原发性高胆固醇血症血管内皮依赖性舒张功能失调的无创性检测

采用无创性高分辨超声技术，检测了１７例无症状的原发性高胆固醇血症患者和１７例血浆胆固醇水平正常的对照者在基础状态下，反应性充血及含服硝酸甘油后肱动脉的内径变化。结果显示，前者血流介导性肱动脉舒张较正常组明显减弱（５．９％±２．３％比１４．５％±３．４％，Ｐ＜０．００１）；血流介导性肱动脉舒张与血总胆固醇（ＴＣ）及低密度脂蛋白胆固醇（ＬＤＬ－Ｃ）呈显著负相关（相关系数ｒ分别为－０．６４２及－０．６２３，Ｐ＜０．００１）；而两组对硝酸甘油的反应差异无显著性（２４．５％±４．３％比２３．０％±７．０％，Ｐ＝０．４９）。结果表明，原发性高胆固醇血症患者血管内皮依赖性舒张功能明显受损，ＬＤＬ－Ｃ升高是内皮依赖性舒张功能障碍主要的独立危险的因素。     

超声评价高脂血症患者肱动脉内皮功能

目的　利用高分辨率超声评价高脂血症 (hyperlipidemia,HL P)患者肱动脉内皮依赖性舒张功能的变化。方法　将 80名研究对象分为 4组。 组 2 0人为正常对照组 , - 组分别为高胆固醇血症组、高甘油三酯血症组和混合性高脂血症组。应用高分辨率超声分别观察记录静息状态下、反应性充血和舌下含服硝酸甘油后的肱动脉内径变化。结果　与正常对照组相比 ,高脂血症患者肱动脉血管内皮依赖性舒张功能明显降低、尤以混合性高脂血症组为甚 (11.3± 3.1) %比 (5 .7± 3.2 ) % ,(5 .4± 3.0 ) %比 (3.8± 2 .4 ) % ,P均 <0 .0 5 )。结论　HL P患者血管内皮依赖性舒张功能较正常人明显受损 ,高分辨率超声能准确可靠地检测血管内皮依赖性舒张功能。     

高频超声检测血管内皮依赖性舒张功能的探讨

目的　探讨高频超声检测血管内皮依赖舒张功能的临床价值。方法　应用７．０ ＭＨｚ探头检测原发性高血压（ｎ＝ ２１）、冠心病（ｎ＝ ２１）、和健康人（ｎ＝ ２１）休息时、反应性充血、舌下含服ＧＴＮ后的肱动脉内径变化。结果　高血压组和冠心病组肱动脉血流介导性扩张百分比明显低于正常组〔（４．６±２．８）％ 、（２．６±０．９）％ ｖｓ （１４．４±２．９）％ , Ｐ＜ ０．０５〕舌下含服ＧＴＮ后肱动脉内径变化在三组间无显著性差异〔（１９．６±６．０）％ 、（２１．１±７．０）％ ｖｓ（２３．５±１０．２）％ , Ｐ＞ ０．０５〕。结论　原发性高血压、冠心病存在血管内皮依赖性舒张功能失调, 高频超声能准确可靠地检测血管内皮依赖性舒张功能。     

冠心病人外周血管内皮依赖性舒张功能的超声研究

目的：探讨高频超声检测冠心病患者外周血管内皮依赖性舒张功能的临床价值，方法：应用7．5MHz高频探头检测25例稳定型心绞痛。23例急性心肌梗塞恢复期病人和22例健康者的肱动脉内皮依赖性舒张功能（EDD）和内皮非依赖性舒张功能（EID）。结果：冠心病组反应性充血诱发的肱动脉内径舒张百分比明显低于健康组（P＜0．001），舌下含服硝酸甘油后三组间肱动脉内径变化无显著性差异（P＞0．05），结论：冠心病患者的血管内皮依赖性舒张功能失调，且与病情有关，应用高频超声可评价冠心病患者的血管内皮依赖性舒张功能，对其病情及预后判断具有重要价值。     

