门冬胰岛素与人胰岛素对妊娠合并糖代谢异常患者的有效性及安全性

目的分析对比门冬胰岛素与人胰岛素对妊娠合并糖代谢异常患者的有效性及安全性及其对妊娠结局的影响。方法将2004年1月1日至2010年5月31日接受孕期检查并分娩的应用门冬胰岛素控制血糖的妊娠合并糖代谢异常者纳入分析（Asp组，n=77），其中妊娠合并糖尿病（DM）患者22例、妊娠期糖尿病（GDM）患者55例。选择同期接受孕期检查并分娩的应用人胰岛素控制血糖的妊娠合并糖代谢异常患者（HI组，n=77）按1：1作为对照进行回顾性对比研究。对比2组胰岛素治疗前后血糖变化、血糖下降至正常水平所需时间、胰岛素最大用量、治疗期间低血糖事件发生率及分娩结局。2组数据比较用t检验及秩和检验。结果治疗1周后，Asp组DM患者早餐、晚餐后2h血糖分别为（6．5±1．1）和（7．1±1．1）mmol／L，HI组则分别为（8．0±1．1）和（7．8±0．8）mmol／L；而Asp组GDM患者早餐、午餐和晚餐后2h血糖分别为（6．5±0．7）、（6．8±0．7）和（6．7±0．7）mmol／L，HI组则分别为（7．1±0．9）、（7．3±0．9）和（7．4±0．8）mmol／L；Asp组餐后2h血糖水平均低于Ⅲ组，差异均有统计学意义（均P〈0．05）。Asp组DM患者早餐后2h血糖首次下降至正常水平所需时间为（3．0±2．2）d，HI组则为（5．0±2．1）d；Asp组GDM患者早餐后2h血糖首次下降至正常水平所需时间为（2．3±1．6）d，HI组则为（4．3±2．6）d；Asp组餐后血糖下降至正常水平所需时间均比HI组短，差异均有统计学意义（均P〈0．05）。Asp组低血糖事件发生率为3．9％（DM患者1例，GDM患者2例），HI组为24．7％（DM患者8例，GDM患者11例）（P〈0．05）。Asp组DM患者新生儿低血糖发生率及新生儿转儿科率分别为4．5％、36．4％，而HI组为18．2％、50．0％；Asp组GDM患者巨大儿、新生儿低血糖发生率及转儿科率分别为10．9％、3．6％、25．5％，HI组则分别为18．2％、10．9％、38．2％；Asp组的分娩结局有优于HI组的趋势，但2组间差异均无统计学意义（均P〉0．05）。结论在妊娠合并糖代谢异常孕妇中，相比人胰岛素，门冬胰岛素能更快、更有效地控制血糖，同时可明显降低低血糖事件的发生。对分娩结局的影响方面，Asp组有优于Ⅲ组的趋势。

Safety and efficacy of insulin aspart versus regular human insulin in pregnant women with abnormal glucose metabolism

Objective To analyze and compare the safety and efficacy of insulin aspart versus regular human insulin in pregnant women with abnormal glucose metabolism.Methods In this study,the data of 77 pregnant women with pre-pregnant diabetes mellitus( DM,n =22 ) or gestational diabetes mellitus ( GDM,n =55 ) treated from January 2004 to May 2010 with insulin aspart ( Asp group) were investigated.And 77 pregnant women with abnormal glucose metabolism using regular human insulin in the mean time were selected as control ( HI group) in a ratio of 1 ∶ 1.The changes of glucose levels,time for reaching glucose targets,incidence of hypoglycemia and pregnancy outcomes after the treatment were compared between the two groups by using t or rank test.Results One week of treatment after,the 2 h post-breakfast and post-supper glucose levels in DM women in Asp group were (6.5 ± 1.1 ) and (7.1 ± 1.1 ) mmol/L and those were (8.0 ± 1.1 ) and (7.8 ±0.8) mmol/L DM women in HI group; the 2 h post-breakfast,postlunch and post-supper glucose levels in GDM women in Asp group were (6.5 ± 0.7 ),(6.8 ± 0.7 ) and (6.7 ± 0.7 ) mmol/L,and those were ( 7.1 ± 0.9),( 7.3 ± 0.9) and ( 7.4 ± 0.8 ) mmoL/L in GDM women in HI group.The postprandial glucose levels were all lower in Asp group than those in the HI group ( all P ＜ 0.05 ).The time for 2 h post-breakfast glucose level to reach standard in DM women in Asp group was (3.0 ± 2.2) d,and it was ( 5.0 ± 2.1 ) d in DM women in HI group; and those were (2.3 ± 1.6) and (4.3 ±2.6)d in GDM women in Asp group and in HI group,respectively.The time for reaching glucose targets in Asp group were all shorter than those in HI group(P ＜0.05).The incidence of hypoglycemia in Asp group was 3.9％ ( 1 case of DM and 2 eases of GDM) and it was 24.7％ in HI group (8 and 11 cases of DM and GDM,respectively) ( P ＜ 0.05 ).The incidence of neonatal hypoglycemia and referral to Pediatrics in DM women in Asp group were 4.5％ and 36.4％,and those were 18.2％ and 50.0％ in DM women in HI group; the prevalence of macrosomia,the neonatal hypoglycemia and referral to Pediatrics in GDM women in Asp group were 10.9％,3.6％ and 25.5％,and those were 18.2％,10.9％ and 38.2％ in GDM women in HI group; it seemed that insulin aspart brought more benefits than human insulin,but there was no significant differences between the two groups( all P ＞ 0.05 ).Conclusions Insulin aspart is safer and more effective than human insulin when used in pregnant women with DM or GDM; it brings better pregnancy outcomes than human insulin without significant differences.