患有CKD的糖尿病患最好适当控制血糖


  【24drs.com】根据一篇新研究,对于患有慢性肾脏病(CKD)的糖尿病患,糖化血色素(HbA1c))目标介于7%-9%者,则副作用风险降低,若数据超出或低于前述范围时,风险则会增加。
  
  加拿大Alberta大学的Sabin Shurraw医师等人在11月28日内科医学志刊载的文章中写道,HbA1c数值较高与多种临床相关结果,包括死亡率、心血管事件、住院与恶化成肾衰竭有独立且强烈的关联。
  
  他们的研究结果和「一般糖尿病患中,患有第3-4期CKD者若有较佳的血糖控制,则倾向可改善临床结果」之假设一致,但是,若过度治疗(HbA1c值低于7%)也可能有伤害。
  
  虽然患有第3-4期CKD之糖尿病患有较佳的血糖控制时,前述4项结果的风险降低,但是,另一个结果:末期肾脏病(ESRD),第4期CKD者的风险降低程度低于3期CKD者。
  
  这篇研究使用的资料,来自2005-2006年该省卫生部与Alberta Kidney Disease Network患有DM和CKD的病患,检视血糖控制和不佳结果之间的关联。
  
  CKD之监定是透过例行性的血清肌酸酐检测,定义为估计肾丝球过滤速率(eGFR)小于60.0 mL/分钟/1.73 m2;总共有23,296名病患符合研究规范,多数(21,155人)为第3期CKD (eGFR,30.0 - 59.9 mL/分钟/1.73 m2,2,141人为第4期CKD (eGFR,15.0 - 29.9 mL/分钟/1.73 m2)。
  
  HbA1c中位数为6.9% (范围2.8% - 20.0%),11%的研究对象其HbA1c值大于9%。
  
  该研究的初级结果为各种原因死亡率,其它结果为心血管事件、住院、恶化为肾脏病(血清肌酸酐值加倍)与ESRD。
  
  追踪期间中位数为3.8年(范围1 – 51个月),16%病患死亡、49%住院、16%有任何一种心血管事件、6%恶化性肾脏病、2%发生ERSD。
  
  这篇分析校正了几项可能的干扰因素:年纪、性别、指标eGFR、个别的健康保险范围(个别收入指标)、邻近地区收入中位数、共病症、居住地区等。
  
  研究者发现,对于第3和第4期CKD者,较高的HbA1c值与各种原因死亡率、心血管事件、住院、恶化成肾脏病等风险增加有关(P < .001),但是,在ESRD这个结果方面,第4期CKD者的关连程度低于3期CKD者。
  
  特别的是,对于这2期的CKD,HbA1c值大于9%时,各种原因的死亡率风险显著高于HbA1c值低于7%者(校正风险比[HR], 1.35;95%信心区间[CI]1.21 - 1.50),不过,这个关联趋势呈现U字型,在HbA1c值大于8%或低于6.5%者,死亡率风险比HbA1c值7%者增加。
  
  作者们推测,如同「Action to Control Cardiovascular Risk in Diabetes (ACCORD)」这项试验的研究对象,有道理的是,患DM和CKD的病患若治疗达到HbA1c值低于6.5%,可能会发生因为严重低血糖事件、或者平均血糖值骤降而引起伤害。
  
  类似的是,对于第3和第4期CKD者,相较于HbA1c值低于7%者,HbA1c值高于9%时和住院率风险增加(校正相对风险[RR]分别是1.44 [95% CI,1.36 - 1.52]和1.25 [95% CI,1.01 - 1.54])、以及恶化成肾脏病(校正HR,1.77分别是[95% CI,1.48 - 2.13]与1.40 [95% CI,1.17 - 1.67])有关。
  
  不过,对于ESRD,相较于第4期CKD患者(校正HR,1.13 [95% CI,0.80 - 1.59]),HbA1c值较高与第3期CKD患者(校正HR,2.52 [95% CI,1.58 - 4.02])风险更高有关。
  
  作者们推测,这个结果或许可以代表肾脏功能的一个「不归路」,超过此指标时,更好的血糖控制或许不足以预防肾功能逐渐丧失。
  
  David C. Goff博士受邀评论这篇报告时指出,研究结果强调了考量相对与绝对利益或风险的重要性,特别是检视风险或治疗效果差异的次组时。
  
  来自南卡罗来纳州Wake Forest医学院流行病学与预防系的Goff博士指出,如果要根据估计的校正绝对风险探讨这些资料,ESRD在良好与不佳血糖控制的差异为,第3期CKD患者是0.60%、第4期CKD患者则是1.41%
  
  就这个观点看来,密集的血糖控制可能会使第4期CKD患者对ESRD有比第3期CKD患者大的预防效果,这个推论和作者们仅根据相对风险(潜在的相对风险降低)时有所不同。
  
  不过,Goff博士认为,整体的研究结果强调了HbA1c值高是心血管和肾脏方面结果之风险指标的重要性,因为没有强力证据针对末期CKD和DM病患,比较慎重的作法是,至少要注意中度风险因素,尽可能使治疗处方的可能严重风险降到最低。
  
  资料来源:http://www.24drs.com/professional/list/content.asp?x_idno=6667&x_classno=0&x_chkdelpoint=Y
  

In Diabetes With CKD, Moderate Glycemic Control May Be Ideal

By Kate Johnson
Medscape Medical News

November 30, 2011 — In patients with diabetes mellitus (DM) and chronic kidney disease (CKD), hemoglobin A1c (HbA1c) targets that fall between 7% and 9% may be associated with decreased risk for adverse outcomes, whereas levels either above or below this range may increase this risk, according to a new study.

