the risk of graft loss, death, cardiovascular event and the level of triglyceride. The following search terms were utilized: ((Hyperuricemic group) OR (Hyperuricaemia) OR (Hyperuric) OR (Urea acid) OR (Uric acid) OR (Acid urate) OR (Urate) OR (Gout)) and ((Transplantation) OR (Transplantations) OR (Transplant) OR (Transplants) OR (Graft)). RESULTS: 28 studies with 18224 patients were eligible for inclusion. There was no significant difference in eGFR (<12 months, p=0.07), the risk of graft loss (<60 months, p=0.07) and death (<60months, p=0.19) between the hyperuricemic and normouricemic group in the early post-transplantation period. But increased uric acid levels contributed to the long-term decline of eGFR, the risk of graft loss and death increased after transplantation. Hyperuricemia increased the risk of cardiovascular event with no significant difference in the level of triglyceride between the two groups. CONCLUSIONS: Increased uric acid levels contributed to the long-term decline of eGFR, increased risk of graft loss and death after transplantation. Although there was no significant effect on triglyceride, hyperuricemia increased the risk of cardiovascular event.


Subject(s)
Graft Rejection/epidemiology , Hyperuricemia/epidemiology , Kidney Transplantation , Glomerular Filtration Rate , Graft Rejection/physiopathology , Humans , Hyperuricemia/physiopathology , Risk Factors , Transplant Recipients , Treatment Outcome
12.
Clin Pharmacokinet ; 60(7): 877-885, 2021 07.
Article in English | MEDLINE | ID: mdl-33751414

ABSTRACT

OBJECTIVE: The aim of this systematic review and meta-analysis was to compare the clinical outcomes between genotype-guided and conventional tacrolimus doses in kidney transplantation patients. MATERIALS AND METHODS: We performed a comprehensive literature search of the PubMed, EMBASE, and Cochrane databases from the date of inception to 26 February 2020. References of the retrieved articles were also reviewed and any further relevant studies were included. The search terms included 'tacrolimus', 'cytochrome P-450 CYP3A', 'polymorphism, genetic', 'genomics', 'genome', 'genotype', 'genes', 'alleles', and 'pharmacogenetics'. RESULTS: Our study showed that the genotype-guided group included an increased proportion of patients with tacrolimus concentrations in the therapeutic range at steady state (risk ratio [RR] 1.40, 95% confidence interval [CI] 1.14-1.72, p = 0.001; high quality), with a trend for achieving therapeutic concentrations earlier compared with those in the conventional group. However, there was no statistical difference in the incidence of delayed graft function (RR 1.98, 95% CI 0.92-1.76, p = 0.12; moderate quality), incidence of acute rejection (RR 1.00, 95% CI 0.64-1.55, p = 1.00; moderate quality), incidence of graft survival censored for death (RR 1.02, 95% CI 0.98-1.06, p = 0.37; moderate quality), and incidence of adverse effects (AEs). CONCLUSIONS: Although the genotype-guided group had a higher proportion of patients within the targeted concentration and less median time to achieve the therapeutic range, the clinical endpoints, including delayed graft function, acute rejection, graft survival censored for death, and AEs were similar in both groups. All in all, evidence suggested there was no utility in pharmacogenetics for tacrolimus based on the cytochrome P450 (CYP) 3A5 genotype. Studies with Chinese and African American populations are needed due to the frequency of genetic polymorphisms of CYP3A5. Furthermore, a dosing algorithm that includes demographic and clinical factors plus multiple genetic variants should be added for consideration, and may optimize early tacrolimus exposure.


Subject(s)
Kidney Transplantation , Tacrolimus , Cytochrome P-450 CYP3A/genetics , Dose-Response Relationship, Drug , Genotype , Graft Rejection/genetics , Graft Rejection/prevention & control , Humans , Immunosuppressive Agents , Randomized Controlled Trials as Topic
13.
Br J Clin Pharmacol ; 87(7): 2937-2944, 2021 07.
Article in English | MEDLINE | ID: mdl-33474758

