Real-World Safety and Performance of Saline Nasal Spray Products for Nasal Cleansing and Reducing Obstruction of the Nasal Cavity

Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.

MedDRA在中国药品监测应用实施的现状分析及建议

目的介绍《监管活动医学词典》(MedDRA)在我国药品监管应用实施中的问题和挑战,以期为更好地实施MedDRA提供参考和建议。方法阐述MedDRA的基本情况,系统分析探讨产品本身的特点、管理机制、用户培训和用户社区建设等方面的问题与挑战,并从完善管理机制、扩展中文版结构、构建编码共享案例库、持续审查和改进MedDRA中文版、补充和完善定义、扩展中医部分内容等方面针对性地提出建议。结果与结论在各方努力下,MedDRA的引入、推广和落地实施已经取得了很好的开局。由于MedDRA产品本身的特点、现有机制等因素,带来了若干问题和挑战,需要各方力量协调一致,共同努力改善和克服相关问题和挑战,更快更好地实现与国际接轨和互认升级,推动中国创新药高质量发展。

基于SPC的电机生产过程质量监督

为解决电机生产过程质量监督问题,提出一种基于统计过程控制(SPC)图的电机生产过程质量监督方法,分析了具体流程和步骤,实例结果表明,该方法是有效、可行的。

智能视频监控技术在海上平台安全生产中的应用研究

我国海洋石油与天然气资源蕴藏着巨大的潜力,成为能源产业发展的战略重点。其中,海上平台的安全生产一直是重中之重。在这一背景下,智能视频监控技术的应用成为保障海上平台安全的重要手段。基于此,探讨了智能视频监控技术在海上平台安全生产中的应用,包括对海上平台的人员、设备和场景进行实时监测和分析。以期有效识别潜在的安全风险,并及时采取相应措施,提高海上平台的生产安全水平。

Postmarketing studies on safety of Dengfeng~ shenmai injection

OBJECTIVE: To systematically research the postmarketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reaction(ADR) case analysis and systematic review. Data from the hospital information system(HIS) and spontaneous reporting system(SRS) were also analyzed. RESULTS: The approximate dosage leading to death in dogs is 45.0-67.5 g raw drug/kg and the toxic reactions are restlessness, skin irritation, salivation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as 6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were positive or qualified. Patient ADR history and ADR family history were closely associated with itching based on the data analysis from SRS. There was no damage to renal function from Shenmai injection use at a dosage and a treatment course outside the recommended dosage and treatment course as specified based on data analysis from HIS. The most common ADR from Shenmai injection are difficulty breathing, facial flushing, nausea, vomiting, chest tightness, skin itching, rash, and back pain. CONCLUSION: This study includes complete information on Shenmai injection ADR incidence rate. We found that Shenmai injection is safe and this study can provide clinical, research, and production institutions with an objective, reliable, and scientific basis for use of Shenmai injection.

Postmarketing evaluation on the safety and effectiveness of Dengzhanxixin injection made from Dengzhanxixin(Herba Erigerontis Breviscapi)

OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted on the production process, quality standards, and pharmacology. Postmarketing clinical studies and literature reviews including adverse reactions(ADR),adverse events(ADE), case analysis and systematic reviews were also conducted. Data from the hospital information system and spontaneous reporting system were analyzed.RESULTS: The acute toxicity test indicated that the Lethal Dose 50 test( LD 50) dosage was 250 times more than the clinical maximum daily dosage(6mg/kg). In long-term toxicity tests, rats experi-enced renal tubular damage at 480 mg/kg. However, the dose of 120 mg/kg is safe and non-toxic,which is 40 times above the clinical daily maximum. Beagles had increased serum creatinine at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. ADR symptoms included rash(16.00%),chills(16.00%), and fever(16.00%).CONCLUSION: There is significant evidence that DZI is safe and effective in a clinical setting.

Postmarketing safety evaluation: depside salt injection made from Danshen(Radix Salviae Miltiorrhizae)

OBJECTIVE: To systematically examine the postmarketing safety of depside salt injection made from Danshen(Radix Salviae Miltiorrhizae),identifythe potential risk factors, and ensure its clinical safety.METHODS: We examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen(Radix Salviae Miltiorrhizae). Data from Ⅰ-Ⅳ clinical drug trials, hospital information systems(HIS), and spontaneous reporting systems(SRS) were also analyzed.RESULTS: The effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached morethan 80%. The median lethal dose(LD50) calculated by the Bliss method was 1.49 g/kg, with 95%confidence intervals of 1.29-1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions(ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen(Radix Salviae Miltiorrhizae) at a dosage higher than the recommended dose.CONCLUSION: This study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen(Radix Salviae Miltiorrhizae),and discusses the factors influencing such reactions. It provides scientific reference and recommendations for clinically safe medication of the Danshen injection.

