论著

中医药治疗儿童哮喘随机对照试验结局指标现状

Current status of outcome indicators of randomized controlled trials of traditional Chinese medicine for the treatment of childhood asthma

:1531-1541
 
       目的   剖析中医药治疗儿童哮喘的随机对照试验(RCT)结局指标,为中医药治疗该病临床试验的核心指标集构建提供初步依据。方法   检索中国知网(CNKI)、万方(WanFang)、维普网(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、Cochrane Library、EmBase、Web of Science。时间跨度为建库至2024年7月1日。此次检索全面覆盖了中医药疗法治疗儿童哮喘的临床随机对照研究,由两名研究者根据纳排标准独立完成文献筛选和资料提取,提取文献基本特征和结局指标。结果   初步检索出2 449篇文献,最终纳入165个RCT,包括205个结局指标,分为症状/体征、中医症状/证候、理化检查、生活质量评价、远期预后、安全性指标六域。结论   中医药治疗儿童哮喘尚存在中医证候诊断和疗效标准不完善、主要和次要结局指标界限不清等问题,应当构建统一规范且广为认可的核心指标集,以促进儿童哮喘核心指标集的完善。
        Objective  To analyze the outcome indicators of randomised controlled trials(RCTs)of traditional Chinese medicine(TCM)for the treatment of childhood asthma,and to provide a preliminary basis for the construction of a core set of indicators for clinical trials of TCM for the treatment of this disease.Methods  A database search was conducted on China Knowledge Network(CNKI),WanFang,VIP,SinoMed,PubMed,Cochrane Library,EmBase,and Web of Science,covering the period from the establishment of the database to 1 July 2024.The search comprehensively covered clinical randomised controlled studies of TCM therapies in the treatment of childhood asthma,and was completed independently by two investigators who screened the literature and extracted information according to the criteria,and extracted the basic characteristics of the literature and outcome indicators.Results  Initially,2 449 literatures were retrieved,and 165 RCTs were finally included,including 205 outcome indicators,which were classified into six domains:symptoms/signs,TCM symptoms/evidence,physical and chemical examination,quality of life evaluation,long-term prognosis,and safety indicators.Conclusions  Currently,there are problems such as imperfect diagnostic and efficacy criteria for TCM evidence,and unclear boundaries between primary and secondary outcome indicators in the treatment of childhood asthma with TCM.A unified,standardised and widely recognised core indicator set should be constructed to promote the improvement of the core indicator set for childhood asthma.
论著

心脉通治疗冠心病临床随机对照试验的系统评价

Systematic review of clinical randomized controlled trials of Xinmaitong in the treatment of coronary heart disease

:118-124
 
目的 系统评价心脉通治疗冠心病的临床疗效及其安全性。方法 2名研究者独立系统地检索心脉通治疗冠心病的文献,其中包括维普中文科技期刊全文数据库(VIP)、PubMed 电子期刊全文数据库、中国学术期刊全文数据库(CNKI)、The Cochrane Library 数据库、万方数据库等6个数据库。同时运用Review Manager 5.4 软件进行本研究的数据处理。结果 最终共纳入8篇文献,共计985名心脉通治疗冠心病患者。治疗前后的临床疗效、发作频率、血脂水平的Meta分析结果显示心脉通组优于常规治疗组。有3项纳入试验报告不良反应。结论 心脉通治疗冠心病的临床疗效优于常规治疗。心脉通不仅可以降低冠心病发作频率,缩短其发作持续时间,还能调节血脂水平,在治疗冠心病方面疗效确切,值得临床参考应用。
Objective To systematically evaluate the clinical efficacy and safety of Xinmaitong in the treatment of coronary heart disease (CHD). Methods Two researchers searched the literatures of Xinmaitong in the treatment of coronary heart disease independently and systematically, including VIP Chinese Sci-tech Journal full-text Database (VIP), PubMed Electronic Journal full-text Database, Chinese Academic Journal full-text Database (CNKI), The Cochrane Library Database and Wanfang Database. At the same time, Review Manager 5.4 software was used to process the data of this study. Results A total of 8 articles were included, and a total of 985 patients with coronary heart disease were treated with Xinmaitong. The results of Meta analysis of clinical efficacy, attack frequency and blood lipids level before and after treatment showed that Xinmaitong group was better than routine treatment group. Three items were included in the report of adverse reactions. Conclusions The clinical effect of Xinmaitong in the treatment of coronary heart disease was better than that of routine treatment. Xinmaitong can not only reduce the frequency and duration of coronary heart disease attack, but also regulate blood lipids level. Xinmaitong was effective in the treatment of coronary heart disease and is worthy of clinical reference.
论著