ABSTRACT

AIMS: This study aimed to assess the impact of pharmacist-led medication therapy management (MTM) performed on ambulatory elderly patients with chronic diseases. METHODS: Patients who came to a pharmacist-led outpatient clinic between January 2016 and June 2018 were enrolled in this study. Eligible subjects received MTM services from the pharmacists at least twice a year and the clinical data of these patients were complete. Drug-related problems (DRPs) and recommendations were evaluated using The Pharmaceutical Care Network Europe Classification for Drug related problems V8.03. RESULTS: A total of 525 DRPs were identified during the study period. Treatment effectiveness (53.71%) was the most common DRP. The most frequently recommended intervention was changing the drug (48.76%). There were 92.38% patients accepting the interventions and 90.48% patients completely implemented. The number of drugs taken was the significant associated factor for DRPs. Postintervention data collection showed lower levels in systolic blood pressure (BP) and diastolic BP compared to the preintervention data collection. There were statistically significant changes in total cholesterol, low-density lipoprotein cholesterol and triglycerides between the pre- and postintervention data collections. The average cost of medications per patient for every month decreased from 387.72 to 355.17 renminbi (P = .009). CONCLUSION: We confirmed that pharmacists had a valuable role to perform MTM services for ambulatory elderly patients, not only in identifying and solving the DRPs, but also in improving clinical outcomes (BP and lipid level) and cost-saving effect.


Subject(s)
Pharmaceutical Services , Pharmacists , Aged , Ambulatory Care Facilities , Chronic Disease , Humans , Medication Therapy Management
14.
J Oncol Pharm Pract ; 27(3): 614-622, 2021 Apr.
Article in English | MEDLINE | ID: mdl-32529950

ABSTRACT

BACKGROUND: Two new drugs, abiraterone and enzalutamide, had recently shown beneficial effects on survival in patients with metastatic castration-resistant prostate cancer. We systematically reviewed the efficacy and safety of abiraterone and enzalutamide in metastatic castration-resistant prostate cancer in real-world practice. METHODS: A search from PubMed, Web of Science, Cochrane, Embase was conducted up to 6 March 2019. Available articles from conferences were searched. The endpoint was prostate-specific antigen response, overall survival, progression-free survival, number of patients with any adverse event. RESULTS: Fourteen cohort studies involving 3469 participants were included. Pooled result showed that prostate-specific antigen response was higher for patients receiving enzalutamide than abiraterone (790 patients, odds ratio (OR) 0.47, 95% confidence interval (CI) 0.29-0.77, P = 0.003, I2=59%). Enzalutamide was significantly associated with increased adverse events rate in comparison with abiraterone (730 patients, OR 0.35, 95%CI 0.13-0.92, P = 0.03, I2=65%). There was no statistical difference between abiraterone and enzalutamide with respect to perceived cognitive impairments (1856 patients, OR 0.90, 95%CI 0.29-2.76, P = 0.85, I2=5%). Enzalutamide was significantly associated with increased fatigue risk in comparison with abiraterone (2477 patients, OR 0.46, 95%CI 0.34-0.63, P<0.00001, I2=0%). CONCLUSIONS: Our results demonstrated that enzalutamide was more efficacious than abiraterone for patients with metastatic castration-resistant prostate cancer, but was associated with a significantly elevated risk of side effects, particularly fatigue.


Subject(s)
Androstenes/therapeutic use , Phenylthiohydantoin/analogs & derivatives , Prostatic Neoplasms, Castration-Resistant/diagnosis , Prostatic Neoplasms, Castration-Resistant/drug therapy , Aged , Androstenes/adverse effects , Benzamides , Cohort Studies , Humans , Male , Nitriles , Phenylthiohydantoin/adverse effects , Phenylthiohydantoin/therapeutic use , Progression-Free Survival , Prostate-Specific Antigen/blood , Prostatic Neoplasms, Castration-Resistant/blood , Treatment Outcome
15.
Front Oncol ; 11: 801199, 2021.
Article in English | MEDLINE | ID: mdl-35127510

