欧盟罕用药政策的分析及其对我国的启示

目的 通过分析欧盟及其成员国的罕用药相关政策,为我国罕用药及罕见病相关制度政策的制定提供参考。方法 采用文献研究法对欧盟及其成员国法国、意大利、荷兰、英国的罕用药相关政策进行检索,并比较分析四国相关政策与制度的异同点。结果 除欧盟统一的罕用药政策外,法国、意大利、荷兰以及英国均制定了相应的罕用药制度,设立罕见病治疗指导中心,有针对罕用药研发与价格制定的政策与措施,对于罕见病的治疗有相应的医疗保障制度,相应的政策制度较为完善。 结论 我国可借鉴其经验尽快制定罕见病的相关定义,建立罕见病中心,出台相应的研发激励与价格制定政策,并完善罕用药的报销与罕见病的医疗保障。     

公立医院临床医生对医疗监管认知的调查及分析

??????? 目的 了解临床医生对公立医院医疗监管的认知情况。方法 对新疆医科大学附属医院202名在职临床医生随机进行问卷调查,用卡方检验处理数据。 结果 不同年龄的临床医生对完善医院监管体制是否有助于加强医师职业管理、提高专业技术能力的看法有差异（P＜0.05）;不同年龄、职称、工龄的医生对医院监管制度的认识、对现有监管制度是否得到严格执行的认识和对管理人员的监管意识认识没有差别（P＞0.05）;不同年龄、职称、工龄的医生对于普通员工监管意识的认识有差别（P＜0.05）;对于医院医疗监管存在的问题及原因,大部分医生认识比较清楚,存在的问题符合社会普遍现象。结论 建立完善的医院医疗监管机制,积极探索科学的,系统的监管模式,内部监管与外部监管相结合。     

基于业务连续性的医院信息系统的构建

目的 打造可靠的医院信息系统,保障医院业务连续性。方法 在中山大学附属第三医院,建立异地容灾系统,创建服务器集群,采用双冗余技术以及完善规章制度,防范存储故障、服务器网络设备故障、人为错误以及自然灾害等风险。结果 通过信息系统建设,提高了医院信息系统的可靠性,进而保障了医院业务连续性。结论 使用信息技术和完善管理,防范信息系统安全风险,是医院业务连续性运行的重要保证。

     

病例组合指数在诊疗行为差异性评价中的应用探讨

目的 运用病例组合指数（CMI）分析不同医生对某一疾病患者的不同年度变化治疗方式及费用差异,指导评估医生的治疗行为和结局。方法 选取某三级甲等综合医院胸外科肺恶性肿瘤疾病患者（ICD-C34）住院病例的住院首页信息,提取患者疾病诊断的CMI值。分析不同医生治疗该类患者的费用,住院时间等治疗相关情况的差异,并按年度分析其变化情况。结果 各位医生诊治患者的CMI差异无统计学意义（P＞0.05）。不同医生的对该疾病的治疗费用差异有统计学意义（P＜0.05）,以住院费用为因变量,CMI、年龄、术式以及医生等为自变量的logistic分析结果表明,CMI对住院费用具有影响。医生治疗费用的差异可能与其选择的术式及手术水平相关。结论 不同医生对同一疾病的治疗情况存在差异,采用CMI对医生诊疗­­­行为的评估和医疗费用的控制都具有指导意义。     

不同生育政策下剖宫产指征变化及医院管理策略研究

目的 分析生育政策调整前后剖宫产率、剖宫产指征的变化趋势,为降低剖宫产率提出建议。方法 应用SPSS 21.0进行统计分析,描述各项指标变化趋势。结果 伴随生育政策调整,剖宫产率下降明显,但是年龄变化趋势不大,胎膜早破、巨大儿、高龄初产近年来呈现上升趋势,而无指征剖宫产在全面二胎政策开放后,顺位排名降低至第7位以后。结论 孕产妇生育方式受到了生育政策调整的影响,伴随生育政策的继续推进,剖宫产率将持续下降,同时,严格把控无指征剖宫产发生率,对孕产妇二胎受孕及分娩的安全性也起到了一定的保证。     

