溃疡性结肠炎患者相关细胞因子的实验性研究

目的:研究溃疡性结肠炎患者TNF-a,IL-6,sIL-2R等因子在其发病机理中的作用。方法:分别采用双抗体放射免疫法和酶联免疫吸附试验(ELISA法)检测活动期溃疡性结肠炎患者25例及对照组血清TNF-a,IL-6,sIL-2R的水平。分别比较活动期溃疡性结肠炎患者与缓解期、正常对照组的TNF-a等细胞因子血清水平的差异;比较缓解期患者与正常对照组的差异;比较重度溃疡性结肠炎患者与轻、中度患者血清TNF-a等细胞因子水平的差异。并观测TNT-a与IL-6之间的相关性。结果:活动期溃疡性结肠炎患者血清TNF-a,IL-6,sIL-2R水平明显高于缓解期和正常对照组(P<0·05);缓解期患者血清TNF-a,IL-6,sIL-2R水平与正常对照组相比差异无统计学意义(P>0·05);重度溃疡性结肠炎患者血清TNF-a,IL-6,sIL-2R水平高于轻、中度组(P<0·05);活动期溃疡性结肠炎患者血清TNF-a与IL-6水平呈正相关(r=0·8476,P<0·05)。结论:活动期溃疡性结肠炎患者存在严重的细胞免疫功能紊乱;TNF-a,IL-6,sIL-2R等在溃疡性结肠炎的发生和病情发展中起着重要作用;测定血清TNF-a,IL-6,sIL-2R水平可反映溃疡性结肠炎的病情变化,并可作为观察疗效和判断预后的生物学指标之一。     

溃疡性结肠炎患者血清趋化因子的变化及其意义

[目的]探讨溃疡性结肠炎(UC)患者血清中白介素-8(IL-8)及单核细胞趋化蛋白-1(MCP-1)水平变化及其临床意义. [方法]采用EUSA法测定27例活动期UC患者,15例缓解期UC患者及30例正常对照者的血清IL-8及MCP-1水平,结肠组织MPO含量采用生化方法检测,同时观察IL-8及MCP-1水平与溃疡性结肠炎的活动性、病变范围及结肠组织MPO含量的关系. [结果]活动期UC患者血清IL-8、MCP-1水平分别为[(47.2±8.6)、(246.2±21.6)pg/ml],肠组织MPO含量为(25_37±5.29)U/g,均明显高于缓解期患者[(35.6±5.8)、 (172.6±19.7)g/ml, (18.22±3.45)U/g]及对照组[(17.3±3.1)、 (113.8±16.3)pg/ml, (8.35±0.76)U/g](P＜0.01),缓解期UC患者血清趋化因子水平及MPO含量明显高于对照组(P＜0.01),不同病变部位的UC患者IL-8、MCP-1水平及MPO含量有明显差异(P＜0.01).血清IL-8、MCP-1水平与患者内镜分级、CAI评分及MPO含量呈显著相关(r=0.753 6、0.826 7、0.763 9;0.745 8、0.876 3、0.684 9,P均＜0.01). [结论]UC患者中趋化因子IL-8及MCP-1可能参与了溃疡性结肠炎炎症损伤过程,血清IL-8及MCP-1水平变化可作为一评估溃疡性结肠炎炎症严重程度的潜在指标.     

肿瘤坏死因子α、白介素8和细胞间粘附分子1在溃疡性结肠炎患者外周血中的表达及其临床意义

目的观察溃疡性结肠炎患者外周血清中白细胞介素8(IL-8)、肿瘤坏死因子α(TNF-α)及细胞间粘附分子1(ICAM-1)的表达情况以及与溃疡性结肠炎疾病严重程度的关系。方法采用ELISA法检测溃疡性结肠炎患者活动期、缓解期及正常对照组不同时期中外周血中IL-8、TNF-α及ICAM-1的分子水平;并进行统计学差异分析。结果溃疡性结肠炎活动期TNF-α、IL-8及ICAM-1的表达较对照组和缓解期组明显增加,有显著性差异(P<0.05)。缓解组患者TNF-α、IL-8及ICAM-1与与正常对照组相比无显著性差异(P>0.05)。活动期溃疡性结肠炎患者TNF-α、IL-8及ICAM-1的水平与患者病情的严重程度呈正相关,且重度组表达水平明显高于轻度组和中度组,有显著性差异(P<0.05)。结论IL-8、TNF-α、ICAM-1在溃疡性结肠炎患者血清中的阳性表达率随疾病活动性增高而增高,提示炎症免疫在溃疡性结肠炎发病机制中起重要作用。     

