Primary osteoporosis is a common systemic skeletal disease characterized by decreased bone mass and increased bone fragility, leading to a higher risk of fractures. Its pathogenesis is associated with an imbalance between bone resorption and bone formation. Commonly used medications include bone resorption inhibitors, bone formation stimulators, and duaaction drugs. In treatment, sequential therapy strategies have gained increasing attention, aiming to maintain bone mineral density and reduce fracture risk through different drug combinations. Recent studies have shown that sequential therapy involving medications such as teriparatide, bisphosphonates, denosumab, and romosozumab demonstrates promising effects. This paper reviews the research progress on sequential therapy for primary osteoporosis, discusses the selection of different drugs and their impact on bone density, and aims to provide a reference for clinical treatment.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse reaction of chemotherapy with clinical symptoms including numbness, tingling, and decreased sensation. Currently there is a lack of standard treatment methods for effectively controlling CIPN. Serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine and venlafaxine can alleviate pain by inhibiting the descending pain conduction pathway and have good efficacy and safety in CIPN patients, while also improving their quality of life of patients. However, the use of duloxetine and venlafaxine for CIPN is off-label, and their clinical application is currently limited. This article elaborates on the clinical efficacy and safety of SNRIs in CIPN patients, aiming to provide references for the clinical application of SNRIs.
Systemic lupus erythematosus (SLE) is a genetically complex autoimmune disease characterized by the production of many different autoantibodies, the formation of immune complexes, and inflammation in different organs, leading to multi organ and multi system dysfunction. The exact pathogenesis of SLE is still unclear, and it is currently believed that the interaction of genetic, ecological, and environmental factors is involved in the onset of SLE. Interferon (IFN) regulates gene activation, leading to IFN imbalance in the body, especially IFN‑α, which affects the patient's epigenetics and the function of various immune cells. It plays an important role in the occurrence and development of SLE and is considered as the core cause of immune abnormalities in SLE. This article mainly reviews the role of IFN-α in SLE and the drugs that affect IFN-α.
Donanemab-azbt is an amyloid β-directed antibody approved for marketing by the FDA on July 2, 2024 for the treatment of adults presenting with early symptoms of Alzheimer's disease (AD), including patients with mild cognitive impairment as well as those with AD in the mild dementia stage. Donanemab binds to insoluble, modified N-terminally truncated forms of β amyloid-like proteins present only in brain amyloid-like plaques and helps clear the plaques through microglia-mediated phagocytosis. This article reviews the mechanism of action, pharmacokinetics, clinical efficacy and safety of donanemab.
Seladelpar, a selective peroxisome proliferator-activated receptor‑δ agonist that regulates multiple genes involved in bile acid synthesis, inflammation, lipid and glucose metabolism, and antifibrotic processes, was approved by the FDA on August 14, 2024 for the treatment of primary biliary cholangitis (PBC). Seladelpar has demonstrated sustained efficacy and safety in numerous clinical trials. It is well absorbed orally, and its adverse events during treatment primarily include pruritus, diarrhea nausea, and muscle-related symptoms (myalgia, cramps). It is the first drug that has statistically significant advantages in biochemical reaction, alkaline phosphatase normalization and pruritis at the same time, filling a gap in the treatment of PBC. This article reviews the mechanism of action, pharmacokinetics, clinical efficacy and safety of seladelpar to inform clinical application.
Objective To analyze the incidence and influencing factors of adverse drug reactions (ADR) associated with second-generation nonionic iodinated contrast media (ICM) in the real world. Methods Data were collected from all patients who received second-generation nonionic ICM (iohexol, ioversol, or iopromide) at Xuanwu Hospital, Capital Medical University, between October 2020 and December 2022. The incidence of ICM-related ADR was analyzed based on the included patient data. Univariate and multivariate logistic regression analyses were performed to compare patients with and without ADR and to identify influencing factors. Results A total of 38205 patients with second-generation non-ionic ICM were collected, among whom 254 (0.66%) experienced ADR, including 10 (0.03%) severe cases.The most commonly affected systems/organs were the skin and appendages, primarily manifesting as rash and pruritus, followed by the urinary system. Univariate analysis showed significant differences between the ADR and non-ADR groups in age, history of hypertension, drug allergies, and antibiotic use (P<0.05). Multivariate logistic regression analysis identified history of hypertension, drug allergies, and antibiotic use as independent risk factors for ADR (P<0.05). Conclusion In clinical practice, patients receiving ICM require close monitoring for potential ADR, with immediate intervention when necessary.Healthcare providers should also strengthen proactive ADR reporting to enhance medication safety.
