Roles of Community Pharmacists in Screening and Disseminating of Information about Non-Steroidal Anti-Inflammatory Drugs Risks: Implications for Drug Safety Assessment

Background: The increasing use of non-steroidal anti-inflammatory drugs (NSAIDs) both on prescription and over the counter raises a major global health concern because of the risks associated with their use if no proper guidance is given by the health care provider. This study assessed the roles of community pharmacists in screening and disseminating information about the risks associated with NSAID use in Zambia. Methodology: This was a national cross-sectional study in which a structured self-administered questionnaire was administered to 245 registered community pharmacists in Zambia. Stata/BE, version 15.1 (Stata Corporation, College Station, Texas, USA) and multivariate logistic regression model was used to determine factors associated with information dissemination about ADRs of NS-NSAIDs. Results: 231 of the 245 distributed questionnaires were returned giving a response rate of 94.3%. All (100%) participating community pharmacists claimed to have practiced dispensing NSAIDs. However, only 26 (11.0%) and 71 (30.8%) regularly screened for risk factor of selective COX-2 NSAIDS (SC2-NSAIDS) and non-selective NSAIDS (NS-NSAIDs) respectively. Information dissemination on adverse drug reactions (ADRs) of SC2-NSAIDS was regularly provided by only 22 (9.5%) of pharmacists while that of NS-NSAIDs was regularly provided by 49 (21.2%). In the multivariate logistic regression model, being the owner of a pharmacy (AOR: 5.4, CI: 1.84 - 16.4) was significantly associated with information dissemination about ADRs of NS-NSAIDs while an hour increase in the working hours per day (AOR: 0.9, CI: 0.64 - 0.95) was associated with less likelihood of information dissemination. Conclusion: Pharmacists working in community pharmacies in Zambia did not regularly screen and disseminate information about the risks associated with NSAID use. Therefore, pharmacists should be able to screen and monitor patients at risk and be aware of the majority of risk factors while dispensing NSAIDs to minimize the associated complications.

Risk factors for hepatocellular carcinoma in patients with drug-resistant chronic hepatitis B

AIM:To investigate the risk factors and characteristics of hepatocellular carcinoma(HCC) in the patients with drug-resistant chronic hepatitis B(CHB).METHODS:A total of 432 patients with drug-resistant CHB were analyzed retrospectively from January 2004to December 2012. The patients were divided into two groups:the HCC group(n = 57) and the non-HCC group(n = 375). Two groups compared using logistic regression for various patients and viral characteristics in order to identify associated risk factors for HCC.Secondarily,patient and tumor characteristics of HCC patients with na ve CHB(N group,n = 117) were compared to the HCC group(R group,n = 57) to identify any difference in HCC characteristics between them.RESULTS:A significant difference was found for age,platelet count,alpha-fetoprotein(AFP),positivity of HBeAg,seroconversion rate of HBeAg,virologic response,the Child-Pugh score,presence of rtM204I,and the duration of antiviral treatment in non-HCC and HCC group. Cirrhosis,age(> 50 years),HBeAg(+),virologic non-responder status,and rtM204I mutants were independent risk factors for the development of HCC. The R group had lower serum C-reactive protein(CRP) and AFP levels,earlier stage tumors,and a shorter mean tumor surveillance period than the N group. However,the total follow-up duration was not significantly different between the two groups.CONCLUSION:13.2% of patients with drug-resistant CHB developed HCC. Age,cirrhosis,YIDD status,HBeAg status,and virologic response are associated with risk of HCC. Patients with drug-resistant CHB and these clinical factors may benefit from closer HCC surveillance.

