水痘减毒活疫苗安全性与免疫原性观察

目的评价水痘减毒活疫苗的安全性及免疫原性。方法按随机、双盲的抽样原则,以国产水痘疫苗为对照,对600名1～12岁儿童接种水痘减毒活疫苗,在接种前后分别采集受试者血清,同时观察其临床反应,利用膜免疫荧光法(FAMA法)检测收集到的血清的水痘抗体滴度,并用统计学方法对结果进行分析。结果试验苗和对照苗不良事件总反应率分别为30.5%和35.0%,二者比较无统计学差异。水痘易感者血清抗体阳转率分别为100.0%和98.73%;抗体GMT分别为1:48.6和1:39.0。水痘非易感者血清抗体4倍增长率分别为89.33%和77.42%;抗体GMT分别为1:139.10和1:153.07。两组抗体阳转率无显著性差异,但易感者接种试验疫苗组受试者抗体GMT高于接种对照疫苗组。结论试验疫苗有良好的安全性和免疫原性,可用于预防水痘-带状疱疹病毒感染。     

儿童接种不同效价冻干麻疹减毒活疫苗的免疫效果研究

目的:采用不同滴度效价的冻干麻疹疫苗,对初次免疫儿童接种,为消除控制麻疹提供依据。方法:选择未接种过麻疹疫苗,未患过麻疹的健康儿童进行麻疹疫苗接种,并对其接种后的一般临床反应进行详细观察,同时对免前、免后血清抗体水平检测。结果:接种麻疹疫苗的婴儿一般临床反应轻微,发热率为5.7%;皮疹发生率为4.3%;局部反应为2.8%。采用ELISA方法检测IgG血清抗体,A组的血清抗体阳转率为95.23%,免疫成功率为86%;GMT值为1 364.22。B组的血清抗体阳转率达到了97.11%,免疫成功率86.13%;GMT值为1275.74。两组婴儿接种后血清抗体阳转率、免疫成功率以及GMT值组间差异性均无统计学意义(P>0.01)。结论:婴儿接种麻疹疫苗后,只要达到药典规定的滴度要求,就能获得良好的免疫应答效果。     

国产冻干无佐剂Vero细胞狂犬病疫苗对暴露后人群接种反应及免疫原性观察

目的 观察国产冻干无佐剂Vero细胞狂犬病疫苗小剂量皮内注射的接种反应及其免疫原性.方法 对256名Ⅱ级狂犬病暴露受试者进行暴露后免疫,按照随机、单盲的原则分成皮内注射组:皮内注射法组128人,按照0,3,7,28,90d作2点、2点、2点、1点、1点皮内注射,每个部位0.1ml;肌肉注射组:肌肉注射法组128人,按照0,3,7,14和28d接受全量(0.5ml)三角肌注射.使用国产冻干无佐剂Vero细胞狂犬病疫苗(PVRV).观察皮内及肌肉注射疫苗后的局部和全身反应情况.采用夹心间接ELISA法检测抗体水平.结果 暴露后皮内注射组局部红肿、硬结、疼痛、瘙痒,发生率分别为1.27%、0.29%、0.49%、11.43%,肌肉注射组分别为1.09%、0.16%、2.81%、1.41%.暴露后皮内注射组发热、皮疹、头痛、疲劳乏力等全身反应,发生率分别为0.31%、0.16%、0.31%、1.09%,肌肉注射组分别为0.31%、0.31%、0.63%、1.09%.所有副反应常发生在第1、第2次注射之后.暴露后免疫皮内注射、肌肉注射狂犬病疫苗后14d抗体阳转率分别是94.53%、95.31%,免疫后42d抗体阳转率分别是96.83%、97.64%.暴露后皮内、肌肉注射法,狂犬病疫苗抗体阳转率差异无统计学意义.结论 国产冻干Vero细胞狂犬病疫苗,接种反应轻微,免疫原性良好.     

多种甲肝疫苗的免疫效果评价

目的观察不同种类的甲型肝炎疫苗在儿童体内的接种反应及免疫效果。方法筛选2—3岁的甲肝易感儿童193人,分别接种进口灭活甲肝疫苗、国产灭活甲肝疫苗和国产冻干减毒甲肝疫苗,观察接种后48h内的局部反应和全身反应,并于完成免疫后1—2个月,采集血清标本检测抗HAV—Igc抗体。结果193名观察对象在接种第1针和第2针后均未见严重不良反应,仅有4例出现轻微局部反应和全身反应。完成免疫接种后,进口灭活甲肝疫苗、国产灭活甲肝疫苗和国产冻干减毒甲肝疫苗抗一HAv—IgG抗体阳转率分别为92．86％、67．61％和61．25％,GMT（ELASA法）平均滴度分别为1：28．28、1：53．39和1：5．76。结论三种疫苗在儿童中的应用是安全、有效的。     

