芪明颗粒治疗糖尿病性黄斑水肿Meta分析
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摘要
目的:评价芪明颗粒治疗糖尿病性黄斑水肿(diabetic macular edema,DME)的临床疗效及安全性。方法:在中国期刊全文数据库、中国生物医学文献数据库、万方医学数据库、中文科技期刊数据库、Pubmed数据库中,检索从建库至2018年以芪明颗粒为干预措施治疗DME随机对照(randomized controlled trial,RCT)的研究文献,由两名研究人员独立地对这些研究的基本特征和方法学质量进行评价,采用RevMan5.3软件对临床疗效(有效率、视力、黄斑厚度改善情况、黄斑水肿复发情况)进行Meta分析。结果:共纳入13篇文献,共991例患者(1783只眼)。Meta分析结果显示,治疗组有效率显著优于对照组,差异具有统计学意义[OR=4.08,95%CI(2.84,5.86),Z=7.61,(P<0.00001)]。治疗组视力提高显著优于对照组,差异有统计学意义[MD=0.15,95%CI(0.12,0.19),Z=8.50,(P<0.00001)]。治疗组黄斑中心凹厚度改善情况显著优于对照组,差异有统计学意义[SMD=-0.84,95%CI(-1.29,-0.39),Z=3.64,(P=0.0003)]。治疗组黄斑水肿复率显著低于较对照组[OR=0.25,95%CI(0.12,0.55),Z=3.49,(P=0.0005)]。1篇文献提及3～10个月后进行随访,个别患者服用芪明颗粒后出现胃脘不适等症状。3篇文献在3个月后进行随访,并未发现服用芪明颗粒明确引起的不良反应。结论:芪明颗粒对治疗DME有一定疗效,且具有一定安全性,但还需更多高质量的RCT进行分析才能对其疗效及安全性得出更为肯定性结论。
Objective:To assess the efficacy and safety of Qiming Granules on diabetic retinopathy. Methods:Retrieved CNKI,WanFang Data,VIP,CBM,PubMed,etc.,and selected clinical trialsconforming with the enrolled criteria from building library to 2018. There were two researchers independently doing a data extrion of valid data. To evaluate the quality of the literature,use the Cochrane collaboration RevMan5.3 software for Meta-analysis. Results:A total number of 13 papers involving 991 patients were concluded. Fixed effect model was used to undergo Meta-analysis and the results showed that the total effective rate of Qiming Granules on diabetic retinopathy against other drugs was statistically difference between the treatment groups[OR=4.08,95%CI(2.84,5.86),Z=7.61,(P<0.00001)]. The visual acuity of the treatment group was significantly better than that of the control group[MD=0.15,95%CI(0.12,0.19),Z=8.50,(P<0.00001)]. The difference was statistically significant. The macular foveal thickness in the treatment group was significantly better than that in the control group[SMD=-0.84,95%CI(-1.29,-0.39),Z=3.64,(P=0.0003)]. The difference was statistically significant. The recovery of macular edema was significantly lower in the treatment group than in the control group[OR=0.25,95%CI(0.12,0.55),Z=3.49,(P=0.0005)]. One article mentioned follow-up after 3-10 months,individual patients had epigastric discomfort after taking Qiming Granules. After three months of follow-up of the three documents,no adverse drug reactions caused by the Qiming Granules were found. Conclusion:Qiming Granules have a certain effect on the treatment of DME,and have a certain degree of safety,but more high-quality RCTs are needed for analysis to reach a positive conclusion on its efficacy and safety.
