开展胆道闭锁多中心研究的价值

<正>胆道闭锁(biliary atresia,BA)是以肝内、外胆管进行性炎症和纤维化梗阻为特征,导致肝内胆汁淤积、肝脏纤维化及硬化的病理过程,是婴儿期严重肝胆系统疾病之一,如不及时治疗,常在1岁左右死亡[1,2]。胆道闭锁病因复杂,可能与遗传、免疫、病毒或其毒素介导等相关;基因突变与环境因素相互作用,促进BA发生及肝脏纤维化形成是其主要致病因素[3,4]。目前早期筛查和早期诊断还存在许多问题,国内尚缺乏相关     

儿童病毒性脑炎多中心诊断治疗研究

目的　探讨儿童病毒性脑炎的诊断与治疗问题。方法　以多中心、前瞻开放、随机对比方法观察儿童病毒性脑炎的临床症状、体征及脑脊液常规生化 ;以聚合酶链反应 (PCR)技术检测儿童病毒性脑炎脑脊液病原 ;在综合治疗的前提下 ,以单一抗病毒药物治疗儿童病毒性脑炎。结果　本组 14 3例病毒性脑炎中发热 134例(93 7% ) ,头痛 86例 (6 4 7% ) ,呕吐 87例 (6 0 8% ) ,呕吐伴头痛 5 9例 ,惊厥发作 4 7例 (32 9% ) ,以全身阵挛发作为主 ;有精神症状 87例 (6 0 8% ) ,意识障碍 2 5例 (17 5 % ) ,颈抵抗 4 6例 (32 2 % ) ,运动障碍 2 0例 ,锥体束征 9例 ;脑脊液常规生化检查异常 90例 ,其中 86例白细胞增多 ,16例蛋白定量增高。 14 3例均做了脑脊液病原学检测 ,病毒阳性 84例 (5 8 7% ) ,其中肠道病毒阳性 4 0例 ,DNA病毒阳性 4 4例 ,另外还检测出了 6例支原体。在症状、体征和脑脊液常规生化检查阳性的 4 6例中 ,脑脊液病毒学阳性 2 6例 (5 6 5 % ) ,在症状和脑脊液常规生化检查阳性者 4 4例中 ,脑脊液病毒学阳性 2 3例 (5 2 3% )。在脑脊液病原学不明的情况下 ,在综合治疗的基础上 ,三种抗病毒药物单药抗病毒治疗临床疗效无差别。结论　除常规诊断条件外 ,病毒病原学检查十分重要 ,抗病毒治疗以覆盖更广     

中国儿童基本药品可及性多中心研究

目的调查我国儿童基本药品的可及性现状,为提高我国儿童基本药品可及性,促进儿童合理用药提供依据。方法采用现况调查方法,于2017年5月26日至6月2日选取我国东部、中南部、西部和北部地区17个省或直辖市的55家公立医院,以调查表的形式对42种儿童基本药品进行可及性调查。每个药品调查原研药和仿制药两个品种。研究内容包括可获得性、价格、可承受性。42种儿童基本药品在所有调查机构中可以得到的百分比,即为该药品的可获得性。价格研究采用中位价格比值(MPR),即某一种药品单位价格的中位数与国际参考价格的比值,并针对所有药物得出中位MPR。药品费用的可承受性研究,是将治疗某一标准疗程疾病所需的费用,折算成赚取全国日最低工资所花费的天数,计算治疗该常见疾病的可承受性。对可获得性、价格、可承受性指标进行描述性分析。结果在42种调查药品中,原研药和仿制药的平均可获得性分别为33%和32%。原研药和仿制药的中位MPR分别为5.43和1.55;既有原研药又有仿制药的19种药品价格比较,原研药和仿制药的中位MPR分别为7.73和2.04。针对4种常见儿童疾病(肺炎、消化性溃疡、先天性甲状腺功能减低症、难治性肾病)的5种基本药品进行可承受性研究,使用仿制药需要花费0.63(0.16~6.17)d全国日最低工资,使用原研药需要花费1.03(0.16~11.53)d全国日最低工资。结论在42种儿童基本药品中,原研药和仿制药的可获得性均较低。仿制药价格基本合理,可承受性较好;原研药价格明显高于国际参考价,可承受性较差。需进一步提高我国儿童基本药品可及性。     

