糖脉康颗粒治疗糖尿病周围神经病变有效性与安全性的系统评价与Meta分析

Systematic review and Meta-analysis of efficacy and safety of Tangmaikang Granules in treatment of diabetic peripheral neuropathy

系统评价糖脉康颗粒治疗糖尿病周围神经病变(DPN)的有效性与安全性。检索PubMed、Cochrane Library、EMbase、中国生物医学文献服务系统(SinoMed)、中国知网(CNKI)、万方(Wanfang)、维普(VIP)数据库,纳入糖脉康颗粒治疗DPN的随机对照试验(RCT)。使用Cochrane评价手册5.3风险偏倚评估工具对文献进行质量评价,采用RevMan 5.4.1及Stata 15.1统计软件进行数据分析与异质性检验,使用GRADEpro证据质量分级系统对结局指标进行质量评价,以临床有效率为主要结局指标,手足麻木、肢体疼痛、感觉迟钝或消退、正中神经和腓神经的感觉神经传导速度(SCV)、正中神经和腓神经的运动神经传导速度(MCV)、空腹血糖(FBG)、餐后2 h血糖(2hPBG)、糖化血红蛋白(HbA1c)改善、不良反应发生率为次要结局指标。最终纳入19项RCTs,1602例患者。Meta分析结果显示,试验组在临床有效率(RR=1.45,95%CI[1.32,1.61],P<0.00001)、肢体疼痛(RR=1.70,95%CI[1.27,2.27],P=0.0003)、腓神经MCV(MD=4.08,95%CI[3.29,4.86],P<0.00001)及HbA1c(SMD=-1.23,95%CI[-1.80,-0.66],P<0.0001)改善方面优于对照组,差异有统计学意义;亚组分析显示试验组联合用药后在手足麻木(RR=1.42,95%CI[1.12,1.80],P=0.003)、感觉迟钝或消退(RR=1.41,95%CI[1.05,1.91],P=0.02)、正中神经SCV(MD=4.59,95%CI[0.92,8.27],P=0.01)、腓神经SCV(MD=4.68,95%CI[3.76,5.60],P<0.00001)及正中神经MCV(MD=5.58,95%CI[4.05,7.11],P<0.00001)改善方面优于对照组,差异有统计学意义;试验组在FBG(MD=-0.57,95%CI[-1.27,0.12],P=0.11)及2hPBG(MD=-0.69,95%CI[-1.70,0.33],P=0.18)改善方面与对照组疗效相当。在不良反应发生率(RR=1.28,95%CI[0.58,2.82],P=0.54)方面2组安全性相当。结果表明,糖脉康颗粒能明显提高临床有效率,改善周围神经症状及血糖水平,提高神经传导速度,目前尚未发现严重不良反应。但今后仍需更多大样本、多中心、高质量的RCT进一步验证。

This study aimed to explore the efficacy and safety of Tangmaikang Granules in the treatment of diabetic peripheral neuropathy(DPN).PubMed,Cochrane Library,EMbase,SinoMed,CNKI,Wanfang and VIP were retrieved for randomized controlled trial(RCT)of Tangmaikang Granules in the treatment of DPN.Cochrane handbook 5.3 was used to evaluate the quality of the inclu-ded studies,and RevMan 5.4.1 and Stata 15.1 were employed to analyze data and test heterogeneity.GRADEpro was used to assess the quality of each outcome index.Clinical effective rate was the major outcome index,while the improvement in numbness of hands and feet,pain of extremities,sluggishness or regression of sensation,sensory conduction velocity(SCV)and motor conduction velocity(MCV)of median nerve and peroneal nerve,fasting blood glucose(FBG),2 h postprandial blood glucose(2hPBG),and glycated hemoglobin(HbA1c)and incidence of adverse reactions were considered as the minor outcome indexes.A total of 19 RCTs with 1602 patients were eventually included.The Meta-analysis showed that the improvements in clinical effective rate(RR=1.45,95%CI[1.32,1.61],P<0.00001),pain of extremities(RR=1.70,95%CI[1.27,2.27],P=0.0003),MCV of peroneal nerve(MD=4.08,95%CI[3.29,4.86],P<0.00001)and HbA1c(SMD=-1.23,95%CI[-1.80,-0.66],P<0.0001)of Tangmaikang Granules alone or in combination in the experimental group were better than those in the control group.Compared with the conditions in the control group,numbness of hands and feet(RR=1.42,95%CI[1.12,1.80],P=0.003),sluggishness or regression of sensation(RR=1.41,95%CI[1.05,1.91],P=0.02),SCV of median nerve(MD=4.59,95%CI[0.92,8.27],P=0.01),SCV of peroneal nerve(MD=4.68,95%CI[3.76,5.60],P<0.00001)and MCV of median nerve(MD=5.58,95%CI[4.05,7.11],P<0.00001)of Tangmaikang Granules in combination in the experimental group were improved by subgroup analysis.The levels of FBG(MD=-0.57,95%CI[-1.27,0.12],P=0.11)and 2hPBG(MD=-0.69,95%CI[-1.70,0.33],P=0.18)in the experimental group were similar to those in the control group after treatment with Tangmaikang Granules alone or in combination.There was no difference in the safety(RR=1.28,95%CI[0.58,2.82],P=0.54)of Tangmaikang Granules in the treatment of DPN between the experimental group and the control group.Tangmaikang Granules could significantly increase clinical effective rate and nerve conduction velocity as well as improve symptoms of peripheral nerve and blood glucose level,and no serious adverse reactions were identified yet.Further validation was needed in future in large-sample,multicenter,high-quality RCTs.