Analysis of Data on Adverse Drug Events Reported to the Food and Drugs Administration of the United States of America

Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.

Enlightenment of COVID-19 Treated by Botanical Drugs on the Development of Drugs for Rare Diseases in China

Objective To study the feasibility of developing botanical drugs to treat intractable diseases and play an important role in dealing with major public health crises.Methods From January 1990 to May 2021,a bibliographic search was carried out on the use of botanical drugs,rare disease drugs,related registration management policies and regulations in PubMed and CNKI.The following keywords were searched in the database:Rare disease policies and regulations,orphan drugs,botanical drugs for intractable diseases,botanical drugs for the treatment of new coronary pneumonia,traditional Chinese medicine,and emergency guidelines for major public health crisis.Other data were obtained from“Chinese Pharmacopoeia”and relevant Chinese government websites for sorting and analysis.Results and Conclusion Based on 39 Chinese corresponding policies and regulations,challenges and opportunities of developing and researching drugs for treating rare diseases were found out after the analysis and comparison.Based on the study of national policies on drugs for rare diseases,the priority review and approval procedures in the drug registration,as well as China’s emergency guidelines and policies for major public health events,some problems in the use of drugs for rare diseases are found out.Therefore,it is recommended to actively adopt the property rights protection system,explore the folk prescriptions of traditional Chinese medicine and the potential of hospital preparations,and the registration review strategy of giving priority to the use of botanical drugs for rare diseases.Thus,the international status of botanical drugs for rare disease and the influence of responding to major public health events can be enhanced.

Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces

Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces.Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021,combined with the current provisions and implementation of drug spot check management in China.Results and Conclusion At present,there are some problems in the drug spot check of Chinese herbal pieces,such as fewer varieties of Chinese herbal pieces in the national drug spot check,the unreasonable sampling links,the insufficient territorial management in some areas,and error-prone sample extraction.It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan.Besides,the variety coverage of drug spot check of traditional Chinese medicine should be strengthened.In the planning,the sampling links shall be made as a whole,and the credit rating and distribution of drug production,operation and use units within the jurisdiction shall be fully combined.While strengthening the sampling management at the production end in areas with concentrated industries,regional special drug spot check should be carried out or the administrative forces at the provincial,municipal and county levels should be fully mobilized to avoid local protection.In the assigned tasks,the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods.

A Retrospective Analysis on 1330Adverse Event Reports of Qingkailing in China:Further Perception of Its Risks and Rational Use

Qingkailing (QKL)is a modern preparation exploited according to the traditional Chinese medicine theory.It becomes the second leading cause of adverse drug events (ADEs)in all traditional Chinese medicine injections.The safety evaluation and rational use of QKL are of special importance.This retrospective study used data from Adverse Drug Reaction Monitoring Center of Hubei Province in China from January 2012 to December 2014.ADE cases induced by QKL were collected and analyzed according to patients'demographics,characteristics of drugs involved,characteristics of ADEs,causality,and outcomes.A total of 1330 qualified ADEs were included.Most ADEs occurred within 30 min after administration and the 0-10 years old age group had the highest number of ADEs.The common ADEs included anaphylactic reaction,dyspnea and nausea.Serious reactions accounted for 5.19%.Combination with cephalosporin (74/146,50.69%) caused more ADEs than other drugs did.Serious attention should be paid when QKL is used for children,and combination with cephalosporin should be avoided.

Clinical profile of medication-related emergencies among patients presenting to the emergency department:An observational study

Objective:To determine the clinical profile of patients presenting with medication-related emergencies to the Emergency Department of our institute.Methods:This was an observational study conducted between November 2018 and September 2020 at Bangalore Baptist Hospital,Karnataka.A total of 138 subjects who satisfied the inclusion criteria were included in the study.The severity of adverse drug reactions(ADR)is assessed based on the Hurwitz severity assessment scale of ADR.Glasgow coma scale at the time of presentation and source of medication were noted.The type of drug overdose,requirement of advanced airway and vasopressors,and the outcome were also assessed.Results:Among medication-related emergencies(n=138)in our study,ADR contributed to 70.3%(n=97)of the study population,and drug overdose accounted for 29.7%(n=41).One-third of the ADR occurred in patients aged above 60 years.Most patients were hemodynamically stable and did not require vasopressors,or advanced airway in both groups.Most patients had Glasgow coma scale ranging from 13-15 in both groups.Nonsteroidal anti-inflammatory drugs were the most used medicine(17/41,41.5%)and most medications were over the counter drugs(25/41,61.0%)in the drug overdose group;meanwhile in the ADR group,anti-diabetic medication was the most used medicine(34/97,35.1%)and most medications were prescribed in the ADR group(93/97,95.9%).Conclusions:Our study shows that ADR is the most common type of medication-related emergency.

