The guideline for therapeutic drug monitoring guidelines development.

Aim: The guideline is meant to standardize the principles, procedures, and methods for developing therapeutic drug monitoring (TDM) guidelines and promoting open, transparent, scientific, and credible TDM guidelines.

Methods: Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society established guideline working groups, declared and managed conflicts of interest. The guideline working groups used the Delphi method to formulate the purpose and scope of the guidelines and questions in the PICO format, searched and synthesized evidence, and integrated with the current situation in China and TDM characteristics to preliminarily develop recommendations for the guideline for TDM guideline development in China.

A Clinical Practice Guideline for the Emergency Management of Anaphylaxis (2020).

For anaphylaxis, a life-threatening allergic reaction, the incidence rate was presented to have increased from the beginning of the 21st century. Underdiagnosis and undertreatment of anaphylaxis are public health concerns. This guideline aimed to provide high-quality and evidence-based recommendations for the emergency management of anaphylaxis.

Conbercept for Treatment of Neovascular Age-Related Macular Degeneration and Visual Impairment due to Diabetic Macular Edema or Pathologic Myopia Choroidal Neovascularization: A Systematic Review and Meta-Analysis.

Conbercept is a new anti-vascular endothelial growth factor (VEGF) drug. Here, we systematically conducted the efficacy, safety, compliance, and pharmacoeconomic evaluation of intravitreal conbercept (IVC) compared with other treatments in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or pathologic myopia choroidal neovascularization (pmCNV). Databases of PubMed, Embase, Cochrane Library, ClinicalTrials.

Cost-Effectiveness of Aprepitant in Preventing Chemotherapy-Induced Nausea and Vomiting: A Systematic Review of Published Articles.

The aim of this systematic review is to assess the published cost-effectiveness analyses of aprepitant for patients with chemotherapy-induced nausea and vomiting (CINV). A systematic literature search was performed on PubMed, EMbase, the Cochrane Library, CNKI, WANFANG DATA, and CBM database. The date of publication is up to January 2019.

A systematic review and meta-analysis of anticoagulation therapy for portal vein thrombosis in patients with cirrhosis: to treat or not to treat?

Purpose: To date, the optimal treatment for portal vein thrombosis (PVT) in cirrhotic patients has not been established in guidelines or consensus. We conducted a systematic review and meta-analysis to evaluate the effect of anticoagulation therapy in patients with cirrhosis and PVT.

Methods: PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.

Cost-effectiveness of empagliflozin in patients with type 2 diabetes and established cardiovascular disease in China.

Background: In several cardiovascular outcome trials (CVOTs), empagliflozin (SGLT-2 inhibitor), sitagliptin (DPP-4 inhibitor) and liraglutide (GLP-1 receptor agonist) + standard of care (SoC) were compared to SoC in patients with type 2 diabetes and established cardiovascular disease (CVD). This study assessed the cost-effectiveness (CE) of empagliflozin + SoC in comparison to sitagliptin + SoC and liraglutide + SoC based on the respective CVOT.

Methods: The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the CVOT outcomes.

Cost-effectiveness analysis of empagliflozin compared with glimepiride in patients with Type 2 diabetes in China.

The study assesses the cost-effectiveness of empagliflozin versus glimepiride in patients with Type 2 diabetes and uncontrolled by metformin alone in China, based on the EMPA-REG H2H-SU trial. A calibrated version of the IQVIA Core Diabetes Model was used. Cost of complications and utility were taken from literature.

Antiemetic regimen with aprepitant in the prevention of chemotherapy-induced nausea and vomiting: An updated systematic review and meta-analysis.

Objective: To systematically evaluate the efficacy and safety of antiemetic regimen with aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) and provide updated information for clinical practice.

Methods: Pubmed, Embase, the Cochrane Library, and 3 Chinese literature databases were systematically searched. Randomized controlled trials comparing standard regimen (5-hydroxytryptamine-3 receptor antagonist and glucocorticoid) with aprepitant triple regimen (aprepitant plus the standard regimen) for preventing CINV were screened.

Empagliflozin in Type 2 Diabetes Mellitus Patients with High Cardiovascular Risk: A Model-Based Cost-Utility Analysis in China.

Purpose: To evaluate the cost-utility of empagliflozin, in addition to best available standard care (BASC), for the treatment of adult patients with T2DM at high cardiovascular risk from the Chinese healthcare system perspective.

