Becton, Dickinson & Company Inc., Franklin Lakes, NJ, USA.
Curr Med Res Opin. 2012 Aug;28(8):1305-11. doi: 10.1185/03007995.2012.709181. Epub 2012 Jul 18.
The shortest pen needle (PN) for subcutaneous insulin therapy is 4 mm. Clinicians may hesitate to use it in obese patients. We report a post hoc analysis of a previously published study of the 4 mm × 32 G PN, evaluating responses in obese (≥30 kg/m(2)) and non-obese (<30 kg/m(2)).
Subjects (BMI 20 to 49 kg/m(2), 52% obese) with diabetes used 4 mm × 32 G PNs and either 5 mm or 8 mm PNs (both 31 G) in two, 3-week treatment periods in a randomized noninferiority cross-over trial. Percentage absolute change in fructosamine (%│Δ Fru│) was the primary endpoint. Equivalent glycemic control was defined as %│Δ Fru│ within 20% (including 95% CI). The impact of obesity on change in fructosamine, pain and reported insulin leakage from the skin is described.
Clinicaltrials.gov - identifier: NCT00928057.
This report is a post hoc analysis of two BMI subgroups resulting in smaller sample sizes.
Of 168 who completed the study, 163 were included in the fructosamine analyses - 83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. For the 4/5 mm group, mean BMI ± SD in non-obese and obese groups were 25.9 ± 2.3 and 35.0 ± 4.9 kg/m(2), respectively; 4/8 mm group 25.2 ± 2.6 and 35.6 ± 4.2 kg/m(2). BMI group was not significant for %│Δ Fru│ for either 4/5 mm or 4/8 mm. Between BMI groups, the difference of the means in %│Δ Fru│ was 0.4% (4/5 mm) and 0.3% (4/8 mm). The 4 mm PN was significantly less painful in all subject groups, except non-obese in 4/5 mm. Regardless of needle size, obese subjects reported more leakage events. For both BMI groups, there were fewer total reported leakage events when using the 4 mm vs 5 mm and 8 mm needles.
The 4 mm pen needle provided equivalent glycemic control in both obese and non-obese patients compared to 5 mm and 8 mm needles with no increase in reports of skin leakage, in this post-hoc analysis. These findings should be confirmed in a prospective randomized controlled trial.
皮下胰岛素治疗用最短的针（PN）是 4 毫米。临床医生可能会犹豫在肥胖患者中使用它。我们报告了先前发表的 4 毫米×32G PN 研究的事后分析，评估了肥胖（≥30kg/m²）和非肥胖（<30kg/m²）患者的反应。
患有糖尿病的受试者（BMI 20 至 49kg/m²，52%肥胖）在一项随机、非劣效交叉试验中使用 4 毫米×32G PN 和 5 毫米或 8 毫米 PN（均为 31G）进行了两个为期 3 周的治疗期。果糖胺（%│Δ Fru│）的绝对变化百分比是主要终点。等效血糖控制定义为%│Δ Fru│在 20%以内（包括 95%CI）。描述了肥胖对果糖胺、疼痛和报告的胰岛素从皮肤泄漏的影响。
Clinicaltrials.gov-标识符：NCT00928057。
本报告是两个 BMI 亚组的事后分析，导致样本量较小。
在完成研究的 168 人中，有 163 人纳入果糖胺分析-4/5 毫米和 4/8 毫米组分别为 83 人和 80 人。对于 4/5 毫米组，非肥胖组和肥胖组的平均 BMI±SD 分别为 25.9±2.3 和 35.0±4.9kg/m²；4/8 毫米组为 25.2±2.6 和 35.6±4.2kg/m²。BMI 组对 4/5 毫米或 4/8 毫米的%│Δ Fru│均无显著性差异。在 4/5 毫米或 4/8 毫米中，BMI 组之间%│Δ Fru│均值的差异分别为 0.4%和 0.3%。在所有受试者组中，4 毫米 PN 明显更疼痛，除了 4/5 毫米的非肥胖者。无论针的大小如何，肥胖受试者报告的泄漏事件更多。对于这两个 BMI 组，与 5 毫米和 8 毫米针相比，使用 4 毫米针报告的总泄漏事件更少。
在这项事后分析中，与 5 毫米和 8 毫米针相比，4 毫米笔式针在肥胖和非肥胖患者中提供了等效的血糖控制，且皮肤泄漏报告没有增加。这些发现应该在一项前瞻性随机对照试验中得到证实。
