基于Meta分析的清开灵注射剂治疗肺炎临床评价研究
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摘要
目的:采用Meta分析方法评价清开灵注射剂治疗肺炎的疗效及安全性。方法:通过计算机检索中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数据库、SinoMed、PubMed、Springer、Web of Science、Cochrane Central Register of Controlled Trials数据库等途径收集清开灵注射剂治疗肺炎的随机对照试验,根据纳入排除标准筛选研究、提取资料并采用Cochrane风险偏倚评价表评价其质量,通过Rev Man 5.3和Stata 13.1软件进行统计分析。结果:共纳入17项研究,累计患者1 702例。Meta分析显示,"清开灵+抗菌药+对症治疗"组相较"抗菌药+对症治疗"组可提高疗效总有效率(RR=1.23,95%CI:1.14~1.33,P<0.000 01),缩短发热时间(MD=-1.41,95%CI:-1.60~-1.21,P<0.000 01);"清开灵+抗菌药+对症治疗"组对比"利巴韦林+抗菌药+对症治疗"组在疗效总有效率方面差异无统计学意义(RR=1.09,95%CI:0.99~1.20,P=0.07)。清开灵注射剂还可缩短咳嗽、肺部啰音的时间,抑制患者炎症反应等。在安全性方面,有4项研究共报告药品不良反应/不良事件91例,其中试验组27例,对照组64例,均无严重不良反应发生。结论:清开灵注射剂治疗肺炎可提高临床疗效,缩短主要症状体征恢复时间,抑制炎症反应,在临床疗效总有效率方面与联合利巴韦林组差异无统计学意义,安全性尚无定论,仍需要临床高质量证据的进一步验证。
Objective: To evaluate the efficacy and safety of Qingkailing Injection( QKLI) for pneumonia. Methods: Randomized controlled trials( RCTs) regarding QKLI for the treatment of pneumonia were collected through searching in CNKI,VIP,WANFANG DATA,SinoMed,PubMed,Springer,Web of Science,Cochrane Central Register of Controlled Trials,etc. Related RCTs were selected according to the inclusion and exclusion criteria. Then,extracting data and assessing the methodological quality of included studies by the Cochrane Collaboration's tool for assessing risk of bias. Data analysis was conducted with Review Manager 5. 3 and Stata 13. 1 software. Results: 17 RCTs involving 1 702 patients were included. Meta-analysis and subgroup-analysis showed,"QKLI + antibiotics + symptomatic treatment( ST) "group compared with "antibiotics + ST"group could improve the clinical total effective rate( RR = 1. 23,95% CI: 1. 14-1. 33,P <0. 000 01) and shorten the duration of fever( MD =-1. 41,95% CI:-1. 60--1. 21,P < 0. 000 01); "QKLI + antibiotics + ST"group provided equally effect in the enhancement of clinical curative effect with "Ribavirin + antibiotics + ST"group,while there was no significant difference between the two groups( RR = 1. 09,95% CI: 0. 99-1. 20,P = 0. 07).Moreover,QKLI could shorten the duration of cough and rale,and inhibit inflammatory reaction in patients with pneumonia. Additionally,27 cases adverse drug reactions/adverse drug events( ADRs/ADEs) in experimental groups and 64 cases ADRs/ADEs in control groups were reported separately in 4 studies. There were no serious ADRs/ADEs reported. Conclusion: QKLI for the treatment of pneumonia could enhance the clinical total effective rate,shorten the duration of the main clinical signs and symptoms,and inhibit inflammatory reaction. However,there was no significant difference between the QKLI group and Ribavirin group in improving the total effective rate and no exact conclusion concluded on safety.
Objective: To evaluate the efficacy and safety of Qingkailing Injection( QKLI) for pneumonia. Methods: Randomized controlled trials( RCTs) regarding QKLI for the treatment of pneumonia were collected through searching in CNKI,VIP,WANFANG DATA,SinoMed,PubMed,Springer,Web of Science,Cochrane Central Register of Controlled Trials,etc. Related RCTs were selected according to the inclusion and exclusion criteria. Then,extracting data and assessing the methodological quality of included studies by the Cochrane Collaboration's tool for assessing risk of bias. Data analysis was conducted with Review Manager 5. 3 and Stata 13. 1 software. Results: 17 RCTs involving 1 702 patients were included. Meta-analysis and subgroup-analysis showed,"QKLI + antibiotics + symptomatic treatment( ST) "group compared with "antibiotics + ST"group could improve the clinical total effective rate( RR = 1. 23,95% CI: 1. 14-1. 33,P <0. 000 01) and shorten the duration of fever( MD =-1. 41,95% CI:-1. 60--1. 21,P < 0. 000 01); "QKLI + antibiotics + ST"group provided equally effect in the enhancement of clinical curative effect with "Ribavirin + antibiotics + ST"group,while there was no significant difference between the two groups( RR = 1. 09,95% CI: 0. 99-1. 20,P = 0. 07).Moreover,QKLI could shorten the duration of cough and rale,and inhibit inflammatory reaction in patients with pneumonia. Additionally,27 cases adverse drug reactions/adverse drug events( ADRs/ADEs) in experimental groups and 64 cases ADRs/ADEs in control groups were reported separately in 4 studies. There were no serious ADRs/ADEs reported. Conclusion: QKLI for the treatment of pneumonia could enhance the clinical total effective rate,shorten the duration of the main clinical signs and symptoms,and inhibit inflammatory reaction. However,there was no significant difference between the QKLI group and Ribavirin group in improving the total effective rate and no exact conclusion concluded on safety.
