中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2016, Vol. 11 ›› Issue (8): 1347-1358.doi: 10.4103/1673-5374.189202

• 原著:脊髓损伤修复保护与再生 • 上一篇    下一篇

黄芪桂枝五物汤治疗糖尿病周围神经病变：16项随机对照试验的Meta分析

  

  • 出版日期:2016-08-31 发布日期:2016-08-31
  • 基金资助:
    973项目(2010CB530600)

Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy: a meta-analysis of 16 randomized controlled trials

Bing Pang1, #, Tian-yu Zhao2, #, Lin-hua Zhao1, Fang Wan1, Ru Ye1, Qiang Zhou3, Feng Tian4, Xiao-lin Tong1, *   

  1. 1 Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China 2 Department of Endocrinology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China 3 Digestive Disease Diagnosis and Treatment Center, Beijing Chinese Medicine Hospital, Capital Medical University, Beijing, China 4 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China
  • Online:2016-08-31 Published:2016-08-31
  • Contact: Xiao-lin Tong, M.D., xiaolintong66@sina.com.
  • Supported by:
    This work was supported by a grant from the National Basic Research Program of China (973 Program), No. 2010CB530600; and Institutes Project from Guang’anmen Hospital of China Academy of Chinese Medical Sciences, No. 2011261.

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摘要：

目的：系统评价中药复方黄芪桂枝五物汤治疗糖尿病周围神经病变的临床疗效及安全性。资料来源：检索 Cochrane图书馆、Medline、中国生物医学文献数据库、中国知网、维普、万方数据库中的相关文献，文献发表时间截止至2014年1月1日。主要检索词为“中医药、糖尿病周围神经病变、随机对照试验”。资料选择：纳入黄芪桂枝五物汤治疗糖尿病周围神经病变的随机对照研究，治疗组的采用（加味）黄芪桂枝五物汤治疗，对照组干预方法不设限制。按照Cochrane Review Handbook进行文献质量评价。采用Rev Man 5.2软件，选择随机或固定效应模型进行meta分析。结局指标：主要结局指标为临床疗效，主要依据症状改变及神经传导速度的变化来判定。次要结局指标为空腹血糖水平和血流变指标变化。结果：共纳入16项随机对照研究，包括1 173例糖尿病周围神经病变患者。Meta分析结果显示，与对照组相比，(加味)黄芪桂枝五物汤改善糖尿病周围神经病变患者症状及体征的总有效率较高(RR=1.33, 95%CI：1.24-1. 42, Z =8.39, P < 0.01)，正中神经的运动和感觉传导速度提高(MD=3.46, 95%CI: 1.88-5.04, Z=4.30, P < 0.01；MD=3.30, 95%CI: 2.04-4.56, Z=5.14, P < 0.01)，腓神经的运动和感觉传导速度也显著提高(MD＝3.22, 95%CI: 2.45-3.98, P < 0.01; MD＝3.05, 95%CI: 2.01-4.09, P < 0.01)，空腹血糖水平差异无显著性意义(MD= -0.12, 95%CI= -0.42-0.19, Z=0.76, P=0.45)，血浆黏度明显降低(MD -0.11, 95%CI -0.21 to -0.02, Z=2.30, P=0.02)，纤维蛋白原水平差异无显著性意义(MD＝-0.53, 95%CI:-1.28-0.22, P =0.17)。有4篇文献显示无明显不良事件发生。纳入文献中未见临床试验报道糖尿病并发症发生率、生活质量等长远指标的描述。结论：黄芪桂枝五物汤治疗糖尿病周围神经病变的临床疗效及安全性较好。但目前临床研究质量普遍较低，黄芪桂枝五物汤长期应用的疗效及安全性仍不确定，所以对待结果应谨慎，需要高质量、大样本、多中心、双盲随机对照试验提供更强有力的证据。 

orcid: 0000-0002-0069-5055 (Bing Pang)

关键词: 神经再生, 周围神经损伤, Meta分析, 糖尿病周围神经病变, 随机对照试验, 黄岐桂枝五物汤, 中医, 甲钴胺, 疗效, 神经传导速度, 空腹血糖, 血液流变学

Abstract: OBJECTIVE: This meta-analysis was performed to systematically assess the effcacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction (HGWWD) for treating diabetic peripheral neuropathy. DATA SOURCES: Six electronic databases, including the Cochrane Library, MEDLINE database, Chinese Biomedical Database, Chinese National Knowledge Infrastructure Database, Chinese Science and Technique Journals Database, and the Wanfang Database, were search ed on the internet for randomized controlled trials published up until 1 December 2015. The search terms included “Chinese herbal medicine”, “diabetic peripheral neuropathy” and “randomized controlled trials” in Chinese and in English. DATA SELECTION: We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group, without restriction for the control group. We assessed literature quality in accordance with the Cochrane Review Handbook. A random or a fxed effects model was used to analyze outcomes using RevMan 5.2 software. OUTCOME MEASURES: The primary outcomes were changes in symptoms and nerve conduction velocities. The secondary outcomes were fasting blood glucose and hemorheological indexes. RESULTS: Sixteen randomized controlled trials, with a total of 1,173 patients, were included. Meta-analysis revealed that the effcacy of HGWWD for diabetic peripheral neuropathy was signifcantly superior compared with the control treatment (i.e., control group) (risk ratio = 0.36, 95% confdence interval (CI): 0.29–0.46, Z =8.33, P < 0.00001) Compared with the control group, there was an increase in median motor nerve conduction velocity (mean difference (MD) = 3.46, 95%CI: 1.88–5.04, Z = 4.30, P < 0.01) and median sensory nerve conduction velocity (MD = 3.30, 95%CI: 2.04–4.56, Z = 5.14, P < 0.01). There was also an increase in peroneal motor nerve conduction velocity (MD = 3.22, 95%CI: 2.45–3.98, Z = 8.21, P < 0.01) and peroneal sensory nerve conduction velocity (MD = 3.05, 95%CI: 2.01–4.09, Z = 5.75, P < 0.01) in the treatment groups. No signifcant difference in fasting blood glucose was found between the treatment groups and the control groups (MD = ?0.12, 95%CI: ?0.42–0.19, Z = 0.76, P = 0.45). Plasma viscosity was signifcantly decreased after treatment (MD = ?0.11, 95%CI: ?0.21 to ?0.02, Z = 2.30, P = 0.02). No signifcant difference in fbrinogen was detectable (MD = ?0.53, 95%CI: ?1.28– 0.22, Z = 1.38, P = 0.17). Four trials reported that treatment groups experienced no adverse reactions. Adverse events were not mentioned in the other 12 trials. No trial reported the incidence of complications, quality of life outcomes, or health economics. CONCLUSION: HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities. Our study suggests that HGWWD may have signifcant therapeutic effcacy for the treatment of diabetic peripheral neuropathy. However, the methodological quality of the randomized controlled trials was generally low. Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.

Key words: nerve regeneration, meta-analysis, diabetic peripheral neuropathy, randomized controlled trials, Huangqi Guizhi Wuwu Decoction; traditional Chinese medicine, mecobalamin, efficacy, nerve conduction velocities, fasting blood glucose, hemorheology, neural regeneration