专家共识

广州地区“港澳药械通”伦理审查共识

Consensus on ethical review of Hong Kong and Macao Drug and Medical Device Access in Guangzhou

:1467-1472
 
       为规范广州地区“港澳药械通”伦理审查工作,满足临床用药用械需求,保障患者用药用械安全,广州市医学会医学伦理分会、广州市医院协会“港澳药械通”工作专业委员会组织行业专家,结合相关政策法规要求与本地实践经验,广泛征求专家意见,经多次讨论,形成《广州地区“港澳药械通”伦理审查共识》。共识涵盖适用范围、术语和定义、伦理审查的原则、伦理审查的类别、伦理审查的流程、伦理审查的方式及多医疗机构申请的伦理审查等方面。共识旨在为广州地区“港澳药械通”指定医疗机构的伦理审查工作提供指导,统一审查标准,提高审查效率与质量,切实保护患者的合法权益,促进临床急需进口港澳药械的安全合理使用,从而促进粤港澳大湾区医疗健康事业发展。
       To standardize the ethical review process of the “Hong Kong and Macao Drugs and Medical Devices Access” in Guangzhou,meet the clinical demand for drugs and medical devices,and ensure the safety of patients’ use of drugs and medical devices,the Medical Ethics Branch of Guangzhou Medical Association and the “Hong Kong and Macao Drugs and Medical Devices Access” Professional Committee of Guangzhou Hospital Association organized industry experts,combined with  relevant policy and regulatory requirements and local practical experience,widely solicited expert opinions,the “Consensus on Ethical Review of Drugs and Medical Devices for Hong Kong and Macao in Guangzhou” were formed after several discussions.The consensus content covers aspects such as the scope of application,terms and definitions,principles of ethical review,categories of ethical review,procedures of ethical review,methods of ethical review,and Ethical Review for Multi-institutional Applications.The consensus aims to provide guidance for the ethical review work of designated medical institutions for the “Hong Kong and Macao Drugs and Medical Devices Access” in the Guangzhou area,unify the review standards,improve the efficiency and quality of the review,effectively protect the legitimate rights and interests of patients,promote the safe and rational use of clinically urgently imported medicines and medical devices Hong Kong Macao,and thereby promote the development of medical and health care in the Guangdong-Hong Kong-Macao Greater Bay Area.
论著

喀什地区和广州地区健康体检儿童血清维生素D3水平和缺乏率比较

:776-780
 
目的 比较喀什地区和广州地区健康体检儿童维生素D3水平和缺乏率。方法 纳入2019年1月—2020年12月喀什地区第一人民医院、广州市番禺区中心医院健康体检儿童,比较汉族儿童不同地区间以及比较喀什儿童不同民族间的维生素D3水平和缺乏率,分析了性别、年龄和季节对血清维生素D3水平的影响。结果 喀什汉族儿童维生素D3低于广州汉族儿童,缺乏率更高(均P<0.05)。喀什维族儿童的维生素D3水平低于喀什汉族儿童,缺乏率更高(均P<0.05)。同一地区、同一民族不同年龄段儿童间维生素D3缺乏率和水平比较差异均有统计学意义(均P<0.05),维生素D3缺乏率随年龄增加而升高,水平则显著下降。同一地区、同一民族儿童不同季节间维生素D3缺乏率和水平比较差异均有统计学意义(均P<0.05),冬季的缺乏率最高、水平最低。同一地区、同一民族儿童不同性别间维生素D3缺乏率和水平比较差异均无统计学意义(P>0.05)。结论 健康体检儿童血清维生素D3水平,喀什维族低于喀什汉族,喀什汉族低于广州汉族,缺乏率间差异明显。健康体检儿童血清维生素D3水平和缺乏率与年龄、季节有关,与性别无关。
临床诊疗