溃疡性结肠炎患者血浆白介素-13检测和临床价值

目的　探讨溃疡性结肠炎 (UC)患者血浆白介素 - 13(IL - 13)临床价值。方法　采用ELISA法检测UC患者和正常健康人血浆IL - 13浓度。结果　 31例UC患者 (16 .6 5± 3.38)pg/ml和 30例健康人 (2 5 .83± 3.5 9)pg/ml血浆IL - 13浓度比较 ,差异有显著性 (P <0 .0 5 )。活动期 (2 1例 )和静止期 (10例 )UC患者血浆IL - 13浓度分别为(12 .0 3± 3.72 )pg/ml和 (18.6 7± 4 .2 2 )pg/ml,两者比较差异有显著性 (P <0 .0 5 )。轻、中、重度活动期UC血浆IL -13浓度相互比较 ,差异有显著性 (P <0 .0 5 )。UC患者血浆IL - 13和血清C -反应蛋白浓度呈负相关 (r=- 0 .5 98,P <0 .0 1)。结论　IL - 13参与UC的炎症过程 ,检测血浆IL - 13可作为判断UC患者病变严重程度和复发的指标之一。     

溃疡性结肠炎患者血清IL-13、IL-8的水平变化及意义

目的探讨IL-13、IL-8在溃疡性结肠炎(UC)患者血清中的表达水平及意义。方法选取38例经明确诊断的UC患者,及30例同期健康体检者作为对照组。采用酶联免疫吸附法(ELISA)检测两组患者血清IL-13和IL-8的水平。结果 UC组患者血清IL-8的水平明显高于对照组,差异有显著统计学意义(P<0.01);UC组患者IL-13的水平低于对照组,差异有统计学意义(P<0.05)。在轻度、中度、重度UC患者的血清中,IL-8的浓度水平呈逐渐升高趋势;而IL-13的浓度水平相反。三组间比较均存在显著差异(P<0.01)。IL-8和IL-13在溃疡性结肠炎患者血清中的表达呈负相关(r=-0.835,P<0.01)。结论 IL-8和IL-13参与了UC的炎症过程;两者表达水平有密切相关性,IL-13与IL-8的平衡失调可能是导致UC形成的一个重要原因。     

IL-8、TNF-α、高敏C反应蛋白检测在溃疡性结肠炎诊断中的临床意义

目的 IL-8、TNF-α、高敏C反应蛋白水平评价溃疡性结肠炎(UC)患者病情严重程度及临床意义。方法126例溃疡性结肠炎患者按照病情程度分为轻度组(42例)、中度组(41例)、重度组(43例),另选40例健康体检者为正常对照组,空腹抽血测定血清IL-8、TNF-α、高敏C反应蛋白水平。结果活动期UC患者与健康对照组血清中IL-8、TNF-α、C反应蛋白比较差异有统计学意义(P<0.01)。其中UC轻度组与健康对照组比较差异无统计学意义(P>0.05);而UC中度组和UC重度组分别与正常对照组比较差异有统计学意义(P<0.05;0.01)。UC轻、中、重度组3组两两比较差异均有统计学意义(P<0.05;0.01)。结论检测UC患者血清中IL-8、TNF-α、CRP,有助于UC的早期临床分级诊断,对判断UC的严重程度及UC形成具有重要价值。     

联合检测血清白蛋白、C反应蛋白及红细胞沉降率对溃疡性结肠炎患者预后的评估

目的 探讨联合检测血清白蛋白(Alb)、C反应蛋白(CRP)及红细胞沉降率(ESR)对溃疡性结肠炎(UC)患者预后的评估价值,提高对疾病的认识和诊治水平.方法 将93例UC患者分为活动期和缓解期,活动期按病情轻重分为轻、中和重度,以15例功能性胃肠病患者作为对照组,分析比较Alb、CRP及ESR等的差异.结果 UC活动期Alb<32 g/L 26例,CRP>8 mg/L 52例,ESR>20mm/l h 58例,血红蛋白(Hb)<100 g/L 17例.Alb降低在UC重度患者中明显高于其他患者和对照组(P<0.01);CRP升高在UC活动期明显高于UC缓解期(P<0.05),UC中、重度患者明显高于UC轻度患者(P<0.01);ESR升高在UC中、重度患者中明显高于UC轻度及缓解期患者(P<0.01).结论 Alb、CRP及ESR与UC相关,三者反映了疾病的活动度及严重程度.三者联合检测对UC病情的预测和预后的判断更全面、更有价值.     