Objective:To assess the efficacy and safety of Qiming Granules on diabetic retinopathy. Methods:Retrieved CNKI,WanFang Data,VIP,CBM,PubMed,etc.,and selected clinical trialsconforming with the enrolled criteria from building library to 2018. There were two researchers independently doing a data extrion of valid data. To evaluate the quality of the literature,use the Cochrane collaboration RevMan5.3 software for Meta-analysis. Results:A total number of 13 papers involving 991 patients were concluded. Fixed effect model was used to undergo Meta-analysis and the results showed that the total effective rate of Qiming Granules on diabetic retinopathy against other drugs was statistically difference between the treatment groups[OR=4.08,95%CI(2.84,5.86),Z=7.61,(P<0.00001)]. The visual acuity of the treatment group was significantly better than that of the control group[MD=0.15,95%CI(0.12,0.19),Z=8.50,(P<0.00001)]. The difference was statistically significant. The macular foveal thickness in the treatment group was significantly better than that in the control group[SMD=-0.84,95%CI(-1.29,-0.39),Z=3.64,(P=0.0003)]. The difference was statistically significant. The recovery of macular edema was significantly lower in the treatment group than in the control group[OR=0.25,95%CI(0.12,0.55),Z=3.49,(P=0.0005)]. One article mentioned follow-up after 3-10 months,individual patients had epigastric discomfort after taking Qiming Granules. After three months of follow-up of the three documents,no adverse drug reactions caused by the Qiming Granules were found. Conclusion:Qiming Granules have a certain effect on the treatment of DME,and have a certain degree of safety,but more high-quality RCTs are needed for analysis to reach a positive conclusion on its efficacy and safety.
引文
[1]XIE X,XU L,YANG H,et al. Frequency of diabetic retinopathy in the adult population in China:the Beijing Eye Study 2001[J].International Ophthalmology,2009,29(6):485-493.
[2]孙瑞雪,李素芬.糖尿病性黄斑水肿的激光治疗[J].河北医科大学学报,2005,26(3):239-240.
[3]陈悦,张金嵩.球后注射曲安奈德联合激光光凝治疗糖尿病弥漫性黄斑水肿的临床观察[J].中国实用眼科杂志,2007,25(2):155-157.
[4]孙河,江海佳.达明饮对背景期糖尿病视网膜病变LDL的影响[J].中医药学报,2013,41(3):138-139.
[5]邓亚平,谢学军.滋阴补肾活血药治疗糖尿病视网膜病变的初步观察[J].中国中西医结合杂志,1992(5):270-273.
[6]孟晶,张旭,张日佳,等. TA联合全视网膜光凝治疗糖尿病性黄斑水肿的效果评价[J].中国实用眼科杂志,2012,30(8):966-969.
[7]朱晶,吴超琼,鲁铭,等.中药联合玻璃体腔内注射雷珠单抗治疗糖尿病性黄斑水肿的疗效观察[J].南京中医药大学学报,2015,31(4):327.
[8]孙晓东,宫媛媛,汪枫桦.慎重应用抗新生血管药物治疗视网膜静脉阻塞继发的黄斑水肿[J].中华眼科杂志,2010,46(2):100.
[9]周沛.芪明颗粒联合眼底激光治疗糖尿病性视网膜病变Ⅲ期的疗效观察[J].养生保健指南,2017(36):83.
[10]付学玲,江颖,赵晓霞,等.芪明颗粒联合普拉洛芬滴眼液预防糖尿病白内障超声乳化术后黄斑水肿50例[J].中国药业,2015(10):82.
[11]孔文基,单洁.芪明颗粒治疗非增殖期糖尿病视网膜病变疗效观察[J].中药药理与临床,2015(5):145.
[12]孙瑞雪,孙朝晖,邸平会,等.芪明颗粒联合视网膜激光治疗糖尿病性黄斑水肿的疗效分析[J].河北医药,2017(8):1168.
[13]孙文翠,郝少峰,原艳波,等.芪明颗粒联合眼底激光治疗单纯型糖尿病性黄斑水肿疗效观察[J].长治医学院学报,2014(6):445.
[14]王家良.芪明颗粒联合激光治疗糖尿病黄斑水肿临床观察[J].实用中医药杂志,2015(12):1093.