北京市某区2022年肉及肉制品监测结果分析

目的:了解和掌握北京市某区2022年肉及肉制品病原微生物的污染情况,发现肉及肉制品存在的安全隐患,为食品安全风险监测工作提供依据。方法:根据《2022年食品微生物及其致病因子监测工作手册》工作要求以及国家标准方法,采集生肉和熟肉制品100件,对其进行致病菌监测。结果:2022年,检测样品阳性率为31.00%,生鲜及冷却禽肉检出率最高,其次是冻禽肉,各类肉制品间致病菌阳性率差异显著(χ^(2)=21.37,P=0.00 <0.05);病原菌检出集中在沙门氏菌和单核细胞增生李斯特氏菌,沙门氏菌共检出5种血清型,以肠炎沙门为主;从食品包装类别来看,散装食品更易受到微生物污染;该地区病原菌检出率没有明显的季节性(χ^(2)=3.41,P=0.18> 0.05)。结论:该地区肉及肉制品存在不同程度的食源性致病菌污染,食品安全状况不容乐观,尤其体现在生鲜及冷却禽肉中。相关监管部门应当加强对食品生产、销售环节的卫生监管,采取针对性措施预防食源性疾病和食物中毒事件的发生。

视频监控在煤炭企业安全环境下的管理应用

安全生产对于煤炭企业至关重要,从现阶段我国煤矿企业广泛存在的员工安全意识不足、安全措施不完善、监察力度不足等问题出发,指出煤矿企业安全生产要走智能化发展道路。针对性指出了目前视频监控在安全生产、疫情时期安防管控、高风险作业、安全预警等方面的应用,强调智能化是煤矿高质量发展的必然趋势。

美国451例婴儿倾斜睡眠产品伤害监测分析

目的通过分析美国消费品安全委员会(Consumer Product Safety Commission,CPSC)对婴儿倾斜睡眠产品的伤害监测数据及其伤害干预方法,为我国开展相关产品伤害监测与干预提供借鉴。方法本文通过婴儿倾斜睡眠产品来研究美国的产品伤害监测与干预方法,重点分析美国倾斜式睡眠产品专项调查研究数据,对伤害事件中的年龄分布、临床信息、产品缺陷等数据进行统计,分析伤害产生的原因,讨论干预策略。结果婴儿睡眠产品伤害与产品设计缺陷的关联度较大,其中一个重要的指标就是产品表面倾斜角度。当此类产品表面倾斜角在20度以上时,倾斜将使婴儿面临肌肉疲劳和窒息的风险;而10度及以下的倾斜不会显著影响婴儿运动或肌肉活动。一个不超过10度倾斜度的表面或更平坦的表面可以为婴儿提供最安全的睡眠环境。结论婴儿倾斜睡眠产品伤害具有事故多发和致死率高等特点,其产品安全问题需要得到包括中国在内的世界范围高度关注,而美国婴儿倾斜睡眠产品伤害监测与干预工作经验对我国开展同类工作具有重要借鉴意义。

南川页岩气田安全生产管理信息化技术应用

南川页岩气田目前正处于产建阶段,钻井、压裂、采气、集输等环节施工作业种类、数量较多,存在压力高、电压等级高、介质易燃易爆等安全隐患。为了在资源勘探开发的同时管理好生产安全,首先分析了目前各开发环节存在的安全隐患,对全环节数据实时监控并预警、智能化视频监控、紧急情况远程控制、振动光缆周界报警、电参实时监测及预警等技术进行了研究优化,在此基础上进一步优化形成了“数据+视频”“数据+远控”“振动光缆+视频”等多参数联动应急技术,最终建成了适用于南川页岩气田的安全生产管理信息化技术体系。实践效果表明,该技术体系在提高安全生产管理效率、缩短应急处置时长、及时制止违章作业、及时发现异常工况等方面效果显著,可为我国其他页岩气田安全生产管理提供借鉴。

