门冬胰岛素30不同注射次数治疗2型糖尿病的临床研究
|
摘要
目的:评价门冬胰岛素30一天2次与一天3次治疗对于初次诊断、使用口服降糖药及其他类型胰岛素治疗血糖控制不良2型糖尿病患者的有效性和安全性。
方法:收集自2007年11月至2009年11月在汕头大学医学院第一附属医院内分泌科住院、使用门冬胰岛素30治疗的2型糖尿病患者129例,按胰岛素皮下注射次数分为一天2次皮下注射62例(2次组);一天3次皮下注射67例(3次组)。两组病例均住院接受门冬胰岛素30治疗2周以上,出院后继续应用原胰岛素方案,且规则使用门冬胰岛素30治疗12周以上。对比两组间血糖控制、低血糖事件及胰岛素用量之间的差异。
结果:
1.两组病例住院治疗2周后,测定空腹、早餐后、午餐后及睡前末梢血糖值均比入院时相同时段血糖值明显下降(P<0.01),3次组比2次组平均下降0.74-1.23mmol/L。但差别没有统计学意义(P>0.05)。
2.两组病例治疗12周后,测定HbA1c值与入院时相比,均明显降低(P<0.01):3次组比2次组平均降低0.41%。2次组实现HbA1c<6.5%、HbA1c<7.0%分别占46.7%、62.9%;而3次组分别为40.3%、64.2%。
3.两组病例住院接受门冬胰岛素30治疗2周,共发生低血糖事件33次,其中2次组发生21次,占33.9%; 3次组发生12次,占17.9%。2次组比3次组低血糖发生率高(P=0.038)。
4.两组病例住院2周每天胰岛素类似物总量0.52±0.18U/Kg,其中2次组为0.43±0.15U/Kg,3次组为0.60±0.17U/Kg,具有显著统计学差异(P<0.01)。
结论:
1.门冬胰岛素30一天2次或一天3次皮下注射,对于初次诊治、口服降糖药失效或其他类型胰岛素治疗效果不满意的2型糖尿病患者,均可有效控制血糖。
2.门冬胰岛素30一天3次皮下注射与一天2次用法相比,胰岛素用量相对较大,但并不增加低血糖风险。
Objective:To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes mellitus(T2DM) by retrospective analysis.
Methods:129 subjects with T2DM were hospitalized and accepted BIAsp 30 therapy in the 1st affiliated hospital of Shantou University Medical College from November 2007 to November 2009. Study subjects were newly diagnosed and inadequately controlled with oral antidiabetes drugs and other types of insulin. Study subjects divided into twice- and thrice-daily BIAsp 30 (BID and TID groups, respectively) without OADs according to the number of insulin injections. All patients were hospitalized for treatment of BIAsp 30 for more than 2 weeks after discharge, and continued the regimen for more than 12 weeks. Comparing with glycemic control, hypoglycemia events and insulin doses between BID and TID groups.
Results:
1. After 2 weeks’hospitalization, glycemic decreased significantly in both groups (P<0.01), Thrice-daily BIAsp 30 decreased 0.74-1.23mmol/L compare to twice-daily BIAsp 30, but without statistical significance (P>0.05).
2. After 12 weeks’treatment of BIAsp 30, HbA1c decreased significantly in both groups (BID group -1.67±1.98%, TID group -2.08±1.71%, P<0.01). TID group showed better improvement in HbA1c (0.41% compared to BID group), but without statistical significance (P>0.05).The rates of achievement of HbA1c<6.5% and 7.0% were 46.7% and 62.9% in BID group, and 40.3% and 64.2% in TID group (P>0.05).
3. During hospitalization, a total of 33 hypoglycemic events occurred in 28 of the 129 subjects. Of these, 21 events (33.9%) were associated with the BID group, and 12 events (17.9%) were associated with the TID group, which were significantly lower than the BID group (P=0.038).