Objective To investigate the trends in the disease burden of drug use disorders in China from 1990 to 2021 and provide insights for prevention and control efforts. Methods Using data from the Global Burden of Disease Study 2021 (GBD 2021), this study analyzed the burden of drug use disorders in China from 1990 to 2021. Key metrics included incidence rate, disability adjusted life year (DALY) rate, age-standardized incidence rate, and age-standardized DALY rate. Joinpoint analysis was employed to examine trends in incidence and DALY rates across different age groups, with calculation of average annual percentage changes and 95% confidence intervals. Results From 1990 to 2021, both the incidence and DALY rate of drug use disorders in China showed downward trends. The incidence rate declined from 249.23/100 000 in 1990 to 172.29/100 000 in 2021, marking a 30.87% reduction. The DALY rate decreased from 301.79/100 000 in 1990 to 116.76/100 000 in 2021, a decrease of 61.31%. Throughout the study period, males consistently had higher incidence and DALY rates than females. Among different age groups, individuals aged 20 to 24 years old and 25 to 29 years old had the highest incidence and DALY rates in both 1990 and 2021. From 1990 to 2021, the incidence and DALY rates for the 10 to 14 age group showed slight increases of 0.98% and 0.95%, respectively. From 1990 to 2021, age-standardized incidence and DALY rates also demonstrated downward trends, with the most significant declines observed. The overall risk and disease burden associated with amphetamines and opioids gradually decreased over time. Opioid use disorders consistently ranked as the leading causes of DALY across the studied years in 1990, 2000, 2010, and 2021, with DALY rates of 163.72/100 000, 144.15/100 000, 67.25/100 000, 59.71/100 000, respectively. Conclusion While the overall burden of drug use disorders in China has decreased from 1990 to 2021, dependency remains a significant public health challenges. Sustained interventions targeting males, adolescents, and individuals with opioid use disorders are essential to further alleviate the burden of drug use disorders in China.
Objective To review the efficacy and safety of shuanghuanglian preparation in the treatment of colds. Methods The RCTs of shuanghuanglian preparation for the treatment of cold and flu were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase and the Cochrane Library. All searches were from inception to 6 May 2024.The data analysis was performed in RevMan 5.3. Cochrane risk of bias assessment tool was used to evaluate the quality of the involved RCT. Results A total of 17 RCTs were included with a total sample size of 2630 cases, including 1536 cases in the experimental group and 1094 cases in the control group. In terms of efficacy, compared with conventional western medicine/other proprietary Chinese medicine, shuanghuanglian preparation alone or combined with conventional western medicine in the treatment of cold can improve the total clinical effective rate (RR: 1.14, 95%CI: 1.08 to 1.20, P=0.12). Compared with conventional western medicine, combined oral preparation can be significantly reduce the time of cough disappearance, throat pain disappearance and nasal congestion and runny nose disappearance, combined injection or oral preparation can significantly reduce the time of fever reduction, accelerate the relief of clinical symptoms (P<0.05). But there was no statistically significant difference between TCM and other proprietary Chinese medicine in reducing TCM syndrome score (MD=0.11,95%CI: -0.86~1.08,P>0.05). In terms of adverse reactions, compared with conventional western medicine/other proprietary Chinese medicine, there was no statistically significant difference in the incidence of adverse reactions of shuanghuanglian preparation alone or in combination with conventional western medicine (RR=1.84, 95%CI: 0.95 to 3.56, P=0.18), but the incidence of adverse reactions of shuanghuanglian injection was higher than that of conventional western medicine (RR=2.57, 95%CI: 1.08~6.09, P=0.03). Conclusion Shuanghuanglian preparation is effective in the treatment of cold, and combination with conventional western medicines can accelerate the relief of symptoms. Shuanghuanglian preparation has good safety in clinical use, and the safety of oral preparation is higher than that of injection.
Objective To develop a medication therapy management (MTM) for patients with coronary heart disease (CHD) following percutaneous coronary intervention (PCI) under the pharmaceutical contract service mode and to evaluate its effectiveness. Methods A self-controlled before-and-after study design was employed. Patients who underwent PCI for CHD and were treated at three community health service centers in Fengtai District, Beijing, from October 2022 to November 2023 were selected. Changes in triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), medication adherence, and patient satisfaction were compared before and after MTM intervention. Additionally, changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and blood glucose control rates were compared for patients with diabetes. Results A total of 82 patients were included in the study, of whom 41 had diabetes. After MTM intervention by community pharmacists, significant reductions were observed in TG, TC, LDL-C levels, while HDL-C levels showed a significant increase (P<0.05). Medication adherence and patient satisfaction scores also improved compared to pre-intervention levels (P<0.05). For patient with diabetes, MTM intervention led to a significant decrease in HbA1c and FBG levels and a significant increase in blood glucose control rates (P<0.05). Conclusion The MTM for post-PCI CHD patients under the pharmaceutical contract service mode effectively improves clinical indicators, enhances medication adherence, and increases patient satisfaction.
