Intravenous thrombolysis for acute ischemic stroke with extended time window

Background:Intravenous thrombolysis (IVT) is an effective way for treating acute ischemic stroke (AIS). However, its effects have not been established among AIS patients with unclear stroke symptoms or with stroke onset for >4.5 h.Methods:We searched PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials and Google Scholar databases for randomized controlled trials that compared IVT (IVT group) and placebo or usual care (control group [CG]) in AIS patients with disease onset for >4.5 h. The outcomes of interest included the favorable functional outcome (defined as modified Rankin Scale [mRS] scores 0–1) at 90 days, the functional independence (defined as mRS scores 0–2) at 90 days, proportion of patients with symptomatic intracerebral hemorrhage (sICH) and death at 90 days. We assessed the risk of bias using the Cochrane tool. Pre-specified subgroup analyses were performed by age (≤70 years or >70 years), National Institute of Health Stroke Scale (NIHSS, ≤10 or >10) and time window (4.5–9.0 h or >9.0 h).Results:Four trials involving 848 patients were eligible. The risk of bias of included trials was low. Patients in the IVT group were more likely to achieve favorable functional outcomes (45.8% vs. 36.7%; OR 1.48, 95% CI 1.12–1.96) and functional independence (63.8% vs. 55.7%; OR 1.43, 95% CI 1.08–1.90) at 90 days, but had higher risk of sICH (3.0% vs. 0.5%; OR 5.28, 95% CI 1.35–20.68) at 90 days than those in the CG. No significant difference in death at 90 days was found between the two groups (7.0% vs. 4.1%; OR 1.80; 95% CI 0.97–3.34).Conclusions:Use of IVT in patients with extended time window may improve their functional outcomes at 90 days, although IVT may induce increased risk of sICH. Care of these patients should well balance the potential benefits and harms of IVT.     

Electroacupuncture for Reflex Sympathetic Dystrophy after Stroke: A Meta-Analysis

Background: Reflex sympathetic dystrophy (RSD) is the common complication among stroke and cerebral injury patients, which is lack of safe and effective treatment. Electroacupuncture (EA) may potentially be a reliably therapy, but the evidence is insufficiency. Methods: Cochrane Library, MEDLINE, Embase, Chinese National Knowledge Infrastructure, Wan Fang Data, the Chinese Biology Medicine disc, etc., were searched, until July 20, 2018. We included random control trials that contrast EA with conventional rehabilitation therapy for the treatment of RSD. Main outcomes were visual analog scale score and Fugl-Meyer upper limb motor function scoring scale, other outcomes such as Barthel index, and hand swelling score were also collected. Data in included studies were extracted into an excel and pooled by Stata/MP 14.1. Results: We incorporated 13 studies involving 1040 RSD patients and outcomes were from 2 to 6 weeks' follow-up. The analgesic effect between 2 groups had statistically significant difference (weighted mean difference [WMD] = ?1.122, 95% confidence interval [CI] [?1.682 to ?.562], P?=?.000], a statistical difference existed in improving dysfunction between 2 groups: (WMD?=?6.039, 95% CI [2.231?.916], P?=?.000). EA groups had a better effect on improving activities of daily life abilities (WMD?=?12.170, 95% CI [6.657?17.682], P < .00011] and better detumescence effect (WMD = ?.800, 95% CI [?1.972 to ?.212], P = .000] contrast to conventional rehabilitation therapy. Conclusions: This meta-analysis supports that EA has a positive effect on alleviating pain, improving limb dysfunction, and promoting activities of daily living. On account of moderate-quality random control trials and high heterogeneity, further high-quality studies are imperative to optimize the EA treatment program.     

基于真实世界数据的高风险植入类无源医疗器械上市后风险监测技术专家共识

高风险植入类无源医疗器械的上市后监测是医疗器械风险管理的重要环节,通过对高风险医疗器械上市后安全性信号的监测和评价,最大限度地控制医疗器械潜在的风险,保证医疗器械安全、有效地使用,避免发生群体性严重后果,是医疗器械生产、经营、使用机构和技术监测部门的共同职责.为了更好地促进和辅助高风险植入类无源医疗器械的上市后监测,本...     