河北省新生儿化脓性脑膜炎多中心流行病学研究

目的　了解新生儿化脓性脑膜炎的临床特征、诊断现状及主要致病菌、治疗转归等状况。方法　采用前瞻性临床流行病学研究方法, 收集2013~2014年连续12月间23家协作医院收治的患化脓性脑膜炎新生儿的临床资料, 对其临床特征及治疗转归等进行分析。结果　研究期间23家协作医院共收治新生儿脑膜炎病例301例。新生儿肺炎是最常见的原发疾病(167例, 55.5%)。临床表现以发热最常见(214例, 71.1%)。血培养阳性者72例(23.9%), 以大肠埃希菌、肺炎克雷伯菌、表皮葡萄球菌常见; 脑脊液培养阳性者36例, 占13.6%(36/264), 以大肠埃希氏菌、表皮葡萄球菌常见。脑脊液检查白细胞计数中位值为80个/mm3(范围0~92 500个/mm3), 其中11例(3.7%)<20个/mm3, >100个/mm3者154例(51.2%)。治愈及好转出院者258例(85.7%)。15例死亡, 病死率为5.0%(15/298)。结论 该地区新生儿化脓性脑膜炎最常见的原发疾病是新生儿肺炎; 最常见的临床表现是发热; 大肠埃希菌是导致该病的常见致病菌。仅凭脑脊液白细胞计数在正常范围不能除外该病。     

多中心临床协作研究的相关问题

张崇凡主任非常高兴能受邀参加孙波教授主持召开的新生儿呼吸疾病协作网合作项目的第一次工作会议,《中国循证儿科杂志》编辑部一直都很关注孙波教授近年来基于多中心协作网的系列研究,这在中国儿科临床研究中是一项创造性的工作,我一直认为孙波教授在国内开展的多中心协作研究,并培养了一支儿科多中心协作研究的队伍,比他的研究成果有更大的价值,他们会像种子一样在中国的儿科临床研究中生根、发芽,将来一定会结出更丰硕的成果。孙波教授和您请来的加拿大、美国专家,你们是否介意将今天工作会议中涉及到的多中心协作研究的相关问题加以整理…     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

胆道闭锁预后相关因素的多中心研究

目的:应用多中心数据研究影响胆道闭锁预后的因素。方法:回顾性分析中国大陆地区11个儿童医学中心2015年6月至2017年6月569例胆道闭锁行Kasai手术,且术后满2年患儿的病历资料。分别记录患儿性别、手术日龄、术前肝功能指标、巨细胞病毒感染情况(血清巨细胞病毒IgM检测结果)、术后有无胆管炎的发生、术后胆管炎发生的...     

东莞地区新生儿听力筛查的多中心研究

目的：探索适合于新生儿听力筛查的临床策略,通过多中心合作获得新生儿听力损失发病的基本资料。方法：应用畸变产物耳声发射技术(DPOAE)进行听力普遍筛查。对复筛未通过者,于生后3个月左右采用听性脑干反应(ABR)和40Hz听性相关电位(40HzAERP)技术诊断。结果：该研究实际筛查17360例,筛查率为89.1%。初筛通过15624例(90.0%)。需复筛的1736例,实际复筛1597例,复筛率92%,复筛通过1491例,复筛通过率93.4%。41例复查ABR其中确诊新生儿先天性听力损失39例,减去2例假阳性,该组新生儿先天性听力损失的发生率为2.25‰。结论：新生儿听力普查十分必要。DPOAE是一种快速行之有效的新生儿听力初筛方法,两步筛查法可及早发现听力损失,听力筛查、诊断、康复统筹运作是使聋儿得以康复的重要保证。     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

胆道闭锁多中心综合诊断治疗方案研究

目的 探讨胆道闭锁综合诊疗方案应用的有效性和安全性.方法 根据具有地域代表性的四家儿童医院专家确定的胆道闭锁诊疗方案,2007年1月开始对胆道闭锁进行诊断及治疗.收集2004年1月至2006年12月四家医院经确诊为胆道闭锁并进行根治手术的病例作为对照组2007年1月至2009年12月病例作为观察组.使用标准化量表统计首次就诊年龄、手术年龄、术前及术后3个月,6个月和1年黄疸清除率,术后胆管炎发生率,2年自体肝生存率.结果 符合诊断标准498例,实施Kasai术456例,其中对照组184例,手术168例;观察组314例,手术288例.二组首次就诊年龄无明显差异[(33±27)d比(34±26)d,P＞0.05],使用标准化诊断方案后平均手术年龄由(64±24)d下降为(74±31)d,P＜0.05;观察组术后3个月、6个月及1年退黄率(53.9%、56.9%、58.0%)较对照组(38.9%、39.9%、43.4%)明显提高(P＜0.05);其术后胆管炎发生率亦显著降低(31.8%比47.8%,P＜0.05);对照组2年自体肝生存率39.3%,观察组56.1%(P＜0.05).结论 标准化胆道闭锁综合诊断治疗方案可降低手术年龄、提高术后黄疸清除率、减少术后反流性胆管炎,显著提高术后2年自体肝生存率.

