Vardi Moshe, Jacobson Eyal, Nini Asaph, Bitterman Haim
Internal Medicine, Carmel Medical Center, 7 Michal St, Haifa, Haifa, Israel, 34362.
Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD006297. doi: 10.1002/14651858.CD006297.pub2.
Diabetes mellitus type 1 is a chronic disease with short and long term complications. Its goals of therapy are to eliminate the symptoms of hyperglycaemia, reduce the long term microvascular and macrovascular complications and allow the patients to achieve a normal life-style. Basal insulin replacement for insulin dependent patients can be achieved with either intermediate or long acting insulin preparations.
To assess the effects of intermediate acting versus long acting insulin preparations for basal insulin replacement in type 1 diabetic patients.
We searched MEDLINE, EMBASE and The Cochrane Library, as well as reference lists, databases of ongoing trials, and requests from authors of included trials.
Randomised controlled trials, assessing long acting insulin preparations compared to intermediate acting insulin preparations, in type 1 diabetic patients.
Two reviewers independently scanned the titles. Data were extracted and analysed accordingly.
Twenty-three randomised controlled trials were identified. A total of 3872 and 2915 participants in the intervention and in the control group, respectively, were analysed. The weighted mean difference (WMD) for the level of glycosylated haemoglobin was -0.08 (95% confidence interval (CI) -0.12 to -0.04) in favour of the long acting insulin arm. The WMD between the groups in fasting plasma and blood glucose levels was -0.63 (95% CI -0.86 to -0.40) and -0.86 (95% CI -1.00 to -0.72) in favour of the long acting insulins. The odds ratio for a patient on long acting insulin to develop any type of hypoglycaemia was 0.93 (95% CI 0.8 to 1.08) compared to that of a patient on intermediate acting insulins. The OR for severe hypoglycaemic episodes was 0.73 (95% CI 0.61 to 0.87), and 0.70 (95% CI of 0.63 to 0.79) for nocturnal episodes. The WMD between the long and intermediate insulin groups for hypoglycaemic events per 100 patient follow up days was -0.77 (95% CI -0.89 to -0.65), -0.0 (95% CI -0.02 to 0.02) and -0.40 (95% CI -0.45 to -0.34) for overall, severe, and nocturnal hypoglycaemic episodes. Weight gain was more prominent in the control group. No difference was noted in the quantity or quality of severe adverse events or deaths.
AUTHORS' CONCLUSIONS: Long acting insulin preparations seem to exert a beneficial effect on nocturnal glucose levels. Their effect on the overall diabetes control is clinically unremarkable. Their use as a basal insulin regimen for type 1 diabetes mellitus warrants further substantiation.
1型糖尿病是一种伴有短期和长期并发症的慢性疾病。其治疗目标是消除高血糖症状,减少长期微血管和大血管并发症,并使患者能够实现正常的生活方式。对于胰岛素依赖型患者,基础胰岛素替代可通过中效或长效胰岛素制剂来实现。
评估中效胰岛素制剂与长效胰岛素制剂在1型糖尿病患者基础胰岛素替代治疗中的效果。
我们检索了MEDLINE、EMBASE和Cochrane图书馆,以及参考文献列表、正在进行的试验数据库,并向纳入试验的作者进行了咨询。
针对1型糖尿病患者,评估长效胰岛素制剂与中效胰岛素制剂对比的随机对照试验。
两名审阅者独立筛选标题。相应地提取并分析数据。
共识别出23项随机对照试验。分别对干预组的3872名参与者和对照组的2915名参与者进行了分析。糖化血红蛋白水平的加权平均差(WMD)为-0.08(95%置信区间(CI)-0.12至-0.04),有利于长效胰岛素组。两组间空腹血浆和血糖水平的WMD分别为-0.63(95%CI -0.86至-0.40)和-0.86(95%CI -1.00至-0.72),有利于长效胰岛素。与使用中效胰岛素的患者相比,使用长效胰岛素的患者发生任何类型低血糖的比值比为0.93(95%CI 0.8至1.08)。严重低血糖事件的比值比为0.73(95%CI 0.61至0.87),夜间低血糖事件的比值比为0.70(95%CI 0.63至0.79)。长效胰岛素组与中效胰岛素组每100患者随访日低血糖事件的WMD分别为总体低血糖事件-0.77(95%CI -0.89至-0.65)、严重低血糖事件-0.0(95%CI -0.02至0.02)和夜间低血糖事件-0.40(95%CI -0.45至-0.34)。体重增加在对照组更为明显。严重不良事件或死亡的数量及质量方面未发现差异。
长效胰岛素制剂似乎对夜间血糖水平有有益影响。它们对总体糖尿病控制的影响在临床上并不显著。其作为1型糖尿病基础胰岛素治疗方案的应用值得进一步证实。