引文
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15 中华医学会呼吸病学分会.中国成人社区获得性肺炎诊断和治疗指南(2016年版)[J].中华结核和呼吸杂志,2016,39(4):253-278
16 中华医学会儿科学分会呼吸学组,《中华实用儿科临床杂志》编辑委员会.儿童肺炎支原体肺炎诊治专家共识(2015年版)[J].中华实用儿科杂志,2015,30(17):1304-1308
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20 张天嵩,钟文昭,李博.实用循证医学方法学[M].长沙:中南大学出版社,2014:88-89,238-279
21 曹卉娟,刘建平.系统综述中图表的设计与应用[J].北京中医药大学学报(中医临床版),2013,20(4):43-49
22 王晓红,宋涛,汪瑞人,等.清开灵注射液联合阿奇霉素对支原体肺炎患儿血清T-Ig E和ECP水平的影响[J].现代生物医学进展,2016,16(4):717-719
23 吴冬庆.肺炎球菌肺炎患者应用清开灵注射液配合青霉素治疗临床疗效[J].现代养生B,2015(2):106
24 车碧英.清开灵注射液联合头孢曲松钠治疗小儿肺炎临床观察[J].北方药学,2015,12(10):57
25 郭艾.清开灵注射液配合青霉素对肺炎球菌肺炎的治疗效果分析[J].医学美学美容(中旬刊),2015,24(6):87
26 陶敬.清开灵注射液配合青霉素治疗肺炎球菌肺炎的临床疗效观察[J].中国医药指南,2014,12(10):207
27 孟兴燕.阿奇霉素联合清开灵注射液治疗小儿支原体肺炎28例临床观察[J].黔南民族医专学报,2014,27(1):18-20
28 陈晓明.清开灵注射液用于小儿肺炎痰热闭肺证疗效观察[J].医学信息,2013,26(7):595-596
29 田玉先,和艳芬.清开灵治疗小儿肺炎76例临床疗效观察[J].中国疗养医学,2011,20(8):751-752
30 许学锋,侯齐霞.清开灵注射液治疗CAP的临床疗效及其PCT和CRP的影响[J].中国现代医生,2011,49(26):75-76,90
31 何方,司春婴.清开灵注射液辅助治疗小儿支气管肺炎90 例[J].河南中医,2010,30(3):271-272
32 刘红梅,李向阳,方和全.清开灵注射液治疗小儿病毒性肺炎的对比研究[J].当代医学,2010,16(21):144
33 杨益宝,吴娜娜,黄美杏.清开灵冻干粉针合抗生素治疗细菌性肺炎60例临床观察[J].河南中医,2008,28(2):69-70
34 魏标松,娄元彤.清开灵注射液联合抗生素治疗社区获得性肺炎疗效观察[J].赣南医学院学报,2008,28(3):449
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38 黄慧.清开灵治疗小儿支气管肺炎60例疗效观察[J].右江医学,2000,28(3):184-185
39 陈薇,刘建平.中医药随机对照试验的严格评价(二)[J].北京中医药大学学报(中医临床版),2013,20(1):47-49
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41 国家药品不良反应监测中心.药品不良反应信息通报(第21期)警惕注射用头孢哌酮钠舒巴坦钠、清开灵注射剂的严重不良反应[EB/OL].(2009-04-22)[2016-09-01 ]http://114.255.93.201/xxtb_255/ypblfyxxtb/200904/t20090422_2838.html
42 罗碧辉.尼可地尔临床疗效的系统评价[D].广州:南方医科大学博士学位论文,2013
43 张林果,赵伟鹏,杨坷.清开灵注射液治疗肺炎的系统评价[J].甘肃中医,2011,24(5):18-21
2 中华医学会儿科学分会呼吸学组,《中华儿科杂志》编辑委员会.儿童社区获得性肺炎管理指南(2013修订)(上)[J].中华儿科杂志,2013,51(10):745-752
3 吴永贵,王爱玲.当代内科学进展[M].合肥:安徽科学技术出版社,2016:1-3
4 胡大一.循证临床内科学[M].上册.北京:北京科学技术出版社,2012:447,453
5 胡亚美,江载芳.诸福棠实用儿科学[M].第7版.上册.北京:人民卫生出版社,2002:1174-1175,1185-1199
6 中华中医药学会儿科分会.小儿肺炎喘嗽中医诊疗指南[J].中医儿科杂志,2008,4(3):1-3
7 王雪峰,董丹,梁茂新,等.数据挖掘技术在小儿肺炎中医临床疗效评价研究中应用的思路与方法[J].中国中西医结合杂志,2007,27(10):949-951
8 中国药典[S].2015年版.一部.1529-1531
9 国家药品标准[S].新药转正标准.第72册.2011.57-59
