中药复方干预糖尿病前期疗效及安全性Meta分析与试验序贯分析

Meta-analysis and Trial Sequential Analysis of the Efficacy and Safety of Chinese Herbal Compound Prescription in the Intervention of Prediabetes

目的:系统评价中药复方治疗糖尿病前期的疗效和安全性。方法:计算机检索13个中英文数据库及临床试验注册中心,纳入随机对照试验,治疗组采用中药复方,并对纳入文献质量进行质量评估,对结局指标进行试验序贯分析(TSA)及疗效评定,GRADE系统评估证据等级。结果:共纳入22个随机对照研究(RCT)试验,总样本量3 063例。糖尿病发病率:RR=0.52,95%CI[0.43,0.62],Z=7.20,P<0.05;糖尿病前期逆转率:RR=1.69,95%CI[1.50,1.90],Z=8.76,P<0.05;空腹血糖:MD=-0.23,95%CI[-0.27,-0.19],Z=10.78,P<0.05;糖耐量试验(OGTT) 2 h血糖:MD=-0.93,95%CI[-1.26,-0.60],Z=5.49,P<0.05;糖化血红蛋白:MD=-0.39,95%CI[-0.54,-0.25],Z=5.19,P<0.05;安全性分析:RR=1.34,95%CI[0.79,2.30],Z=1.08,P=0.28>0.05,不良事件及不良反应表现为轻度,未报道严重不良反应。TSA:对上述5项结局指标进行分析,当前研究的样本量均超过期望信息量(RIS),说明研究结局提前得到肯定结论。对上述5项结局指标进行GRADE评价,证据水平达到中高质量,其中糖尿病发病率为高质量证据,血糖指标为中质量证据,进一步验证了中药复方干预糖尿病前期的疗效。结论:现有证据表明,中药复方在降低糖尿病的发病率,提高糖尿病前期逆转率方面有明显优势,且降低血糖指标,尤其明显降低OGTT 2 h血糖(0.93 mmol/L),中药复方干预糖尿病前期具有较好的临床疗效及安全性。

Objective:To systematically evaluate the efficacy and safety of Chinese herbal compound prescription in the treatment of prediabetes.Methods:A computer search was conducted on 13 Chinese and English databases and clinical trial registration centers,and randomized controlled trials were included.The treatment group used Chinese herbal compound prescriptions,and the quality of the included literature was evaluated.Trial sequential analysis(TSA)and efficacy evaluation were conducted on the outcome indicators,and the GRADE system was used to evaluate the level of evidence.Results:A total of 22 RCT trials were included,with a total sample size of 3063 cases.Incidence rate of diabetes:RR=0.52,95%CI[0.43,0.62],Z=7.20,P<0.05.Prediabetes reversal rate:RR=1.69,95%CI[1.50,1.90],Z=8.76,P<0.05.Fasting blood glucose:MD=-0.23,95%CI[-0.27,-0.19],Z=10.78,P<0.05.2-hour blood glucose tolerance test(OGTT):MD=-0.93,95%CI[-1.26,-0.60],Z=5.49,P<0.05.Hemoglobin:MD=-0.39,95%CI[-0.54,-0.25],Z=5.19,P<0.05.Safety analysis:RR=1.34,95%CI[0.79,2.30],Z=1.08,P=0.28>0.05,adverse events and reactions were mild,and no serious adverse reactions were reported.TSA:Analysis of the above 5 outcome indicators showed that the sample size of the current study exceeded the required information size(RIS),indicating that the research outcome was positively concluded in advance.GRADE evaluation was conducted on the above five outcome indicators,and the level of evidence reached medium and high quality.Among them,the incidence rate of diabetes was high quality evidence,and the blood glucose index was medium quality evidence,which further verified the efficacy of Chinese herbal compound prescription in the intervention of prediabetes.Conclusion:The existing evidence shows that the Chinese herbal compound prescription has obvious advantages in reducing the incidence rate of diabetes and improving the reversion rate of prediabetes,and it also reduces the blood glucose indicators,especially the OGTT 2 h blood glucose(0.93 mmol/L).The Chinese herbal compound prescription intervention in prediabetes has good clinical efficacy and safety.