目的对润明颗粒中重金属及有害元素的残留进行测定和风险评估,为润明颗粒的安全用药提供参考依据。方法采用电感耦合等离子体质谱(inductively coupled plasma mass spectrometry,ICP-MS)法测定其18种重金属及有害元素的残留量,并结合...目的对润明颗粒中重金属及有害元素的残留进行测定和风险评估,为润明颗粒的安全用药提供参考依据。方法采用电感耦合等离子体质谱(inductively coupled plasma mass spectrometry,ICP-MS)法测定其18种重金属及有害元素的残留量,并结合各元素测定值对其进行风险评估。结果20批次样品中各元素的危害系数均低于风险值,基于风险评估结果,得出润明颗粒中Pb、Cd、As、Hg的限度分别为2、1、2、0.2 mg·kg^(-1)。结论润明颗粒中重金属及有害元素的安全风险较低,该方法为润明颗粒的用药安全和质量控制提供参考。展开更多
Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have bee...Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.展开更多
文摘Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.
基金Teaching Reform Project"Science&Technology Law"Curriculum of ZUEL Postgraduate Students(KCJS202245)General Project of Legal Research"Research on Legal Issues of Intellectual Property Protection of New BusinessForms"funded by China Law Society(CLS(2021)C22)。
