本文選題：甲型肝炎減毒活疫苗 + 甲型肝炎滅活疫苗　； 參考：《中國(guó)疾病預(yù)防控制中心》2010年碩士論文

【摘要】： 背景：甲型肝炎(甲肝)減毒活疫苗(Hepatitis A Vaccine, Live,HepA-L)和HepA-I (Hepatitis A Vaccine,Inactivated,HepA-I)上市后疑似預(yù)防接種異常反應(yīng)(Adverse Events Following Immunization, AEFI)監(jiān)測(cè)是評(píng)價(jià)HepA安全性的重要方法。我國(guó)從2005年開(kāi)展AEFI監(jiān)測(cè),本文對(duì)2007～2008年北京、河北、上海、廣東、廣西5個(gè)省(自治區(qū)、直轄市,下同)接種HepA-L和HepA-I后發(fā)生的AEFI和嚴(yán)重不良反應(yīng)(Serious Adverse Reaction)的發(fā)生率及特征進(jìn)行分析,評(píng)價(jià)兩種類(lèi)型甲肝疫苗上市后的安全性。 目的：分析我國(guó)5個(gè)省接種HepA-L和HepA-I后發(fā)生的AEFI和嚴(yán)重不良反應(yīng)的發(fā)生率及特征,評(píng)價(jià)兩種HepA的安全性。 方法：通過(guò)中國(guó)免疫規(guī)劃監(jiān)測(cè)信息管理系統(tǒng)和兒童預(yù)防接種信息管理系統(tǒng)(AEFI監(jiān)測(cè)系統(tǒng))報(bào)告收集2007年1月1日～2008年12月31日接種的HepA-L和HepA-I后發(fā)生的AEFI和嚴(yán)重不良反應(yīng)個(gè)案信息,采用描述性方法對(duì)嚴(yán)重不良反應(yīng)的發(fā)生率及特征進(jìn)行流行病學(xué)統(tǒng)計(jì)分析。 結(jié)果：從AEFI發(fā)生情況看,2007年1月1日～2008年12月31日,5省共報(bào)告由HepA AEFI220例,總報(bào)告發(fā)生率為41.34／100萬(wàn)；報(bào)告發(fā)病率依次為河北、上海、廣東、北京和廣西,范圍在3.39～274.22／100萬(wàn)；其中不良反應(yīng)200例,報(bào)告發(fā)生率為37.61／100萬(wàn),嚴(yán)重不良反應(yīng)106例,報(bào)告發(fā)生率為19.93／100萬(wàn)。HepA-L嚴(yán)重不良反應(yīng)28例,報(bào)告發(fā)生率為11.84／100萬(wàn)；HepA-I78例,報(bào)告發(fā)生率26.41／100萬(wàn)。 兩種HepA106例嚴(yán)重不良反應(yīng)中,重度發(fā)熱(腋溫≥38.6℃)53例,報(bào)告發(fā)生率9.97／100萬(wàn)；過(guò)敏反應(yīng)52例,報(bào)告發(fā)生率9.78／100萬(wàn)(包括過(guò)敏性皮疹41例,報(bào)告發(fā)生率7.71／100萬(wàn)；過(guò)敏性休克1例,報(bào)告發(fā)生率0.19／100萬(wàn)；其它過(guò)敏反應(yīng)10例,報(bào)告發(fā)生率1.88／100萬(wàn))；無(wú)菌性膿腫1例,報(bào)告發(fā)生率0.19／100萬(wàn)。無(wú)局部紅腫直徑5cm、硬結(jié)直徑5cm、過(guò)敏性紫癜、血小板減少性紫癜、阿瑟(Arthus)反應(yīng)、血管性水腫、多發(fā)性神經(jīng)炎、GBS、臂叢神經(jīng)炎、癲癇、腦病、腦炎和腦膜炎等嚴(yán)重不良反應(yīng)。 在HepA-L28例嚴(yán)重不良反應(yīng)中,重度發(fā)熱15例,報(bào)告發(fā)生率6.34／100萬(wàn)；過(guò)敏反應(yīng)13例,報(bào)告發(fā)生率5.50／100萬(wàn)(包括過(guò)敏性皮疹11例,報(bào)告發(fā)生率3.00／100萬(wàn)；過(guò)敏性休克1例,報(bào)告發(fā)生率0.42／100萬(wàn)；其它過(guò)敏反應(yīng)1例,報(bào)告發(fā)生率0.42／100萬(wàn))。 在HepA-I78例嚴(yán)重不良反應(yīng)中,高熱38例,報(bào)告發(fā)生率12.87／100萬(wàn)；過(guò)敏反應(yīng)39例,報(bào)告發(fā)生率13.20／100萬(wàn)(包括過(guò)敏性皮疹30例,報(bào)告發(fā)生率10.16／100萬(wàn)；其它過(guò)敏反應(yīng)9例,報(bào)告發(fā)生率3.05／100萬(wàn))；無(wú)菌性膿腫1例,報(bào)告發(fā)生率0.34／100萬(wàn)。 從性別構(gòu)成比看,106例嚴(yán)重不良反應(yīng)中,男性68例,女性38例,男女性別比為1.79：1。HepA-L的嚴(yán)重不良反應(yīng)28例,男性22例,女性6例,男女性別比為3.37：1；HepA-I的嚴(yán)重不良反應(yīng)78例,男性46例,女性32例,男女性別比為1.44：1。 從年齡構(gòu)成比看,HepA的嚴(yán)重不良反應(yīng)年齡分布情況：1歲1例,占1.28%；1歲為34例,占43.59%；2～6歲43例,占55.13%。HepA-L的嚴(yán)重不良反應(yīng)為為28例,1歲0例；1～2歲為11例,占39.29%；2～6歲17例,占60.71%。HepA-I的嚴(yán)重不良反應(yīng)為78例,1歲1例,占1.28%；1～2歲為34例,占43.59%；2-6歲43例,占55.13%。從劑次分布上看,HepA-L28例嚴(yán)重不良反應(yīng)均是1劑次；在HepA-I78例嚴(yán)重不良反應(yīng)中,第1劑次為53例,占67.95%,第2劑次25例,占32.05%。 106例嚴(yán)重不良反應(yīng)中,接種后≤1d發(fā)生的為27例,占79.24%；2-3d18例,占16.98%。