Evaluation of Abuse Drugs and Clinical Laboratory Tests Variations in Whole Blood ＆ Urine Samples of Abusers

In this study, five hundred urine samples and five hundred blood samples of abusers were examined for the presence of alkaloid substances and abuse drugs in urines and bloods. These numbers of blood and urine samples of addicts in clinics of welfare organization, during detoxification treatment or maintenance treatment were screened for abuse drugs presence. The all of samples were tested through as a view of clinical laboratory methods. Age ranges of female patients were 35 ~ 15 and age range of males patients were 45 ~ 15. All patients filled questionnaire and satisfy forms too. First, all fresh urine and blood samples were examined to confirm presence drugs abuses, depend on their addiction and treatment, so all samples were confirmed by two tests. Then they were examined to other clinical laboratory tests. All data were analyzed by t-test and were Anova one way and two ways of Anova Turkey, and p 〈 0.05 was considered significant. The p-value of this study was p = 0.0001. The results of this study were showed that 4% of abusers had mild increase in hematocrite level and 2% of narcotic drugs abusers had mild lower level of blood sugars than normal range and 4% of participants had increase liver enzymes such ALT （alanine transferase）, AST （aspartat transferase）, ALP （alkaline phosphatease） and 1% of them had renal failure. Although blood level BUN （blood urea nitrogen） and creatinin were examined to evaluation of their renal failure .The results in Tabriz/Iran undrevision of welfare organization clinics were approximately showed that positive results of addiction are in each of urine and blood samples. Because some of abusers directly consumed full long time agonist or partial agonists＇ drugs such as methadone and buprenorphine for their maintenance therapy in clinics. Also doing test on blood samples has high importance in distinguishing and confirmation of drugs abuse in samples. Also in this study we conclude that among all drug analytical methods the cheapest and easiest test to screening opioids and other abuse drugs in urine and blood samples is strip test for rapid diagnosis, also tests on blood samples have high importance as a view point of accuracy to distinguishing of drugs abuse, and serum levels of some other parameters showed all abusers patients situation such as liver and renal dysfimction through clinical laboratory tests.

Distinguishing of Abuse Drugs in Urine and Blood Samples of Abusers in Iran

In this study, one hundred urine samples and one hundred blood samples of abusers were examined for the presence of alkaloid substances and abuse drugs in urines and bloods. These numbers of blood and urine samples referred who addicts in clinics of Welfare Organization, during of detoxification treatment or maintenance treatment were screened for abuse drugs presence. Age ranges of female patients were 35 ± 15 and age range of males patients were 42 ± 18. All patients filled questionnaire and satisfy forms too. All data were analyzed by t-test and were Anowa one way, and P 〈 0.05 was considered significant. The P value of this study was P = 0.000. In this study we conclude that among all drug analytical methods the cheapest and easiest test to screening opioids and other abuse drugs in urine and blood samples is strip test for rapid diagnosis and TLC （thin-layer chromatography） is appropriate confirmation method to drug abuse distinguishing. Also tests on blood samples have high importance as a view point of accuracy to distinguishing of drugs abuse.

Evaluation of Mass Drug Administration Impact on Transmission of Lymphatic Filariasis in 13 Sanitary Districts in Burkina Faso

Introduction: Lymphatic filariasis (LF) is one of the neglected tropical diseases targeted for elimination as a public health issue in the world by 2020. To achieve this goal, one of the strategies is interruption of transmission using chemotherapy (mass drug administration). Burkina Faso in west Africa, an endemic country, has endorsed this resolution. In 2000, all Sanitary Districts (SD) in the country were endemic, and then a national elimination program has made it possible to stop mass treatment in 45 out of 70 SD over 12 years. Sixteen years later, 13 other SD were reeligible for Transmission Assessment Surveys (TAS). This study aimed to determine the current level of the Mass drugs Administration (MDA) impact indicators in these 13 targeted SD in order to decide whether we need to continue MDA. Method: It was a descriptive study that took place from June to September 2017 in 13 SD regrouped into 7 Evaluation Units (EU). The population of the study was 6 to 7 years old children. The community-based cluster survey method was used. The diagnostic test used to detect Wuchereria bancrofti’s circulating antigen (W. bancrofti) is the Filariasis Test Strip (FTS). The critical threshold of positivity was set at 18 positive subjects per EU. Results: We sampled a total of 12,060 children, 48.9% were female and 51.1% male. In the 7 EU, 13 children were positive to W. bancrofti test. The average antigenic prevalence was 0.11% (13/12,060). In all EU, the number of positive subjects was below the critical threshold. Conclusion: At the end of this evaluation of the transmission of lymphatic filariasis in 13 SD of Burkina Faso, we can tell the MDA could be stopped in these areas without risk of resurgence of the disease, according to the current recommendations of WHO. This can be possible by setting up post-TMM surveillance, considering migratory flows, and including villages where positive cases were found to search possible residual transmission zones.

