Drug approval highlights for 2003

In the past 12 months, the FDA has approved important new pharmaceutical drugs and devices of particular interest to primary health care providers. The drugs include: Oxytrol (for urinary incontinence), Valtrex (for reducing the risk of heterosexual transmission of genital herpes), Femring (for vaginal delivery of hormone therapy), Uroxatral (for benign prostatic hypertrophy), Levitra (for erectile dysfunction), Flumist (for preventing influenza), Xolair (for asthma), Raptiva (for psoriasis), Cubicin (for skin infections), Crestor (for hypercholesterolemia), and Coreg (for severe heart failure).     

Effect of iodination site on binding of radiolabeled ligand by insulin antibodies and insulin autoantibodies

Four human insulins and four porcine insulins, each monoiodinated to the same specific activity at one of the four tyrosine residues (A14, A19, B16, B26) and purified by reversed-phase liquid chromatography, were tested in a radiobinding assay against a panel of insulin-antibody (IA)-positive sera from 10 insulin-treated diabetics and insulin-autoantibody-positive (IAA) sera from 10 nondiabetics. Of the 10 IAA-positive sera, five were fully cross reactive with both insulin species, and five were specific for human insulin. The rank order of binding of sera with the four ligands from each species was random for IA (mean rank values of 1.9 for A14, 2.0 for A19, 2.5 for B16, and 3.6 for B26 from a possible ranking range of 1 to 4), but more consistent for non-human-insulin-specific IAA (mean rank values 1.3 for A14, 3.8 for A19, 1.7 for B16, and 3.2 for B26 for labeled human insulins; 1.2 for A14, 4.0 for A19, 1.8 for B16, and 3.0 for B26 for labeled porcine insulins). The rank order of binding was virtually uniform for human-insulin-specific IAA (mean values 1.2 for A14, 3.0 for A19, 1.8 for B16, and 4.0 for B26). The influence of iodination site on the binding of labeled insulin appears to be dependent on the proximity of the labeled tyrosine to the antibody binding site and the clonal diversity, or restriction, of insulin-binding antibodies in the test serum. When IA and IAA are measured, the implications of this study regarding the choice of assay ligand may be important.     

Comparative pharmacokinetics of YM-13115, ceftriaxone, and ceftazidime in rats, dogs, and rhesus monkeys.

The pharmacokinetics of YM-13115, ceftriaxone, and ceftazidime were studied in rats, dogs, and rhesus monkeys (only YM-13115 and ceftriaxone were studied in rhesus monkeys). The plasma half-lives in rats were 48 min for YM-13115, 34 min for ceftriaxone, and 14 min for ceftazidime. In dogs, they were 21.9 min for YM-13115, 50.7 min for ceftriaxone, and 49.0 min for ceftazidime. In monkeys, they were 5.30 h for YM-13115 and 3.40 h for ceftriaxone. The 24-h urinary recoveries in rats were 26.7% of the dose for YM-13115, 32.0% for ceftriaxone, and 97.1% for ceftazidime. In dogs, they were 13.3% for YM-13115, 62.5% for ceftriaxone, and 86.3% for ceftazidime. In monkeys, they were 22.5% for YM-13115 and 29.3% for ceftriaxone. The 24-h biliary recoveries in rats were 72.2% for YM-13115, 61.8% for ceftriaxone, and 0.63% for ceftazidime.     

Malignant lymphoma in Olmsted County, Minnesota, 1970 through 1977

A study of the incidence of malignant lymphoma in Olmsted County, Minnesota, revealed 91 new cases during the period 1970 through 1977. On the basis of the analyzed data, the overall average annual incidence rate per 100,000 population was 12.2 for males and 14.2 for females. The rates for both sexes combined (unadjusted for age) were 1.5 for Hodgkin's disease, 6.2 for lymphosarcoma, and 5.5 for reticulum cell sarcoma. The incidence rate for Hodgkin's disease decreased insignificantly, whereas that for both lymphosarcoma and reticulum cell sarcoma increased significantly during the period 1970 through 1977 in comparison with rates from the period 1945 through 1969. The largest increase was for rural males, for whom the rates for all three histologic types of lymphoma were substantially higher than those for urban males.     