Abstract：

Objective To evaluate the efficacy and safety of a standardized protocol for the diagnosis and treatment of biliary atresia (BA) in children.Methods This study enrolled 498 patients from 4 hospitals diagnosed with BA from January 2004 to December 2009.The BA patients of the standardized protocol group,who enrolled in this study after January 2007,were diagnosed and treated using the standardized protocol.The rest of the patients were taken as controls.The patients were followed up for 2 years.The age of the first diagnosis,the age at operation,jaundice clearance,the occurrence of cholangitis and two year survival rates with native liver were retrospectively reviewed and compared between the 2 groups.Results Among the 498 patients,456 patients underwent Kasai procedure.Age of the first diagnosis between the two groups showed no difference (33 ± 27 vs 34 ± 26 days,P＞0.05),but the patients of the standardized protocol group received surgeries at earlier ages (64 ± 24 vs 74 ± 31 days,P＜0.05).The jaundice clearance rates of 3,6 and 12 months after operation in the patients of the standardize protocol group were higher than those of controls (53.9%,56.9%,58.0% vs 38.9%,39.9%,43.4%,P＜0.05).Patients of the standard protocol group had lower occurrence of cholangitis (31.8% vs 47.8%,P＜0.05),and better two years survival rate (56.1% vs 39.3%,P＜0.05).Conclusions The standardized protocol for the diagnoses and treatment of BA improves the clinical outcomes of the children with BA.     

新生儿局部脑组织氧检测的多中心研究

目的 探讨近红外光谱测定技术(near-infrared spectroscopy,NIRS)检测新生儿局部脑组织氧饱和度(Regional oxygen saturation,rSO2)对评估脑氧合状态的价值,建立新生儿脑rSO2的测定值,为临床应用提供依据.方法 采用NIRS技术对无特殊疾病的223例足月儿和95例早产儿分别在生后第1天、第2天及第3天进行脑rSO2测定,选取102例患有影响脑氧合疾病的新生儿,对照两组间脑rSO2数值差异.同步分析脑rSO2与脉搏氧饱和度(pulse oxygen saturation,SpO2)及动脉血氧饱和度(arterial oxygen saturation,SaO2)间的关系.结果 (1)正常足月新生儿脑rSO2测定值为(62±2)%,以低于两个标准差作为脑rSO2测定值异常,可以认为低于58%提示为脑组织缺氧.疾病状态新生儿脑rSO2范围(55±7)%,与无特殊疾病新生儿组差异有统计学意义(P<0.05).(2)脑rSO2与经皮SpO2及SaO2呈正相关,直线相关系数r分别为0.74和0.71.(3)特殊的疾病状态下,脑rSO2与SpO2可出现不同步的变化趋势,表现为:①spO2尚正常,而脑rSO2已降低.体现在18例严重的颅脑疾病及血红蛋白较低的病例.②一些危重病儿病情恢复过程中,脑rSO2的恢复滞后于SpO2在6例多脏器功能衰竭患儿尤为突出.③在3例重度缺氧缺血性脑损伤(HIE)急性期,脑rSO2有异常增高现象.结论 正常足月新生儿脑rSO2测定值为(62±2)%,低于58%提示脑组织缺氧.NIRS技术客观反映了脑组织的氧合变化,可为临床应用提供依据.     

中国儿童慢性咳嗽病因构成比多中心研究

目的 了解中国儿童慢性咳嗽的病因分布及构成比,推动其诊治的标准化和规范化.方法 根据2008年中华医学会儿科学分会呼吸学组制定的《儿童慢性咳嗽诊断和治疗指南》,设计儿童慢性咳嗽病因调查表,组织全国19个省、直辖市、自治区共29所医院前瞻性入组慢性咳嗽病例并完成3个月随访;对汇总的各项数据统计分析、得出全国儿童慢性咳嗽病因构成比等.结果 实际入组病例数共4582例,合格病例4529例,合格率98.80％.列病因构成比前3位的分别是咳嗽变异性哮喘1900例(41.95％)、上气道咳嗽综合征1119例(24.71％)、呼吸道感染和感染后咳嗽984例(21.73％).胃食管反流28例(占0.62％);其他病因者498例(11.00％),其中多病因者占387例(8.54％),首位是上气道咳嗽综合征合并有咳嗽变异性哮喘(占50.13％),其次是呼吸道感染和感染后咳嗽合并上气道咳嗽综合征占(26.10％).总诊断修正率18.83％.不同病因在不同性别间和不同年龄间的分布是有显著差异的,不同病因致慢性咳嗽的好发时相各有特点.结论 中国儿童慢性咳嗽的主要病因构成比依次为咳嗽变异性哮喘、上气道咳嗽综合征、呼吸道感染和感染后咳嗽和其他各种病因,要注意多病因和病因未明的病例.不同年龄和不同性别组儿童慢性咳嗽病因构成比是不同的.要重视观察、等待和随访的原则.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

