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综述:他汀致新发糖尿病发病风险研究进展

2016-09-18 苏欣 赵水平 中华心血管病杂志

美国糖尿病学会(ADA)在Diabetes Care发表了《2015年ADA糖尿病医学诊疗标准》[1],强调40岁以上糖尿病患者均应常规接受他汀治疗;40~75岁糖尿病患者应接受中等或高等强度的他汀治疗;此外,对所有伴心血管疾病的糖尿病患者以及存在任一心血管疾病风险因素的40~75岁患者,均应接受高强度他汀治疗。新版ADA指南一个明显变化是,对糖尿病患者是否应用他汀治疗及用药强度,应根据患者的

美国糖尿病学会(ADA)在Diabetes Care发表了《2015年ADA糖尿病医学诊疗标准》[1],强调40岁以上糖尿病患者均应常规接受他汀治疗;40~75岁糖尿病患者应接受中等或高等强度的他汀治疗;此外,对所有伴心血管疾病的糖尿病患者以及存在任一心血管疾病风险因素的40~75岁患者,均应接受高强度他汀治疗。新版ADA指南一个明显变化是,对糖尿病患者是否应用他汀治疗及用药强度,应根据患者的风险评估情况来决定,而不再是根据低密度脂蛋白胆固醇(LDL-C)水平[1,2]。


然而,随着药物研究深入以及他汀使用人群扩大,由他汀所致的新发糖尿病等不良反应事件发生率增高。尽管他汀对心血管的益处毋庸置疑,但该药潜在的致糖尿病风险已经引起了人们担忧。如何合理应用他汀、减少由他汀引起的不良事件,是目前广受关注的一个重要医疗问题。

一、他汀引起新发糖尿病现状

已有多项研究表明他汀可升高新发糖尿病发病风险。2012年,Ridker等[3]对JUPITER研究进行再分析,结果显示对具有至少1项糖尿病主要危险因素的受试者,他汀治疗5年可使新发糖尿病的风险增加28%,同时糖化血红蛋白也明显增高。2013年,对住院期间服用他汀治疗的136 966例患者进行分析表明,在常规服用他汀治疗的头2年,约3 600例患者被确诊患有糖尿病,使用大剂量他汀者较使用较小剂量者糖尿病患病数增加了15%;新发糖尿病风险增高,且在服用他汀治疗开始的头4个月,新发糖尿病增加的风险最高(增加26%)[4,5]。研究表明大剂量他汀治疗所致新发糖尿病风险高于低剂量他汀,且风险与他汀剂量呈正相关性。

2014年,JACC上发表1篇针对他汀潜在新发糖尿病风险的研究结果,针对TNT、IDEAL和SPARCL试验的15 056例初始无糖尿病的冠心病患者进行分析,发现基线时伴有0~1个危险因素的患者,在高剂量他汀组4 407例中有142例、低剂量他汀组4 418例中有148例新发糖尿病;基线时伴有2~4个危险因素的患者中,在高剂量组3 128例患者中有448例、低剂量组3 103例患者有368例新发糖尿病[6,7]。同年,意大利发表1项大型人群队列研究结果,纳入意大利115 709名居民,结果显示,11 154名参与者在随访期间出现新发糖尿病,且发病风险比随着依从性而变化,相比他汀治疗依从性极低(他汀治疗天数比例<25%)的人群,依从性低(26%~50%)、依从性中等(51%~75%)和依从性高(≥75%)的风险比分别为1.12、1.22和1.32[8]。研究表明新发糖尿病风险随着他汀治疗依从性提高而增加。

2015年,一项男性代谢综合征试验研究,纳入8 749例年龄为45~73岁无糖尿病男性患者,随访6年,在2 142例服用他汀患者中625例诊断为糖尿病,他汀所致糖尿病风险达到46%。在调整年龄、性别等相关因素后发现,他汀治疗与2型糖尿病风险增加相关,风险比(HR)为1.46;大剂量辛伐他汀的HR为1.44,小剂量为1.28;大剂量阿托伐他汀HR为1.37,说明他汀致糖尿病风险有剂量依赖性。此外,他汀治疗组较非他汀治疗组患者胰岛素敏感性降低24%,胰岛素分泌减少12%[9,10]。这些研究结果提示,在决定应用他汀类药物进行心血管疾病一级预防时,需审慎考虑[11]。

二、他汀致新发糖尿病的机制

1.他汀可影响胰岛素敏感性及细胞摄取血糖过程:

JUPITER和CORALL研究[12]结果均显示,他汀可降低胰岛素敏感性,从而影响血糖控制,引起2型糖尿病发病增加。Koh等[13]的荟萃分析纳入24项他汀试验,比较普伐他汀、阿托伐他汀、辛伐他汀和瑞舒伐他汀对胰岛素敏感性的影响,发现普伐他汀可增加患者胰岛素敏感性和脂联素分泌,而辛伐他汀、瑞舒伐他汀、阿托伐他汀可致胰岛素敏感性下降和脂联素分泌减少,且三者剂量与空腹血浆胰岛素和糖化血红蛋白水平呈正相关,与胰岛素敏感性呈负相关。这表明,他汀可通过降低胰岛素敏感性,致使患者出现新发糖尿病。