2019—2021年广州地区无偿献血后回告及保密性弃血工作分析及思考

:95-98
 
目的 通过分析2019—2021年广州地区保密性弃血工作情况,完善献血者献血后回告受理和保密性弃血管理。方法 通过分析广州市血液中心2019年1月—2021年12月期间受理的无偿献血者献血后保密性弃血回告记录,统计分析无偿献血者要求保密性弃血的各种原因,以及保密性弃血施行程序中出现的新情况。结果 2019年、2020年、2021年保密性弃血人数分别占当年献血人数的0.156‰,0.090‰,0.091‰。2020年之后出现接触或疑似接触新型冠状病毒患者的回告案例;在这3年间,87.6%的保密性弃血在72小时内完成回告。结论 无偿献血者保密性弃血回告以及血液屏蔽是保障血液用血安全的重要举措之一,目前广州市回告率相对较低,提示要强化血液保密性弃血回告及方法途径指引宣传,注意对新回告原因的收集以有针对性开展献血前征询工作,从源头筛选出合格、低风险的无偿献血者,同时完善长时间(72小时以上)才回告的血液保密性弃血处理程序。
论著

广州地区某三甲医院急诊综合病区疾病谱分析与护理对策

Disease spectrum analysis and nursing countermeasures in Emergency Comprehensive Ward of a third class hospital in Guangzhou

:87-90
 
目的 了解急诊科综合病区患者疾病分类构成的特点,为护士进行有针对性的培训,并为合理调配护理人员提供依据。方法 对2020年1月—2021年12月我院急诊科综合病区收治的1 901例患者疾病分类、收治时间等进行回顾性调查分析。结果 研究期间急诊综合病区共收治患者1 901例,收治患者以呼吸系统的患者居多,占比47.71%;以循环系统疾病的患者平均发病年龄最高,为(66.434±11.691)岁;全年各月以1月、12月收治病人居多。结论 根据调查分析,有针对性地对护士进行呼吸系统疾病护理技能培训,并在收治高峰期,合理调配护理人员,实施弹性排班,保障患者安全,提高护理质量。
Objective To understand the characteristics of disease classification and composition of patients in Comprehensive Ward of Emergency Department, provide targeted training for nurses, and provide basis for rational deployment of nursing staff. Methods A total of 1 901 patients in the Comprehensive Ward of Emergency Department of our hospital from January 2020 to December 2021 were investigated and analyzed retrospectively according to different diseases and time of admission. Results A total of 1 901 patients were treated in the Emergency Comprehensive Ward during the study period. Most of the patients were with respiratory system disease, accounting for 47.71%. The average onset age of patients with circulatory diseases was the oldest, which was (66.434±11.691). Most patients were admitted in January and December. Conclusions According to the investigation and analysis, nurses should be trained with the skills of respiratory diseases nursing, nursing staff should be reasonably allocated and flexible shift should be scheduled during the peak period of admission, so as to ensure the safety of patients and improve the quality of nursing.
论著

广州地区鲍曼不动杆菌的多位点序列分型及流行克隆

Multilocus sequence typing and epidemic clones of Acinetobacter baumannii in Guangzhou area

:20-25
 
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目的 本研究对广州地区5家教学医院的鲍曼不动杆菌进行分子流行病学分析。方法 5家教学医院共采集138株鲍曼不动杆菌,利用多位点序列分型(multilocus sequence typing,MLST)及eBURST算法评价菌株之间的遗传关系。结果 MLST将138株鲍曼不动杆菌分为8个已有序列类型(STs),分别为ST195、ST208、ST457、ST136、ST254、ST548、ST445和ST53,还发现17个新STs。其中ST195的数量最多,占所有分离株的35.5%(49/138),其次为ST208,占所有分离株的21.0%(29/138)。eBURST算法分析显示以ST195为预测祖先型的克隆复合体(clonal complex, CC) 195在医院环境中广泛传播。结论 鲍曼不动杆菌CC195是广州地区的流行克隆,各家医疗机构应根据其自身实际制定感染防控策略。
Objective We analyzed the molecular epidemiology of A.baumannii isolated from 5 teaching hospitals in Guangzhou to identify the epidemic clone in this area. Methods A total of 138 strains of A.baumannii were collected from 5 teaching hospitals, and the genetic relationship was evaluated by multilocus sequence typing (MLST) and eBURST algorithm. Results MLST divided 138 strains of A.baumannii into 8 existing sequence types (STs), namely ST195, ST208, ST457, ST136, ST254, ST548, ST445 and ST53, and 17 new STs. Among them, ST195 had the largest number, accounting for 35.5% (49/138) of all isolates, followed by ST208, accounting for 21.0% (29/138) of all isolates. eBURST algorithm showed that the clonal complex (CC) 195, the predicted founder ST195, was widely spread in the hospital environment. Conclusion A.baumannii CC195 was an epidemic clone in Guangzhou area. Medical institution should develop infection prevention and control strategies according to its own actual conditions.
论著

