Utilities of the P‐value Distribution Associated with Effect Size in Clinical Trials

The P‐value, which is widely used for assessing statistical evidence in randomized comparative clinical trials, is a function of the observed effect size of the experimental treatment relative to the control treatment. The relationship of the P‐value with the observed effect size at study completion and the effect size anticipated at the design stage has potential usefulness in providing guidance for planning and interpretation of a clinical trial. The post‐trial power associated with a statistically significant P‐value from a completed study is also a random variable and its use may assist in planning a follow‐up trial to confirm the statistically significant findings in an initial study. A measure of robustness is explored to quantify the degree of sensitivity of the observed P‐value to potential bias that may be contained in the observed effect size.     

血清OPN、HE4和CA125检测对卵巢癌的临床意义

目的：探讨联合检测血清OPN、HE4和CA125对卵巢癌的临床意义。方法：选择2010年6月-2012年7月西安市中心医院妇科及陕西省肿瘤医院妇瘤科收治的35例卵巢癌患者、73例卵巢良性肿瘤患者及40例同期体检的健康妇女为研究对象,应用ELISA法检测患者手术前后血清OPN、HE4水平,电化学发光法检测患者手术前后血清CA125水平,计算3种肿瘤标志物单项以及联合检测在卵巢癌诊断中的敏感性及特异性。结果：（1）卵巢癌患者术前血清OPN、HE4和CA125水平分别为94.6±61.06ng/mL、412.3±278.62 pmol/mL和398.64±220.91 U/mL,与卵巢良性肿瘤组及正常对照组比较差异有统计学意义（P〈0.05）;（2）卵巢癌患者手术前与术后1月血清OPN、HE4和CA125水平比较,差异均有统计学意义（P〈0.05）;（3）血清OPN、HE4和CA125水平联合检测诊断卵巢癌的敏感性（94.3%）显著高于血清OPN、HE4和CA125单项指标检测（分别为37.1%、71.4%和77.1%）,联合检测与单项指标检测比较差异均有统计学意义（P〈0.05）,而血清OPN、HE4和CA125联合检测诊断卵巢癌的特异性（78.8%）稍低于血清OPN、HE4和CA125单项指标检测（分别为87.6%、100%和80.5%）,联合检测与单项指标检测的特异性比较差异无统计学意义（P〉0.05）。血清HE4单项指标检测的特异性高达100%。结论：联合检测卵巢癌患者血清OPN、HE4和CA125水平可作为诊断和评估卵巢癌预后的参考指标。     

数字化表达谱差异分析方法-DGE-P

目的：目前,关于数字化表达谱差异分析的方法及软件极少,且需懂得R语言等,操作繁琐,这给数字表达谱分析带来了不少困难,DGE-P软件针对数字化表达谱开发的差异分析软件。方法：DGE-P软件,利用倍数分析及数字化基因表达谱差异基因检测方法,对通过本软件标准化后的数据进行差异显著性分析。结果：DGE-P软件包含了丰度统计、数据标准化、求倍数分析和p-value值三个模块。可得出倍数分析与数字化基因表达谱差异基因检测方法（p-value）两个值。结论：DGE-P较以前的差异分析软件相比是一款针对数字化表达谱分析的软件,克服了其他软件在无重复实验数据时无法避免误差的缺陷。并且DGE-P较其他的软件相比使用方便,可在windows系统下运行,操作简单。     

Omega-3 fatty acids in neurodegenerative diseases: Focus on mitochondria

Mitochondrial dysfunction represents a common early pathological event in brain aging and in neurodegenerative diseases, e.g., in Alzheimer’s (AD), Parkinson’s (PD), and Huntington’s disease (HD), as well as in ischemic stroke. In vivo and ex vivo experiments using animal models of aging and AD, PD, and HD mainly showed improvement of mitochondrial function after treatment with polyunsaturated fatty acids (PUFA) such as docosahexaenoic acid (DHA). Thereby, PUFA are particular beneficial in animals treated with mitochondria targeting toxins. However, DHA showed adverse effects in a transgenic PD mouse model and it is not clear if a diet high or low in PUFA might provide neuroprotective effects in PD. Post-treatment with PUFA revealed conflicting results in ischemic animal models, but intravenous administered DHA provided neuroprotective efficacy after acute occlusion of the middle cerebral artery. In summary, the majority of preclinical data indicate beneficial effects of n-3 PUFA in neurodegenerative diseases, whereas most controlled clinical trials did not meet the expectations. Because of the high half-life of DHA in the human brain clinical studies may have to be initiated much earlier and have to last much longer to be more efficacious.     