Methods: A Microsoft Excel-based patient-level simulation model, based on the EMPA-REG OUTCOME trial data, was adapted and used to project individual's clinical and economic outcomes over a lifetime horizon. The cost and utility values were derived from databases and published studies.

Thalidomide as a treatment for inflammatory bowel disease in children and adolescents: A systematic review.

What Is Known And Objective: Thalidomide is used off-label for the treatment of inflammatory bowel disease (IBD) and not as a first-line treatment option. The instructions clearly state that thalidomide is contraindicated in children because its safety and effectiveness in children are unknown. In this article, we review the efficacy and safety of thalidomide as a treatment for IBD in children and adolescents.

Lixisenatide for Type 2 Diabetes Mellitus Patients Inadequately Controlled on Oral Antidiabetic Drugs: A Mixed-Treatment Comparison Meta-analysis and Cost-Utility Analysis.

Introduction: The aim of this study was to compare the efficacy, safety and cost-utility (from the Chinese health insurance perspective) of lixisenatide and insulin regimens in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).

Methods: A comprehensive literature search of English (PubMed and Cochrane Library) and Chinese (CNKI and WanFang) language databases was performed, and head-to-head relevant randomized controlled trials (RCTs) were retrieved and analyzed by performing a mixed-treatment comparison (MTC) meta-analysis for efficacy and safety endpoints. A cost-utility analysis was then conducted using the IQVIA CORE Diabetes Model to compare the lifetime pharmacoeconomic profiles among the treatment groups.

Comparative cost-effectiveness of amisulpride and olanzapine in the treatment of schizophrenia in China.

Background: Both amisulpride and olanzapine are leading treatments for schizophrenia in China. This study aimed to investigate the long-term cost-effectiveness of amisulpride and olanzapine in the treatment of schizophrenia in China.

Methods: A decision-analytic Markov model was developed to simulate the lifetime clinical and economic outcomes of schizophrenia treatment from the healthcare payer perspective.

Risk of Gastrointestinal Adverse Events in Cancer Patients Treated With Immune Checkpoint Inhibitor Plus Chemotherapy: A Systematic Review and Meta-Analysis.

The combination of immune checkpoint inhibitors (ICIs) and chemotherapy can improve clinical outcomes in the treatment of various tumors, but may also be associated with more adverse events (AEs). We performed a systematic review and meta-analysis to characterize the risk of gastrointestinal AEs in cancer patients treated with ICI plus chemotherapy. This review was based on comprehensive search through PubMed, EMBASE, and the Cochrane Library for randomized controlled trials (RCTs) that reported gastrointestinal AEs following the use of ICI plus chemotherapy.

Is De-escalated Bisphosphonates Therapy a Suitable Alternative to Standard Dosing in Malignant Tumor Patients With Bone Metastases: A Systematic Review and Meta-Analysis.

Previous studies have preliminarily identified the non-inferior efficacy for reducing skeletal-related event (SRE) rates between de-escalated (Q12w) and standard (Q3-4w) bone-targeting agents therapy in malignant tumor patients with bone metastases. In this study, we aim to make further efforts to analyze whether the de-escalated bisphosphonates (BPs) strategy is a suitable option by comprehensively retrieving and synthesizing state-of-the-art evidence. An extensive electronic search for randomized controlled trials (RCTs) comparing a BPs standard strategy with the de-escalated one in patients with bone metastases was performed up to June 2018.

Lixisenatide versus insulin glulisine on top of insulin glargine in patients with type 2 diabetes mellitus: a cost-per-responder analysis in China.

To compare the cost per responder of lixisenatide versus insulin glulisine once daily (basal-plus) and three times daily (basal-bolus) on top of basal insulin for the treatment of patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin in China. The cost per responder was estimated based on clinical data obtained from the GetGoal Duo-2 clinical trial and direct medical costs from the perspective of the Chinese healthcare system over a 52-week time horizon. The response was assessed at week 26 in the clinical trial, which was extrapolated to 52 weeks to estimate the annual cost per responder.

Comparison of lixisenatide in combination with basal insulin vs other insulin regimens for the treatment of patients with type 2 diabetes inadequately controlled by basal insulin: Systematic review, network meta-analysis and cost-effectiveness analysis.