基于病例组合指标的医生疾病治疗费用差异研究

目的 应用诊断相关分组项目中的病例组合指标（CMI）分析医生对某一疾病患者的治疗方式及费用差异。方法 选取某三级甲等医院胸外科肺恶性肿瘤疾病患者住院病例的住院首页信息（ICD-C34）,提取不同患者疾病诊断的CMI值。采用非参数检验、Logistic分析病种的住院费用影响因素,包括医生,CMI等,比较参与治疗该病的四位医生之间差异。结果 影响患者住院费用的主要因素是不同医生、CMI、住院日和患者年龄;不同医生诊治的患者的 CMI无统计学差异,以住院费用为因变量,医生和CMI为自变量的Logistic分析结果表明CMI对住院费用具有影响。结论 CMI有可能作为一项重要指标用于评价医生对某一疾病治疗的合理性和工作质量。     

重点疾病非计划重返住院的影响因素分析

目的 研究某三甲综合医院2012年18类重点疾病非计划重返住院的影响因素。方法 对样本院2012年18类重点疾病7 406例患者进行分析,研究其出院后15天、31天非计划重返住院的原因。 结果 9类疾病33名患者出现了非计划再次入院情况,慢性病和60岁以上老年人更有可能非计划重返住院,患者出院时疾病状态、出院主张、病情加重或病情复发、住院天数等是影响非计划重返住院的主要因素。 结论 要从熟练掌握相关疾病的临床治愈好转标准,加强医患沟通,加强健康宣教,加强出院随访等方面来提高医院的医疗质量。     

2007—2009年全国监测点医院药物利用分析

目的 评价2007—2009年全国监测点医院的药物使用状况。方法 根据全国监测点医院的用药数据,采用金额分析和数据汇总的方法进行分析。结果 2007——2009年监测点医院的购药总金额呈现逐年上升的趋势,但各个省市的增长速度有所区别。抗感染药物、抗肿瘤药、心血管用药连续3年位列前3名。结论 随着医疗市场的扩大,药品消耗仍将在相当长的一段时期内持续增长,用药结构将发生变化。     

支持复杂疾病的临床路径知识库平台的构建及应用

目的 为了提高医疗服务质量、降低医疗成本,建立临床路径知识库平台,为临床提供决策服务。方法 围绕临床路径知识库的构建,主要解决三个问题：临床规则库的建立、临床路径自适应及修复模型和HIS数据整合框架。结果 构建支持复杂疾病的临床路径知识库,并实现共享平台。结论 通过建立支持复杂疾病的临床知识库平台,为患者提供准确的医疗服务,为医院提供临床路径决策支持,具有良好的应用效果。     

北京市某三甲医院31天内非计划性再入院研究

目的 了解北京市某三甲综合性医院住院患者出院31天内非计划再入院的现状及其影响因素。方法 对北京市某三甲综合性医院2008年1月1日—12月31日之间出院后31天内非计划性再入院的患者进行描述性分析，通过t 检验和χ²检验进行单因素分析，选择有统计学意义的危险因素用向后逐步回归法进行非条件Logistic分析。结果 患者性别、患者年龄、出院—再入院的间隔天数、前次入院时入院状况和前次入院疾病是否治愈是31天内非计划性再入院的主要影响因素。结论 患者特征和医院相关因素均与患者出院31天内非计划性再入院相关。     

End Stage Renal Disease Predicts Increased Risk of Death in First Degree Relatives in the Norwegian Population

BackgroundIncreased risk of end stage renal disease (ESRD) and death in Norwegian living kidney donors has been reported, most of the donors were related to the recipient. The present study investigates risk of death in first degree relatives of ESRD patients.MethodsThe Norwegian Population Registry, The Norwegian Cause of Death Registry and the Norwegian Renal Registry were linked. All citizens born in Norway, alive in 1960 and with at least one registered first degree relative were included; individuals who died during the first year of life were excluded. A cohort-design was used, ESRD in a first degree relative was the main exposure variable and death and causes of death were the main outcome variables. Cox regression statistics were used to investigate mortality risks.Results5 130 600 individuals were included, 27 508 had at least one first degree relative with ESRD. 828 022 died during follow-up, of whom 4105 had a first degree relative with ESRD. Adjusted hazard ratio (aHR) for death was 1.13 (1.09–1.16) in individuals with a relative with ESRD compared to those without a relative with ESRD. Excluding known hereditary renal disease, aHR decreased to 1.12 (1.09–1.15). Cardiovascular death aHR was 1.15 (1.10–1.21), of which cerebrovascular death 1.34 (1.22–1.50). aHR for death due to non-hereditary renal/ureteric disease was 2.29 (1.81–2.91) with renal failure 1.80 (1.26–2.56) and glomerular disease 5.69 (3.88–8.34) as main contributors. Diabetes mellitus death aHR was 1.68 (1.35–2.10). Absolute mortality risks increased most for the oldest cohorts with excess mortality of 148 per 100.000 person years for the cohort born 1920–39 and 218 for the cohort born 1900–1919.ConclusionsESRD in first degree relatives was associated with increased hazard ratio for death. Death due to cardiovascular disease, renal disease and diabetes mellitus increased the most.     