广州地区儿童2019新型冠状病毒感染筛查/疑似病例129例临床特征分析

Analysis of clinical characteristics of 129 children screening/suspected 2019-nCoV infection in Guangzhou

:12-19
 
目的 探讨广州地区儿童2019新型冠状病毒(2019 novel coronavirus, 2019-nCoV)感染筛查/疑似病例的流行病学特点、发病特点、可能的原因及防控建议。方法 回顾性分析2020年1月20日—2020年2月29日广州市唯一一家儿童2019-nCoV感染隔离定点医疗单位隔离病房收治住院的符合儿童2019-nCoV感染筛查/疑似病例129例,对其流行病学、发病特点、临床特征、实验室检查及转归、随访等进行总结分析。 结果 男 79例,女 50例,最小1个月,最大13岁,中位数2岁,51例(39.5%)有武汉疫区旅游或居住史,20例(15.5%)有与来自疫区有呼吸道症状人员接触史,17例(13.1%)周边或社区有确诊病例,3例(2.3%)有确诊病人接触史(其中2例为家庭确诊病例密切接触史),38例(29.5%)为临床符合或聚集性发病;临床症状:发热121例(93.8%),咳嗽92例(71.3%),流涕50例(38.8%),32例伴有腹泻、呕吐/腹痛(24.8%),102例(79.0%)白细胞降低或正常,C反应蛋白(C-reactive protein,CRP)<20 mg/L有103例(79.8%),57例(44.2%)胸片或CT示肺部斑片状影或实变;病原学检查:2019-nCoV实时荧光定量反转录PCR检测结果:所有患儿及陪同家属都有行咽拭子检查,只有21例患儿(16.3%)有行肛拭子检查,仅有1例(0.78%)家庭确诊病例密切接触者肛拭子阳性,但连续多次咽拭子结果阴性,余患者肛拭子和咽拭子及陪同家属咽拭子结果均阴性。其他病原学检查结果61例(47.3%),包括14例RSV阳性,9例流感病毒A,8例人偏肺病毒,6例肠道病毒,6例流感病毒B,6例肺炎支原体,4例副流感病毒1型,1例副流感病毒3型,2例人博卡病毒,3例腺病毒,1例肺炎克雷伯菌,1例人型葡萄球菌,其中1例合并副流感病毒1型及人博卡病毒。跟踪唯一1例确诊患者咽拭子多次检查均阴性,肛拭子持续19天后才转阴,一直无任何症状。其余患者好转出院后第3天、7天及14天进行随访,无异常发现。结论 儿童2019-nCoV感染筛查/疑似病例临床多表现为呼吸道或消化道症状,确诊主要依靠核酸检测,新冠病毒感染确诊率极低,而其将近50%病例能找到除新冠病毒外的其它相关病原体;高危患者为密切接触者,但存在漏诊的可能,肛拭子阳性率或高于咽拭子。
Objective To explore the epidemiological characteristics, onset characteristics, pathogenic mechanism of 2019-nCoV infection in children, and its control and prevention in Guangzhou. Methods From January 20, 2020 to February 29, 2020, a retrospective analysis was carried out on 129 suspected cases of 2019-nCoV infection admitted to the isolation ward of the only medical unit designated for children in Guangzhou. The epidemiology, disease characteristics, clinical characteristics, laboratory examination, outcome and follow-up were summarized and analyzed. Results There were 79 males and 50 females, with a minimum age of 1 month and a maximum age of 13 years. Anong them, 51 cases (39.5%) had a history of tourism or residence in the epidemic area of Wuhan, 20 cases (15.5%) had a history of contact with people with respiratory symptoms from the epidemic area, 17 cases (13.1%) with a confirmed case in the surrounding area or community, 3 cases (2.3%) had a history of contact with a confirmed patient (2 of them were family clustering cases), 38 cases (29.5%) were clinically suspected cases. Clinical symptoms: 121 cases with fever (93.8%), 92 cases with coughing (71.3%), 50 cases with runny nose (38.8%), 32 cases with diarrhea, vomiting or abdominal pain (24.8%). In 102 cases (79.0%), white blood cells were decreased or normal, 103 cases (79.8%) with CRP<20 mg/L, and 57 cases (44.2%) showed focal infection on chest X-ray or CT scan. Etiological examination: only one case (0.78%) of the family confirmed cases had positive anal swab result, but the throat swab results were negative all the time. The anal swab and throat swab results of other patients and the throat swab results of their accompanying family members were negative. Other pathogens were detected in 61 cases (47.3%), including 14 RSV positive cases, 9 influenza A positive cases, 8 human metapneumovirus positive cases, 6 enterovirus positive cases, 6 influenza B positive cases, 6 Mycoplasma pneumoniae positive cases, 4 parainfluenza virus type 1 positive cases, 1 parainfluenza virus type 3 positive cases, 2 human bocavirus positive cases, 3 adenovirus positive cases, 1 Klebsiella pneumoniae positive cases, 1 Human Staphylococcus positive case, and 1 case with parainfluenza virus type 1 and human bocavirus. The only confirmed patient was followed up while multiple pharyngeal swab results were negative, and the positive anal swab results lasted for 19 days before turning negative and remained asymptomatic. Other patients were followed up on the 3rd, 7th and 14th day after discharge, and no abnormal findings were found. Conclusion Screening/suspected cases of 2019-nCoV infection in children were mostly clinically manifested as respiratory or gastrointestinal symptoms. The diagnosis rate of nucleic acids was extremely low, and there was a possibility of missed diagnosis. Nearly 50% of cases could find other relevant pathogens excluding the 2019-nCoV. The positive rate of anal swab results was higher than that of pharyngeal swab.
论著

