The POSCH data processing experience

Metadata, the term, may be new but metadata, the concept, is not new. For purposes of this paper, the term metadata is defined as the data used to define, store, retrieve, combine, analyze, and present the data values (the “real” data, so to speak). As clinical research studies get larger, it becomes desirable to use automated managers of the metadata. The Program on the Surgical Control of the Hyperlipidemias (POSCH), a national multiclinic clinical trial, manages most of its metadata manually but has been experimenting with ways to more fully automate them. Its Information Management System (IMS) is described with special emphasis on how it manages the metadata. The case is presented for further automation and standardization of metadata in large clinical research studies so that costs can be contained and smaller increments of “progress” can be measured. The concept of a Metadatabase Management System (MDBMS) is developed and illustrated using POSCH.     

Pharmacokinetics of vindesine bolus and infusion

Summary The pharmacokinetics of vindesine were investigated during treatment of 15 patients with progressive malignancies refractory to conventional treatment. Patients were administered one of three IV dose schedules: 3.0 mg/m² bolus injection, 1.2 mg/m²/day infusion for 5 days, or 2.0 mg/m²/day infusion for 2 days. Concentrations of the drug in the serum and urine were determined by radioimmunoassay. Serum concentrations were highest (5×10^-7 M) in patients receiving a bolus injection, but fell to nondetectable levels by 48 h in four of five patients (terminal t_1/2 15.0±9.4 h). Compared with bolus injection, 1.2-to 1.4-fold greater areas under the blood concentration curve were observed during infusions of 2.0 mg/m² and 1.2 mg/m². Whereas steady-state concentrations (1×10^-8 M) were maintained throughout the infusion of 1.2 mg/m²/day progressively increasing serum levels were observed during the infusion of 2.0 mg/m²/day. Serum concentrations fell rapidly following discontinuation of the 2.0-mg/m² infusion, but were somewhat more sustained in the 1.2-mg/m² infusion group. The average urinary excretion was similar for each dose-schedule (8%–11% of the total dose). The pharmacokinetics of vindesine are influenced by variations in dose schedule.     

2018—2020年珠海市学校流感样病例暴发疫情流行特征及影响因素分析

目的 分析珠海市2018—2020年学校流感样病例暴发疫情的流行特征和影响疫情规模的相关因素,为制定防控策略提供依据。方法 采用描述流行病学方法分析学校流感样病例暴发疫情流行特征,采用χ2检验和Logistic回归分析疫情规模的影响因素。结果 2018—2020年珠海市学校累计报告67起流感样病例暴发疫情,累计发病人数1 746例。发病高峰为每年3月—6月和12月—次年1月,主要发生在小学,流感样病例的发病年龄高峰为6～8岁。病原体主要为B型、A(H3N2)亚型和A(H1N1)亚型流感病毒。暴发疫情涉及病例咽痛发生率>50%的学校发生大规模流感样病例暴发疫情的风险是咽痛发生率≤50%学校的4.308倍(95%CI:1.100～16.864)。结论 2018—2020年珠海市学校流感样病例暴发疫情主要集中在冬春季节的小学,高咽痛发生率是学校发生大规模疫情流感样病例暴发疫情的危险因素。     

国产万拉法新治疗肠易激综合征的初步临床研究

目的 观察国产新药万拉法新对肠易激综合征（IBS）及其伴随的焦虑和抑郁症状的临床治疗效果。方法 选择48例IBS患者,随机分为治疗组和对照组,分别服用万拉法新及硝苯地平进行为期4周的治疗,通过对IBS各项症状的改善率和总体改善率评定观察治疗效果。同时采用Zung编制的抑郁自评量表和焦虑自评量表进行评分观察治疗前后抑郁和焦虑的改善程度。结果 万拉法新对IBS的治疗总体改善率为80％,对照组为52．17％（P＜0．05）。万拉法新治疗前后焦虑和抑郁的改善程度经检验均有统计学意义（P＜0．01）。结论 单独应用万拉法新对IBS的总体治疗效果优于硝苯地平组,对改善伴随的焦虑和抑郁症状有明显的疗效。     

