预防接种后发生的过敏性休克及其他相关疾病参考诊断标准的探索性研究

发布时间：2018-05-09 22:24

本文选题：预防接种 + 过敏性休克　；参考：《中国疾病预防控制中心》2012年硕士论文

【摘要】：目的随着疑似预防接种异常反应(AEFI)监测水平的不断提高,AEFI报告数量的不断增加,及时发现和报告AEFI相关疾病,并准确做出诊断显得尤为重要,同时也是保证疫苗安全性预警的关键。目前,AEFI相关疾病还没有诊断标准,急需出台全国统一的AEFI相关疾病诊断标准,以保证AEFI监测系统报告相关疾病特异性。本研究以疫苗接种后发生的过敏性休克的诊断为模板,确定诊断标准研究方法和内容,也为其他AEFI相关疾病诊断标准研究积累经验。方法遵循循证医学的原则,对疫苗接种过敏性休克的文献采用系统评价方法进行分析,同时对2008-2010年间全国疑似预防接种异常反应监测系统中报告过敏性休克的个案采用描述性流行学方法进行分析,找出过敏性休克发生特征和诊断存在的问题,起草预防接种后过敏性休克的诊断标准,然后请专家评议,完善标准。采用循证医学方法,筛选疑似预防接种异常反应其它相关疾病并起草初步标准。结果 1.过敏性休克的系统评价共纳入52篇文献的76例个案,其中男性56例,女性20例,男女性比例为2.8：1。发病年龄最大69岁,最小仅出生1d,各年龄组均有发生。共涉及疫苗17种,54例为接种灭活疫苗,20例为接种减毒活疫苗,2例为同时接种减毒活疫苗和灭活疫苗,其中居前三位的是人用狂犬病疫苗(14例)、乙型肝炎疫苗(13例)、流行性乙型脑炎灭活疫苗(8例)。接种疫苗至发生过敏性休克时间最短lmin,最长4h,中位数时间为l0min。最终结局有9例死亡,67例痊愈。临床表现以呼吸急促、呼吸困难、血压下降、紫绀、四肢湿冷、面色苍白、意识不清或丧失为主要症状和体征。依据卫生部《预防接种工作规范》有关过敏性休克的诊断原则,可以发现报道的文献中,对于过敏性休克的诊断不完全准确,占个案数的31.6%。 2.过敏性休克监测分析评价2008-2010年共报告180例过敏性休克,175例被分类为异常反应。175例过敏性休克病例中,发病年龄最大71岁,最小1为出生一天,各年龄组均有发生。共涉及疫苗25种,121例为接种灭活疫苗,54例为接种减毒活疫苗。接种疫苗至发生过敏性休克时间最短1分钟,最长18小时,中位数时间为10分钟,30分钟内病例的占86.2%。临床表现以呼吸急促、呼吸困难、血压下降、紫绀、四肢湿冷、面色苍白、意识不清或丧失为主要症状和体征。依据过敏性休克临床表现及发生时间间隔,可以发现监测报告的过敏性休克,有的诊断不够准确,占个案数的43.4%。 3.过敏性休克诊断标准的制定拟定了预防接种后过敏性休克诊断标准,并进行了专家评议,进行了适当的修正。预防接种后过敏性休克的诊断标准为：①发生突然,多数发生于接种疫苗后1小时内；②症状严重,出现循环衰竭,血压急剧下降至休克水平,即10.7/6.7KPa(80/50mmHg)以下；③出现意识障碍或呼吸困难、紫绀或面色苍白；④血清IgE升高有助于确诊；⑤多合并皮疹或瘙痒症,早期可出现眼瘁、流泪、鼻塞、打喷嚏或卡他性鼻炎,头晕、胸闷、气短及腹部不定位的隐痛或绞痛,继之则可出现喉头水肿和支气管等呼吸道症状。可伴有为四肢厥冷、烦躁不安、脉搏细弱、心动过速等,在非常严重的过敏反应中也可以表现为心动过缓。患者还可有胃肠道症状如恶心、呕吐、腹泻甚至大小便失禁等其他表现。 4.起草了25个疑似预防接种异常反应相关疾病参考诊断标准定义。结论 1.对过敏性休克的系统性评价和监测数据分析提示,绝大多数(分别有87.3%和86.2%)的接种疫苗所致过敏性休克发生于接种后30min内；过敏性休克的主要临床特征表现为呼吸急促、呼吸困难、血压下降、紫绀、四肢湿冷、面色苍白、意识不清或丧失等。 2.部分接种疫苗后的“过敏性休克”的临床特征不完全符合过敏性休克的诊断；部分病例的发病与接种的间隔较长,不符合过敏性休克的本身的发生间隔；过敏性休克的疾病诊断和因果关系判断尚缺乏统一的执行标准。 3.预防接种后过敏性休克等疑似预防接种异常反应诊断标准的制定,必需考虑疾病的临床诊断标准、时间关联性、生物学合理性等原则。预防接种后过敏性休克的诊断标准对于规范调查诊断接种疫苗后发生的过敏性休克有着重要的指导作用。
[Abstract]:objective
With the continuous improvement of suspected abnormal vaccination response (AEFI) monitoring level, the increasing number of AEFI reports, the timely detection and reporting of AEFI related diseases, and accurate diagnosis is particularly important. At the same time, it is also the key to ensure the early warning of the safety of the vaccine. At present, there is no diagnostic standard for the related diseases of AEFI, and the national unification is urgently needed. The diagnostic criteria for AEFI related diseases were used to ensure that the AEFI monitoring system reported related disease specificity. The diagnosis of anaphylactic shock after vaccination was used as a template to determine the research methods and contents of the diagnostic criteria and to accumulate experience for other diagnostic criteria for AEFI related diseases.
Method
According to the principles of evidence-based medicine, the systematic evaluation method was used in the literature of vaccinating allergic shock. At the same time, a descriptive epidemiological method was used to analyze the cases of allergic shock reported in the national suspected abnormal response monitoring system of 2008-2010 years. The characteristics and diagnosis of anaphylactic shock were found. In the light of the problem, draft diagnostic criteria for anaphylactic shock after vaccination should be drafted, and experts are invited to review and perfect the criteria.
Evidence based medicine was used to screen suspected adverse reactions and other related diseases and draft preliminary criteria.
Result
1. the systematic evaluation of anaphylactic shock included 76 cases of 52 literature, of which 56 were male and 20 in women. The male and female ratio of 2.8:1. was 69 years old, the minimum was only 1D, and all age groups were all. There were 17 vaccines, 54 vaccinated, 20 vaccinated and 2 at the same time. Of the vaccine and inactivated vaccine, the top three were Purified Hamster Kidney Cell Rabies Vaccine (14 cases), hepatitis B vaccine (13 cases) and epidemic Inactivated Japanese Encephalitis Vaccine for Humanuse (8 cases). Inoculated to the shortest time lmin, the longest 4h, the median time of l0min. was 9 cases of death and 67 cases were cured. The clinical manifestations were shortness of breath, and respiratory distress. It is difficult to reduce blood pressure, cyanosis, damp and cold limbs, pale face, lack of consciousness or loss of main symptoms and signs. According to the Ministry of health, the health department < Standard for vaccination > diagnosis of anaphylactic shock, we can find that in the literature, the diagnosis of anaphylactic shock is not complete, accounting for 31.6%. of the case.