Selection of Test Samples for Monitoring Veterinary Drug Residue in Bred Animals

[Objective] This study aimed to compare the residue situation of cimaterol,a kind of forbidden veterinary drug in hair, urine and flesh of pig, so as to provide theoretical basis for monitoring veterinary drug residue in bred animals. [Method]Total three different concentrations of cimaterol were administered to pigs, and the residue amounts of cimaterol in pig hair, urine and flesh were monitored at different raising stage. [Result] During the administration period, the residue amount of cimaterol was highest in urine, so urine is the suitable sample for rapid detection of cimaterol in manufacturing enterprises. Cimaterol could be accumulated in pig hair,where cimaterol was metabolized slowly. Thus, pig hair can be used as the test sample for tracing illegal use of veterinary drugs and for vivo detection. Flesh can be used as test sample for direct judgment whether cimaterol residue exceeds the relevant standard. [Conclusion] This study will provide certain theoretical basis for drug monitor in animal husbandry.

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。

基于问卷调研的中药材质量监测机制优化探索

目的:为进一步优化完善中药材质量监测机制,探索建立国家与省级中药材质量监测统筹模式提供参考。方法:基于国家药品抽检协作网络,在国家药品抽检信息系统内,采用在线问卷调研的方式,面向国家药品抽检承检机构以及省级药品监督管理部门征集意见建议。结果:共有46家承检机构与32家药品监督管理部门作答问卷,汇总分析显示,中药材质量监测逐步建立相互衔接、各有侧重的国家与省级协作体系,适当扩大监测品种范围,对药材市场与种植基地、饮片和中成药生产企业重点监测,建立风险分级管理制度,并与国家药品抽检协同发布监测结果。结论:中药材质量监测应当基于国家药品抽检协作网络,进一步优化品种遴选流程与范围,围绕药品生产企业、药材市场与种植基地,完善风险处置机制。

药品抽检收检环节常见问题分析

目的:汇总药品抽检中收检环节发现的问题,提出改进方法和建议,进一步规范药品收检工作,从而提高收检工作效率。方法:介绍药品收检工作流程,以2019~2023年国家药品收检工作实践为基础,汇总分析样品接收、样品核对、样品受理、样品购买等多个节点容易出现的问题,提出注意事项。结果与结论:提高抽样队伍和收检人员的知识技能和专业水平,规范收检工作流程,端正工作态度,明确个人职责分工,全面提升抽检工作质量。

药品网络抽检存在的问题及对策分析

目的:在网络销售渠道开展药品抽检工作存在挑战,需改进抽检工作的实际操作和完善理论研究,以适应药品监管的新形势。方法:在药品网络抽检试点工作中,依据网售药品的特点,制定抽检方案并执行。分析抽查检验程序、处方开具及审核、药品储运等方面的困难及风险点,并提出对策和建议。结果与结论:建议修订和完善相关法律规章中关于网络抽检的内容,对抽样凭证和处方获取等作统一要求;核实样品真实性,优化混批样品的处置流程,设立动态检验机制。

非法排放制毒废水生态环境损害鉴定技术研究

随着环境污染事件的逐渐增加,生态环境损害鉴定评估作为开展相应工作的重要依据和基础,其重要性越来越突出。因此,以某具体环境污染事件为例,在资料收集、初步踏勘等工作的基础上,确定生态环境损害鉴定评估工作方案,根据样品采集检测分析结果判定疑似污染土壤为危险废物,确定非法排放制毒废水行为是造成案发地周边地表水、地下水和土壤生态环境损害的直接原因。通过研究可为固体废物鉴别、生态环境损害鉴定评估、环境监测和环境咨询等相关从业者提供可参考性实操建议。

