痰热清注射液辅助化疗治疗肺结核临床疗效及安全性的Meta分析
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摘要
目的评价痰热清注射液辅助化疗治疗肺结核的临床疗效及安全性,为临床制定抗结核治疗方案提供科学依据。方法计算机检索万方数据知识服务平台、中国生物医学文献数据库、维普网、中国知网、ISI、PubMed、EMBase、Cochrane Library等数据库中已发表文献及中国临床试验注册中心、美国临床试验注册中心中未发表文献,筛选有关痰热清注射液辅助化疗治疗肺结核临床疗效及安全性的随机对照研究,其中化疗组患者给予单纯化疗治疗,痰热清辅助化疗组患者给予化疗联合痰热清注射液治疗。采用RevMan 5.3软件进行Meta分析。结果共纳入9篇文献,包括736例肺结核患者。Meta分析结果显示,痰热清辅助化疗组患者显效率[优势比(OR)=2.15,95%可信区间(CI)(1.43,3.24)]和总有效率[OR=3.10,95%CI(1.92,4.99)]高于化疗组,差异有统计学意义(P<0.05);两组患者有效率[OR=1.24,95%CI(0.87,1.78)]、病灶吸收率[OR=2.15,95%CI(0.48,9.62)]及痰菌转阴率[OR=1.82,95%CI(0.95,3.47)]比较,差异无统计学意义(P>0.05)。5篇文献报道了药物相关不良反应/毒副作用,主要包括头晕、失眠、恶心呕吐、食欲下降、四肢关节疼痛、瘙痒、腹痛、腹泻。结论痰热清注射液辅助化疗可有效提高肺结核患者临床疗效,但其有效改善患者临床症状及体征、促进痰菌转阴及安全性等证据尚不足。
Objective To evaluate the clinical effect and safety of tanreqing injection in the adjuvant chemotherapy for pulmonary tuberculosis. Methods Computer was used to search RCTs about clinical effect and safety of tanreqing injection in the adjuvant chemotherapy for pulmonary tuberculosis,including published literatures in Wanfanng Data,CBM,VIP,CNKI,ISI,PubMed,EMBase and Cochrane Library,unpublished literatures in Chinese Clinical Trial Registry and American Clinical Trial Registry,thereinto patients of control group received chemotherapy only,while patients of test group received chemotherapy combined with tanreqing injection. Rev Man 5. 3 software was used to carry out the Meta-analysis. Results A total of 9 literatures were involved, including 736 patients with pulmonary tuberculosis. Meta-analysis results showed that, obvious effective rate [OR = 2. 15,95% CI( 1. 43,3. 24) ] and total effective rate [OR = 3. 10,95% CI( 1. 92,4. 99) ] of test group were statistically significantly higher than those of control group( P < 0. 05),while no statistically significant differences of effective rate [OR = 1. 24,95% CI( 0. 87,1. 78) ], lesions absorption rate [OR = 2. 15,95% CI( 0. 48,9. 62) ] or sputum negative conversion rate [OR = 1. 82,95% CI( 0. 95,3. 47) ] was found between the two groups( P > 0. 05). A total of 5 literatures reported the adverse reactions/toxic and side effects,mainly included dizziness,aypnia,nausea and vomiting,loss of appetite, limbs joint pain, cutaneous pruritus, stomachache and diarrhea. Conclusion Tanreqing injection can effectively improve the clinical effect in the adjuvant chemotherapy for pulmonary tuberculosis,but still lack sufficient evidence to support that tanreqing injection can effectively relive the clinical symptoms and signs,promote the sputum negative conversion or confirm the safety.