2. a total of 180 cases of anaphylactic shock were reported in 2008-2010 years, and 175 cases were classified as abnormal response to.175 cases of anaphylactic shock, the maximum age was 71 years old, the minimum 1 was one day of birth, and all age groups occurred. A total of 25 vaccines, 121 inactivated vaccine and 54 vaccinated live attenuated vaccine were involved. The shortest time of the vaccine to anaphylactic shock was 1 minutes, the longest time was 18 hours, the median time was 10 minutes. In 30 minutes, the cases accounted for 86.2%. clinical manifestations with shortness of breath, dyspnea, blood pressure drop, cyanosis, wet cold, pale face, lack of consciousness or loss of symptoms and signs. According to the clinical manifestation and occurrence of anaphylactic shock. Interval intervals can detect allergic shock reported in monitoring reports, some of which are not accurate enough, accounting for 43.4%. of cases.
3. the criteria for the diagnosis of anaphylactic shock were formulated and the criteria for the diagnosis of anaphylactic shock after vaccination were developed and an expert review was carried out. The criteria for the diagnosis of anaphylactic shock after vaccination were: (1) sudden onset, most of which occurred within 1 hours after vaccination; (2) severe symptoms, circulatory failure, and sharp blood pressure Drop to the level of shock, that is, below 10.7/6.7KPa (80/50mmHg); (3) disturbance of consciousness or dyspnea, cyanosis or paleness of the face; (4) the elevation of IgE in the serum helps to confirm the diagnosis; (5) more skin rashes or pruritus, early eyes, tears, nasal congestion, sneezing or karrhh rhinitis, dizziness, chest tightness, shortness of breath, or abdominal no localization pain or pain. Colic, followed by edema of the larynx and respiratory symptoms such as bronchi, can be accompanied by cold limbs, irritability, weak pulse, tachycardia and so on. In very serious allergic reactions, it can also be expressed as bradycardia. Patients may also have other manifestations of gastrointestinal symptoms such as nausea, vomiting, diarrhea and even incontinence.
4. 25 diagnostic criteria for suspected adverse events associated with vaccination were drafted.
conclusion
1. the systematic evaluation and monitoring data analysis of anaphylactic shock showed that the overwhelming majority (87.3% and 86.2% respectively) of anaphylactic shock occurred in 30min after inoculation; the main clinical features of anaphylactic shock were respiratory shortness, dyspnea, blood pressure drop, cyanosis, wet cold, pale face, or poor consciousness. Lose and so on.
The clinical characteristics of "anaphylactic shock" after the 2. vaccinations are not completely consistent with the diagnosis of anaphylactic shock; some cases have a long interval of onset and inoculation, which do not conform to the interval of anaphylactic shock itself; the diagnosis of anaphylactic shock and the judgment of causality still lack a unified standard of execution.
3. the criteria for diagnosis of abnormal response to allergic shock, such as anaphylactic shock after vaccination, must be taken into consideration of the principles of clinical diagnosis, time correlation and biological rationality. The diagnostic criteria for anaphylactic shock after vaccination are important for the standardized investigation of anaphylactic shock after vaccination. Guide action.

【学位授予单位】：中国疾病预防控制中心
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R186

【参考文献】