目的探讨体针、头皮针加电针联合应用对卒中恢复期吞咽困难患者的吞咽功能改善是否优于常规康复训练。方法将148例卒中恢复期吞咽困难的患者随机分配至针刺组和康复训练组,每组74例。针刺组取患侧风池、完骨、翳风、廉泉、金津、玉液穴...目的探讨体针、头皮针加电针联合应用对卒中恢复期吞咽困难患者的吞咽功能改善是否优于常规康复训练。方法将148例卒中恢复期吞咽困难的患者随机分配至针刺组和康复训练组,每组74例。针刺组取患侧风池、完骨、翳风、廉泉、金津、玉液穴;头皮针围刺;体针、头皮针加电针联合应用,每天针刺1次,每周5次为1个疗程,共2~4个疗程。对照组由语言治疗师进行康复训练。治疗后3~6个月对主要结局同时使用意向性分析和符合方案数据分析两种方法评价,并报告＂为了避免1例不良事件发生必须治疗的患者数（num-ber needed to treat,NNT）＂、＂处理多少病例可以引起1次副作用（number needed to harm,NNH）＂及其95%的可信区间。治疗结束时评价次要结局。结果治疗结束时和治疗后3个月针刺组洼田吞咽功能痊愈率、洼田饮水试验痊愈率优于康复训练组,差异有统计学意义（P〈0.05）。治疗结束时肺部感染率和病死率、治疗后6个月病死率两组比较差异无统计学意义（P〉0.05）。两组依从性均为100%,针刺组未出现不良反应。结论针刺对卒中恢复期吞咽困难患者的吞咽功能改善优于常规康复训练,且安全、耐受性好。展开更多
Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statisti...Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.展开更多
文摘目的探讨体针、头皮针加电针联合应用对卒中恢复期吞咽困难患者的吞咽功能改善是否优于常规康复训练。方法将148例卒中恢复期吞咽困难的患者随机分配至针刺组和康复训练组,每组74例。针刺组取患侧风池、完骨、翳风、廉泉、金津、玉液穴;头皮针围刺;体针、头皮针加电针联合应用,每天针刺1次,每周5次为1个疗程,共2~4个疗程。对照组由语言治疗师进行康复训练。治疗后3~6个月对主要结局同时使用意向性分析和符合方案数据分析两种方法评价,并报告＂为了避免1例不良事件发生必须治疗的患者数（num-ber needed to treat,NNT）＂、＂处理多少病例可以引起1次副作用（number needed to harm,NNH）＂及其95%的可信区间。治疗结束时评价次要结局。结果治疗结束时和治疗后3个月针刺组洼田吞咽功能痊愈率、洼田饮水试验痊愈率优于康复训练组,差异有统计学意义（P〈0.05）。治疗结束时肺部感染率和病死率、治疗后6个月病死率两组比较差异无统计学意义（P〉0.05）。两组依从性均为100%,针刺组未出现不良反应。结论针刺对卒中恢复期吞咽困难患者的吞咽功能改善优于常规康复训练,且安全、耐受性好。
基金the Research Institute of Primary Care and Health Sciences, Keele University, United Kingdom, for providing full funding through bursary and scholarship awards and an enabling environment for a successful completion of the PhD
文摘Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.
