OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)form...OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.展开更多
根据2021年全球疾病负担(global burden of disease,GBD)研究统计,缺血性卒中(ischemic stroke,IS)位列全球致死病因第二位,占全因死亡病例的11.6%。同时,IS也是全球伤残调整生命年(disability-adjusted life years,DALYs)损失的第四大...根据2021年全球疾病负担(global burden of disease,GBD)研究统计,缺血性卒中(ischemic stroke,IS)位列全球致死病因第二位,占全因死亡病例的11.6%。同时,IS也是全球伤残调整生命年(disability-adjusted life years,DALYs)损失的第四大诱因,占总DALYs的5.6%,其中IS占卒中相关病例的65.3%^([1])。因此,探索新型治疗靶点至关重要。IS的病理机制复杂,涉及血管阻塞、细胞代谢紊乱、凋亡和坏死等多种生物学过程^([2])。展开更多
近40年来,随着人口老龄化与生活方式的变化,我国2型糖尿病(diabetes mellitus type 2,T2DM)的患病率显著增加,从1980年的0.67%飙升至2020年的11.2%,糖尿病从少见病变成一个流行病[1]。最近研究发现,T2DM患者普遍存在睡眠障碍,睡眠障碍...近40年来,随着人口老龄化与生活方式的变化,我国2型糖尿病(diabetes mellitus type 2,T2DM)的患病率显著增加,从1980年的0.67%飙升至2020年的11.2%,糖尿病从少见病变成一个流行病[1]。最近研究发现,T2DM患者普遍存在睡眠障碍,睡眠障碍不仅影响T2DM患者的血糖水平和胰岛素抵抗,还可能加重其认知功能的下降,目前已受到学者们广泛关注。我们现对T2DM患者的睡眠障碍特点及其对认知功能的影响等作一综述。展开更多
基金Supported by the National Key Research and Development Program of China(Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke,No.2018YFC1705002)
文摘OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.
文摘根据2021年全球疾病负担(global burden of disease,GBD)研究统计,缺血性卒中(ischemic stroke,IS)位列全球致死病因第二位,占全因死亡病例的11.6%。同时,IS也是全球伤残调整生命年(disability-adjusted life years,DALYs)损失的第四大诱因,占总DALYs的5.6%,其中IS占卒中相关病例的65.3%^([1])。因此,探索新型治疗靶点至关重要。IS的病理机制复杂,涉及血管阻塞、细胞代谢紊乱、凋亡和坏死等多种生物学过程^([2])。
文摘近40年来,随着人口老龄化与生活方式的变化,我国2型糖尿病(diabetes mellitus type 2,T2DM)的患病率显著增加,从1980年的0.67%飙升至2020年的11.2%,糖尿病从少见病变成一个流行病[1]。最近研究发现,T2DM患者普遍存在睡眠障碍,睡眠障碍不仅影响T2DM患者的血糖水平和胰岛素抵抗,还可能加重其认知功能的下降,目前已受到学者们广泛关注。我们现对T2DM患者的睡眠障碍特点及其对认知功能的影响等作一综述。
