Negative results and impact factor: a lesson from neonatology

OBJECTIVE: To test the hypothesis that articles with negative results are more likely than articles with positive results to be published in journals with lower impact factor. DESIGN AND SETTING: We selected all of the randomized, placebo-controlled trials conducted during the neonatal period between October 1, 1998, and October 1, 2003. Trials were classified as having positive results or negative results (significant or no significant difference, respectively). Only studies dealing with primary outcomes (efficacy) were included. MAIN OUTCOME MEASURES: The impact factor of each journal was determined, and the sample size for each study was noted. RESULTS: There were 233 articles that fulfilled the inclusion criteria. There was a significant difference between the 2 groups in terms of impact factor (P = .03) but not sample size (P = .30). Impact factor correlated with both sample size and the type of study results (positive results vs negative results; P<.05). CONCLUSION: Articles with negative results are more likely than articles with positive results to be published in journals with lower impact factor.     

Japan''s contribution to clinical pediatrics research in the last decade

OBJECTIVE: To determine Japan's contribution to research in clinical pediatrics over the last decade. METHODS: Articles published in highly reputable pediatrics journals from 1991-2000 were accessed through the MEDLINE database. The number of articles which had an affiliation with a Japanese institution were counted for each of the journals and also summed in total. Proportions of randomized controlled trials (RCTs) and case-control/cohort studies among the articles from Japan were also generated and compared with the average for the entirety. In addition, shares of the top-ranking countries were presented along with their trend over time. RESULTS: In total, 20 189 articles were published in the selected seven pediatric journals from 1991-2000. Japan contributed 3.0% of these articles and this contribution was ranked 7th in the world. A negative trend was noticed in Japan's contribution over time but it was not statistically significant (z = -0.40, P = 0.16). RCTs accounted for 7.3% of the total articles, but only 0.34% of those from Japan. CONCLUSIONS: Japan's share of articles in pediatrics research was smaller than that in basic science and some of the other clinical fields. The number of articles from Japan providing a high level of evidence was meager in this field.     

2010年至2014年《中华小儿外科杂志》发表的临床随机对照研究文献分析

目的 分析2010年至2014年《中华小儿外科杂志》发表临床随机对照试验(randomized control trial,RCT)文献情况.方法 人工逐条检索出2010年至2014年《中华小儿外科杂志》所有期刊刊载的临床RCT文献,对每篇文章收稿时间、发表时间、引文总数、中文引文数、英文引文数、文章所属单位、单(或多)中心研究情况、研究阳性结论情况、研究中患儿例数、基金资助情况、参研作者人数和相关RCT研究起止时间、随访时间等指标进行分析.结果 2010年至2014年《中华小儿外科杂志》共刊出临床RCT文章82篇,2012年发表最多,为20篇;2014年最少,为11篇.期均RCT数1.4篇.临床RCT在所有临床研究类文献中占比为11.6％.82篇临床RCT研究的平均发文时滞202 d,其中2010年最短,为160 d(标准差最低,为40),篇均引文数14.3条,篇均研究对象数为116例.临床RCT研究中多中心研究仅3篇,量偏少,所有RCT研究都得出阳性意义的结论,有基金资助的RCT研究17篇,占所有临床RCT总数的20.73％,部分临床RCT文章存在随机分组描述不清,随访时间偏短的问题.发表临床RCT最多的单位是温州医学院附属第二医院和郑州大学第一附属医院,均为9篇.结论 《中华小儿外科杂志》在同类医学期刊中影响较广.该刊RCT研究内容丰富、发文时滞较短,篇均引文数量较多、作者群稳定、级别高.这与其作为国内小儿外科领域最具有影响力和代表我国小儿外科学界最高学术水平杂志的身份相符.     

