Phase II cancer clinical trials with a one-sample log-rank test and its corrections based on the Edgeworth expansion

The response rate has been frequently used as the primary endpoint of phase II cancer clinical trials. It may not be an appropriate endpoint when a new treatment is not expected to produce any tumour shrinkage. When a large database for a historical control is available, the direct comparison of survival curves between a new treatment and the historical control may be made in phase II cancer clinical trials. In this paper, a one-sample log-rank test is introduced for the design and analysis of phase II cancer clinical trials with time-to-event endpoints. Corrections to the one-sample log-rank test are also derived based on the Edgeworth expansion. Simulations showed that the original one-sample log-rank test may be preferred if strictly controlling for type I error is important or when the sample size of a phase II trial is as large as 50, and a corrected one-sample log-rank test is used if the sample size of a phase II trial is small. A data set from a clinical trial conducted by the NCIC Clinical Trials Group is used to illustrate the proposed procedures.     

四川大学教职工1691名健康体检结果分析

目的：了解高校教职工的常见病症并采取相应的防治措施。 方法：于2003年对四川大学1691名教职工进行健康体检，项目包括：内科、外科、妇科、五官科、眼科、心电图、胸透、B超（消化系统和泌尿生殖系统）、血生化（血糖、血脂，肾功、肝功）、乙肝标志物。对不同性别、不同年龄段常见病症检出率进行统计和比较。 结果：1691名全部进入结果分析。①检出率较高的病症依次为高脂血症（21．94％）、脂肪肝（13．48％）、前列腺增生（12．94％）、心电图异常（10．41％）、高血压（7．09％）、胆囊结石（5．62％）、高血糖（4．49％）、肾功能异常（4．19％）、乙型肝炎（3．61％）。②≥45岁组高脂血症、脂肪肝、前列腺增生、心电图异常、高血压、胆囊结石、高血糖和肾功能异常检出率高于〈45岁组（P〈0．05）；两年龄组乙型肝炎检出率差异无显著性（P〉0．05）。③胆囊结石检出率女性高于男性（P〈0．05），高脂血症、脂肪肝、心电图异常、高血压、肾功能异常和乙型肝炎检出率男性高于女性（P〈0．05）；不同性别高血糖检出率差异无显著性（P〉0．05）。 结论：高校教职工患病种类较多，常见病症检出率较高，应采取有效措施予以防治。     

组织工程皮肤修复皮肤缺损成功率与手术方法的相关性

背景：皮肤缺损的常规修复方法多采用自体皮肤移植，需要健康供皮区且会遗留不同程度的瘢痕畸形。组织工程皮肤的成功构建并应用于临床，标志着皮肤缺损治疗的重大突破。目的：通过组织工程皮肤修复皮肤缺损，分析手术方法与愈合率的关系，为组织工程皮肤的临床应用提供实验依据。设计：随机对照观察。单位：解放军第四军医大学口腔医学院口腔颌面外科，组织病理学教研室，组织工程实验中心。材料：实验于2003-10／2004-03在解放军第四军医大学口腔医学院口腔组织工程实验中心完成。选用2．5-3月龄健康清洁级约克猪6只，随机分为3组：组织工程全层组、组织工程真皮＋自体表皮组、自体移植组，2只／组。每只猪制作8个直径50mm的圆形皮肤缺损创面，16个创面／组，共48个创面。方法：①制备组织工程全层皮肤和组织工程真皮。②组织工程全层组：沿画线自脂肪层切除全厚皮肤，彻底止血，以湿生理盐水纱布覆盖创面备用，此时取出组织工程全层皮肤并于组织工程皮肤上均匀打引流孔以利引流，用生理盐水冲去组织工程皮肤表面的培养液，使表皮层向上平铺于创面上，注意与创面间不能产生气泡。其上分别覆盖单层油纱布，生理盐水纱布、无菌干纱布、弹性海绵垫，每层厚度约为3～5mm，常规打包包扎，最后再以弹性绷带加压包扎。③组织工程真皮＋自体表皮组：以同样方法切除全厚皮肤，将取下的皮肤用取皮鼓反取厚约0．1～0．2mm的刃厚表皮泡于生理盐水中备用。以同样方法取出处理组织工程真皮后覆盖于创面上，即刻覆盖自体刃厚表皮。其余处理同组织工程全层组。④自体移植组：切除全厚皮肤并去除脂肪组织后，回植于自体创面，覆盖各层敷料，加压包扎。⑤每次换药打开创面时，移植皮肤无感染、坏死、脱落且直径不小于3mm即为成活，否则即为失败。于术后4周统计各组创面成活率。主要观察指标：术后4周各组移植皮肤成活情况。结果：术后4周时，组织工程全层组移植皮肤成活率75％，组织工程真皮＋自体表皮组移植皮肤成活率87％，自体移植组移植皮肤成活率94％，3组比较基本相似（χ^2=2．34，P〉0．05）。结论：组织工程皮肤移植修复皮肤缺损的效果与自体表皮移植接近，证明组织工程皮肤修复皮肤缺损是可行的。     

Increased plasma/serum levels of prolactin in systemic lupus erythematosus: a systematic review and meta-analysis

Background: Prolactin (PRL), a polypeptide hormone produced by the pituitary gland, is involved in the regulation of humoral and cell mediated immune responses. PRL levels have been investigated in several autoimmune diseases including systemic lupus erythematosus (SLE), however, yielded different and inconsistent results. This study aims to derive a more precise evaluation on plasma/serum PRL levels in SLE patients, as well as the potential influential factors.

