药物临床试验伦理审查质量风险的管理研究

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。     

Management and outcome of burn injuries during pregnancy: A systematic review and presentation of a comprehensive guideline

Pregnant women are a vulnerable subgroup of burn patients, due to altered physiological state and possible adverse effect on the fetus. The aim of this study was to develop a guideline for a tailored treatment of pregnant patients with burns to optimally treat both mother and fetus. This study consists of two parts: the first part contains a systematic review that presents a comprehensive overview of the literature on the management and outcome of pregnant women who sustain severe burn injuries and based on the results of this review, a guideline on the general, obstetric and burn management was developed and presented in the second part. A total of 35 studies including 1395 patients were included. Although the clinical outcomes seemed to be similar to non-pregnant patients, one study showed that mortality might be higher in the pregnant population. Predictive factors for maternal and fetal mortality were a total burned surface area of over 40% and inhalation injury. Early surgery may lead to a higher chance of survival of mother and fetus. A comprehensive guideline on the general management of pregnant patients with burns, obstetric management and specific burn management is provided. We encourage international burn organizations and guideline committees to use and evaluate the presented guideline.     

The motor and the non-motor outcomes of Nordic Walking in Parkinson's disease: A systematic review

BackgroundThe current study investigated the motor and the non-motor outcomes of Nordic Walking (NW) in Parkinson's disease (PD) using a systematic review of studies with any design.MethodsThe search of PubMed, PsycInfo, Medline and SCOPUS until November 2018 identified k = 13 relevant studies: five randomised controlled-trials (RCTs) and eight observational studies. Study designs, intervention, patient and outcome details were coded. Study quality was assessed with the Physiotherapy Evidence Database scale.ResultsAll studies reported either benefits or no effects of NW in 318 patients at the early stages of PD with low to moderate severity. NW was well accepted and relatively safe. Symptom severity, walking speed and gait pattern consistently improved after 4 – 24 weeks of NW relative to baseline or any control condition during the ON-phases of pharmacotherapy. The NW benefits were less consistent during the OFF-phases and at the follow-up in the absence of regular training.ConclusionsNW may contribute to the maintenance of the overall mobility in addition to pharmacotherapy. Since the quality of studies was poor to moderate, future single-blind RCTs should investigate the clinical relevance of the NW outcomes and the training parameters necessary to optimise the benefits of NW in PD.     

The effect of cocoa consumption on markers of oxidative stress: A systematic review and meta-analysis of interventional studies

A number of studies have examined the beneficial effects of cocoa consumption on markers of oxidative stress in different population, however, the findings have been inconclusive. Herein, we systematically reviewed available interventional studies to elucidate the overall impact of cocoa consumption on markers of oxidative stress among adult population. PubMed, Cochrane's library, Science Direct, Scopus, Google scholar and ISI web of science databases were searched for all available literature until March 2019 for relevant studies. The Jadad scale was used to assess the quality of each study. A total of 48 studies out of 1402 met the inclusion criteria and were included in our systematic review and 16 of them were entered in meta-analysis. The pooled estimate from the random-effect model showed cocoa consumption significantly reduced malondialdehyde (SMD: -0.71; 95 % CI, -1.41 to -0.01; P = 0.048) and 8-iso-prostaglandin F2α (WMD: -43.76; 95 % CI, -76.25 to -11.28; P = 0.008) but not the other markers of oxidative stress. Our findings support the concept that cocoa consumption plays an important role in the human metabolic pathway through reducing the oxidative stress. In order to draw a firm link between cocoa and oxidative stress, more clinical trials with adequate sample size and sufficient follow-up periods are warranted.     