肠粘膜NF-κBp65及血清IL-23、IL-17水平变化与溃疡性结肠炎患病的关系研究

目的探究肠粘膜NF-κBp65及血清IL-23、IL-17水平变化与溃疡性结肠炎患病的关系。方法选取60例溃疡性结肠炎患者作为观察组,同期60例健康体检者作为对照组,采用免疫组化法检测观察组患者结肠粘膜NF-κBp65蛋白表达,采用酶联免疫吸附实验(ELISA)检测各组受试者血清IL-23及IL-17水平,比较不同严重程度溃疡性结肠炎患者结肠粘膜NF-κBp65表达以及血清IL-23、IL-17水平。结果溃疡性结肠炎不同程度患者肠粘膜NF-κBp65蛋白表达有显著差异,缓解期患者肠粘膜NF-κBp65蛋白表达弱,而活动期患者肠粘膜NF-κBp65蛋白表达显著增强,且随程度加重而逐渐升高;与健康体检者相比,溃疡性结肠炎患者血清IL-23、IL-17水平均显著升高(P0.05),而活动期组患者血清IL-23、IL-17水平随病情加重逐渐升高(P0.05)。结论溃疡性结肠炎的发生发展与患者血清IL-23、IL-17水平和结肠粘膜NF-κBp65蛋白表达有一定的相关性。     

血清IL-18与溃疡性结肠炎的关系

目的 探讨IL-18在溃疡性结肠炎(UC)发病、发展和治疗中的作用.方法 采用双抗体夹心ELISA法检测58例UC患者外周血中IL-18水平,并分别比较其与临床活动指数(CAI)和ESR、CRP等的相关性.结果 UC活动期患者血清IL-18水平较缓解期患者和健康对照者明显升高(P<0.05),而缓解期患者与健康对照者比较差异无统计学意义.重度UC患者血清IL-18水平[(392.78±50.17)pg/ml]明显高于中度UC患者[(138.92±23.41)pg/ml]和健康对照者[(73.76±20.27)pg/ml],但轻、中度UC之间差异无统计学意义.病变的范围越大,水平越高(P<0.05).并与临床指标ESR、CRP、WBC计数呈正相关.与CAI呈正相关(r=0.775,P<0.01).激素治疗后IL-18显著性下降.结论 IL-18可能参与UC的发病,血清IL-18可作为UC判断病情和活动性的参考指标.     

溃疡性结肠炎患者血小板平均体积和D-二聚体及血清C-反应蛋白检测的临床意义

目的:通过检测血小板参数MPV、D-二聚体及血清C-反应蛋白(CRP)水平,探讨其对溃疡性结肠炎(UC)的活动性的评价。方法:分别采用免疫扩散比浊法和自动血细胞分析系统分析及免疫比浊法检测65例活动期和36例缓解期溃疡性结肠炎患者及53位健康对照者的血小板参数MPV、D-二聚体及血清C-反应蛋白的水平及其间的关系,比较临床严重程度对MPV及D-二聚体及CRP的影响。结果:(1)、活动期溃疡性结肠炎患者平均血小板体积(MPV)明显低于缓解期患者及正常对照组(P0.01),血清CRP及D-二聚体与缓解期患者及正常对照组相比明显增高(P0.01),缓解期患者MPV较正常对照组也降低(P0.05),缓解期CRP水平与对照组比较,差别有统计学意义(P0.05),而D-二聚体水平与对照组比较,差别无统计学意义(P0.05),(2)、重型UC患者MPV、CRP及D-二聚体水平与轻中型患者比较,差别有统计学意义(P0.05)。结论:MPV、CRP及D-二聚体水平可作为溃疡性结肠炎(UC)的活动性的评定指标。     