The Incidence of End-Stage Renal Disease in the Diabetic (Compared to the Non-Diabetic) Population: A Systematic Review

End-stage renal disease (ESRD) in diabetes is a life threatening complication resulting in a poor prognosis for patients as well as high medical costs. The aims of this systematic review were (1) to evaluate the incidence of ESRD due to all causes and due to diabetic nephropathy in the diabetic population and differences between incidences of ESRD with respect to sex, ethnicity, age and regions, (2) to compare incidence rates in the diabetic and non-diabetic population, and (3) to investigate time trends. The systematic review was conducted according to the PRISMA group guidelines by performing systematic literature searches in the biomedical databases until January 3^rd 2015; thirty-two studies were included. Among patients with incident type 1 diabetes the 30-year cumulative incidence ranged from 3.3% to 7.8%. Among patients with prevalent diabetes, incidence rates of ESRD due to all causes ranged from 132.0 to 167.0 per 100,000 person-years, whereas incidence rates of ESRD due to diabetic nephropathy varied from 38.4 to 804.0 per 100,000 person-years. The incidence of ESRD in the diabetic population was higher compared to the non-diabetic population, and relative risks varied from 6.2 in the white population to 62.0 among Native Americans. The results regarding time trends were inconsistent. The review conducted demonstrates the considerable variation of incidences of ESRD among the diabetic population. Consistent findings included an excess risk when comparing the diabetic to the non-diabetic population and ethnic differences. We recommend that newly designed studies should use standardized methods for the determination of ESRD and population at risk.     

血液透析和腹膜透析对终末期肾病患者预后的影响及其安全性比较

目的:分析和比较血液透析和腹膜透析终末期肾病患者预后的影响及其安全性。方法:选取2010年1月至2016年4月本医院收治的透析患者246例作为研究对象,将其分为血液透析组和腹膜透析组,比较两组患者治疗后的生存情况及并发症的发生情况。结果:两组患者死亡原因是心力衰竭、消化道出血、重度感染、脑梗死,两组的病死率及死因构成比较差异均无统计学意义(P0.05)。腹膜透析组患者1年、3年、5年生存率均显著高于血液透析组(P0.05),两组患者7年生存率比较差异无统计学意义(P0.05)。首次透析年龄超过60岁的终末期肾病患者中,腹膜透析组1年、3年、5年、7年生存率均显著低于血液透析组(P0.05)。血液透析组心力衰竭、动静脉内瘘闭塞发生率显著高于腹膜透析组(P0.05),腹膜透析组腹膜炎的发生率显著高于血液透析组(P0.05),血液透析组总并发症发生率明显高于腹膜透析组(P0.05)。结论:血液透析和腹膜透析各有优缺点,对终末期肾病患者应个体化选择透析方式,减少并发症,提高生活质量及生存率。     

Retinal Microvascular Abnormalities and Risk of Renal Failure in Asian Populations

BackgroundRetinal microvascular signs may provide insights into the structure and function of small vessels that are associated with renal disease. We examined the relationship of retinal microvascular signs with both prevalent and incident end-stage renal disease (ESRD) in a multi-ethnic Asian population.MethodsA total of 5763 subjects (aged ≥40 years) from two prospective population-based studies (the Singapore Malay Eye Study and the Singapore Prospective Study) were included for the current analysis. Retinopathy was graded using the modified Airlie House classification system. Retinal vascular parameters were measured using computer-assisted programs to quantify the retinal vessel widths (arteriolar and venular caliber) and retinal vascular network (fractal dimension). Data on ESRD was obtained by record linkage with the ESRD cases registered by National Registry of Diseases Office, Singapore. Multi-variable adjusted regression analyses were performed to assess the associations of baseline retinal vascular parameters and prevalent and incident ESRD.ResultsAt baseline, 21(0.36%) persons had prevalent ESRD. During a median follow-up of 4.3 years, 33 (0.57%) subjects developed ESRD. In our analyses, retinopathy was associated with prevalent ESRD (multi-variable adjusted odds ratio [OR], 3.21, 95% confidence interval [CI]: 1.28–8.05) and incident ESRD (multi-variable adjusted hazard ratio [HR], 2.51, 95%CI: 1.14–5.54). This association was largely seen in person with diabetes (HR, 2.60, 95%CI: 1.01–6.66) and not present in persons without diabetes (HR, 1.65, 95%CI: 0.14–18.98). Retinal arteriolar caliber, retinal venular caliber and retinal vascular fractal dimension were not associated with ESRD.ConclusionRetinopathy signs in persons with diabetes are related to an increased risk of ESRD; however, other microvascular changes in the retina are not associated with ESRD.     

