基于多中心的中国糖尿病足患者临床资料分析

目的：通过多中心横断面调查探讨现阶段糖尿病足患者的临床特征、危险因素和影响病情严重程度的因 素。方法：采用统一制定的糖尿病足患者临床资料收集表,于2017年10月至11月收集全国13家三级综合医院326例糖 尿病足患者(男205例,女121例)的临床资料,分析其临床特征,并采用logistic回归分析发生重型糖尿病足的影响因 素。结果：在326例糖尿病足患者中,68.4%的患者年龄>60岁,60.1%的患者文化程度为小学或初中;96.3%的糖尿病 足发生于2型糖尿病患者,80.1%的糖尿病足患者糖化血红蛋白A1c(glycated hemoglobin,HbA1c)≥7%,60.1%的患者血 脂代谢异常。鞋袜穿着不当(38.5%)为发生糖尿病足的主要诱因。其并发症以糖尿病神经病变(76.7%)、糖尿病视网 膜病变(62.3%)和下肢血管病变(57.4%)最为多见。Logistic回归分析显示：糖尿病肾病、糖尿病下肢血管病变、HbA1c 水平为发生重型糖尿病足的独立危险因素,接受足部护理教育为其保护因素。结论：糖尿病足多发于男性、年龄偏 大、文化程度低、血糖控制差、血脂异常的2型糖尿病患者。其发生常有诱因,并伴有糖尿病并发症。糖尿病肾病、 糖尿病下肢血管病变、HbA1c和接受足部护理教育为糖尿病足严重程度的独立影响因素。     

祛瘀解毒益气方治疗严重脓毒症多中心随机对照临床研究

目的：观察祛瘀解毒益气方治疗严重脓毒症的临床疗效。方法：将235例严重脓毒症患者随机分为治疗组（给予祛瘀解毒益气方加常规治疗）和对照组（仅给予常规治疗）,疗程2周;观察两组治疗前后急性生理学与慢性健康状况评价（APACHElI评分）、中医证候疗效和第28天病死率情况。结果：治疗后两组APACHElI评分均降低（P〈0．05）,且治疗组降低幅度大于对照组（P〈0．05）;治疗组中医证候疗效优于对照组（P〈0．05）;第28天病死率治疗组为23．07％,对照组为33．05％,治疗组明显低于对照组（P〈0．05）。结论：祛瘀解毒益气方可提高严重脓毒症的临床疗效、降低病死率。     

荣心丸治疗病毒性心肌炎(气阴两虚或兼心脉瘀阻证)的多中心临床研究

目的 观察荣心丸治疗病毒性心肌炎(气阴两虚或兼心脉瘀阻证)的有效性以及临床应用的安全性。方法 采用随机、双盲双模拟法进行试验。选择病毒性心肌炎(气阴两虚或兼心脉瘀阻证)患者160例,按3∶1比例分为试验组和对照组,试验组口服荣心丸每次9 g,对照组口服芪冬颐心颗粒每次5 g,均3次/d,疗程均28 d。观察治疗前后心肌炎症状积分和、心电图、超声心动图、心肌酶,以及中医证候疗效、疾病疗效的改善情况。结果 疗后28 d试验组、对照组的心肌炎症状积分和下降的均值分别为6.106、5.026,证候疗效的总有效率分别为92.04%、71.05%,疾病疗效的总有效率分别为92.04%、71.05%,试验组高于对照组,组间差异有统计学意义。研究者未报告临床不良事件与不良反应。结论 荣心丸治疗病毒性心肌炎(气阴两虚或兼心脉瘀阻证)疗效优于上市药物芪冬颐心颗粒,并且未提示更高临床应用风险。     

2001~2010年中国胰腺神经内分泌肿瘤的临床流行病学特征分析

[目的]分析中国2001～2010年胰腺神经内分泌肿瘤患者的流行病学特征.[方法]将中国大陆按传统的习惯分为七个区,每个大区选取至少一家肿瘤医院和综合医院.收集医院2001～2010年间所有经病理确诊为胰腺神经内分泌肿瘤的病例信息,摘录至病例信息收集表并进行统计分析.[结果]研究共纳入中国七个地理大区23家医院共633例胰腺神经内分泌肿瘤患者,平均年龄45.7±14.0岁,男性占41.2％.10年间病例数持续增加,且以低级别早期肿瘤的增加为主.功能性胰腺神经内分泌肿瘤占57.1％.其中,出现Whipple三联征的患者占46.8％.诊断时局限于胰腺内(70.0％)、G1/G2级(57.8％)的患者较多.临床上最常用的影像学检查手段为超声(78.2％)和CT(85.9％).手术是最主要的治疗方式,92.4％的患者接受了手术切除.[结论]中国胰腺神经内分泌肿瘤患者的诊断年龄较早,分期及分级较低,且10年间以低级别病变的检出增加为主.传统影像学手段对于肿瘤的检出率较高,手术治疗为主要的治疗方式.     

