Objective To investigate the effectiveness of Xuanshen Yishen Decoction(XYD)in the treatment of hypertension.Methods Hospital electronic medical records from 2019–2023 were utilized to emulate a randomized pragmatic ...Objective To investigate the effectiveness of Xuanshen Yishen Decoction(XYD)in the treatment of hypertension.Methods Hospital electronic medical records from 2019–2023 were utilized to emulate a randomized pragmatic clinical trial.Hypertensive participants were eligible if they were aged≥40 years with baseline systolic blood pressure(BP)≥140 mm Hg.Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group,whereas those who followed only antihypertensive regimen were assigned to the control group.The primary outcome assessed was the attainment rate of intensive BP control at discharge,with the secondary outcome focusing on the 6-month all-cause readmission rate.Results The study included 3,302 patients,comprising 2,943 individuals in the control group and 359 in the treatment group.Compared with the control group,a higher proportion in the treatment group achieved the target BP for intensive BP control[8.09%vs.17.5%;odds ratio(OR)=2.29,95%confidence interval(CI)=1.68 to 3.13;P<0.001],particularly in individuals with high homocysteine levels(OR=3.13;95%CI=1.72 to 5.71;P<0.001;P for interaction=0.041).Furthermore,the 6-month all-cause readmission rate in the treatment group was lower than in the control group(hazard ratio=0.58;95%CI=0.36 to 0.91;P=0.019),and the robustness of the results was confirmed by sensitivity analyse.Conclusions XYD could be a complementary therapy for intensive BP control.Our study offers real-world evidence and guides the choice of complementary and alternative therapies.(Registration No.ChiCTR2400086589)展开更多
Evidence-based practice address to use the best available evidence to support clinical practice.The evidence can be diverse according to the evidence hierarchy model ranging from case report and expert experience up t...Evidence-based practice address to use the best available evidence to support clinical practice.The evidence can be diverse according to the evidence hierarchy model ranging from case report and expert experience up to randomized controlled trials(RCTs).However,the hierarchy of evidence in modern medicine is undergoing a fundamental transformation.While RCTs have long occupied the apex of the evidence pyramid,their idealized designs often fail to address complex clinical questions.Other types of evidence such as case series,case-control study,and cohort study can be part of decision-making aid.The US FDA's 2016 Real-World Evidence Program marked a pivotal moment,formally recognizing real-world evidence(RWE)as valid supplementary evidence for regulatory decisions.Nowadays,people are thinking how clinical evidence could be adopted to refl ect the real-world practice.In this context,real world study was generated.展开更多
目的:建立玄参中哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C含量快速测定近红外光谱定量的模型。方法:以高效液相色谱法(HPLC)检测值作为参照,采用傅里叶变换近红外漫反射光谱技术采集玄参的近红外光谱,结合偏最小二乘法(PLS)分别建立哈...目的:建立玄参中哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C含量快速测定近红外光谱定量的模型。方法:以高效液相色谱法(HPLC)检测值作为参照,采用傅里叶变换近红外漫反射光谱技术采集玄参的近红外光谱,结合偏最小二乘法(PLS)分别建立哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C含量的快速测定方法。结果:玄参中哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C的校正模型相关系数(R)、校正均方差(root mean square error of calibration,RMSEC)、预测均方差(root mean square error of prediction,RMSEP)分别为0.96705、0.0101、0.02532;0.96176、0.0141、0.02443;0.99853、0.00889、0.02732;0.96134、0.0189、0.02191。通过外部验证,玄参中四种成分的预测值与真实值相关系数分别达为0.9842(哈巴俄苷)、0.9960(肉桂酸)、0.9994(毛蕊花糖苷)、0.9939(安格洛苷)。结论:该方法准确、快速、简便,可实现大批量样品的快速分析。展开更多
目的采用氢核磁脉冲宽度定量法(Pulse length based concentration determination,PULCON)对玄参对照提取物中的哈巴苷、安格洛苷C和哈巴俄苷进行定性及定值研究,探讨玄参对照提取物代替相应对照品在提升玄参复方制剂质量控制水平的可...目的采用氢核磁脉冲宽度定量法(Pulse length based concentration determination,PULCON)对玄参对照提取物中的哈巴苷、安格洛苷C和哈巴俄苷进行定性及定值研究,探讨玄参对照提取物代替相应对照品在提升玄参复方制剂质量控制水平的可行性。方法采用Bruker Avance III HD 700超导核磁共振波谱仪,以DMSO-d6为溶剂,苯甲酸为外标物,利用PULCON法比较苯甲酸定量峰(δ_(H)7.94)的峰面积和不同批次玄参对照提取物中3种化学成分的不同定量峰(哈巴苷δ_(H)6.24、安格洛苷Cδ_(H)7.08和哈巴俄苷δ_(H)5.97)的峰面积,测定不同批次中3种成分的含量,并采用配对t检验将测定结果与高效液相色谱法(High performance liquid chromatography,HPLC)的定值结果进行比对。分别以已知含量的玄参对照提取物和3个相应对照品为对照,建立增液汤的HPLC含量测定方法,采用配对t检验对2种方法所得结果进行比较。结果采用PULCON法测得3种成分的含量与HPLC法的定值结果基本一致,以玄参对照提取物为对照,3种成分的线性关系相关系数均大于0.9997,平均回收率为99.36%~102.31%。t检验结果显示,2种方法测定的哈巴苷、安格洛苷C、哈巴俄苷含量P值分别为0.279、0.105、0.623,均大于0.05,表明2种含量测定方法差异无统计学意义。结论PULCON法可在无对照品且无需分离的条件下,直接、快速、准确地分析玄参对照提取物成分的物质组成和含量,并将已标定准确含量的玄参对照提取物用于玄参复方制剂的质量控制,为中药对照提取物在中药质量研究中的应用提供了科学依据。展开更多