国产水痘减毒活疫苗在中国人群中安全性和免疫原性的Meta分析

目的：评价国产水痘减毒活疫苗在中国人群中的安全性及免疫效果。方法：电子检索1996年1月至2010年6月公开发表的有关水痘减毒活疫苗安全性和免疫原性的研究文献,辅以手工检索以及利用搜索引擎在互联网上查询文献、追查纳入文献的参考文献的综合检索方式,纳入比较中国人群分别接种国产与进口、不同品牌国产水痘减毒活疫苗的随机对照试验。对符合纳入标准的研究采用RevMan 5.0统计分析软件进行Meta分析。结果：有7篇文献符合入选标准,其中涉及国产与进口水痘减毒活疫苗的随机对照试验5项、不同品牌国产水痘减毒活疫苗随机对照试验3项。Meta分析结果显示,安全性指标比较：国产水痘减毒活疫苗与进口水痘减毒活疫苗接种后局部不良反应发生率差异无统计学意义[OR=0.74,95%CI（0.37,1.49）,Z=0.83,P=0.40];全身发热反应发生率差异有统计学意义[OR=2.34,95%CI（1.5,3.64）,Z=3.75,P=0.000 2];全身其他不良反应发生率差异无统计学意义[OR=0.56,95%CI（0.18,1.70）,Z=1.03,P=0.30]。不同品牌国产水痘减毒活疫苗接种后局部不良反应发生率差异无统计学意义[OR=0.91,95%CI（0.43,1.91）,Z=0.26,P=0.80];全身发热反应发生率差异无统计学意义[OR=0.80,95%CI（0.59,1.08）,Z=1.44,P=0.15];全身其他不良反应发生率差异无统计学意义[OR=0.89,95%CI（0.50,1.59）,Z=0.40,P=0.69]。免疫原性指标比较：国产水痘减毒活疫苗与进口水痘减毒活疫苗接种后血清抗体阳转率差异无统计学意义[OR=1.41,95%CI（0.69,2.87）,Z=0.94,P=0.35];国产水痘减毒活疫苗接种后血清抗体阳转率差异无统计学意义[OR=3.41,95%CI（0.82,14.19）,Z=1.68,P=0.09]。结论：与进口水痘减毒活疫苗相比,国产水痘减毒活疫苗具有同等的免疫效果,在安全性方面,除接种后发热率稍高外,其他局部和全身反应性良好。国产水痘减毒活疫苗之间安全性和免疫原性差异无统计学意义。鉴于接种国产水痘减毒活疫苗在安全性和免疫原性方面的良好表现以及价格上的优势,可作为儿童预防水痘经济、安全、有效的选择。     

冻干甲型肝炎减毒活疫苗H2株的安全性和免疫原性研究

为观察H2株冻干甲型肝炎(甲肝)减毒活疫苗接种人体后的安全性和免疫原性，选择广西壮族自治区蒙山县一小学学生(年龄7～12岁)164人和浙江省台州市椒江区一幼儿园儿童(年龄3-6岁)114人为接种对象，免疫前筛选抗甲肝病毒IgG抗体(抗-HAV-IgG)阴性，血清丙氨酸氨基转移酶(SGPT)正常，无肝炎病史、症状和体征者，分别接种2个批号的H2株冻干甲肝活疫苗。观察接种疫苗后30min，8、24、48、72h的局部及全身反应，以后隔天记录体温及其它有关临床反应。接种疫苗后1、2个月采静脉血测定SGPT及抗-HAV-IgG，同时长期随访检测免疫后13、24个月血清抗-HAV-IgG水平。检测用酶免疫测定（EIA)竞争抑制法，用世界卫生组织(WHO)提供的标准品(含100mlU／ml)进行标定。结果显示：在整个观察期间，所有观察者未见中、强反应及其它临床反应发生，SGPT检测结果无异常升高。H2株冻干甲肝活疫苗具有良好的安全性。接种疫苗后2个月抗体阳性率为99．1％-100．0％，13～24个月阳性率仍高达97．8％-98．9％；免疫后2个月抗体几何平均滴度(GMT)达1607mlU/ml，在免疫后24个月抗体GMT仍维持在448．3mlU／ml。表明H2株冻干甲肝活疫苗安全性良好，接种后有较高的抗体阳转率和GMT。     