An Updated Mini Review on Grapefruit: Interactions with Drugs, Obesity and Cardiovascular Risk Factors

The paper examines the effects of grapefruit consumption in relation to drugs, obesity and cardiovascular risk factors. The review includes the most updated studies found in Pub-Med. The grapefruit effect refers to the ability of grapefruit juice and supplements to interact with a wide variety of pharmaceuticals, either enhancing or limiting their systemic availability. Due to altering the active dosage of the pharmaceutical, Grapefruit juice is commonly not allowed to be used alongside with many drugs. Naringin is the most important one, which can inhibit absorption of some drugs but more commonly 6’7’-dihydroxybergamottin, which inhibits CYP3A4. Lately, grapefruit has been found both in rats and adults to reduce body weight, blood pressure, improve lipid and hepatic profile and decrease platelet aggregation. These promising results must be followed by additional studies in order to add to the importance of the role and effects of grapefruit as part of our diet.

Prevalence of Human Immunodeficiency Virus (HIV), Risk Behavior, and Recent Substance Use in a Sample of Urban Drug Users: Findings by Race and Sex

The aim of the current study was to examine the prevalence of HIV, past six-month illicit drug use, and risk behaviors among a population of heavy drug users living in an urban setting. Although many studies investigate substance use, sex-risk behavior, and HIV by race and gender, no studies have examined these variables simultaneously. The current study seeks to fill this gap in the literature by exploring HIV prevalence among a predominantly heterosexual sample of recent substance users by injection drug use (IDU) status, race, and sex. Baseline data from the Baltimore site of the NEURO-HIV epidemiologic study was used in this study. This study examines neuropsychological and social-behavioral risk factors of HIV, hepatitis A, hepatitis B, and hepatitis C among both injection and non-injection drug users. Descriptive statistics and chi-square statistics were used in data analyses. Blood and urine samples were obtained to test for the presence of recent drug use, viral hepatitis, HIV, and other sexually transmitted diseases (STDs). Findings presented here have several important implications for HIV prevention and care among substance users. Intervention programs that incorporate substance use treatment in addition to HIV education, particularly with respect to substance use and sex risk behavior are imperative.

Risk Factors for Group B <i>Streptococcus</i>Colonization and Drugs Sensitivity Pattern in a Nigerian Obstetric Population

Background: Group B Streptococcus (GBS) is a major cause of bacterial infections in the perinatal period, of which colonization prevalence among Northern-Nigerian pregnant women is scarce. We attempted to determine 1) its prevalence, 2) risk factors for GBS colonization and 3) drugs-susceptibility. Methodology: This cross-sectional study involved 185 pregnant women between 35 - 37 weeks of gestation at tertiary health center of Sokoto, Nigeria. Vaginal/rectal swabs were collected, were cultured for GBS and tested for drug-susceptibilities. The study was conducted between December, 2017 and April, 2018. Results: One hundred and eighty five (185) pregnant women participated in this study. GBS vaginal-colonization-rate was 3.8% (7/185). A significance relationship was observed between GBS-colonization and socio-economic class, as 57.10% (4/7) of the GBS positive women were of low-socio economic class (p 0.035). No associations were observed between GBS-colonization and the followings: maternal age, parity, poor obstetric outcome-history. All the 7 GBS positive cultures were sensitive to Clindamycin. One was sensitive to both Clindamycin and Ceftriaxone. None was sensitive to Penicillin. Conclusion: The prevalence of GBS colonization was low in this area. Maternal socio-economic class is found to be a risk of GBS-colonization.

靶向药物治疗肺动脉高压患者的近期随访

目的 探讨肺动脉高压诊疗中心就诊的肺动脉高压患者临床特点并观察靶向药物治疗的疗效,分析肺动脉高压患者发生心血管不良事件的危险因素。方法 回顾性研究收集了2016年1月至2021年2月于徐州医科大学附属医院和重庆医科大学附属第一医院首次住院的肺动脉高压患者124例,分析患者的临床特点、主要病因、首发症状等;观察靶向药物治疗后总体疗效;总结心血管不良事件的发生情况,分析危险因素。结果 以女性患者为主[103例(83.1%)],发病中位年龄38.0(27.5, 51.0)岁。呼吸困难是最常见的首发症状(85.0%)。先天性心脏病相关肺动脉高压占比最高(49.2%)。>38岁组心功能较差且具有高的脑钠肽水平(P<0.05)。以5型磷酸二酯酶抑制剂+内皮素受体拮抗剂的两联治疗方案最为常见(88.0%),高危患者占比明显下降。结论 肺动脉高压患者以女性多见,年龄越大心功能越差,以先天性心脏病相关的肺动脉高压多见,靶向药物治疗效果显著,1年生存率显著提高。心指数是肺动脉高压患者的保护因素。