"[W]e found strong and independent associations between higher levels of HbA1c and multiple clinically relevant outcomes, including mortality, [cardiovascular] events, hospitalization, and progression to kidney failure," write Sabin Shurraw, MD, from the University of Alberta in Edmonton, Canada, and colleagues, in an article published in the November 28 issue of the Archives of Internal Medicine.

"Our findings are consistent with the hypothesis that (as in the general population of patients with DM) better glycemic control in patients with stage 3 to 4 CKD tends to improve clinical outcomes, but that overly intensive therapy (ie, HbA1c target level lower than 7%) may be harmful," they write.

However, although risk reduction for 4 outcomes was associated with better glycemic control among patients with both stage 3 and 4 CKD, findings for a fifth outcome, end-stage renal disease (ESRD), showed that the association between better glycemic control and reduced risk was actually weaker for those with stage 4 CKD compared with for those with stage 3 disease.

The study used data on patients with both DM and CKD from the Alberta Kidney Disease Network and the provincial health ministry from 2005 through 2006 to examine the association between glycemic control and adverse outcomes.

CKD was identified through routine serum creatinine measurements and was defined as an estimated glomerular filtration rate (eGFR) of less than 60.0 mL/minute per 1.73 m2.

A total of 23,296 patients met criteria for the study, most (n = 21,155) with stage 3 CKD (eGFR, 30.0 - 59.9 mL/minute per 1.73 m2), and 2141 with stage 4 CKD (eGFR, 15.0 - 29.9 mL/minute per 1.73 m2).

The median HbA1c level was 6.9% (range, 2.8% - 20.0%), and 11% of the participants had an HbA1c level higher than 9%.

The primary outcome for the study was all-cause mortality, with other outcomes being cardiovascular events, hospitalizations, progression of kidney disease (based on a doubling of serum creatinine level), and ESRD.

During the median follow-up period of 3.8 years (range, 1 - 51 months), 16% of patients died, 49% were hospitalized, 16% had any cardiovascular event, 6% had progression of kidney disease, and 2% developed ERSD.

The analysis was adjusted for the following potential confounders: age, sex, index eGFR, individual health insurance premium level (a marker for individual level income), median neighborhood income, comorbidity, and residence location.

The researchers found that for both stage 3 and stage 4 CKD, higher HbA1c levels were associated with an increased risk for all-cause mortality, cardiovascular events, hospitalizations, and progression of kidney disease (P < .001), but for the ERSD outcome, the magnitude of this association was weaker among those with stage 4 CKD compared with those with stage 3 CKD.

Specifically, for both stages of CKD, HbA1c levels above 9% were associated with significantly higher all-cause mortality than HbA1c levels below 7% (adjusted hazard ratio [HR], 1.35; 95% confidence interval [CI], 1.21 - 1.50), although there was a U-shape to this association, in that HbA1c levels greater than 8% or lower than 6.5% were associated with increased mortality compared with levels of 7%.

"As with participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, it is plausible that patients with DM and CKD who are treated to an HbA1c level lower than 6.5% might experience iatrogenic harm owing to serious hypoglycemic events or too precipitous a fall in average glucose," the authors speculate.

Similarly, for both stages 3 and 4 CKD, HbA1c levels higher than 9%, compared with those lower than 7%, were associated with an increased risk for hospitalization (adjusted relative risk [RR], 1.44 [95% CI, 1.36 - 1.52] and 1.25 [95% CI, 1.01 - 1.54], respectively), as well as with progression of kidney disease (adjusted HR, 1.77 [95% CI, 1.48 - 2.13] and 1.40 [95% CI, 1.17 - 1.67], respectively).

However, for ERSD, the higher HbA1c level was associated with more risk among in patients with stage 3 CKD (adjusted HR, 2.52 [95% CI, 1.58 - 4.02]) compared with those with stage 4 CKD (adjusted HR, 1.13 [95% CI, 0.80 - 1.59]).

"We speculate that this finding may represent a 'point of no return' for kidney function — beyond which better glycemic control may simply not be enough to prevent progressive kidney function loss," the authors write.

In an invited commentary accompanying the paper, David C. Goff, MD, PhD, writes that the findings "underscore the importance of considering relative and absolute risks (or benefits) when examining potential subgroup differences in risk (or treatment) effects."

If one were to look at the data according to estimated adjusted absolute risks, the difference in risk for ESRD between good and poor glycemic control would be 0.60% in patients with stage 3 CKD and 1.41% in patients with stage 4 CKD, noted Dr. Goff, who is from the Department of Epidemiology and Prevention at Wake Forest School of Medicine in Winston-Salem, North Carolina.

"From this perspective, intensive glucose control might lead to greater absolute prevention of ESRD in stage 4 CKD than in stage 3 CKD, an inference that conflicts with the speculation of the authors based on considering relative risk (and potential relative risk reduction) alone."

However, acknowledging that the overall study results "emphasize the importance of a high HbA1c level as a risk marker for cardiovascular and renal outcomes," Dr. Goff suggests that "[i]n the absence of strong evidence specific to patients with advanced CKD and DM, prudent practice may be to pursue at least moderately intensive risk factor management while minimizing the potential for serious adverse effects of the treatment regimens."

The study was funded by an operating grant from the Heart and Stroke Foundation of Canada, and by an interdisciplinary team grant from the Alberta Heritage Foundation for Medical Research. Four authors were supported by career salary awards from the foundation. One author was also supported by a Government of Canada Research Chair. Four authors were supported by a joint initiative between Alberta Health and Wellness and the Universities of Alberta and Calgary. Dr. Goff is an ACCORD investigator. He has received compensation as a member of the Operations Committee for a trial of a glucose-lowering medication marketed by Merck. He serves as a Data and Safety Monitoring Board member for a trial of a glucose-lowering medication marketed by Takeda.

Arch Intern Med. 2011;171:1920-1927.

    
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