增城市2004年市售熟肉卫生质量分析

为了解增城市市售烧、卤肉制品的卫生状况并作卫生学评价,以便为进一步加强烧、卤肉市场的卫生监督管理提供参考,卫生监督人员,每月不定期对本市辖区内市场、超市烧、卤肉摊档及酒家销售的烧、卤肉制品进行随机抽样468份,样品按照国家标准规定的方法检测菌落总数、大肠菌群、致病菌及亚硝酸盐含量。468份烧、卤肉制品总体合格率为70.7%,其中菌落总数、大肠菌群及亚硝酸盐含量合格率分别为84.8%、75.4%及98.5%,未检出致病菌。监测结果表明增城市市售烧、卤肉制品的卫生质量不容乐观,细菌尤其是大肠菌群污染严重,市场与超市销售的熟肉制品合格率较低,应进一步加强对烧、卤肉制品生产、运输和销售环节的卫生监督管理。

对10374例青霉素V片剂安全性评价的多中心研究

目的：评价１０３７４例细菌性感染病人不做皮试口服青霉素Ｖ的安全性及有效性。方法：青霉素Ｖ２５０～５００ｍｇ，ｐｏ，ｔｉｄ，疗程５ｄ。结果：参加疗效评定９０６３例，显效率４２．１８％（３８２３／９０６３例），总有效率８１．１８％（７３５７／９０６３例）。１９３０例病人用药前后做细菌培养，１１６３例阳性，共培养出致病菌１１６３株，治疗后细菌清除９６０株（８２．５５％）。不良反应发生率０．７４％（７６／１０３１１例），４４例因不良反应在治疗中被迫停药，主要为胃肠道反应。过敏反应发生率低，仅为０．１８％。但没有一例病人出现过敏性休克。１５３８例病人用药前后做了肝、肾功能检查：２例ＡＬＴ升高，发生率为０．１３％（２／１５３８）。结论：不做皮试口服青霉素Ｖ治疗细菌感染是安全有效的。

郴州市海、水产品霍乱弧菌污染状况监测

目的分析郴州市海、水产品霍乱弧菌污染状况及菌型特征。方法采集市场销售的海、水产品,对其整体或部分及相应的体表、肛门或鳃部涂片进行增菌、分离、鉴定。用家兔小肠段结扎实验检测O139群肠毒素。结果郴州市海、水产品霍乱弧菌带菌率为0.64%(2/311),两株霍乱弧菌均来自甲鱼(2/77),经鉴定分别为O1群和O139群,后者能产霍乱肠毒素(CT),还检出其他致病性弧菌9株。结论郴州市水产品存在O139群霍乱弧菌污染,给我们提出了一个新的卫生学问题,建议在今后的监测中采用整体或部分采集法。

2006年湖南省霍乱监测结果分析

目的监测人群中霍乱病例和被霍乱弧菌污染的水体及食物,以便尽早采取预防控制措施,防止疫情扩散。方法全省范围开展腹泻患者及外环境、食品监测,选择重点地区开展甲鱼霍乱弧菌污染状况专项监测。结果2006年湖南省共登记腹泻患者111526例,检测霍乱弧菌89661例,检测率为80.39%,检出阳性4例,均为O139群霍乱弧菌感染;检测环境和食品样44533份,其中水体35113份,全部为阴性,水产品5377份,阳性16份,阳性率为0.30%,阳性标本为甲鱼和牛蛙,其他食品4043份,均为阴性;甲鱼专项监测2323份,检出阳性33份,阳性率为1.42%;霍乱毒素基因检测34株菌,20株为产毒株,占58.80%;药敏试验28株菌,均对诺氟沙星、环丙沙星、丁胺卡那霉素100%敏感,对强力霉素、复方新诺明的敏感率为92.86%。结论甲鱼、牛蛙等水产品是湖南省发生霍乱的主要因素,应加强水产品的监测和卫生管理。