中国西南地区艾滋病病毒感染者治疗前和获得性抗逆转录病毒耐药性研究

背景中国不同地区人类免疫缺陷病毒(HIV)感染者的治疗前耐药(PDR)和获得性耐药(ADR)的患病率及流行情况差异较大。这两种耐药对患者的抗病毒治疗效果具有不良影响,可能会加剧患者不良预后的发生。目前针对中国西南地区的HIV感染者PDR和ADR患病率及流行情况的研究较少。目的调查在中国西南地区HIV感染者PDR和ADR的患病率及流行情况。方法纳入2021-01-01—2023-06-30在贵阳市公共卫生救治中心就诊并进行耐药基因检测的HIV感染者。使用HIV-1 pol序列分析HIV-1基因型和耐药性。使用斯坦福大学HIV耐药性数据库分析逆转录酶和蛋白酶Sanger序列的主要耐药性突变。通过Logistic回归模型评估与PDR相关的风险因素。结果共1613例HIV感染者参与研究,其中824例初治,789例经治。初治患者最常见的基因型为B+C(47.0%),耐药率为18.7%(154/824),非核苷类逆转录酶抑制剂(NNRTIs)为14.9%(123/824),核苷类逆转录酶抑制剂(NRTIs)为1.7%(14/824),蛋白酶抑制剂(PIs)为2.7%(22/824),整合酶链转移抑制剂(INSTIs)为1.9%(16/824)。经治患者最常见的基因型为CRF01-AE(37.4%),耐药率为27.8%(219/789),NNRTIs、NRTIs、PIs和INSTIs的突变率分别为7.7%(61/789)、19.3%(152/789)、2.7%(21/789)和1.1%(9/789)。多因素Logistic回归分析结果显示,传播途径、CD_(4)^(+)T细胞计数、病毒载量和确诊与抗逆转录病毒疗法(ART)间隔时间是HIV感染者PDR的影响因素(P<0.05)。结论流行于中国西南地区的HIV感染者PDR和ADR发生率较高,分别为18.7%和27.8%。PDR的影响因素包括传播途径、CD_(4)^(+)T细胞计数、病毒载量和确诊与ART间隔时间。因此,为了避免耐药性发生,迫切需要常规基线基因型耐药性检测和足够的病毒载量监测间隔时间。

Medical influences,surgical outcomes: Role of common medications on the risk of perforation from untreated diverticular disease

Numerous drugs,largely used in the wards or at home,have a significant influence on patients with untreated diverticular disease.The consequences can be disastrous,may require an emergency operation,postoperative intensive care,and overall influence the patient’s length of stay and the final outcomes.Bearing these considerations in mind the routine or chronic administration of pain-killers,steroids and non-steroidal anti-inflammatory should be balanced in patients with known diverticular disease as it normally happens with other conditions potentially affected by these drugs(i.e.,peptic ulcer disease or chronic obstructive pulmonary disease).This is even more important in the old and frail patient where an eventual surgical treatment may not always be possible.

2022年国家药品抽检质量状况分析研究

目的了解和掌握2022年国家药品抽检质量状况及可能存在的药品质量风险。方法以问题为导向,以风险防控为目标,采取“分散抽样、集中检验、探索研究、综合评价”的抽检模式。回顾国家药品抽检历年检验情况,针对2022年国家药品抽检的整体质量情况进行总体分析,重点对发现的主要质量问题及风险进行挖掘和分析。结果2022年抽检平均合格率为99.4%。中国上市后药品质量总体安全形势平稳可控,药品质量处于较高水平。结论通过开展与药品安全性、真实性、有效性等方面的探索性研究,国家抽检在全面评价药品质量状况、提升品种质量控制水平及行业标准、强化质量安全监管、打击掺杂掺假等违法违规行为、警示公众用药安全等方面发挥重要作用。