在HepA-L28例嚴(yán)重不良反應(yīng)中,接種后≤1d發(fā)生的為27例,占96.43%；2～3d1例,占3.57%；在HepA-I78例嚴(yán)重不良反應(yīng)中接種后≤1d發(fā)生的為57例,占73.08%；2～3d17例,占21.79%。 從嚴(yán)重不良反應(yīng)的轉(zhuǎn)歸看,106例嚴(yán)重不良反應(yīng)中,治愈74例,占69.81%；好轉(zhuǎn)29例,占27.36%；無(wú)死亡和殘留后遺癥；不詳3例,占2.83%。HepA-L的嚴(yán)重不良反應(yīng)治愈17例,占60.71%；好轉(zhuǎn)10例,占35.71%；后遺癥0例；死亡0例；不詳1例,占3.57%。HepA-I的嚴(yán)重不良反應(yīng)治愈57例,占73.08%；好轉(zhuǎn)19例,占24.363%；后遺癥0例；死亡0例；不詳2例,占2.56%。 106例嚴(yán)重不良反應(yīng)住院的個(gè)案14例,占13.21%,其中住院≤10d的11例,占10.38%；10d為3例,占2.83%。HepA-L住院個(gè)案7例,占43.75%,0～2d為1例,占3.57%,3～5天6例,占21.43%,平均住院天數(shù)為3.57天。HepA-I住院個(gè)案7例,占8.97%,0～2d為0例,3～5天2例,占2.56%,6～10天2例,占2.56%,11～15天1例,占1.28%,16～30天1例,占1.28%,31～60天1例,占1.28%,平均住院天數(shù)為13.71天。 從企業(yè)發(fā)生嚴(yán)重不良反應(yīng)的構(gòu)成比看,HepA-L廠商A報(bào)告例數(shù)為3例,占10.71%；B為9例,占32.14%；C為10例,占35.71%；D為2例,占7.14%；E為4例,占14.29%。HepA-I廠商a報(bào)告例數(shù)為30例,占38.46%,；b為21例,占26.92%；c為14例,占17.95%；d為7例,占1.75%；e為6例,占7.69%。 HepA-L和HepA-I各生產(chǎn)企業(yè)均疫苗嚴(yán)重不良反應(yīng)以發(fā)熱(腋溫≥38.6℃)和過(guò)敏性皮疹為主。 各企業(yè)疫苗批號(hào)未發(fā)現(xiàn)聚集性反應(yīng)。 結(jié)論：我國(guó)接種HepA-L和HepA-I后發(fā)生的AEFI和嚴(yán)重不良反應(yīng)報(bào)告發(fā)生率均較低。嚴(yán)重不良反應(yīng)以發(fā)熱(腋溫≥38.6℃)和過(guò)敏性反應(yīng)居多,男性報(bào)告發(fā)病率高于女性,2-6歲組報(bào)告發(fā)病率高,多發(fā)生在1d內(nèi),多在3d內(nèi)治愈或好轉(zhuǎn)。未報(bào)告聚集性反應(yīng)。 HepA-L嚴(yán)重不良反應(yīng)報(bào)告發(fā)生率較HepA-I低,二者均以發(fā)熱(腋溫≥38.6℃)和過(guò)敏性反應(yīng)為主,各年齡組HepA-L嚴(yán)重不良反應(yīng)報(bào)告發(fā)生率較HepA-I低,HepA-L嚴(yán)重不良反應(yīng)住院平均時(shí)間較HepA-I短,二者均未報(bào)告聚集性反應(yīng)。
[Abstract]:Background: hepatitis A virus (HAV) attenuated live vaccine (Hepatitis A, Vaccine, Live, HepA-L) and HepA-I (Hepatitis A Vaccine, Inactivated, HepA-I) after the listing of suspected abnormal reaction to vaccination (Adverse Events Following Immunization, AEFI) monitoring is an important method to evaluate the safety of HepA in our country. The development of AEFI monitoring from 2005. In 2007~2008 years in Beijing, Hebei, Shanghai, Guangdong, Guangxi 5 provinces (autonomous regions and municipalities directly under the central government, the same below) occurred HepA-I after inoculated with HepA-L and AEFI and serious adverse reactions (Serious Adverse Reaction) the incidence and characteristics analysis, evaluation of two types of hepatitis A vaccine after the listing of the security.
Objective: to analyze the incidence and characteristics of AEFI and severe adverse reactions in 5 provinces of China after inoculation of HepA-L and HepA-I, and to evaluate the safety of two kinds of HepA.
Methods: the immunization information management system through the China immunization monitoring information management system (AEFI system) and children's information report from January 1, 2007 to December 31, 2008 with HepA-L and HepA-I after AEFI and serious adverse reaction cases, using descriptive methods on the incidence of serious adverse reactions and characteristics were collected and analyzed.