Epidemiology of Monoclonal Gammopathy of Undetermined Significance (MGUS): The experience from the specialized registry of hematologic malignancies of Basse-Normandie (France)

Multiple myeloma (MM) is the third most common haematologic malignancy in European countries, and is usually preceded by Monoclonal Gammopathy of Undetermined Significance (MGUS). Therefore epidemiologic studies of MGUS are very limited in a population-based status. Here we report all new cases of MGUS exhaustively recorded by the Basse-Normandie Regional Registry for Hematologic Malignancies (a French region registry) between January 1997 and December 2005, and analyze outcome of patients until 2009 in term of evolution in MM or death. All cases were analyzed by an expert file review, and MGUS diagnosis was retained for: evidence of a monoclonal component <30 g/l and no CRAB criteria (hyperCalcemia, renal insufficiency, anemia, bone lesions). We showed that the world standardized incidence rate (WSR) for MGUS was 3.76 ± 0.26 per 100,000 inhabitants, increasing regularly with age, and that the median overall survival (OS) was 115.9 months (CI 95%: 10.5–130.2 months) with 78.3% patients alive at 5 years (CI 95%: 74.1–81.9%). We also observed a rate of progression to multiple myeloma of 1.41% per year, concordant with previous reports in a reallife exhaustive registry.     

腹腔镜子宫肌瘤剔除术的临床应用分析

目的:探讨腹腔镜子宫肌瘤剔除术的临床效果及安全性。方法:回顾性分析在我院行腹腔镜子宫肌瘤剔除术的患者68例(实验组)及同期行腹式子宫肌瘤剔除术的患者58例(对照组)的临床资料,比较其临床表现、术中出血量、手术时间,术后最高体温、术后应用抗生素时间、住院时间。结果:实验组术中出血量、术后应用抗生素时间、住院平均时间均显著优于对照组(P0.05);手术时间较对照组长(P0.05);两组术后放置引流、术后最高体温比较无差异(P0.05)。多发、直径≥5 cm的肌瘤腹腔镜子宫肌瘤剔除术术中出血、手术时间较单发、直径5 cm的肌瘤(P0.05)显著增加(P0.05),肌瘤部位对术中出血及手术时间无影响(P0.05)。结论:腹腔镜子宫肌瘤剔除术术中出血量少,术后恢复快,术中出血及手术时间与肌瘤类型及大小有关,与肌瘤部位无关,是一种治疗子宫肌瘤安全、有效的术式。     

PBL教学模式在八年制《医学导论》教学中的应用

《医学导论》课对于八年制临床医学专业学员的学习非常重要,将PBL教学模式应用到《医学导论》教学中,从课程设计、问题筛选、团队精神培养等环节进行实施,有利于培养学员自主学习和解决实际问题的能力,圆满完成了《医学导论》的教学任务。     

PBL 教学模式在八年制《医学导论》教学中的应用

《医学导论》课对于八年制临床医学专业学员的学习非常重要,将PBL教学模式应用到《医学导论》教学中,从课程设计、问题筛选、团队精神培养等环节进行实施,有利于培养学员自主学习和解决实际问题的能力,圆满完成了《医学导论》的教学任务。     

Mixed-beam approach for high-risk prostate cancer: Carbon-ion boost followed by photon intensity-modulated radiotherapy. Dosimetric and geometric evaluations (AIRC IG-14300)