Aims: To evaluate the comparative efficacy and safety of lixisenatide combined with basal insulin (BI) vs intensive premix insulin (premix), BI plus prandial insulin with the main meal (basal-plus) or progressively covering all meals (basal-bolus) in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by BI, and the long-term cost-effectiveness of lixisenatide from a Chinese healthcare system perspective.

Materials And Methods: Randomized controlled trials (RCTs) published between 1998 and 2018 were systematically searched. The clinical efficacy and safety of each treatment were compared by network meta-analysis (NMA).

Effect of dipeptidyl-peptidase-4 inhibitors on C-reactive protein in patients with type 2 diabetes: a systematic review and meta-analysis.

Background: Dipeptidyl peptidase-4 inhibitors (DPP-4i) are emerging glucose-lowering agents through interacting with DPP-4 substrate, impact of which on systemic inflammation in type 2 diabetes mellitus (T2DM) remains unknown. This study aimed to evaluate the effect of DPP-4i on modulating serum levels of C-reactive protein (CRP) in T2DM.

Methods: PubMed, Cochrane library and Embase databases were searched.

Comparative efficacy and safety between amisulpride and olanzapine in schizophrenia treatment and a cost analysis in China: a systematic review, meta-analysis, and cost-minimization analysis.

Background: Amisulpride was introduced into China in 2010 as a second-generation atypical antipsychotic, while olanzapine has been on the market since 1999 as one of the leading treatments for schizophrenia in China. Since more Chinese patients are gaining access to amisulpride, the study aims to compare the efficacy, safety, and costs between amisulpride and olanzapine for schizophrenia treatment in China.

Methods: PubMed, Embase, the Cochrane library, China National Knowledge Infrastructure (CNKI) and WanFang database were systematically searched for randomized controlled trials (RCTs) up to July 2018.

Efficacy and safety of saxagliptin in patients with type 2 diabetes: A systematic review and meta-analysis.

Objective: To evaluate the comparative efficacy and safety of saxagliptin for type 2 diabetes (T2D).

Methods: A systematic search of PubMed, Embase, the Cochrane Library, Web of Science, ClinicalTrials.gov and two Chinese databases for randomized controlled trials (RCTs) comparing saxagliptin with placebo or active comparators was performed up to July 2017.

Efficacy and Safety of Lomitapide in Hypercholesterolemia.

Background: Despite extensive use of statins, patients with hypercholesterolemia, especially homozygous familial hypercholesterolemia (HoFH), do not achieve recommended targets of low-density lipoprotein cholesterol (LDL-C). There is an urgent need for novel options that could reduce proatherogenic lipoprotein cholesterol levels. Lomitapide, a microsomal triglyceride transport protein (MTP) inhibitor, was approved three years ago as an orphan drug for the treatment of patients with HoFH.

Impact of dipeptidyl peptidase-4 inhibitors on serum adiponectin: a meta-analysis.

Background: Adiponectin, an adipose-specific protein, is negatively correlated with pro-atherogenic low-density lipoprotein cholesterol (LDL-C) and other cardiovascular risk factors such as insulin resistance. Therefore, low levels of adiponectin are associated with a higher risk for diabetes and cardiovascular disease. Dipeptidyl peptidase-4 inhibitors (DPP4i) have been used for the treatment of type 2 diabetes mellitus (T2DM) as reversible inhibitors through interacting with DPP4 substrate and increase serum incretins such as glucagon-like peptide-1 (GLP-1).

Association between the AUC0-24/MIC Ratio of Vancomycin and Its Clinical Effectiveness: A Systematic Review and Meta-Analysis.

Background: A target AUC0-24/MIC ratio of 400 has been associated with its clinical success when treating Staphylococcus aureus infections but is not currently supported by state-of-the-art evidence-based research.

Objective: This current systematic review aimed to evaluate the available evidence for the association between the AUC0-24/MIC ratio of vancomycin and its clinical effectiveness on hospitalized patients and to confirm the existing target value of 400.

Methods: PubMed, Embase, Web of Sciences, the Cochrane Library and two Chinese literature databases (CNKI, CBM) were systematically searched.

Discovery, synthesis and biological evaluation of 2-(4-(N-phenethylsulfamoyl)phenoxy)acetamides (SAPAs) as novel sphingomyelin synthase 1 inhibitors.

Sphingomyelin synthase (SMS) has been proved to be a potential drug target for the treatment of atherosclerosis. However, few SMS inhibitors have been reported. In this paper, structure-based virtual screening was performed on hSMS1.