ABSTRACT

INTRODUCTION: Enfortumab vedotin (EV) has been demonstrated to have a significant response rate in early phase trials and is known for its tolerable side-effect profile. Emerging case reports have raised awareness of cutaneous toxicities, which may be a potentially fatal complication. OBJECTIVE: To assess the potential relevance between EV and cutaneous toxicities reports through data mining of the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS). METHODS: Data from January 1, 2019, to November 4, 2021, in the FAERS database were retrieved. Information component (IC) and reporting odds ratio (ROR) were used to evaluate the association between EV and cutaneous toxicities events. RESULTS: EV was significantly associated with cutaneous toxicities in the database compared with both all other drugs (ROR 12.90 [10.62-15.66], IC 2.76 [2.52-3.01], middle signal) and platinum-based therapy (ROR 15.11 [12.43-18.37], IC 2.91 [2.66-3.15], middle signal) in the FAERS database. A significant association was detected between EV and all the cutaneous adverse effects (AEs) except erythema, palmar-plantar erythrodysesthesia syndrome, and dermatitis allergic. Both Stevens-Johnson syndrome and toxic epidermal necrolysis occurred 15 times as frequently for EV compared with all other drugs (ROR = 15.20; ROR = 15.52), while Stevens-Johnson syndrome occurred 18 times and toxic epidermal necrolysis occurred 7 times as frequently for EV compared with platinum-based therapy in the database (ROR = 18.74; ROR = 7.80). All groups that limited the gender and age showed a significant association between EV and cutaneous toxicities. CONCLUSIONS: A significant signal was detected between EV use and cutaneous toxicities. It is worth noting that Stevens-Johnson syndrome and toxic epidermal necrolysis were significantly associated with EV use.

16.
J Clin Pharm Ther ; 46(1): 4-16, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33085789

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: The incidence of diabetes has been rising worldwide and is expected to increase to affect 591.9 million people by 2035 in China. Strict control of blood glucose can significantly reduce the risk of diabetic complications, but traditional interventions lack continuity, timeliness and teleonomy. The development of mobile health management has become a hot topic, as a very popular app in China, WeChat platform, has a large number of users every day. Many studies show the health management of patients with diabetes through WeChat can achieve the ideal effect. This study aims to evaluate the application of WeChat based on clinical research data, provide clinical evidence for medical staff and promote the self-management of patients with diabetes. METHODS: The PubMed, EMBASE, Cochrane Library, CNKI and Wanfang database were searched to identify related reports that were published up to 9 March 2020. The quality of included studies was assessed by Cochrane Collaboration risk assessment tool. Measures of interest were mean difference (MD) and 95% confidence interval (CI). Random-effect model was used according to the absence or presence of significant heterogeneity. Heterogeneity among trials was evaluated by I2 test. Publication bias was assessed by funnel plots. RESULTS AND DISCUSSION: Thirty-eight articles involved 2,709 controls and 2,709 patients who used WeChat were identified. Relative to the traditional group, WeChat group had a lower level in fasting plasma glucose (FPG in mmol/L; MD: 1.36, 95% CI 1.10-1.62, P < .00001), so did 2hPG (MD: 1.91, 95% CI 1.48-2.35, P < .00001) and HbA1C (MD: 1.07, 95% CI 0.86-1.27, P < .00001). Self-efficacy scale improved significantly, including diet score (MD: -1.31, 95% CI -1.77 to -0.86, P < .00001), exercise score (MD: -1.92, 95% CI -2.44 to -1.40, P < .00001), medication taking score (MD: -1.45, 95% CI: -1.94 to -0.97, P < .00001), monitoring of blood glucose score (MD: -1.17, 95% CI -1.83--0.51, P = .0005) and foot care score (MD: -1.71, 95% CI -2.08 to -1.34, P < .00001). Patients' understanding of the disease and satisfaction with follow-up increased significantly, whereas the incidence of adverse reactions and complications decreased. WHAT IS NEW AND CONCLUSION: WeChat follow-up appears to be helpful to improve the level of blood glucose and self-management, reduce the incidence of adverse reactions and complications, and improve the satisfaction rate of patients with type 2 diabetes. It should be noted that this meta-analysis has limitations, such as small sample sizes and the low quality of included literature, as well as the lack of research in Western countries. Therefore, more high-quality studies with larger samples are needed in the future to verify our results.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Mobile Applications , Self Care , Humans , Hypoglycemic Agents/administration & dosage
17.
J Pharm Pharm Sci ; 23: 451-461, 2020.
Article in English | MEDLINE | ID: mdl-33217255

