Objective： To investigate the effects of Hedan Tablet（荷丹片） on serum lipid profile, proprotein convertase subtilisin/kexin type 9（PSCK9） and high-density lipoprotein（HDL） subfractions in patients with hyperli...Objective： To investigate the effects of Hedan Tablet（荷丹片） on serum lipid profile, proprotein convertase subtilisin/kexin type 9（PSCK9） and high-density lipoprotein（HDL） subfractions in patients with hyperlipidemia. Methods： Thirty-seven patients with hyperlipidemia were randomized to treatment with Hedan Tablet 4.38 g/day as Hedan group（18 cases） or placebo（19 cases） as control group for 8 weeks. The lipid profile, PCSK9 and HDL subfractions were determined at day 0 and week 8 in both groups respectively. Results： Hedan treatment for 8 weeks mildly decreased serum low-density lipoprotein cholesterol（LDL-C） levels, while no changes were found in total cholesterol（TC）, triglycerides（TG） and PCSK9 concentrations. Furthermore, Hedan treatment increased the concentration of large high-density lipoprotein cholesterol（HDL-C） and the percentage of large HDL subfraction, while decreased the concentration of small HDL-C and the percentage of small HDL subfraction without changing serum HDL-C levels in patients with hyperlipidemia. Conclusion： Hedan treatment of 4.38 g per day for 8 weeks could confer a favorable effects on serum LDL-C concentration as well as HDL subfractions.展开更多
Objective Due to the complicated compounds and the synergistic effect of multi-compounds,the quality control and assessment of Chinese materia medica(CMM)encounters a great challenge about how to identify the key comp...Objective Due to the complicated compounds and the synergistic effect of multi-compounds,the quality control and assessment of Chinese materia medica(CMM)encounters a great challenge about how to identify the key compounds,which are directly correlated with its efficacy and safety.On the guidance of study on quality marker(Q-Marker),identification of Q-Markers was performed from Hedan Tablet(HDT)by the aid of the“spider-web”mode and hepatotoxicity evaluation derived from our previous researches and literatures.Methods By the established ultra performance liquid chromatography with photodiode array detector(UPLC-PDA)method,online UPLC-DPPH·and offline antioxidant assay,21 candidate compounds of HDT were systematically investigated and comprehensively evaluated by the“spider-web”mode for them properties of Q-Marker based on“content-stability-activity”.In addition,the Q-Markers related with hepatotoxicity based on our previous researches and literatures were identified.Results Salvianolic acid B(SaB),quercetin-3-O-glucuronide(Qug),isoquercitrin(IQ)and hyperoside(Hyp)were adopted as the preferable Q-Markers of HDT according to the shaded area(A)of tested compounds in“spider-web”mode.Psoralen(Ps),isopsoralen(IP),psoralenoside(PO)and isopsoralenoside(IPO)were also strongly recommended as Q-Markers closely related with safety by considering hepatotoxicity of the accumulated Ps and IP and conversion between glycoside(PO and IPO)and aglycone(Ps and IP).Conclusion This study provided scientific evidence for quality control and assessment of HDT,and also provided a meaningful reference for application of Q-Markers in CMM.展开更多
目的系统评价中成药荷丹片对血脂异常患者血脂水平及炎症因子的影响。方法检索PubMed、中国知网、维普网、万方数据库、中国生物医学文献服务系统建库至2022年3月收录的荷丹片治疗血脂异常的临床随机对照试验。通过Rev Man 5.3分析软件...目的系统评价中成药荷丹片对血脂异常患者血脂水平及炎症因子的影响。方法检索PubMed、中国知网、维普网、万方数据库、中国生物医学文献服务系统建库至2022年3月收录的荷丹片治疗血脂异常的临床随机对照试验。通过Rev Man 5.3分析软件和Stata 16.0软件对纳入文献的研究结果进行meta分析。结果共纳入15项临床随机对照研究,包括1227例患者。meta分析结果显示,试验组临床总有效率高于对照组(OR=0.28,95%CI:0.19~0.44,P<0.00001)。与试验组比较,对照组血清总胆固醇(MD=0.65,95%CI:0.16~1.14,P=0.01)、甘油三酯(MD=0.84,95%CI:0.45~1.23,P<0.00001)、低密度脂蛋白胆固醇(MD=0.76,95%CI:0.08~1.44,P=0.03)、C反应蛋白(SMD=2.60,95%CI:0.50~4.69,P=0.02)水平更高,高密度脂蛋白胆固醇水平更低(MD=-0.41,95%CI:-0.70~-0.12,P<0.00001)。两组不良反应总发生率比较,差异无统计学意义(OR=1.11,95%CI:0.71~1.72,P=0.65)。meta回归分析显示,发表时间、样本量大小、他汀种类和用药时间不影响荷丹片对血脂异常患者血脂水平及炎症因子的作用。敏感性分析结果显示meta分析结果稳定。漏斗图基本对称,无明显发表偏倚。结论荷丹片在改善血脂异常患者血脂及炎症反应指标方面优于单用西药,不增加不良反应,效果值得肯定。展开更多
文摘Objective： To investigate the effects of Hedan Tablet（荷丹片） on serum lipid profile, proprotein convertase subtilisin/kexin type 9（PSCK9） and high-density lipoprotein（HDL） subfractions in patients with hyperlipidemia. Methods： Thirty-seven patients with hyperlipidemia were randomized to treatment with Hedan Tablet 4.38 g/day as Hedan group（18 cases） or placebo（19 cases） as control group for 8 weeks. The lipid profile, PCSK9 and HDL subfractions were determined at day 0 and week 8 in both groups respectively. Results： Hedan treatment for 8 weeks mildly decreased serum low-density lipoprotein cholesterol（LDL-C） levels, while no changes were found in total cholesterol（TC）, triglycerides（TG） and PCSK9 concentrations. Furthermore, Hedan treatment increased the concentration of large high-density lipoprotein cholesterol（HDL-C） and the percentage of large HDL subfraction, while decreased the concentration of small HDL-C and the percentage of small HDL subfraction without changing serum HDL-C levels in patients with hyperlipidemia. Conclusion： Hedan treatment of 4.38 g per day for 8 weeks could confer a favorable effects on serum LDL-C concentration as well as HDL subfractions.
