鼻渊通窍颗粒联合曲安奈德鼻喷雾剂对比曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎疗效和安全性的Meta分析和试验序贯分析
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摘要
目的:系统评价鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床疗效和安全性,为临床治疗提供循证参考。方法:计算机检索Embase、PubMed、Cochrane图书馆、中国知网、中国生物医学文献数据库、维普网、万方数据等,检索时限均为建库起至2018年12月8日,收集鼻渊通窍颗粒联合曲安奈德鼻喷雾剂(试验组)对比曲安奈德鼻喷雾剂(对照组)治疗慢性鼻-鼻窦炎的随机对照试验(RCT),对符合纳入标准的文献进行资料提取,并采用Cochrane偏倚风险评估工具5.1.0进行质量评价后,采用Rev Man 5.3软件对临床总有效率、鼻黏膜纤毛传输速率(MTR)、鼻腔分泌物中白细胞介素5(IL-5)和IL-8水平、鼻腔鼻窦结局测试-20(SNOT-20)评分、视觉模拟(VAS)评分、Lund-Mackey鼻窦CT评分和不良反应(恶心、皮疹)发生率等指标进行Meta分析,采用TSA 0.9软件进行试验序贯分析。结果:共纳入9项RCT,合计998例患者。Meta分析结果显示,试验组患者临床总有效率[RR=1.20,95%CI(1.14,1.26),P<0.001]显著高于对照组,MTR[MD=-231.74,95%CI(-291.89,-171.58),P<0.001]、IL-5[MD=-0.86,95%CI(-1.37,-0.35),P<0.001]、IL-8[MD=-0.50,95%CI(-0.76,-0.25),P<0.001]水平均显著低于对照组,SNOT-20评分、视觉模拟(VAS)评分、Lund-Mackey鼻窦CT评分均低于对照组,差异均有统计学意义(P<0.001);两组患者恶心[RR=0.57,95%CI(0.17,1.92),P=0.37]、皮疹[RR=2.25,95%CI(0.70,7.20),P=0.17]发生率比较,差异均无统计学意义。试验序贯分析提示,鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效证据确切。结论:鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎在提高患者临床总有效率,降低MTR、IL-5、IL-8水平,改善SNOT-20评分、VAS评分、Lund-Mackey鼻窦CT评分方面优于单用曲安奈德鼻喷雾剂,且未增加恶心和皮疹的发生率。
OBJECTIVE:To systematically evaluate clinical efficacy and safety of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis,and to provide evidence-based reference for clinical treatment. METHODS:Retrieved from Embase,PubMed,the Cochrane library,CNKI,CBM,VIP and Wanfang database,RCTs about Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray(trial group) versus Triamcinolone acetonide nasal spray(control group) in the treatment of chronic rhinosinusitis were collected during database establishment to Dec. 8 th,2018. After data extraction and quality evaluation with Cochrane bias risk evaluation tool 5.1.0,Meta-analysis was performed for total response rate,nasal mucociliary transmission rate(MTR),the levels of IL-5 and IL-8 in nasal secretion,SNOT-20 score,VAS score,Lund-Mackey nasal sinus CT score,the incidence of ADR(nausea,rash)by using Rev Man 5.3 software. TSA0.9 software was used for trial sequential analysis(TSA).RESULTS:A total of 9 RCTs were included,involving 998 patients. Results of Meta-analysis showed that total clinical response rate [RR=1.20,95% CI(1.14,1.26),P<0.001] of trial group was significantly higher than that of control group;MTR [MD=-231.74,95% CI(-291.89,-171.58),P<0.001],IL-5 [MD=-0.86,95%CI(-1.37,-0.35),P<0.001] and IL-8 [MD=-0.50,95%CI(-0.76,-0.25),P<0.001]levels of trial group were significantly lower than those of control group. SNOT-20 score,VAS score and Lund-Mackey nasal sinus CT score of trial group were all lower than those of control group,with statistical significance(P<0.001). There was no statistical significance in the incidence of nausea [RR=0.57,95%CI(0.17,1.92),P=0.37] or rash [RR=2.25,95%CI(0.70,7.20),P=0.17]between 2 groups. TSA analysis showed that the evidence for therapeutic efficacy of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis was reliable. CONCLUSIONS:Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray is better than Triamcinolone acetonide nasal spray alone in improving total response rate of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis,reducing MTR,the levels of IL-5 and IL-8,and improving SNOT-20 score,VAS score and Lund-Mackey nasal sinus CT score,without increasing the incidence of nausea,rash.
