Design of clinical trials for chronic diseases: implications for periodontal disease

In order to make effective use of the statistical theory of design of clinical trials for chronic diseases such as periodontal disease, certain issues must be considered. Any clinical trial requires that the disease definition be well-specified; that patient eligibility be explicit; that the observation times be explicit; that the duration and endpoint of therapy be specified; that the duration of subsequent followup observation be specified; and that the unit of observation (e.g., tooth, set of teeth, patient) be defined. In a chronic disease, the potential biases that can readily be introduced by self-selection of patients who enter the trial and/or who return for subsequent observation become more important, because subjects are required to remain on treatment and/or observation for prolonged periods. Further, the cyclical nature of some chronic diseases may require special attention to baseline definitions of active disease and disease outcome. These issues are illustrated with examples from clinical trials of hypertension, breast cancer screening, and Polycythemia Vera. Implications for periodontal disease are discussed.     

家庭干预在精神分裂症患者社会功能障碍康复中的效果分析

目的分析精神分裂症患者社会功能障碍的现状并探讨家庭干预对其康复效果的影响。方法分析我院门诊收治的128例精神分裂症患者入院治疗前的社会功能状况;患者出院后,将患者随机分为家庭干预组和对照组各64例;对照组给予常规精神病药物维持治疗,干预组在此基础上给予家庭干预治疗1年,并采用社会功能缺陷量表（SDSS）及康复状态量表（MRSS）评估患者的治疗效果;并观察患者的服药依从性及病情复发情况。结果 120（93.7%）例的患者存在明显的社会功能障碍,集中表现在职业及工作、计划性及责任心、对外界的关心及兴趣方面;家庭干预前两组间SDSS、MRSS评分并无显著差异（P〉0.05）,干预后干预组此两项得分均低于对照组（P〈0.05）;同时干预组的服药依从性、复发率情况均优于对照组（P〈0.05）。结论精神分裂症患者大都存在较为严重的社会功能障碍,家庭干预可以显著提高患者生活质量,改善社会功能,降低复发率。     

简易神经查体在基层医院糖尿病性周围神经病变筛查中的应用价值

目的探讨简易神经查体在基层医院糖尿病性周围神经病变(diabetic peripheral neuropathy,DPN)筛查中的应用价值。方法选取500例2型糖尿病患者,所有患者均进行简易神经查体,观察DPN的发生情况,以神经电生理检查结果为标准,比较简易神经查体与踝反射、针刺痛觉、温度觉、振动觉、压力觉诊断DNP的灵敏度、特异度、准确度差异。将确诊DPN患者随机分为观察组与对照组,两组患者均严格控制血糖,观察组在严格控制血糖的基础上加用甲钴胺治疗,疗程3个月,观察两组治疗前后神经电生理指标的差异。结果简易神经查体诊断DPN的灵敏度、特异度、准确度明显高于踝反射、针刺痛觉、温度觉、振动觉、压力觉各项检查的诊断(P0.05或0.01)。两组治疗前正中神经、腓总神经及胫神经MCV、SCV比较无统计学差异(P0.05),对照组治疗后正中神经、腓总神经及胫神经MCV、SCV与治疗前比较无明显变化(P0.05),观察组治疗后正中神经、腓总神经及胫神经MCV、SCV与治疗前比较明显改善(P0.05)。结论采用简易神经查体诊断DPN诊断准确性高,是一种筛查DPN的简单、有效的检查方法,适合在基层医院推广使用,早期药物干预治疗能改善DPN患者的预后。     

The Basis of Racial Differences in the Incidence of Thyroid Cancer

Background The incidence of thyroid cancer in black Americans is half that in white Americans. It is unknown whether this gap represents a population difference in disease or is attributable to inferior cancer screening in the black population. Methods A population-based cohort study of 53,990 patients (1973–2003) was performed using the National Cancer Institute’s Surveillance Epidemiology End Results database. Socioeconomic variables were explored using the Healthcare Cost and Utilization Project database and macroeconomic data. Results Since 1973, thyroid cancer incidence among whites has increased 150.2% (4.0 to 9.9 of 100,000), while incidence among blacks has increased 73.2% (3.0 to 5.1 of 100,000). Across 17 regions, the incidence correlated with the percentage of the population with health insurance (r = 0.56, P = .02). Regression analysis suggested that half of the black-white incidence gap might be attributable to differences in health insurance status. Patients with thyroid cancer were more likely to be insured or reside in wealthier ZIP codes. Black patients were more likely to present at advanced age (RR 1.08, P < .0001) and with tumors >4 cm in size (RR 1.13, P <.0001). Black patients were slightly less likely to present with advanced disease (RR 0.96, P = .0008). Cancer-specific mortality was identical in the two populations. Discussion Sociodemographic data and differences at presentation support a small detection disparity in thyroid cancer, which may contribute to part of the incidence gap. However, this effect is not sufficiently strong to fully explain the incidence gap. A population difference in the incidence of disease may be coexistent.     

Urinary markers in screening patients with hematuria

Hematuria is a common presenting symptom of urothelial malignancy. Although conventional urine analysis is very sensitive in detecting the presence of hematuria, it is not specific in detecting bladder cancer or other urinary-tract cancers. The noninvasive urinary tests NMP22 and UroVysion have been approved by the U.S. Food and Drug Administration for bladder cancer screening. These tests have better sensitivity than cytology for detecting bladder cancer in patients who present with hematuria. The positive predictive values of both tests increase in individuals with hematuria who have risk factors for bladder cancer. Evaluating hematuria with sensitive markers, such as NMP22 and UroVysion, in high-risk populations offers an opportunity to develop effective strategies for bladder cancer screening.