SCI对我国医学期刊的影响:我国在SCI收录期刊发表的医学论文10年数据分析

目的 探讨科学引文索引(SCI)对我国医学期刊的影响.方法 检索SCI扩展版(SCI-E)数据库,得到2000至2009年各年被SCI-E收录的中国医学论文和其刊载期刊,对刊载这些论文的期刊的影响因子分布、变化进行分析.查阅2000至2008年度中国科学技术信息研究所发布的<中国科技论文统计与分析>(2009年数据还未公布),得到2000至2008年中国科技论文与引文数据库(CSTPCD)收录的论文数,比较SCI-E和CSTPCD收录论文的变化趋势.对一组动态(与时间相关)资料的分析,采用"定基比"(与1个固定时间2000年的数值比)和"环比"(后1年与前1年比).求平均速度时,采用几何均数(G),影响因子数的分布描述采用中位数.结果 2000年SCI-E收录期刊刊出我国医学论文3774篇,其后逐年上升,到2008年增加到16 714篇,增加了442.87%,较同期CSTPCD收录期刊刊出的我国医学论文增加百分比(281.33%)高出161.54个百分点.10年来,SCI期刊收录的中国医学论文的几何平均增长速度为20.87%,2000至2008年CSTPCD的几何平均增长速度为18.2l%.2000至2009年,发表我国医学论文的SCI收录的期刊,影响因子并没有上升,甚至有下降,中位影响因子逐年为1.866、2.073、2.390、2.702、2.409、2.496、2.380、2.218、2.280、2.331;在SCI收录期刊上发表的论文平均被引次数也只有5.87次,仅为国际被引次数平均值(10.57次)的一半;发表在影响因子＞5的SCI期刊上的医学研究论文一直低于20%,平均仅占16.38%.结论 l0年来,我国在SCI收录期刊发表的论文数量逐年上升,增加幅度明显高于CSTPCD,但其影响力有限.要区别对待SCI期刊,控制在影响因子＜3的SCI期刊上发表论文,要鼓励在影响因子＞5的SCI期刊上发表研究论文.

Abstract：

Objective This study was designed to investigate the influence of journals indexed by Science Citation Index(SCI)on Chinese medical journals. Method Articles on medicine written by Chinese and the journals that published these articles from 2000 to 2009 were searched using Science Citation Index Expanded(SCI-E)database,and the status and variation tendency of the impact factors(IF)of these journals were analyzed.Data of articles on medicine included Chinese Scientific and Technical Paper and Citations Data(CSTPCD)from 2000 to 2008 were searched(the data of 2009 have not been released).The included articles and the time-dependent changing profile were studied.These outcomes were evaluated as the fixed base relative or link relative when compared with the data of 2000 or those of last year,respectively.Geometric mean was used when mean increase was calculated and IF distribution was described with median.Result Totally 3774 articles from China were published by journals indexed by SCI-E in 2000,and the number of articles published by Chinese authors increased every year. In 2008,16 714 articles were indexed by SCI-E,442.87% higher than those of 2000.The increment was 161.54% higher than that of articles published in the journals indexed by CSTPCD(281.33%)during the same period.From 2000 to 2009,the geometric mean of increase in the number of published articles from China in journals indexed by SCI-E was 20.87% but it was 18.21% in CSTPCD.From 2000 to 2009,the median of IF of SCI-E indexed journals that published Chinese medical articles was 1.866,2.073,2.390,2.702,2.409,2.496,2.380,2.218,2.280 and 2.331,respectively,and they did not increase or even decreased.Conclusion The number of the articles indexed by SCI-E increased year by year,much faster than that of CSTPCD.However,it does not necessarily mean the increase in impact.     

