We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(R...We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.展开更多
Objective:To investigate the clinical efficacy and safety of miniscalpel-needle(MSN)treatment for tension-type headache(TTH).Method:Seven medical databases were searched to identify randomized controlled trials(RCTs)e...Objective:To investigate the clinical efficacy and safety of miniscalpel-needle(MSN)treatment for tension-type headache(TTH).Method:Seven medical databases were searched to identify randomized controlled trials(RCTs)evaluating the effect and safety of MSN treatment.All articles published up to November 15,2018 were retrieved.A meta-analysis was conducted for the included studies,and the risk of bias was assessed.Primary outcomes were visual analogue scale(VAS)or numeric rating scale(NRS)score.Secondary outcomes were clinical effective rates including total effective rate(TER),markedly effective rate(MER),and totally cured rate(TCR)determined by improvement in clinical symptoms or VAS scores,the frequency of adverse events(AEs)that occurred during the study,and participant quality of life(QOL).Results:Seven RCTs involving 724 participants were included.MSN treatment showed significantly higher MER and TCR[relative risk(RR)1.27,95%confidence interval(Cl)1.01 to 1.61;RR 1.31,95%Cl 1.09 to 1.57,respectively],but not TER(RR 1.03,95%Cl 0.96 to 1.10)compared to acupuncture.MSN treatment plus conventional treatment showed significant lower VAS and higher TER,MER,and TCR(mean difference-3.54,95%Cl-3.80 to-3.28;RR 1.14,95%Cl 1.06 to 1.23;RR 2.31,95%Cl 1.50 to 3.58;RR 3.01,95%Cl 2.25 to 4.02,respectively)compared to conventional treatment.Conclusions:According to current evidence,MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH.However,since the number and the sample size of studies included were both small and the methodological quality was poor,the findings of this review should be interpreted with great caution,and our confidence in the results is low.A high quality RCT using objective outcomes should be performed on this topic.展开更多
目的:探讨A型肉毒毒素(Botulinum toxin type A,BTX-A)联合眶隔膜张力重建术整复松弛型下睑袋临床效果。方法:选取2020年12月-2022年12月在笔者医院治疗的松弛型下睑袋就医者为研究对象,共87例。根据治疗方法分为实验组(n=47)和对照组(n...目的:探讨A型肉毒毒素(Botulinum toxin type A,BTX-A)联合眶隔膜张力重建术整复松弛型下睑袋临床效果。方法:选取2020年12月-2022年12月在笔者医院治疗的松弛型下睑袋就医者为研究对象,共87例。根据治疗方法分为实验组(n=47)和对照组(n=40),实验组行BTX-A联合眶隔膜张力重建术,对照组行眶隔膜张力重建术,术后对就医者进行随访,比较下睑袋术后效果、泪沟畸形(Barton分级)、术后外观满意度、手术并发症。结果:治疗后,实验组瘢痕宽度、VSS低于对照组(P<0.05),手术时间及切口恢复时间与对照组比较,差异无统计学意义(P>0.05);两组就医者Barton分级均有所改善,且实验组0级和1级(95.74%)高于对照组(82.50%)(P<0.05);治疗后,实验组满意度(95.74%)高于对照组(80.00%)(P<0.05);治疗后,实验组与对照组并发症发生率比较,差异无统计学意义(P>0.05)。结论:BTX-A联合眶隔膜张力重建术整复松弛型下睑袋,能够有效消除下睑袋,减少瘢痕增生,改善Barton分级构成,就医者外观满意度较高。展开更多
基金the National Key Research and Development Program of China:Research on“the Pattern Dominating Disease”of Postmarket Evaluation on Two Classic Chinese Herbal Formulas based on Basket Design(No.2018YFC1707407)。
文摘We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.
基金Chung-Yeon Central Institute(Research Program 2020)。
文摘Objective:To investigate the clinical efficacy and safety of miniscalpel-needle(MSN)treatment for tension-type headache(TTH).Method:Seven medical databases were searched to identify randomized controlled trials(RCTs)evaluating the effect and safety of MSN treatment.All articles published up to November 15,2018 were retrieved.A meta-analysis was conducted for the included studies,and the risk of bias was assessed.Primary outcomes were visual analogue scale(VAS)or numeric rating scale(NRS)score.Secondary outcomes were clinical effective rates including total effective rate(TER),markedly effective rate(MER),and totally cured rate(TCR)determined by improvement in clinical symptoms or VAS scores,the frequency of adverse events(AEs)that occurred during the study,and participant quality of life(QOL).Results:Seven RCTs involving 724 participants were included.MSN treatment showed significantly higher MER and TCR[relative risk(RR)1.27,95%confidence interval(Cl)1.01 to 1.61;RR 1.31,95%Cl 1.09 to 1.57,respectively],but not TER(RR 1.03,95%Cl 0.96 to 1.10)compared to acupuncture.MSN treatment plus conventional treatment showed significant lower VAS and higher TER,MER,and TCR(mean difference-3.54,95%Cl-3.80 to-3.28;RR 1.14,95%Cl 1.06 to 1.23;RR 2.31,95%Cl 1.50 to 3.58;RR 3.01,95%Cl 2.25 to 4.02,respectively)compared to conventional treatment.Conclusions:According to current evidence,MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH.However,since the number and the sample size of studies included were both small and the methodological quality was poor,the findings of this review should be interpreted with great caution,and our confidence in the results is low.A high quality RCT using objective outcomes should be performed on this topic.
文摘目的:探讨A型肉毒毒素(Botulinum toxin type A,BTX-A)联合眶隔膜张力重建术整复松弛型下睑袋临床效果。方法:选取2020年12月-2022年12月在笔者医院治疗的松弛型下睑袋就医者为研究对象,共87例。根据治疗方法分为实验组(n=47)和对照组(n=40),实验组行BTX-A联合眶隔膜张力重建术,对照组行眶隔膜张力重建术,术后对就医者进行随访,比较下睑袋术后效果、泪沟畸形(Barton分级)、术后外观满意度、手术并发症。结果:治疗后,实验组瘢痕宽度、VSS低于对照组(P<0.05),手术时间及切口恢复时间与对照组比较,差异无统计学意义(P>0.05);两组就医者Barton分级均有所改善,且实验组0级和1级(95.74%)高于对照组(82.50%)(P<0.05);治疗后,实验组满意度(95.74%)高于对照组(80.00%)(P<0.05);治疗后,实验组与对照组并发症发生率比较,差异无统计学意义(P>0.05)。结论:BTX-A联合眶隔膜张力重建术整复松弛型下睑袋,能够有效消除下睑袋,减少瘢痕增生,改善Barton分级构成,就医者外观满意度较高。
