Measurement in clinical trials: A neglected issue for statisticians?

Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so‐called ‘responder analysis’, which may involve not only a loss of information through dichotomization, but also extravagant and unjustified causal inference regarding individual treatment effects at the patient level, and, increasingly, the use of the so‐called number needed to treat scale of measurement. Other problems involve inefficient use of baseline measurements, the use of covariates measured after the start of treatment, the interpretation of titrations and composite response measures. Many of these bad practices are becoming enshrined in the regulatory guidance to the pharmaceutical industry. We consider the losses involved in inappropriate measures and suggest that statisticians should pay more attention to this aspect of their work. Copyright © 2009 John Wiley & Sons, Ltd.     

基于免疫系统非线性模型对中医正邪相争理论和扶正祛邪治则的一个非线性动力学诠释

文中基于免疫系统有关免疫活性细胞或分子与外来抗原相互作用的非线性的动力学模型对中医学正邪相争理论及其扶正祛邪治则进行了新的诠释,提出了新的研究思路。认为:中医学关于外感邪气致病的六经、卫气营血和三焦辨证在本质上是识别抗原与免疫活性细胞或分子相互作用的三种不同的非线性动力学诊断模式,其证相应于这一过程中不同的非线性动力状态,可以用一个或一组非线性动力学方程进行定量描述。一个证常常对应于抗原与免疫活性的细胞或分子非线性动力学相互作用相空间中的一个稳定或不稳定的极限环和混沌,这可以作为证诊断的图形或形象标识。以中医学扶正祛邪的治疗思想为先导,有可能研制出全新靶向的和更有效的治疗传染性疾病的药物。     

腹腔镜胆囊切除术转开腹可能性评分系统建立和运用

目的　根据术前临床资料建立预测腹腔镜胆囊切除术转开腹可能性的评分系统。方法　对邵逸夫医院 1994年 4月 4日至 2 0 0 1年 6月 30日的 7134例LC的术前临床资料进行单因素分析 ,筛选出中转开腹的危险因素 ,再进行logistic多元回归分析。男性、高龄 (≥ 6 5岁 )、上腹部手术史、糖尿病、总胆红素升高 (≥ 1 2mg/dl)、胆囊壁增厚 (≥ 4cm )、胆总管直径增宽 (≥ 8cm)、急性胆囊炎是转开腹的危险因素并被分别赋值 ,建立预测转开腹可能性的评分系统。计算 7134例LC的综合得分 ,比较不同得分组转开腹率。用ROC曲线评价该评分系统的效能。 2 0 0 1年 7月 1日至 2 0 0 1年 12月 31日 938例LC运用该评分系统 ,比较各得分组转开腹率的差异。结果　 7134例LC中各组得分越高 ,转开腹率越高 ,且多数相邻两组的转开腹率有显著性差异 (P <0 0 1)。ROC曲线以下面积为0 81,标准误为 0 0 1。 938例LC中的各组也是得分越高 ,转开腹率越高 ,且多数相邻两组的转开腹率有显著性差异 (P <0 0 5 )。结论　根据危险因素预测LC转开腹可能性 ,以指导临床工作。     

17β-雌二醇对子宫内膜异位症患者在位子宫内膜间质细胞β-catenin mRNA和蛋白表达的影响

目的研究17β-雌二醇(17β-E2)对子宫内膜异位症(内异症)患者在位子宫内膜间质细胞β-catenin mRNA和蛋白表达的影响,探讨Wnt/β-catenin信号通路在介导雌激素促进内异症发生发展的作用。方法体外分离培养内异症患者在位子宫内膜间质细胞。用不同浓度17β-E2处理子宫内膜间质细胞48 h;此后选用10-10mol/L 17β-E2处理子宫内膜间质细胞12、24和48 h,逆转录聚合酶链反应(RT-PCR)和免疫印迹法(Western blotting)检测17β-E2处理前后子宫内膜间质细胞β-catenin mRNA和蛋白的表达水平。同法分析雌激素受体拮抗剂ICI182,780(10-6mol/L)对17β-E2促进β-catenin mRNA和蛋白表达的影响。免疫组织化学染色观察17β-E2作用后β-catenin在子宫内膜间质细胞中的定位。结果17β-E2能明显促进内异症患者在位子宫内膜间质细胞β-catenin mRNA和蛋白的表达,并呈剂量和时间依赖性,于10-10mol/L作用48 h最明显。雌激素受体拮抗剂ICI182,780能明显抑制17β-E2对子宫内膜间质细胞β-catenin mRNA和蛋白的表达。免疫组织化学染色发现17β-E2能促进β-catenin在子宫内膜间质细胞核内的表达。结论雌激素可能通过激活Wnt/β-catenin信号通路促进内异症在位子宫内膜的异位种植。     

人血清载脂蛋白A-I的分离、纯化及其测定

用超离心法制备人血清高密度脂蛋白(HDL);甲醇/氯仿脱脂;经Sephadex G-150层析及DEAE-纤维素(DE-52)离子交换得纯化载脂蛋白A-I(Apo A-I),免疫新西兰兔,获得效价为1:32的特异性抗人Apo A-I抗血清。用本室建立的单向火箭免疫电泳法测定了158名健康中年人与9名老人的血清Apo A—I含量,结果发现:β-脂蛋白<5g/L,总胆固醇<2mmol/L的人血清Apo A-I含量男女分别为2.06±0.16g/L和2.07±0.15g/L;而β脂蛋白≥5g/L,总胆固醇≥2mmol/L的人血清Apo A-I含量男女分别为1.75±0.15g/L和1.82±0.1g/L,由此可见,血脂正常的男性和女性的Apo A—I含量均显著高于血脂高的男性和女性。80岁以上老年人的血清Apo A-I含量为2.1±0.1g/L,也在正常范围。与文献报道比较,我国人的血清Apo A-I含量高于外国人,这与我国人HDL水平较外国人高一致。     

The Application of Number Needed to Treat (NNT) to Clinical Problems in Radiotherapy

The goals of this report are: 1) to review the number needed to treat (NNT) concept, which, although well established in many sectors of medicine, is still relatively new to the radiotherapy community; 2) to discuss several clinical radiotherapy examples illustrating the inherent advantages of the NNT approach; and 3) to discuss potential future roles of the NNT concept within radiotherapy.     

Central circulation in rats with different tolerance to acute blood loss

Study of the dynamics of cardiac output in rats with different tolerance to acute massive blood loss showed that the pumping ability of the heart remains intact during the entire posthemorrhagic period in all high-resistant and in 65% low-resistant rats. In 35% rats that were low-resistant to blood loss, the cardiac output deficiency syndrome developed after cessation of bleeding against the background fall in arterial pressure and a decrease in the hepatic blood flow, which are the signs of rapid variant of the dysfunction produced by acute blood loss. Translated fromByulleten' Eksperimental'noi Biologii i Meditsiny, Vol. 126, No. 10, pp. 384–388, October, 1998     

Infantile depression,nonorganic failure to thrive,and DSM-III-R: A different perspective

A controversy exists regarding the classification of nonorganic failure to thrive within the psychiatric nomenclature. There are a number of DSM-III-R diagnoses that may be applied to NOFTT, including Reactive Attachment Disorder of Infancy (RADI) and Major Depressive Disorder (MDD). The behaviors characteristic of NOFTT are symptomatic of depression, and are similar to those exhibited by infants with anaclitic depression as well as those of the adult with depression. The correspondence of the behaviours of NOFTT and the DSM-III-R criteria for Major Depression are reviewed, as are the conceptual and therapeutic reasons to view NOFTT infants as suffering from Depression.