匹伐他汀治疗糖尿病高胆固醇血症的疗效研究

目的探讨匹伐他汀治疗糖尿病高胆固醇血症的临床治疗效果及应用价值。方法选择涪陵区中心医院治疗的糖尿病高胆固醇血症患者142例,分为试验组和对照组各71例。两组均给予常规降糖治疗,对照组给予阿托伐他汀治疗,试验组给予匹伐他汀治疗,观察两组治疗效果。结果试验组空腹血糖及餐后血糖改善程度、糖化血红蛋白降低程度均优于对照组,差异有统计学意义(P0.05)。试验组患者不良反应发生率低于对照组,差异有统计学意义(P0.05)。两组患者三酰甘油、总胆固醇和低密度脂蛋白水平较治疗前均明显降低,但两组治疗后相比较差异无统计学意义(P0.05)。结论采用匹伐他汀治疗糖尿病高胆固醇血症可以明显改善糖尿病患者血糖、血脂代谢紊乱状态,不良反应少,值得在临床上推广使用。     

瑞舒伐他汀与辛伐他汀治疗高胆固醇血症的疗效及安全性

选取我院收治的高胆固醇血症患者80例,将所有患者随机分为观察组和对照组,观察组给予瑞舒伐他汀治疗,对照组给予辛伐他汀治疗。观察组总有效率明显大于对照组(P0.05);两组患者的不良反应均较轻微,均不影响治疗,且经肝肾功能等检查均未见异常。与辛伐他汀相比,瑞舒伐他汀治疗高胆固醇血症患者疗效更加确切,可明显改善患者血脂情况,且安全可靠,值得临床推广。     

氟伐他汀治疗老年高胆固醇血症的临床研究

目的：研究氟伐他汀对老年高胆固醇血症的治疗效果并与辛伐他汀比较。方法：采用随机、单盲的方法,６８例老年高胆固醇血症患者随机分为两组,服药前及服药后４周、８周测定血脂（胆固醇、甘油三酯）,同时测血尿素氮、肌酐、ＡＬＴ、肌酸激酶和血糖。结果：治疗后４周ＴＣ分别降低了２３．２％和２２．１％;降低ＬＤＬ－Ｃ分别是２９．１％和２８．２％作用相似;氟伐他汀明显降低血清ＴＧ水平１９．２％;载脂蛋白（ＡＰＯ）Ａ１分别增加了１３．１％和１２．２％;ＡＰＯＢ水平分别下降８．１％和７．０％;分别使脂蛋白Ａ（ＬＰａ）水平降低了３１．１％和２４．０％;治疗８周后疗效与４周比较无明显差异。结论：氟伐他汀治疗老年高胆固醇血症能显著降低Ⅱａ和Ⅱｂ型高胆固醇血症患者ＴＣ、ＬＤＬ－Ｃ,其作用与辛伐他汀相等;氟伐他汀降低ＴＧ作用优于辛伐他汀。     

匹伐他汀的降糖效果及其治疗糖尿病高胆固醇血症的疗效

目的观察匹伐他汀的降糖效果及其治疗糖尿病高胆固醇血症的疗效。方法选取2012年1月至2013年3月就诊治疗的106例糖尿病高胆固醇血症患者作为研究对象,随机分为对照组和观察组各53例。所有患者在服用二甲双胍降糖药和控制饮食治疗的同时,对照组给予口服阿托伐他汀药物治疗,观察组给予匹伐他汀药物治疗,比较分析两种药物的降糖效果及降脂效果。结果与治疗前比较,观察组空腹血糖(FBS)和糖化血红蛋白(HbA1c)均显著降低(P0.05),对照组FBS、餐后血糖(PBG)、HbA1c变化均无显著性差异(P0.05);治疗后观察组FBS、HbA1c与对照组相比差异具有显著性(P0.05),而PBG两组比较差异无显著性(P0.05)。两组患者治疗前后总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)和高密度脂蛋白胆固醇(HDL-C)比较差异均具有显著性(P0.05),治疗后观察组TC、TG和LDL分别降低了10.41%、17.92%和12.98%,对照组TC、TG和LDL-C分别降低了9.94%、15.97%和13.46%,组间比较差异无统计学意义(P0.05);而观察组HDL-C升高达9.12%,对照组HDL-C升高6.31%,观察组明显高于对照组,组间比较差异具有统计学意义(P0.05)。观察组不良反应发生率为3.77%,对照组不良反应发生率为7.55%,组间比较差异无显著性(P0.05)。结论匹伐他汀能够增加高密度脂蛋白胆固醇水平,而且对患者FBS和HbA1c的降低作用优于阿托伐他汀,是一种安全有效的治疗糖尿病高胆固醇血症的药物,值得临床广泛应用。     