4. During hospitalization, the mean daily insulin doses were 0.43±0.15units/kg in the BID group, which were significantly lower than the TID group (0.60±0.17units/kg, P<0.01).
Conclusions:Twice- and thrice-daily BIAsp30 were effective in Chinese subjects with poorly controlled type 2 diabetes. Thrice-daily BIAsp30 increased insulin dose, but offered better reduction in HbA1c without increasing risk of hypoglycemia.
方法:收集自2007年11月至2009年11月在汕头大学医学院第一附属医院内分泌科住院、使用门冬胰岛素30治疗的2型糖尿病患者129例,按胰岛素皮下注射次数分为一天2次皮下注射62例(2次组);一天3次皮下注射67例(3次组)。两组病例均住院接受门冬胰岛素30治疗2周以上,出院后继续应用原胰岛素方案,且规则使用门冬胰岛素30治疗12周以上。对比两组间血糖控制、低血糖事件及胰岛素用量之间的差异。
结果:
1.两组病例住院治疗2周后,测定空腹、早餐后、午餐后及睡前末梢血糖值均比入院时相同时段血糖值明显下降(P<0.01),3次组比2次组平均下降0.74-1.23mmol/L。但差别没有统计学意义(P>0.05)。
2.两组病例治疗12周后,测定HbA1c值与入院时相比,均明显降低(P<0.01):3次组比2次组平均降低0.41%。2次组实现HbA1c<6.5%、HbA1c<7.0%分别占46.7%、62.9%;而3次组分别为40.3%、64.2%。
3.两组病例住院接受门冬胰岛素30治疗2周,共发生低血糖事件33次,其中2次组发生21次,占33.9%; 3次组发生12次,占17.9%。2次组比3次组低血糖发生率高(P=0.038)。
4.两组病例住院2周每天胰岛素类似物总量0.52±0.18U/Kg,其中2次组为0.43±0.15U/Kg,3次组为0.60±0.17U/Kg,具有显著统计学差异(P<0.01)。
结论:
1.门冬胰岛素30一天2次或一天3次皮下注射,对于初次诊治、口服降糖药失效或其他类型胰岛素治疗效果不满意的2型糖尿病患者,均可有效控制血糖。
2.门冬胰岛素30一天3次皮下注射与一天2次用法相比,胰岛素用量相对较大,但并不增加低血糖风险。
Objective:To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes mellitus(T2DM) by retrospective analysis.
Methods:129 subjects with T2DM were hospitalized and accepted BIAsp 30 therapy in the 1st affiliated hospital of Shantou University Medical College from November 2007 to November 2009. Study subjects were newly diagnosed and inadequately controlled with oral antidiabetes drugs and other types of insulin. Study subjects divided into twice- and thrice-daily BIAsp 30 (BID and TID groups, respectively) without OADs according to the number of insulin injections. All patients were hospitalized for treatment of BIAsp 30 for more than 2 weeks after discharge, and continued the regimen for more than 12 weeks. Comparing with glycemic control, hypoglycemia events and insulin doses between BID and TID groups.
Results:
1. After 2 weeks’hospitalization, glycemic decreased significantly in both groups (P<0.01), Thrice-daily BIAsp 30 decreased 0.74-1.23mmol/L compare to twice-daily BIAsp 30, but without statistical significance (P>0.05).
2. After 12 weeks’treatment of BIAsp 30, HbA1c decreased significantly in both groups (BID group -1.67±1.98%, TID group -2.08±1.71%, P<0.01). TID group showed better improvement in HbA1c (0.41% compared to BID group), but without statistical significance (P>0.05).The rates of achievement of HbA1c<6.5% and 7.0% were 46.7% and 62.9% in BID group, and 40.3% and 64.2% in TID group (P>0.05).
3. During hospitalization, a total of 33 hypoglycemic events occurred in 28 of the 129 subjects. Of these, 21 events (33.9%) were associated with the BID group, and 12 events (17.9%) were associated with the TID group, which were significantly lower than the BID group (P=0.038).