Evidence-based expert consensus on clinical management of safety of Bruton’s tyrosine kinase inhibitors(2024)

Bruton’s tyrosine kinase inhibitors(BTKis)have revolutionized the treatment of B-cell lymphomas.However,safety issues related to the use of BTKis may hinder treatment continuity and further affect clinical efficacy.A comprehensive and systematic expert consensus from a pharmacological perspective is lacking for safety issues associated with BTKi treatment.A multidisciplinary consensus working group was established,comprising 35 members from the fields of hematology,cardiovascular disease,cardio-oncology,clinical pharmacy,and evidencebased medicine.This evidence-based expert consensus was formulated using an evidence-based approach and the Delphi method.The Joanna Briggs Institute Critical Appraisal(JBI)tool and Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach were used to rate the quality of evidence and grade the strength of recommendations,respectively.This consensus provides practical recommendations for BTKis medication based on nine aspects within three domains,including the management of common adverse drug events such as bleeding,cardiovascular events,and hematological toxicity,as well as the management of drug-drug interactions and guidance for special populations.This multidisciplinary expert consensus could contribute to promoting a multi-dimensional,comprehensive and standardized management of BTKis.

Spontaneous and iatrogenic dehydration in the elderly alone or in combination with antiplatelet/anticoagulation agents and risk of subdural hematoma

Background and Purpose: To evaluate the role of preadmission conditions, dehydration specifically, in the development of subdural hematoma in the elderly. Methods: Retrospective chart review. Results: The most prevalent pre-admission medical condition was hypertension, followed by atrial fibrillation, CAD, hyperlipidemia, diabetes, and cancer. Out of 95 patients, 69 (73%) had features of dehydration, 27% were on diuretics and 28% were on antiplatelet agents and anticoagulation. Conclusions: Elderly population is prone to dehydration. Overzealous use of diuretics especially in combination with anticoagulation or antiplatelet therapy can contribute to the development of subdural hematomas, both spontaneous and traumatic.

The Adverse Event Profile in Patients Treated with Transferon^TM(Dialyzable Leukocyte Extracts): A Preliminary Report

Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.

Interim Outcomes and Adverse Events among Drug-Resistant Tuberculosis Patients Treated with Bedaquiline in the Philippines

Objectives: This study aimed to assess the interim outcomes for drug-resistant tuberculosis (DR-TB) patients treated with bedaquiline regimen under the operational research conditions compared to DR-TB patients treated without bedaquiline in their regimen, and to describe the adverse events that occurred among patients treated with bedaquiline in the Philippines. Design: Patients who were treated with a bedaquiline-containing regimen from June 2016 to May 2017 were included in this study as the intervention group, while patients who were treated without bedaquiline regimen from January 2013 to May 2016 were included as the comparison group. The interim treatment outcomes were compared using Chi-square test. The analysis of time to culture conversion within 6 months of treatment was conducted. A Cox proportional hazard model was constructed to identify the variables associated with a favorable interim treatment outcome. The R program was used for statistical analysis. Results: On the 6th month of treatment, the culture conversion for patients treated with a bedaquiline-containing regimen was significantly higher than with the comparison group [63/75 (84.0%) vs 84/117 (71.8%), p = 0.012)]. Nearly 15% of the patients treated with bedaquiline were lost to follow-up. Frequent adverse events included vomiting, dizziness, nausea, joint pain, and abdominal pain. Conclusion: The patients who were treated with bedaquiline-containing regimen have better interim treatment outcomes than those treated without bedaquiline, but the proportion of patients who were lost to follow-up remains substantial.