ABSTRACT

PURPOSE: To compare the effectiveness and safety between abiraterone and enzalutamide in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS: We systematically searched for relevant articles from PubMed, Cochrane, Embase from their inception through November 4, 2019. Available articles from conferences were searched. The endpoints were prostate-specific antigen (PSA) response, overall survival (OS), progression-free survival (PFS), number of patients with any adverse event (AE). RESULTS: 15 cohort studies involving 3546 participants were included in this meta-analysis. Pooled result showed that PSA response rate in the enzalutamide group was significantly greater than that in the abiraterone group (867 patients, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.61-0.79, p<0.00001, I2=29%). There was no significant difference in the total incidence of AEs between two groups (730 patients, RR 0.42, 95% CI 0.14-1.31, p = 0.14, I2=84%). The common adverse events observed in the published articles were fatigue and perceived cognitive impairments. Patients who received enzalutamide had the higher risk to have the feeling of fatigue compared with abiraterone group (2555 patients, RR 0.45, 95% CI 0.24-0.85, p=0.01, I2=92%). And there was no statistical difference between two groups respect to the side effect of perceived cognitive impairments (1856 patients, RR 0.94, 95% CI 0.47-1.88, p=0.85, I2=15%). CONCLUSIONS: Our results demonstrated that enzalutamide was associated with higher PSA response rate compared to abiraterone in patients with mCRPC, and no significant difference was found between two groups in the overall AE. But enzalutamide use induced higher risk of the AE of fatigue.


Subject(s)
Androstenes/administration & dosage , Benzamides/administration & dosage , Nitriles/administration & dosage , Phenylthiohydantoin/administration & dosage , Prostatic Neoplasms, Castration-Resistant/drug therapy , Androstenes/adverse effects , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Benzamides/adverse effects , Humans , Male , Nitriles/adverse effects , Phenylthiohydantoin/adverse effects , Progression-Free Survival , Prostate-Specific Antigen/blood , Prostatic Neoplasms, Castration-Resistant/pathology , Survival Rate , Treatment Outcome
18.
J Cell Mol Med ; 24(20): 11718-11728, 2020 10.
Article in English | MEDLINE | ID: mdl-32881246

ABSTRACT

Pioglitazone (PIO) attenuates cisplatin nephrotoxicity whereas the underlying mechanism remains unknown. Apoptosis is associated with mitochondrial dysfunction and SIRT1 activation can decrease cell apoptosis in cisplatin nephrotoxicity. Therefore, we explored whether the protective effect of PIO in cisplatin nephrotoxicity is achieved by suppressing mitochondria-mediated apoptosis through SIRT1/p53 signalling regulation. Cell viability, apoptosis, survival rate, renal pathology and function were examined. Moreover, we also analysed the expression of SIRT1, Acetyl-p53, mitochondrial membrane potential (MMP), reactive oxygen species (ROS), mitochondrial permeability transition pore (mPTP) opening, adenosine triphosphate (ATP) and apoptosis-related protein in vivo and in vitro. Pioglitazone treatment significantly increased cell viability, promoted SIRT1-p53 interaction, upregulated Bcl-2 expression, activated SIRT1 and elevated mitochondrial ATP synthesis after cisplatin treatment. However, PIO decreased the generation of ROS, opening of mPTP, dissipation of MMP and translocation of cytochrome c after cisplatin treatment. Pioglitazone also reduced the activation of caspase-3 and caspase-9, lowered the ratio of Bax/Bcl-2, attenuated kidney pathological damage and dysfunction, down-regulated the expression of Acetyl-p53, PUMA-α and Bax and abated cell apoptosis after cisplatin treatment. The SIRT1 inhibitor, EX527, clearly reversed the protective effects of PIO. These results implied PIO attenuated cisplatin nephrotoxicity by suppressing mitochondria-mediated apoptosis through regulating SIRT1/p53 signalling.