国内针刺临床试验缺失数据的报告情况及其对研究结论的影响

目的总结国内针刺临床试验数据缺失报告情况,并初步探讨缺失数据经二次分析后对原始结论的影响。方法检索中国知网自2006年1月至2015年12月中文发表的针刺随机对照试验(RCT)文献,筛查后计算缺失数据报告率及数据缺失率,分析数据缺失的原因及意向性分析使用情况;对纳入研究中有缺失数据的两臂分类变量结局指标研究进行意向性分析(ITT),比较分析结果与原文结论的一致性。结果纳入3008篇针刺RCT文献,其中1184篇(39.4%)研究报告了数据缺失情况。2007年数据缺失情况报告率有所下降,但2006—2015年间报告率总体呈上升趋势。3008篇RCT报告中343篇(11.4%)报告了数据缺失原因。对1184篇报告数据缺失情况的研究分析显示,321篇(27.1%)试验报告无缺失数据,余863篇存在数据缺失,数据缺失率≥20%、≥10%且<20%、<10%的报告分别为28篇(2.4%)、209篇(17.6%)、626篇(52.9%)。3008篇纳入报告中仅有63篇(2.1%)提及了ITT分析,且只有30篇(1.0%)报告了ITT分析结果。对358篇报告了分类结局变量的两臂试验数据进行了二次分析,其中108篇(30.2%)研究与原始结论不一致;92篇(85.2%)可能存在假阳性结果,16篇(14.8%)可能存在假阴性结果。结论国内针刺临床研究者对缺失数据的报告及其对研究结果产生的影响的重视程度较低,未采用合理方法处理缺失数据可能会造成假阴性或假阳性的结论。     

Moxibustion is an Alternative in Treating Knee Osteoarthritis: The Evidence From Systematic Review and Meta-Analysis

Knee osteoarthritis (KOA) is a common disorder in elderly. There is no known cure for KOA, and thus therapeutic strategies of alleviating symptoms are increasingly emphasized. Moxibustion has been widely used to treat KOA; however, results are inconclusive. The aim of our study is to critically reassess the effects of moxibustion on KOA.We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Chinese Biomedical Literature database (CBM) through 25 November 2015. Two independent reviewers selected studies and abstracted information, as well as assessed the risk of bias using Cochrane risk of bias tool. The random-effects meta-analyses were performed based on abstracted data.We initially captured 163 citations and added 4 records through checking review. After critical appraisal, 13 RCTs were included. Meta-analyses indicated that moxibustion is not statistically different from oral drug in improving the response rate (MD = 1.09; 95% CI = 1.00, 1.20; P = 0.05), alleviating pain and improving physical function. Our meta-analysis also found that moxibustion is superior to usual care and sham moxibustion in reducing WOMAC score (MD = 7.56; 95% CI = 4.11, 11.00; P = 0.00), pain and function, as well as increasing QoL. Moreover, most AEs caused by moxibustion can heal without medical care.We concluded that moxibustion treatment is equal to the oral drugs and intra-articular injections and may be an alternative in treating patients with KOA.     

Thread embedding acupuncture for herniated intervertebral disc of the lumbar spine: A multicenter,randomized, patient-assessor-blinded,controlled, parallel,clinical trial

Backgroundand purpose: Although several studies have reported that thread embedding acupuncture (TEA) is effective for lumbar herniated intervertebral disc (LHIVD), the evidence remains limited because previous studies had a high risk of bias. This study aimed to investigate the efficacy and safety of TEA for LHIVD through a rigorously designed trial.Materials and methodsThis was a randomized, patient-assessor-blinded, sham-controlled trial. Participants were screened according to eligibility criteria, and 70 patients with LHIVD were randomly allocated to the TEA and sham TEA (STEA) groups in a 1:1 ratio. Both groups received TEA or STEA treatment at 23 acupoints once per week for eight weeks. Changes in low back pain, radiating pain, Oswestry disability index, Roland–Morris disability questionnaire, EuroQol 5–Dimensions 5–Levels, and global perceived effect were measured at baseline and at 4, 8, 12, and 16 weeks after screening and compared between the two groups.ResultsTEA showed no significant difference in all outcomes compared to STEA immediately after eight weeks of treatment. After an additional eight weeks of follow-up, TEA showed a more significant effect on the low back pain than STEA (p < 0.05) and showed a better tendency in maintaining or enhancing the improvement of radiating pain, function, and quality of life even after the end of treatment. No serious adverse events were observed.ConclusionTEA is effective in improving low back pain in patients with LHIVD and may help improve function and quality of life, especially in the long term.     

