Objective To assess the net health effect caused by the consumption of specific marine species based on Benefit-Risk Analysis for Foods （BRAFO）-tiered approach. Methods Twenty species were collected from the Zhousha...Objective To assess the net health effect caused by the consumption of specific marine species based on Benefit-Risk Analysis for Foods （BRAFO）-tiered approach. Methods Twenty species were collected from the Zhoushan Archipelago, China. Concentrations of n-3 long-chain polyunsaturated fatty acids, methyl mercury （MeHg）, and dioxin-like compounds （DLCs） in the samples were analyzed for benefit risk assessment based on BRAFO-tiered approach. Results Based on the BRAFO-tiered approach, reference scenario （no intake） and alternative scenario （intake of specific species of 200 g/week） were determined. The exposure to MeHg/DLCs via alternative scenario of all studied species did not exceed provisional tolerable weekly/monthly intake. However, the adult population with high DLCs exposure in China would significantly exceed the upper limit of DLCs via an additional alternative scenario of some species such as Auxis thazard. The results of deterministic computation showed that alternative scenario of all studied species generated clear net beneficial effects on death prevention and child IQ gain. Conclusion The alternative scenario of all studied species could be recommended to population with average DLCs exposure, and the reference scenario of species with relatively high DLCs concentration could be recommended to population exposed to high DLCs.展开更多
ObjectiveTo evaluate the benefit-risk of 3 commonly used Chinese medicine injections, Aidi Injection (ADI), Cinobufagin Injection (CINI) and Compound Kushen Injection (CKI), in the treatment of primary liver cancer (P...ObjectiveTo evaluate the benefit-risk of 3 commonly used Chinese medicine injections, Aidi Injection (ADI), Cinobufagin Injection (CINI) and Compound Kushen Injection (CKI), in the treatment of primary liver cancer (PLC), so as to provide a reference for clinical decision-making.MethodsRandomized controlled trials (RCTs) of ADI, CINI and CKI in the treatment of PLC published in the databases of China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, SinoMed, PubMed, Cochrane Library, and Web of Science were retrieved from January 2020 to October 2022. The data of benefit and risk indicators were combined to obtain the effect value. The multi-criteria decision analysis (MCDA) model was applied to build the decision tree. The benefit value, risk value and benefit risk value of the 3 injections in PLC treatment were calculated. Monte Carlo simulation was carried out to calculate the 95% confidence interval and probability of differences among the 3 injections, so as to optimize the evaluation results.ResultsA total of 71 RCTs were included. The benefit values of ADI, CINI and CKI combined with transcatheter arterial chemoembolization (TACE) were 42, 38 and 36, respectively. The risk values were 42, 25 and 37, respectively. The benefit risk values were 42, 31 and 37, respectively. The benefit risk differences of ADI vs. CINI, ADI vs. CKI, and CKI vs. CINI were 11 (−0.86, 17.75), 5 (−5.01, 11.09), and 6 (−1.87, 12.63), respectively. The probability that ADI superior to CINI, ADI superior to CKI, and CKI superior to CINI was 96.26%, 77.27%, and 92.62%, respectively.ConclusionBased on the results of MCDA model, CINI combined with TACE has the greatest risk in the treatment of the PLC. Considering the efficacy and safety, the possible priority of the 3 Chinese medicine injections combined with TACE in the treatment of PLC is ADI, CKI and CINI.展开更多
目的评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立...目的评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立价值树。应用Hiview 3.2软件计算5种治疗方案用于不可切除肝细胞癌的效益值、风险值以及效益风险值,并进行敏感性分析评价结果的稳健性。借助Oracle Crystal Ball软件运行蒙特卡洛模拟,计算5种治疗方案两两比较的效益风险差值、95%可信区间以及出现差异的概率。结果阿替利珠单抗与贝伐珠单抗(AB)、信迪利单抗与贝伐珠单抗生物类似物(SB)、多纳非尼(DN)、仑伐替尼(LF)、索拉非尼(SL)用于不可切除肝细胞癌的效益值分别是35、59、14、25、0;风险值分别是55、40、59、39、50;效益风险值分别是45、50、37、32、25。敏感性分析表明结果较稳健。蒙特卡洛模拟优化模型结果显示,5种治疗方案之间效益风险差有确定差异的是:AB vs SL,SB vs SL和DN vs SL。结论在当前权重下,SB方案可使患者获益最大,为最优治疗方案,其次是AB、DN、LF和SL。临床医师可综合评估患者个体特征及风险耐受度制定决策方案。展开更多
目的:以儿童癫痫为研究病种,调研该院门诊儿科患者面临的超说明书用药情况,建立门诊儿科超说明书用药风险获益评估体系。方法:对2021—2022年该院儿科诊断为癫痫的1400例患者的门诊处方进行分析,运用Logistic回归分析推测影响儿童癫痫...目的:以儿童癫痫为研究病种,调研该院门诊儿科患者面临的超说明书用药情况,建立门诊儿科超说明书用药风险获益评估体系。方法:对2021—2022年该院儿科诊断为癫痫的1400例患者的门诊处方进行分析,运用Logistic回归分析推测影响儿童癫痫患者超说明书用药的独立因素,并使用“Benefit and Risk Assessment for Off-label Use”(BRAvO)评估表对托吡酯超说明书用药进行分析。结果:1400例门急诊癫痫患儿中,共有112例超说明书用药。多因素Logistic回归分析结果显示,年龄和用药品种数是癫痫患儿超说明书用药的独立影响因素。运用BRAvO评估表确定了托吡酯在2岁以下儿童使用的有效性,但是未确定具体给药剂量。结论:超说明书用药仍然是门诊儿科患者面临的主要问题,BRAvO评估表可为门诊儿科超说明书用药提供决策,规范儿科超说明书用药,降低超说明书用药风险。展开更多
基金funded by the National Nature Science of Foundation of China(No.81172675)the National Key Basic Research Program of China(No.2012CB720804)
文摘Objective To assess the net health effect caused by the consumption of specific marine species based on Benefit-Risk Analysis for Foods （BRAFO）-tiered approach. Methods Twenty species were collected from the Zhoushan Archipelago, China. Concentrations of n-3 long-chain polyunsaturated fatty acids, methyl mercury （MeHg）, and dioxin-like compounds （DLCs） in the samples were analyzed for benefit risk assessment based on BRAFO-tiered approach. Results Based on the BRAFO-tiered approach, reference scenario （no intake） and alternative scenario （intake of specific species of 200 g/week） were determined. The exposure to MeHg/DLCs via alternative scenario of all studied species did not exceed provisional tolerable weekly/monthly intake. However, the adult population with high DLCs exposure in China would significantly exceed the upper limit of DLCs via an additional alternative scenario of some species such as Auxis thazard. The results of deterministic computation showed that alternative scenario of all studied species generated clear net beneficial effects on death prevention and child IQ gain. Conclusion The alternative scenario of all studied species could be recommended to population with average DLCs exposure, and the reference scenario of species with relatively high DLCs concentration could be recommended to population exposed to high DLCs.