中国儿科领域随机对照试验报告质量横断面调查

摘要目的评估CONSORT声明自1997年引入中国以来,中国儿科杂志发表RCT的报告质量是否得到提高。方法手工检索中国大陆被中国科学引文数据库（CSCD）收录的6种国内儿科杂志（《中华儿科杂志》、《中华小儿外科杂志》、《中国当代儿科杂志》、《中国实用儿科杂志》、《中国循证儿科杂志》和《临床儿科杂志》）,检索时间均为创刊至2010年12月。对照CONSORT声明的评价条目清单,设计标准的资料提取表格,评估纳入文献的报告质量,使用SPSS 18.0软件进行统计分析。结果619篇RCT文献进入分析。1997至2010年与1997年前发表的RCT相比,其在文题、摘要、引言、受试者招募、基线资料和辅助分析等方面的报告质量有一定的改善（P<0.05）,但在方法学的报告方面存在报告不充分或不准确的问题,如确定样本量的方法（0.6% vs 1.1%）、随机序列产生的方法（3.2% vs 7.6%）、分配隐藏（0 vs 1.1%）、盲法（0 vs 2.6%）等。进一步对稿约中要求CONSORT声明的《中国循证儿科杂志》发表的9篇RCT进行评估,其CONSORT条目符合率均高于其他儿科杂志,特别在方法学的报告方面,如确定样本量的方法、随机序列产生的方法、分配隐藏和盲法等。结论总体而言,CONSORT声明的引入并没有使中国儿科领域RCT的报告质量从根本上提高。在稿约中要求CONSORT声明的杂志可显著提高RCT的报告质量。     

Conclusiveness of the Cochrane Neonatal Reviews: a systematic analysis

Aim: To assess the conclusiveness of the Cochrane Neonatal Reviews (CNRs). We tested the hypotheses that: 1) the majority of the reviews is inconclusive; 2) the majority of reviews recognizes the need for further studies; 3) the ability to reach a conclusion is dependent upon both the number of studies and the number of patients. We also aimed to determine whether the conclusiveness of the CNRs was affected by time.

Methods: We selected CNRs available in the Cochrane Library in June 2004. The number of randomized clinical trials (RCTs) found, number of RCTs included for analysis, number of patients enrolled, the stated need for further studies, and the conclusiveness of CNRs were recorded.

Results: Out of 170 CNRs, 67.7% were conclusive. The average number of articles was similar, but the total number of patients enrolled was three times higher in the conclusive CNRs. The percentage of articles included in conclusive studies was significantly higher than in inconclusive ones. The vast majority of CNRs recognized the need for further studies. The number of studies included correlated significantly with the total number of patients included. The percentage of conclusive CNRs correlated negatively with year of publication.

Conclusion: The majority of CNRs is conclusive, but emphasizes the need for further studies. The ability of a CNR to reach a conclusion is affected by the cumulative sample size and by the number of studies performed. The probability of a newer review to be conclusive is lower than that of an older review.     

北京大学医院儿科发表论著的文献计量学分析

目的对1999-2003年北京大学(北大)医院儿科发表的中西文论著进行文献计量学分析,以期揭示北大医院儿科的学术科研水平方法统计1999-2003年北大医院儿科发表的医学论著总量、第一作者构成及发表论著的核心文献源。计算中文论著出自核心期刊比率对于西文论著,统计其被科学引文索引(SCI)收录、被引、来源期刊的影响因子及其变化趋势。统计论著引用文献的构成情况,用文献计量学指标评价论文的学术价值、结果 北大医院儿科于1999-2003年,在59种学术期刊上共发表医学专业文献513篇,其中论著275篇 在238篇中文论著中,出自核心期刊论著占总量的79.0％。西文论著37篇,被SCI收录比率为83.8％;其来源期刊的平均影响因子为1 447,最高为7.717,5年间平均影响因子从0.768升高至2.206;被SCI收录的论著,总被引频次为38次,篇平均被引1.41次。5年间北大医院儿科发表的论著篇平均参考文献为9.8篇,1999年篇平均参考文献为8.1篇至2003年上升到12.0篇;引用中、外文文献的比例为80.7 ％,普赖斯指数为43.2％。结论在1999-2003年间北大医院儿科一直保持着相对稳定的发文量,并在2003年有较大增加。西文论著的学术水平明显升高,作者利用外文文献的能力较强,但对于学科最新知识的利用能力还有待提高。     