2018—2019年度广州地区甲型和乙型流感儿童实验室检测与分析

The laboratory detection and analysis of influenza A and B of children in Guangzhou area from 2018 to 2019

:89-94
 
目的 通过血常规分析和C反应蛋白(CRP)水平检测,探讨其对儿童甲型和乙型流感的辅助诊断价值,为临床治疗提供参考依据。方法 选择3 069名甲型流感患儿、2 307名乙型流感患儿、855名健康儿童,统计分析血常规参数以及CRP水平。采用ROC曲线分析血常规对甲乙型流感的区分效能。结果 甲组白细胞计数(WBC)均值高于正常组,乙组则相反,甲乙组中性粒细胞百分比(Neut%)、中性粒细胞与淋巴细胞百分比比值(NLR)、单核细胞百分比(Mono%)的均值高于正常组,甲乙组淋巴细胞百分比(Lymph%)、血小板计数(PLT)的均值低于正常组。甲组中性粒细胞计数(Neut#)、单核细胞计数(Mono#)、CRP、PLT的均值均高于乙组,Lymph%和淋巴细胞计数(Lymph#)的均值低于乙组。甲组在WBC>13×109/L、Neut%>70.7、Lymph%<19.1的构成比高于乙组。NLR预测甲型流感临界值为2.08(敏感度为75.9%,特异度为89.4%),预测乙型流感临界值为2.11(敏感度为50.5%,特异度为89.8%)。结论 血常规参数和CRP水平变化可用于判断流感患儿是否存在细菌感染,指导临床用药;NLR作为一种新型预测标志物,其变化可以对区分甲型、乙型流感,尤其是甲型流感具有临床价值。
Objective Through blood analysis and C-reactive protein (CRP) level detection, to explore its value in the auxiliary diagnosis of influenza A and B in children, and to provide reference for clinical treatment. Methods 3 069 children with influenza A, 2 307 children with influenza B, and 855 healthy children were selected, and blood routine parameters and CRP levels were statistically analyzed. The ROC curve was used to analyze the discriminatory efficacy of blood routine on influenza A and B. Results The mean value of white blood cell count (WBC) in group A was higher than that in normal group, but in group B it had the opposite result. The percentage of neutrophils (Neut%), the ratio of neutrophils to lymphocytes (NLR), and the percentage of monocytes (the mean value of Mono%) is higher than that of normal group, and the mean value of lymphocyte percentage (Lymph%) and platelet count (PLT) of group A and B is lower than that of normal group. The mean values of neutrophil count (Neut#), monocyte count (Mono#), CRP and PLT in group A were higher than those in group B, and the mean values of Lymph% and lymphocyte count (Lymph#) were lower than those in group B. The composition ratios of group A in WBC>13×109/L, Neut%>70.7, Lymph%<19.1 were higher than that in group B. The NLR predicted the critical value of influenza A was 2.08 (sensitivity 75.9%, specificity 89.4%), and the predicted influenza B threshold value was 2.11 (sensitivity 50.5%, specificity 89.8%). Conclusion Changes in blood routine parameters and CRP levels can be used to determine whether there is a bacterial infection in children with influenza and to guide clinical medication; NLR as a new predictive marker, its changes can distinguish influenza A or B. Especially in influenza A determination, it has clinical value.
论著