基金Supported by State Administration of Traditional Chinese Medicine High-Level Chinese Medicine Key Discipline Construction Project(No.zyyzdxk-2023120)the Joint Scientific and Technological Projects of Department of Science and Technology,National Administration of Traditional Chinese Medicine(No.GZY-KJS-SD-2023-036)。
文摘Objective To investigate the effectiveness of Xuanshen Yishen Decoction(XYD)in the treatment of hypertension.Methods Hospital electronic medical records from 2019–2023 were utilized to emulate a randomized pragmatic clinical trial.Hypertensive participants were eligible if they were aged≥40 years with baseline systolic blood pressure(BP)≥140 mm Hg.Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group,whereas those who followed only antihypertensive regimen were assigned to the control group.The primary outcome assessed was the attainment rate of intensive BP control at discharge,with the secondary outcome focusing on the 6-month all-cause readmission rate.Results The study included 3,302 patients,comprising 2,943 individuals in the control group and 359 in the treatment group.Compared with the control group,a higher proportion in the treatment group achieved the target BP for intensive BP control[8.09%vs.17.5%;odds ratio(OR)=2.29,95%confidence interval(CI)=1.68 to 3.13;P<0.001],particularly in individuals with high homocysteine levels(OR=3.13;95%CI=1.72 to 5.71;P<0.001;P for interaction=0.041).Furthermore,the 6-month all-cause readmission rate in the treatment group was lower than in the control group(hazard ratio=0.58;95%CI=0.36 to 0.91;P=0.019),and the robustness of the results was confirmed by sensitivity analyse.Conclusions XYD could be a complementary therapy for intensive BP control.Our study offers real-world evidence and guides the choice of complementary and alternative therapies.(Registration No.ChiCTR2400086589)
文摘Evidence-based practice address to use the best available evidence to support clinical practice.The evidence can be diverse according to the evidence hierarchy model ranging from case report and expert experience up to randomized controlled trials(RCTs).However,the hierarchy of evidence in modern medicine is undergoing a fundamental transformation.While RCTs have long occupied the apex of the evidence pyramid,their idealized designs often fail to address complex clinical questions.Other types of evidence such as case series,case-control study,and cohort study can be part of decision-making aid.The US FDA's 2016 Real-World Evidence Program marked a pivotal moment,formally recognizing real-world evidence(RWE)as valid supplementary evidence for regulatory decisions.Nowadays,people are thinking how clinical evidence could be adopted to refl ect the real-world practice.In this context,real world study was generated.
文摘目的:建立玄参中哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C含量快速测定近红外光谱定量的模型。方法:以高效液相色谱法(HPLC)检测值作为参照,采用傅里叶变换近红外漫反射光谱技术采集玄参的近红外光谱,结合偏最小二乘法(PLS)分别建立哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C含量的快速测定方法。结果:玄参中哈巴俄苷、肉桂酸、毛蕊花糖苷及安格洛苷C的校正模型相关系数(R)、校正均方差(root mean square error of calibration,RMSEC)、预测均方差(root mean square error of prediction,RMSEP)分别为0.96705、0.0101、0.02532;0.96176、0.0141、0.02443;0.99853、0.00889、0.02732;0.96134、0.0189、0.02191。通过外部验证,玄参中四种成分的预测值与真实值相关系数分别达为0.9842(哈巴俄苷)、0.9960(肉桂酸)、0.9994(毛蕊花糖苷)、0.9939(安格洛苷)。结论:该方法准确、快速、简便,可实现大批量样品的快速分析。
文摘目的采用氢核磁脉冲宽度定量法(Pulse length based concentration determination,PULCON)对玄参对照提取物中的哈巴苷、安格洛苷C和哈巴俄苷进行定性及定值研究,探讨玄参对照提取物代替相应对照品在提升玄参复方制剂质量控制水平的可行性。方法采用Bruker Avance III HD 700超导核磁共振波谱仪,以DMSO-d6为溶剂,苯甲酸为外标物,利用PULCON法比较苯甲酸定量峰(δ_(H)7.94)的峰面积和不同批次玄参对照提取物中3种化学成分的不同定量峰(哈巴苷δ_(H)6.24、安格洛苷Cδ_(H)7.08和哈巴俄苷δ_(H)5.97)的峰面积,测定不同批次中3种成分的含量,并采用配对t检验将测定结果与高效液相色谱法(High performance liquid chromatography,HPLC)的定值结果进行比对。分别以已知含量的玄参对照提取物和3个相应对照品为对照,建立增液汤的HPLC含量测定方法,采用配对t检验对2种方法所得结果进行比较。结果采用PULCON法测得3种成分的含量与HPLC法的定值结果基本一致,以玄参对照提取物为对照,3种成分的线性关系相关系数均大于0.9997,平均回收率为99.36%~102.31%。t检验结果显示,2种方法测定的哈巴苷、安格洛苷C、哈巴俄苷含量P值分别为0.279、0.105、0.623,均大于0.05,表明2种含量测定方法差异无统计学意义。结论PULCON法可在无对照品且无需分离的条件下,直接、快速、准确地分析玄参对照提取物成分的物质组成和含量,并将已标定准确含量的玄参对照提取物用于玄参复方制剂的质量控制,为中药对照提取物在中药质量研究中的应用提供了科学依据。
