机构地区:[1]北京中医药大学东直门医院,北京100700 [2]北京中医药大学,北京100029
出 处:《世界中西医结合杂志》2024年第7期1312-1325,1329,共15页World Journal of Integrated Traditional and Western Medicine
基 金:国家中医药管理局青年岐黄学者支持项目(批文号:国中医药人教发[2020]7号)。
摘 要:目的系统评价养阴清热法联合常规降糖西药治疗2型糖尿病(Type 2 diabetes mellitus,T2DM)的有效性及安全性。方法计算机检索CNKI、万方、维普、SinoMed、PubMed、Cochrane Library以及Web of Science,检索时限为建库至2022年5月,筛选关于养阴清热法治疗T2DM的临床随机对照试验(Randomized controlled trials,RCTs),其中对照组予常规西医基础治疗,试验组在对照组基础上加用以养阴清热为主要功效的中药或复方,采用Cochrane风险偏倚评估工具进行文献质量评价,使用RevMan 5.4软件进行统计学分析。结果最终纳入40篇RCTs,共计3637例患者。Meta分析结果显示,试验组临床总有效率高于对照组[RR=1.23,95%CI(1.19,1.27),P<0.00001],试验组在降低空腹血糖[MD=-1.17,95%CI(-1.33,-1.01),P<0.00001]、餐后2 h血糖[MD=-1.77,95%CI(-2.10,-1.44),P<0.00001]、糖化血红蛋白[MD=-1.03,95%CI(-1.28,-0.77),P<0.00001]、空腹胰岛素[MD=-3.35,95%CI(-4.01,-2.69),P<0.00001]、胰岛素抵抗指数[MD=-0.66,95%CI(-1.19,-0.13),P=0.01]、肿瘤坏死因子-α[SMD=-3.88,95%CI(-5.74,-2.02),P<0.00001]、白介素-6[SMD=-3.17,95%CI(-4.54,-1.80),P<0.00001]、甘油三酯[MD=-0.51,95%CI(-0.69,-0.33),P<0.00001]、总胆固醇[MD=-0.75,95%CI(-0.99,-0.50),P<0.00001]方面优于对照组。两组不良反应发生率比较,差异有统计学意义[RR=0.52,95%CI(0.36,0.76),P=0.0007]。结论养阴清热法辅助治疗2型糖尿病具有良好临床疗效及一定安全性,但由于纳入研究质量限制,仍需要更多大样本、多中心RCTs以提供更可靠的循证依据。Objective To systematically evaluate the effectiveness and safety of nourishing yin and clearing heat combined with conventional hypoglycemic Western medicine in treating type 2 diabetes mellitus(T2DM).Methods comprehensive search was conducted in databases including CNKI,WanFang,VIP,SinoMed,PubMed,Cochrane Library,A and Web of Science from their inception to May 2022.The search aimed to identify randomized controlled trials(RCTs)evaluating the efficacy of nourishing yin and clearing heat in treating T2DM.The control group received conventional Western medical treatment,while the experimental group received additional traditional Chinese medicine(TCM)or formulas primarily focusing on nourishing yin and clearing heat.The quality of the included studies was assessed using the Cochrane risk of bias tool,and statistical analysis was performed using RevMan 5.4 software.Results A total of 40 RCTs with 3637 patients were included in the meta-analysis.The results indicated that the overall clinical efficacy rate was higher in the experimental group compared to the control group[RR=1.23,95%CI(1.19,1.27),P<0.00001].The experimental group also showed superior outcomes in reducing fasting blood glucose[MD=-1.17,95%CI(-1.33,-1.01),P<0.00001],2-h postprandial blood glucose[MD=-1.77,95%CI(-2.10,-1.44),P<0.00001],glycated hemoglobin[MD=-1.03,95%CI(-1.28,-0.77),P<0.00001],fasting insulin[MD=-3.35,95%CI(-4.01,-2.69),P<0.00001],insulin resistance index[MD=-0.66,95%CI(-1.19,-0.13),P=0.01],tumor necrosis factor-α[SMD=-3.88,95%CI(-5.74,-2.02),P<0.00001],interleukin-6[SMD=-3.17,95%CI(-4.54,-1.80),P<0.00001],triglycerides[MD=-0.51,95%CI(-0.69,-0.33),P<0.00001],and total cholesterol[MD=-0.75,95%CI(-0.99,-0.50),P<0.00001].Additionally,the incidence of adverse reactions was significantly lower in the experimental group[RR=0.52,95%CI(0.36,0.76),P=0.0007].Conclusion The adjunctive treatment of T2DM with nourishing yin and clearing heat method shows good clinical efficacy and a certain level of safety.However,due to the limitations in the qu
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