女性癲癇患者妊娠期的藥物治療缺乏等級較高的臨床證據支持，而單中心研究很難納入足夠大的樣本，并且對妊娠期癲癇患者進行隨機對照試驗也不符合醫學倫理，因而多國家、多中心合作的癲癇妊娠登記系統應運而生。目前國際上最大三個癲癇妊娠登記分別為英國及愛爾蘭癲癇妊娠登記（the UK and Ireland Epilepsy and Pregnancy Registers，UKIEPR）、北美抗癲癇藥物妊娠登記（the North American AED Pregnancy Registry）和國際抗癲癇藥物妊娠登記（International Registry of Antiepileptic Drugs and Pregnancy，EURAP）。文章首先簡要介紹上述三大癲癇妊娠登記，并對這三大登記系統的方法學等特點進行比較，其次從多角度總結國外癲癇妊娠登記的研究成果，最后簡述癲癇與妊娠登記的延伸研究，以期為我國抗癲癇藥物妊娠登記的開展提供有益借鑒。
Objective To explore the effects of aggressive lipid lowering therapy and its influence on cardiovascular events using lipitor (20 mg daily) for Chinese people after percutaneous coronary intervention (PCI). Methods We did a double-blind and randomized controlled trial. From July 2005 to June 2006, 120 patients with PCI procedure who were discharged from the Shanghai Chest Hospital were randomly divided into aggressive lipid lowering group (atorvastatin 20 mg daily, n=60) and an ordinary lipid lowering group (atorvastatin 10 mg daily, n=60). The trial treatment was administered from the day of PCI to the third month after PCI. Atorvastatin at 10 mg daily was then used until one year after PCI. Blood biochemistry, cardiovascular events and drug adverse reactions were compared between the two groups. Results Among the 120 patients, 5 discontinued treatment and 4 more withdrew from the study. Therefore 115 and 111 were included in our main analyses [Comment from Mike: it is not ITT if the 5 who discontinued treatment are excluded] and a per-protocol (PP) analysis, respectively. Baseline clinical characteristics were comparable between the two groups. The reduction in TG and the increase in HDL-C were similar between the two groups (Pgt;0.05), but the reductions in LDL-C and TC were significantly different between the two groups (Plt;0.05). This was observed from the beginning of follow-up to the third month after PCI. In the PP analysis, the percentage of patients whose LDL-C met the predefined requirement at the third month in the 20 mg group was significantly higher than in the group receiving the lower dose (87.03% vs. 70.17%, P=0.031). A similar result was also obtained if the patients who withdrew were retained in the analysis (P=0.044). The change in C reaction protein (CRP) from baseline at the first and the third month was significantly different between the two groups (Plt;0.05), but become relatively stable at the sixth month (Pgt;0.05). The mean follow-up duration was 6.5±3.0 months in the higher dose group, with 1 case of recurring angina pectoris and 1 case of revascularization were identified. It was 7.2±3.6 months in the 10 mg daily group, with 3 cases of recurring angina pectoris, 1 case of nonfatal myocardial infarction, 2 cases of revascularization and 1 case of sudden cardiogenic death. The difference in the Kaplan-Meier event curves was of borderline statistical significance from the fourth month (P=0.048). Drug adverse reactions were mild and myopathy was not identified in any patients. Conclusions After PCI procedure, the use of atorvastatin 20 mg daily for aggressive lipid lowering was safe and effective.