Objective To evaluate the clinical effect and safety of tanreqing injection in the adjuvant chemotherapy for pulmonary tuberculosis. Methods Computer was used to search RCTs about clinical effect and safety of tanreqing injection in the adjuvant chemotherapy for pulmonary tuberculosis,including published literatures in Wanfanng Data,CBM,VIP,CNKI,ISI,PubMed,EMBase and Cochrane Library,unpublished literatures in Chinese Clinical Trial Registry and American Clinical Trial Registry,thereinto patients of control group received chemotherapy only,while patients of test group received chemotherapy combined with tanreqing injection. Rev Man 5. 3 software was used to carry out the Meta-analysis. Results A total of 9 literatures were involved, including 736 patients with pulmonary tuberculosis. Meta-analysis results showed that, obvious effective rate [OR = 2. 15,95% CI( 1. 43,3. 24) ] and total effective rate [OR = 3. 10,95% CI( 1. 92,4. 99) ] of test group were statistically significantly higher than those of control group( P < 0. 05),while no statistically significant differences of effective rate [OR = 1. 24,95% CI( 0. 87,1. 78) ], lesions absorption rate [OR = 2. 15,95% CI( 0. 48,9. 62) ] or sputum negative conversion rate [OR = 1. 82,95% CI( 0. 95,3. 47) ] was found between the two groups( P > 0. 05). A total of 5 literatures reported the adverse reactions/toxic and side effects,mainly included dizziness,aypnia,nausea and vomiting,loss of appetite, limbs joint pain, cutaneous pruritus, stomachache and diarrhea. Conclusion Tanreqing injection can effectively improve the clinical effect in the adjuvant chemotherapy for pulmonary tuberculosis,but still lack sufficient evidence to support that tanreqing injection can effectively relive the clinical symptoms and signs,promote the sputum negative conversion or confirm the safety.
引文
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[2]刘晶.抗肺结核药物不良反应发生率的分析[J].中国医药指南,2014,12(9):73.
[3]潘景芝,孟庆龙,李晓红,等.中药在肺结核治疗中的应用现状[J].中国药房,2012,23(43):4112-4113.
[4]王小美,刘光陵.中药在耐多药肺结核治疗中临床运用概述[J].新中医,2014,46(1):209-211.
[5]蒋劲柏,李大亮.痰热清注射液临床应用近况[J].内蒙古中医药,2015,18(2):125-126.DOI:10.3969/j.issn.1006-0979.2015.02.126.
[6]李红英,刘小阳,杜万红.痰热清注射液临床应用概况[J].中医药导报,2011,17(6):122-123.DOI:10.3969/j.issn.1672-951X.2011.06.067.
[7]周华,汪成琼,田应彪,等.痰热清注射液辅助治疗恶性肿瘤并肺部感染的有效性及安全性评价[J].中国中医急症,2015,24(6):969-973.
[8]张丽.老年肺结核患者实施抗肺结核药物治疗的临床分析[J].中国实用医刊,2015,42(5):55-57.
[9]袁巨平.痰热清注射液联合抗结核药治疗初治菌阳肺结核120例效果分析[J].临床肺科杂志,2008,13(4):466.
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[13]苏锦瑞,梅草仙,李丽.痰热清注射液配合抗痨药物治疗肺结核发热的疗效观察[J].新中医,2008,40(11):46-47.
[14]李文忠,李庆杰,李庆荣.痰热清注射液佐治活动性肺结核[J].中华临床医学研究杂志,2008,14(11):1628.
[15]曹雪松,林治范,王玉昆.痰热清治疗肺结核124例疗效观察[J].中国当代医药,2009,16(10):146.DOI:10.3969/j.issn.1674-4721.2009.10.104.
[16]朱芳成,岳华山,李远勤,等.痰热清治疗耐多药肺结核临床观察[J].中国医学创新,2009,6(20):68-69.DOI:10.3969/j.issn.1674-4985.2009.20.033.
[17]韩丽.痰热清治疗耐多药肺结核的26例临床观察[J].世界最新医学信息文摘:连续型电子期刊,2014,14(33):170.DOI:10.3969/j.issn.1671-3141.2014.33.146.
[18]俆爱华.抗肺结核药物治疗老年肺结核临床效果观察[J].河南医学研究,2016,25(5):905-906.DOI:10.3969/j.issn.1004-437X.2016.05.073.
[19]姚芳.痰热清注射液辅助治疗肺结核的临床疗效观察[J].内蒙古中医药,2016,35(1):29-30.DOI:10.3969/j.issn.1006-0979.2016.01.028.
[20]张建武,王芳,王燕波,等.痰热清注射液在肺结核治疗中的作用[J].中国民间疗法,2016,24(8):60-61.