中国临床实践指南引文分析

目的 系统分析我国医学期刊发表的临床实践指南的引文现状。方法 运用“指南”、“指引”在万方、维普、CNKI中进行题名检索,运用“指南”在CBM中进行主题词检索,检索截止时间为2012年12月,纳入符合标准的文献。提取纳入文献信息,运用Excel软件整理、统计数据。结果 共纳入380篇指南,其中172篇（45%）附有引文,引文总量为6255条（单篇引文量范围：1~283条）,平均引文量为36条。引文来源以期刊（5767条/92%）为主,中文引文来源最多为《中华心血管病杂志》,英文为《新英格兰医学杂志》;引文文献类型中系统评价/meta分析545条（8.7%）、RCT517条（8.3%）,平均单篇指南引用Cochrane系统评价仅为0.4条。结论 中国期刊发表指南的引文报告率低,单篇引文量少,主要引用来自英文期刊的研究,引文中系统评价比率低。     

Fate of abstracts published in the proceedings of the first annual Perinatal Society of Australia and New Zealand Congress in 1997

OBJECTIVES: To examine the fate of research presented at the first annual Perinatal Society of Australia and New Zealand (PSANZ) Congress in 1997, by determining: the rate of publication in peer-reviewed biomedical journals; publication rate by discipline; journals in which work was published; concordance for aims, conclusions, authors and number of study subjects; and time from presentation to publication. METHODS: A MEDLINE search was conducted for any publication in a peer-reviewed journal resulting from a publishable abstract from the proceedings of the first annual PSANZ Congress in 1997. Searching was completed 42 months post-congress. The concordance of aims, conclusions, authors and number of subjects between abstract and published paper was determined. RESULTS: There were 172 publishable abstracts in the proceedings of the PSANZ Congress in 1997, and 78 (45%) were published as 83 articles. Basic sciences had the highest publication rate (67%) and midwifery the lowest (20%). Articles were published in 41 journals, with one-third of the articles in three paediatric journals. There was a match with aims in 75%, and with conclusions in 65%. There were 47/77 with the same number of subjects, 20/77 with more and 10/77 with fewer. There were 22 articles with one author added, 12 had more than one author added, 11 had one author removed and five had more than one author removed. Median time-to-publication was 18 months (interquartile range 9-26 months). CONCLUSIONS: A publication rate of 45% is comparable to other conferences. Basic science and neonatology had the highest publication rates. There were considerable differences between abstract and published article in terms of aims, conclusions, number of subjects and authors.     

《中华儿科杂志》文献计量分析

目的从文献引证的角度分析《中华儿科杂志》的学术水平和影响力。方法依据中国科技期刊引证报告,对2000至2003年儿科学类及其相关学科期刊的影响因子、总被引频次、即年指标、他引总引比、引用刊数、被引半衰期六个主要指标进行对比分析。检索中国生物医学期刊引文数据库,统计《中华儿科杂志}2000至2003年发表论文被引情况,从单篇被引情况、被引论文地区分布、主要被引机构等指标进行分析。结果2000至2003年《中华儿科杂志》影响因子分别为0．937、1．025、1．052、ll252,总被引频次分别为1378、1468、1863和2396。即年指标、引用刊数、被引半衰期保持稳定的增长趋势,他引总引比始终在0．9以上;单篇平均被引次数为3．3次,被引作者群的地域分布26个省、自治区、直辖市。结论《中华儿科杂志》影响因子、总被引频次始终在国内儿科学类期刊中排名第一位,说明该刊办刊宗旨明确,连贯性好,近两年的影响力在不断扩大,在国内儿科学界有较大影响。即年指标、引用刊数、被引半衰期呈稳步增长,表明该刊即时反映速率高,文章受关注程度高、影响时间长、范围广。他引率高、自引率低,说明该刊办刊严谨、求实,各项计量指标真实可靠。《中华儿科杂志》不仅是我国妇儿科学研究领域最重要的信息源之一,也是我国医学领域的主要核心期刊。     