[15]王家良,金学民,栗小丽,等.康柏西普联合芪明颗粒治疗糖尿病性黄斑水肿的临床观察[J].中国继续医学教育,2016(16):186.
[16]王家良,金学民,马宏杰,等.芪明颗粒联合曲安奈德治疗糖尿病性黄斑水肿临床观察[J].亚太传统医药,2017(15):127.
[17]王晓兰.卵磷脂络合碘联合芪明颗粒治疗糖尿病视网膜病变黄斑囊样水肿的临床观察[J].中医药信息,2016(3):111.
[18]徐仁权.芪明颗粒联合玻璃体注射雷珠单抗对糖尿病性黄斑水肿的效果[J].中国乡村医药,2018(2):38.
[19]殷莉,张德龙,任骞,等.芪明颗粒辅助雷珠单抗治疗糖尿病性黄斑水肿的临床疗效观察[J].世界临床药物,2016(11):735.
[20]郑茜.芪明颗粒对非增殖期糖尿病视网膜病变治疗效果观察[J].中国现代药物应用,2016(17):181.
[21]周莎.芪明颗粒对比复方血栓通胶囊治疗非增殖期糖尿病视网膜病变的临床观察[D].武汉:湖北中医药大学,2013.
[22]包银兰,王立军.糖尿病黄斑水肿发病机制及相关因素的研究概况[J].湖南中医杂志,2014,30(2):161.
[23]陈辉雄,张丽萍,陈玉华,等.探讨同型半胱氨酸血脂及血液流变学在糖尿病视网膜病变中的意义[J].检验医学与临床,2014(9):1179.
[24]李琳娜,张晓峰.糖尿病黄斑水肿的发病机制及治疗研究进展[J].临床眼科杂志,2014,22(1):86-90.
[25]汪彬,吴晓蓉,周琼.糖尿病性黄斑水肿的发病机制和治疗进展[J].南昌大学学报(医学版),2014(2):101.
[26]刘路宏.优糖明颗粒对糖尿病视网膜病变非增殖期作用的实验研究[D].成都:成都中医药大学,2001.
[27]杨力,蔚慧,玲香,等.芪明颗粒对糖尿病患者血脂的影响[J].海南医学院学报,2014,20(5):657.
[28]段俊国,廖品正,吴烈,等.中药复方芪明颗粒治疗糖尿病视网膜病变双盲双模拟随机对照多中心临床研究[J].成都中医药大学学报,2006,29(2):1-5.
[29]曹平,阳仁达.针灸治疗糖尿病周围神经病变的meta分析[J].中医药导报,2011(1):97-101.
[30]王雪,李晓.健脾益气法治疗2型糖尿病疗效的Meta分析[J].中医药导报,2015(18):82.
[2]孙瑞雪,李素芬.糖尿病性黄斑水肿的激光治疗[J].河北医科大学学报,2005,26(3):239-240.
[3]陈悦,张金嵩.球后注射曲安奈德联合激光光凝治疗糖尿病弥漫性黄斑水肿的临床观察[J].中国实用眼科杂志,2007,25(2):155-157.
[4]孙河,江海佳.达明饮对背景期糖尿病视网膜病变LDL的影响[J].中医药学报,2013,41(3):138-139.
[5]邓亚平,谢学军.滋阴补肾活血药治疗糖尿病视网膜病变的初步观察[J].中国中西医结合杂志,1992(5):270-273.
[6]孟晶,张旭,张日佳,等. TA联合全视网膜光凝治疗糖尿病性黄斑水肿的效果评价[J].中国实用眼科杂志,2012,30(8):966-969.
[7]朱晶,吴超琼,鲁铭,等.中药联合玻璃体腔内注射雷珠单抗治疗糖尿病性黄斑水肿的疗效观察[J].南京中医药大学学报,2015,31(4):327.
[8]孙晓东,宫媛媛,汪枫桦.慎重应用抗新生血管药物治疗视网膜静脉阻塞继发的黄斑水肿[J].中华眼科杂志,2010,46(2):100.