老年高血压患者血管内皮舒张功能与内皮素相关性

目的：研究老年高血压患内皮依赖性血管舒张功能和血浆内皮素（ET）的关系。方法：检测51例老年高血压患和15例正常血压老年患肱动脉的内皮依赖性及内皮非依赖性血管舒张功能，同时测定血浆ET－1含量。结果：ET－1含量随血压分级水平递增；高血压各级内皮依赖性血管舒张功能均较对照组明显减弱（P＜0．001）；线性回归分析表明，内皮依赖性血管舒张功能与血管内皮受损的ET释放水平呈负相关，多元逐步回归分析显示进入影响血管内皮舒张功能方程的唯一因素为收缩压。结论：ET测定与超声检测内皮依赖性血管舒张功能具有较好的相关性，但血浆ET水平不能预测内皮依赖性血管舒张功能的损害。高血压是内皮功能受损的独立危险因素。     

原发性高血压及高血压合并高胆固醇血症血管内皮功能的超声研究

目的 探讨原发性高血压及高血压合并高胆固醇血症患者血管内皮依赖性舒张功能的改变。方法 采用彩色多普勒高频超声的间歇成像和能量多普勒成像，对24例原发性高血压患者（EH组）、24例高血压合并高胆固醇血症患者（EH＋HC组）及24例正常血压、血胆固醇者（NT组）的血管内皮依赖性舒张功能，包括静息时血管内径（BD）、增加流量引起的血管舒张（FMD）、服用硝酸甘油引起的血管舒张（GTN）等，以及对血浆一氧化氮（NO）、内皮素（ET）、血栓素B2（TXB2）和前列腺环素（PGI2）等血管活性物质进行检测并比较分析。结果 EH和EH＋HC组反应性充血引起的FMD值明显减弱，与NT组比较差异有非常显著性（均P〈0．01），EH与EH＋HC组之间比较差异亦有统计学意义（P〈0．05）；含服硝酸甘油后肱动脉内径明显扩张，但各组间GTN值差异无统计学意义（P〉0．05）；EH＋HC、EH组与NT组比较血浆中NO、PGI2水平明显降低，而ET、TXB2水平明显升高（均P〈0．01），EH＋HC与EH组间比较差异亦有统计学意义（P〈0．05）。结论 高血压患者存在血管内皮依赖性舒张功能受损，高血压合并高胆固醇血症时，内皮功能受损进一步加重。彩色多普勒超声是评价血管内皮舒张功能的简单、无创且可靠方法。     

高分辨率超声评价高脂血症患者肱动脉内皮功能

背景：以往对血管内皮依赖性舒张功能的评估采用冠状动脉内直接输注乙酰胆碱和数字性血管造影的方法，但这种有刨性检查限制了对疾病早期发生、发展及临床干预治疗后的动态观察。目的：探讨利用高分辨率超声评估高脂血症患者肱动脉内皮依赖性舒张功能的变化，并与健康者进行对照。设计：病例-对照。单位：一所市级医院超声科和心内科。对象：选择2001-05／2002-03信阳市中心医院心内科收治的高脂血症患者60例，男37例，女23例；年龄36-75岁。根据患者血脂情况将患者分为3组：高胆固醇血症组20例，高三酰甘油血症组20例，混合性高脂血症组20例。选择同期健康体检志愿者20人为正常对照组，男12人，女8人。所有纳人对象均知情同意。方法：肱动脉内径及血流量变化测量采用使用高分辨率超声诊断系统。患者休息至少10min后测量安静时肱动脉内径及基础血流量。然后用袖套式充气带在肘关节以下加压300mmHg，持续四五分钟，突然放气，测量放气后15s时的血流介导的肱动脉内径及反应性充血血流量。再休息至少15min，待血管完全恢复正常后，于舌下含服硝酸甘油400μg，三四分钟后，再次测量含服硝酸甘油后肱动脉内径及含服硝酸甘油后血流量。然后计算反应性充血后肱动脉内径较基础内径变化的百分率=（血流介导的肱动脉内径-安静时肱动脉内径）／安静时肱动脉内径&;#215;100％；含服硝酸甘油后肱动脉内径较基础内径变化的百分率：（含服硝酸甘油后肱动脉内径-安静时肱动脉内径）／安静时肱动脉内径&;#215;100％。反应性充血血流量增长百分率=反应性充血血流量／基础血流量&;#215;100％；含服硝酸甘油后血流量增长百分率=含服硝酸甘油后血流量／基础血流量&;#215;100％。主要观察指标：应用高分辨率超声仪器观察3组高脂血症患者和正常对照组体检者静息状态下、反应性充血时、舌下含服硝酸甘油后的肱动脉内径变化。结果：高脂血症患者60例和健康体检者20人均进入结果分析。高胆固醇血症组、高三酰甘油血症组、混合性高脂血症组患者反应性充血后肱动脉内径较基础内径变化的百分率明显低于正常对照组[（5．7&;#177;3．2）％，（5．4&;#177;3．0）％，（3．8&;#177;2．4）％，（11．3&;#177;3．1）％，P〈0．05]，其中以混合性高脂血症患者降低最明显。而3个患者组反应性充血及含服硝酸甘油后血流量增长百分率，以及含服硝酸甘油后肱动脉内径较基础内径变化的百分率差异不明显（P〉0．05）。结论：高脂血症患者血管内皮依赖性舒张功能较正常人明显受损，高分辨率超声能准确可靠地检测血管内皮依赖性舒张功能。     