Objective To evaluate the pharmacokinetics (PK), safety, and bioequivalence of two formulation of famitinib malate capsules under fasting condition, and to provide sufficient evidence for new formulation application in the late-stage clinical trials. Methods This single-center, randomized, open-label, two-period crossover study was conducted at the Phase Ⅰ Clinical Trial Center of Xuanwu Hospital, Capital Medical University, from May 20 to July 18, 2020. A total of 24 healthy Chinese subjects were enrolled to receive a single 25 mg oral dose of the test formulation (T, new formulation) or the reference formulation (R, old formulation) under fasting conditions, followed by a 14-day washout period before crossover administration. Blood concentrations were measured up to 192 hours post-dose using LC-MS/MS. PK parameters (Cmax, AUC0~t, AUC0~∞) were calculated via non-compartmental analysis. Bioequivalence was assessed using geometric mean ratios and their 90% confidence interval (CI). Safety events were recorded throughout the study. Results Among 73 screened subjects, 24 were enrolled and completed the study. The 90%CI of the geometric mean ratios of the test to reference formulations were 103.71% (98.95% to 108.69%) for Cmax, 103.67% (98.42% to 109.20%) for AUC0~t, and 103.50% (98.26% to 109.03%) for AUC0~∞, all of which were within the bioequivalence range of 80.00% to 125.00%. Both formulations were well-tolerated, with no serious adverse events reported. Conclusion The results showed that the T and R were bioequivalent and both formulations were safe and well tolerated.
Objective To evaluate the effectiveness, safety and economy of brentuximab vedotin for relapse and refractory classic hodgkin lymphoma (R/R cHL). Methods English and Chinese databases such as PubMed,the Cochrane Library, Embase, CNKI, and Wanfang databases were searched. Two researchers identified literatures, extracted data and assessed the quality of included studies based on inclusion and exclusion criteria independently. Results A total of 1 HTA report, 7 systematic review/meta-analysis and 5 pharmacoeconomic studies. In terms of effectiveness, compared with chemotherapy (CT), brentuximab vedotin could improve the overall survival (OS), progressive-free survival (PFS), complete response (CR) and objective remission rate (ORR) of patients with R/R cHL. Compared with placebo, brentuximab vedotin could improve the progressive-free survival (PFS) of patients with R/R cHL. Compared with allo-HSCT, brentuximab vedotin could improve the overall survival (OS) of patients with R/R cHL. Subgroup analysis showed that brentuximab vedotin could improve ORR in patients received 6 or more cycles therapy compared with CT. In terms of safety, compared with the non-brentuximab vedotin group, brentuximab vedotin group significantly increased the risk of all-grade adverse events (AEs) and high-grade AEs. In terms of pharmacoeconomics, compared with chemotherapy combined with (or without) radiotherapy, the economics of brentuximab vedotin in the treatment of R/R cHL at home and abroad were inconsistent. Conclusion Brentuximab vedotin has favorable efficacy in the treatment of R/R cHL, but its safety and economics need further research.
Objective To mine risk signals of adverse events associated with olopatadine using the U.S. FDA adverse event reporting system (FAERS) database, and to provide a reference for the safe use of drugs in clinical practice. Methods The FAERS database was accessed via Openvigil 2.1. Data related to olopatadine as the primary drug were retrieved from June 1, 2014, to June 1, 2024. Adverse event reports linked to olopatadine were analyzed using the proportional reporting ratio (PRR) method to detect potential signals. Results A total of 11 349 adverse event reports were retrieved, of which 6211 listed olopatadine as the primary suspected drug. Initial screening identified 600 adverse event signals, and 101 signals related to olopatadine were detected through PRR method, involving 12 system organ classes (SOCs). After manual screening and reorganization, 63 signals were obtained, involving 10 SOCs. The top 5 preferred terms (PTs) in terms of the number of reports were eye irritation, blurred vision, eye itching, eye congestion, and eye pain. The top 5 PTs in terms of the PRR signal intensity were eyelid hemorrhage, keratoconus, eye discharge, crusting of the eyelid margin, and sticky skin. Compared with the instructions of olopatadine, signals such as eyelid hemorrhage, keratoconus, and sticky skin, which were not mentioned in 34 drug product labels, mainly involved diseases of the eye organs. Conclusion Mining and analyzing real-world adverse event data of olopatadine helps summarize common adverse drug reactions and identify new potential risk signals, providing a basis for the rational and safe use of drugs in clinical practice.