Risk of end-stage renal disease associated with gout: a nationwide population study

Introduction

We explored the risk of end-stage renal disease (ESRD) among gout patients in a representative cohort in Taiwan.

Methods

The primary database used was the Taiwan National Health Insurance Research Database. Subjects older than 20 years without ESRD, coronary heart disease, or stroke were included in the study. The case definition of gout in the present study was gout diagnosis and medical treatment for gout. An ESRD case was defined by the presence of chronic renal failure necessitating long-term renal replacement therapy. Multivariate Cox proportional hazards models were used to evaluate the risk of ESRD among gout patients.

Results

The analysis included data of 656,108 patients who were followed up for a mean of 8.0 years. Among them, 19,963 (3.0%) patients had gout. At the end of 2008, 2,377 individuals (gout, n = 276; non-gout, n = 2,101) had ESRD, and 861 individuals (gout, n = 77, 27.9%; non-gout, n = 521, 24.8%) died due to ESRD. The rates of incidence of ESRD were 1.73 and 0.41 cases per 1,000 patient-years in the gout and non-gout groups. After adjustment for age, sex, and history of diabetes mellitus and/or hypertension, gout was associated with a hazard ratio (HR) of 1.57 for ESRD (95% confidence interval [CI], 1.38-1.79; P < 0.001). In patients with ESRD, the adjusted HR for death in patients with gout was 0.95 (0.74-1.23, P = 0.71), which was similar to the HR obtained in patients without gout.

Conclusions

Gout is associated with an increased hazard for development of ESRD.     

Relationship of income and childlessness

ABSTRACT

We investigated the impact of diabetes on US life expectancy by sex and race/ethnicity using a prospective cohort study design. Cohorts were drawn from 1997 to 2009 waves of the National Health Interview Survey and linked to death records through December 31, 2011. We combined data on the prevalence of diabetes among decedents with estimates of the hazard ratios of individuals diagnosed with diabetes to calculate population attributable fractions (PAFs) by age, sex, and race/ethnicity at ages 30 and above. These estimates were then applied to deaths in the official US life table for 2010 to estimate effects of diabetes on life expectancy.

Diabetes was responsible for a reduction of 0.83 years of life expectancy for men at age 30 and 0.89 years for 30-year-old women. The impact was greatest among Black women at 1.05 years. Estimates based on traditional demographic and actuarial methods using the frequency with which a disease appears as an underlying cause of death on death certificates produced a reduction in life expectancy at age 30 of only 0.33 years.

We conclude that diabetes is substantially reducing US longevity and that its effect is seriously underestimated when using data on underlying causes of death.     

Renal Function Outcomes and Risk Factors for Risk Factors for Stage 3B Chronic Kidney Disease after Urinary Diversion in Patients with Muscle Invasive Bladder Cancer

ObjectivesTo assess the effects of urinary diversion on renal function, we retrospectively investigated renal function over 5 years after urinary diversion using a propensity score matching strategy.MethodsBetween May 1996 and November 2013, 345 consecutive adult patients underwent radical cystectomy and urinary diversion in our hospital; one hundred and fifteen patients with more than a 5-year follow-up were enrolled. Propensity scores were calculated using logistic analysis, and the data used in the analyses included age, gender, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), clinical tumor stage, presence of cardiovascular disease; hypertension; and type 2 diabetes and preoperative eGFR at the initial visit. Multivariate logistic regression analysis was used to assess the risk factors for stage 3B chronic kidney disease (CKD) after the different types of urinary diversion.ResultsContinent and incontinent diversion were performed in 68 and 47 patients, respectively. The mean preoperative eGFR was significantly lower in the incontinent than in the continent group (P < 0.001). In propensity score-matched patients (n = 34 each), no significant differences were observed in pre- and postoperative eGFR and 5-year eGFR decrease rates between the groups. In the incontinent group, the number of postoperative stage 3B CKD patients was significantly increased than the continent group. Using multivariate analysis, independent risk factors significantly associated with stage 3B CKD at 5 years after surgery were older age, eGFR before surgery, incontinent diversion (cutaneous ureterostomy), and postoperative hydronephrosis.ConclusionsThe types of urinary diversion had no significant impact on renal function decline, whereas older age, preexisting impaired renal function, postoperative hydronephrosis, and cutaneous ureterostomy were independent risk factors for stage 3B CKD at 5 years after radical cystectomy.     