糖尿病前期患者血管内皮舒张功能与血脂关系的超声研究

目的通过高频超声检测糖耐量低减（IGT）和空腹血糖调节受损（IFG）患者的血管内皮舒张功能，并探讨其与血脂的关系。方法选择经临床诊断为IGT，IFG的患者各20例，同时选择健康人群30例作为对照。采用高频超声测定肱动脉内皮依赖性和非内皮依赖性舒张功能。同时测定空腹血糖、总胆固醇（TC）、三酰甘油（TG）、高密度脂蛋白胆固醇（HDL）及低密度脂蛋白胆固醇（LDL）。结果IGT及IFG患者空腹血糖，TC，TG，LDL—C较正常对照组增高（P〈0．05），反应性充血后肱动脉内径变化百分率较正常对照组降低（P〈0.05）。硝酸甘油介导的血管扩张肱动脉内径变化百分率在各组问无显著差异性（P〉0．05）。糖尿病前期患者肱动脉血管内皮依赖性舒张功能与血糖、TG水平呈明显负相关。结论糖尿病前期患者存在着血糖、血脂异常和血管内皮依赖性舒张功能障碍，且血管内皮舒张功能与血糖、TG水平密切相关。     

心肌梗塞及中风患者血管内皮功能的变化

目的　探讨彩色多普勒超声对冠心病、脑卒中患者肱动脉血管内皮依赖性舒张功能检测的临床意义。方法　应用高分辨的血管外超声检测 3 3 6例急性心肌梗塞、急性脑出血、急性脑梗塞和健康者肱动脉血管内皮依赖性舒张功能。结果　冠心病、脑梗塞、脑出血患者与健康对照组比较 ,基础血管内径与硝酸甘油含化后血管内径扩张百分率差异有显著性 (P <0 .0 1) ;基础血流速度和硝酸甘油含化后血流速度 ,脑梗塞组明显低于健康对照组、脑出血组及冠心病组 (P <0 .0 1～ 0 .0 5 )。结论　超声检测肱动脉血管内皮功能是判断和预测冠心病和脑卒中发生值得研究的方法 ;静息时肱动脉基础血管内径、对硝酸甘油扩血管反应是判断内皮功能损害的有用指标     

高分辨率超声检测血管内皮功能的临床应用

目的：应用高分辨率超声观察血脂康对血脂正常的冠心病患肱动脉的内皮依赖性舒张功能的改善作用。方法：应用高分辨率血管外超声技术对56例冠心病患（分为血脂康组和安慰剂组）治疗前后的血管内皮功能进行检测。结果：56例冠心病患治疗前肱动脉血管内皮舒张功能减低，8周后，血脂康组肱动脉血管内皮依赖性舒张功能较治疗前明显改善（P＜0．01）。安慰剂组则无明显差异（P＞0．05）。结论：高分辨率超声可应用于检测冠心病患的内皮依赖性舒张功能及药物治疗前后的改善情况。     