Recent clinical trials of surfactant treatment for neonates

OBJECTIVE: To search for recent clinical trials of neonatal surfactant treatment and report their findings. METHODS: Recent was defined as published between 2000 and 2005. An online search on PubMed was made on 30th December 2005 using the following terms: surfactant treatment, clinical trials and neonate, with limits of years 2000 to 2005 and age - newborn from birth to 1 month. Randomised clinical trials (RCTs) and systematic reviews of RCTs were prioritised and studies in children and animals were excluded from further analysis. RESULTS: 175 papers were found in this search. Only about half of these papers were directly related to some aspect of surfactant treatment and of these just over one-half were either RCTs or systematic reviews of RCTs. Of the 34 RCTs of surfactant treatment, 3 were excluded as they involved children or animals rather than neonates. Twenty-nine trials studied preterm babies with respiratory distress syndrome (RDS) and 2 were for meconium aspiration syndrome (MAS) in term infants. The median sample sizes of these studies were RDS (92, range 19-1,361) and MAS (42, range 22-61). Eighteen of the RDS trials compared two or more surfactant preparations, the most frequently studied being Curosurf and Survanta but altogether 11 different surfactants were compared. These new RCTs need to be analysed by meta-analyses in systematic reviews. Twelve systematic reviews were found and these demonstrated the superiority of prophylactic over selective use of surfactant in babies <30 weeks, natural over synthetic surfactant and the absence of an increase in long-term developmental sequelae. Surfactant for MAS may reduce the severity of respiratory illness and the need for extracorporeal membrane oxygenation. Of the non-randomised trials' novel delivery methods, failure to use evidence-based guidelines and the benefit of surfactant for babies <25 weeks were the most interesting. CONCLUSIONS: Surfactant remains one of the most effective and safest interventions in neonatology. Prophylactic natural surfactant seems to be the most evidence-based treatment for babies <30 weeks. Of the newer synthetic surfactants, only Surfaxin has been compared with currently used surfactants and systematic reviews are needed to establish if it has a role in treatment of RDS.The improvement in outcome for babies <25 weeks has been due to a number of interventions: prenatal steroids, prenatal antibiotics and postnatal surfactant. Clinical trials of surfactant replacement in the neonate continue to be published with remarkable frequency.     

Using online databases to find journal articles on injury prevention and safety promotion research: key journals and the databases that index them.

OBJECTIVES: (1) To determine the trends of the number of journals that publish injury prevention and safety promotion (IPSP) articles and the number of articles published each year from 1900 through 2006; (2) to determine the coverage of key IPSP journals in widely used literature databases. METHODS: Journals were identified through a structured procedure that included hand-searching selected classification categories of two major listings of periodicals that publish four or more IPSP-relevant articles per year. Article relevance was assessed using the inclusion criteria for SafetyLit (a database of scholarly literature selected for its relevance to the IPSP field). Each identified journal was hand-searched from its first issue, and IPSP-relevant articles were added to the SafetyLit archive database. A MySQL database was used to perform basic queries and statistical summary analyses for journals published 1900-2006. The number of IPSP journals and journal articles was plotted for these years to identify publication trends. The publication year range of each IPSP journal was compared with the coverage, if any, of the journals in each of the five databases. RESULTS: Of the 17 839 journals assessed, 597 met the threshold for inclusion in this study. This amounts to thousands of IPSP-related articles published each year: 6100 in 2006. Only 160 (26.8%) of the journals are included in all five databases, and none have all publication years included in all of the databases. CONCLUSIONS: Some key IPSP journals are completely excluded from some of the databases. Thus, a search in a single database may miss key information from one of the many disciplines that publish IPSP-relevant information.     