两性霉素B脂质体治疗侵袭性真菌感染病人发生急性肾损伤危险因素分析

目的研究两性霉素B脂质体(L-AMB)治疗侵袭性真菌感染病人发生急性肾损伤(AKI)的危险因素。方法回顾性分析南京医科大学附属淮安第一医院2018年1月至2021年12月61例两性霉素B脂质体治疗侵袭性真菌感染病人的临床资料,根据是否发生两性霉素B脂质体相关AKI分为AKI组23例(37.7%),非AKI组38例(62.3%)。采用单因素分析法比较两组临床资料,logistic回归分析两性霉素B脂质体(L-AMB)治疗侵袭性真菌感染病人发生AKI的危险因素,应用受试者操作特征曲线(ROC曲线)评价L-AMB使用累积剂量及治疗前血清钾水平在诊断AKI方面的能力。结果有23例病人在使用L-AMB治疗过程中发生AKI,AKI发生率为37.7%。L-AMB疗程、累积剂量、日剂量,L-AMB治疗前血钾水平在AKI及非AKI两组病人比较中均差异有统计学意义(均P<0.05);累积剂量是发生L-AMB相关AKI的独立危险因素[OR=1.46,95%CI:(1.08,1.98),P=0.014];在L-AMB治疗前低血钾水平是发生L-AMB相关AKI的另一个独立危险因素[OR=0.05,95%CI:(0.01,0.43),P=0.007]。累积剂量和治疗前血钾水平曲线下面积(AUC)及其95%CI分别为0.88(0.79,0.98)、0.88(0.79,0.96),灵敏度分别为86.9%、81.5%,特异度分别为89.4%、86.9%。结论L-AMB累积剂量及治疗前低血钾水平均是L-AMB相关AKI的独立危险因素,两者在L-AMB相关AKI的诊断中均有一定的预测价值,而且累积剂量的诊断价值大于治疗前低血钾水平。

急性髓系白血病合并血流感染的病原菌分布与耐药性变迁及患者死亡的危险因素分析

目的探讨成人急性髓系白血病(AML)合并血流感染的病原菌分布与耐药性变迁,并分析患者死亡的危险因素。方法比较85例AML合并血流感染确诊时间的前30个月(2017年1月—2019年6月检出的病原菌)和后30个月(2019年7月—2021年12月)的病原菌检出率和主要病原菌耐药率变迁情况。并按患者血流感染后6个月预后分为死亡组33例和生存组52例。采用Logistic回归分析影响AML合并血流感染患者死亡的危险因素。结果85例AML合并血流感染患者共检出98株病原菌,以革兰阴性菌为主(65/98,66.33%),其次为革兰阳性菌(29/98,29.59%)、真菌(4/98,4.08%)。后30个月检出真菌(均为念珠菌)比例较前30个月增多(P<0.05)。后30个月与前30个月检出革兰阴性菌、革兰阳性菌比例及大肠埃希菌、金黄色葡萄球菌耐药率比较差异均无统计学意义(P>0.05)。Logistic回归分析显示,确诊前1个月内抗生素使用史、感染性休克为AML合并血流感染患者死亡的独立危险因素(P<0.05)。结论成人AML合并血流感染的病原菌以革兰阴性菌为主,但近年念珠菌感染率升高,且血流感染前使用抗生素及并发感染性休克者易出现预后不良。