四种药物对兔动脉粥样硬化血管内皮功能的影响

目的　应用超声技术对比舒降之、普罗布考、开搏通和中药对兔动脉粥样硬化内皮依赖性血管扩张功能的影响。方法　新西兰兔 45只 ,随机分为动脉粥样硬化模型组 (40只 )和正常对照组 (5只 )。1 2周末 ,模型组兔停喂胆固醇饲料 ,随机分成 5组 :自然消退组、舒降之组、普罗布考组、开搏通组和中药组。治疗时间为 1 2周。 2 4周末 ,股动脉插管至胸主动脉 ,经导管注入乙酰胆碱 ,然后给予硝酸甘油 ,超声测量管腔内径变化及腹主动脉血流速度。结果　乙酰胆碱在正常对照组的作用为扩血管反应 ,在自然消退组则引起明显的血管收缩 ,4种药物减轻乙酰胆碱血管收缩作用的效果由强到弱依次为普罗布考、舒降之、中药和开搏通。硝酸甘油在各组动物均引起血管扩张 ,且扩张程度差异无显著性意义 (P >0 .2 5 )。总胆固醇与乙酰胆碱注射后动脉内径变化率呈中度负相关关系 (r =- 0 .57,P <0 .0 0 2 ) ,与硝酸甘油所致的内径变化率无明显相关关系。结论　舒降之、普罗布考、开搏通和中药对兔动脉粥样硬化内皮依赖性血管扩张功能具有不同的改善作用     

Simvastatin and pravastatin equally improve flow-mediated dilation in males with hypercholesterolemia

BACKGROUND: Both simvastatin and pravastatin have been shown to improve endothelial function in patients with hypercholesterolemia. To our knowledge there has been no comparative study of these two HMG-CoA reductase inhibitors on endothelial dysfunction measured by flow-mediated dilation of the brachial artery in patients with hypercholesterolemia. METHODS: Fourteen middle-aged males with hypercholesterolemia (means +/- SD: total cholesterol 7.03 +/- 0.88 mmol/l, LDL cholesterol 5.02 +/- 0.63 mmol/l, HDL cholesterol 1.3 +/- 0.38 mmol/l and triglycerides 1.47 +/- 0.26 mmol/l) were randomised, after a 6 weeks' run-in phase with AHA step I diet treatment, to 12 weeks' treatment either with simvastatin or pravastatin. Both statins were given in a daily dose of 10 mg for 6 weeks, which was increased to 20 mg daily in patients who did not achieve an LDL-cholesterol goal of < 3.4 mmol/l. Endothelial dysfunction was measured as flow-mediated brachial artery dilation (FMD) using high resolution ultrasound. RESULTS: There were no significant differences between the drugs in reduction of total cholesterol, LDL cholesterol and triglycerides, or elevation of HDL cholesterol. FMD increased in the simvastatin group from 6.8 +/- 3.2 to 12.3 +/- 2.9% (p < 0.03) and in the pravastatin group from 6.3 +/- 4.8 to 13.3 +/- 4.7% (p = 0.001). The improvement in FMD was the same in both groups (p = 0.64) and did not correlate with changes of the lipid parameters measured. CONCLUSIONS: Both simvastatin and pravastatin reduce endothelial dysfunction to the same degree in patients with hypercholesterolemia, independently of changes in lipid parameters.     

