Background:Whether lactated Ringer's solution is clinically superior to normal saline for routine intravenous administration of fluids is uncertain.Methods:In an open-label,two-period,two-sequence,cross-sectional,...Background:Whether lactated Ringer's solution is clinically superior to normal saline for routine intravenous administration of fluids is uncertain.Methods:In an open-label,two-period,two-sequence,cross-sectional,cluster-randomized,crossover trial,we assigned hospitals in Ontario,Canada,to use either lactated Ringer's solution or normal saline hospital-wide for a period of 12 weeks.展开更多
High temperature exposure has been identified as a significant risk factor for respiratory diseases.However,causal evidence is needed to confirm the respiratory effects associated with heat exposure and to elucidate t...High temperature exposure has been identified as a significant risk factor for respiratory diseases.However,causal evidence is needed to confirm the respiratory effects associated with heat exposure and to elucidate the underlying mechanisms.We conducted a randomized crossover trial among healthy adults in Shanghai,China.Participants received 2 h exposures to moderate-temperature(22℃)and hightemperature(32℃)conditions.Spirometry tests,fractional exhaled nitric oxide(FeNO)measurements,and collections of pharyngeal secretion and peripheral blood samples were performed before and after each session.Pharyngeal microbiota was analyzed via 16S rRNA amplicon sequencing.Serum biomarkers,including Clara cell protein(CC16)and Chitinase-3-like protein 1(YKL-40)were also measured.Heat exposure was associated with decreases of 18.8%(95%CI:4.7%,32.8%)in peak expiratory flow,9.6%(95%CI:1.9%,17.3%)in forced expiratory volume in the first second,and 8.8%(95%CI:3.5%,14.1%)in the ratio of forced expiratory volume in the first second and forced vital capacity.Corresponding increases were observed in FeNO(13.9%;95%CI:3.5%,24.2%),serum CC16(20.4%,95%CI:1.6%,39.3%),and serum YKL-40(17.1%,95%CI:3.9%,30.2%).Additionally,three pathogenic pharyngeal bacteria exhibited a higher relative abundance.In summary,acute heat exposure was associated with reductions in lung function and airway injury.Potential biological mechanisms may involve lung epithelial damage,airway inflammation,and disruption of the airway microbiota.展开更多
Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial（RCT） research of thalamic pai...Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial（RCT） research of thalamic pain treated with acupuncture under the guidance of evidence-based medicine（EBM）.Methods The crossover trial design was adopted.Eleven cases with the definite diagnosis were randomized into a program-I group（6 cases,treated with acupuncture before western medicine） and a program-II group（5 cases,treated with western medicine before acupuncture） according to the minimal imbalance index method.In the statistical analysis,the groups were named as an acupuncture group and a western medicine group separately,11 cases in each one.Acupuncture was applied to Xìmén（郄门 PC 4）,Yīnxì（阴郄 HT 6）,Xuèhǎi（血海 SP 10）,etc.In the control treatment,Carbamazepine was prescribed for oral administration.Either the duration of treatment or the wash-out period was 10 days.The visual analogue scale（VAS） was adopted for the efficacy assessment.Results The total effective was 100.0%（11/11） after treatment in either group.The remarkably effective rates were 63.6%（7/11） and 36.4%（4/11） in the acupuncture group and the western medicine group separately,without statistically significant difference in comparison.Conclusion The crossover trial design and the minimal imbalance index distribution method can accomplish RCT of the clinical acupuncture and moxibustion research with the small sample size involved.They can provide the high-quality evidences for clinical acupuncture research.Acupuncture therapy can achieve the same therapeutic effect as Carbamazepine,the common western medicine,and the efficacy of it is potentially superior to that of western medicine.展开更多
文摘Background:Whether lactated Ringer's solution is clinically superior to normal saline for routine intravenous administration of fluids is uncertain.Methods:In an open-label,two-period,two-sequence,cross-sectional,cluster-randomized,crossover trial,we assigned hospitals in Ontario,Canada,to use either lactated Ringer's solution or normal saline hospital-wide for a period of 12 weeks.
基金supported by National Natural Science Foundation of China(82430105)(H.K.)Shanghai Municipal Science and Technology Major Project(2023SHZDZX02)(H.K.)+2 种基金Shanghai B&R Joint Laboratory Project(22230750300)(H.K.)Shanghai International Science and Technology Partnership Project(21230780200)(H.K.)the Shanghai Committee of Science and Technology(21TQ015)(R.C.and H.K.).
文摘High temperature exposure has been identified as a significant risk factor for respiratory diseases.However,causal evidence is needed to confirm the respiratory effects associated with heat exposure and to elucidate the underlying mechanisms.We conducted a randomized crossover trial among healthy adults in Shanghai,China.Participants received 2 h exposures to moderate-temperature(22℃)and hightemperature(32℃)conditions.Spirometry tests,fractional exhaled nitric oxide(FeNO)measurements,and collections of pharyngeal secretion and peripheral blood samples were performed before and after each session.Pharyngeal microbiota was analyzed via 16S rRNA amplicon sequencing.Serum biomarkers,including Clara cell protein(CC16)and Chitinase-3-like protein 1(YKL-40)were also measured.Heat exposure was associated with decreases of 18.8%(95%CI:4.7%,32.8%)in peak expiratory flow,9.6%(95%CI:1.9%,17.3%)in forced expiratory volume in the first second,and 8.8%(95%CI:3.5%,14.1%)in the ratio of forced expiratory volume in the first second and forced vital capacity.Corresponding increases were observed in FeNO(13.9%;95%CI:3.5%,24.2%),serum CC16(20.4%,95%CI:1.6%,39.3%),and serum YKL-40(17.1%,95%CI:3.9%,30.2%).Additionally,three pathogenic pharyngeal bacteria exhibited a higher relative abundance.In summary,acute heat exposure was associated with reductions in lung function and airway injury.Potential biological mechanisms may involve lung epithelial damage,airway inflammation,and disruption of the airway microbiota.
基金Supported by research project of "Innovation Engineering" of The First Affiliated Hospital of Tianjin University of TCM:Academy 0804
文摘Objective To study the feasibility of the crossover trial design and the minimal imbalance index random distribution method in the clinical small-sample-size randomized controlled trial（RCT） research of thalamic pain treated with acupuncture under the guidance of evidence-based medicine（EBM）.Methods The crossover trial design was adopted.Eleven cases with the definite diagnosis were randomized into a program-I group（6 cases,treated with acupuncture before western medicine） and a program-II group（5 cases,treated with western medicine before acupuncture） according to the minimal imbalance index method.In the statistical analysis,the groups were named as an acupuncture group and a western medicine group separately,11 cases in each one.Acupuncture was applied to Xìmén（郄门 PC 4）,Yīnxì（阴郄 HT 6）,Xuèhǎi（血海 SP 10）,etc.In the control treatment,Carbamazepine was prescribed for oral administration.Either the duration of treatment or the wash-out period was 10 days.The visual analogue scale（VAS） was adopted for the efficacy assessment.Results The total effective was 100.0%（11/11） after treatment in either group.The remarkably effective rates were 63.6%（7/11） and 36.4%（4/11） in the acupuncture group and the western medicine group separately,without statistically significant difference in comparison.Conclusion The crossover trial design and the minimal imbalance index distribution method can accomplish RCT of the clinical acupuncture and moxibustion research with the small sample size involved.They can provide the high-quality evidences for clinical acupuncture research.Acupuncture therapy can achieve the same therapeutic effect as Carbamazepine,the common western medicine,and the efficacy of it is potentially superior to that of western medicine.