小剂量右美托咪定改善臂丛神经阻滞效果的随机对照研究

Low dose of dexmedetomidine as an adjunction to ropivacaine in supraclavicular brachial plexus block: a randomized controlled trial

:20-26
 
目的 观察右美托咪定作为佐剂对罗哌卡因在锁骨上入路臂丛神经阻滞效果的影响。方法 将55例上肢择期手术的受试者随机分为右美组和对照组。右美组:30 μg右美托咪定(0.3 mL)+0.5%罗哌卡因,对照组:生理盐水(0.3 mL)+0.5%罗哌卡因。在臂丛神经阻滞操作后,按步骤评估和记录臂丛感觉、运动阻滞程度和起效时间。在术中定期监测和记录生命体征、不良事件的发生。手术后评估和记录术毕24小时生命体征、术后镇痛时间、臂丛神经感觉、运动阻滞的持续时间、术后恶心呕吐评分、补救镇痛药物用量和不良事件等数据。结果 在臂丛神经的感觉和运动起效时间、感觉和运动阻滞持续时间、术后镇痛时间方面,右美组长于对照组,存在统计学差异(P<0.05)。两组间在术后生命体征变化、补救镇痛药物用量、术后恶心呕吐评分、不良事件等数据的比较,未见明显统计学差异(P>0.05)。结论 右美托咪定(30 μg)作为佐剂能加快罗哌卡因在锁骨上入路对臂丛神经阻滞的起效时间,增加其术后镇痛时间和对臂丛神经的感觉、运动阻滞时间,同时较少影响患者生命体征,具备一定的有效性和临床安全性。
Objective To observed the effect of dexmedetomidine as an adjunction with ropivacaine in supraclavicularbrachial plexus block. Methods 55 subjects with elective upper extremity operation were randomly divided into two groups: DEX group and control group. The drugs in DEX group was 30 μg dexmedetomidine (0.3 mL) + 0.5% ropivacaine, 20 mL in total. And the one in control group was normal saline (0.3 mL) +0.5% ropivacaine, 20 mL in total. After the operation of brachial plexus block, the value of sensory and motor block of brachial plexus and the onset time were evaluated and recorded according to the protocol. Vital signs and adverse events were monitored and recorded regularly during the operation.Postoperative vital signs, postoperative analgesia time, duration of brachial plexus sensationsensory and motion block, postoperative nausea and vomiting score, dosage of remedial analgesics and adverse events were assessed and recorded in 24 hours after surgery. Results In terms of sensory and motor onset time of brachial plexus, duration of sensory and motor block and postoperative analgesia, DEX group was longer than the control group, with statistical differences (P<0.05).There were no significant statistical differences between the two groups in postoperative vital signs, the amount of remedial analgesic drugs, postoperative nausea and vomiting scores, adverse events etc(P>0.05). Conclusion As an adjuvant, dexmedetomidine (30 μg) can accelerate the onset time of ropivacaine in the supraclavicular approach of brachial plexus block.It can also increase the postoperative analgesia time and sensory and motor block time of brachial plexus.With less impact on the vital signs of patients, the efficacy and clinical safety of dexmedetomidinecan be found in our study.
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