Trends in neonatology and pediatrics publications over the past 12 years

OBJECTIVE: To test the hypothesis that the number of publications in Neonatology and Pediatrics increases over time, and to verify whether the categories of publications all follow the same pattern over time. DESIGN AND SETTING: We evaluated all Medline articles during 1994-2005. Search was limited to humans, English and to 'newborn' or 'all-child'. We used regression analysis to determine the effect of year-of-publication upon the number-of-publications of each type. RESULTS: Medline reported 36,141 publications in Neonatology and 169,823 in Pediatrics during the evaluation period. There was a significant linear increase in the number of publications in Neonatology and Pediatrics. There was a steady increase over time in Neonatology and in Pediatrics in meta-analyses, reviews and editorials. There was a steady decrease over time in letters in Neonatology, but no significant change in letters in Pediatrics. While there was no significant change in clinical trials (CTs), randomized control trials (RCTs) in Neonatology, there was a significant increase in CTs and RCTs in Pediatrics. CONCLUSIONS: The field of neonatology has not had a significant yearly increase of original studies, but has seen an increase of reviews, meta-analyses and editorials. This contrasts with Pediatrics, which shows a similar increase in reviews, meta-analyses and editorials, but also an increase in the number of CTs and RCTs and guidelines.     

Data monitoring committees, interim analysis and early termination in paediatric trials

Aim: To evaluate whether paediatric randomized clinical trials (RCTs) adopt recent guidance on Data Monitoring Committees (DMCs), interim analysis and early termination. Methods: We reviewed paediatric RCTs that reported on DMCs, interim analysis or early termination, published in eight general medical and paediatric journals (2005–2007). We searched full‐text databases for eligible trials and recorded predefined parameters on each item. Reported activities were compared with current scientific guidance. Results: A total of 110 of 648 paediatric trials (17%) reported on DMC, interim analysis or early stopping. Various approaches for convening a DMC were identified; information on DMC composition and independence was limited. Strict predefined statistical stopping ‘rules’ were reported in 10 of 23 trials, and interim analyses were more frequently performed on efficacy than on safety outcomes (39/45 vs 27/45). No adjustment for repeated testing was reported in 11 of 33 trials reporting monitoring methods and in 7 of 17 early terminated trials. Validity of results from early stopped trials was threatened by small sample sizes. Incomplete reporting hampered a full analysis. Conclusion: Few paediatric trials report on DMCs’ roles, interim analysis or early stopping. Heterogeneous practices and apparent shortcomings jeopardize the validity of trial results. Easily accessible guidelines for the design, conduct and reporting of paediatric DMCs are needed.     

Review of the efficacy and safety of antidepressants in youth depression

BACKGROUND: Depression in children and adolescents is a cause of substantial morbidity and mortality in this population. It is a common disorder that affects 2% of children and up to 6% of adolescents. Although antidepressants are used frequently for the treatment of this disorder, there has been recent controversy about the efficacy and safety of these medications in this population. This review examined the available evidence from clinical trials of antidepressants in adolescents and children with depression. METHODS: Clinical trial data reviewed were obtained from published reports, including peer review journals and meeting abstracts, as well as unpublished data in the public domain. Clinical trials in this review included large RCTs of antidepressants in youth under the age of 19 with depression. Studies were identified in 2 stages: 1) all RCTs included in the 2004 FDA safety report were reviewed; and 2) to ensure that no additional studies not reported to the FDA were missed, MEDLINE and PSYCH Info were searched from inception until December 2004. A total of 8 published studies and 9 unpublished studies were identified and reviewed. RESULTS: Efficacy and safety results from each study are reviewed in detail. There are significant differences in remission and response rates between different antidepressants but also between placebo groups across studies. Adverse events are common in clinical trials involving children and adolescents with depression. Due to lack of access to full data sets, effect sizes could not be calculated. CONCLUSIONS: With the variability in trial methodology and the variation in the drug/placebo response rates within a single trial, clinicians need to be judicious in their interpretation of research data on pediatric antidepressant trials. Significant methodological issues may also have affected the efficacy and safety results from these clinical trials.     

