摘要
目的系统评价双时相门冬胰岛素30每日3次注射治疗2型糖尿病的有效性和安全性。方法计算机检索CENTRAL、MEDLINE、PubMed及CNKI等中、外文数据库,并手检相关文献及美国糖尿病学会等相关会议论文集,追索所有文献的参考文献,收集双时相门冬胰岛素30每日3次注射治疗2型糖尿病的随机对照试验。由两位研究者进行资料提取和质量评价后,采用RevMan 5.0软件进行Meta分析。结果共纳入10个研究,共计1 415例患者。Meta分析结果显示:(1)糖化血红蛋白下降率(2个研究):双时相门冬胰岛素30每日3次注射组优于每日2次注射组[WMD=0.28,95%CI(0.16,0.40),P<0.000 01]。(2)双时相门冬胰岛素30每日3次注射与诺和灵R(三餐前)+诺和灵N(睡前)每日4次注射比较:①平均空腹血糖水平(6个研究):两组差异无统计学意义(P=0.65);②平均餐后2小时血糖水平(5个研究):前者优于后者(P=0.000 3);③血糖达标时间(6个研究):两组差异无统计学意义(P=0.38);④胰岛素用量(4个研究):前者优于后者(P=0.001);⑤胰岛素费用(2个研究):前者高于后者(P=0.02);⑥低血糖发生率(5个研究):前者优于后者(P=0.000 2)。(3)双时相门冬胰岛素30每日3次注射与口服降糖药物比较,前者糖化血红蛋白下降率明显高于后者[WMD=1.19,95%CI(0.47,1.92),P=0.001]。结论目前证据提示:双时相门冬胰岛素30每日3次注射作为简单的胰岛素强化方案治疗2型糖尿病安全有效,值得临床推广应用。受纳入研究数量及质量限制,本系统评价结论仍需进一步开展更多大样本、严格设计的随机对照试验加以验证。
Objective To assess the effectiveness and safety of biphasic insulin aspart 30 given three times a day in the management of type 2 diabetes. Methods Such databases as CENTRAL, MEDLINE, PubMed and CNKI were searched on computer; additionally, the relevant conference proceedings from associations like American Diabetes Association, and the references of all selected literatures were also hand-searched. The randomized controlled trials （RCTs） on biphasic insulin aspart 30 given three times a day in treating type 2 diabetes were screened according to inclusive and exclusive criteria, without concerning the limitation of languages and blind methods. After data extraction and quality evaluation, Meta-analysis was performed by using RevMan 4.2 software. Results Ten trials involving 1 415 patients were included. The sub-group analysis showed that compared with the group of given biphasic insulin aspart 30 twice a day （the bid group）, the group of given biphasic insulin aspart 30 three times a day （the tid group） was superior in decreasing HbAlc （P〈0.000 01）. Compared with the group of thrice preprandial injection of Novolin R plus one injection of Novolin N at bedtime （the qid group）, Meta-analysis showed that, a） As to the average fasting glucose levels： the tid group was not superior to the qid group （P=0.65）; b） As to the average 2-hour postprandial glucose levels： the tid group was superior to the qid group （P=0.0003）; c） As to the therapeutic time： the tid group was not superior to the qid group （P=0.38）; d） As to the insulin doses： the tid group was superior to the qid group （P=0.000 1）; e） As to the insulin costs： the tid group was inferior to the qid group （P=0.02）; and e） As to the incidence of hypoglycaemia： the tid group was superior to the qid group （P=0.000 2）. Compared with the oral antidiabetic drugs, the results of Meta-analyses showed： the tid group was superior in decreasing HbAlc （P=0.001）. Conclusion The limited current evidence shows that biphasic insulin aspart 30 given threetimes a day, as a simple insulin intensified scheme, is safe and effective for type 2 diabetes, and is worth recommending in clinic. However, all these findings should be further confirmed with more large sample and well-designed RCTs.
出处
《中国循证医学杂志》
CSCD
2012年第7期822-829,共8页
Chinese Journal of Evidence-based Medicine