中医治疗脑出血的研究进展

脑出血是指非外伤性脑实质内血管破裂引起的出血,具有高致死率和高致残率的特点。目前,西方医学对脑出血的治疗手段比较单一,多采用脱水降颅压、脑保护等对症治疗。而中医注重整体观和辨证法,对脑出血的治疗有独特的优势。近年来研究表明中医治疗脑出血可促进血肿的吸收,抑制水肿的形成,保护脑神经,改善患者的预后。目前,临床上常用的治法有活血化瘀法、平肝熄风法、活血利水法、通腑法、添精补髓法,对上述疗法做一综述。     

牛黄降压片联合硝苯地平治疗原发性高血压的临床研究

目的探讨牛黄降压片联合硝苯地平缓释片治疗原发性高血压的临床疗效。方法选取2019年3月—2019年6月在成都市第七人民医院治疗的原发性高血压患者86例,根据用药差别分为对照组(43例)和治疗组(43例)。对照组口服硝苯地平缓释片,20 mg/次,2次/d;治疗组在对照组基础上口服牛黄降压片,2 g/次,1次/d。两组患者均经4周治疗。观察两组患者临床疗效,同时比较治疗前后两组患者血压变化,SPIEGEL、SAS、SDS和GQOL-74评分,及血清同型半胱氨酸(Hcy)、血管性血友病因子(vWF)、可溶性细胞间黏附分子-1(sICAM-1)、可溶性凝集素样氧化低密度脂蛋白受体1(sLOX-1)、血管紧张素Ⅱ(AngⅡ)水平。结果治疗后,对照组和治疗组临床有效率分别为81.40%和97.67%,两组比较差异具有统计学意义(P0.05)。经治疗,两组收缩压(SBP)、舒张压(DBP)均显著下降(P0.05),且治疗组患者血压水平明显好于对照组患者(P0.05)。经治疗,两组患者SPIEGEL评分、SAS评分和SDS评分明显降低(P0.05),但是GQOL-74评分明显升高(P0.05),且治疗组患者这些评分明显好于对照组(P0.05)。经治疗,两组血清Hcy、vWF、 ICAM-1、sLOX-1、AngⅡ水平均明显降低(P0.05),且治疗组明显低于对照组(P0.05)。结论牛黄降压片联合硝苯地平缓释片治疗原发性高血压可有效控制血压水平,改善患者负面情绪、睡眠及生活质量,具有一定的临床推广应用价值。     

Proteomics as a reliable approach for discovery of blood-based Alzheimer’s disease biomarkers: A systematic review and meta-analysis

In order to gauge the impact of proteomics in discovery of Alzheimer’s disease (AD) blood-based biomarkers, this study had systematically reviewed articles published between 1984−2019. Articles that fulfilled the inclusion criteria were assessed for risk of bias. A meta-analysis was performed for replicable candidate biomarkers (CB). Of the 1651 articles that were identified, 17 case-control and two cohort studies, as well as three combined case-control and longitudinal designs were shortlisted. A total of 207 AD and mild cognitive impairment (MCI) CB were discovered, with 48 reported in >2 studies. This review highlights six CB, namely alpha-2-macroglobulin (α2M)_ps, pancreatic polypeptide (PP)_ps, apolipoprotein A-1 (ApoA-1)_ps, afamin_p, insulin growth factor binding protein-2 (IGFBP-2)_ps and fibrinogen-γ-chain_p, all of which exhibited consistent pattern of regulation in >three independent cohorts. They are involved in AD pathogenesis via amyloid-beta (Aβ), neurofibrillary tangles, diabetes and cardiovascular diseases (CVD). Meta-analysis indicated that ApoA-1_ps was significantly downregulated in AD (SMD = −1.52, 95% CI: −1.89, −1.16, p < 0.00001), with low inter-study heterogeneity (I² = 0%, p = 0.59). α2M_ps was significantly upregulated in AD (SMD = 0.83, 95% CI: 0.05, 1.62, p = 0.04), with moderate inter-study heterogeneity (I² = 41%, p = 0.19). Both CB are involved in Aβ formation. These findings provide important insights into blood-based AD biomarkers discovery via proteomics.