基金Supported by National Natural Science Foundation of China(No.82174529)Scientific Research Innovation Project of Henan University of Chinese Medicine(No.2022KYCX037)。
文摘ObjectiveTo evaluate the benefit-risk of 3 commonly used Chinese medicine injections, Aidi Injection (ADI), Cinobufagin Injection (CINI) and Compound Kushen Injection (CKI), in the treatment of primary liver cancer (PLC), so as to provide a reference for clinical decision-making.MethodsRandomized controlled trials (RCTs) of ADI, CINI and CKI in the treatment of PLC published in the databases of China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, SinoMed, PubMed, Cochrane Library, and Web of Science were retrieved from January 2020 to October 2022. The data of benefit and risk indicators were combined to obtain the effect value. The multi-criteria decision analysis (MCDA) model was applied to build the decision tree. The benefit value, risk value and benefit risk value of the 3 injections in PLC treatment were calculated. Monte Carlo simulation was carried out to calculate the 95% confidence interval and probability of differences among the 3 injections, so as to optimize the evaluation results.ResultsA total of 71 RCTs were included. The benefit values of ADI, CINI and CKI combined with transcatheter arterial chemoembolization (TACE) were 42, 38 and 36, respectively. The risk values were 42, 25 and 37, respectively. The benefit risk values were 42, 31 and 37, respectively. The benefit risk differences of ADI vs. CINI, ADI vs. CKI, and CKI vs. CINI were 11 (−0.86, 17.75), 5 (−5.01, 11.09), and 6 (−1.87, 12.63), respectively. The probability that ADI superior to CINI, ADI superior to CKI, and CKI superior to CINI was 96.26%, 77.27%, and 92.62%, respectively.ConclusionBased on the results of MCDA model, CINI combined with TACE has the greatest risk in the treatment of the PLC. Considering the efficacy and safety, the possible priority of the 3 Chinese medicine injections combined with TACE in the treatment of PLC is ADI, CKI and CINI.
文摘目的评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立价值树。应用Hiview 3.2软件计算5种治疗方案用于不可切除肝细胞癌的效益值、风险值以及效益风险值,并进行敏感性分析评价结果的稳健性。借助Oracle Crystal Ball软件运行蒙特卡洛模拟,计算5种治疗方案两两比较的效益风险差值、95%可信区间以及出现差异的概率。结果阿替利珠单抗与贝伐珠单抗(AB)、信迪利单抗与贝伐珠单抗生物类似物(SB)、多纳非尼(DN)、仑伐替尼(LF)、索拉非尼(SL)用于不可切除肝细胞癌的效益值分别是35、59、14、25、0;风险值分别是55、40、59、39、50;效益风险值分别是45、50、37、32、25。敏感性分析表明结果较稳健。蒙特卡洛模拟优化模型结果显示,5种治疗方案之间效益风险差有确定差异的是:AB vs SL,SB vs SL和DN vs SL。结论在当前权重下,SB方案可使患者获益最大,为最优治疗方案,其次是AB、DN、LF和SL。临床医师可综合评估患者个体特征及风险耐受度制定决策方案。
文摘目的:以儿童癫痫为研究病种,调研该院门诊儿科患者面临的超说明书用药情况,建立门诊儿科超说明书用药风险获益评估体系。方法:对2021—2022年该院儿科诊断为癫痫的1400例患者的门诊处方进行分析,运用Logistic回归分析推测影响儿童癫痫患者超说明书用药的独立因素,并使用“Benefit and Risk Assessment for Off-label Use”(BRAvO)评估表对托吡酯超说明书用药进行分析。结果:1400例门急诊癫痫患儿中,共有112例超说明书用药。多因素Logistic回归分析结果显示,年龄和用药品种数是癫痫患儿超说明书用药的独立影响因素。运用BRAvO评估表确定了托吡酯在2岁以下儿童使用的有效性,但是未确定具体给药剂量。结论:超说明书用药仍然是门诊儿科患者面临的主要问题,BRAvO评估表可为门诊儿科超说明书用药提供决策,规范儿科超说明书用药,降低超说明书用药风险。