阿托伐他汀对混合型高脂血症患者血管内皮依赖性舒张功能的影响

目的　观察阿托伐他汀对混合型高脂血症患者血管内皮依赖性舒张功能的影响。方法　 60例混合型高脂血症患者进行 8周阿托伐他汀片 10mg/d ,口服治疗 ,60例健康人群为对照组 ,治疗前后测定血脂以及用超声多普勒测定肱动脉血管内径、血流量以及反应性充血和含服硝酸甘油片后肱动脉内径和血流量变化。 2 8例经阿托伐他汀治疗 8周后血脂正常的患者停药 4周、8周 ,再次测定血脂以及肱动脉血管内径和血流量。结果　混合型高脂血症患者血管内皮依赖性舒张功能明显受损 (P <0 .0 0 1) ,而对硝酸甘油反应两组无差异 (P >0 .0 5 ) ,阿托伐他汀治疗 8周后血清TG、TC、LDL C、ApoB显著下降 ,对肱动脉内皮依赖性舒张功能较治疗前明显改善 (P <0 .0 0 1) ,停药后 4周、8周肱动脉血管内皮依赖性舒张功能明显下降 (P <0 .0 0 1) ,而治疗前后肱动脉内径以及对硝酸甘油的反应无变化。结论　阿托伐他汀治疗混合型高脂血症疗效明显 ,并显著改善肱动脉内皮依赖性舒张功能 ,这一作用源于其对内皮细胞的直接作用 ,可能独立于降脂作用之外     

Efficacy and safety of ezetimibe/simvastatin association on non-diabetic and diabetic patients with polygenic hypercholesterolemia or combined hyperlipidemia and previously intolerant to standard statin treatment

Background and objective: One of the problems associated with reaching the low‐density lipoprotein cholesterol (LDL‐C) target during statin treatment is the emergence of laboratory or clinical side effects. The aim of our study was to evaluate the prevalence of statin‐associated adverse events in diabetic and non‐diabetic patients affected by polygenic hypercholesterolemia or combined hyperlipidemia and the efficacy and tolerability of treatment with ezetimibe/simvastatin 10/10 mg/day on the same subjects experiencing the adverse events. Methods: Consecutively enrolment of patients affected by polygenic hypercholesterolemia or combined hyperlipidemia with or without type 2 diabetes mellitus. Each Centre used any of the available statins on the basis of current clinical judgement and monitored enrolled patients for adverse events during the following 2 years. Those patients with moderate adverse events suspended the current statin therapy for 1 month (washout period), and then were shifted to treatment with ezetimibe/simvastatin 10/10 mg/day and again monitored for adverse events in the following 6 months. We assessed body mass index, glycated haemoglobin, fasting plasma glucose, total cholesterol, LDL‐C, high‐density lipoprotein cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, creatinine phosphokinase and monitored adverse events such as asthenia and myalgia. Results and discussion: All 1170 Caucasian patients affected by polygenic hypercholesterolemia obtained a significant reduction in LDL‐C during the observation period (P < 0·05), while those with combined hyperlipidemia also showed a reduction in TG plasma level (P < 0·05) and a significant increase in HDL‐C (P < 0·05). Patients affected by polygenic hypercholesterolemia experiencing adverse event under statin treatment obtained a significantly lower reduction than those tolerating the treatment (P < 0·001). The prevalence of adverse events under statin treatment was 4·9% in non‐diabetic patients with polygenic hypercholesterolemia, 8·6% in those with combined hyperlipidemia, 7·1% in diabetic patients with polygenic hypercholesterolemia and 7·6% in those with combined hyperlipidemia. Six months after the shift to treatment with ezetimibe/simvastatin 10/10 mg, all patients experienced a significant improvement in LDL‐C, TG and HDL‐C plasma level. No adverse event was registered during the ezetimibe/simvastatin 10/10 mg treatment period. It seems that previous side effects observed with statins did not re‐appear with the administration of ezetimibe/simvastatin 10/10 mg/day. Conclusions: The efficacy and adverse effect profile of the ezetimibe and simvastatin combination appear to be good for both diabetic and non‐diabetic patients, and in both conditions.     