流行性乙型脑炎减毒活疫苗与灭活疫苗免疫效果及人体接种反应观察

目的比较乙脑减毒活疫苗和灭活疫苗的免疫效果和安全性。方法选择中宁县8～10月龄应初免的儿童285名,分组接种乙脑减毒活疫苗和乙脑灭活疫苗,观察人体接种反应,采用细胞蚀斑减少中和试验(PRNT)检测免疫前和免疫后乙脑中和抗体。结果减毒活疫苗组(JE Attenuated Live Vaccine,JEV-L)抗体阳转率和抗体几何平均滴度(GMT)分别为90.14%和1∶30.68;灭活疫苗组[Japanese Encephalitis(JE)Inactivate Vaccine(Vero Cell),JEV-1(Vero)]为60.84%和1∶12.08,减毒活疫苗组抗体阳转率和阳性抗体(GMT)均高于灭活组。经观察,减毒活疫苗组和灭活疫苗组人体反应均为发热和接种部位轻度红肿,发热率分别为34.75%和39.86%,中、强反应率为8.45%和7.69%,红肿率为1.42%和0.81%,所有发热及轻度红肿者均于72小时恢复正常。结论乙脑减毒活疫苗免疫效果好,免疫针次少,安全性好,是现阶段预防乙脑比较理想的疫苗,适宜推广使用。     

Observation of JE live attenuated vaccine and inactivated vaccine effects and human vaccination reactions

目的 比较乙脑减毒活疫苗和灭活疫苗的免疫效果和安全性.方法 选择中宁县8～10月龄应初免的儿童285名,分组接种乙脑减毒活疫苗和乙脑灭活疫苗,观察人体接种反应,采用细胞蚀斑减少中和试验(PRNT)检测免疫前和免疫后乙脑中和抗体.结果 减毒活疫苗组(JE Attenuated Live Vaccine,JEV-L)抗体阳转率和抗体几何平均滴度(GMT)分别为90.14%和1∶30.68;灭活疫苗组[Japanese Encephalitis(JE)Inactivate Vaccine(Vero Cell),JEV-1(Vero)]为60.84%和1∶12.08,减毒活疫苗组抗体阳转率和阳性抗体(GMT)均高于灭活组.经观察,减毒活疫苗组和灭活疫苗组人体反应均为发热和接种部位轻度红肿,发热率分别为34.75%和39.86%,中、强反应率为8.45%和7.69%,红肿率为1.42%和0.81%,所有发热及轻度红肿者均于72小时恢复正常.结论 乙脑减毒活疫苗免疫效果好,免疫针次少,安全性好,是现阶段预防乙脑比较理想的疫苗,适宜推广使用.     

国产冻干风疹减毒活疫苗免疫持久性研究

目的评价新研制成功的国产冻干风疹减毒活疫苗的免疫持久性,为制定风疹疫苗免疫策略提供依据.方法在桃江县城关镇三所小学选择5～9岁风疹血清HI抗体阴性的健康儿童,为其接种风疹疫苗,跟踪观察风疹疫苗免疫后抗体动态变化.结果免疫1个月后风疹HI抗体的阳转率为98.94%,抗体几何平均滴度倒数(GMT)为877.79.免后1、2、3、4、5年风疹HI抗体阳性率仍维持较高水平,分别为99.21%、100.00%、100.00%、100.00%、100.00%;而风疹HI抗体的GMT则逐年下降,分别为767.18、550.18、363.08、223.92、158.42;第8年风疹HI抗体阳性率和GMT均明显下降,分别为91.30%和30.96.结论国产冻干风疹减毒活疫苗具有良好的免疫原性,免疫效果至少可维持8年.     