理化检验中样品前处理的方法探讨

本文分析了样品前处理在理化检验中的重要性,并提出微波消解法、微波萃取法和固相萃取法等常见样品前处理方法在食品(药品)理化检验中的具体运用,以期结合实际情况,合理选择样品前处理方法,实现高效率、高精准度测定样品中目标物质,切实提升理化检验效率和检验结果准确性。

Current challenges in applying gene-driven therapies in clinical lung cancer practice

Over the last twenty years,with the development of gene-driven therapies,numerous new drugs have entered clinical use.Very few of these new drugs are suitable for a large number of patients,and all require molecular genetic testing.In lung cancer,gene-targeted therapy has evolved rapidly and has placed demands on the development of diagnostics and tissue sample preparation and logistics.Rapid diagnosis and prevalence assessment are necessary to determine the prognosis of a lung cancer patient based on the latest research findings.Therefore,the molecular-genetic diagnostic pathway must also be accelerated and matured to do the necessary analyses on small samples.Because lung cancer rebiopsy can be difficult,liquid biopsy techniques should be developed to cover more of the treatable mutations.There are obstacles related to tissue sampling,new genomic techniques and access to gene-driven cancer drugs,including their affordability.With this review and case study,we go into the obstacles faced by our clinic and discuss how to tackle these obstacles in lung cancer.We use lung cancer as an example due to its complexity,though these same obstacles are found in different cancers on a minor scale.

药品抽检的抽样常见问题分析与应对策略

目的:对药品抽检的抽样常见问题进行分析并提出相关建议,以期为提高药品抽检的抽样工作质量提供参考。方法:介绍药品抽检的抽样相关政策法规和抽样模式,以2016-2021年国家药品抽检不符合检验要求的样品为例,分析抽样中的常见问题,提出完善建议。结果:目前,抽样的常见问题包括品种错误、抽样环节错误、样品保护不当、样品重复、抽样量不足、资料信息有误、混批、剩余效期不足等情况。结论:抽样是药品抽检整个工作链条的上游环节,其工作质量对药品抽检成效具有重要影响。样品因不符合检验要求而被承检机构拒收,既浪费资源又不利于全面评价药品质量,发生拒收的主要原因在于抽样人员的知识技能欠缺和工作态度有待提高,需引起抽样单位的重视。建议加强对抽样人员的教育培训及考核,慎重拒收样品并对确需拒收的样品细化原因记录,探索建立拒收样品再利用机制。

基于问题导向的国家药品抽检计划设计方法探讨

目的通过分析讨论国家药品抽检计划,提出可行优化举措和建议,推动药品抽检管理模式创新。方法从国家药品抽检计划的制定原则、方法程序、存在问题等方面进行介绍,重点讨论如何对品种遴选、抽样层级划分、检验专项设计,以及购样环节进行科学合理的设计规划。结果将风险管理理念融入品种遴选,探索精准抽样模式,通过深度数据挖掘确定监管重点,建立周期性回顾机制,动态更新抽检方案。结论药品质量抽查检验是上市后药品监管的重要手段之一,必须从顶层设计入手,以问题为导向,制定科学合理的计划方案,才能提高抽检效能,为加强药品监管提供技术支持。

