The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective.

Current regulatory guidances do not address specific study designs for in vitro and in vivo drug-drug interaction studies. There is a common desire by regulatory authorities and by industry sponsors to harmonize approaches, to allow for a better assessment of the significance of findings across different studies and drugs. There is also a growing consensus for the standardization of cytochrome P450 (P450) probe substrates, inhibitors and inducers and for the development of classification systems to improve the communication of risk to health care providers and to patients. While existing guidances cover mainly P450-mediated drug interactions, the importance of other mechanisms, such as transporters, has been recognized more recently, and should also be addressed. This article was prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism and Clinical Pharmacology Technical Working Groups and represents the current industry position. The intent is to define a minimal best practice for in vitro and in vivo pharmacokinetic drug-drug interaction studies targeted to development (not discovery support) and to define a data package that can be expected by regulatory agencies in compound registration dossiers.     

2340例胰腺癌临床病例分析

目的 探讨提高胰腺癌治愈性切除相关因素和获得更佳疗效。方法 中国抗癌协会胰腺癌专业委员会回顾性分析了8省2市14大医院的1990年-2000年诊治的2340例胰腺病例。多因素生存分析采用Cox比例风险模型找出可能影响胰腺癌病人预后的独立因素。单因素生存分析用寿命表法计算,以生存曲线描述生存率,并进行Gehan比分检验。结果 COX单因素分析表明在a=0.05水平上有意义的有年龄、职业、病程、肿瘤部位、手术方式、术后胰瘘、术后肝衰、化疗、TNM分期、免疫治疗、有无肝转移、肠系膜上血管有无侵犯等变量。COX多因素分析表明在a=0.05水平上有意义的有患者年龄、手术方式、术后胰瘘、术后肝衰、化疗、免疫治疗等变量,这些变量为影响胰腺癌预后的独立因素。根治性手术者相对于未手术者,以及化疗、免疫治疗均为保护性因素。其中40岁以上的占了92.91％,40岁以下的仅占7.09％。胰头癌根治性手术组中位生存时间为 17.11个月,1年、3年和5年生存率分别为54.36％、13.47％、8.47％。结论 有必要将40岁以上的人群视为高危人群,能及时发现早期病例。各种综合治疗措施的结合都将有助于改善胰腺癌患者的生活质量和延长生存期。     

前列康宝的药理学研究

实验结果表明，前列康宝具有明显的抗前列腺增生，抗炎及改善微循环作用。     

瞬目反射正常值及初步临床应用

目的 了解健康成人瞬目反射正常值及其临床应用价值。方法 采用Ｅｖｏｌｕｔｉｏｎ型神经肌肉记录仪检测，表面电极直接刺激眶上神经，诱发瞬目反射。在同侧眼轮匝肌记录出短潜伏期波和双侧眼轮匝肌记录出长潜伏期波。对２０名（４０例）健康人和３０例患者（其中包括三叉神经疾病，面神经疾病及听神经瘤）进行瞬目反射测试。结果 ＢＲ潜伏期健康成人平均值Ｒ１为１０．０ｍｓ，Ｒ２和Ｒ２‘为３０．４ｍｓ和３０．７ｍｓ，患者组     

瞬目反射正常值及初步临床应用

目的了解健康成人瞬目反射正常值及其临床应用价值。方法采用Ｅｖｏｌｕｔｉｏｎ型神经肌肉记录仪检测，表面电极直接刺激眶上神经，诱发瞬目反射（ｂｌｉｎｋｒｅｆｌｅｘ，ＢＲ）。在同侧眼轮匝肌记录出短潜伏期波（Ｒ１）和双侧眼轮匝肌记录出长潜伏期波（Ｒ２，Ｒ２’）。对２０名（４０侧）健康人和３０例患者（其中包括三叉神经疾病，面神经疾病及听神经瘤）进行瞬目反射测试。结果ＢＲ潜伏期健康成人平均值Ｒ１为１０．１ｍｓ，Ｒ２和Ｒ２’为３０．４ｍｓ和３０．７ｍｓ。患者组患侧ＢＲ各波潜伏期延长，与健侧和健康人相比较，经ｔ检验，Ｐ＜０．０１，差异有极显著性。结论测试结果表明该技术简单、可靠，对三叉神经、面神经疾病和听神经瘤的早期诊断能提供有价值的电生理测试结果。     