[21]雷扬,周爱民,郭涛,等.一种改良的ANIT急性肝损伤方法及痰热清注射液的保护作用[J].中药药理与临床,2014,30(2):179-182.
[22]王琴,潘静.痰热清注射液的药理作用和临床应用[J].解放军中药杂志,2010,22(1):41-43.DOI:10.3969/j.issn.2095-140X.2010.01.020.
[23]马鸣,杨兴肖,张洁,等,痰热清注射液对肺癌患者外周血淋巴细胞免疫活性的影响[J].中国中药杂志,2015,40(6):1207-1211.DOI:10.4268/cjcmm20150641.
[24]刘厚艳,吴萍.阿奇霉素联合痰热清注射液治疗老年性肺炎疗效观察[J].中国现代药物应用,2014,8(3):170-171.
[25]吴俭,金国强,余伟,等.痰热清注射液对小鼠内毒素性急性肺损伤的保护作用研究[J].中国医院药学杂志,2014,34(6):443-447.DOI:10.13286/j.cnki.chinhosppharmacyj.2014.06.06.
[26]祝晨,黄小民.痰热清注射液对内毒素型急性肺损伤大鼠的保护作用[J].中华中医药学刊,2012,30(8):1743-1745.
[27]LIU W,JIANG H L,CAI L L,et al.Tanreqing Injection Attenuates Lipopolysaccharide-Induced Airway Inflammation through MAPK/NF-βSignaling Pathways in Rats Model[J].Evid Based Complement Alternat Med,2016:27366191.DOI:10.1155/2016/5292346.
[28]艾坤,肖政,汪成琼,等.痰热清注射液治疗血液肿瘤并肺部感染有效性及安全性的Meta分析[J].安徽医学,2015,36(5):592-596.DOI:10.3969/j.issn.1000-0399.2015.05.023.
[29]卢起飞,汪成琼,王俊,等.痰热清注射液辅助治疗放射性肺炎的有效性及安全性评价[J].中国中医急症,2015,24(7):1149-1152.DOI:10.3969/j.issn.1004-745X.2015.07.008.
[30]艾坤,肖政,汪成琼,等.痰热清注射液联合抗生素治疗血液肿瘤并肺部感染有效性及安全性的Meta分析[J].中国中医急症,2015,24(4):593-595,601.DOI:10.3969/j.issn.1004-745X.2015.04.009.
[2]刘晶.抗肺结核药物不良反应发生率的分析[J].中国医药指南,2014,12(9):73.
[3]潘景芝,孟庆龙,李晓红,等.中药在肺结核治疗中的应用现状[J].中国药房,2012,23(43):4112-4113.
[4]王小美,刘光陵.中药在耐多药肺结核治疗中临床运用概述[J].新中医,2014,46(1):209-211.
[5]蒋劲柏,李大亮.痰热清注射液临床应用近况[J].内蒙古中医药,2015,18(2):125-126.DOI:10.3969/j.issn.1006-0979.2015.02.126.
[6]李红英,刘小阳,杜万红.痰热清注射液临床应用概况[J].中医药导报,2011,17(6):122-123.DOI:10.3969/j.issn.1672-951X.2011.06.067.
[7]周华,汪成琼,田应彪,等.痰热清注射液辅助治疗恶性肿瘤并肺部感染的有效性及安全性评价[J].中国中医急症,2015,24(6):969-973.
[8]张丽.老年肺结核患者实施抗肺结核药物治疗的临床分析[J].中国实用医刊,2015,42(5):55-57.
[9]袁巨平.痰热清注射液联合抗结核药治疗初治菌阳肺结核120例效果分析[J].临床肺科杂志,2008,13(4):466.
[10]中华人民共和国卫生部.肺结核诊断标准(WS288-2008)[S].北京:人民卫生出版社,2008:1-15.
[11]Julian PT Higgins and Sally Green.Cochrane Handbook for Systematic Reviewsof Interventions Version 5.1.0[EB/OA].[updated March 2011].http://wwwhandbookcochraneorg/.