糖尿病患者血管内皮舒张功能的超声研究

目的 :研究 型糖尿病 (non-insulin-dependent diabetes mellitus,NIDDM)患者尿蛋白排泄量与血管内皮舒张功能损伤的关系。方法 :采用高分辨率超声测定伴有不同程度蛋白尿的 型糖尿病患者血流介导的肱动脉内皮依赖性血管舒张和硝酸甘油介导的非内皮依赖性血管舒张。结果 :糖尿病尿蛋白正常组、微量组、大量组内皮依赖性血管舒张功能较正常对照组降低 (P<0 .0 0 1) ;大量蛋白尿组较尿蛋白正常组降低 (P<0 .0 5) ;硝酸甘油介导的非内皮依赖性血管舒张各组间无差异 (P>0 .0 5)。多因素线性相关性分析 ,糖尿病患者血管内皮依赖性舒张功能损伤和尿蛋白排泄量、糖化血红蛋白、血浆甘油三酯呈负相关。结论 :糖尿病患者血管内皮舒张功能损伤早于蛋白尿出现     

辛伐他汀对急性冠脉综合征患者颈动脉粥样硬化的影响

目的：探讨辛伐他汀对急性冠脉综合征患者颈动脉粥样硬化的影响及其机制。方法：80例急性冠脉综合征患者随机分成辛伐他汀20 mg组（40例）和辛伐他汀40 mg组（40例）,于治疗前及治疗6个月后分别测定血清总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）及高密度脂蛋白胆固醇（HDL-C）水平,并超声检测颈动脉内-中膜厚度（IMT）及颈动脉斑块面积。结果：两组治疗后TC、TG、LDL-C水平均明显降低（P〈0.01）,HDL-C明显升高（P〈0.01）;而辛伐他汀40 mg组较20 mg组作用更为明显（P〈0.05）。治疗6个月后IMT及颈动脉斑块面积明显缩小（P〈0.01）,且辛伐他汀40 mg组作用更显著（P〈0.01）。结论：辛伐他汀对急性冠脉综合征患者颈动脉粥样硬化斑块具有延缓和稳定作用。     

复方丹参气雾剂合用硝酸甘油治疗冠心病心绞痛的疗效

评价复方丹参气雾剂合用硝酸甘油治疗冠心病心绞痛的疗效。方法：将９０例冠心病心绞痛患者随机分为３组：Ａ组３０例给予复方丹参气雾剂;Ｂ组３０例给予复方丹参气雾剂,另加硝酸甘油静滴;Ｃ组单用硝酸甘油静滴。观察治疗前后３组疗效（心电图和症状）,并观察Ａ、Ｂ组血液流变学改变,Ｂ,Ｃ组硝酸甘油用量。结果：Ａ组症状及心电图总有效率分别为７６．７％和４６．７％;Ｃ组症状及心电图总有效率分别为７３．３％和４３．３％     

高胆固醇血症环境下注射造影剂诱发急性肾功能衰竭

目的：探讨高胆固醇血症是否是造影剂肾损害的促进因素。方法：24只雄性Wistar大鼠随机分成两组，分别给予正常饮食(N组)和高胆固醇饮食（H组，4％胆固醇和1％胆酸钠）8周。8周末从N组和H组中各取半数大鼠（6只）尾静脉注射60％泛影葡胺（6ml/kg，NC组和HC组），另半数大鼠尾静脉注射等量生理盐水。注射造影剂后的第二天测定血清总胆固醇、甘油三酯、血肌酐、内生肌酐清除率、肾皮质一氧化氮的含量；彩色多普勒和频谙式多普勒测定肾血流；光镜观察肾组织学改变。结果：HC组和H组血清总胆固醇及肾血管阻力指数显著性增加，而内生肌酐清除率、肾皮质一氧化氮含量显著性降低。HC组的内生肌酐清除率显著低于H组，HC组的血清肌酐、钠钾排泄分数显著高于其它三组。组织病理也显示HC组大鼠肾小管上皮细胞发生严重变性和坏死，而NC组和H组大鼠仅见肾小管变性。结论：高胆固醇血症是造影剂肾损害的促进因素；肾皮质一氧化氮含量的减少可介导了高胆固醇血症环境下造影剂诱导的急性肾功能衰竭。     