Comparison of clinical outcomes of Chinese men and women after coronary stenting for coronary artery disease:a multi-center retrospective analysis of 4,334 patients

The outcome differences between Chinese male and female patients within one-year follow-up after percutaneous coronary intervention（PCI） with stent remain unclear.The present study was aimed to compare clinical outcomes in such two populations.From May 1999 to December 2009,4,334 patients with acute myocardial infarction（MI）,unstable angina,stable angina,or silent ischemia,who underwent PCI,were registered at our centers.Among these,3,089 were men and 1,245 were women.We compared these groups with respect to the primary outcomes of MI and secondary outcomes including a composite of major adverse cardiac events（MACE） including cardiac death,MI,target lesion revascularization,target vessel revascularization（TVR）,stent thrombosis（ST）,definite ST and probable ST at one-year follow-up.Chinese male patients had a higher MACE rate（13%vs.10.7%,P =0.039）,mainly led by TVR（9.09%vs.6.98%,P=0.024） at one year,which was significantly different than female patients.Chinese male and female patients showed a significant difference on MACEs.However,there was no significant difference with respect to MI between these groups.

Modes of failure with fractional flow reserve guidewires:Insights from the manufacturer and user facility device experience database

BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Systematic review on the adverse reactions of oral administration of Indigo Naturalis and its preparations

Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.

Domestic versus imported drug-eluting stents for the treatment of patients with acute coronary syndrome

BACKGROUND:The application of coronary stents,especially drug-eluting stents(DESs),has made percutaneous coronary intervention(PCI) one of important therapeutic methods for CHD. DES has reduced the in-stent restenosis to 5%–9% and signifi cantly improved the long-term prognosis of patients with CHD. The study aimed to investigate the long-term eff icacy and safety of domestic drugeluting stents(DESs) in patients with acute coronary syndrome(ACS).METHODS:All patients with ACS who had undergone successful percutaneous coronary intervention(PCI) in the First Aff iliated Hospital of Zhengzhou University from July 2009 to December 2010 were included in this study. Patients were excluded from the study if they were implanted with bare metal stents or different stents(domestic and imported DESs) simultaneously. The included patients were divided into two groups according to different stents implanted:domestic DESs and imported DESs.RESULTS:In the 1 683 patients of this study,1 558(92.6%) patients were followed up successfully for an average of(29.1±5.9) months. 130(8.3%) patients had major adverse cardiovascular events(MACEs),including cardiac death in 32(2.1%) patients,recurrent myocardial infarction in 16(1%),and revascularization in 94(6%). The rates of cardiac death,recurrent myocardial infarction,revascularization,in-stent restenosis,stent thrombosis and other MACEs were not signif icantly different between the two groups(all P>0.05). Multivarite logistic regression revealed that diabetes mellitus(OR=1.75,95%CI:1.09–2.82,P=0.021),vascular numbers of PCI(OR=2.16,95%CI:1.22–3.83,P=0.09) and PCI with left main lesion(OR=9.47,95%CI:2.96–30.26,P=0.01) were independent prognostic factors of MACEs. The Kaplan-Meier method revealed that there was no significant difference in cumulative survival rates and survival rates free from clinical events between the two groups(all P>0.05).CONCLUSIONS:The incidences of clinical events and cumulative survival rates are not statistically different between domestic DESs and imported DESs. Domestic DES is effective and safe in the treatment of patients with ACS.

Therapeutic effect of interventional therapy for unprotected left main coronary artery lesions in aged patients

ObjectiveTo assesse 在有没有防卫的左主要冠的动脉( UPLM )的年老的病人的 interventional 治疗的治疗学的效果是超过 60 年并且在我们的医院里从2012年1月接受了 UPLM 的 interventional 治疗到2013年11月的 61 个病人全部的 lesions.MethodsA 被跟随在上面为由电话的一般水准 14.6 月或门诊病人访问。我们分析了 interventional 治疗的临床的特征数据并且估计了多半影响了 61 个病人的临床的 prognosis.ResultsThe 一般水准年龄的因素是 73.9 年。平均左室的喷射部分(LVEF ) 是 47.7% 。估计的 glomerular 过滤率(eGFR ) 中部每 1.73 公里 2 是 52 mL/min。平均句法分数是 27.4 并且 stent 中部长度是 36 公里。在在一年以后的 30 天和主要不利心脏的事件(向) 的心脏的死亡的累积发生是 6.6% 和 32.5% 分别地由 Kaplan-Meier 阴谋估计了。没有严重出血性的复杂并发症在后续时期期间被观察。在有比例的危险建模的艇长的 multivariate 回归分析上， LVEF 是在 30 天的心脏的死亡的一个独立预言者[危险比率(HR ) ：0.7， P = 0.01 ] 。至于在一年以后的向， LVEF 和 eGFR 两个都是独立预言者(HR：0.91， P = 0.06 为 LVEF， HR：0.03， P = 0.097 为 eGFR ) 为 UPLM 的 .ConclusionsThe interventional 治疗在年老的病人有效、安全。LVEF 是在 30 天的心脏的死亡的唯一的预言者，当 LVEF 和 eGFR 两个都是在一年以后的向的独立预言者时。