慢性乙型肝炎患者TNF-α和IL-6的变化及双利肝对其影响

目的探讨TNF-α、IL-6在慢性乙肝不同阶段的作用及双利肝对于两种细胞因子的影响.方法 55 例慢性乙肝患者在治疗前测定血清TNF-α、IL-6水平及肝功能.在一般保肝治疗基础上口服双利肝,在治疗前后测定血清TNF-α、IL-6水平及肝功能.结果随着肝功能损害加重,TNF-α、IL-6水平显著升高(P＜0.01,P＜0.05),经过双利肝治疗,患者转氨酶、胆红素、TNF-α水平明显下降(P＜0.01),IL-6水平略有上升但无显著性差异(P＞0.05).结论慢性乙肝病程中,TNF-α与肝细胞坏死程度有关,可作为病情轻重的判别指示.IL-6与肝脏损伤过程有关.双利肝可明显降低慢性乙肝患者TNF-α水平,有效地改善肝功能.     

新疆和田红葡萄体外抑制肿瘤作用的研究

目的：研究和田红葡萄体外抑瘤效果。方法：采用体外细胞培养方法观察和田红葡萄与红葡萄皮的醇提液对四株细胞株。即：正常小鼠成纤维细胞株（3T3）、胃癌细胞株（MGC－803,NKM）和肝癌细胞株（Q3）细胞存活率及蛋白质含量影响。结果：（1）和田红葡萄醇提液与和田红葡萄皮醇提液都显著抑制NKM和Q3存活（P＜0．01）,后者对MGC－803存活率亦显著影响（P＜0．01）,最强作用浓度0．01g/ml。两种醇提液作用于NKM、Q3、MGC－803的抑制率分别为11．0％、14．0％、24．0％。葡萄皮醇提液抑瘤效果强于葡萄醇提液（P＜0．05）;（2）两种醇提液皆对细胞蛋白质含量无影响（P＞0．05）;（3）葡萄醇提液促进3T3生长作用较葡萄皮醇提液强（P＜0．05）。结论：和田红葡萄可能具有一定的体外抑癌作用。     

表皮生长因子及染料木黄酮对垂体瘤细胞增殖的调节

12例垂体瘤做原代细胞培养 ,检测了表皮生长因子 ( EGF)及染料木黄酮 ( Genistein)对肿瘤细胞 3H- Td R掺入率及酪氨酸激酶产物表达的影响。研究表明 EGF使大部分功能性腺瘤及所有非功能性腺瘤细胞的 3H- Td R掺入率明显增加 ,酪氨酸激酶活性增强 ,而 Genistein能抑制 EGF的作用使所有瘤细胞的 3H- Td R掺入率下降。提示表皮生长因子对垂体瘤细胞有明显的增殖刺激作用 ;Genistein能消除表皮生长因子的细胞增殖刺激作用 ,抑制肿瘤细胞增生 ,对垂体瘤治疗有重大意义。     

反相高效液相色谱分析胺甲硫磷和甲基毒死蜱的方法研究

建立了生物组织中胺甲硫磷和甲基毒死蜱的反相高效液相色谱分析方法。选用YWG-C18H375mm(内径)×200mm柱作为分析柱,流动相选用80∶20（V/V）的甲醇/水二元体系,流速为1.0ml/min,检测波长胺甲硫磷为252nm,甲基毒死蜱为290nm。该方法简单、快速、准确。其最小检出量为2.5×10-8g,最小检出浓度为0.25mg/L。     

Safety and efficacy of thulium laser resection of bladder tumors versus transurethral resection of bladder tumors: a systematic review and meta-analysis

Lasers in Medical Science - The thulium laser resection of bladder tumor (TmLRBT) is widely used in the treatment of non-muscle-invasive bladder cancer (NMIBC), and we conduct this study to compare...