中药注射剂治疗心律失常的系统评价再评价

目的：对中药注射剂治疗心律失常的Meta分析或系统评价进行再评价。方法：计算机检索PubMed、EMbase、the Cochrane Library、知网、万方、维普、CBMdisc等中英文数据库,检索中药注射剂治疗心律失常的系统评价,时间为建库至2019年6月。2位评价者独立进行文献筛选以及资料提取工作,应用AMSTAR2量表以及GRADE评估工具进行评价。结果：最终纳入7篇Meta分析或系统评价,包含25个结局指标,涉及4种中药注射剂。AMSTAR2量表评价结果中"是否提供前期设计方案"、"是否提供排除文献清单"、"纳入标准中是否考虑发表文献,如灰色文献"、"是否说明相关利益冲突"4项为导致方法学质量降低的主要因素。GRADE评估工具的评价结局中,纳入系统评价的局限性以及发表偏倚为引起结局指标证据质量降低的原因。对纳入文献再进行Meta分析显示,中药注射剂治疗心律失常,可提高治疗总有效率[Z=10.99,RR=1.45,95% CI （1.36,1.55）,P<0.01]、血管再通率[Z=2.29,OR=1.34,95% CI （1.04,1.72）,P=0.02],改善心率[Z=21.52,MD=4.80,95% CI （10.12,12.15）,P<0.01],降低心律失常发生率[Z=4.38,RR=0.53,95% CI （0.40,0.70）,P<0.01]、病死率[Z=5.94,RR=0.49,95% CI （0.39,0.62）,P<0.01]。结论：中药注射剂在治疗心律失常中发挥重要作用,但现今关于中药注射剂治疗心律失常的Meta分析或系统评价的评价方法尚不规范,证据质量偏低,对此次评价结论可靠性产生了影响。     

中医药治疗抗肿瘤分子靶向药物相关腹泻的Meta分析

[目的] 系统评价中医药治疗抗肿瘤分子靶向药物(以下简称靶向药物)相关腹泻的有效性和安全性,为临床治疗提供循证依据。 [方法] 检索中国期刊全文数据库(China National Knowledge Infrastructure,CNKI)、万方数据平台(Wanfang Data)、中国科技期刊数据库(China Science and Technology Journal Database,VIP)、中国生物医学文献服务系统(China Biomedical Literature Database,SinoMed)、PubMed、Cochrane Library、Web of Science等数据库,获取中医药治疗靶向药物相关腹泻的随机对照试验(randomized controlled trial,RCT)。使用Cochrane风险偏倚评估工具对研究进行质量评价,使用Stata 15.0和TSA 0.9软件进行Meta分析和试验序贯分析,依据推荐等级的评估、制定与评价(Grading of Recommendations Assessment,Development and Evaluation,GRADE)标准进行证据质量评价。[结果] 最终纳入9项研究,共484例患者。Meta分析显示,在常规西药治疗的基础上加用或单用中医药,可以明显提高治疗的总有效率[相对危险度(relative risk,RR)=1.347,95%可信区间(confidence interval,CI)(1.212,1.497),P=0.000],降低腹泻症状积分[RR=1.527,95%CI(1.287,1.812),P=0.000]与分级[RR=1.218,95%CI(1.064,1.393),P=0.004],改善患者生活质量(Karnofsky physical status,KPS)评分[RR=1.116,95%CI(1.039,1.198),P=0.003],并能改善腹痛[标准化均数差(standardized mean difference,SMD)=-1.050,95%CI(-2.016,-0.083),P=0.033]、腹胀[SMD=-0.942,95%CI(-1.865,-0.018),P=0.046]、食欲不振[SMD=-1.534,95%CI(-2.682,-0.385),P=0.009]等症状,且未增加不良反应。试验序贯分析进一步说明,中医药治疗靶向药物相关腹泻具有确切疗效。但根据GRADE标准,提高有效率的证据为低质量,改善生活质量及降低中医症状积分为极低质量。[结论] 中医药能提高靶向药物相关腹泻的临床疗效,且安全性良好。但由于样本量小及文献质量低,相关证据有赖于更多高质量的临床试验。     

Canadian Association of Gastroenterology policy on the application for,and implementation of,clinical practice guidelines

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association’s governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include:

• Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research;
• Improving patient care provided by members by providing focus on quality and evidence;
• Creating legislative environments that favour effective clinical practice;
• Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and
• Identifying areas that require further information or research to improve clinical care.

The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.     

Guidelines should not recommend the type of decision-making for the medical encounter

Clinical practice guidelines (CPGs) often include a recommendation regarding how to approach a clinical encounter and which decision-making model should be used. The GRADE framework, a popular method for developing CPGs, suggests a paternalistic model when recommendations are “strong” and shared decision making (SDM) when recommendations are “weak”. Tying the model of decision making and patient participation to the strength of a recommendation is not justified theoretically and/or empirically in the GRADE literature. Thus, why a CPG should offer any advice on which model to use in the clinical encounter is not clear. We argue that including such instruction is not justified and potentially violates the bioethical norms of autonomy and respect for individual choice and may even violate the clinician’s legal obligation. Rather, the model to be used is better determined by the participants in the individual encounter during the encounter and not the panel developing the CPG.     