Do we measure the right end points? A systematic review of primary outcomes in recent neonatal randomized clinical trials

OBJECTIVES: We performed a systematic review of primary outcomes in recently published neonatal randomized clinical trials to determine what end points are chosen for the evaluation of therapies in newborn infants. METHODS: MEDLINE was searched in May 1998 for neonatal RCTs that had been published since 1993 in the British Medical Journal, The Journal of Pediatrics, Lancet, The New England Journal of Medicine, and Pediatrics. The primary outcome was identified wherever possible. Continuous measures were distinguished from discrete outcome events. The latter were classified as "long-term" if they were ascertained at least 6 months after birth. The hypothesized relative risk reduction for primary outcome event rates was calculated, where possible. RESULTS: Of 119 eligible reports, 91 had an identifiable primary outcome that was a continuous measure in 46 trials and a discrete event in 45 trials. The median relative risk reduction was 50% for 28 of 40 short-term trials and 40% for 3 of 5 long-term trials. CONCLUSIONS: Most authors of recently published neonatal RCTs in 5 high-profile journals either failed to specify a primary end point or chose a continuous outcome measure. Trials with a discrete primary outcome were often short-term and designed to detect large risk reductions. Therefore modest but important treatment effects were likely missed by many of these trials.     

Glomerulopathy with mesangial IgM deposits: Long-term follow up of 64 children

BACKGROUND: The aim of the present study was to investigate to what extent IgM nephropathy in children with minimal change nephrotic syndrome (MCNS) and diffuse mesangial hypercellularity (DMH) evolves to focal segmental glomerulosclerosis (FSGS). METHODS: Tissues from renal biopsies were examined by light microscopy (LM), immunofluorescence (IF) and, in four cases, by electron microscopy (EM). From a total of 352 nephrotic children, 121 had renal biopsy results as steroid dependent or resistant. A diagnostic renal biopsy was also performed in 331 children with non-nephrotic proteinuria and/or hematuria. A second renal biopsy was performed in 16 children whose renal function was impaired during the follow up. The clinical course of IgM-positive children was compared with that of IgM-negative children. RESULTS: Of the 121 nephrotic children with renal biopsy, 85 were MCNS. Twenty were IF positive mainly for IgM, six of whom (30%) presented evolution to FSGS, while of the remaining 65 IF-negative children, only three (4.6%) presented evolution to FSGS. Of the total 331 children with non-nephrotic proteinuria and/or hematuria, 139 were diagnosed as IgA--IgG nephropathy, 44 had positive IF for IgM and 148 were IF negative. Of the 44 children IF positive for IgM, seven (15.9%) presented evolution to FSGS, while none of the 148 IF-negative children presented evolution to FSGS. The follow-up time for all children ranged from 1 to 14 years. CONCLUSIONS: Of IgM nephropathy patients with MCNS and DMH, a significant percentage develop impaired renal function, due to the evolution of FSGS, as revealed by repeat biopsy during long-term follow up.     

Infliximab dependency in a national cohort of children with Crohn's disease

AIM: The aim was to evaluate the pattern of responsiveness and to monitor side effects of episodic administration of infliximab in children with active Crohn's disease (CD) treated in Denmark from 1999 to 2003. MATERIAL AND METHODS: The National Danish Crohn Colitis Database of infliximab was used to identify all Danish CD patients treated at pediatric departments with infliximab. The clinical outcome was assessed by pattern recognition of the disease course 30 days after the first infliximab infusion and 90 days after intended end of treatment. RESULTS: During a 3 year period, infliximab was given to 24 CD patients (9 male/15 female) aged median 15.4 (range 9.8-18.6) years with a median disease duration of 26 (range 0.7-93) months and a median number of infusions of 6 (range 2-11). Five milligrams of infliximab per kilogram infusions were given intravenously. Immediate response was as follows: 8 (33%) patients achieved complete response (CR), 10 (42%) partial response (PR), and 6 (25%) no response (NR). Long-term response was as follows: 7 (29%) patients achieved prolonged response (PRO), defined as maintenance of CR or PR, 10 (42%) were infliximab dependent (ID), defined as relapse of symptoms requiring reinfusions of infliximab to regain CR or PR, and 6 (25%) had NR. Six (25%) patients needed surgery during or after treatment with infliximab. Side effects were seen in four (17%) patients. No serious events were noted. CONCLUSION: Seventy-one percent of the children appeared to benefit (PRO or ID) from infliximab treatment with minor side effects when given episodically. Among these patients, two response patterns were recognized: PRO after ending infliximab treatment (29%) or dependency on reinfusions of infliximab (42%).