作业流程重组在住院患者院内检查护送流程中的应用研究

目的 探讨作业流程重组在住院患者院内检查护送过程中应用的临床价值.方法 采用作业流程重组理论中"系统性重新整合"的方法,对住院患者院内检查的护送流程和服务环节进行重组,应用重组后的流程护送住院患者进行院内检查,分别随机选取心电图检查患者126例,X线片检查患者130例,头颅CT检查患者128例为观察组,以护送检查所需时限、患者满意率为研究监测指标,并分别与流程重组前的112例心电图检查、112例X线片检查和120例CT检查患者进行对照比较.结果 流程重组后,心电图检查、X线片检查、头颅cT检查所需时限明显缩短,患者满意率明显提高,与对照组比较,差异均有统计学意义(U值分别为14.55、12.26、13.57,X2值分别为17.37、14.65、10.75,P＜0.01).结论 作业流程重组在住院患者院内检查护送过程中具有非常重要的应用价值,可达到缩短护送检查所需时间,提高患者满意率的目的,对提高效益及医院竞争能力具有重要的现实意义.     

Reliability of goniometric measurements and visual estimates of knee range of motion obtained in a clinical setting

The purpose of this study was to examine the intratester and intertester reliability for goniometric measurements of knee flexion and extension passive range of motion (PROM). In addition, parallel-forms reliability for PROM measurements of the knee obtained by use of a goniometer and by visual estimation was examined. The intertester reliability for visual estimates of the PROM of the knee was also examined. Repeated measurements were obtained on 43 patients in a clinical setting. The intraclass correlation coefficients (ICCs) for intratester reliability of measurements obtained with a goniometer were .99 for flexion and .98 for extension. Intertester reliability for measurements obtained with a goniometer was .90 for flexion and .86 for extension. The ICCs for parallel-forms reliability for measurements obtained with a goniometer and by visual estimation ranged from .82 to .94. The intertester reliability for measurements obtained by visual estimation was .83 for flexion and .82 for extension. Results suggest clinicians should use a goniometer to take repeated PROM measurements of a patient's knee to minimize the error associated with these measurements.     

The nutritional index 'CONUT' is useful for predicting long-term prognosis of patients with end-stage liver diseases

Organ allocation in Japan remains difficult due to the shortage of deceased-donor livers. The screening tool for controlling nutritional status (CONUT) has been considered to be an established assessment model for evaluating nutritional aspects in surgical patients. However, the application of this CONUT for evaluating the prognosis of patients with end-stage liver diseases has not been evaluated. We assessed the predictability of the prognoses of 58 patients with end-stage liver disease using various prognostic models. The patients registered at the transplantation center of Tohoku University Hospital for the waiting list of Japan Organ Transplant Network for liver transplantation were retrospectively analyzed. The prognoses of the patients were evaluated using the following 5 models: CONUT, the model for ELD with incorporation of sodium (MELD-Na), Child-Turcotte-Pugh score (CTP), prognostic nutritional indices (Onodera: PNI-O), and the Japan Medical Urgency criteria of the liver (JMU). Cox's proportional hazard model, log-rank test and concordance(c)-static were used for the statistics. The indices were 17.74 ± 5.80 for MELD-Na, 9.21 ± 2.19 for CTP, 33.92 ± 11.16 for PNI-O, and 7.57 ± 3.09 for CONUT. Univariate analysis revealed the significance of CONUT (p = 0.017, Odds: 1.325) but not MELD-Na, CTP, JMU or PNI-O for prediction. The cumulative survival rate was clearly discriminated at CONUT point 7. The c-static was 0.081 for the 6-month (M) survival rate, 0.172 for 12M, 0.517 for 36M, 0.821 for 48M, and 0.938 for 60M for CONUT. In conclusion, CONUT shows best predictability for the distant prognoses of patients with ELD.     