OBJECTIVE:To systematically evaluate clinical efficacy and safety of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis,and to provide evidence-based reference for clinical treatment. METHODS:Retrieved from Embase,PubMed,the Cochrane library,CNKI,CBM,VIP and Wanfang database,RCTs about Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray(trial group) versus Triamcinolone acetonide nasal spray(control group) in the treatment of chronic rhinosinusitis were collected during database establishment to Dec. 8 th,2018. After data extraction and quality evaluation with Cochrane bias risk evaluation tool 5.1.0,Meta-analysis was performed for total response rate,nasal mucociliary transmission rate(MTR),the levels of IL-5 and IL-8 in nasal secretion,SNOT-20 score,VAS score,Lund-Mackey nasal sinus CT score,the incidence of ADR(nausea,rash)by using Rev Man 5.3 software. TSA0.9 software was used for trial sequential analysis(TSA).RESULTS:A total of 9 RCTs were included,involving 998 patients. Results of Meta-analysis showed that total clinical response rate [RR=1.20,95% CI(1.14,1.26),P<0.001] of trial group was significantly higher than that of control group;MTR [MD=-231.74,95% CI(-291.89,-171.58),P<0.001],IL-5 [MD=-0.86,95%CI(-1.37,-0.35),P<0.001] and IL-8 [MD=-0.50,95%CI(-0.76,-0.25),P<0.001]levels of trial group were significantly lower than those of control group. SNOT-20 score,VAS score and Lund-Mackey nasal sinus CT score of trial group were all lower than those of control group,with statistical significance(P<0.001). There was no statistical significance in the incidence of nausea [RR=0.57,95%CI(0.17,1.92),P=0.37] or rash [RR=2.25,95%CI(0.70,7.20),P=0.17]between 2 groups. TSA analysis showed that the evidence for therapeutic efficacy of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis was reliable. CONCLUSIONS:Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray is better than Triamcinolone acetonide nasal spray alone in improving total response rate of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis,reducing MTR,the levels of IL-5 and IL-8,and improving SNOT-20 score,VAS score and Lund-Mackey nasal sinus CT score,without increasing the incidence of nausea,rash.
引文
[1]周兵,韩德民.临床实践促进慢性鼻-鼻窦炎诊疗观念的变化[J].中华耳鼻咽喉头颈外科杂志,2013,48(2):89-91.
[2]CHEN B,ANTUNES MB,CLAIRE SE,et al.Reversal of chronic rhinosinusitis-associated sinonasal ciliary dysfunction[J].Am J Rhinol,2007,21(3):346-353.
[3]龙振华,韩兵,刘军洋,等.曲安奈德鼻喷雾剂联合鼻渊舒治疗慢性鼻窦炎临床疗效观察[J].中国当代医药,2016,19(27):55-56.
[4]楚选云.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效及对鼻纤毛传输功能的影响[J].世界中医药,2017,12(10):2382-2385.
[5]何良如,刘俊,黄炳锋.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效观察[J].中国基层医药,2018,25(12):1584-1588.
[6]郭明刚.曲安奈德鼻喷雾剂联合鼻渊通窍颗粒治疗慢性鼻-鼻窦炎临床观察[J].实用中医药杂志,2018,34(10):1233.
[7]王俊杰,马爱华.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效及对鼻纤毛传输功能的影响[J].中国保健营养,2016,26(16):95.
[8]谢坤.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床疗效及安全性[J].心理医生,2017,23(11):127-128.
[9]雍军,王咏峰.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床观察[J].中国药房,2016,27(20):2795-2797.
[10]邓清红.中西医结合治疗慢性鼻-鼻窦炎疗效及对鼻纤毛传输功能的影响[J].现代中西医结合杂志,2016,25(6):626-628.
[11]杨欣欣.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂对慢性鼻窦炎鼻纤毛传输功能的影响分析[J].航空航天医学杂志,2017,28(8):988-989.
[12]金攀,姚士红.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床价值探究[J].中国卫生标准管理,2018,8(2):111-112.
[13]MOHER D,LIBERATI A,TETZLAFF J,et al.Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J].PLoS Med,2009,6(7):873-880.
[14]中华耳鼻咽喉头颈外科杂志编辑委员会鼻科组,中华医学会耳鼻咽喉头颈外科学分会鼻科学组.慢性鼻-鼻窦炎诊断和治疗指南(2012年,昆明)[J].中华耳鼻咽喉头颈外科杂志,2013,48(2):92-94.
[15]王永钦.中医耳鼻咽喉口腔科学[M].2版.北京:人民卫生出版社,2003:542.
[16]中华医学会耳鼻咽喉科学会,中华耳鼻咽喉科学杂志编辑委员会.慢性鼻窦炎及鼻息肉临床分型及内窥镜鼻窦手术疗效评定标准[J].中华耳鼻咽喉杂志,1998,33(3):134-135.
[17]HIGGINS JP,ALTMAN DG,GOTZSCHE PC,et al.The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials[J].BMJ,2011.DOI:10.1136/bmj.d5928.
[18]HIGGINS JPT,GREEN S.Cochrane handbook for systematic reviews of interventions[EB/OL].[2018-10-24].https://taning.cochrane.org/handbook.
[19]DER SIMONIAN R,NAN L.Meta-analysis in clinical trials[J].Control Clin Trials,1986,7(3):177-188.
[20]郑明华.Meta分析软件应用与实例解析[M].北京:人民卫生出版社,2013:4-5.
[21]HIGGINS JP,THOMPSON SG.Quantifying heterogeneity in a meta-analysis[J].Stat Med,2002,21(11):1539-1558.