T抗原单克隆抗体法在大肠癌筛检中的应用初探

目的 探讨T抗原单克隆抗体法在大肠癌筛检中的临床价值.方法 同时采用T抗原单克隆抗体法和半乳糖氧化酶法检测207例直肠粘液中的T抗原.结果 T抗原单克隆抗体法和半乳糖氧化酶法的敏感性和特异性分别为69.2%、67.3%和64.2%、65.6%,两者的筛检价值无明显差别.结论T抗原单克隆抗体法对大肠癌筛检有较大临床价值,且操作简便.     

全肠外营养对早产儿营养、免疫功能及行为发育的影响

【目的】探讨全肠外营养(TPN)对早产儿营养、免疫功能及行为发育的影响。【方法】监测55例TPN治疗早产儿的营养状况、肝肾功能、血脂水平、免疫功能及矫正胎龄40周时行为发育情况，并与25例未行TPN的早产儿对照分析。【结果】TPN治疗组体重增长快、体重日增长及治疗后体重高于对照组，TPN治疗后血清蛋白、免疫球蛋白及补体水平升高，肝肾功能及血脂检查无明显异常，矫正胎龄40周时NBNA评分高于对照组。【结论】TPN能改善早产儿营养状况、促进免疫水平的提高和行为神经的发育，对早产儿的治疗有重要意义。     

茵栀黄注射液治疗新生儿高未结合胆红素血症的150例

目的 :及早有效纠正新生儿高未结合胆红素血症 ,以预防胆红素脑损伤。方法 :在常规治疗的同时 ,加用茵栀黄注射液静脉滴注。结果 :治疗组胆红素日均下降值为 (50 17±25 26) μmol/L ,明显高于对照组的 (37 95±21 58) μmol/L。结论 :茵栀黄注射液治疗新生儿高未结合胆红素血症 ,可迅速降低血胆红素水平 ,明显缩短治疗时间。     

Characteristics and trends in incidence of inflammatory bowel disease in Taiwanese children.

BACKGROUND AND PURPOSE: Although chronic inflammatory bowel disease (IBD) is rare in Asian children, increasing numbers of pediatric patients with chronic IBD worldwide have been noted in recent years. This study was conducted to delineate the trend in incidence and clinical patterns of childhood IBD in Taiwan. METHODS: All children admitted to National Taiwan University Hospital (NTUH) between 1979 and 2000 who met the criteria for IBD, Crohn's disease (CD), ulcerative colitis (UC), probable CD (PCD), or indeterminate colitis were included. The clinical features and outcomes were analyzed retrospectively. Incidence was calculated using cases of chronic diarrhea during the same period of time as the risk population. RESULTS: IBD was diagnosed in 17 children (9 females and 8 males, aged 2 months to 18 years) during the study period. Six (35%) of these children had UC, 9 (53%) had CD, and 2 (12%) had PCD. The cumulative incidence of CD during 1979-1995 was 0.85%, and increased to 2.6% during 1996-2000 (p < 0.001), while the incidence of UC did not change significantly between these periods (from 0.85% to 0.99%, p = 0.16). The median interval from onset to diagnosis was 7.7 months. Eighty percent of patients had moderate to severe disease activity at diagnosis. The follow-up duration ranged from less than 1 year to 20 years, with a mean of 4.3 years. Two patients were lost to follow-up. Eighty six percent of patients responded to treatment, and 80% of patients had inactive to mild disease activity when re-evaluated at the end of 2000. CONCLUSION: There has been a marked recent increase in the incidence of childhood CD in Taiwan but the rate of childhood UC has remained unchanged. Eighty percent of cases of childhood IBD responded well to treatment.