基于大数据挖掘下多重耐药菌风险评估的研究价值

目的 基于大数据构建多重耐药菌感染的风险预测模型,并对其应用价值进行评估。方法 收集2018年1月至2022年12月于新疆医科大学第五附属医院诊治的405例患者,根据是否发生多重耐药菌(multidrug-resistant organisms,MDRO)感染分为非MDRO组(n=324)和MDRO组(n=81),比较并分析各指标与MDRO发生风险的相关性。构建大数据风险预测模型,分析各指标重要性,验证其准确性。结果 MDRO组合并糖尿病、原发肺部感染的患者比例,机械通气、广谱抗菌药物使用时间及降钙素原水平显著高于非MDRO组,而血红蛋白、白蛋白水平显著低于非MDRO组(均P <0.05);相关性分析显示,合并糖尿病、原发肺部感染等因素与MDRO风险的相关性较高,且合并糖尿病与原发肺部感染及联合使用抗生素等指标间相关性较高;大数据模型示抗生素使用时间、吞咽功能障碍等因素重要性较高,而血红蛋白及白蛋白重要性较低;大数据模型预测MDRO发生风险的AUC显著高于Logistic回归模型(Z=2.415,P=0.016),两种预测模型的训练集预测准确率差异无统计学意义(P>0.05);但测试集大数据模型预测准确率、敏感度及特异度均显著高于Logistic回归模型(χ^(2)=9.062,5.385,4.267;均P<0.05)。结论 合并糖尿病、原发肺部感染及联合使用抗生素等因素与MDRO发生风险具有一定相关性,基于MDRO危险因素指标的大数据模型对MDRO发生风险具有较高预测价值。

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。

医疗机构药品使用风险管理研究进展

本文通过梳理药品使用风险管理的概念和内涵,分析医疗机构药品使用风险管理在理论和实践中与药品上市许可持有人药物警戒的对应关系,明确药品使用风险管理与药物警戒的异同点,阐述包括药品不良反应监测、合理用药、药品上市后评价等方面的药品使用风险管理制度的实施方向和实施路径,提出关于医疗机构与药品上市许可持有人相互配合、共同践行药品使用风险管理的具体建议和措施,以期为医疗机构药品使用风险管理制度和规范的建立奠定基础,促进药品在医疗机构的安全使用。

老年人药物相关性跌倒预防与管理的证据总结

目的 :检索并总结老年人药物相关性跌倒预防与管理的相关证据,为降低老年人药物相关性跌倒发生率提供循证依据。方法 :按照证据资源“6S”模型自上而下依次系统检索国内外相关数据库和网站中关于老年人药物相关性跌倒预防与管理的临床决策、指南、专家共识、证据总结和系统评价,检索时限为从建库至2023年12月1日,对纳入文献进行质量评价和资料提取,根据证据汇总原则提取并整合证据。结果 :共纳入16篇文献,包括1篇临床决策、3篇指南、5篇专家共识、2篇证据总结和5篇系统评价。从跌倒风险评估、跌倒相关用药评估、预防策略、使用管理和健康教育5个方面形成了21条证据。结论 :本研究总结的老年人药物相关性跌倒预防与管理的证据内容可协助医护人员结合患者实际情况制定个性化干预方案,降低老年人药物相关性跌倒发生率。

Risk factors and outcomes of imipenem-resistant Acinetobacter bloodstream infection in North-eastern Malaysia

Objective:To determine the risk factors and outcomes of imipenem-resistant Acinetobacter baumannii(IRAB) bloodstream infection(BSI) cases,since there is very little publication on Aeinetobacter baumannii infections from Malaysia.Methods:A cross sectional study of 41 cases(73.2%) of imipenem-sensitive Acinetobacter baumanii(ISAB) and 15 cases(26.8%) of IRAB was conducted in a teaching hospital which was located at North-Eastern state of Malaysia.Results:There was no independent risk factor for IRAB BSI identified but IRAB BSI was significantly associated with longer bacteraemic days[OR 1.23(95%CI 1.01,1.50)].Although prior use of carbepenems and cephalosporin were higher among IRAB than ISAB group,statistically they were not significant.There was no significant difference in term of outcomes between the two groups.Conclusions:Although statistically not significant,this analysis compliments previous publication highlighting the importance of appropriate empiric antibiotic usage in hospital especially carbepenems and need further evaluation with bigger subjects.