4. During hospitalization, the mean daily insulin doses were 0.43±0.15units/kg in the BID group, which were significantly lower than the TID group (0.60±0.17units/kg, P<0.01).
Conclusions:Twice- and thrice-daily BIAsp30 were effective in Chinese subjects with poorly controlled type 2 diabetes. Thrice-daily BIAsp30 increased insulin dose, but offered better reduction in HbA1c without increasing risk of hypoglycemia.
引文
[1]. International Diabetes Federation. Latest Diabetes Figures Paint Grim Global Picture. ScienceDaily, 2009, October 26.
[2]. Yang WY, Lu JM, Weng JP, et al. Prevalence of Diabetes among Men and Women in China. The New England Journal of Medicine, 2010, 362:1090-1101.
[3].王克安,李天麟,向红丁,等.中国糖尿病流行特点研究-糖尿病和糖耐量低减患病率调查.中华流行病学杂志, 1998, 19: 282-285.
[4]. Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A: Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: the ACTION study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab, 2007 (Epub ahead of print).
[5]. Weng JP, Li YB, Xu W, et al. Effect of intensive insulin therapy onβ-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet 2008, 371: 1753–1760.
[6]. Riddle M, Rosenstock J, Gerich J, the Insulin Glargine 4002 Study Investigators: The treat-to-target trial: randomized addition of glargine of human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003, 26: 3080–3086.
[7]. Khutsoane D, sharma SK, Almustafa M, et a1.Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting:experience from the PRESENT study[J].Diabetes Obes Metab,2008,10(3):212-222.
[8]. Garber AJ, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes. Metab, 2006, 8: 58–66.
[9]. Yoshioka N, Kurihara Y, Manda N, et al. Step-up therapy with biphasic insulin aspart-70/30—Sapporo 1-2-3 study. Diabetes Res Clin Pract, 2009, 85(1): 47-52.
[10]. World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. In: Report of a WHO Consultation. WHO/NCD/NCS/99.2. Geneva: WHO, 1999.
[11]. American Diabetes Association Workgroup on hypoglycemia. Defining and Reporting Hypoglycemia in Diabetes: A report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care, 2005, 28: 1245-1249.
[12].项坤三,杨文英,翁建平,等.中国2型糖尿病防治指南. 2007年版.中华医学会糖尿病学分会. 2007,8.
[13]. Valensi P, Benroubi M, Borzi V, et al. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix1 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. International Journal of Clinical Practice, 2009, 63: 522–531.
[14]. Yang WY, Ji QH, Zhu DL, et al. Biphasic Insulin Aspart 30 Three Times Daily Is More Effective Than a Twice-Daily Regimen, Without Increasing Hypoglycemia, in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Drugs. Diabetes Care, 2008, 31(5): 852-856.
[15]. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA (1c). Diabetes Care, 2003, 26(3): 881-885.
[16]. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM: Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. The New England Journal of Medicine. 2002, 346: 393–403.
[17]. Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M: Guidelines and recommendations for laboratory analysis in the diagnosis andmanagement of diabetes mellitus. Clin Chem Lab Med, 2002, 48:436–472.
[18]. Cryer PE, Hypoglycaemia: the limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia, 2002, 45:937–948.
[19]. Lüddeke HJ, Sreenan S, Aczel S, et al. PREDICTIVE– a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycemia from the European cohort. Diabetes Obes Metab, 2007, 9: 428–434.
[20]. McSorley PT, Bell PM, Jacobson LV, et al. Twice-daily biphasic insulin aspart versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clinical therapeutics, 2002, 24: 530–539.
[21]. McNally P, Dean J, Morris A, Wilkinson PD, et al. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care, 2007, 30: 1044–1048.
[22]. P. Raskin, E. Allen, P. Hollander, A. Lwein, R.A. Gabbay, P. Hu, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care, 2005, 28: 260–265.