[12]迪军荣,撖耀斌,马丽.痰热清注射液配合化疗治疗肺结核32例[J].陕西中医,2005,26(4):300-301.DOI:10.3969/j.issn.1000-7369.2005.04.008.
[13]苏锦瑞,梅草仙,李丽.痰热清注射液配合抗痨药物治疗肺结核发热的疗效观察[J].新中医,2008,40(11):46-47.
[14]李文忠,李庆杰,李庆荣.痰热清注射液佐治活动性肺结核[J].中华临床医学研究杂志,2008,14(11):1628.
[15]曹雪松,林治范,王玉昆.痰热清治疗肺结核124例疗效观察[J].中国当代医药,2009,16(10):146.DOI:10.3969/j.issn.1674-4721.2009.10.104.
[16]朱芳成,岳华山,李远勤,等.痰热清治疗耐多药肺结核临床观察[J].中国医学创新,2009,6(20):68-69.DOI:10.3969/j.issn.1674-4985.2009.20.033.
[17]韩丽.痰热清治疗耐多药肺结核的26例临床观察[J].世界最新医学信息文摘:连续型电子期刊,2014,14(33):170.DOI:10.3969/j.issn.1671-3141.2014.33.146.
[18]俆爱华.抗肺结核药物治疗老年肺结核临床效果观察[J].河南医学研究,2016,25(5):905-906.DOI:10.3969/j.issn.1004-437X.2016.05.073.
[19]姚芳.痰热清注射液辅助治疗肺结核的临床疗效观察[J].内蒙古中医药,2016,35(1):29-30.DOI:10.3969/j.issn.1006-0979.2016.01.028.
[20]张建武,王芳,王燕波,等.痰热清注射液在肺结核治疗中的作用[J].中国民间疗法,2016,24(8):60-61.
[21]雷扬,周爱民,郭涛,等.一种改良的ANIT急性肝损伤方法及痰热清注射液的保护作用[J].中药药理与临床,2014,30(2):179-182.
[22]王琴,潘静.痰热清注射液的药理作用和临床应用[J].解放军中药杂志,2010,22(1):41-43.DOI:10.3969/j.issn.2095-140X.2010.01.020.
[23]马鸣,杨兴肖,张洁,等,痰热清注射液对肺癌患者外周血淋巴细胞免疫活性的影响[J].中国中药杂志,2015,40(6):1207-1211.DOI:10.4268/cjcmm20150641.
[24]刘厚艳,吴萍.阿奇霉素联合痰热清注射液治疗老年性肺炎疗效观察[J].中国现代药物应用,2014,8(3):170-171.
[25]吴俭,金国强,余伟,等.痰热清注射液对小鼠内毒素性急性肺损伤的保护作用研究[J].中国医院药学杂志,2014,34(6):443-447.DOI:10.13286/j.cnki.chinhosppharmacyj.2014.06.06.
[26]祝晨,黄小民.痰热清注射液对内毒素型急性肺损伤大鼠的保护作用[J].中华中医药学刊,2012,30(8):1743-1745.
[27]LIU W,JIANG H L,CAI L L,et al.Tanreqing Injection Attenuates Lipopolysaccharide-Induced Airway Inflammation through MAPK/NF-βSignaling Pathways in Rats Model[J].Evid Based Complement Alternat Med,2016:27366191.DOI:10.1155/2016/5292346.
[28]艾坤,肖政,汪成琼,等.痰热清注射液治疗血液肿瘤并肺部感染有效性及安全性的Meta分析[J].安徽医学,2015,36(5):592-596.DOI:10.3969/j.issn.1000-0399.2015.05.023.
[29]卢起飞,汪成琼,王俊,等.痰热清注射液辅助治疗放射性肺炎的有效性及安全性评价[J].中国中医急症,2015,24(7):1149-1152.DOI:10.3969/j.issn.1004-745X.2015.07.008.
[30]艾坤,肖政,汪成琼,等.痰热清注射液联合抗生素治疗血液肿瘤并肺部感染有效性及安全性的Meta分析[J].中国中医急症,2015,24(4):593-595,601.DOI:10.3969/j.issn.1004-745X.2015.04.009.