Institutional review board and regulatory solutions in The Dental PBRN

Objectives: Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network called "DPBRN" ( http://www.DPBRN.org ) comprises dentists in two health maintenance organizations, several universities, seven US states, and three Scandinavian countries. Our objectives are to describe: a) the various human participants and regulatory requirements and solutions for each of DPBRN's five regions; b) their impact on study protocols and implementation; and c) lessons learned from this process.
Methods: Following numerous discussions with IRB and grants administrative personnel for each region, some practitioner-investigators are attached to their respective IRBs and contracting entities via sub-contracts between their organizations and the network's administrative site. Others are attached via Individual Investigator Agreements and contractually obligated via Memoranda of Agreement.
Results: IRBs approve general operations under one approval, but specific research projects via separate approvals. Various formal IRB and grants administrative agreements have been arranged to customize research to the network context. In some instances, this occurred after feedback from patients and practitioners that lengthy written consent forms impeded research and raised suspicion, instead of decreasing it.
Conclusions: Instead of viewing IRBs and institutional administrators as potentially adversarial, customized solutions can be identified by engaging them in collegial discussions that identify common ground within regulatory bounds. Although time-intensive and complex, these solutions improve acceptability of practice-based research to patients, practitioners, and university researchers.     

输卵管注药绝育术有效性安全性五年随访研究

研究设计采用多中心随机化临床试验,1705例合格受术对象被随机分配使用两种粘堵剂,867例使用8％阿的平苯酚糊剂(PAP),838例使用显影苯酚胶浆(PM)。两组受术对象人口学特征、妇科检查结果和术时情况均衡可比。五年随访率分别为97.5％和98.1％。多终点递减率生命表法分析表明,两组间各顺序月的粗累积失败率经log-rank检验均有显著差异。第60个顺序月的粗累积失败率,PAP组为4.61％,PM组为11.87％。PAP的节育效果显著优于PM。97.7％受术对象做了宫颈刮片检查,均未查见可疑癌细胞或癌细胞。同时,也未发现与粘堵剂可能有关的潜在疾患。这可能由于注入每侧输卵管内的粘堵剂的剂量(0.08ml)甚微之故。五年随访结果进一步表明,该术是一种简便、安全、有效的女性绝育术。作者建议在进一步改进粘堵剂配制、规范手术操作和加强施术技术标准化管理的基础上适时地推广这项新技术。     

痹祺胶囊治疗腰椎间盘突出症多中心观察

[目的】探索痹祺胶囊的适用范围及用药规律。[方法】选择68例患者，单纯使用痹祺胶囊治疗，观察治疗前后症状、体征变化。[结果】67例患者临床症状、体征均有不同程度改善，总疗效临床治愈14例，显效34例，有效19例，无效1例，有效率为98．5％，愈显率为70．6％。[结论】痹祺胶囊治疗腰椎间盘突出症疗效突出稳定。     

Prospective multi-center study on expansion sphincter pharyngoplasty

Background and objective: The aim of this study was to demonstrate the long-term effectiveness of Expansion Sphincter Pharyngoplasty (ESP) as a standalone surgical treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS) patients through a prospective multi-center study.

Material and methods: A prospective non-comparative multicenter study of patients suffering from OSHAS selected after drug-induced sleep endoscopy, with ESP as standing alone procedure was performed. Inclusion criteria were lateral collapse on oropharynx and preoperative AHI between 5 and 70. Minimum follow-up was >12 months. Outcome measures were Epworth sleepiness scale (ESS), AHI, success rate and CPAP need after surgery.

Results: A total of 75 ESP were performed. Mean patient age was 46.7?±?10.5 years. Mean pre-operative and post-operative AHI was 22.1?±?12.2 and 8.6?±?6.7, respectively (p?<?.001). Mean pre-operative and post-operative ESS score was 11.5?±?4.7 and 4.6?±?6.6, respectively (p?<?.001). AHI <5 was obtained in 25 patients (33.3%), and CPAP was not further needed after surgery in a total of 62 patients (82.6%).

Conclusions and significance: In this prospective multi-center study, patients undergoing ESP standing alone for the treatment of OSAHS have a reasonable expectation for success with minimal morbidity.     

儿童恶性实体瘤诊断与治疗现状

国际儿童实体瘤多中心协作研究、多学科协同工作模式对儿童实体瘤预后进步有重要影响,以青少年/儿童恶性生殖细胞瘤、长春花碱对儿童间变大细胞淋巴瘤预后影响、骨肉瘤随机分组研究维持治疗的有效性多中心临床研究结果为例进行探讨。对放疗、造血干细胞移植、靶向治疗等在儿童实体瘤儿童肿瘤综合治疗中地位作用进行介绍。同时讨论了我国儿童实体瘤诊治现状和加以改善的期望。     

General design issues in efficacy, equivalency and superiority trials

Critical discussion is offered of design issues pertinent to three categories of clinical trials: efficacy trials, in which an experimental intervention is compared to an inert control, and equivalency and superiority trials, in which an experimental intervention is compared to an active control. The issues discussed are sample-size determination and power, problems in designing and analyzing multicenter trials, broad versus concentrated sampling of patients, the need (or not) for a placebo control group in an active control trial, the possible appropriateness of crossing patients over from one regimen to another, various methods of randomization, the intention-to-treat principle in repeated measurements studies, and possible logical conflicts between inferences from superiority trials and inferences from equivalency trials.