Effects of dry needling plus exercise therapy on post-stroke spasticity and motor function: A case report

Background and purposeThe use of dry needling (DN) with other treatments may be more beneficial in managing post-stroke spasticity. We report the effects of DN plus exercise therapy (ET) on wrist flexor spasticity.Patient presentationThe patient was a 45-year-old man with an 8-year history of stroke. The outcome measures included the Modified Modified Ashworth Scale (MMAS), H_max/M_max ratio, H-reflex latency, Action Research Arm Test (ARAT), Fugl-Meyer Assessment (FMA), and range of motion (ROM) which were assessed before (T1), after (T2), and after 3-week follow-up (T3).ConclusionThe MMAS was improved at T2 from “3” to “2”. The H_max/M_max decreased from 0.77 to 0.53 at T3. The H-reflex latency increased from 15.4 ms to 18.5 ms at T3. The wrist active and passive ROM increased ∼30° and ∼20° at T2, respectively.A 4-session DN plus ET may improve spasticity and ROM. No meaningful improvement was observed in function.     

运用多准则决策分析法的中药临床综合评价文献特征分析及设计要点

目的 分析运用多准则决策分析法(MCDA)进行中药临床综合评价研究的文献特征和方法学现状,为今后研究者设计和实施中药MCDA研究提供建议.方法 计算机检索PubMed、The Cochrane Library、EMbase、SinoMed及中国知网(CNKI)、维普数据库(CQVIP)、万方数据库,获取自各数据库建库至...     

成都市乡镇卫生院/社区卫生服务中心负责人或业务骨干对09版国家基本药物认知与培训需求调查

目的了解成都市乡镇卫生院/社区卫生服务中心负责人或业务骨干对国家基本药物的认识和态度,以及对基本药物培训的需求和建议,为在成都市进一步推广应用基本药物目录（EML）提供必要的基线信息。方法根据现代认知心理学原理和方法,设计问卷并进行面对面调查。调查数据采用EpiData 3.1双录入并两次核对录入结果,用EXCEL软件进行统计分析,统计指标采用构成比。结果共发放调查问卷300份,回收有效问卷257份,有效回收率85.7%,调查对象分属200家乡镇卫生院、95家社区卫生服务中心,分别覆盖成都市84%的乡镇卫生院和76%的社区卫生服务中心。①257名被调查者对基本药物的概念、EML使用范围、EML与基本医保药物目录关系的回答正确率分别为89%、91%和87%;②46%（117）的被调查者处方时＂总是首先考虑使用基本药物＂,81名被调查者（31%）＂在多数情况下考虑使用基本药物＂;③103名被调查者（41%）对EML表示＂较欢迎＂;④被调查者认为乡镇卫生院/社区卫生服务中心实施EML所面临的问题依次为＂收入与补偿＂、＂医生对基本药物认知与处方习惯＂、＂患者对基本药物认知与用药偏好＂,＂基本药物的安全性、有效性＂,＂基本药物目录的适用性＂,＂采购与配送＂;⑤获知基本药物信息的主要途径依次为文件（187人次,19.6%）、会议（177人次,18.6%）、学术讲座（146人次,15.3%）;⑥154名被调查者（占60%）参加过1次或2次EML的培训或学习;⑦196名被调查者（77%）累计接受培训或学习EML的时间少于1周;⑧被调查者对培训的需求与建议依次为增加培训对象（71人次,42%）、增加培训时间（38人次,22%）、增强培训内容的实用性与具体性（27人次,16%）、培训形式多样化（18人次,11%）、希望经调查后进行针对具体问题的＂按需培训＂（15人次,9%）。结论亟待加强乡镇卫生院/社区卫生服务中心医务工作者的基本药物目录理念及使用培训,开展对EML适用性及使用绩效评价、财政补助、医务人员收入、采购与报销等问题的研究。     

四川省公立医院药房经营管理现状调查之四——运营管理与文化建设

目的 了解四川省公立医院药房运营管理和文化建设现状,为提高公立医院药房管理水平提供证据与建议。 方法 依据运营管理和文化建设的理论和研究方法,设计调查问卷,调查74 家公立医院药房的管理者及骨干306 人对公立医院药房运营管理水平和文化建设的认识。采用率和构成比进行统计学描述。 结果 ① 超过70% 的被调查者认为员工的服务意识和质量意识一般;约70% 的被调查者认为相互间配合较好、职责较明确。②近60% 的被调查者认为公立医院药房员工的效率成本意识一般。③ 近50% 的被调查者认为存在不能及时获得信息及沟通不充分现象。④ 约50% 的被调查者认为服务流程不合理,需要优化。⑤ 60% 的被调查者认为文化建设对科室发展有一定作用;超过70% 的被调查者认为现有管理制度较健全,但偶尔有违反制度现象。 结论 公立医院药房运营管理有待完善,科室文化尚未发挥应有的作用。