2002年云南非脊灰病毒测序定型和ECHO13病毒基因特征分析

目的对云南省2002年急性弛缓性麻痹(acute flaccid paralysis,AFP)病例中非脊灰病毒(non-polio,NPV)的带毒情况及埃柯病毒13型(echovirus 13,E13)的基因特征进行描述。方法按Obster等介绍的方法,对2002年云南省脊灰实验室分离到的21株NPV进行基因测序定型。结果 2002年云南省共报告267例AFP病例,共采集到<15岁AFP病例的合格粪便标本257份,257份便标本中共检测到NPV43株(带毒率为16.7%),其中脊髓灰质炎病毒(poliovirus,PV)22株(阳性率8.6%),均为疫苗株,未发现脊灰野病毒;检测到非脊灰病毒(NPV)21株(阳性率8.2%)。21株EV中,12株为人类肠道病毒B组(HEV-B,11个血清型,其中3株为E13),3株为人类肠道病毒C组(HEV-C,1个血清型),未分离到HEV-A和HEV-D组病毒。结论 2002年云南省AFP病例中非脊灰病毒携带率不高。对3株常见的E13进行基因进化分析,表明E13病毒存在基因多样性特点(即存在不同的基因型)。     

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18–49 years of age,naive to 23-valent pneumococcal polysaccharide vaccine

BackgroundBased on the success of vaccination with pneumococcal conjugate vaccines (PCVs) in children, recent studies have focused on PCVs in adults. Data from a randomized, double-blind study comparing the immunogenicity, tolerability, and safety of the 13-valent PCV (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in PPSV23-naive adults 60–64 years of age have been published. The same study also included a cohort of adults aged 18–49 years that received open-label PCV13. The purpose of this cohort was to examine the immunogenicity, safety, and tolerability of PCV13 in adult subjects 18–49 years of age compared with adults 60–64 years of age for whom PCV13 is approved.MethodsAdults naive to PPSV23 were grouped by age into 2 cohorts: 18–49 years (n = 899; further stratified by age into 3 subgroups 18–29, 30–39, and 40–49 years) and 60–64 years (n = 417). All subjects received 1 dose of PCV13. In both age groups, immunogenicity was assessed by antipneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) 1 month after vaccination. Safety and tolerability were evaluated.ResultsIn adults aged 18–49 years, OPA GMTs and IgG GMCs were noninferior for all 13 serotypes and statistically significantly higher for all except 1 serotype (OPA GMT) and 5 serotypes (IgG GMCs) compared with adults 60–64 years. Immune responses were highest in the youngest age subgroup (18–29 years). Local reactions and systemic events were more common in adults 18–49 years compared with 60–64 years and were self-limited.ConclusionImmune responses to PCV13 are robust in adults ≥18 years of age, with highest responses observed in the youngest subgroup. Based on its safety and immunologic profile, PCV13 may serve an important therapeutic role in younger adults, particularly those with underlying medical conditions who have an increased risk of serious pneumococcal infections.     

Rethinking number-needed-to-vaccinate for pneumococcal conjugate vaccines in older adults: Current and future implications

BackgroundNumber-needed-to-vaccinate (NNV) is increasingly used to inform decisions about vaccine use, but it is not calculated uniformly across studies. This study compared two methodologies for calculating NNV with 13-valent pneumococcal conjugate vaccine (PCV13) to prevent one case of community-acquired pneumonia (CAP) among US adults aged ≥65 years: (i) using one-year absolute rate differences as was originally performed by the Centers for Disease Control and Prevention (CDC) and (ii) using absolute risk reduction over 5 years.MethodsWe constructed a hypothetical fixed cohort of 200,000 adults aged ≥65 years equally separated into PCV13-vaccinated and PCV13-unvaccinated groups. We incorporated the same conservative assumptions used by CDC in 2014 regarding annual incidence of hospitalized (1375 per 100,000) and outpatient (2010 per 100,000) CAP, the initial (2014) proportion of adult PCV13-type CAP (10%), and PCV13 efficacy against vaccine-type CAP (45%). To model PCV13 impact over time, we assumed annual mortality was 5% for both groups, the percentage of adult PCV13-type CAP declined annually due to pediatric herd effects, and PCV13 efficacy did not wane over 5 years.ResultsAmong adults aged ≥65 years, NNV with PCV13 to prevent one hospitalized and one outpatient case of CAP as originally calculated by CDC in 2014 were 1620 and 1110, respectively. Accounting for 5-year cumulative effects, NNV with PCV13 to prevent one hospitalized and one outpatient case of CAP over 5 years were 576 and 394, respectively. These revised NNV estimates are roughly one third of initial estimates in which cumulative effects were ignored. NNV to prevent any CAP (inpatient or outpatient) over 5 years with one PCV13 dose was 234.ConclusionAccounting for cumulative preventive effects of PCV13 vaccination over time is critical. Failing to do so, even when using conservative disease burden parameters, can grossly underestimate the public health impact of adult PCV13 use.     

