亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整的填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Clinical effectiveness of Qilong capsule in patients with ischemic stroke: A prospective, multicenter, non-randomized controlled trial

医学 随机对照试验 血瘀 物理疗法 冲程(发动机) 临床试验 改良兰金量表 内科学 中医药 缺血性中风 替代医学 机械工程 缺血 病理 工程类
作者
Jian Lyu,Yang Gao,Rui-Li Wei,Yefeng Cai,Xiaoming Shen,Dexi Zhao,Xingquan Zhao,Yingzhen Xie,Haiqing Yu,Yan Chai,Yan‐Ming Xie
出处
期刊:Phytomedicine [Elsevier]
卷期号:104: 154278-154278 被引量:6
标识
DOI:10.1016/j.phymed.2022.154278
摘要

The Qilong capsule (QLC) is a Chinese patented medicine characterized by an equal emphasis on replenishing Qi and activating blood circulation. In 2000, China's FDA approved the use of QLC for ischemic stroke (IS). However, there is not yet much high-quality evidence of the clinical effectiveness of QLC combined with conventional treatment (CT) for IS with Qi deficiency and blood stasis syndrome.In this study, we conducted a prospective, multicenter, non-randomized controlled trial at 7 hospitals in China to investigate the clinical effectiveness of QLC combined with CT for IS with Qi deficiency and blood stasis syndrome.Participants aged 35 to 80 years old diagnosed as IS with Qi deficiency and blood stasis syndrome in TCM were recruited. Participants were treated with QLC (intervention group) or non-QLC (control group). The intervention course of QLC was 12 weeks. All participants in two groups received standard treatment. All participants returned for in-person follow-up visits at the 12th week and 24th week. Primary outcome measures included a modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the Barthel Index (BI). Secondary outcome measures included TCM syndromes (Qi deficiency syndrome score, blood stasis syndrome score), psychological index (self-rating depression scale, SDS; self-rating anxiety scale, SAS), blood lipid index, blood coagulation index, homocysteine, and favorable functional outcome (mRS 0 - 3). Multiple imputations were used for any missing data. Propensity score matching (PSM) was used to deal with any confounding factors (age, gender, scale score, etc.). Rank alignment transformation variance analysis (ART ANOVA) and generalized linear mixed model (GLMM) were introduced to improve the scientific and accuracy of repeated measurement data. All statistical calculations were carried out with R 3.6.1 statistical analysis software.A total of 2468 participants were screened from November 2016 to January 2019. Finally, 2302 eligible participants were included in the analysis. There were 1260 participants in the intervention group (QLC group) and 1042 participants in the control group (non-QLC group). After PSM matching, sub-samples of 300 participants in the QLC group and 300 participants in the non-QLC group were finally formed. The final results of clinical effectiveness are the same results shared by the total samples and sub-samples after PSM. In the 24th week after treatment, QLC combined with CT proved to be significantly better than CT alone in reducing the scores of mRS (p < 0.05), NIHSS (p < 0.001), Qi deficiency syndrome (p < 0.01), and blood stasis syndrome (p < 0.001), SAS (p < 0.05), as well as in improving BI score (p < 0.05). The favourable functional outcome (mRS score of 0 to 3 at week 12) was statistically different between QLC and non-QLC group in the sub-samples (p < 0.01, 97% vs 91.7%). The results of the ART ANOVA showed that the improvement of mRS (p < 0.01), BI (p < 0.05) and NIHSS (p < 0.001) in QLC group was better than non-QLC group when the interaction effect was considered. The results of GLMM showed that the reduction of mRS and NIHSS scores of patients in the QLC group were better than those of the non-QLC group (p < 0.001). The BI score of the QLC group in the sub-samples after PSM increased more than the non-QLC group (p < 0.001). There was no evidence showing that QLC can cause serious adverse reactions (ADRs) in treating patients with IS.QLC combined with CT was better than CT alone in reducing mRS score, NIHSS score, Qi deficiency syndrome score, blood stasis syndrome score, and SAS score, as well as improving BI score after treatment. Further high-quality RCTs are needed to confirm the positive results. The study protocol was embedded in a registry study that registered in the Clinical Trials USA Registry (registration No. NCT03174535).
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
激动的似狮完成签到,获得积分10
13秒前
奔跑的蒲公英完成签到,获得积分10
18秒前
22秒前
Frequently2012完成签到 ,获得积分10
22秒前
25秒前
41秒前
调研昵称发布了新的文献求助10
1分钟前
1分钟前
1分钟前
1分钟前
li完成签到,获得积分10
1分钟前
1分钟前
li发布了新的文献求助10
1分钟前
makabaka完成签到 ,获得积分10
2分钟前
2分钟前
科研通AI2S应助科研通管家采纳,获得10
2分钟前
2分钟前
nanfang完成签到 ,获得积分10
2分钟前
www完成签到,获得积分10
2分钟前
2分钟前
Qvby3完成签到 ,获得积分10
3分钟前
拼搏的败完成签到 ,获得积分10
3分钟前
九哥发布了新的文献求助10
4分钟前
4分钟前
Lynn完成签到,获得积分0
4分钟前
4分钟前
4分钟前
5分钟前
allenpp发布了新的文献求助10
5分钟前
小蘑菇应助SCT采纳,获得10
5分钟前
小田完成签到,获得积分10
5分钟前
6分钟前
6分钟前
Bin发布了新的文献求助10
6分钟前
6分钟前
科研通AI2S应助科研通管家采纳,获得10
6分钟前
英俊的铭应助科研通管家采纳,获得10
6分钟前
情怀应助科研通管家采纳,获得30
6分钟前
allenpp完成签到,获得积分10
6分钟前
Lynn发布了新的文献求助10
6分钟前
高分求助中
Production Logging: Theoretical and Interpretive Elements 2500
Востребованный временем 2500
Agaricales of New Zealand 1: Pluteaceae - Entolomataceae 1040
Healthcare Finance: Modern Financial Analysis for Accelerating Biomedical Innovation 1000
Classics in Total Synthesis IV: New Targets, Strategies, Methods 1000
지식생태학: 생태학, 죽은 지식을 깨우다 600
ランス多機能化技術による溶鋼脱ガス処理の高効率化の研究 500
热门求助领域 (近24小时)
化学 医学 材料科学 生物 工程类 有机化学 生物化学 纳米技术 内科学 物理 化学工程 计算机科学 复合材料 基因 遗传学 物理化学 催化作用 细胞生物学 免疫学 电极
热门帖子
关注 科研通微信公众号,转发送积分 3460082
求助须知:如何正确求助?哪些是违规求助? 3054376
关于积分的说明 9041875
捐赠科研通 2743741
什么是DOI,文献DOI怎么找? 1505182
科研通“疑难数据库(出版商)”最低求助积分说明 695609
邀请新用户注册赠送积分活动 694864