Evidence for single-limb exercises on exercise capacity,quality of life,and dyspnea in patients with chronic obstructive pulmonary disease or chronic heart failure

Abstract

Background: Although single-limb exercise (SLE) has been used for patients with chronic obstructive pulmonary disease (COPD) and for patients with chronic heart failure (CHF), the evidence for SLE has not been evaluated systematically and remains unclear.

Objectives: Determine the evidence for the effect of SLE compared to any comparator on outcome measurements for exercise capacity, quality of life (QoL) or dyspnea in patients with COPD or CHF.

Methods: PubMed, PEDro, and CENTRAL databases were searched from inception until 31 May 2011. Searches started 1 April 2011. English language randomized controlled trials (RCTs) were included. Extraction of data was performed by two review authors. Data and evidence for SLE were summarized in accordance with grading of recommendations assessment, development and evaluation (GRADE) guidelines. Authors of included studies were contacted for missing data.

Results: Six RCTs (two COPD and four CHF) were included. Low to very low-quality evidence indicates that SLE significantly improved exercise capacity, but not dyspnea, in patients with COPD, and significantly improved exercise capacity outcomes compared to a control in patients with CHF. However, when SLE was compared to non-SLE regimes in patients with CHF, positive effects were found irrespective of training regime regarding exercise capacity and QoL.

Conclusions: SLE appears to be effective in both conditions especially regarding exercise capacity, and might be included in exercise programs in patients with COPD or CHF. However, the evidence is low to very low according to GRADE and more clinical studies of high quality are required.     

Morphometric analyses of endometriotic tissues to determine their grade of activity

The last revised classification of endometriosis of the American Fertility Society takes the extension of endometriotic lesions and the three macroscopic appearances of this disease into consideration. The aim of this study was to determine whether morphometric analyses are able to describe the grade of activity of endometriotic lesions according to their macroscopic-morphological appearances. Endometriotic samples of 45 patients were analyzed morphometrically using a semiautomatical planimeter. Six different parameters were investigated: the cytoplasmic surface of epithelial cells, the nucleus surface of epithelial cells, the nucleus surface of stromal cells, the gland surface, the gland circumference and the gland diameter. No statistically significant differences (p > 0.05) between the macroscopic appearances of the endometriotic lesions and the six analyzed morphometric parameters were found. The majority of the endometriotic lesions showed median values for the cytoplasmic surface of epithelial cells, the nucleus surface of epithelial cells and the gland surface that did not differ from the median values of all tissues, independently of the macroscopic appearances of these lesions and of the corresponding serum hormonal levels of 17β-estradiol and progesterone that were measured at the time of biopsy (p > 0.05). Our morphometric data showed that the red and so-called 'active' endometriotic lesions did not exhibit different morphometric characteristics from the so-called 'inactive' black or white lesions. We found that white and black lesions showed in some cases higher morphometric values than the mean values, so that these macroscopic appearances of endometriotic lesions cannot be considered as 'burned-out' endometriotic tissues. Therefore, black or white endometriotic lesions also have to be considered as therapeutically relevant, as they cannot be defined as 'inactive' endometriosis.     

注射用益气复脉(冻干)治疗心力衰竭有效性及安全性的系统评价和试验序贯分析

目的系统评价注射用益气复脉(冻干)联合常规西药治疗心力衰竭的有效性及安全性。方法检索Pub Med数据库、维普数据库、中国知网、万方数据库等数据库自建库以来至2020年4月收录的关于注射用益气复脉(冻干)联合常规西药治疗心力衰竭的临床随机对照试验,根据纳入及排除标准筛选文献,使用Rev Man5.3软件进行Meta分析,TSA 0.9.5.10 Beta软件进行试验序贯分析,GRADE3.6进行GRADE证据质量评价。共纳入33项随机对照试验,合计2977例。结果注射用益气复脉(冻干)联合常规西药在改善左室射血分数(MD=4.32,95%CI[0.92,7.72],P=0.01)、B型钠尿肽(MD=-228.29,95%CI[-361.74,-94.84],P=0.0008)、N末端B型利钠肽原(MD=-360.92,95%CI[-491.04,-230.80],P<0.00001)、临床心功能疗效(RR=1.21,95%CI[1.16,1.25],P<0.00001)、E/A比值(MD=0.13,95%CI[0.07,0.18],P<0.00001)、心输出量(MD=0.30,95%CI[0.19,0.42],P<0.00001)、左心室舒张末期内径(MD=-3.08,95%CI[-5.43,-0.74],P=0.01)、6 min步行距离测试(MD=47.80,95%CI[35.92,59.67],P<0.00001)方面的疗效优于单纯西药组,亚组分析结果显示疗程大于等于14天的试验组在改善左室射血分数方面效果更好,不良反应差异无统计学意义(P=0.80),表明注射用益气复脉(冻干)联合常规西药的不良反应发生率与对照组无明显差别,均未出现肝肾功的损伤,试验序贯分析显示临床疗效累积纳入的研究穿过了传统界值和TSA界值,进一步肯定了其临床疗效。GRADE评价显示证据级别多为低级或极低级。结论临床应用注射用益气复脉(冻干)联合常规西药治疗心力衰竭的疗效明确并且具有一定的安全性,推荐临床应用。