新生儿局部脑组织氧检测的多中心研究

Objectives To understand the value of measuring neonatal cerebral regional oxygen ‘saturation(rSO2)using near infrared spectroscopy (NIRS) in assessing cerebral oxygenation,to establish the normal range of neonatal cerebral rSO2,and to collect data of the changes of cerebral rSO2 under certain disease status.Methods Nine large hospitais participated in the multicenter randomized clinical trial from Jan 2007 to Apr 2008.Using the NIRS human tissue oximeter(TSAH-100)independently developed in China.tIle cerebral rSO2 of 223 normal full-term and 95 otherwise healthy preterm neonates without any stmcial disease,Was detected at 1.2 and 3 days after birth,respectively.The cerebral rSO2 of 102 neonates with diseases which may affect the cerebral oxygenation.Was also detected during the severe phases.The pulse oxygen saturation(SpO2)measured at the finger tip,and also the arterial oxygen saturation(SaO2) measured by blood gas analysis,which could indicate the oxygen supply of the whole body,were obtained simultaneously.The correlations among cerebral rSO2,putse SpO2 and arterial SaO2 were analyzed.Results (1)The cerebral rSO2 of the normal full-term neonates wag(62±2)%.Cerebral hypoxia Was deftned as rSO2 lower than 58%. The cerebral rSO2 of the normal full-terms was steady at 1, 2 and 3 days after birth respectively, without any significant differences among them (F = 0. 610, P >0. 05 ). The cerebral rSO2 of the neonates with diseases was ( 55 + 7 ) %, which was significantly lower that that of the normal full-term neonates (t = 15.492,P <0. 05). (2) The cerebral rSO2 was positively correlated with the SpO2(r =0. 74,P < 0. 01 ) and the SaO2 ( r = 0. 71, P < 0. 01 ). ( 3 ) Under some special diseases, the changes of cerebral relatively low hemoglobin concentration, the cerebral rSO2 was significantly low (50%～58% ), but the cerebral rSO2 was lagged as compared with that of pulse SpO2. Especially, during the severe phases of 6 cases with multi-organ failure, the SpO2 and the cerebral rSO2 were both significantly low (55%～80% for SpO2, and 44%～50% for cerebral rSO2 ) ; when the diseases were alleviated, although the SpO2 recovered phases of serious hypoxic-ischemic encephalopathy (HIE), the cerebral rSO2 significantly increased to 70%～72%, which was significantly higher than the normal value (62%). Condusions The range of cerebral rSO2 of the normal full-term neonates was (62 + 2) %. Cerebral oxygenation can be externally indicated by the rSO2 noninvasively and continuously measured by NIP, S, which was positively correlated with traditional pulse SpO2 and arterial SaO2. In some special diseases, the rSO2 measured by NIRS can be helpful for clinical diagnoses and treatments.     

持续性咳嗽儿童百日咳临床多中心调查研究

目的 调查上海、重庆、银川和昆明地区年龄≥6岁连续咳嗽2周以上的儿童及青少年中百日咳博德特菌感染情况.方法 2008年11月1日至2009年10月31日期间,收集年龄≥6岁,连续咳嗽2周以上患儿血清和鼻咽拭子,采用百日咳博德特菌培养、多重PCR及ELISA检测百日咳博德特菌毒素IgG(PTIgG)方法进行百日咳博德特菌检测.结果 入组患儿1001例,入组者白百破(DPT)疫苗接种率93.5%.百日咳博德特菌感染率11.3%(113/1001),其中6～8岁组感染率为7.2%(22/307),10岁组11.2%(28/249),～12岁组10.4%(22/212),～18岁组17.6%(41/233),各年龄组百日咳博德特菌感染率差异有统计学意义(χ2=2915.2,P＜0.01).上海地区总感染率16.7%(65/402),高于其他地区(χ2=3003.0,P＜0.01).结论 尽管儿童及青少年普遍接种白百破疫苗,百日咳博德特菌感染仍是儿童持续性咳嗽的一个重要致病因素.