[22]STERNE JA,EGGER M.Funnel plots for detecting bias in meta-analysis:guidelines on choice of axis[J].J Clin Epidemiol,2001,54(10):1046-1055.
[23]SONG F,GILBODY S.Bias in meta-analysis detected by asimple,graphical test.Increase in studies of publication bias coincided with increasing use of meta-analysis[J].BMJ,1998,316(7129):471.
[24]王权,田金徽,李伦,等.试验序贯分析简介[J].中国循证医学杂志,2013,13(10):1265-1268.
[25]吴晖,唐月英.鼻渊汤鼻腔冲洗配合西药治疗肺脾气虚型儿童慢性鼻-鼻窦炎的临床观察[J].中国中西医结合耳鼻咽喉科杂志,2012,20(1):31-34.
[2]CHEN B,ANTUNES MB,CLAIRE SE,et al.Reversal of chronic rhinosinusitis-associated sinonasal ciliary dysfunction[J].Am J Rhinol,2007,21(3):346-353.
[3]龙振华,韩兵,刘军洋,等.曲安奈德鼻喷雾剂联合鼻渊舒治疗慢性鼻窦炎临床疗效观察[J].中国当代医药,2016,19(27):55-56.
[4]楚选云.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效及对鼻纤毛传输功能的影响[J].世界中医药,2017,12(10):2382-2385.
[5]何良如,刘俊,黄炳锋.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效观察[J].中国基层医药,2018,25(12):1584-1588.
[6]郭明刚.曲安奈德鼻喷雾剂联合鼻渊通窍颗粒治疗慢性鼻-鼻窦炎临床观察[J].实用中医药杂志,2018,34(10):1233.
[7]王俊杰,马爱华.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的疗效及对鼻纤毛传输功能的影响[J].中国保健营养,2016,26(16):95.
[8]谢坤.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床疗效及安全性[J].心理医生,2017,23(11):127-128.
[9]雍军,王咏峰.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床观察[J].中国药房,2016,27(20):2795-2797.
[10]邓清红.中西医结合治疗慢性鼻-鼻窦炎疗效及对鼻纤毛传输功能的影响[J].现代中西医结合杂志,2016,25(6):626-628.
[11]杨欣欣.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂对慢性鼻窦炎鼻纤毛传输功能的影响分析[J].航空航天医学杂志,2017,28(8):988-989.
[12]金攀,姚士红.鼻渊通窍颗粒联合曲安奈德鼻喷雾剂治疗慢性鼻-鼻窦炎的临床价值探究[J].中国卫生标准管理,2018,8(2):111-112.
[13]MOHER D,LIBERATI A,TETZLAFF J,et al.Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J].PLoS Med,2009,6(7):873-880.
[14]中华耳鼻咽喉头颈外科杂志编辑委员会鼻科组,中华医学会耳鼻咽喉头颈外科学分会鼻科学组.慢性鼻-鼻窦炎诊断和治疗指南(2012年,昆明)[J].中华耳鼻咽喉头颈外科杂志,2013,48(2):92-94.
[15]王永钦.中医耳鼻咽喉口腔科学[M].2版.北京:人民卫生出版社,2003:542.
[16]中华医学会耳鼻咽喉科学会,中华耳鼻咽喉科学杂志编辑委员会.慢性鼻窦炎及鼻息肉临床分型及内窥镜鼻窦手术疗效评定标准[J].中华耳鼻咽喉杂志,1998,33(3):134-135.
[17]HIGGINS JP,ALTMAN DG,GOTZSCHE PC,et al.The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials[J].BMJ,2011.DOI:10.1136/bmj.d5928.
[18]HIGGINS JPT,GREEN S.Cochrane handbook for systematic reviews of interventions[EB/OL].[2018-10-24].https://taning.cochrane.org/handbook.
[19]DER SIMONIAN R,NAN L.Meta-analysis in clinical trials[J].Control Clin Trials,1986,7(3):177-188.
[20]郑明华.Meta分析软件应用与实例解析[M].北京:人民卫生出版社,2013:4-5.
[21]HIGGINS JP,THOMPSON SG.Quantifying heterogeneity in a meta-analysis[J].Stat Med,2002,21(11):1539-1558.
[22]STERNE JA,EGGER M.Funnel plots for detecting bias in meta-analysis:guidelines on choice of axis[J].J Clin Epidemiol,2001,54(10):1046-1055.
[23]SONG F,GILBODY S.Bias in meta-analysis detected by asimple,graphical test.Increase in studies of publication bias coincided with increasing use of meta-analysis[J].BMJ,1998,316(7129):471.
[24]王权,田金徽,李伦,等.试验序贯分析简介[J].中国循证医学杂志,2013,13(10):1265-1268.
[25]吴晖,唐月英.鼻渊汤鼻腔冲洗配合西药治疗肺脾气虚型儿童慢性鼻-鼻窦炎的临床观察[J].中国中西医结合耳鼻咽喉科杂志,2012,20(1):31-34.
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