瑞舒伐他汀对高胆固醇血症患者炎症细胞因子的影响

目的:探讨瑞舒伐他汀对高胆固醇血症患者炎症细胞因子的影响,证实瑞舒伐他汀的抗炎作用.方法:入选110例高胆固醇血症患者,随机分成瑞舒伐他汀治疗组36例、阿托伐他汀治疗组38例和饮食治疗组36例;我院体检中心入选30例健康者作为正常对照组.给予瑞舒伐他汀、阿托伐他汀治疗及饮食治疗治疗8周,治疗前及治疗后分别检测白介素-6(IL-6)、白介素-10(IL-10)及肿瘤坏死因子α(TNF-α)等.结果:与治疗前相比,瑞舒伐他汀治疗组和阿托伐他汀治疗组治疗8周后IL-6及TNF-α显著降低(均P<0.05),而IL-10显著升高(均P<0.05).饮食治疗组治疗8周后IL-6、IL-10及TNF-α差异无显著性(均P>0.05).结论:瑞舒伐他汀能够显著升高血清IL-10水平,而显著降低血清IL-6和TNF-α水平,可能是其抗动脉粥样硬化及改善心血管疾病预后的重要机制之一.     

老年冠心病患者应用匹伐他汀钙治疗的疗效及安全性分析

选择80例老年冠心病患者,将其分成两组,对照组使用辛伐他汀进行治疗,观察组使用匹伐他汀进行治疗,观察两组的治疗效果以及患者磷酸肌酸激酶、血脂、肝功能的情况。结果治疗后观察组无不良反应,对照组不良反应较轻,有3例谷草转氨酶轻度的增高。对于老年冠心病患者使用匹伐他汀钙治疗的效果不错,且对肝功能的损害也较轻。     

阿托伐他汀对家族性高胆固醇血症的临床治疗和药理作用

目的 用阿托伐他汀治疗家族性高胆固醇血症并对其药理作用进行研究.方法 95 例患者服用阿托伐他汀10 mg/d,疗程一个月,观察其疗效,并分析治疗前后的数据.结果 治疗1 个月后患者病情均有所好转,数据均反映患者的总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL-C)下降,高密度脂蛋白(HDL-C)升高,对C反应蛋白(CRP)升高有减低作用.结论 阿托伐他汀能安全有效的治疗家族性高胆固醇血症.     

阿托伐他汀联合应用依折麦布治疗高胆固醇血症者

目的：观察联合应用阿托伐他汀与依折麦布治疗对严重高胆固醇血症患者的降脂疗效。方法：40例严重高胆固醇血症患者用阿托伐他汀（20mg&#183;d^-1）治疗后低密度脂蛋白胆固醇（LDL-C）未达标（〈2．6mmol．L）的患者联合应用依折麦布（10mg&#183;d^-1），观察治疗12周后的血脂水平，并观察对谷转氨酸（AST）、谷丙转氨醇（ALT）和肌酸激醇（CK）的影响。结果：全部患者的基线总胆固醇（TC）、低密度脂蛋白的胆固醇（LDL-C）、三酰甘油（TG）、载脂蛋白B（ApoB）、脂蛋白[α（Lp（a））]在服用阿托伐他汀后均有明显降低，高密度脂蛋白的胆固醇（HDL-C）有明显上升，P〈0．01。联用依折麦布后，TC、LDL-C、ApoB有进一步的下降，P〈0．01，TG、HDL-C和Lp（a）虽有下降但无统计学差异。治疗前后AST、ALT和CK均无明显异常变化。结论：阿托伐他汀联合应用依折麦布对高胆固醇血症患者有更好的降脂（LDL—C）效果，并提高降脂达标率。     

Therapeutic Effects and Safety of Pitavastatin Calcium Tablets on Clinical Hypercholesterolemia

目的 观察匹伐他汀钙治疗高胆固醇血症的安全性和有效性.方法 采用随机、双盲、阳性药物平行对照方法,将入选的高胆固醇血症48例经4周停用降血脂药物处理后,随机接受A药(匹伐他汀钙每日1 mg,A组)、B药(匹伐他汀钙每日2 mg,B组)和C药(辛伐他汀胶囊每日20 mg,C组)治疗,疗程8周.分别于治疗前、治疗4周及8周末检测计算血清低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)改变百分数,并记录血常规、尿常规、心电图、血生化检测结果及不良反应发生情况,分析降脂效果和安全性,并对3组进行比较.结果 治疗前3组年龄、性别、身高、体重、收缩压、舒张压、心率以及LDL-C、TC、TG水平比较差异均无统计学意义(P ＞0.05);HDL-C水平比较差异有统计学意义(P＜0.05),行Kruskal-Wallis检验,发现B组与C组比较差异有统计学意义(P＜0.05).与治疗前比较,治疗4周和8周末3组LDL-C、TG、TC水平均下降,差异有统计学意义(P＜0.05).3组血脂改变百分数比较差异均无统计学意义(P＞0.05).3组均未出现严重不良反应及紧急破盲事件,且无未预知的不良反应发生.结论 临床使用匹伐他汀钙每日1～2 mg治疗高胆固醇血症,能有效降低LDL-C、TC、TG水平,效果确切、安全.     