影响广州地区Rh阴性红细胞采供情况的原因

Analysis on the factors affecting the collection and supply of RhD(-) red blood cells in Guangzhou city

:54-57
 
目的 通过回顾分析广州地区Rh阴性血的采供情况,了解Rh阴性红细胞的供应特点,更好地实施Rh阴性血液库存管理,保障输血安全。方法 统计2011—2017年广州血液中心Rh阴性血液采集量与供应量,血型及医院供血量的分布情况。结果 2011—2017年广州血液中心Rh阴性全血采集量为11 283 U,占总采血量的0.39%(11 283/2 902 485),供应总量为11 693 U,占红细胞类成分血总供应量的0.43%(11 693/2 762 229),其中悬浮红细胞供应比例逐年增加,冰冻解冻去甘油红细胞供应比例逐年下降,并从2014年起Rh阴性悬浮红细胞供应增长率明显高于血液采集增长率;4种血型供应量总体比较,差异有统计学意义(F=22.217,P<0.05),A、B型Rh阴性悬浮红细胞供应增长最快,增长率分别为137.3%和134.1%,医院分布以三级以上及综合医院为主。结论 应根据广州地区Rh阴性红细胞采供特点,来持续改进Rh阴性血源招募和采供策略。通过建立一支Rh阴性定期献血者队伍,加强Rh阴性血液统筹管理和临床科室-输血科-采供血机构的沟通,促进Rh阴性血液的供需平衡,保障Rh阴性患者输血安全。
Objective To understand the characteristics of Rh-negative red blood cells (RBC) supply, improve the management of storage and guarantee the safety of blood transfusion. The collection and supply of Rh-negative RBC in Guangzhou city was retrospectively analyzed. Methods The amount of Rh-negative RBC collection and supply, the distribution of ABO blood type and the consumption of blood by different hospitals in Guangzhou Blood Center from 2011 to 2017 were statistically analyzed. Results During 2011-2017, 11 283 U Rh-negative RBC was collected in Guangzhou Blood Center, accounting for 0.39% of total RBC collection (11 283/2 902 485); 1 693 U Rh-negative RBC was supplied, accounting for 0.43% of the total blood supply (11 693/2 762 229). The proportion of suspended RBC supply increased year by year, in contrast with the decease of proportion of frozen defrosteddeglyceal RBC supply. In addition, the growth rate of Rh-negative suspended RBC supply was higher than that of RBC collection since 2014 (F=217, P<0.05). A-and B-Rh negative suspended RBC supply increased, with growth rates of 137.3% and 134.1%, respectively. The Rh negative RBC was predominantly supplied to Grade III and general hospitals. Conclusion By establishing a team of Rh-negative regular blood donors, the strategies for recruitment, collection and supply of Rh-negative RBC should be continuously improved according to the characteristics of Rh-negative RBC collection and supply in Guangzhou. The coordinating management of Rh-negative, as well as the communication of clinical departments, departments of transfusion and blood banks should be improved. In addition, the balance between supply and demand of Rh-negative blood should be promoted, and the safety of blood transfusion for Rh-negative patients can be improved.
临床诊疗