Background and purposeThe aim was to evaluate dosimetric uncertainties of a mixed beam approach for patients with high-risk prostate cancer (PCa). The treatment consists of a carbon ion radiotherapy (CIRT) boost followed by whole-pelvis intensity-modulated RT (IMRT).Materials and methodsPatients were treated with a CIRT boost of 16.6 Gy/4 fractions followed by whole-pelvis IMRT of 50 Gy/25 fractions, with consequent long term androgen deprivation therapy. Deformable computed tomography image registration (DIR) was performed and corresponding doses were used for plan sum. A comparative IMRT photon plan was obtained as whole-pelvis IMRT of 50 Gy/25 fractions followed by a boost of 28 Gy/14 fractions. DIR performances were evaluated through structure-related and image characteristics parameters.ResultsUntil now, five patients out of ten total enrolled ended the treatment. Dosimetric parameters were lower in CIRT + IMRT than IMRT-only plans for all organs at risk (OARs) except femoral heads.Regarding DIR evaluation, femoral heads were the less deformed OAR. Penile bulb, bladder and anal canal showed intermediate deformation. Rectum was the most deformed. DIR algorithms were patient (P)-dependent, as performances were the highest for P3 and P4, intermediate for P2 and P5, and the lowest for P1.ConclusionsCIRT allows better OARs sparing while increasing the efficacy due to the higher radio-biological effect of carbon ions. However, a mixed beam approach could introduce DIR problems in multi-centric treatments with different operative protocols. The development of this prospective trial will lead to more mature data concerning the clinical impact of implementing DIR procedures in dose accumulation applications for high-risk PCa treatments.     

2 152例门诊发热患者情况分析

目的 分析2152例门诊发热患者情况,探讨发热患者年龄分布;发热疾病的比率;呼吸道传染病对发热患者门诊就诊率的影响以及就诊前后用药情况。方法2152例患者为2003年5月～2004年5月在大连市开发区医院成人发热门诊就诊的全部发热患者,统计发热患者的平均年龄及性别差异;计算门诊初步诊断各疾病占总发热患者的百分率;计算发热患者占总门诊量的百分率;分析呼吸道传染病对发热患者门诊就诊率的影响;统计发热患者来院前的用药情况及门诊用药情况。结果 成人发热门诊患者,年龄15～90岁,平均年龄26．37岁;其中男性1150例女性1002例,各占总发热患者的53．44％、46．56oA;发热患者占同期医院总门诊量的0．82％,在“SARS”严重的2003年5、6月和禽流感流行的2004年1月发热患者分别占各月总门诊量的3．71％、2．51％、1．31％;发热患者中首诊为急性上呼吸道感染1379例,占总发热患者的64．03％,其中扁桃体炎397例,占急性上呼吸道感染的28．79％;其他发热患者首诊依次为急性胃肠炎157例,肺炎148例,支气管炎40例,肺结核20例,泌尿系感染8例,急性阑尾炎8例,妇科炎症5例,其他皮肤感染、疥、痛等明确原因的18例（其中流脑1例）,首诊未明确发热原因的18例。发热患者中WBC升高的348例,占总发热患者的16．17％;来院就诊前应用抗炎退热药者528例,占总发热患者的24．54％;在院静点抗菌药物者l052例,占总发热患者的48．88％,其中应用喹诺酮者529例,占总用药患者的50．28％,应用大环内脂类的511例（主要为阿奇霉素）,占总用药患者的48．57％,应用氨基糖苷类的8例,应用β-内酰胺类的4例;在用药者中,联合其他中成药或抗病毒药者122例,占总用药患者的11．59％。结论 成人门诊发热患者以青壮年为主,男性略多于女性;呼吸道传染病的流行大大增强了人们对发热的重视程度,到医院发热门诊就诊人数明显增多;在门诊就诊的发热患者中以急性上呼吸道感染为主,其他依次为急性胃肠炎、肺炎、支气管炎、肺结核等;门诊发热患者并非以细菌感染为主;患者就诊前、后不合理应用抗菌药物情况相当严重。