丹参川芎嗪注射液联合甲钴胺治疗糖尿病周围神经病变的系统评价及 Meta 分析方案
Salviae miltiorrhizae and ligustrazine hydrochloride injection combined with mecobalamin for treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis.
机构信息
Gaozhou Hospital of Traditional Chinese Medicine (Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine.
The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou.
出版信息
Medicine (Baltimore). 2021 Jan 22;100(3):e24103. doi: 10.1097/MD.0000000000024103.
OBJECTIVE
Currently, it is unclear whether the salviae miltiorrhizae (Danshen Salvia) and ligustrazine hydrochloride (Chuanxiong Chuanxiong) (SMLH) injection combined with mecobalamin can improve diabetic peripheral neuropathy (DPN). We conducted a systematic analysis to evaluate the clinical effects of SMLH injection combined with mecobalamin for treating DPN.
METHODS
Seven databases, including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Database (Wang Fang), Chinese Biomedical Literature Database (CBM), and VIP Database for Chinese Technical Periodicals (VIP) were searched for systematic literature retrieval. Each database was searched up to 2020 to identify randomized controlled trials on DPN treated with SMLH injection combined with mecobalamin. We used the RevMan 5.3 and Stata 14.0 software to assess the risk of bias in the included trials.
RESULTS
A total of 15 publications, including 1349 samples, were reviewed. The total effective rate of SMLH injection combined with mecobalamin was 31% higher than that of mecobalamin alone (95% confidence interval [CI] = 1.23-1.38; P < .00001). The experimental group showed a significant increase in the motor conduction velocity (MCV) of the peroneal nerve (weighted mean difference [WMD] = 4.81, 95% CI 3.53-6.09; P < .00001). In addition, SMLH injection combined with mecobalamin showed a statistical significant effect on the sensory conduction velocity (SCV) of the peroneal nerve (WMD = 5.03, 95% CI = 4.16-5.90; P < .00001), and MCV of the median nerve (WMD = 5.38, 95% CI = 4.05-6.72; P < .00001). The WMD for the change in SCV in the median nerve was 4.89 m/s (95% CI = 3.88-5.89; P < .00001). The P-values of the Egger and Begg tests were 0.967 and 0.961, respectively, indicating no publication bias. Subgroup and sensitivity analyses indicated that the results for MCV and SCV of the peroneal nerve and the median nerve were stable.
CONCLUSION
SMLH injection combined with mecobalamin can improve DPN, compared with mecobalamin alone.
目的
目前尚不清楚丹参川芎嗪（SMLH）注射液联合甲钴胺是否能改善糖尿病周围神经病变（DPN）。我们进行了系统分析，以评估 SMLH 联合甲钴胺治疗 DPN 的临床疗效。
方法
检索 PubMed、Embase、Cochrane 图书馆、中国知网（CNKI）、万方数据库（Wang Fang）、中国生物医学文献数据库（CBM）和中文科技期刊全文数据库（VIP）共 7 个数据库，检索时间截至 2020 年，以获取 SMLH 联合甲钴胺治疗 DPN 的随机对照试验的系统文献检索。我们使用 RevMan 5.3 和 Stata 14.0 软件评估纳入试验的偏倚风险。
结果
共纳入 15 篇文献，包含 1349 个样本。SMLH 联合甲钴胺的总有效率比甲钴胺单独治疗组高 31%（95%置信区间[CI]：1.23-1.38；P<0.00001）。实验组腓总神经运动传导速度（MCV）显著增加（加权均数差[WMD] = 4.81，95% CI：3.53-6.09；P<0.00001）。此外，SMLH 联合甲钴胺对腓总神经感觉传导速度（SCV）也有显著影响（WMD = 5.03，95% CI：4.16-5.90；P<0.00001）和正中神经 MCV（WMD = 5.38，95% CI：4.05-6.72；P<0.00001）。正中神经 SCV 变化的 WMD 为 4.89 m/s（95% CI：3.88-5.89；P<0.00001）。Egger 和 Begg 检验的 P 值分别为 0.967 和 0.961，表明无发表偏倚。亚组和敏感性分析表明，腓总神经和正中神经的 MCV 和 SCV 结果稳定。
结论
与甲钴胺单药治疗相比，SMLH 联合甲钴胺可改善 DPN。
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