随机对照试验

顺机对照试验
  • 文章类型: Clinical Trial Protocol
    背景:在中国,精神卫生服务目前无法满足有长期悲伤障碍(PGD)症状的丧亲者的需求。基于互联网的悲伤干预可能有助于填补这一空白,但此类项目尚未在中国开发或评估。拟议的研究旨在调查有效性,可接受性,以及一项名为“治愈悲伤”的在线自助干预计划的可行性,并探索潜在改善的心理机制。方法:我们设计了一项双臂随机对照试验。至少有128名参与者将被随机分配到基于Internet的干预组或等待列表控制组。基于互联网的干预将基于双重过程模型进行开发,整合心理教育技术,行为激活,认知重估,意味着重建,并将通过表达性写作传递。干预包括六个模块,每个模块中有两个会话,并要求参与者每周完成两次会议,并在6周内完成干预。主要结果包括有效性,可接受性,和可行性。有效性将通过长期悲伤的措施来评估,创伤后应激,焦虑,和抑郁症状。可接受性和可行性将通过对用户体验特征的调查和访谈来评估。次要结果包括主持人和调解人,如双重过程应对,哀思,正念,和持续的债券,探讨潜在改善的心理机制。评估将在干预前进行,干预后,和3个月的随访。结论:拟议的研究将确定有效性,可接受性,以及新开发的在线自助干预措施对长期悲伤的丧亲中国人的可行性,并阐明干预措施如何帮助症状改善。这种干预可能在缓解中国丧亲心理服务的提供和接收之间的不平衡方面发挥重要作用。
    在中国,失去亲人的人无法广泛获得精神卫生服务。这项拟议的研究将是第一个开发和评估基于互联网的自助悲伤干预措施的研究,该措施适用于长期悲伤的丧亲中国人。拟议的研究将确定干预措施是否以及如何帮助改善长期悲伤的丧亲中国人的心理健康。
    Background: In China, mental health services do not currently meet the needs of bereaved people with symptoms of prolonged grief disorder (PGD). Internet-based grief interventions may help fill this gap, but such programmes have not yet been developed or evaluated in China. The proposed study aims to investigate the effectiveness, acceptability, and feasibility of an online self-help intervention programme named Healing Grief for bereaved Chinese with prolonged grief, and to explore the psychological mechanisms of potential improvements.Methods: We designed a two-arm randomised controlled trial. At least 128 participants will be randomly assigned to either an Internet-based intervention group or a waitlist-control group. The Internet-based intervention will be developed based on the dual process model, integrating techniques of psychoeducation, behavioural activation, cognitive reappraisal, and meaning reconstruction, and will be delivered via expressive writing. The intervention comprises six modules, with two sessions in each module, and requires participants to complete two sessions per week and complete the intervention in 6 weeks. The primary outcomes include effectiveness, acceptability, and feasibility. The effectiveness will be assessed by measures of prolonged grief, posttraumatic stress, anxiety, and depressive symptoms. Acceptability and feasibility will be evaluated using survey and interview on user experience characteristics. Secondary outcomes include moderators and mediators, such as dual process coping, grief rumination, mindfulness, and continuing bond, to explore the psychological mechanisms of potential improvement. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.Conclusion: The proposed study will determine the effectiveness, acceptability, and feasibility of the newly developed online self-help intervention for bereaved Chinese with prolonged grief and clarify how the intervention helps with symptom improvements. Such an intervention may play an important role in easing the imbalance between the delivery and receipt of bereavement psychological services in China.
    In China, mental health services are not widely available for bereaved people.The proposed study will be the first one to develop and evaluate an Internet-based self-help grief intervention for bereaved Chinese with prolonged grief.The proposed study will determine whether and how the intervention helps to improve the mental health of bereaved Chinese with prolonged grief.
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  • 文章类型: Meta-Analysis
    简介:补硒对多囊卵巢综合征的疗效难以捉摸。本Meta分析旨在探讨补硒治疗多囊卵巢综合征的疗效。方法:PubMed,EMBase,WebofScience,EBSCO,Cochrane图书馆数据库,CNKI,重庆VIP数据库和万方数据库已在2022年7月进行了搜索,我们纳入了随机对照试验(RCT),报告了补硒与安慰剂对多囊卵巢综合征患者的影响。结果:5个RCT纳入meta分析。与安慰剂组相比,对于多囊卵巢综合征,硒补充与总睾酮(SMD=-0.42;95%CI=-0.78至-0.06;p=0.02)和胆固醇(SMD=-0.71;95%CI=-1.41至-0.02;p=0.04)显着降低相关,但对SHBG没有显着影响(SMD=-0.52;95%CI=-1.29至0.25;p=0.19),甘油三酯(SMD=-1.45;95%CI=-3.62至0.73;p=0.19),LDL(SMD=-0.17;95%CI=-0.72至0.37;p=0.53),FPG(SMD=-0.95;95%CI=-3.72至1.82;p=0.50)或HOMA-IR(SMD=-0.51;95%CI=-3.79至2.77;p=0.76)。结论:补硒可改善多囊卵巢综合征患者的代谢反应。这一发现应谨慎解释。
    Introduction: The efficacy of selenium supplementation was elusive for polycystic ovary syndrome. This meta-analysis aimed to explore the efficacy of selenium supplementation for polycystic ovary syndrome. Methods: PubMed, EMbase, Web of science, EBSCO, Cochrane library database, CNKI, Chongqing VIP database and Wanfang databases have been searched through July 2022 and we included randomized controlled trials (RCTs) reporting the effect of selenium supplementation versus placebo in patients with polycystic ovary syndrome. Results: Five RCTs were included in the meta-analysis. Compared with placebo group for polycystic ovary syndrome, selenium supplementation was associated with significantly reduced total testosterone (SMD=-0.42; 95% CI=-0.78 to -0.06; p = 0.02) and cholesterol (SMD=-0.71; 95% CI=-1.41 to -0.02; p = 0.04), but revealed no remarkable influence on SHBG (SMD=-0.52; 95% CI=-1.29 to 0.25; p = 0.19), triglyceride (SMD=-1.45; 95% CI=-3.62 to 0.73; p = 0.19), LDL (SMD=-0.17; 95% CI=-0.72 to 0.37; p = 0.53), FPG (SMD=-0.95; 95% CI=-3.72 to 1.82; p = 0.50) or HOMA-IR (SMD=-0.51; 95% CI=-3.79 to 2.77; p = 0.76). Conclusions: Selenium supplementation may be able to improve the metabolic response for polycystic ovary syndrome, and this finding should be interpreted with caution.
