补阳还五汤治疗糖尿病周围神经病变的疗效和安全性的系统评价和 Meta 分析。
Efficacy and safety of Buyang Huanwu decoction for diabetic peripheral neuropathy: a systematic review and Metaanalysis.
机构信息
Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100053, China.
Graduate School of Beijing University of Chinese Medicine, Beijing 100029, China.
出版信息
J Tradit Chin Med. 2023 Oct;43(5):841-850. doi: 10.19852/j.cnki.jtcm.20230802.002.
OBJECTIVE
To evaluate the efficacy and safety of Buyang Huanwu decoction (BYHWD) in treating diabetic peripheral neuropathy (DPN).
METHODS
Eight electronic databases, including China National Knowledge Infrastructure Database, Wanfang Database, China Science and Technology Journal Database, Chinese Biomedical Literature Database, Cochrane Library, Embase, Web of Science, and PubMed, were searched for randomized controlled trials (RCTs) of BYHWD to treat DPN. We identified all RCTs related to BYHWD and those on the treatment of DPN with the combination of mecobalamin. RevMan software was used for the statistical analysis.
RESULTS
Twentyone RCTs with a total of 1945 patients were included. The methodological quality of the literature included was low. Metaanalysis showed that the efficacy of the treatment group was significantly better than that of the control group in the treatment of DPN with BYHWD [risk ratio () = 0.33, 95% (0.27, 0.40), 11.25, 0.000 01]. The median nerve of median motor nerve conduction velocity (MNCV) [mean difference () = 4.16, 95% (1.35, 6.98)] and median sensory NCV (SNCV) [(= 3.28, 95% (2.35, 4.22)] were improved in the treatment group. The MNCV in the common peroneal nerve [(= 1.63, 95% (0.39, 2.87)] and SNCV [(= 4.56, 95% (3.16, 5.97)] were significantly higher than those in the control group ( 0.01). Plasma viscosity [(= －0.15, 95% (－0.20, －0.09), 5.17, 0.01)], whole blood high shear [(= 0.83, 95% (1.56, －0.11), 2.26, 0.02)]and whole blood low shear [(= 1.61, 95% (2.28, 0.94), 4.68, 0.01)] decreased significantly after treatment. There was no significant difference in fasting blood glucose [(= 0.42, 95% ( 0.89, 0.05), 1.76, 0.08)] between the treatment and control groups; postprandial blood glucose [(= 0.62, 95% ( 1.19, 0.05), 2.12, 0.03)] decreased significantly. No significant difference was found in the blood lipid levels between the treatment and control groups, including triglycerides [(= 0.21, 95% (0.52, 0.10), 1.34, 0.18)] and cholesterol [(= 0.13, 95% ( 0.27, 0.00), 1.92, 0.06)]. Of the 21 RCTs, only five reported adverse reactions, and four studies reported the length of followup. No serious adverse events were reported. None of the studies reported the quality of life and economic conditions.
CONCLUSIONS
Our study suggests that BYHWD has a significant therapeutic effect on DPN. Highquality, largescale RCTs are needed to provide more reliable evidence.
目的
评估补阳还五汤（BYHWD）治疗糖尿病周围神经病变（DPN）的疗效和安全性。
方法
检索中国知网、万方数据库、中国科技期刊数据库、中国生物医学文献数据库、Cochrane 图书馆、Embase、Web of Science、PubMed 等 8 个电子数据库，查找关于 BYHWD 联合甲钴胺治疗 DPN 的随机对照试验（RCT）。纳入所有与 BYHWD 相关的 RCT 及联合甲钴胺治疗 DPN 的 RCT。采用 RevMan 软件进行统计学分析。
结果
共纳入 21 项 RCT，纳入患者 1945 例。文献的方法学质量较低。Meta 分析结果显示，治疗组治疗 DPN 的疗效明显优于对照组 [风险比（RR）=0.33，95%（0.27，0.40），11.25，0.00001]。治疗组正中神经运动神经传导速度（MNCV）[均数差（MD）=4.16，95%（1.35，6.98）]和正中感觉神经传导速度（SNCV）[MD=3.28，95%（2.35，4.22）]均有改善。治疗组腓总神经 MNCV[MD=1.63，95%（0.39，2.87）]和 SNCV[MD=4.56，95%（3.16，5.97）]均显著高于对照组（0.01）。治疗后，治疗组血浆黏度[MD=－0.15，95%（－0.20，－0.09），5.17，0.01]、全血高切黏度[MD=0.83，95%（1.56，－0.11），2.26，0.02]、全血低切黏度[MD=1.61，95%（2.28，0.94），4.68，0.01]均显著降低。治疗组与对照组空腹血糖[MD=0.42，95%（0.89，0.05），1.76，0.08]差异无统计学意义；餐后血糖[MD=0.62，95%（1.19，0.05），2.12，0.03]显著降低。治疗组与对照组的血脂水平[甘油三酯（TG）MD=0.21，95%（0.52，0.10），1.34，0.18]、胆固醇（TC）MD=0.13，95%（0.27，0.00），1.92，0.06]差异无统计学意义。21 项 RCT 中，仅有 5 项报道了不良反应，4 项研究报道了随访时间。未发生严重不良事件。研究均未报告生活质量和经济状况。
结论
本研究表明，BYHWD 对 DPN 有显著的治疗作用。需要高质量、大样本的 RCT 来提供更可靠的证据。
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