In vitro activities of pazufloxacin, a novel injectable quinolone, against bacteria causing infections in obstetric and gynecological patients

T-3762 is an injectable new quinolone with a broad spectrum of antibacterial activity. Pazufloxacin (T-3761) is an active form of T-3762. The minimal inhibitory concentrations (MICs) of pazufloxacin for 50% of the clinical isolates tested were 3.13 microg/ml for Streptococcus agalactiae, 6.25 microg/ml for Gardnerella vaginalis, 0.025 microg/ml for Escherichia coli, 0.78 microg/ml for Pseudomonas aeruginosa, 6.25 microg/ml for Peptostreptococcus magnus, 6.25 microg/ml for Bacteroides fragilis and 12.5 microg/ml for Prevotella bivia. The MICs of T-3762 for 90% of the clinical isolates tested were 3.13 microg/ml for S. agalactiae, 6.25 microg/ml for G. vaginalis, 0.10 microg/ml for E. coli, 12.5 microg/ml for P. aeruginosa, 25 microg/ml for P. magnus, 12.5 microg/ml for B. fragilis and 25 microg/ml for P. bivia. The results of this study suggest that, subject to confirmation by clinical trials, T-3762, in combination with an agent with reliable activity against anaerobic bacteria, is suitable as an empirical therapy of patients with obstetric and gynecological infections.     

机械通气患者及家属的心理反应与护理

目的：了解机械通气治疗患者及家属的心理反应和心理需求。方法：以问卷方法调查神志清楚的28例及128位患者及家属的心理反应。结果：28例患者中，忧郁占92．8％，多疑占85．7％，脆弱占100％；敌对占82．1％，易怒占96．4％，偏激占93．8％，120位家属中，忧郁占90．8％，多疑占81．6％，敌对占80％脆弱占97．5％，易怒占93．3％，偏激占82．5％，其余项目无明显差异；心理需求调查中，患者需要陪护占100％，健康教育需要占92％，减少费用为75％、临终关怀为67．8％，而家属对陪护的需求为83．3％，减少费用为77．7％、临终关怀为90．8％外，其余项目无差异性。结论：机械通气患者在治疗期间心理反应、心理需求基本上与家属一致，需对患者和家属进行心理护理。     

Sampling and analysis techniques used in a blood lead survey of 1241 children in Port Pirie, South Australia

Methods are described for taking finger-prick blood samples and for analyzing these samples for lead. Quality-control techniques and procedures for the validation of all results are described. Results of a survey of 1241 children are given and results for 149 venous samples are compared with results for the corresponding finger-prick samples. This finger-prick sampling method evidently is suitable for use in screening large numbers of children.     

临床实验室精密度性能的评估

目的　评估满足操作规范和保证室间质量评价准则规定的质量要求 ,具有足够精密度性能实验室的百分比。方法　累积分布描述在室间质量评价活动中回报的 5 0 0家实验室的不精密度。允许的不精密度可从常用的单规则和多规则 (每批具有 2～ 4个质控测定值 )质控方法的操作过程规范图中的x轴截距获得。结果　导出的允许不精密度值放在累积分布可获得满足规范实验室百分比图形上的估计值。对于白蛋白 ,2 8%的实验室达到允许的不精密度 ;总胆红素为 6 4 % ,钙为 5 2 % ,氯为 35 % ,胆固醇为 4 8% ,肌酐为 84 % ,葡萄糖为 6 1% ,钾为 95 % ,总蛋白为 6 6 % ,钠为 18% ,三酰甘油为 87% ,尿素氮为 35 % ,尿酸为 81%。结论　对于许多试验 ,为了保证满足室间质量评价要求的分析质量仍需提高其精密度水平。     

三种SCI收录的结直肠疾病专业杂志腹腔镜结直肠手术随机对照试验报告质量评价

目的调查三种SCI收录的结直肠病专业杂志中腹腔镜随机对照试验（RCT）的报告质量。方法电子检索MEDLINE（R）1950to Present with Daily Update数据库中Diseases of the Colon＆amp;Rectum,International Journal of Colorectal Disease和Colorectal Disease三种杂志刊载的腹腔镜结直肠手术的RCT,采用CONSORT声明修订版和根据外科临床情况制定的条目进行报告质量评价。若文章完全符合该条目,得1分;若完全没有提及该项条目,得0分;若有提及但阐述不全面的,得0.5分。结果共检出28篇文献,8篇不符合纳入标准。RCT报告整体质量不高。其中以下条目平均分较低：资料收集的地点与背景0.150;确定样本量0.250;产生随机分配序列的方法0.500;分配隐藏0.325;执行情况0.150;提高测量质量的方法0.475;受试者每阶段的流程0.150;各干预组中所有重要不良事件或副作用0.450;外部真实性0.450;资助0.400;术前药物处理0.250;术前非药物处理0.075;方法学家参与0.000;术者年资0．350。得分较低的条目集中于方法、结果和外科特色条目。结论三种SCI收录的结直肠病杂志腹腔镜RCT报告的方法学质量均不高,结直肠外科医师在采用RCT结论时需进行严格评价。     