盐酸二甲双胍联合辛伐他汀对奥氮平诱导性肥胖大鼠代谢紊乱及肿瘤坏死因子-α的调节作用

目的探讨盐酸二甲双胍联合辛伐他汀对奥氮平诱导性肥胖大鼠血糖、血脂代谢紊乱和肿瘤坏死因子-α的调节作用。方法60只SD雄性健康大鼠随机分成模型组、盐酸二甲双胍联合辛伐他汀组（观察组）与对照组各20只,对照组给予普通饲料喂养,在普通饲料喂养基础上模型组给予奥氮平1．2mg／kg灌胃,观察组给予奥氮平1．2mg／kg、盐酸二甲双胍0．75g／d联合辛伐他汀10mg／d灌胃,4周后建立模型,检测3组空腹血糖、血脂生化和肿瘤坏死因子-α水平。结果模型组空腹血糖、总胆固醇、三酰甘油、低密度脂蛋白胆固醇及肿瘤坏死因子-α水平明显高于对照组和观察组（P〈0．01）,高密度脂蛋白胆固醇水平低于对照组与观察组（P〈O．01）;观察组空腹血糖、总胆固醇、三酰甘油、低密度脂蛋白胆固醇水平高于对照组,高密度脂蛋白胆固醇低于对照组（P〈0．01）,肿瘤坏死因子水平与对照组比较差异无统计学意义（P〉0．05）。结论盐酸二甲双胍联合辛伐他汀具有降低奥氮平诱导性肥胖大鼠空腹血糖、肿瘤坏死因子-α水平及调节血脂的作用。     

A randomized, open-label study to evaluate the efficacy and safety of pitavastatin compared with simvastatin in Korean patients with hypercholesterolemia

BACKGROUND: Pitavastatin is a 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor used to treat hypercholesterolemia. OBJECTIVE: The goal of this study was to compare the efficacy and safety of pitavastatin versus those of simvastatin in Korean patients with hypercholesterolemia. METHODS: This was an 8-week, multicenter, prospective, randomized, open-label, Phase III clinical trial. Male and female Korean patients with hypercholesterolemia who were between the ages of 20 and 75 years and who had a fasting triglyceride level <600 mg/dL and a low-density lipoprotein (LDL) cholesterol level >130 mg/dL after a 4-week dietary lead-in period were eligible for entry. Eligible patients were randomized into 2 groups in a 1:1 ratio. Patients received pitavastatin 2 mg once daily or simvastatin 20 mg once daily for 8 weeks. The medication was administered initially for 4 weeks, and an additional 4 weeks of study medication was prescribed at week 4. The final visit was conducted 8 weeks after randomization. RESULTS: Of the 104 patients randomized to treatment, 95 patients (59 women; 36 men) completed the study (49 in the pitavastatin group [mean age, 59.9 years] and 46 in the simvastatin group [mean age, 56.4 years]). No significant difference was found between groups with respect to patient age, sex, or body mass index. There was no significant difference in the percent decrease in LDL cholesterol levels (mean [SD], 38.2% [11.6%] decrease for the pitavastatin group vs 39.4% [12.9%] decrease for the simvastatin group [P = 0.648]). Also, there were no significant differences between the 2 study groups in the percent changes in total cholesterol, triglyceride, or high-density lipoprotein (HDL) cholesterol levels from baseline to study end. No significant difference was observed for the proportion of patients who achieved the LDL cholesterol goal of the National Cholesterol Education Program Adult Treatment Panel III: 93.9% (46/49) of patients in the pitavastatin group and 91.3% (42/46) of patients in the simvastatin group (P = 0.709) met the target level. At least 1 clinical adverse event and at least 1 adverse drug reaction were observed in 25.0% (13/52) and 11.5% (6/52), respectively, of patients in the pitavastatin group, and 37.3% (19/51) and 23.5% (12/51), respectively, in the simvastatin group; this difference was not statistically significant. The most common adverse event was an elevation in creatine kinase levels >2 times the upper limit of normal in 3.8% of pitavastatin-treated patients and 9.8% of simvastatin-treated patients (P = 0.269). There were no serious adverse drug reactions observed in either group. CONCLUSION: The HMG-CoA reductase inhibitor pitavastatin was found to be noninferior to simvastatin in terms of reducing LDL cholesterol, total cholesterol, and triglyceride levels, and increasing HDL cholesterol levels, in Korean patients with hypercholesterolemia after 8 weeks of treatment.