Using genomics to examine the persistence of Streptococcus pneumoniae serotype 19A in Ireland and the emergence of a sub-clade associated with vaccine failures

BackgroundStreptococcus pneumoniae serotype 19A remains a significant cause of invasive pneumococcal disease (IPD) in Ireland despite the successful introduction of a 13-valent pneumococcal conjugate vaccine (PCV13) in 2010 which reduced the overall incidence of IPD in children.MethodsInvasive Streptococcus pneumoniae serotype 19A isolates from the Irish reference laboratory between 2007–08 and 2017–18 were analysed using whole genome sequencing (WGS) to investigate the persistence of this vaccine-preventable serotype. We compared the entire national 19A collection to other international collections using a standardised nomenclature of Global Pneumococcal Sequencing Clusters (GPSC).ResultsExpansion of GPSCs and clonal complexes (CCs) may have been associated with vaccine introduction and antimicrobial prescribing policies. A sub-clade of GPSC1-CC320 (n = 25) unique to Ireland, included five of the ten vaccine failures/breakthrough cases identified (p = 0.0086). This sub-clade was not observed in a global GPSC1-CC320 collection. All isolates within the sub-clade (n = 25) contained a galE gene variant rarely observed in a global pneumococcal collection (n = 37/13454, p < 0.001) nor within GPSC1-CC320 (n = 19/227) (p < 0.001). The sub-clade was estimated to have emerged at the start of the PCV-vaccine era (ancestral origin 2000, range 1995–2004) and expanded in Ireland, with most isolated after PCV13 introduction (n = 24/25).ConclusionsThe identification of a sub-clade/variant of serotype 19A highlights the benefit of using WGS to analyse genotypes associated with persistence of a preventable serotype of S. pneumoniae. Particularly as this sub-clade identified was more likely to be associated with IPD in vaccinated children than other 19A genotypes. It is possible that changes to the galE gene, which is involved in capsule production but outside of the capsular polysaccharide biosynthesis locus, may affect bacterial persistence within the population. Discrete changes associated with vaccine-serotype persistence should be further investigated and may inform vaccine strategies.     

Impact of 13-valent pneumococcal conjugate vaccination on invasive pneumococcal disease in children under 15 years old in Madrid,Spain, 2007 to 2016: The HERACLES clinical surveillance study

Streptococcus pneumoniae is a major cause of morbidity and mortality worldwide. Using the data from the HERACLES clinical surveillance study (2007–2016), we describe the population impact of the 13-valent pneumococcal conjugate vaccine (PVC13) on invasive pneumococcal disease (IPD) in children <15?years of age in the Community of Madrid, Spain. After six years of the inclusion of PCV13 in the vaccination calendar (2010–2016), and despite changes in the Regional Immunization Programme that limited its availability, the net benefit incidence rate (IR) of IPD fell by 70.1% (IRR 0.3 [95% CI: 0.22–0.4]; p?≤?0.001), mainly due to a significant reduction (91%) in the PCV13 serotypes (IRR 0.09 [95% CI: 0.05–0.16], p?≤?0.001). Furthermore, no significant changes were detected in the IR of IPD caused by non-PCV13 serotypes. The IRs of the aggressive, resistant and most prevalent serotype in the analysed population, the 19A serotype, dramatically decreased from the beginning to the end of the study (98%) [IRR 0.03 (95% CI: 0.00–0.19), p?≤?0.001], to its almost total disappearance. Remarkably, this reduction led to a pronounced decline in the percentage of cefotaxime-resistant isolates and the incidence of meningitis cases. Assessment of the clinical impact revealed a reduction in the number of all clinical presentations of IPD, confirming the effectiveness of the PCV13. Finally, PCV13 detected by PCR is predicted to have a stronger impact than the one based on culture methods, which can overlook more than 20% of cases of IPD, mainly pleural empyemas.     