甲型H1N1流感疫苗安全性和免疫原性初步研究

目的:评价国产甲型H1N1流感病毒裂解疫苗的临床安全性和免疫原性.方法:按照随机、对照、盲法的原则,选择老年(60岁以上)组、少年(12～17岁)组和少儿(3～11岁)组各220人,按1:1比例随机接种15、30μg甲型H1N1流感疫苗;成年(18～60岁)组330人,按1:1:1比例随机接种15、30μg甲型H1N1流感疫苗和安慰剂对照.比较两种剂量疫苗免后总体不良反应率、全身和局部不良反应率、HI抗体阳转率、HI抗体(≥1:40者)保护率、免后HI抗体GMT和免后HI抗体GMT 较免前平均增长倍数.结果:免后21 d,各剂量组征集性不良反应总发生率为10.81%(107/990),均以1级不良反应为主,未观察到3级及以上不良反应.安全性观察期内未观察到其它异常反应、偶合反应和任何有临床意义的严重不良事件.30、15μg的HI抗体阳转率分别为87.24%、84.45%,差异无显著性,均显著高于安慰剂对照组的HI抗体阳转率;HI抗体(≥1:40者)保护率分别为87.94%和85.61%,差异无显著性,均显著高于安慰剂对照组的HI抗体保护率;免后HI抗体GMT 30μg组高于15μg组,15μg组高于安慰剂对照组,且差异均有显著性,其中12～17岁组和＞60岁组免后抗体GMT水平30μg组均高于15μg组,且差异均有显著性;30、15μg两个剂量组间免后HI抗体GMT 较免前平均增长倍数差异无显著性,与安慰剂对照组差异有显著性.结论:此国产甲型H1N1流感病毒裂解疫苗具有良好的安全性和免疫原性.     

Value of D-Dimers in patients with acute aortic dissection

Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P ＜ 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (＞0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P ＜0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P ＜ 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.     

Research of combined liver-kidney transplantation model in rats

Objective： To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods： SD rats served as both donors and recipients. 4℃ sodium lactate Ringer＇s was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava （IVC） inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results： Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion： This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.     

BLOOD PRESSURE CHANGE WITH AGE IN SALT-SENSITIVE TEENAGERS

Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P＜ 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P＜ 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.     

安心颗粒对急诊经皮冠状动脉介入术后生活质量影响的研究

目的：评价使用安心颗粒对急诊经皮冠状动脉介入术（PPCI）术后生活质量的影响.方法：将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组（术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次）和对照组（仅接受基础药物治疗）.所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表（MIDAS）、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果：入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异（P＞0.05）;出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低（P＜0.05）;组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低（P＜0.05）.两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血（P＞0.05）.两组发生轻度血小板减少症的患者数比较无差异（P＞0.05）.结论：PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.     

The comparative studies of the influences of Urapidil and Nicardipine on sino-atrial node function, atrio-ventricular node function and hemodynamics

Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P＜0.01);the MAP decreased(P＜0.01)and the HR increased drastically(P＜0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.     

Expression of OPGmRNA and ODFmRNA in the patients of hip fracture due to osteoporosis

Objective：To investigate the gene expression of osteoprotegerin（OPG） and osteoclast differentiation factor（ODF） in the bone tissue of patients with hip fracture due to osteoporosis. Methods：OPGmRNA and ODFmRNA in the bone tissue in 50 cases of osteoporosis sufferers（over 50 years old） with hip fracture（Observer Group） and 30 cases of hip facture sufferers with no osteoporosis（Control group） were analyzed with the Semi-Quantitative RT-PCR method. Results：The mRNA expressed of ODF, OPG were both high in the patients with hip fracture. In the control group, the expression of OPG mRNA was observed, while the expression of ODF mRNA was very slight. Conclusion：Aged patients contained all signals including OPG, ODF that are essential for inducing osteoclastogenesis and promoting bone resorption.     

Dynamic Changes in Serum Estradiol and Progesterone levels in Patients of Premenstrual Syndrome with Adverse Flow of Liver-qi

Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P.     

Real-time Three-dimensional Echocardiography in Assessment of Left Ventricular and Right Ventricular Volumes

Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine.     

SCREENING FOR A 21-CHROMOSOME ABNORMALITY IN PREIMPLANTED EMBRYOS OF ELDERLY WOMEN

Increasing maternal age is the only etiological factor unequivocally linked to Down's syndrome in humans. The occurrence rate of newborns with Down's syndrome is about 1/220 in women over 35 years old. However, the occurrence rate in embryos fertilized in vitro, of the elder woman is unclear. Using FISH we screened the number of chromosome 21 in preimplanted embryos of 5 elderly women (average age, 38.4 years) to study the feasibility and necessity of screening trisomy 21 in embryos in patients over 35 years old at the in vitro fertilization (IVF) center.     

Scientific principles and rigorous processes should be followed in developing clinical guidelines for therapeutic interventions of integrative medicine

A clinical guideline for the therapeutic interventions of integrative medicine may be defined as a written document which states a series of recommendations on therapeutic interventions of integrative medicine for a special disease or condition. The guideline may provide assistance to medical professionals in making clinical decisions aimed at improving the clinical outcome of patients and reducing the costs of medical care（~＇4~. Recommendations issued by a guideline should be based on the best available evidence in both Western and Chinese medicine. For fulfilling this purpose, the development of clinical guidelines for therapeutic interventions in the field of integrative medicine should follow scientific principles and undergo a rigorous processes.