基于国家药品评价性抽检的巴戟天饮片质量分析与研究

目的:通过国家药品评价性抽检工作,了解市场上的巴戟天饮片质量及存在的问题,为巴戟天的质量标准提高和市场监管提供数据支持。方法:从全国24个省级行政区抽取巴戟天饮片,按照《中华人民共和国药典》2015年版(一部)巴戟天性状项和薄层鉴别项方法开展检验工作,并进行DNA条形码技术、指纹图谱、环烯醚萜含量测定、真菌毒素残留量共4项探索性研究,分析检验结果以评价巴戟天饮片的市场情况。结果:本次抽检的88家企业的巴戟天饮片共计108批,按照国家法定标准检验的合格率为100%。DNA条形码技术可以有效区分巴戟天及其混伪品。指纹图谱研究结果显示,正品巴戟天指纹图谱相似度均超过95%,混伪品相似度均低于70%。含量测定结果显示,不同巴戟天炮制品中环烯醚萜从种类和含量上具有显著性差别。真菌毒素筛查试验结果显示,有1批样品的黄曲霉毒素G1超出药典限度。结论:按标检验结果显示,市场上巴戟天饮片质量基本合格。根据探索性研究结果,建议标准增加环烯醚萜含量测定和黄曲霉毒素限量检查。

2017年至2021年上海市药品质量抽检不合格数据分析

目的通过统计分析2017年至2021年上海市药品质量抽检情况,为药品质量抽检工作提供参考和建议。方法采用数据统计软件对2017年至2021年上海市药品监督管理局发布的药品质量抽检通告中不合格数据进行统计。结果2017年至2021年上海市药品质量抽检样品约5.8万件,有588件不合格。其中经营环节中的药房和使用环节中的营利性医疗机构不合格数量较多;中药饮片检出不合格最多;不合格项目主要为性状、检查、炮制和含量测定。结论上海市药品质量年度抽检不合格数量整体呈下降趋势,但仍需加强对经营环节和使用环节的抽检力度;加大对中药饮片的抽检力度;针对不合格品种和项目开展专项抽检,提高抽检的靶向性,确保药品质量安全。

欧盟DCP/MRP药品市场监督抽检策略研究

目的:研究欧盟分散审批与互认审批药品(DCP/MRP)市场监督抽检策略,为我国完善省级药品抽检,进一步探索国抽与省抽统筹模式提供参考。方法:采用文献研究法,汇总欧盟分散审批与互认审批药品(DCP/MRP)市场监督抽检相关法规框架、程序性文件等信息,讨论并分析关键措施。结果:欧盟建立了风险评估制度框架与指导通则,形成了基于互评制度的计划管理模式,制定了针对检验协作网络的专项质管体系,搭建了单点协作的假劣药品管控平台以及多元开放的转化应用链条。结论:研究欧盟分散审批与互认审批药品(DCP/MRP)市场监督抽检采取的关键措施,对我国完善省级药品抽检管理,具有一定参考价值。

扶正通络中药雾化吸入治疗慢性阻塞性肺疾病急性加重临床研究

目的观察扶正通络中药雾化吸入治疗慢性阻塞性肺疾病急性加重(AECOPD)患者的临床疗效。方法将207例AECOPD患者采用简单随机抽样法随机分为2组,2组均予常规基础治疗,对照组115例予吸入用布地奈德混悬液雾化吸入治疗,治疗组92例予扶正通络中药雾化吸入,2组均连续治疗30天后统计疗效。比较2组治疗前后COPD患者自我评估测试(CAT)、改良呼吸困难(mMRC)评分,血清白细胞介素6(IL-6)、超氧化物歧化酶(SOD)、C反应蛋白(CRP)水平,痰液黏蛋白5AC(MUC5AC)、中性粒细胞弹性蛋白酶(NE)水平。结果治疗组显效率及总有效率分别为75.00%(69/92),95.65%(88/92),对照组分别为51.30%(59/115)、82.61%(95/115),2组显效率及总有效率比较差异均有统计学意义(P<0.05),治疗组均高于对照组。治疗后2组CAT、mMRC评分均较本组治疗前降低(P<0.05),且治疗组均低于对照组(P<0.05)。治疗后2组FVC、FEV 1、FEV 1/FVC均较本组治疗前升高(P<0.05),且治疗组均高于对照组(P<0.05)。治疗后2组IL-6、CRP水平均较本组治疗前降低(P<0.05),SOD水平升高(P<0.05),且治疗组IL-6、CRP水平低于对照组(P<0.05),SOD水平高于对照组(P<0.05)。治疗后2组MUC5AC及NE水平均较本组治疗前降低(P<0.05),且治疗组均低于对照组(P<0.05)。结论扶正通络中药雾化吸入治疗AECOPD临床疗效显著,可改善患者肺功能,控制炎性反应,改善气道黏液高分泌状态。