[23]. Two Feathers J, Kieffer EC, Palmisano G, et al. Racial and Ethnic Approaches to Community Health (REACH) Detroit partnership: improving diabetes-related outcomes among African American and Latino adults. American Journal of Public Health, 2005, 95(9):1552-1560.
[2]. Yang WY, Lu JM, Weng JP, et al. Prevalence of Diabetes among Men and Women in China. The New England Journal of Medicine, 2010, 362:1090-1101.
[3].王克安,李天麟,向红丁,等.中国糖尿病流行特点研究-糖尿病和糖耐量低减患病率调查.中华流行病学杂志, 1998, 19: 282-285.
[4]. Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A: Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: the ACTION study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab, 2007 (Epub ahead of print).
[5]. Weng JP, Li YB, Xu W, et al. Effect of intensive insulin therapy onβ-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet 2008, 371: 1753–1760.
[6]. Riddle M, Rosenstock J, Gerich J, the Insulin Glargine 4002 Study Investigators: The treat-to-target trial: randomized addition of glargine of human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003, 26: 3080–3086.
[7]. Khutsoane D, sharma SK, Almustafa M, et a1.Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting:experience from the PRESENT study[J].Diabetes Obes Metab,2008,10(3):212-222.
[8]. Garber AJ, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes. Metab, 2006, 8: 58–66.
[9]. Yoshioka N, Kurihara Y, Manda N, et al. Step-up therapy with biphasic insulin aspart-70/30—Sapporo 1-2-3 study. Diabetes Res Clin Pract, 2009, 85(1): 47-52.
[10]. World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. In: Report of a WHO Consultation. WHO/NCD/NCS/99.2. Geneva: WHO, 1999.
[11]. American Diabetes Association Workgroup on hypoglycemia. Defining and Reporting Hypoglycemia in Diabetes: A report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care, 2005, 28: 1245-1249.
[12].项坤三,杨文英,翁建平,等.中国2型糖尿病防治指南. 2007年版.中华医学会糖尿病学分会. 2007,8.
[13]. Valensi P, Benroubi M, Borzi V, et al. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix1 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. International Journal of Clinical Practice, 2009, 63: 522–531.
[14]. Yang WY, Ji QH, Zhu DL, et al. Biphasic Insulin Aspart 30 Three Times Daily Is More Effective Than a Twice-Daily Regimen, Without Increasing Hypoglycemia, in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Drugs. Diabetes Care, 2008, 31(5): 852-856.
[15]. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA (1c). Diabetes Care, 2003, 26(3): 881-885.
[16]. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM: Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. The New England Journal of Medicine. 2002, 346: 393–403.
[17]. Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M: Guidelines and recommendations for laboratory analysis in the diagnosis andmanagement of diabetes mellitus. Clin Chem Lab Med, 2002, 48:436–472.
[18]. Cryer PE, Hypoglycaemia: the limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia, 2002, 45:937–948.
[19]. Lüddeke HJ, Sreenan S, Aczel S, et al. PREDICTIVE– a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycemia from the European cohort. Diabetes Obes Metab, 2007, 9: 428–434.
[20]. McSorley PT, Bell PM, Jacobson LV, et al. Twice-daily biphasic insulin aspart versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clinical therapeutics, 2002, 24: 530–539.
[21]. McNally P, Dean J, Morris A, Wilkinson PD, et al. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care, 2007, 30: 1044–1048.
[22]. P. Raskin, E. Allen, P. Hollander, A. Lwein, R.A. Gabbay, P. Hu, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care, 2005, 28: 260–265.
[23]. Two Feathers J, Kieffer EC, Palmisano G, et al. Racial and Ethnic Approaches to Community Health (REACH) Detroit partnership: improving diabetes-related outcomes among African American and Latino adults. American Journal of Public Health, 2005, 95(9):1552-1560.