Results: the occurrence of AEFI, from January 1, 2007 to December 31, 2008, 5 provinces were reported by HepA AEFI220 cases, the total incidence was 41.34 / 1 million; the report incidence rate was followed by Hebei, Shanghai, Guangdong, Beijing and Guangxi, in the range of 3.39 ~ 274.22 / 1 million; of which 200 cases of adverse reactions, the incidence of reported as 37.61 106 / 1 million cases of serious adverse reactions, the incidence was 28 cases of serious adverse reactions of the 19.93 / 1 million.HepA-L, the incidence of reported as 11.84 / 1 million; HepA-I78 cases, report the incidence of 26.41 / 1 million.
Two HepA106 cases of serious adverse reactions, severe fever (axillary temperature more than 38.6 DEG C) in 53 cases, the report incidence rate of 9.97 / 1 million; 52 cases of allergic reactions, reported incidence of 9.78 / 1 million (including 41 cases of allergic rash, reported incidence of 7.71 / 1 million; 1 cases of anaphylactic shock report incidence 0.19 / 1 million; 10 cases and other allergic reactions occurred in 1.88 / 1 million) report; 1 cases of aseptic abscess, report the incidence of 0.19 / 1 million. No local swelling and induration diameter 5cm, diameter 5cm, allergic purpura, thrombocytopenic purpura, Arthur (Arthus) reaction, vascular edema, multiple neuritis, GBS, brachial neuritis, seizures, encephalopathy, encephalitis and meningitis and other serious adverse reactions.
In serious adverse reactions in HepA-L28 cases, 15 cases of severe fever, reported incidence of 6.34 / 1 million; 13 cases of allergic reactions, reported incidence of 5.50 / 1 million (including 11 cases of allergic rash, reported incidence of 3 / 1 million; 1 cases of anaphylactic shock reported incidence of 0.42 / 1 million; in 1 cases, other allergy reported incidence of 0.42 / 1 million).
In serious adverse reactions in HepA-I78 cases, 38 cases of high fever, the incidence of 12.87 / 1 million; 39 cases of allergic reactions, reported incidence of 13.20 / 1 million (including 30 cases of allergic rash, reported incidence of 10.16 / 1 million; 9 cases of allergic reactions, other reporting rate 3.05 / 1 million); 1 cases of aseptic abscess the report, the incidence of 0.34 / 1 million.
From the gender perspective, 106 cases of serious adverse reactions, 68 cases were male, 38 were female, male and female sex ratio of serious adverse reactions of 1.79:1.HepA-L in 28 cases, 22 cases were male, 6 female, male to female ratio was 3.37:1; 78 cases of serious adverse reactions of HepA-I, 46 cases were male, 32 cases of female, male and female the sex ratio was 1.44:1.