Objective To provide a basis for the safe clinical use of antibody-drug conjugate (ADC), the relationship between eight ADCs and cardiac-related adverse events using the FDA adverse event reporting system (FAERS) database to ensure their safe clinical use. Methods Instances of cardiac-related adverse events linked to eight ADC, identified as the primary suspected medications, were gathered from the FAERS database covering the period from the third quarter of 2011 to the fourth quarter of 2023. The association between various drugs and adverse cardiac events was assessed using the reported odds ratio (ROR) method and the Bayesian credible interval progression neural network (BCPNN) approach. Results A total of 2439 reports of cardiac-related adverse events associated with 8 ADCs were analyzed, involving 1742 cases. Among these, 63.78% (1110/1742) were classified as serious events. After removing confounding factors related to congenital heart disease, signal detection using the ROR and BCPNN methods indicated positive signals of cardiotoxicity for gemtuzumab ozogamicin and brentuximab vedotin among the eight ADCs. In the analysis of preferred terms (PTs), 36 cardiac-related PTs signals were identified, including left ventricular dysfunction, cardiac failure, tachycardia, and various other adverse effects. Notably, 31 of these signals (such as left ventricular dilatation and defect conduction intraventricular) were not mentioned in the drug labeling. Conclusion ADC medications have a possible risk of cardiac toxicity, and it is important to enhance clinical monitoring of these drugs, especially regarding unusual side effects that are not included in the specifications.
This case report describes a patient with extensive-stage small cell lung cancer who developed immune myocarditis, peripheral neuropathy, and hypothyroidism following one cycle of durvalumab therapy. The occurrence and management of these immune related adverse reactions were analyzed in detail based on literature review. The aim of this study is to provide reference for physicians and pharmacists in the differentiation, diagnosis, and treatment of immune myocarditis, peripheral neuropathy, and hypothyroidism associated with durvalumab.
This paper reported a case of a patient who was routinely treated with sodium valproate for antiepileptic therapy after ventricular tumor resection, resulting in decreased fibrinogen (FIB), skin ecchymosis, and coagulation dysfunction. The prothrombin time algorithm showed that FIB function was normal, while the Clauss method showed that FIB function activity was decreased, D-dimer was increased, and FIB degradation products were normal, which ruled out the possibility of decreased synthesis or increased consumption of FIB. Referred to literature reports, it was speculated that the special structure of sodium valproate and its metabolites may competitively inhibit the binding sites of FIB and thrombin, thereby interfering with the process of conversion of FIB to fibrin and resulting in prolonged plasma coagulation time. After drug withdrawal, the patient's FIB level gradually returned to normal. For the patient treated with sodium valproate in this case, the FIB function should be monitored in time and the Clauss method should be especially used to avoid the potential risk of bleeding and provide a reference for clinical medication.
This case report provided details of the involvement of clinical pharmacists in managing a patient with central nervous system infection caused by Candida tropicalis. Guided by cerebrospinal fluid culture and metagenomic next-generation sequencing results, voriconazole combined with allicin was initially administered. Considering emerging fluconazole resistance, the regimen was escalated to liposomal amphotericin B combined with flucytosine. Therapeutic efficacy was systematically monitored through serial cerebrospinal fluid cultures while implementing pharmaceutical vigilance for adverse effects including allergic reactions, renal impairment, and electrolyte disturbances. The antimicrobial strategy was dynamically optimized based on therapeutic drug monitoring and clinical progression, ultimately achieving microbial eradication with negative fungal cultures and successful infection control. Through personalized pharmacotherapeutic management and comprehensive pharmaceutical care, the clinical pharmacy team ensured both therapeutic efficacy and medication safety throughout the treatment course.
This article reports the case data of a patient with metallo-beta-lactamase-producing escherichia coli bloodstream infection and searches the relevant literature at home and abroad. The clinical pharmacist recommended phosphomycin combined with amikacin for anti-infective treatment after combining the results of pathogenesis and drug sensitivity test. The patient got improved, and there were no adverse reactions during the treatment period. The clinical pharmacist assisted the physician to individualize the patient's medication, provided an economical and appropriate anti-infective solution, and carried out pharmaceutical care at the same time, which guaranteed the patient's medication safety.