Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain： a rapid health technology assessment

GAO Ning; FENG Bing; GAO Shengnan; ZHANG Ranran; ZHANG Yuxi; LIU Guoqiang

doi:10.6039/j.issn.1001-0408.2025.08.20

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Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain： a rapid health technology assessment

更新时间：2025-09-23

- Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain： a rapid health technology assessment
- ZHONGGUO YAOFANG Vol. 36, Issue 8, Pages: 1001-1007(2025)
- 作者机构：
  
  1.河北医科大学第三医院临床药学部，石家庄　050051
  2.河北省药物与卫生技术综合评估学会，石家庄　050051
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.08.20
  CLC： R971
- Received：20 September 2024，
  
  Revised：2025-02-20，
  
  Accepted：27 February 2025，
  
  Published：30 April 2025
- 稿件说明：
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高宁,冯冰,高胜男,等.钙离子通道调节剂治疗糖尿病周围神经病理性疼痛的快速卫生技术评估 [J].中国药房,2025,36(08):1001-1007.

GAO Ning,FENG Bing,GAO Shengnan,et al.Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain： a rapid health technology assessment[J].ZHONGGUO YAOFANG,2025,36(08):1001-1007.
高宁,冯冰,高胜男,等.钙离子通道调节剂治疗糖尿病周围神经病理性疼痛的快速卫生技术评估 [J].中国药房,2025,36(08):1001-1007. DOI： 10.6039/j.issn.1001-0408.2025.08.20.

GAO Ning,FENG Bing,GAO Shengnan,et al.Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain： a rapid health technology assessment[J].ZHONGGUO YAOFANG,2025,36(08):1001-1007. DOI： 10.6039/j.issn.1001-0408.2025.08.20.

摘要

目的

评价钙离子通道调节剂治疗糖尿病周围神经病理性疼痛（DPNP）的有效性、安全性与经济性，为临床药物选择和决策提供循证证据。

方法

检索PubMed、Embase、Cochrane Library、中国知网、万方数据、维普网、中国生物医学文献数据库和国外卫生技术评估（HTA）相关机构官方网站，收集普瑞巴林、加巴喷丁、克利加巴林和美洛加巴林治疗DPNP的HTA报告、系统评价/Meta分析和药物经济学研究，检索时限均为建库起至2024年6月。资料提取、质量评价后，对纳入研究的结果进行描述性分析。

结果

共纳入16篇文献，其中HTA报告1篇、系统评价/Meta分析7篇、药物经济学研究8篇，未检索到克利加巴林的研究。与安慰剂比较，普瑞巴林和美洛加巴林均能降低患者的终点疼痛评分，提高疼痛评分减少≥30%和/或≥50%的患者比例，且普瑞巴林可改善患者总体印象变化（PGIC）；加巴喷丁在降低患者终点疼痛评分和提高疼痛评分减少≥30%和/或≥50%的患者比例方面与安慰剂相似，但其可以改善患者的PGIC；与普瑞巴林比较，美洛加巴林疼痛治疗效果更好。普瑞巴林和美洛加巴林的安全性相似，相比安慰剂均会增加患者头晕、嗜睡等常见不良反应的发生风险；加巴喷丁与安慰剂、度洛西汀的安全性相似。与度洛西汀比较，普瑞巴林和加巴喷丁不具有经济性；与加巴喷丁比较，普瑞巴林具有经济性；与安慰剂和普瑞巴林比较，美洛加巴林具有经济性。

结论

普瑞巴林和美洛加巴林治疗DPNP的疗效显著，且美洛加巴林疗效优于普瑞巴林，两者安全性相似；经济性结论在不同国家存在差异，有待开展基于我国人群的药物经济学研究。

Abstract

OBJECTIVE

To evaluate the efficacy， safety and economics of calcium channel modulators in the treatment of diabetic peripheral neuropathic pain （DPNP）， and provide evidence-based evidence for clinical drug selection and decision-making.

METHODS

PubMed， Embase， Cochrane Library， CNKI， Wanfang data， VIP net， CBM and official websites of foreign health technology assessment （HTA） institutions were systematically searched to collect HTA reports， systematic review/meta-analyses， and pharmacoeconomic studies of pregabalin， gabapentin， crisugabalin， and mirogabalin for the treatment of DPNP. The timeframe for all searches was from the inception to June 2024. After data extraction and quality assessment， the results of the included studies were analyzed descriptively.

RESULTS

A total of 16 articles were included， involving 1 HTA report， 7 systematic reviews/meta-analyses， and 8 pharmacoeconomic studies. No studies on crisugabalin were retrieved. Compared with placebo， both pregabalin and mirogabalin reduced end point pain scores and increased the proportion of patients with ≥30% and/or ≥50% reduction in pain scores. Pregabalin also improved patient global impression of change （PGIC）. Gabapentin was similar to placebo in reducing end point pain scores and increasing the proportion of patients with ≥30% and/or ≥50% reduction in pain scores， but gabapentin improved PGIC of patients. Compared with pregabalin， mirogabalin was more effective in the treatment of pain. The safety of pregabalin and mirogabalin was similar， and compared with placebo， both pregabalin and mirogabalin increased the risk of common adverse reactions such as dizziness and somnolence. The safety of gabapentin was similar to placebo and duloxetine. Compared with duloxetine， pregabalin and gabapentin were not cost-effective. Compared with gabapentin， pregabalin was cost-effective. Mirogabalin was cost-effective， as compared with placebo and pregabalin.

CONCLUSIONS

Pregabalin and mirogabalin are effective in the treatment of DPNP， the efficacy of mirogabalin is better than pregabalin， and the safety is similar between them. The economic conclusions vary from country to country， pending a pharmacoeconomic study based on our population.

关键词

Keywords

references

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