[9]周沛.芪明颗粒联合眼底激光治疗糖尿病性视网膜病变Ⅲ期的疗效观察[J].养生保健指南,2017(36):83.
[10]付学玲,江颖,赵晓霞,等.芪明颗粒联合普拉洛芬滴眼液预防糖尿病白内障超声乳化术后黄斑水肿50例[J].中国药业,2015(10):82.
[11]孔文基,单洁.芪明颗粒治疗非增殖期糖尿病视网膜病变疗效观察[J].中药药理与临床,2015(5):145.
[12]孙瑞雪,孙朝晖,邸平会,等.芪明颗粒联合视网膜激光治疗糖尿病性黄斑水肿的疗效分析[J].河北医药,2017(8):1168.
[13]孙文翠,郝少峰,原艳波,等.芪明颗粒联合眼底激光治疗单纯型糖尿病性黄斑水肿疗效观察[J].长治医学院学报,2014(6):445.
[14]王家良.芪明颗粒联合激光治疗糖尿病黄斑水肿临床观察[J].实用中医药杂志,2015(12):1093.
[15]王家良,金学民,栗小丽,等.康柏西普联合芪明颗粒治疗糖尿病性黄斑水肿的临床观察[J].中国继续医学教育,2016(16):186.
[16]王家良,金学民,马宏杰,等.芪明颗粒联合曲安奈德治疗糖尿病性黄斑水肿临床观察[J].亚太传统医药,2017(15):127.
[17]王晓兰.卵磷脂络合碘联合芪明颗粒治疗糖尿病视网膜病变黄斑囊样水肿的临床观察[J].中医药信息,2016(3):111.
[18]徐仁权.芪明颗粒联合玻璃体注射雷珠单抗对糖尿病性黄斑水肿的效果[J].中国乡村医药,2018(2):38.
[19]殷莉,张德龙,任骞,等.芪明颗粒辅助雷珠单抗治疗糖尿病性黄斑水肿的临床疗效观察[J].世界临床药物,2016(11):735.
[20]郑茜.芪明颗粒对非增殖期糖尿病视网膜病变治疗效果观察[J].中国现代药物应用,2016(17):181.
[21]周莎.芪明颗粒对比复方血栓通胶囊治疗非增殖期糖尿病视网膜病变的临床观察[D].武汉:湖北中医药大学,2013.
[22]包银兰,王立军.糖尿病黄斑水肿发病机制及相关因素的研究概况[J].湖南中医杂志,2014,30(2):161.
[23]陈辉雄,张丽萍,陈玉华,等.探讨同型半胱氨酸血脂及血液流变学在糖尿病视网膜病变中的意义[J].检验医学与临床,2014(9):1179.
[24]李琳娜,张晓峰.糖尿病黄斑水肿的发病机制及治疗研究进展[J].临床眼科杂志,2014,22(1):86-90.
[25]汪彬,吴晓蓉,周琼.糖尿病性黄斑水肿的发病机制和治疗进展[J].南昌大学学报(医学版),2014(2):101.
[26]刘路宏.优糖明颗粒对糖尿病视网膜病变非增殖期作用的实验研究[D].成都:成都中医药大学,2001.
[27]杨力,蔚慧,玲香,等.芪明颗粒对糖尿病患者血脂的影响[J].海南医学院学报,2014,20(5):657.
[28]段俊国,廖品正,吴烈,等.中药复方芪明颗粒治疗糖尿病视网膜病变双盲双模拟随机对照多中心临床研究[J].成都中医药大学学报,2006,29(2):1-5.
[29]曹平,阳仁达.针灸治疗糖尿病周围神经病变的meta分析[J].中医药导报,2011(1):97-101.
[30]王雪,李晓.健脾益气法治疗2型糖尿病疗效的Meta分析[J].中医药导报,2015(18):82.