Prevalence of use of cardiovascular drugs in 499 patients with suspected coronary artery disease at time of hospitalization for coronary angiography and in 357 patients with obstructive coronary artery disease documented by coronary angiography

In a prospective study of 499 patients with suspected coronary artery disease (CAD) hospitalized for coronary angiography, the prevalence of use of cardiovascular drugs at hospital admission was 80% for antiplatelet drugs, 66% for beta blockers, 55% for angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), 65% for lipid-lowering drugs, 24% for calcium channel blockers (CCBs), and 16% for nitrates. In 357 patients with obstructive CAD diagnosed by coronary angiography, the prevalence of use of these drugs at hospital discharge was 100% for antiplatelet drugs, 97% for beta blockers, 91% for ACE inhibitors or ARBs, 98% for lipid-lowering drugs, 17% for CCBs, and 27% for nitrates. Obstructive CAD was significantly more prevalent in men (P < 0.025), in cigarette smokers (P < 0.01), and in patients with hypertension, diabetes, or hypercholesterolemia (P < 0.001). Age, race, body mass index, and neck circumference were not significantly different for patients with versus without obstructive CAD.     

Isothermal microcalorimetry: a novel method for real-time determination of antifungal susceptibility of Aspergillus species

We evaluated microcalorimetry for real-time susceptibility testing of Aspergillus spp. based on growth-related heat production. The minimal heat inhibitory concentration (MHIC) for A. fumigatus ATCC 204305 was 1 mg/L for amphotericin B, 0.25 mg/L for voriconazole, 0.06 mg/L for posaconazole, 0.125 mg/L for caspofungin and 0.03 mg/L for anidulafungin. Agreement within two 2-fold dilutions between MHIC (determined by microcalorimetry) and MIC or MEC (determined by CLSI M38A) was 90% for amphotericin B, 100% for voriconazole, 90% for posaconazole and 70% for caspofungin. This proof-of-concept study demonstrated the potential of isothermal microcalorimetry for growth evaluation of Aspergillus spp. and real-time antifungal susceptibility testing.     

鼻咽癌放射治疗患者延续性护理需求的调查研究

目的：探讨鼻咽癌放射治疗患者对延续性护理的需求。方法采用“鼻咽癌放疗患者延续性护理需求问卷”调查80例鼻咽癌放疗患者对延续性护理内容和随访方式的需求。结果在专科护理方面患者对口腔黏膜炎的护理需求(含非常需要、需要)最高,达92.5%;在心理家庭社会方面患者对家庭支持的需求达85.0%;在健康教育方面对饮食指导需求达75.0%。电话随访是患者认为最能接受的实施方式,占51.2%;其次是家庭访视占28.8%。结论患者对延续性护理服务的需求强烈,应注重专科护理的指导,给予心理家庭社会方面的支持,提供具有针对性的护理延伸服务,提高患者的生活质量。     

Effectiveness of massage therapy for chronic, non-malignant pain: a review

Previous reviews of massage therapy for chronic, non-malignant pain have focused on discrete pain conditions. This article aims to provide a broad overview of the literature on the effectiveness of massage for a variety of chronic, non-malignant pain complaints to identify gaps in the research and to inform future clinical trials. Computerized databases were searched for relevant studies including prior reviews and primary trials of massage therapy for chronic, non-malignant pain. Existing research provides fairly robust support for the analgesic effects of massage for non-specific low back pain, but only moderate support for such effects on shoulder pain and headache pain. There is only modest, preliminary support for massage in the treatment of fibromyalgia, mixed chronic pain conditions, neck pain and carpal tunnel syndrome. Thus, research to date provides varying levels of evidence for the benefits of massage therapy for different chronic pain conditions. Future studies should employ rigorous study designs and include follow-up assessments for additional quantification of the longer-term effects of massage on chronic pain.     