From the age structure, serious adverse reactions of the age distribution of HepA: 1 years old in 1 cases, accounting for 1.28%; 1 for 34 cases, accounting for 43.59%; 2~6 years old 43 cases of serious adverse reactions of 55.13%.HepA-L for 28 cases, 1 cases at the age of 0; 1~2 of 11 cases, accounting for 39.29%; 2~6 years old in 17 cases, accounting for serious adverse reactions of 60.71%.HepA-I for 78 cases, 1 of 1 cases, accounting for 1.28%; 1~2 for 34 cases, accounting for 43.59%; 2-6 in 43 cases, accounting for 55.13%. from the dose distribution, serious adverse reactions of HepA-L28 cases are 1 doses; serious adverse reactions in HepA-I78 patients. First doses for 53 cases, accounting for 67.95%, second times in 25 cases, accounting for 32.05%.
106 cases of serious adverse reactions occurred in less than 1D after inoculation for 27 cases, accounting for 79.24%; 2-3d18 cases, accounted for 16.98%. of serious adverse reactions occurred in HepA-L28 cases, less than 1D after inoculation for 27 cases, accounting for 96.43%; 2 ~ 3D1 cases, accounting for 3.57%; there is less than or equal to 1D were inoculated in HepA-I78 cases of serious adverse reactions in the 57 cases, accounting for 73.08%; 2 ~ 3d17 cases, accounting for 21.79%.
From the outcome of severe adverse reactions, 106 cases of serious adverse reactions, 74 cases were cured, accounting for 69.81%; 29 cases were improved, 27.36%; no death and residual sequelae; 3 cases were unknown, serious adverse reactions of 2.83%.HepA-L accounted for 60.71%; 17 cases were cured, 10 cases improved, accounting for 35.71%; 0 cases of sequelae; 0 cases died; 1 cases were unknown, serious adverse reactions of 3.57%.HepA-I accounted for 73.08%; 57 cases were cured, 19 cases improved, accounting for 24.363%; 0 cases of sequelae; 0 cases died; 2 cases were unknown, accounting for 2.56%.
106 cases of serious adverse reactions in 14 cases, accounting for 13.21%, of which 11 cases of hospitalization, less than 10d accounted for 10.38%; 3 cases with 10d, accounting for 2.83%.HepA-L hospitalized cases, 7 cases, accounting for 43.75%, 0 ~ 2D for 1 cases, accounting for 3.57%, 3~5 days in 6 cases, accounting for 21.43%, the average hospital stay was 3.57 days.HepA-I in 7 cases, accounting for 8.97%, 0 to 2D for 3~5 days in 0 cases, 2 cases, accounting for 2.56%, 6~10 days in 2 cases, accounting for 2.56%, 11~15 days in 1 cases, accounting for 1.28%, 16~30 days in 1 cases, accounting for 1.28%, 31~60 days in 1 cases, accounting for 1.28%, the average hospital stay was 13.71 days.
The occurrence of serious adverse reactions from the constituent ratio, HepA-L manufacturer A report for 3 cases, accounting for 10.71%; 9 cases with B, accounting for 32.14%; 10 cases with C, accounting for 35.71%; 2 cases with D, accounting for 7.14%; 4 cases with E, accounting for 14.29%.HepA-I manufacturers a report for 30 cases. 38.46%, B; 21 cases, accounting for 26.92%; 14 cases with C, accounting for 17.95%; 7 cases with D, accounting for 1.75%; 6 cases with E, accounting for 7.69%.
HepA-L and HepA-I each production enterprise serious adverse reactions to the vaccine fever (axillary temperature more than 38.6 DEG C) and allergic rash.
No aggregated response was found in the batch number of every enterprise vaccine.
Conclusion: our inoculation of HepA-L and HepA-I after AEFI and reports of severe adverse reactions incidence rate was low. Serious adverse reactions with fever (axillary temperature more than 38.6 DEG C) and the majority of allergic reactions, the reported incidence of male was higher than female, 2-6 years old group reported high incidence occurred in the 1D, how to cure or better in 3D. No aggregation reaction was reported.
HepA-L reports of severe adverse reactions incidence was lower than that of HepA-I, two of them were fever (axillary temperature more than 38.6 DEG C) and allergic reactions, each age group HepA-L reports of severe adverse reactions compared with the incidence of HepA-I is low, serious adverse reactions HepA-L average hospitalization time is short of HepA-I, the two did not report aggregation reaction.

【學(xué)位授予單位】：中國(guó)疾病預(yù)防控制中心
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2010
【分類(lèi)號(hào)】：R186

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