除了影响胰岛素敏感性,他汀还可直接影响细胞对血糖的摄取过程。研究证明,释放至细胞外液的胰岛素,通过激活胰岛素受体酪氨酸激酶,增加细胞膜外葡萄糖转运体4水平,从而促进细胞摄取血糖[14]。研究者对2型糖尿病小鼠模型的研究表明,阿托伐他汀和辛伐他汀可通过甲羟戊酸途径阻碍葡萄糖转运体4表达,减少小鼠细胞血糖摄取,从而导致胰岛素抵抗[14]。该机制还被1项来自日本的研究所证实[15],该研究针对78例2型糖尿病和高胆固醇血症患者,接受常规阿托伐他汀治疗后,患者糖化血红蛋白显著升高,提示他汀不仅影响胰岛素敏感性,还可直接作用于细胞摄取葡萄糖的过程。

他汀引发糖代谢异常很可能只是一种药物类效应。但他汀所致新发糖尿病风险的强度具有异质性,依赖于他汀种类、剂量或个体自身的糖尿病易患因素[13,14,15]。

2.他汀通过β细胞影响胰岛素分泌:

他汀既可通过抑制HMG-COA还原酶的直接作用,又可经过减少体内胆固醇而减少胰岛素分泌,从而引起新发糖尿病。相关研究证明[4,5,6],当葡萄糖浓度低时,辛伐他汀和阿托伐他汀能升高MIN6细胞(属于β细胞系)的基础胰岛素分泌;而当葡萄糖浓度高时,两者不增加胰岛素分泌。而普伐他汀没有明显改变胰岛素分泌。由于辛伐他汀和阿托伐他汀是亲脂性他汀,而普伐他汀是水溶性他汀,因此,可以推测亲脂性他汀被β细胞摄取后,通过抑制HMG-CoA还原酶作用,降低了β细胞内葡萄糖介导的胰岛素释放。另外,Xia等[16]通过抑制MIN6细胞的鲨烯环氧酶,使胆固醇分泌减少。当胆固醇缺乏时,细胞膜上电压门控钙通道受到抑制,引起胰岛素释放减少,而这一现象在胆固醇充足时会逆转。可推断他汀的降胆固醇作用会间接导致胰岛素分泌减少。

此外,有实验说明胰岛β细胞极易受损并凋亡[17]。而人体内LDL,尤其氧化型LDL,可刺激细胞免疫应答,导致炎症级联反应,损伤β细胞结构与功能完整性,抑制β细胞增殖,导致胰岛素分泌减少。他汀虽能降低体内胆固醇,但其具有不可忽视的抑制内源性胆固醇合成作用,会促使外源性胆固醇激活β细胞内有害的免疫炎症反应,加重β细胞受损。

3.遗传基因突变作用促进血糖增高:

近期由Swerdlow等[18]的多国研究团队深入探讨了他汀升血糖的作用机制,评估其是否与他汀直接抑制HMG-COA还原酶有关。该项研究收集了223 463名个体的数据,采用孟德尔随机化原理,研究HMG-COA编码基因的常见突变(单核苷酸多态性位点rs17238484和rs12916)。结果显示,rs17238484-G等位基因个体平均LDL-C下降0.06 mmol/L,但胰岛素浓度增加1.62%,血糖上升0.23%, 2型糖尿病发病风险增加(HR=1.02)。rs12916-T等位基因个体有类似的结果。此外,在129 170名参与临床试验的个体中,他汀治疗1年后进行随访,发现患者LDL-C平均下降0.92 mmol/L,而体重平均增加0.24 kg;随访4.2年,他汀组新发2型糖尿病风险比较对照组增加。研究结果提示,当HMG-COA编码基因的发生突变使HMG-CoA还原酶结构或功能受抑制时,患者体内血糖升高。而他汀作为HMG-CoA还原酶抑制剂,其抑制HMG-CoA还原酶的功能很可能是引起新发糖尿病的机制之一。

三、如何防治他汀相关性新发糖尿病

他汀致新发糖尿病是诸多因素综合作用的结果。虽然与中等剂量他汀组相比,强化剂量他汀组糖尿病风险增加12%,但是心血管事件风险却降低16%。现有的研究结果表明,他汀降低心血管事件的益处明显超过其致新发糖尿病的风险。因此,针对心血管事件高风险人群,使用他汀降脂治疗、防治心血管事件的策略无需改变,但应完善监测糖尿病高风险患者的血糖水平;而对于心血管事件低风险或健康人群,运用他汀治疗前,应进行利弊分析,慎重抉择。

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    分享一下!

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    2016-09-27 童小孩

    学习了,很受益,谢谢分享,继续关注中!

    0

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    2016-09-22 1e10c84am36(暂无匿称)

    文章很好,非常有益

    0

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    2016-09-20 忠诚向上

    多学学会有用

    0

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