胰岛素泵持续强化治疗妊娠期糖尿病的临床研究  

Clinical trial of continuous insulin pump intensive therapy in the treatment of gestational diabetes mellitus

作　　者：黄赞怡 李雪娇 戴小萍[2] HUANG Zan-yi;LI Xue-jiao;DAI Xiao-ping(Department of Obstetrics and Gynecology,Hainan Maternal and Child Health Hospital,Haikou 570000,Hainan Province,China;Department of Obstetrics and Gynecology,Hainan Provincial Hospital of Traditional Chinese Medicine,Haikou 570000,Hainan Province,China)

机构地区：[1]海南省妇幼保健院妇产科,海口570000 [2]海南省中医院妇产科,海口570000

出　　处：《中国临床药理学杂志》2018年第15期1792-1795,共4页The Chinese Journal of Clinical Pharmacology

基　　金：海南省自然科学基金项目(1426360.10A1006)

摘　　要：目的观察胰岛素泵持续强化治疗妊娠期糖尿病的临床疗效及安全性。方法将148例妊娠期糖尿病患者随机分为对照组和试验组,每组74例。对照组于三餐前分别予以生物合成人胰岛素每次0.1~0.45 U·kg^(-1),皮下注射+睡前予以精蛋白生物合成人胰岛素每次0.1~0.15 U·kg^(-1),皮下注射;试验组用712型胰岛素泵经导管皮下输注0.4~0.6 U·kg^(-1)·d^(-1)生物合成人胰岛素。2组患者均治疗1个月。比较2组患者的血糖水平、糖化血红蛋白(Hb A1c)、新生儿并发症发生率,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的空腹血糖分别为(5.27±0.73)和(5.94±0.54)mmol·L^(-1),餐后2 h血糖分别为(6.31±0.65)和(7.08±0.47)mmol·L^(-1),Hb A1c分别为(5.84±0.62)%和(6.67±0.82)%,差异均有统计学意义(均P<0.05)。试验组和对照组的新生儿并发症主要有低血糖(12.16%vs 27.03%)、巨大儿(6.76%vs 24.32%)、急性呼吸窘迫综合征(13.51%vs 29.73%),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以低血糖为主。试验组和对照组的总药物不良反应发生率分别为12.16%和27.03%,差异有统计学意义(P<0.05)。结论胰岛素泵持续强化治疗能有效地控制妊娠期糖尿病女性的血糖水平,减少新生儿并发症,且安全性较高。Objective To observe the clinical efficacy and safety of continuous insulin pump intensive therapy in the treatment of gestational diabetes mellitus. Methods A total of 148 patients with gestational diabetes mellitus were randomly divided into control and treatment groups with74 cases per group. Control group was treated with 0. 1-0. 45 U·kg^（-1） of biosynthetic human insulin with subcuta-neous injection ＋ 0. 1-0. 15 U· kg^（-1） isophane protamine biosynthetic human insulin with subcutaneous injection before bedtime. Treatment group received 0. 4-0. 6 U·kg^（-1）·d^（-1） of biosynthetic human insulin with 712 insulin pump.Two groups were treated for 1 month. The blood glucose,glycosylated hemoglobin（ Hb A1 c）,incidence of neonatal complications and adverse drug reactions were compared between two groups. Results After treatment,the main indexes of treatment and control groups were compared：fasting plasma glucose were（ 5. 27 ± 0. 73） and（ 5. 94 ± 0. 54）mmol·L^（-1）,2-hour postprandial blood glucose were（ 6. 31 ± 0. 65）and（ 7. 08 ± 0. 47） mmol · L^（-1）,Hb A1 c were（ 5. 84 ± 0. 62） % and（ 6. 67 ± 0. 82） %,the differences were statistically significant（ all P 0. 05）. The neonatal complications of experimental group and control group are mainly hypoglycemia（ 12. 16% vs 27. 03%）,macrosomia（ 6. 76% vs 24. 32%）,and acute respiratory distress syndrome（ 13. 51% vs 29. 73%）,the differences were statistically significant（ all P 0. 05）. The adverse drug reactions of two groups were hypoglycemia. The total incidences of adverse drug reactions in treatment and control groups were 12. 16% and 27. 03% with significant difference（ P 0. 05）. Conclusion Continuous insulin pump intensive therapy can effectively control the level of blood sugar in women with gestational diabetes mellitus,and reduce neonatal complications,with high safety.

关 键 词：生物合成人胰岛素注射液 精蛋白生物合成人胰岛素注射液 妊娠期糖尿病 安全性 

分 类 号：R977.15[医药卫生—药品]