Subject(s)
Apoptosis , Cisplatin/adverse effects , Kidney/pathology , Mitochondria/metabolism , Pioglitazone/pharmacology , Signal Transduction , Sirtuin 1/metabolism , Tumor Suppressor Protein p53/metabolism , Acetylation/drug effects , Animals , Apoptosis/drug effects , Apoptosis Regulatory Proteins/metabolism , Caspases/metabolism , Cell Line , Cell Survival/drug effects , Cytochromes c/metabolism , Enzyme Activation/drug effects , Kidney/drug effects , Kidney/physiopathology , Kidney Function Tests , Male , Mice, Inbred C57BL , Mitochondria/drug effects , Protein Binding/drug effects , Signal Transduction/drug effects , Tumor Suppressor Proteins/metabolism , bcl-2-Associated X Protein/metabolism
19.
J Clin Pharm Ther ; 45(6): 1325-1333, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32710453

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Pneumocystis jiroveci (P jiroveci) is an important opportunistic fungus and causes pneumocystis jiroveci pneumonia (PJP) in kidney transplant recipients (KTRs). By using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, the objective of this study was to evaluate the quality of PJP prophylaxis clinical practice guidelines (CPGs), and to help develop, update or improve guideline. METHODS: A search was conducted for PJP prophylaxis CPGs using PubMed, Embase, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), WanFang data, VIP Database, Google and guideline websites (until 18 January 2020). Data extraction and quality assessment were independently assessed by two appraisers, and the intra-class correlation coefficient (ICC) was used to assess interrater reliability. The specific recommendations were evaluated based on the quality results. RESULTS AND DISCUSSION: A total of 6 CPGs were included. The highest median scores were in the clarity of presentation domain (92%), and the lowest median scores were in the applicability domain (25%). The Kidney Disease Improving Global Outcome (KDIGO) and Renal Association (RA)/British Transplantation Society (BTS) CPGs were strongly recommended. The specific recommendations were inconsistent, such as the dose, frequency and duration. WHAT IS NEW AND CONCLUSION: The KDIGO and RA/BTS CPGs were strongly recommended. Not only the quality of the PJP prophylaxis CPGs needs to be improved during the development progress, but also the specific recommendations should be further refined.


Subject(s)
Pneumocystis carinii/isolation & purification , Pneumonia, Pneumocystis/prevention & control , Practice Guidelines as Topic/standards , Humans , Kidney Transplantation , Observer Variation , Opportunistic Infections/microbiology , Opportunistic Infections/prevention & control , Pneumonia, Pneumocystis/microbiology , Reproducibility of Results
20.
J Clin Pharm Ther ; 45(5): 1058-1065, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32516504

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: This study aimed to investigate the prevalence and the type of drug-related problems (DRPs) in ambulatory patients and identify factors that may be associated with risk of DRPs. METHODS: Consecutive patients were enrolled from pharmacist outpatient clinics between January 2018 and June 2019. The pharmacists performed a comprehensive assessment of the patient's drug therapy. The DRPs and recommendations were evaluated using the DOCUMENT classification system. RESULTS AND DISCUSSION: The study population consisted of 248 patients with a mean age of 72.55 ± 6.29. The patients had a mean of 7.55 ± 4.72 ongoing medications during patients' routine clinic visits. A total of 1188 DRPs were identified during the study period. An average of 4.79 DRPs per patient was detected. Sixty-two different traditional Chinese patent medicines (TCPMs) contributed to 102 DRPs. Drug selection (24.9%) was the most common DRP followed by under treated (24.2%) and monitoring needed (24.2%). The number of medications taken was the significant factor for DRPs. Pharmacists made 1092 recommendations to address the DRPs (an average 0.92 recommendations per DRP). A change in therapy was the most common recommendation (43.6%), followed by the category 'monitoring' (28.6%). The overall acceptance rate of clinical pharmacist recommendations was 88.7%. More than a half (51.6%) of all interventions were assigned a moderate level of clinical significance. WHAT IS NEW AND CONCLUSION: Drug-related problems were commonly observed among ambulatory Chinese patients. Clinical pharmacists had a valuable role to play in identifying and solving the DRPs.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Drugs, Chinese Herbal/adverse effects , Pharmaceutical Services/organization & administration , Pharmacists/organization & administration , Aged , Aged, 80 and over , Ambulatory Care Facilities , China , Drugs, Chinese Herbal/administration & dosage , Female , Humans , Male , Medicine, Chinese Traditional/adverse effects , Professional Role
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