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度洛西汀与普瑞巴林和加巴喷丁治疗糖尿病性周围神经病变性疼痛的疗效比较:一项德国观察性研究的结果

Effectiveness of duloxetine compared with pregabalin and gabapentin in diabetic peripheral neuropathic pain: results from a German observational study.

作者信息

Happich Michael, Schneider Edith, Boess Frank G, Wilhelm Stefan, Schacht Alexander, Birklein Frank, Ziegler Dan

机构信息

*Medical Department, Health Technology Appraisal Group †Regional Medical Affairs ‡Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg §Klinik und Poliklinik für Neurologie, Johannes Gutenberg Universität, Mainz ∥Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research, Heinrich Heine University ¶Department of Endocrinology and Diabetology, University Hospital, Düsseldorf, Germany.

出版信息

Clin J Pain. 2014 Oct;30(10):875-85. doi: 10.1097/AJP.0000000000000057.

Abstract

OBJECTIVES

This study aimed to compare the effectiveness of duloxetine (DLX) and the anticonvulsants pregabalin (PGB) and gabapentin (GBP) for the treatment of diabetic peripheral neuropathic pain (DPNP) in routine clinical care.

MATERIALS AND METHODS

Data from a 6-month, noninterventional study involving 2575 patients in whom treatment of DPNP was initiated with or changed to DLX, PGB, or GBP (n=1523) were analyzed post hoc; patients treated with other medications or combinations were excluded from this analysis. Propensity scoring was used to compare patient groups, assessing Brief Pain Inventory (BPI), Clinical and Patient Global Impression (CGI/PGI), the Hospital Anxiety and Depression Scale (HADS), the Sheehan Disability Scale (SDS), and the Short Form Health Survey (SF 12).

RESULTS

Mean median daily dosage over 6 months was 53.9 mg for DLX (N=931), 173.5 mg for PGB (N=248), and 727.8 mg for GBP (N=351). BPI average pain severity (last observation carried forward, mean [SD]) decreased by 2.3 [2.30] points for DLX patients, and by 1.9 [2.22] in PGB, and 1.1 [2.15] in GBP patients. This difference remained statistically significant (DLX vs. PGB: P=0.029; DLX vs. GBP: P<0.001) after adjustment by propensity scores. Similar findings were also seen for the BPI interference score, CGI and PGI, the HADS anxiety score, the HADS depression score.

DISCUSSION

When compared with DLX, the low doses of PGB and GBP used in this noninterventional study might have contributed to the lower effectiveness found for both anticonvulsants in the treatment of patients with DPNP.

摘要

目的

本研究旨在比较度洛西汀(DLX)与抗惊厥药物普瑞巴林(PGB)和加巴喷丁(GBP)在常规临床护理中治疗糖尿病性周围神经病变性疼痛(DPNP)的有效性。

材料与方法

对一项为期6个月的非干预性研究的数据进行事后分析,该研究涉及2575例患者,这些患者开始使用或改用DLX、PGB或GBP治疗DPNP(n = 1523);接受其他药物或联合治疗的患者被排除在本分析之外。采用倾向评分法比较患者组,评估简明疼痛量表(BPI)、临床和患者整体印象(CGI/PGI)、医院焦虑抑郁量表(HADS)、希恩残疾量表(SDS)和健康调查简表(SF-12)。

结果

6个月期间,DLX(N = 931)的平均每日剂量中位数为53.9 mg,PGB(N = 248)为173.5 mg,GBP(N = 351)为727.8 mg。DLX患者的BPI平均疼痛严重程度(末次观察结转,均值[标准差])下降了2.3[2.30]分,PGB患者下降了1.9[2.22]分,GBP患者下降了1.1[2.15]分。经倾向评分调整后,这种差异仍具有统计学意义(DLX与PGB:P = 0.029;DLX与GBP:P < 0.001)。BPI干扰评分、CGI和PGI、HADS焦虑评分、HADS抑郁评分也有类似发现。

讨论

在这项非干预性研究中,与DLX相比,使用的低剂量PGB和GBP可能导致这两种抗惊厥药物在治疗DPNP患者时有效性较低。

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