Hayward R A, Manning W G, Kaplan S H, Wagner E H, Greenfield S
Veterans Affairs Center for Practice Management and Outcomes Research, Ann Arbor Veterans Affairs Medical Center, 48113-0170, USA.
JAMA. 1997 Nov 26;278(20):1663-9.
Although experimental studies show that insulin therapy can be safe and efficacious in improving glycemic control in type 2 diabetes under optimal conditions (ie, using patient volunteers with close monitoring under strict study protocols), little is known about its effectiveness, complication rates, and associated resource utilization in actual clinical practice.
Cohort study.
Large staff-model health maintenance organization.
A total of 8668 patients with type 2 diabetes cared for by generalist physicians from 1990 through 1993.
Resource use (hospitalizations, outpatient visits, laboratory testing, and home glucose monitoring) and glycemic control were evaluated using combined clinical, survey, and administrative information systems data. Detailed clinical case-mix data, including a newly validated case-mix method, the Total Illness Burden Index, were collected on a subsample of 1738 patients.
Among patients starting insulin therapy, hemoglobin A1c (HbA1c) decreased by 0.9 percentage point (95% confidence interval, 0.7-1.0) at 1 year compared with those receiving stable medication regimens; however, 2 years after starting insulin therapy, 60% still had HbA1c levels of 8% or greater. There was no evidence that some primary care physicians achieved better results than other primary care physicians when starting insulin therapy in their patients. Patients with the poorest baseline glycemic control achieved substantially greater HbA1c reductions; those with a baseline HbA1c level of 13% had a 3-fold greater decline in HbA1c than those whose baseline HbA1c level was 9%. For a subset of all patients for whom detailed clinical case-mix data were obtained, those taking insulin had higher resource use than those taking sulfonylureas, independent of illness severity. After adjusting for age, sex, race, socioeconomic status, disease duration, and severity of diabetes and comorbidities, insulin users had slightly more laboratory tests performed, 2.4 more outpatient visits per year, and almost 300 more fingersticks for home glucose testing per year compared with sulfonylurea users (all P<.01). Although 15% of patients receiving insulin therapy reported weekly symptoms of hypoglycemia, insulin therapy was not associated with an increase in emergency department visits (after case-mix adjustment) and resulted in only 0.5 hypoglycemia-related hospitalizations per 100 patient-years.
For patients with type 2 diabetes who were cared for by generalist physicians, starting insulin therapy was generally safe and effective in achieving moderate glycemic control in patients who initially had poor glycemic control. However, insulin therapy was associated with increases in resource use and was rarely effective in achieving tight glycemic control, even for those with moderate control.
尽管实验研究表明，在最佳条件下（即使用患者志愿者并在严格的研究方案下进行密切监测），胰岛素治疗在改善2型糖尿病患者的血糖控制方面可以是安全有效的，但对于其在实际临床实践中的有效性、并发症发生率及相关资源利用情况却知之甚少。
队列研究。
大型员工模式的健康维护组织。
1990年至1993年期间由全科医生诊治的共8668例2型糖尿病患者。
利用临床、调查和管理信息系统的数据组合来评估资源使用情况（住院、门诊就诊、实验室检查和家庭血糖监测）以及血糖控制情况。在1738例患者的子样本中收集了详细的临床病例组合数据，包括一种新验证的病例组合方法——总疾病负担指数。
在开始胰岛素治疗的患者中，与接受稳定药物治疗方案的患者相比，1年后糖化血红蛋白（HbA1c）下降了0.9个百分点（95%置信区间为0.7 - 1.0）；然而，开始胰岛素治疗2年后，仍有60%的患者HbA1c水平在8%或更高。没有证据表明在为患者开始胰岛素治疗时，一些初级保健医生比其他初级保健医生能取得更好的效果。基线血糖控制最差的患者HbA1c降低幅度显著更大；基线HbA1c水平为13%的患者HbA1c下降幅度是基线HbA1c水平为9%的患者的3倍。在所有获取了详细临床病例组合数据的患者子集中，使用胰岛素的患者资源使用高于使用磺脲类药物的患者，且与疾病严重程度无关。在对年龄、性别、种族、社会经济地位、病程、糖尿病严重程度和合并症进行调整后，与磺脲类药物使用者相比，胰岛素使用者每年进行的实验室检查略多，门诊就诊次数多2.4次，家庭血糖检测的指尖采血每年多近300次（所有P <.01）。尽管15%接受胰岛素治疗的患者报告每周有低血糖症状，但胰岛素治疗与急诊就诊增加无关（病例组合调整后），且每100患者年仅导致0.5次低血糖相关住院。
对于由全科医生诊治的2型糖尿病患者，开始胰岛素治疗对于最初血糖控制不佳的患者在实现适度血糖控制方面总体上是安全有效的。然而，胰岛素治疗与资源使用增加相关，并且即使对于中度控制的患者，在实现严格血糖控制方面也很少有效。
