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度洛西汀治疗非糖尿病周围神经性疼痛患者的疗效与血糖控制:一项荟萃分析。

Duloxetine treatment and glycemic controls in patients with diagnoses other than diabetic peripheral neuropathic pain: a meta-analysis.

机构信息

Novartis Vaccines and Diagnostics, Siena, Italy.

出版信息

Curr Med Res Opin. 2010 Nov;26(11):2579-88. doi: 10.1185/03007991003769241. Epub 2010 Sep 27.

Abstract

OBJECTIVE

Mood disorders are often associated with poor glycemic control, and antidepressant treatments for mood and pain disorders can alter plasma glucose levels in patients with diabetes. A previous meta-analysis from three studies showed that duloxetine modestly increased fasting plasma glucose (FPG) and HbA(1c) levels in patients with diabetic peripheral neuropathic pain (DPNP). This meta-analysis examined whether there were any short- and long-term effects of duloxetine (20-120 mg/day) on glycemic control in patients with diagnoses other than DPNP.

RESEARCH DESIGN AND METHODS

Short-term data (9-27 weeks): seven studies of duloxetine in general anxiety disorder, fibromyalgia, and chronic lower back pain (CLBP). Long-term data: 41-week, uncontrolled extension of the short-term CLBP study and 52-week study in patients with recurrence of major depressive disorder.

MAIN OUTCOME MEASURES

Baseline-to-endpoint changes in FPG and HbA(1c) levels.

RESULTS

In short-term studies, patients were randomly assigned to placebo (n = 1098) or duloxetine (n = 1563). Mean baseline-to-endpoint changes in FPG and HbA(1c) did not significantly differ in duloxetine-treated patients compared with placebo-treated patients. In the 41-week study (n = 181), duloxetine-treated patients experienced a small but significant within-group baseline-to-endpoint increase in HbA(1c) (mean change = 0.1%; p < 0.001). This result was in contrast to absence of effect on mean baseline-to-endpoint within-group changes in FPG (p = 0.326) in that study, and to absence of between-treatment changes in FPG (p = 0.744) and HbA(1c) (p = 0.180) in the 52-week placebo-controlled study.

CONCLUSION

Duloxetine treatment did not significantly alter FPG and HbA(1c) levels compared with placebo treatment in the short-term studies. A small but statistically significant within-group increase in HbA(1c) was found in the 41-week study, but not in between-treatment group differences in the 52-week study. Neither of the long-term studies showed significant changes in the FPG levels. The small, non-reproducible HbA(1c) increase in one study of patients without DPNP may have resulted from patients with unrecognized diabetes in these trials.

摘要

目的

心境障碍常伴有血糖控制不佳,而治疗心境和疼痛障碍的抗抑郁药物会改变糖尿病患者的血浆葡萄糖水平。此前来自三项研究的荟萃分析显示,度洛西汀可适度升高糖尿病周围神经病理性疼痛(DPNP)患者的空腹血糖(FPG)和糖化血红蛋白(HbA1c)水平。本荟萃分析研究了度洛西汀(20-120mg/天)对除 DPNP 以外的其他诊断患者血糖控制的短期和长期影响。

研究设计和方法

短期数据(9-27 周):度洛西汀在广泛性焦虑症、纤维肌痛和慢性下腰痛(CLBP)的 7 项研究。长期数据:为期 41 周的无对照短期 CLBP 研究扩展和复发性重度抑郁症患者的 52 周研究。

主要观察指标

FPG 和 HbA1c 水平的基线至终点变化。

结果

在短期研究中,患者被随机分配至安慰剂组(n=1098)或度洛西汀组(n=1563)。与安慰剂组相比,度洛西汀治疗患者的 FPG 和 HbA1c 均值基线至终点变化无显著差异。在为期 41 周的研究(n=181)中,度洛西汀治疗患者的 HbA1c 出现了一个小但有统计学意义的组内基线至终点升高(平均变化=0.1%;p<0.001)。这一结果与该研究中 FPG 组内基线至终点均值无变化(p=0.326),以及 52 周安慰剂对照研究中 FPG(p=0.744)和 HbA1c(p=0.180)无治疗组间差异形成对比。

结论

与安慰剂治疗相比,短期研究中度洛西汀治疗并未显著改变 FPG 和 HbA1c 水平。在为期 41 周的研究中发现了 HbA1c 的一个小但有统计学意义的组内升高,但在 52 周的研究中未发现治疗组间差异。两项长期研究均未显示 FPG 水平有显著变化。在一项无 DPNP 患者的研究中,HbA1c 出现的这种小而不可复制的升高,可能源于这些试验中未被识别的糖尿病患者。

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