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
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R587.1

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浙江省“十三五”中医药重点专科建设项目(浙卫办中医〔2019〕1号)


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

    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。

    Abstract:

    Abstract: 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 3 063 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.

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林晓柔,吴文哲,杨佳琦,黄晓玲.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[J].新中医,2023,55(17):21-31

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  • 在线发布日期: 2023-09-07
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