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  • 文章类型: Journal Article
    BACKGROUND: Jinlida granules are a commonly prescribed oral medication in China used in combination with antidiabetic drugs to lower blood glucose. The aim of this study was to systematically identify and pool the findings of randomized controlled trials evaluating the effectiveness and safety of Jinlida granules as add-on therapy for glycemic control in type 2 diabetes (T2D).
    METHODS: The China National Knowledge Infrastructure (CNKI), Wang Fang, PubMed, China biology medicine (CBM), and VIP Database for Chinese Technical Periodicals (VIP) databases were searched for papers regarding the effects of Jinlida granules in T2D published before 1 July 2018. A pooled analysis of extracted data was performed using random-effects models.
    RESULTS: In all, data were retrieved for 15 studies including 1810 individuals. Decreases in HbA1c were greater in groups receiving Jinlida granules as add-on therapy compared with control groups (n = 1820; mean difference - 0.66; 95% confidence interval - 0.72, -0.60; P < 0.00001; I2  = 38%). In addition, Jinlida granules reduced body mass index and had beneficial effects on homeostatic model assessment of β-cell function and homeostasis model assessment of insulin resistance. No obvious adverse events were reported.
    CONCLUSIONS: Findings from this meta-analysis demonstrate additional benefits of Jinlida granules as an add-on therapy for T2D and that Jinlida granules are generally safe. Treatment with Jinlida granules provided clinically and statistically significant reductions in fasting plasma glucose, 2-hour post-load glucose, and HbA1c levels in patients with T2D. However, the findings should be interpreted with caution due to the small sample size and study limitations.
    背景: 津力达颗粒是我国常用的口服中成药,常与降糖药联合应用以降低血糖。本研究旨在系统评价津力达颗粒作为叠加疗法联合降糖药物治疗2型糖尿病的有效性和安全性。 方法: 检索2018年7月1日前发表的关于津力达颗粒干预2型糖尿病随机对照试验的论文,使用CNKI、 Wangfang、PubMed、CBM、VIP数据库。使用随机效应模型对提取的数据进行meta分析。 结果: 检索得到15项研究数据,包括1810名受试者。加用津力达颗粒的治疗组糖化血红蛋白下降明显高于对照组(n=1820;平均差= -0.66;95%置信区间(-0.72,-0.60);P < 0.00001;I2 = 38%)。此外,津力达颗粒可降低体重指数,改善β细胞功能和胰岛素抵抗。服药期间无明显不良事件发生。 结论: meta分析结果显示,接受津力达颗粒作为叠加疗法干预2型糖尿病具有额外的受益且安全性高。口服津达颗粒治疗2型糖尿病的患者空腹血糖、餐后2小时血糖和糖化血红蛋白水平均有显著降低。然而,由于样本量小和研究的局限性,研究结果应谨慎解释。.
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  • 文章类型: Comparative Study
    BACKGROUND: Differences exist between Western and Asian people with type 2 diabetes (T2D). The aim of the present systematic review was to determine whether there are differences in chronic diabetic vascular complications (CDVCs) and mortality between Western and Asian patients with T2D.
    METHODS: Three databases (EMBASE, MEDLINE, and Cochrane library) were searched for publications from 1966 to March 2013 describing interventional randomized control trials (RCTs) targeting to lower blood glucose levels. The RCTs included had follow-up durations of at least 4 years as an endpoint or in their initial design, analyzed effects on mortality and/or CDVCs in T2D and compared differences in mortality and/or CDVCs among patients of different ethnicities.
    RESULTS: Two studies, including 19 439 patients with advanced diabetes, were eligible for analysis. Patients were divided into those of Western (including Australia and New Zealand) and Asian ethnicities. The incidence of all-cause mortality, cardiovascular death, and major coronary events was significantly higher in Western than Asian patients, whereas the incidence of major cerebrovascular events, microvascular events (except for peripheral neuropathy), new or worsening nephropathy, and retinopathy was significantly lower in Western patients. There were no-between group differences in macrovascular events, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
    CONCLUSIONS: There are differences in CDVCs and mortality rates between Western and Asian patients with advanced T2D, primarily due to ethnicity-specific factors (e.g. different genetic background, lifestyle). Knowledge of these disparities may allow more effective monitoring and management of individual patients based on ethnic differences.
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