2011—2020年北京市怀柔区耐药结核病高危人群利福平耐药筛查情况分析

目的:通过筛查耐药结核病高危人群,了解北京市怀柔区耐药结核病高危人群利福平耐药情况。方法:统计2011—2020年登记管理的肺结核患者中耐药结核病高危人群筛查情况,包括筛查对象、结核菌培养及药敏试验,对耐药高危人群利福平耐药情况进行分析。结果:2011—2020年北京市怀柔区共登记利福平耐药高危人群130例,完成耐药筛查130例,筛查率为100.00%。实验室污染率为3.08%,其中,涂阳培阴率为34.62%,主要体现在治疗2个月及以上的痰涂片或培养仍为阳性的初治患者中;耐药结核病高危人群培养阳性81例,菌种鉴定为结核分枝杆菌75例,检出利福平耐药23例,检出率为30.67%,明显高于与同期初治培养阳性的肺结核患者利福平耐药检率的3.33%,差异有统计学意义(χ^(2)=40.82,P<0.05)。结论:北京市怀柔区积极开展监测,使利福平耐药结核病能够得到有效的管理和医治,做到早发现、早治疗,避免因贫致病、因病返贫,更重要的是能够有效遏制利福平耐药肺结核的传播风险,减少对人们健康的危害。

医疗机构药品使用风险管理立意探究

药品作为特殊商品,其使用环节的复杂性导致药品风险管理颇具挑战性。新修订《药品管理法》明确提出风险管理是药品管理的原则之一,要切实保障公众用药安全。本文通过对药品使用风险管理的研究成果和实践探索进行全面阐述,探讨了药品使用风险管理的内涵及其在医疗机构中的应用,强调了医疗机构在此过程中应承担的责任,提出医疗机构应建立涵盖早期预警、系统评估、科学防范、有效交流和总体评价等多个环节的全面药品使用风险管理体系,贯穿药品从遴选采购到患者使用的全过程。此外,本文探讨了药品使用风险管理的未来发展方向,包括利用真实世界数据、数据挖掘和人工智能技术等手段,进一步推动药品使用风险管理的科学化和系统化,促进医药卫生体系的高质量发展。

高体质量指数和使用促排卵药的交互作用与子宫内膜癌保留生育功能治疗后复发风险的关联分析

目的探讨高体质量指数和使用促排卵药的交互作用与子宫内膜癌(EC)保留生育功能治疗后复发风险的关联。方法选取2021年1月至2023年1月于长治医学院附属和平医院接受保留生育功能治疗的58例早期EC患者,所有患者经孕激素联合宫腔镜治疗均已达到完全缓解,收集并统计患者的临床资料。采用单因素、多因素Logistic回归以及相加模型分析影响早期EC保留生育功能治疗后复发的危险因素及其交互作用。结果58例早期EC患者经治疗后均已达到完全缓解,其中16例出现治疗后复发,42例未出现复发,复发率为27.59%(16/58)。2组患者体质量指数、病灶直径以及是否使用促排卵药物比较差异均有统计学意义(χ^(2)=13.110,P<0.001;χ^(2)=9.166,P=0.002;χ^(2)=8.133,P=0.004)。体质量指数≥25 kg/m^(2)(OR=13.316,95%CI:2.734~23.899)、病灶直径≥2 cm(OR=6.773,95%CI:1.225~12.322)、使用促排卵药物(OR=32.983,95%CI:1.354~64.613)是早期EC患者保留生育功能治疗后复发的危险因素。早期EC患者保留生育功能治疗后复发的危险因素之间存在相加交互作用,体质量指数≥25 kg/m^(2)与病灶直径≥2 cm、体质量指数≥25 kg/m^(2)与使用促排卵药物、病灶直径≥2 cm与使用促排卵药物的交互作用指数分别为2.836、3.609、2.626,超额相对危险度分别为6.936、12.384、5.653。结论体质量指数≥25 kg/m^(2)、病灶直径≥2 cm、使用促排卵药物是早期EC患者保留生育功能治疗后复发的危险因素,且危险因素间具有正向交互作用。