Field testing the WHOQOL-100 in Canada.

The purpose of this project was to test the WHOQOL-100, an instrument for assessing quality of life (QOL), developed to facilitate cross-cultural comparison. The instrument was tested with a convenience sample of 144 people. The mean age of participants was 58 years and 41% were female.Test-retest reliability was .86 for the physical domain, .78 for the psychological domain, .91 for independence, .87 for social relationships, .77 for environment, and .60 for spirituality. Consistency reliability was .77 for physical, .79 for psychological, .89 for independence, .71 for social relationships, .80 for environment, and .89 for spirituality/ personal beliefs. Correlations of the various domains with other instruments, including the SF-36, the Self-Anchoring Striving Scale, and the Visual Analogue Scale for Pain, supported the convergent validity of the instrument. The instrument was able to discriminate between healthy and ill populations, providing support for construct validity.     

Anti-hyperlipidemic agents

There are several drugs for hyperlipidemia except for statin and fibrate. Resin is a commonly used drug for hypercholesterolemia and is known to very useful for the prevention of coronary heart disease(CHD). Probucol is also used for hypercholesterolemia and recently is known that it prevent the restenosis of the coronary artery after PTCA. Nicotinic acid is used for hypertriglyceridemia and hypercholesterolemia, both. It is also known to very useful for the prevention of CHD. Eicosapentaenoic acid is effective for hypertriglyceridemia and also shows an inhibition of platelets aggregation. These drugs as well as statin and fibrate are used in combination with each other for severe hyperlipidemia.     

External quality assessment of methylmalonic acid and total homocysteine.

BACKGROUND: The use of analyses for methylmalonic acid (MMA) and total homocysteine (HCY) in plasma has become widespread. Realizing the need for external quality assessment for these measurements, we started a program in 1997. The results for 1998 are reviewed in this report. METHODS: Fourteen laboratories participated with 15 sets of results for MMA, and 28 laboratories participated with 34 sets of results for HCY. Results for four identical samples, made up from the same unmodified serum (MMA) or EDTA-plasma (HCY) pool, sent out under different identifications, were used for assessing the imprecision. Samples made up from the same pools supplemented with MMA or L-HCY to three concentrations were used for assessing the recovery. By using literature data for the biological variation, quality goals for both analytes were calculated. RESULTS: The overall within-laboratory CV was 12% for MMA and 7.5% for HCY. Gas chromatography-mass spectrometric HCY results had lower imprecision than the HPLC or immunoassay results. For MMA, no significant between-laboratory component of variance was found. Only results for HCY obtained with HPLC methods showed significant between-laboratory variance. CONCLUSIONS: Eight of the 15 participants achieved the minimum imprecision goal for MMA vs 9 of the 34 participants for HCY. The minimum quality goals for bias as approximated by the recovery were achieved by 13 participants for MMA and 26 for HCY.     

中国汉族人群凝血因子Ⅸ基因限制性片段长度多态性的研究

为探讨中国人群中凝血因子Ⅸ（FⅨ）基因SalⅠ，NruⅠ和MseⅠ酶切位点的限制性片段长度多态性（RFLP），采用聚合酶链反应（PCR）方法，以三代内相互间无亲缘关系的正常汉族人为研究对象，对其FⅨ基因内含子1第192位以及5′端－793位核苷酸A和G的频率和5′端－698位核苷酸T和C的频率进行了分析，其中对FⅨ－192共分析了214条X染色体，对FⅨ－793共分析了210条X染色体，对FⅨ－698共分析了206条X染色体。结果表明，FⅨ基因内含子1第192位A和G的频率分别为0．878和0．122，杂合体频率为0．213；－793位核苷酸A和G的频率分别为0．552和0．448，杂合体频率为0．494，FⅨ－698位核苷酸T和C的频率分别为0．311和0．689，杂合体频率为0．429。结论提示：FⅨ基因SalⅠ,NruⅠ和MseⅠ酶切位点的RFLP有利于我国血友病B的携带检测和产前诊断。