10 李文杰,曹力,李红梅.清开灵注射液药理作用与儿科疾病中的应用[J].时珍国医国药,2002,13(5):302-303
11 杨坚毅,陈慧红.清开灵注射液临床与药理研究进展[J].中国医院药学杂志,2001,21(8):494-497
12 李东,杨芳炬,黄继华,等.注射用清开灵冻干粉解热镇痛作用及解热机制的试验研究[J].中药材,2005,28(9):796-799
13 李东,黄继华,张淑华,等.注射用清开灵冻干粉体外抗菌活性研究[J].四川生理科学杂志,2008,30(4):164-166
14李莉,李东,黄继华,等.注射用清开灵冻干粉抗炎及免疫调节作用研究[J].中国药理与临床,2008,24(5):59-60
15 中华医学会呼吸病学分会.中国成人社区获得性肺炎诊断和治疗指南(2016年版)[J].中华结核和呼吸杂志,2016,39(4):253-278
16 中华医学会儿科学分会呼吸学组,《中华实用儿科临床杂志》编辑委员会.儿童肺炎支原体肺炎诊治专家共识(2015年版)[J].中华实用儿科杂志,2015,30(17):1304-1308
17 中华人民共和国卫生行业标准肺炎诊断(WS 382-2012)[S].2012
18 Higgins JPT,Green S.Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[R/OL].(2011-03)[2016-07]http://www.cochrane-handbook.org
19 罗杰,冷卫东.系统评价/meta分析理论与实践[M].北京:军事医学科学出版社,2013:67-68,120-125
20 张天嵩,钟文昭,李博.实用循证医学方法学[M].长沙:中南大学出版社,2014:88-89,238-279
21 曹卉娟,刘建平.系统综述中图表的设计与应用[J].北京中医药大学学报(中医临床版),2013,20(4):43-49
22 王晓红,宋涛,汪瑞人,等.清开灵注射液联合阿奇霉素对支原体肺炎患儿血清T-Ig E和ECP水平的影响[J].现代生物医学进展,2016,16(4):717-719
23 吴冬庆.肺炎球菌肺炎患者应用清开灵注射液配合青霉素治疗临床疗效[J].现代养生B,2015(2):106
24 车碧英.清开灵注射液联合头孢曲松钠治疗小儿肺炎临床观察[J].北方药学,2015,12(10):57
25 郭艾.清开灵注射液配合青霉素对肺炎球菌肺炎的治疗效果分析[J].医学美学美容(中旬刊),2015,24(6):87
26 陶敬.清开灵注射液配合青霉素治疗肺炎球菌肺炎的临床疗效观察[J].中国医药指南,2014,12(10):207
27 孟兴燕.阿奇霉素联合清开灵注射液治疗小儿支原体肺炎28例临床观察[J].黔南民族医专学报,2014,27(1):18-20
28 陈晓明.清开灵注射液用于小儿肺炎痰热闭肺证疗效观察[J].医学信息,2013,26(7):595-596
29 田玉先,和艳芬.清开灵治疗小儿肺炎76例临床疗效观察[J].中国疗养医学,2011,20(8):751-752
30 许学锋,侯齐霞.清开灵注射液治疗CAP的临床疗效及其PCT和CRP的影响[J].中国现代医生,2011,49(26):75-76,90
31 何方,司春婴.清开灵注射液辅助治疗小儿支气管肺炎90 例[J].河南中医,2010,30(3):271-272
32 刘红梅,李向阳,方和全.清开灵注射液治疗小儿病毒性肺炎的对比研究[J].当代医学,2010,16(21):144
33 杨益宝,吴娜娜,黄美杏.清开灵冻干粉针合抗生素治疗细菌性肺炎60例临床观察[J].河南中医,2008,28(2):69-70
34 魏标松,娄元彤.清开灵注射液联合抗生素治疗社区获得性肺炎疗效观察[J].赣南医学院学报,2008,28(3):449
35潘博希,万启南,陈晓华.清开灵冻干粉针干预治疗早期肺炎临床观察[J].中国中医药信息杂志,2007,14(9):55
36王化珍.清开灵注射液治疗小儿肺炎[J].医药论坛杂志,2003,24(9):14-16
37 徐文芳,卢萍.清开灵治疗小儿肺炎95例疗效观察[J].上海医药,2002,23(4):167-168
38 黄慧.清开灵治疗小儿支气管肺炎60例疗效观察[J].右江医学,2000,28(3):184-185
39 陈薇,刘建平.中医药随机对照试验的严格评价(二)[J].北京中医药大学学报(中医临床版),2013,20(1):47-49
40 国家药品不良反应监测中心.药品不良反应信息通报(第1期)乙双吗啉(片剂、胶囊剂)治疗银屑病可能诱发白血病、壮骨关节丸与肝损害、清开灵注射液与过敏反应、双黄连注射剂与过敏反应[EB/OL].(2008-06-26)[2016-09-01]http://114.255.93.201/xxtb_255/ypblfyxxtb/200806/t20080626_2815.html
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