Thrailkill K M, Quattrin T, Baker L, Kuntze J E, Compton P G, Martha P M
Department of Pediatrics, University of Kentucky, Lexington, USA.
Diabetes Care. 1999 Apr;22(4):585-92. doi: 10.2337/diacare.22.4.585.
To study the effects of 12 weeks of cotherapy with recombinant human IGF-I (rhIGF-I) and insulin on glycemic control in patients with type 1 diabetes.
The study population consisted of 223 patients who ranged in age from 11-66 years and were randomized in a double-blind study to receive 12 weeks of treatment with twice-daily subcutaneous injections of placebo (n = 54), or rhIGF-I at a dose (A.M/P.M) of 40/40 micrograms/kg (n = 56), 80/40 micrograms/kg (n = 57), or 80/60 micrograms/kg (n = 56), while continuing to receive standard insulin therapy. Patients were instructed to test blood glucose levels four times daily and adjust insulin doses to optimize blood glucose control. HbAlc, insulin requirements, body weight, and parameters of the IGF-IGF-binding protein axis were assessed before and during treatment.
All groups were comparable at baseline with respect to mean age, gender distribution, duration of diabetes, HbAlc, and BMI. Cotherapy with rhIGF-I/insulin produced a mean decrease in HbAlc of 1.2%, compared with a 0.7% decrease in HbAlc for patients receiving intensified insulin therapy alone (P < or = 0.01). Subjects receiving rhIGF-I/insulin cotherapy also decreased their daily insulin usage by 11-19%, compared with a 7% increase in insulin usage reported by the placebo group. Moreover, the incidence of hypoglycemia was similar in subjects treated with rhIGF-I/Insulin cotherapy compared with those treated with insulin alone, despite the better glycemic control of the former group. The 40/40 dose of rhIGF-I was well tolerated. Higher doses of rhIGF-I did not further improve efficacy yet were associated with unacceptable levels of adverse events, including edema, jaw pain, and early worsening of retinopathy.
These results demonstrate that rhIGF/insulin cotherapy improves glycemic control in patients with type 1 diabetes better than optimized insulin management alone; longer-term trials would be required to determine an acceptable benefit-risk profile.
研究重组人胰岛素样生长因子-I（rhIGF-I）与胰岛素联合治疗12周对1型糖尿病患者血糖控制的影响。
研究对象为223例年龄在11至66岁之间的患者，在一项双盲研究中随机分组，接受为期12周的每日两次皮下注射安慰剂（n = 54）、剂量为40/40微克/千克（上午/下午）的rhIGF-I（n = 56）、80/40微克/千克（n = 57）或80/60微克/千克（n = 56）的治疗，同时继续接受标准胰岛素治疗。患者被要求每天检测4次血糖水平，并调整胰岛素剂量以优化血糖控制。在治疗前和治疗期间评估糖化血红蛋白（HbAlc）、胰岛素需求量、体重以及胰岛素样生长因子-胰岛素结合蛋白轴的参数。
所有组在基线时的平均年龄、性别分布、糖尿病病程、HbAlc和体重指数（BMI）方面具有可比性。与仅接受强化胰岛素治疗的患者HbAlc平均降低0.7%相比，rhIGF-I/胰岛素联合治疗使HbAlc平均降低了1.2%（P≤0.01）。接受rhIGF-I/胰岛素联合治疗的受试者每日胰岛素用量也减少了11%至19%，而安慰剂组报告的胰岛素用量增加了7%。此外，尽管rhIGF-I/胰岛素联合治疗组血糖控制更好，但与仅接受胰岛素治疗的受试者相比，其低血糖发生率相似。40/40剂量的rhIGF-I耐受性良好。更高剂量的rhIGF-I并未进一步改善疗效，但与包括水肿、颌部疼痛和视网膜病变早期恶化等不可接受的不良事件水平相关。
这些结果表明，rhIGF/胰岛素联合治疗在改善1型糖尿病患者血糖控制方面优于单纯优化胰岛素治疗；需要进行长期试验以确定可接受的效益风险状况。
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