Kähler Pernille, Grevstad Berit, Almdal Thomas, Gluud Christian, Wetterslev Jørn, Lund Søren Søgaard, Vaag Allan, Hemmingsen Bianca
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Medicine F, Gentofte Hospital, Gentofte, Denmark.
BMJ Open. 2014 Aug 19;4(8):e004806. doi: 10.1136/bmjopen-2014-004806.
To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus.
A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials.
The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013.
Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included.
Two authors independently assessed studies for inclusion and extracted data.
18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2.08) or cardiovascular mortality (0.49, 0.19 to 1.24). Targeting intensive glycaemic control reduced the relative risks for the composite macrovascular outcome (0.63, 0.41 to 0.96; p=0.03), and nephropathy (0.37, 0.27 to 0.50; p<0.00001. The effect estimates of retinopathy, ketoacidosis and retinal photocoagulation were not consistently statistically significant between random and fixed effects models. The risk of severe hypoglycaemia was significantly increased with intensive glycaemic targets (1.40, 1.01 to 1.94). Trial sequential analyses showed that the amount of data needed to demonstrate a relative risk reduction of 10% were, in general, inadequate.
There was no significant effect towards improved all-cause mortality when targeting intensive glycaemic control compared with conventional glycaemic control. However, there may be beneficial effects of targeting intensive glycaemic control on the composite macrovascular outcome and on nephropathy, and detrimental effects on severe hypoglycaemia. Notably, the data for retinopathy and ketoacidosis were inconsistent. There was a severe lack of reporting on patient relevant outcomes, and all trials had poor bias control.
评估1型糖尿病患者强化血糖控制与传统血糖控制的利弊。
对随机临床试验进行系统评价，并进行荟萃分析和试验序贯分析。
截至2013年1月的考克兰图书馆、MEDLINE、EMBASE、科学引文索引扩展版和LILACS。
纳入对任何年龄的1型糖尿病参与者预先设定不同血糖控制目标的随机临床试验。
两位作者独立评估纳入研究并提取数据。
18项随机临床试验纳入了2254例1型糖尿病患者。所有试验均有较高的偏倚风险。强化血糖控制对全因死亡率（风险比1.16，95%可信区间0.65至2.08）或心血管死亡率（0.49，0.19至1.24）无统计学显著影响。强化血糖控制降低了复合大血管结局（0.63，0.41至0.96；p=0.03）和肾病（0.37，0.27至0.50；p<0.00001）的相对风险。视网膜病变、酮症酸中毒和视网膜光凝的效应估计在随机效应模型和固定效应模型之间并非始终具有统计学显著性。强化血糖目标显著增加了严重低血糖的风险（1.40，1.01至1.94）。试验序贯分析表明，一般来说，证明相对风险降低10%所需的数据量不足。
与传统血糖控制相比，强化血糖控制对改善全因死亡率无显著影响。然而，强化血糖控制可能对复合大血管结局和肾病有有益影响，对严重低血糖有不利影响。值得注意的是，视网膜病变和酮症酸中毒的数据不一致。与患者相关结局的报告严重不足，所有试验的偏倚控制都很差。
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