喀什地区和广州地区过敏性疾病儿童过敏原IgE阳性率比较

:123-126
 
目的 对喀什地区和广州地区过敏性疾病儿童血清过敏原特异性IgE进行检测并比较检测结果。方法 选择喀什地区第一人民医院(喀什地区)和广东省妇幼保健院、广州市番禺区中心医院(广州地区)过敏性疾病儿童,血清标本采用国产欧博克试剂盒(酶联免疫法)检测过敏原特异性IgE。结果 两地区过敏性疾病儿童的过敏原IgE总阳性率均随年龄增长逐渐升高。广州地区过敏性疾病儿童对牛奶的IgE阳性率随年龄增长逐渐降低,对屋尘螨/粉尘螨则逐渐升高,组间比较均有统计学意义差异(P均<0.05)。喀什地区过敏性疾病儿童对花生/榛子/开心果、葎草/艾蒿/豚草、猫/狗毛皮屑的血清IgE阳性率明显高于广州地区,而对牛奶、屋尘螨/粉尘螨的血清IgE阳性率明显低于广州地区(P均<0.05)。结论 喀什地区和广州地区过敏性疾病儿童过敏原特异性IgE结果存在显著差异,过敏性疾病需要做好不同地区过敏原的监测。
论著

广州地区老年住院患者营养状态与日常生活能力相关性研究

Relationship between nutritional status and activities of daily living in elderly inpatients in Guangzhou

:68-72
 
目的 探讨广州地区老年住院患者营养状态与日常生活能力(ADL)的相关性。方法 选取2018年7月—2019年6月在广州市第一人民医院住院年龄≥60岁的老年人共275例,收集其一般资料信息,各项临床营养指标(BMI、血清白蛋白、血红蛋白、总胆固醇、甘油三酯)、并运用营养风险筛查2002(NRS2002)评估营养风险、采用Barthel指数评定量表评估日常生活能力;分析老年住院患者营养状态与ADL之间的相关性。结果 在本组研究中,根据NRS2002评分(营养风险:NRS2002≥3;无营养风险NRS2002<3),营养风险发生率58.9%(162/275);无营养风险发生率41.1%(113/275)。老年住院患者的NRS2002评分与ADL评分呈负相关关系(r=-0.393,P<0.05);ADL评分与BMI、血清白蛋白、总胆固醇、血红蛋白水平呈正相关关系(P<0.05)。结论 广州地区老年住院患者NRS2002为日常生活能力的影响因素,通过降低NRS2002评分来减少营养风险可改善老年人的日常生活能力;老年人的营养风险发生率高,应当尽早进行营养干预。
Objective To investigate relationship between nutritional status and activities of daily living(ADL) in elderly inpatients in Guangzhou. Methods Total of 275 people older than 60 were included in this study from Guangzhou First People's Hospital from July 2018 to June 2019. Their nutritional markers(including BMI, plasma albumin, hemoglobin, total cholesterol, triglyceride),the activities of daily living(ADL) were evaluated with Barthel index and the nutrition risk screening 2002(NRS2002)used to assess the nutritional risk status were collected to analyze the relationship between nutrition and ADL. Results In these subjects, based on the NRS2002 scores(nutritional risk that the NRS2002 scores were equal or greater than 3, and the non-nutritional risk that the NRS2002 scores were less than 3),58.9%(162/275) patients were having nutritional risk and 41.1%(113/275) were having non-nutritional risk. In elderly inpatients,NSR2002 were negatively associated with ADL(r=-0.393,P<0.05). ADL was positively associated with BMI, plasma albumin and hemoglobin level(P<0.05). Conclusion In the old, the NRS2002 is an influencing marker of activities of daily living in Guangzhou. Reducing the nutritional risk by lowering the NRS2002 scores can improve ADL in the elderly. The incidence of nutritional risk is highly prevalent in elderly and early nutritional treatment will be needed.
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