本文選題：預(yù)防接種 + 過敏性休克�。� 參考：《中國疾病預(yù)防控制中心》2012年碩士論文

【摘要】：目的 隨著疑似預(yù)防接種異常反應(yīng)(AEFI)監(jiān)測水平的不斷提高,AEFI報(bào)告數(shù)量的不斷增加,及時(shí)發(fā)現(xiàn)和報(bào)告AEFI相關(guān)疾病,并準(zhǔn)確做出診斷顯得尤為重要,同時(shí)也是保證疫苗安全性預(yù)警的關(guān)鍵。目前,AEFI相關(guān)疾病還沒有診斷標(biāo)準(zhǔn),急需出臺全國統(tǒng)一的AEFI相關(guān)疾病診斷標(biāo)準(zhǔn),以保證AEFI監(jiān)測系統(tǒng)報(bào)告相關(guān)疾病特異性。本研究以疫苗接種后發(fā)生的過敏性休克的診斷為模板,確定診斷標(biāo)準(zhǔn)研究方法和內(nèi)容,也為其他AEFI相關(guān)疾病診斷標(biāo)準(zhǔn)研究積累經(jīng)驗(yàn)。 方法 遵循循證醫(yī)學(xué)的原則,對疫苗接種過敏性休克的文獻(xiàn)采用系統(tǒng)評價(jià)方法進(jìn)行分析,同時(shí)對2008-2010年間全國疑似預(yù)防接種異常反應(yīng)監(jiān)測系統(tǒng)中報(bào)告過敏性休克的個(gè)案采用描述性流行學(xué)方法進(jìn)行分析,找出過敏性休克發(fā)生特征和診斷存在的問題,起草預(yù)防接種后過敏性休克的診斷標(biāo)準(zhǔn),然后請專家評議,完善標(biāo)準(zhǔn)。 采用循證醫(yī)學(xué)方法,篩選疑似預(yù)防接種異常反應(yīng)其它相關(guān)疾病并起草初步標(biāo)準(zhǔn)。 結(jié)果 1.過敏性休克的系統(tǒng)評價(jià)共納入52篇文獻(xiàn)的76例個(gè)案,其中男性56例,女性20例,男女性比例為2.8：1。發(fā)病年齡最大69歲,最小僅出生1d,各年齡組均有發(fā)生。共涉及疫苗17種,54例為接種滅活疫苗,20例為接種減毒活疫苗,2例為同時(shí)接種減毒活疫苗和滅活疫苗,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)、流行性乙型腦炎滅活疫苗(8例)。接種疫苗至發(fā)生過敏性休克時(shí)間最短lmin,最長4h,中位數(shù)時(shí)間為l0min。最終結(jié)局有9例死亡,67例痊愈。臨床表現(xiàn)以呼吸急促、呼吸困難、血壓下降、紫紺、四肢濕冷、面色蒼白、意識不清或喪失為主要癥狀和體征。依據(jù)衛(wèi)生部《預(yù)防接種工作規(guī)范》有關(guān)過敏性休克的診斷原則,可以發(fā)現(xiàn)報(bào)道的文獻(xiàn)中,對于過敏性休克的診斷不完全準(zhǔn)確,占個(gè)案數(shù)的31.6%。 2.過敏性休克監(jiān)測分析評價(jià)2008-2010年共報(bào)告180例過敏性休克,175例被分類為異常反應(yīng)。175例過敏性休克病例中,發(fā)病年齡最大71歲,最小1為出生一天,各年齡組均有發(fā)生。共涉及疫苗25種,121例為接種滅活疫苗,54例為接種減毒活疫苗。接種疫苗至發(fā)生過敏性休克時(shí)間最短1分鐘,最長18小時(shí),中位數(shù)時(shí)間為10分鐘,30分鐘內(nèi)病例的占86.2%。臨床表現(xiàn)以呼吸急促、呼吸困難、血壓下降、紫紺、四肢濕冷、面色蒼白、意識不清或喪失為主要癥狀和體征。依據(jù)過敏性休克臨床表現(xiàn)及發(fā)生時(shí)間間隔,可以發(fā)現(xiàn)監(jiān)測報(bào)告的過敏性休克,有的診斷不夠準(zhǔn)確,占個(gè)案數(shù)的43.4%。 3.過敏性休克診斷標(biāo)準(zhǔn)的制定擬定了預(yù)防接種后過敏性休克診斷標(biāo)準(zhǔn),并進(jìn)行了專家評議,進(jìn)行了適當(dāng)?shù)男拚�。預(yù)防接種后過敏性休克的診斷標(biāo)準(zhǔn)為：①發(fā)生突然,多數(shù)發(fā)生于接種疫苗后1小時(shí)內(nèi)；②癥狀嚴(yán)重,出現(xiàn)循環(huán)衰竭,血壓急劇下降至休克水平,即10.7/6.7KPa(80/50mmHg)以下；③出現(xiàn)意識障礙或呼吸困難、紫紺或面色蒼白；④血清IgE升高有助于確診；⑤多合并皮疹或瘙癢癥,早期可出現(xiàn)眼瘁、流淚、鼻塞、打噴嚏或卡他性鼻炎,頭暈、胸悶、氣短及腹部不定位的隱痛或絞痛,繼之則可出現(xiàn)喉頭水腫和支氣管等呼吸道癥狀。可伴有為四肢厥冷、煩躁不安、脈搏細(xì)弱、心動過速等,在非常嚴(yán)重的過敏反應(yīng)中也可以表現(xiàn)為心動過緩�；颊哌€可有胃腸道癥狀如惡心、嘔吐、腹瀉甚至大小便失禁等其他表現(xiàn)。 4.起草了25個(gè)疑似預(yù)防接種異常反應(yīng)相關(guān)疾病參考診斷標(biāo)準(zhǔn)定義。 結(jié)論 1.對過敏性休克的系統(tǒng)性評價(jià)和監(jiān)測數(shù)據(jù)分析提示,絕大多數(shù)(分別有87.3%和86.2%)的接種疫苗所致過敏性休克發(fā)生于接種后30min內(nèi)；過敏性休克的主要臨床特征表現(xiàn)為呼吸急促、呼吸困難、血壓下降、紫紺、四肢濕冷、面色蒼白、意識不清或喪失等。 2.部分接種疫苗后的“過敏性休克”的臨床特征不完全符合過敏性休克的診斷；部分病例的發(fā)病與接種的間隔較長,不符合過敏性休克的本身的發(fā)生間隔；過敏性休克的疾病診斷和因果關(guān)系判斷尚缺乏統(tǒng)一的執(zhí)行標(biāo)準(zhǔn)。 3.預(yù)防接種后過敏性休克等疑似預(yù)防接種異常反應(yīng)診斷標(biāo)準(zhǔn)的制定,必需考慮疾病的臨床診斷標(biāo)準(zhǔn)、時(shí)間關(guān)聯(lián)性、生物學(xué)合理性等原則。預(yù)防接種后過敏性休克的診斷標(biāo)準(zhǔn)對于規(guī)范調(diào)查診斷接種疫苗后發(fā)生的過敏性休克有著重要的指導(dǎo)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.

【學(xué)位授予單位】：中國疾病預(yù)防控制中心
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2012
【分類號】：R186

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