Hypercholesterolemia: a look at low-cost treatment and treatment adherence

PURPOSE: To determine whether a positive cholesterol-lowering effect could be achieved with a psyllium dose of 6 grams per day instead of the usual 10 grams per day as advocated by other researchers. DATA SOURCES: Randomized trial of 46 males and females with hypercholesterolemia; multivariate analysis of variance with repeated measures on 1 factor done on 28 subjects (18 in treatment group, 10 in control group) remaining after 16 weeks of treatment. CONCLUSIONS: Lipoprotein analysis at 2, 8, and 16 weeks indicated that a daily dose of 6 grams of psyllium hydrophilic mucilloid did not significantly affect serum total cholesterol nor low-density lipoproteins in either men or women with hypercholesterolemia. The effects of psyllium on hypercholesterolemia appear to be dose dependent. PRACTICE IMPLICATIONS: Although it is a low cost option, the addition of psyllium to the diet has unpleasant side-effects, including abdominal distention, flatulence, and discomfort. Because these side effects are troublesome, the lowest effective dose of psyllium may be an important factor in improving treatment adherence.     

辛伐他汀对高胆固醇血症患者动脉弹性的影响

目的探讨辛伐他汀对高胆固醇血症患者动脉弹性的影响。方法采用动脉弹性功能测定仪检测52例高胆固醇血症患者使用辛伐他汀前和使用4周后大动脉弹性（C1）、小动脉弹性（C2）和血浆总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）。结果用药4周后，TC和LDL-C均较用药前明显下降（均为P〈0．01），C1和C2较用药前明显升高（均为P〈0．01）。结论辛伐他汀可明显降低高胆固醇血症患者TC和LDL-C，同时显著改善动脉弹性。     

Comparison of Scaled-average,Population, and Individual Bioequivalence on 2 Tablets of Pitavastatin Calcium: A 3-Period,Reference-replicated,Crossover Study in Healthy Chinese Volunteers

Background

Pitavastatin, a fully synthetic β-hydroxy-β-methylglutaryl–coenzyme A reductase inhibitor, is potent for the treatment of primary hyperlipidemia and mixed dyslipidemia. Recently, the original product and some generic products of pitavastatin calcium have become available in China. However, the intrasubject variability and interchangeability of this newly developed generic product and the branded innovator product have rarely been investigated in the Chinese population.

Purpose

The aim of this study is to develop and compare the scaled-average, population, and individual bioequivalence (BE) of pitavastatin calcium tablets in healthy Chinese volunteers. This study will be used to allow for the interchangeability (switchability and prescribability) of the 2 products in clinical medication in China.

Methods

A single-dose, reference-replicated, 3-period crossover BE study was conducted in 36 healthy male volunteers. Plasma samples were collected before and after oral administration of 2-mg test or reference tablets. A LC-MS/MS method was used to determine the concentration of pitavastatin calcium. A noncompartmental method was used to investigate the pharmacokinetic parameters. The ANOVA and 90% CIs of ln(AUC_0–t) and ln(C_max) were used for statistical analysis of scaled-average BE. A nonparametric test (Wilcoxon signed rank test) was performed to T_max. The analyses of population BE and individual BE were used to assess the switchability and prescribability of the 2 products.

Findings

Thirty-six volunteers were enrolled in this clinical research; 33 volunteers completed the 3 treatment periods. The mean (SD) relative bioavailability calculated from the ratios (T/R) of AUC_0–t was 101.3% (19.7%). The mean ln(AUC_0–t) and ln(C_max) were 98.64 (90% CI, 93.44–104.13) and 98.68 (90% CI, 91.88–105.99) within previously stipulated ranges recommended by the US Food and Drug Administration and the China Food and Drug Administration (CFDA). The intrasubject %CVs of AUC_0–t and C_max were 12.0% and 18.0% for the reference tablet and 13.0% and 17.0% for the test tablet. No significant differences were found among T_max (0.742 ± 0.276, 0.674 ± 0.202, and 0.689 ± 0.226, respectively) for reference tablet 1, reference Supplemental Table II in the online version at 10.1016/j.clinthera.2014.06.21, and test tablet by a Wilcoxon test (P > 0.05). For ln(AUC_0–t) and ln(C_max), the statistical test-reference ratios were 99.13% and 98.95%, respectively. After inspecting the results for reference and mixed scaling, all the upper confidence limits were <0; therefore, population and individual BE were given.