Impact of five annual rounds of mass drug administration with ivermectin on onchocerciasis in Sierra Leone

Background:Onchocerciasis is endemic in 12 of the 14 health districts of Sierra Leone.Good treatment coverage of community-directed treatment with ivermectin was achieved between 2005 and 2009 after the 11-year civil conflict.Sentinel site surveys were conducted in 2010 to evaluate the impact of five annual rounds of ivermectin distribution.Methods:In total,39 sentinel villages from hyper-and meso-endemic areas across the 12 endemic districts were surveyed using skin snips in 2010.Results were analyzed and compared with the baseline data from the same 39 villages.Results:The average microfilaridermia(MF)prevalence across 39 sentinel villages was 53.10%at baseline.The MF prevalence was higher in older age groups,with the lowest in the age group of 1-9 years(11.00%)and the highest in the age group of 40-49 years(82.31%).Overall mean MF density among the positives was 28.87 microfilariae(mf)/snip,increasing with age with the lowest in the age group of 1-9 years and the highest in the age group of 40-49 years.Males had higher MF prevalence and density than females.In 2010 after five rounds of mass drug administration,the overall MF prevalence decreased by 60.26%from 53.10%to 21.10%;the overall mean MF density among the positives decreased by 71.29%from 28.87 mf/snip to 8.29 mf/snip;and the overall mean MF density among all persons examined decreased by 88.58%from 15.33 mf/snip to 1.75 mf/snip.Ten of 12 endemic districts had>50%reduction in MF prevalence.Eleven of 12 districts had≥50%reduction in mean MF density among the positives.Conclusions:A significant reduction of onchocerciasis MF prevalence and mean density was recorded in all 12 districts of Sierra Leone after five annual MDAs with effective treatment coverage.The results suggested that the onchocerciasis elimination programme in Sierra Leone was on course to reach the objective of eliminating onchocerciasis in the country by the year 2025.Annual MDA with ivermectin should continue in all 12 districts and further evaluations are needed across the country to assist the NTDP with programme decision making.

《药品质量抽查检验管理办法》与《药品质量抽查检验管理规定》中检验和复验内容的对比分析

目的:为药品抽检工作相关人员理解并执行《药品质量抽查检验管理办法》中的新要求提供参考。方法:对比《药品质量抽查检验管理办法》和《药品质量抽查检验管理规定》中对检验和复验工作的要求,分析修订或新增内容并提出实施建议。结果与结论:针对药品监管需要,在《药品质量抽查检验管理规定》的基础上,《药品质量抽查检验管理办法》对检验和复验工作的相关要求进行了修订和补充。在对检验工作的要求中,该办法修订了检验项目要求,明确了检验时限要求,新增了检验报告、原始记录、质量管理体系要求以及“严重风险”的定义及报告要求,对检验机构提出了开展探索性研究的要求,并新增了检验机构和检验人员行为要求。在对复验工作的要求中,该办法修订了申请复验应提交的资料,增加了经办人身份证明、时限证明,修订了不得复验的情况,增加了检出为明显可见异物时的处理方式,并新增了复验报告传递要求。建议药品检验工作的相关人员关注上述变更内容,加强检验能力建设,加强检验时间和检验质量管理,重视严重质量风险,积极开展探索性研究,并加强对自身检验行为的规范;严格审核复验资料,重视新修订的不得复验的情形,并应按要求和实际情况全面传递复验报告,积极执行并落实《药品质量抽验管理办法》。

药品快速检测技术基层应用研究

目的针对药品快速检测基层运用的工作实际,探索快检技术应用新思路,提出进一步提高工作效能的对策。方法运用文献研究的方法,结合辖区监管实际,对药品快检技术的基层应用情况做效能分析。结果药品快检技术在基层药品监管工作中发挥了重要作用,提高了药品监管工作效能,但仍存在模型库局限性较大、假阳性率较高等问题。结论应在技术创新的基础上,完善抽检协作、信息交流、宣传、预警等工作机制,进一步发挥药品快检技术在基层药品监管中的作用。