基金supported by Science and Technology Program of Tianjin(20ZYJDJC00070)National Key R&D Program of China(2018YFC1704500)TCM Standardization Project Supported by State Administration of Traditional Chinese Medicine(ZYBZHC-JX-38)。
文摘Objective Due to the complicated compounds and the synergistic effect of multi-compounds,the quality control and assessment of Chinese materia medica(CMM)encounters a great challenge about how to identify the key compounds,which are directly correlated with its efficacy and safety.On the guidance of study on quality marker(Q-Marker),identification of Q-Markers was performed from Hedan Tablet(HDT)by the aid of the“spider-web”mode and hepatotoxicity evaluation derived from our previous researches and literatures.Methods By the established ultra performance liquid chromatography with photodiode array detector(UPLC-PDA)method,online UPLC-DPPH·and offline antioxidant assay,21 candidate compounds of HDT were systematically investigated and comprehensively evaluated by the“spider-web”mode for them properties of Q-Marker based on“content-stability-activity”.In addition,the Q-Markers related with hepatotoxicity based on our previous researches and literatures were identified.Results Salvianolic acid B(SaB),quercetin-3-O-glucuronide(Qug),isoquercitrin(IQ)and hyperoside(Hyp)were adopted as the preferable Q-Markers of HDT according to the shaded area(A)of tested compounds in“spider-web”mode.Psoralen(Ps),isopsoralen(IP),psoralenoside(PO)and isopsoralenoside(IPO)were also strongly recommended as Q-Markers closely related with safety by considering hepatotoxicity of the accumulated Ps and IP and conversion between glycoside(PO and IPO)and aglycone(Ps and IP).Conclusion This study provided scientific evidence for quality control and assessment of HDT,and also provided a meaningful reference for application of Q-Markers in CMM.
文摘目的系统评价中成药荷丹片对血脂异常患者血脂水平及炎症因子的影响。方法检索PubMed、中国知网、维普网、万方数据库、中国生物医学文献服务系统建库至2022年3月收录的荷丹片治疗血脂异常的临床随机对照试验。通过Rev Man 5.3分析软件和Stata 16.0软件对纳入文献的研究结果进行meta分析。结果共纳入15项临床随机对照研究,包括1227例患者。meta分析结果显示,试验组临床总有效率高于对照组(OR=0.28,95%CI:0.19~0.44,P<0.00001)。与试验组比较,对照组血清总胆固醇(MD=0.65,95%CI:0.16~1.14,P=0.01)、甘油三酯(MD=0.84,95%CI:0.45~1.23,P<0.00001)、低密度脂蛋白胆固醇(MD=0.76,95%CI:0.08~1.44,P=0.03)、C反应蛋白(SMD=2.60,95%CI:0.50~4.69,P=0.02)水平更高,高密度脂蛋白胆固醇水平更低(MD=-0.41,95%CI:-0.70~-0.12,P<0.00001)。两组不良反应总发生率比较,差异无统计学意义(OR=1.11,95%CI:0.71~1.72,P=0.65)。meta回归分析显示,发表时间、样本量大小、他汀种类和用药时间不影响荷丹片对血脂异常患者血脂水平及炎症因子的作用。敏感性分析结果显示meta分析结果稳定。漏斗图基本对称,无明显发表偏倚。结论荷丹片在改善血脂异常患者血脂及炎症反应指标方面优于单用西药,不增加不良反应,效果值得肯定。
