Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/De...Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/Design:We conducted a randomized,blank parallel-controlled,open-label,multi-center,basal therapy-loaded design clinical trial.A total of 40 patients are going to be recruited after satisfying the criteria.Participants will be allocated randomly into the treatment group with the combination of Arbidol and Liushen capsules and the control group with the basic therapy.Each group will receive treatment at least 7-days or until the virus becomes negative,and visits after drug administration at day 3(visit 1),the day when the virus becomes negative(visit 2),day 7(visit 3),the day before discharge(visit 4)and day 28(visit 5),to collect their survival status and disease prognosis so that the efficacy and safety of a combination of Arbidol and Liushen capsule will be evaluated.Discussion:We described the protocol of the first clinical trial for treatment COVID-19 by using a combination of Arbidol and Liushen capsules.The results of this study will provide a basis for the design and sample size estimate of subsequent large-scale clinical trials.Trial registration:This study has been registered at Chinese clinical trial Registry(chictr.org.cn):ChiCTR2000029993.展开更多
目的研究六神丸对食管癌的作用及基于炎性微环境的机制探讨。方法将60只裸小鼠随机分为6组:空白组,顺铂组,食管癌模型组,六神丸高、中、低剂量组,顺铂取浓度为0.l mg·m L^(-1),于造模后24、48 h腹腔注射l次,0.2 m L/只,共给药2次...目的研究六神丸对食管癌的作用及基于炎性微环境的机制探讨。方法将60只裸小鼠随机分为6组:空白组,顺铂组,食管癌模型组,六神丸高、中、低剂量组,顺铂取浓度为0.l mg·m L^(-1),于造模后24、48 h腹腔注射l次,0.2 m L/只,共给药2次。六神丸于造模第1日后开始按浓度灌胃给药,食管癌模型组、空白组每日一次蒸馏水0.2 m L灌胃,均为20 d。结果与实验前比较,顺铂组、六神丸高、中、低剂量组的移植瘤瘤重明显降低(P<0.01),TNF-α、NF-κB m RNA及蛋白的相对表达量明显下调,与模型组相比较,以顺铂组下调最明显,其次为六神丸高剂量组(P<0.01)。结论六神丸对食管癌裸鼠移植瘤具有一定的抗肿瘤作用,能在一定程度上减慢肿瘤的生长,其抗肿瘤的机制可能是与抑制了炎症微环境中TNF-α、NF-κB炎症因子相关。展开更多
基金This work was supported by the Science research project of the Guangdong Province[Grant No.2020B111110001]Guangzhou Medical University High-level University Clinical Research and Cultivation Program(Guangzhou Medical University released[2017]No.159,160).
文摘Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/Design:We conducted a randomized,blank parallel-controlled,open-label,multi-center,basal therapy-loaded design clinical trial.A total of 40 patients are going to be recruited after satisfying the criteria.Participants will be allocated randomly into the treatment group with the combination of Arbidol and Liushen capsules and the control group with the basic therapy.Each group will receive treatment at least 7-days or until the virus becomes negative,and visits after drug administration at day 3(visit 1),the day when the virus becomes negative(visit 2),day 7(visit 3),the day before discharge(visit 4)and day 28(visit 5),to collect their survival status and disease prognosis so that the efficacy and safety of a combination of Arbidol and Liushen capsule will be evaluated.Discussion:We described the protocol of the first clinical trial for treatment COVID-19 by using a combination of Arbidol and Liushen capsules.The results of this study will provide a basis for the design and sample size estimate of subsequent large-scale clinical trials.Trial registration:This study has been registered at Chinese clinical trial Registry(chictr.org.cn):ChiCTR2000029993.
文摘目的研究六神丸对食管癌的作用及基于炎性微环境的机制探讨。方法将60只裸小鼠随机分为6组:空白组,顺铂组,食管癌模型组,六神丸高、中、低剂量组,顺铂取浓度为0.l mg·m L^(-1),于造模后24、48 h腹腔注射l次,0.2 m L/只,共给药2次。六神丸于造模第1日后开始按浓度灌胃给药,食管癌模型组、空白组每日一次蒸馏水0.2 m L灌胃,均为20 d。结果与实验前比较,顺铂组、六神丸高、中、低剂量组的移植瘤瘤重明显降低(P<0.01),TNF-α、NF-κB m RNA及蛋白的相对表达量明显下调,与模型组相比较,以顺铂组下调最明显,其次为六神丸高剂量组(P<0.01)。结论六神丸对食管癌裸鼠移植瘤具有一定的抗肿瘤作用,能在一定程度上减慢肿瘤的生长,其抗肿瘤的机制可能是与抑制了炎症微环境中TNF-α、NF-κB炎症因子相关。