Methods: Studies published from 1 January 1987 to 31 December 2015 in English, which comparing plasma/serum PRL levels between SLE group and control group were searched in PubMed, EMBASE and The Cochrane Library databases. Pooled standard mean difference (SMD) with 95% confidence interval (CI) was calculated by fixed-effects or random-effect model analysis. Heterogeneity test was performed by the Q statistic and quantified using I², publication bias was evaluated using a funnel plot and Egger’s linear regression test.

Results: Five-hundred and forty-seven articles were obtained after searching databases, and 12 studies with 429 SLE patients and 326 controls were finally included. Meta-analysis revealed that, compared with the control group, the SLE group had significantly higher plasma/serum PRL levels (P < 0.001), with the SMD of 1.26 and 95%CI (0.70,1.82). Subgroup analyses showed that SLE patients from Asia and Europe had higher plasma/serum PRL levels. However, no significant change in plasma/serum PRL levels was observed in SLE patients from America (P > 0.05).

Conclusions: Overall, our study suggests that SLE patients have higher plasma/serum PRL level, but with a regional difference.     

经膀胱^125Ⅰ粒子植入联合雄激素阻断治疗中晚期前列腺癌

目的 观察经膀胱径路前列腺内植入^125Ⅰ粒子联合全雄激素阻断治疗中晚期前列腺癌的临床疗效。方法 对21例C期及D期的前列腺癌患者，经膀胱前列腺内植入^125Ⅰ粒子，同时行膀胱造瘘、双侧睾丸切除，并口服氟他胺等治疗。结果随访6～38个月（平均18．6个月），除一例死亡外，其余20例全部存活，术后6月，PSA0．1～2．4ng／ml，平均1．4ng／ml，前列腺体积平均缩小24．7％。术后9个月时，C期前列腺癌PSA正常，2例D期PSA复又升高。术后12个月，除3例D期患者PSA明显升高外，其余C期患者PSA〈4ng／ml。术后无直肠溃疡、穿孔等并发症，术后21例中有7例拔除造瘘管，自行排尿。结论放射性^125I粒子植入联合全雄激素阻断治疗可发挥两者优势，并发症少，是治疗C期前列癌的有效方法之一。     

The efficacy of probucol combined with hydration in preventing contrast-induced nephropathy in patients with coronary heart disease undergoing percutaneous coronary intervention: a multicenter,prospective, randomized controlled study

Purpose

To investigate the preventive effect of probucol combined with hydration on contrast-induced nephropathy (CIN) in patients with coronary heart disease undergoing percutaneous coronary intervention (PCI).

Methods

A total of 641 patients undergoing PCI were randomly assigned to either a probucol group (probucol 500 mg twice daily and hydration; n = 321) or a control group (hydration only; n = 320). The primary endpoint was the incidence of CIN, defined as an increase in serum creatinine (Scr) by ≥ 44.2 μmol/L or ≥ 25% within 72 h after the administration of contrast agent. Secondary endpoints were changes in Scr, cystatin-C (Cys-C), creatinine clearance rate (Ccr), C-reactive protein (CRP), superoxide dismutase (SOD), and glutathione (GSH) within 72 h, and major adverse events during hospitalization or the 14-day follow-up period.

Results

The incidence of CIN was 4.0% (13/321) in the probucol group and 10.9% (35/320) in the control group. The probucol group had lower Cys-C and higher Ccr at 48 and 72 h after PCI compared with the control group. At 48 and 72 h following the operation, Cys-C and CRP were lower in the probucol group compared with the control group, but Ccr, SOD, and GSH were higher. There were no differences in the incidence of major adverse events during hospitalization or the 14-day follow-up between the groups. Multivariate logistic regression analysis showed that probucol was an independent protective factor for CIN.

Conclusions

Probucol combined with hydration more effectively decreased the incidence of CIN in patients with coronary heart disease undergoing PCI compared with hydration alone.

     

Clinicopathological study of male and female patients with lupus nephritis: a retrospective study

Purpose

The aim of this study was to assess the impact of sex on long-term outcomes in patients with lupus nephritis (LN).

Methods

Data of patients were collected at a single tertiary hospital from June 2010 to June 2016. Clinicopathological features and treatment responses of LN patients with different genders were compared. The primary endpoint was serum creatinine level doubled, GFR < 15 mL/min, initiation of renal replacement treatment or death. The secondary endpoint was complete remission or partial remission.

Results

In total, 101 male patients and 579 females were included. The follow-up time was 49.7 ± 15.2 months. In clinical data, photosensitivity and mouth ulcers were more common in the female patients, while males had more serositis and vasculitis. In laboratory data, males had higher values of blood pressure, hemoglobin, urine protein, serum creatinine and a lower level of serum albumin. Activity index and endocapillary hypercellularity scores in the male group were significantly increased. No sex disparity was identified across secondary endpoints in all cases, despite a lower ratio of CR in males. As for the long-term survival, no statistic difference between the two groups was observed. In a further multivariate Cox hazard analysis, male gender was not identified as an independent risk factor for poor outcomes.

Conclusion

Despite a greater disease activity and more severe organ damage in males with LN, we did not observe any significant gender disparity in long-term survival. Large multicenter collaborative efforts are necessary.

     

Abilities and barriers to practicing evidence-based nursing for burn specialist nurses

Objective

To explore the abilities and barriers of practicing evidence-based nursing (EBN) for burn specialist nurses so as to provide rationales for its clinical training and practice.