淮安市2010~2016年肉及肉制品中沙门氏菌污染状况及耐药性分析

目的了解江苏省淮安市肉及肉制品中沙门氏菌污染及耐药性情况。方法 2010~2016年,在淮安市选择超市、农贸市场、酒店餐厅、街头食品摊等,共采集719份肉及肉制品样品,按照食品安全国家标准方法(GB 4789.4-2010)对沙门氏菌进行鉴定及血清学分型,耐药性测定使用美国临床和实验室标准协会(Clinical and Laboratory Standards Institute,CLSI)推荐的肉汤稀释法。结果 2010~2016年淮安市肉及肉制品中沙门氏菌总检出率为7.37%(53/719),其中生肉及肉制品中检出率为9.16%(24/262),熟肉及肉制品中检出率为6.35%(29/457)。餐饮服务环节、流通环节和生产加工环节沙门氏菌检出率分别为2.22%、7.41%和9.16%。53株沙门氏菌主要血清型为肠炎型和鼠伤寒型,分别为41.51%(22/53)和22.64%(12/53)。53株沙门氏菌多重耐药率达64.7%,对红霉素、氨苄西林、萘啶酸耐药性较高。结论淮安市肉及肉制品中沙门氏菌污染严重,其中生产加工环节和流通环节沙门氏菌污染率较高,耐药形势严峻,相关部门对此应加强监管力度。

我国2市/县6所医院门急诊产品伤害监测结果的描述性分析

目的了解我国产品伤害的特点,探索在我国建立以医院为基础的产品伤害监测系统模式,为今后开展产品伤害预防控制工作提供基础资料和科学依据。方法选取两个全国伤害监测系统监测点作为试点,在试点地区6所监测医院由护士或医生填写统一制定的《产品伤害监测报告卡》,收集伤害就诊患者的伤害及相关产品信息。结果共上报有效伤害病例数39 573例,其中与产品相关的伤害25 102例（63.43%）。涉及人次数居前三位的产品依次为道路交通工具（25.52%）、公共场所设施（23.45%）和家庭用品（21.82%）。产品相关伤害中,男性占67.05%,主要发生在25~44岁（42.86%）、20~24岁（16.51%）和45~64岁（11.95%）。主要发生原因为跌倒/坠落（31.36%）、道路交通伤害（28.12%）和钝器伤（20.08%）;主要伤害部位为上肢（33.34%）、头部（24.16%）和下肢（23.59%）;主要伤害性质是挫伤/擦伤（41.94%）、锐器伤/咬伤/开放伤（41.13%）和扭伤/拉伤（10.48%）;以非故意伤害（94.15%）、轻度伤害（84.04%）和接受治疗后回家（87.00%）为主。结论男性和25~44岁青壮年是产品相关伤害的主要影响人群,道路交通工具、公共场所设施和家庭用品是伤害涉及的主要产品类型,应针对上述特点进一步挖掘信息,针对性地采取有效的预防措施,为制定产品伤害管理政策、策略提供基础信息。以医院为基础的产品伤害监测模式收集产品伤害基础信息在我国可行。

控制图在肉及肉制品微生物监测过程中的应用

介绍控制图的基本概念,并试列举控制图在肉及肉制品微生物监测结果方面的应用示例。结果表明在肉及肉制品微生物监测中应用控制图能够对肉及肉制品生产过程进行监控,以达到控制产品质量、提高经济效益的目的。

建立我国产品伤害监测系统探索

在介绍国外产品伤害监测基本情况的基础上,分析了在我国建立产品伤害监测项目的必要性,介绍了我国产品伤害监测试点的开展情况,并提出了建议。

湖南省2005年霍乱监测分析

目的掌握湖南省霍乱流行规律和霍乱弧茵在环境水体及食品的污染情况,为指导今后的霍乱防治工作提供依据。方法运用主动监测、被动监测、专项调查、现场流行病学调查等多种方法对湖南省的腹泻病人、环境水体、水产品、食品、霍乱疫情等进行监测。结果2005年湖南省腹泻病人检索阳性率为0．02％,全部为O_(139)群；外环境和食品监测阳性率为0．04％,18份阳性标本中主要为水体8份,水产品8份；全年共发生霍乱疫情13起,其中11起与聚餐有关,共报告病例43例,带茵者29例,均为O_(139)群；所检测其中20株O_(139)霍乱弧茵均为产毒株；从病人、带菌者、甲鱼中分离的O_(139)霍乱菌株高度同源。结论开展霍乱疫源监测是早期发现疫情、及时掌握疫情动态的重要措施,今后应加强对甲鱼等海水产品的霍乱弧菌污染状况监测和加强对农村集体聚餐的卫生指导和管理,以及加大外环境的检索力度和加强各种水体的消毒措施,防止疫情通过水体扩散。