Onset Time Profiles for Syncope Associated with <i>α</i>₁-Adrenoceptor Blockers in Males: Analysis of a Spontaneous Adverse Drug Event Database

Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present study was to evaluate the onset time profiles for syncope associated with the use of α1Bs. Methods: We analyzed the data obtained from?the Japanese Adverse Drug Event Report (JADER) database for a period from April 2004 until November 2016 and calculated reporting odds ratios (RORs) for eight α1Bs available on the Japanese market, using disproportionality analysis. Moreover, time information recorded in the JADER database was analyzed to evaluate the onset times of adverse events. Results: In total, 186,724 reports for males older than 20 years were analyzed. Significant RORs for syncope, with 95% confidence intervals, were obtained for naftopidil (2.53, 1.81 - 3.53), silodosin (4.24, 2.37 - 5.20), and tamsulosin (2.22, 1.75 - 2.81). The median onset times of syncope for naftopidil, silodosin, and tamsulosin were 37, 26, and 108 days, respectively. The shape parameters obtained by fitting the data for the three α1Bs to the Weibull distribution were all less than 1.0, indicating that all these drugs could be classified as the early failure type. The cumulative incidence rates showed that the onset times of syncope tended to be similar among the three α1Bs. Conclusions: Patients treated with selective α1Bs should be closely monitored for 100 days, especially in the first 20 to 40 days after initiation of silodosin or naftopidil. This information may be useful for patients and healthcare professionals in preventing syncope due to the use of selective α1Bs.

Use of Cholesterol-Lowering Medications of Patients with Myocardial Infarction from 2007-2015 in Cardiology Clinic to “Mother Teresa” University Hospital in Albania

Background: Coronary Heart Disease (CHD) remains the leading cause of morbidity and mortality in Albania. According to Institute of Statistics of Albania (ISA), CHD remains in the 5 first places caused mortality and morbidity in our country. Currently, all the protocol treatments to Mother Teresa University Hospital (MTUH) are focused on low-density lipoprotein cholesterol (LDL-C) as the primary target for risk reduction therapy, followed by triglycerides (TG) and high-density lipoprotein cholesterol (HDL). Our clinicians recommend that the intensity and target goals of LDL-C-lowering therapy should be adjusted to individual treatment. The choice of a specific drug from anti hypercholesterolemia class depends on several factors which need to be evaluated better from our health providers. Methods and Findings: Data was collected between 2007 to 2015 at Mother Teresa University Hospital (MTUH), Intensive Care Unit in Cardiology Clinic. 700 patients were treated with statins as follows: Fluvastain 40 mg and 80 mg, Atorvastatin 10 mg and 20 mg, Simvastatin and Rosuvastatin 20 mg. Statins are increased significantly during the years compared with fibrates. Their use grew from 87% of all statin types to 95% in 2015, with different types from fluvastatin in 2007 to atorvastatin being the leading medication in 2015. Coronary Heart Disease, especially Myocardium Infarct, were studied as diseases when meanly the hypolipidic drugs were usually used in medical protocol treatment. Statins and fibrates were the therapy target to be studied when statin dominated the patients’ treatment and fibrates were used in limited quantity. Atorvastatin is now dominating the market, while fluvastatin was on the first statin therapy for several years in the past. Fibrate were used in the modest quantities in value from 2% to 1.5% in years 2007 to 2015. The use of statins in moderate-risk and high-risk patients showed continued growth subsequently, but stable with dosage of atorvastatin 20 mg. Lower statin dosage used was independently associated for all patients, young patients had used high dosage of statins and fluvastatin respectively 40 mg and 80 mg. The missing high dosage of atorvastatin was notable. The values of LDL were improved but not in the level of efficacy of treatment. Conclusion: Statin therapy becomes more selected compared with fibrate. Atorvastatin 20 mg remains the most important stain used in our clinic, but low dosage remains still a problem. The expected level of LDL-C is the target for the practitioners. More aggressive statins such as rosuvastatin start to be present in our clinic, but it is less used by the patients. Meanwhile the lifestyle, exercises, balance diet, smoking cessation are parts of the patients’ files. The side effects are minors and the medication process has continued.

Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database

Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.

Research on the Development of Drug Regulatory Science in China

Objective To study the situation of the development of China’s drug regulatory science and to provide some suggestions for its future development.Methods Based on the origin of regulatory science in China,the methods of literature research and comparison were used to make a detailed analysis of China’s drug regulatory science plan and its implementation effect,the research direction,the number of key laboratories,regulatory science exchange conferences and professional papers published,so as to put forward the development trend of China’s regulatory science.Results and Conclusion According to China’s national conditions,the government should continue to promote the development of the regulatory science system from three aspects:basic theoretical research,discipline construction and action plan.China’s drug regulatory science can not only promote the rapid development of pharmaceutical industry,but also guarantee public health.

广东省药物临床试验机构备案情况及监管现状分析

目的:了解广东省药物临床试验机构备案形势、临床试验开展情况和临床试验机构监管现状,为监管相关工作提供参考。方法:从药物临床试验机构备案管理信息系统提取药物临床试验机构备案信息,通过电子调查问卷收集药物临床试验项目数量,梳理汇总药物临床试验机构监督检查情况,并从多个维度统计分析相关数据。结果:截至2023年12月31日,广东省共备案140家药物临床试验机构,主要为三级甲等公立医院,累计备案118个专业。备案药物临床试验机构分布于19个地级市,其中位于广州市的药物临床试验机构(占比32%)承接了广东省78%的药物临床试验。监督检查中发现一些机构在组织管理、责任意识和伦理审查方面尚存在问题,新备案机构尤为突出。结论:药物临床试验机构备案制的施行促进了广东省药物临床试验资源的释放,但凸显了技术层次不齐、专业布局不合理和区域发展不均衡等制约资源有效利用的问题。建议监管部门从加强指导服务力度方面完善监管机制,助力提升药物临床试验资源的利用效率,进而推动广东省药物临床试验机构健康发展。

基于美国FDA不良事件报告系统数据库的西尼莫德风险信号挖掘

目的利用美国FDA不良事件报告系统(FAERS)数据库对西尼莫德的风险信号进行挖掘,为保障临床用药安全提供参考。方法提取2019年1月1日至2022年12月31日FAERS数据库中收录的西尼莫德的药物不良事件(ADE)报告,采用《国际医学用语词典》(23.1版)中标准化不良事件术语集的首选术语(PT)和系统器官分类(SOC)对西尼莫德的ADE报告进行分类和标准化处理。采用报告比值比(ROR)法和比例报告比值(PRR)法对西尼莫德的ADE报告进行风险信号挖掘。结果2019年1月1日至2022年12月31日FAERS数据库共收到西尼莫德的ADE报告6435例,其中男1426例(22.16%),女4603例(71.53%),性别信息缺失者406例(6.31%)。根据ADE阳性信号判定标准共筛选风险信号243个,其中报告数排序居前5位的PT分别为疲劳、头痛、头晕、步态障碍、淋巴细胞计数降低,涉及的SOC包括全身性疾病及给药部位各种反应、各类神经系统疾病、各类检查。信号强度排序居前5位的PT分别为肺肿瘤、血脂异常、脑脊液寡克隆区带阳性、淋巴细胞计数降低、淋巴细胞计数升高,涉及的SOC包括良性、恶性及性质不明的肿瘤以及各类检查,其中血脂异常、腰椎神经根病、下肢轻瘫是未被药品说明书收录的风险信号。结论临床在使用西尼莫德时,除了关注药品说明书中已有的常见不良反应外,还应警惕说明书上未提及的不良反应,保证患者的用药安全。