益肾活血法治疗非增殖期糖尿病视网膜病变的Meta分析及用药规律总结

Meta analysis and data mining of the method of yishenhuoxue in the treatment of nonproliferative diabetic retinopathy

目的:运用Meta分析和数据挖掘方法评价益肾活血法治疗非增殖期糖尿病视网膜病变(NPDR)的有效性和安全性并总结其用药规律。方法:检索CNKI、VIP、WF、PubMed、the Cochrane Library、SinoMed、Embase中英文医学数据库中收录的有关中医药治疗NPDR的文献。参照Cochrane系统评价员手册对纳入的文献进行质量评价,应用RevMan 5.4.1软件进行统计分析。对中药名称进行规范化处理后,使用SPSS Modeler 18进行关联规则分析,然后使用Cytoscape制作复杂网络图。结果:共纳入20项RCT,Meta分析结果显示,益肾活血法单用或联合西药治疗在提高NPDR患者的临床总有效率[RR=1.21,95%CI(1.16,1.27),P<0.00001]、中医症候疗效[RR=1.28,95%CI(1.18,1.39),P<0.00001]、视力[MD=0.11,95%CI(0.05,0.17),P=0.0001]、HDL-C[MD=0.14,95%CI(0.03,0.25),P=0.02];减少眼底血管瘤个数[MD=−3.51,95%CI(−5.73,−1.28),P=0.002]、出血斑面积[MD=−0.70,95%CI(−0.95,−0.46),P<0.00001];降低CMT[MD=−35.31,95%CI(−55.47,−15.14),P=0.0006]、FBG[MD=−0.39,95%CI(−0.72,−0.05),P=0.02]、LDL-C[MD=−0.36,95%CI(−0.64,−0.08),P=0.01]、全血高切黏度[MD=−0.43,95%CI(−0.75,−0.12),P=0.006]、血浆黏度[MD=−0.36,95%CI(−0.67,−0.06),P=0.02]和纤维蛋白原[MD=−0.50,95%CI(−0.81,−0.19),P=0.002]等方面均优于单纯西药治疗,差异有统计学意义。所录入的20首方剂共涉及中药70味。枸杞子、三七、丹参、黄芪、生地黄为高频和核心药物,关联规则分析总结常用的药对包括生地黄-三七、生地黄-枸杞子等。结论:益肾活血法单用或联合西药可以更有效提高NPDR的临床疗效,但仍需更高质量的临床研究加以验证。

Objective:To evaluate the efficacy and safety of the method of Yishen Huoxue in the intervention of nonproliferative diabetic retinopathy(NPDR)by Meta analysis and explore the medication regularity of Chinese Medicine(TCM)based on data mining.Methods:The related literature of TCM in the treatment of NPDR published in CNKI,VIP,WF,PubMed,the Co-chrane Library,SinoMed,Embase were collected.The quality of the included literature was evaluated with reference to the Co-chrane System Evaluators'Handbook,and statistical analysis was performed by applying Revman 5.4.1 software.After normaliza-tion of the Chinese medicine names,association rule analysis was performed by using SPSS Modeler 18,and then Cytoscape was used to produce complex network diagrams.Results:20 RCTs were included.Meta-analysis results showed that the method of Yishen Huoxue or Yishen Huoxue combined with western medicine were better than the control group in improving the total clinical efficiency[RR=1.21,95%CI(1.16,1.27),P<0.00001],TCM symptom efficacy[RR=1.28,95%CI(1.18,1.39),P<0.00001],and visual acuity[MD=0.11,95%CI(0.05,0.17),P=0.0001],HDL-C[MD=0.14,95%CI(0.03,0.25),P=0.02];reduc-ing the number of fundus hemangiomas[MD=−3.51,95%CI(−5.73,−1.28),P=0.002],hemorrhagic spot area[MD=−0.70,95%CI(−0.95,−0.46),P<0.00001],CMT[MD=−35.31,95%CI(−55.47,−15.14),P=0.0006],FBG[MD=−0.39,95%CI(−0.72,−0.05),P=0.02],LDL-C[MD=−0.36,95%CI(−0.64,−0.08),P=0.01],whole high blood viscosity[MD=−0.43,95%CI(−0.75,−0.12),P=0.006],plasma viscosity[MD=−0.36,95%CI(−0.67,−0.06),P=0.02]and fibrino-gen[MD=−0.50,95%CI(−0.81,−0.19),P=0.002].The differences were statistically significant.The 20 recipes entered in-volved a total of 70 herbal medicines.It is analyzed that the high-frequency drugs and the core drugs are Gouqizi,Sanqi,Danshen,Haungqi,Shengdihuang,etc.The association rule analysis summarizes the commonly used pairs including:Shengdihuang-San qi、Shengdihuang-Gouqi,etc.Conclusion:Compared with western medicine treatment alone,the method of Yishen Huoxue or Yishen Huoxue combined with western medicine produce better effects,but it still needs to be verified by higher quality clinical studies.