Implications

In the healthy Chinese males, the generic and branded name tablets of pitavastatin calcium are bioequivalent at the rate and extent of absorption after a comparison of scaled-average, population, and individual BE and thus may be used interchangeably. Both the formulations are generally well tolerated. Chinese Clinical Trial identifier: ChiCTR-TTRCC-13003973.     

Alleviation of Migraines with Therapeutic Vitamin D and Calcium

SYNOPSIS
Two postmenopausal migraineurs who developed frequent and excruciating migraine headaches (one following estrogen replacement therapy and the other following a stroke) were treated with combination vitamin D and calcium. Therapeutic replacement with vitamin D and calcium resulted in a dramatic reduction in the frequency and duration of their migraine headaches.     

术前提高血钙浓度对剖宫产产后出血的影响

目的:探讨术前应用葡萄糖酸钙对剖宫产产后出血的有效性及安全性。方法:对709例患者采用随机对照的方法进行研究。研究组术前30 min静脉滴注10%葡萄糖酸钙10 mL,对照组静脉滴注生理盐水100 mL,分别于术中胎儿娩出时、术后2 h测定血清钙离子的浓度,并用容积法和称重法对两组出血量进行对比观察。结果:胎儿娩出时和术后2 h研究组血清钙高于对照组(P<0.01);研究组平均出血量和产后出血的发生率低于对照组(P<0.01);术前血钙浓度高的产后出血量少(P<0.01);不同剖宫产指征的出血量比较研究组低于对照组(P<0.01);各项指标均具统计学意义。结论:术前提高血钙浓度可减少剖宫产产后出血量,并未见副作用。     

A Multicenter,Randomized, Double-blind,Active-controlled,Factorial Design,Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia

PurposePitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia.MethodsKorean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4–8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients.FindingsThe percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (–52.8% [11.2%]) and pooled pitavastatin (–37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C–lowering effect than that with pitavastatin (difference, –15.8 mg/dL; 95% CI, –18.7 to –12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups.ImplicationsPitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. ClinicalTrials.gov identifier: NCT04584736.     

高胆固醇血症是造影剂肾损害的促进因素

目的 评价高胆固醇血症对造影剂肾损害的影响。方法 雄性Wistar大鼠给予正常饮食（N组）或高胆固醇饮食（H组，4％胆固醇和1％胆酸钠）。在第4周和第8周末，分别从每组大鼠中取6只大鼠尾静脉注射60％泛影葡胺（6mL/kg,NC组和HC组），另取6只大鼠尾静脉注射等量生理盐水。注射造影剂后的第2天测定四组大鼠的血清总胆固醇（TC）、甘油三酯（TG）、血肌酐（Scr)、内生肌酐清除率（Ccr)、钠钾排泄分数（FENa%、FEK％）及肾皮质一氧化氮（NO）的含量；彩色多普勒和频谱式多普勒测定肾血液；光镜观察肾组织学改变。结果 4周和8周时，H组和HC组TC均显著性高于N组和NC组。HC组大鼠4周时出现Ccr下降及FEK％升高，8周时还出现Scr、FENa%显著性升高；NC组大鼠在4周和8周时均仅见FEK％增加；H组大鼠在8周时出现Ccr下降。4周时HC组大鼠肾血管阻力指数显著性增加，8周时H组及HC组大鼠肾血管阻力指数均显著性增加。8周时H组及HC组大鼠肾皮质NO含量显著性降低。组织形态学显示：4周和8周时HC组大鼠分别出现肾小管上皮细胞的灶性坏死及弥漫坏死，NC组及H组均仅见肾小管变性。结论 高胆固醇血症是造影剂肾损害的促进因素，NO的减少可能介导了高胆固醇血症环境下造影剂诱导的急性肾衰的发病。     

高胆固醇血症患者血浆对氧磷酯酶1活性变化的研究

目的：观察高胆固醇血症（HC）患者血浆对氧磷酯酶1（PON1）活性的变化及其与高胆固醇血症之间的关系。方法：测定109例高胆固醇血症组患者和66例对照组患者血浆PON1活性、血脂、氧化修饰低密度脂蛋白（ox-LDL）水平及丙二醛（MDA）含量,并进行对比分析。结果：高胆固醇血症患者血浆PON1活性（138．1±62．4kU·L^-1）较对照组（171．4±66．2kU·L^-1）显著降低（P〈0．01）;而MDA及ox-LDI。含量（12．8±3．8μmol·L^-1,589．1±198．2μg·L^-1）均较对照组（9．7±2．3μmol·L^-1,455．1±178．2μg·L^-1）显著升高（P（0．01）。相关分析显示,PON1活性与MDA及ox-LDL含量呈显著负相关（r=-0．441,P〈0．01;r=-0．402,P〈0．01）。结论：高胆固醇血症患者存在的氧化应激可能导致血浆PON1活性降低。