Uncoupling Protein 2 Expression Modulates Obesity in Chronic Kidney Disease Patients

Background:Obesity is a multifactorial metabolic disease resulting from behavioral and genetic factors. Obesity is linked to diabetes mellitus and hypertension, which are considered as major risk factors for chronic kidney disease (CKD); moreover, it has a direct effect on developing CKD and end stage renal disease (ESRD). Here was aimed to examine the association between uncoupling protein 2 (UCP2) gene expression and obesity in CKD patients. Methods:UCP2 gene expression was analyzed by real time polymerase chain reaction (RT-PCR) in 93 participants divided into three groups. The groups included 31 non-obese CKD patients, 31 obese CKD patients, and 31 healthy, age-matched, unrelated volunteers as a control group. Results:UCP2 gene expression was significantly relevant when comparing the non-obese CKD and obese CKD groups to the control group (p< 0.001). No significant association was found when the groups were compared by gender; Chi-square (X2) was 2.38 and p= 0.304. A significant negative correlation was found between UCP2 gene expression and BMI in CKD (p< 0.05).Conclusion:These results indicate that UCP2 gene expression plays a significant role as a risk factor for obesity in CKD patients. Key Words: Chronic Kidney Disease (CKD), Obesity, Uncoupling Protein 2 (UCP2) Gene Expression, Real-Time Polymerase Chain Reaction (RT-PCR)     

Hemodynamics and Function of Resistance Arteries in Healthy Persons and End Stage Renal Disease Patients

Introduction

Cardiovascular disease is the leading cause of death in patients with end stage renal disease (ESRD). The vasodilator mechanisms in small resistance arteries are in earlier studies shown to be reduced in patients with end stage renal disease. We studied whether endothelium dependent vasodilatation were diminished in ESRD patients and the interaction between the macro- and microcirculation.

Methods

Eleven patients with ESRD had prior to renal transplant or insertion of peritoneal dialysis catheter measured pulse wave velocity. During surgery, a subcutaneous fat biopsy was extracted. Resistance arteries were then dissected and mounted on a wire myograph for measurements of dilator response to increasing concentrations of acetylcholine after preconstriction with noradrenaline. Twelve healthy kidney donors served as controls.

Results

Systolic blood pressure was elevated in patients compared to the healthy controls; no difference in the concentration of asymmetric dimethyl arginine was seen. No significant difference in the endothelium dependent vasodilatation between patients and controls was found. Correlation of small artery properties showed an inverse relationship between diastolic blood pressure and nitric oxide dependent vasodilatation in controls. Pulse pressure was positively correlated to the total endothelial vasodilatation in patients. A negative association between S-phosphate and endothelial derived hyperpolarisation-like vasodilatation was seen in resistance arteries from controls.

Conclusion

This study finds similar vasodilator properties in kidney patients and controls. However, correlations of pulse pressure and diastolic blood pressure with resistance artery function indicate compensating measures in the microcirculation during end stage renal disease.     

Primary kidney growth and its consequences at the onset of diabetes mellitus

Summary. Diabetes mellitus is a primary contributor to progressive kidney dysfunction leading to end-stage renal disease (ESRD). In the early phase of diabetes, prior to the onset of further complications, both kidney size and glomerular filtration rate (GFR) increase. Glomerular hyperfiltration is considered a risk factor for downstream complications and progression to ESRD. Abnormalities in vascular control have been purported to account for the glomerular hyperfiltration in early diabetes. In this review we discuss a tubulo-centric concept in which tubular growth and subsequent hyper-reabsorption contribute to the onset of glomerular hyperfiltration that demarks the early stage of diabetes. Kidney growth, in this concept, is no longer relegated to a compensatory response to hyperfiltration, but rather plays a primary and active role in its genesis and progression. As such, components of kidney growth, such as the polyamines, may provide a means of early detection of diabetic kidney dysfunction and more effective therapeutic intervention.