白细胞介素13在系膜增生性肾小球肾炎患者血浆及肾组织的表达

目的 探讨系膜增生性肾小球肾炎(MsPGN)患者血浆及肾组织白细胞介素13(IL—13)的表达，进一步了解MsPGN的分子病理机制，为临床治疗探索新的途径。方法 应用酶联免疫吸附试验(ELISA)和免疫组化ABC技术检测30例MsPGN患者血浆IL—13水平及其在肾组织的表达、定位和分布。结果 MsPGN患者血浆IL—13水平较正常对照组明显增高，以IgAN增高明显MsPGN患者肾小球及肾小管间质区IL—13表达较正常对照组增高，而以肾小管间质区表达更强，non-Iga MsPGN与IgAN相比，肾小管间质区IL—13表达无明显差异。结论 IL—13可能参与了MsPGN分子病理机制。     

益肾化湿颗粒辅助治疗慢性肾小球肾炎的效果研究

目的 探究慢性肾小球肾炎患者应用益肾化湿颗粒辅助治疗的临床疗效。方法 选择2017年3月1日—2019年3月1日在河南科技大学第一附属医院接受治疗的慢性肾小球肾炎患者120例作为临床研究对象,随机投掷硬币法分组。对照组60例患者应用氯沙坦钾片治疗,观察组60例患者应用氯沙坦钾片与益肾化湿颗粒联合治疗,比较所有患者治疗后的临床疗效以及对血清中白细胞诱素-1(LKN－1)、肿瘤坏死因子α(TNF－α)和白细胞介素13(IL－13)水平的影响情况。结果 经治疗后,观察组患者的治疗总有效率为96.67%,高于对照组患者的73.33%(P<0.05);观察组患者的尿红细胞为(4.09±1.01)个/HP、24 h尿蛋白定量为(0.79±0.35)g/L、血尿素氮(BUN)为(9.11±2.65)mmol/L以及血肌酐(Scr)为(119.44±48.99)umol/L,均低于对照组患者水平(P<0.05):尿红细胞(6.20±1.98)个/HP、24 h尿蛋白定量(1.25±0.39)g/L、血尿素氮(BUN)(10.60±3.18)mmol/L以及血肌酐(Scr)(137.01±55.43)umol/L;观察组患者血清中IL-13水平为(12.08±2.24)ng/L、TNF-α为(13.57±4.34)ng/L、LKN－1为(70.43±33.88)pmol/L,均低于对照组患者水平,差异均具有统计学意义(P<0.05)。结论 应用益肾化湿颗粒治疗慢性肾小球肾炎患者,可有效消除炎症,改善肾功能,提高临床治疗效果,值得推广应用。     

Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19 years old in the United States,Vaccine Adverse Event Reporting System (VAERS), June 1, 2012–December 31, 2015

BackgroundThe 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19 years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65 years.MethodsWe assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19 years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting.ResultsVAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19–64 years and 86% were in persons aged ⩾65 years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19–64 years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65 years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19–64 years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65 years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE.ConclusionsThe results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs.     

中文版儿童事件影响量表在汶川地震极重灾区中小学生中的应用及分析

目的 评价中文版(简体)儿童事件影响量表(CRIES-13)的信度和效度,探讨利用该量表筛检创伤后应激障碍(PTSD)的价值及最佳评分切割点.方法 采用分层随机整群抽样原则,选取253名汶川地震后幸存儿童作为被评估对象,采用量表白评和临床诊断相结合的方法,分析量表的内部一致性、条目间平均相关系数;总分与各因子间的相关系数、内容区分效度.临床诊断依据DSM-Ⅳ诊断标准中PTSD诊断标准确诊患者.采用受试者工作特征曲线计算曲线下面积和不同切割点下筛检PTSD的灵敏度、特异度及约登指数,以约臀指数最大的点为最佳切割点.结果 CRIES-13的Cronbach's α系数为0.903,条目间平均相关系数0.283～0.689.总分与各因子的相关系数0.836～0.868,各因子间的相关系数0.568～0.718;在总分、闯入、回避和高警觉因子评分方面,PTSD组均高于非PTSD组,差异有统计学意义(P<0.05).因子分析产生两个主成分,解释了总方差的59.68%,主要反映闯入症状和回避症状.汶川地震后7个月儿童PTSD的临床检出率为20.9%,男、女性PTSD患病率差异无统计学意义(P>0.05),CRIES-13以18分为切割点时筛检PTSD的约登指数最大,为57.6%,PTSD患者诊断预测的灵敏度为81.1%,特异度为76.5%,诊断效率81.1%.而选取32分切割点,筛查结果与临床诊断一致性较高(Kappa值=0.529).结论 CRIES-13在汶川地震后幸存儿童中具有良好的信、效度,可作为该群体一个较好的创伤后应激症状测评丁具.CRIES-13评分18分切割点可作为汶川地震后极重灾区中小学生筛检PTSD患者和确诊高危人群的切割点,而32分切割点筛检阳性率可初步预测灾后极重灾区中小学生PTSD患病率,此结论还有待于进一步研究证实.