喘可治注射液穴位注射治疗慢性阻塞性肺疾病稳定期的Meta分析及试验序贯分析
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摘要
目的系统评价喘可治注射液穴位注射治疗慢性阻塞性肺疾病(COPD)稳定期的疗效。方法电子检索中国学术期刊全文数据库(CNKI)、PubMed等7大中英文数据库,检索时间限定为自建库至2018年11月12日,检出所有喘可治注射液穴位注射治疗COPD稳定期的临床随机对照试验(RCT)文献,由2名研究员各自独立严格按照纳入和排除标准进行纳入研究的质量评价和资料提取,用STATA 13.0软件进行Meta分析,用TSA 0.9.5.10 Beta软件进行试验序贯分析(TSA)。结果共纳入10个RCT,包括902例患者。Meta分析:与对照组相比,在西医常规治疗基础上联合喘可治注射液穴位注射,可以改善COPD稳定期患者的临床症状[RR=1.21,95%CI(1.08,1.36),P=0.001];提高患者免疫功能(CD4~+/CD8~+)[SMD=0.91,95%CI(0.31,1.52),P=0.003];此外,喘可治组的不良反应发生率低,且无严重不良反应事件。TSA显示CD4~+/CD8~+比值纳入的研究同时穿过了传统界值和TSA界值,进一步肯定了喘可治注射液对COPD稳定期患者的疗效。结论在西医常规治疗基础上联合喘可治注射液穴位注射治疗COPD稳定期,可提高临床疗效和机体的免疫功能,安全性较好,但在改善肺功能方面未显示出优势。受纳入研究数量及质量的限制,本研究的结果尚需要更多高质量RCT的进一步验证。
Objective To systematically review the efficacy of acupoint injection with Chuankezhi injection for treating stable-stage patients with chronic obstructive lung disease(COPD). Methods The randomized controlled trials included acupoint injection with Chuankezhi injection in the treatment of COPD patients during stable-stage were collected from 7 databases(PubMed,CNKI,et al)from establishment to November 12,2018. All the studies searched were strictly evaluated and screened independently by two researchers according to the inclusion and exclusion criteria, and the methodological quality of included studies was evaluated. The meta-analysis and trial sequential analysis(TSA)were conducted using Stata 13.0 and TSA 0.9.5.10 Beta,respectively. Results A total of10 RCTs involving 902 patients were included. The results of meta-analysis suggested that, compared with the control groups, Chuankezhi injection combined with conventional western medicine treatment may improved the clinical symptoms in patients with COPD at their stable-stage [RR=1.21, 95%CI(1.08, 1.36), P = 0.001];improved the immune function(CD4~+/CD8~+)[SMD=0.91,95%CI(0.31,1.52),P = 0.003]. The TSA showed that the studies included in the improvement of the ratio of CD4~+/CD8~+had passed the conventional and TSA threshold,which further affirmed the conclusion. Conclusion Conventional western medicine treatment combining with acupoint injection of Chuankezhi injection in treating stable-stage patients with COPD could improve the efficiency and the immune function of patients with a high safety,but was powerless on improving pulmonary functions. The qualities of existing studies were so low and the case number was so small that higher quality clinical trials are required for further validation.
Objective To systematically review the efficacy of acupoint injection with Chuankezhi injection for treating stable-stage patients with chronic obstructive lung disease(COPD). Methods The randomized controlled trials included acupoint injection with Chuankezhi injection in the treatment of COPD patients during stable-stage were collected from 7 databases(PubMed,CNKI,et al)from establishment to November 12,2018. All the studies searched were strictly evaluated and screened independently by two researchers according to the inclusion and exclusion criteria, and the methodological quality of included studies was evaluated. The meta-analysis and trial sequential analysis(TSA)were conducted using Stata 13.0 and TSA 0.9.5.10 Beta,respectively. Results A total of10 RCTs involving 902 patients were included. The results of meta-analysis suggested that, compared with the control groups, Chuankezhi injection combined with conventional western medicine treatment may improved the clinical symptoms in patients with COPD at their stable-stage [RR=1.21, 95%CI(1.08, 1.36), P = 0.001];improved the immune function(CD4~+/CD8~+)[SMD=0.91,95%CI(0.31,1.52),P = 0.003]. The TSA showed that the studies included in the improvement of the ratio of CD4~+/CD8~+had passed the conventional and TSA threshold,which further affirmed the conclusion. Conclusion Conventional western medicine treatment combining with acupoint injection of Chuankezhi injection in treating stable-stage patients with COPD could improve the efficiency and the immune function of patients with a high safety,but was powerless on improving pulmonary functions. The qualities of existing studies were so low and the case number was so small that higher quality clinical trials are required for further validation.
引文
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[11]刘军,吴国伟,徐军英,等.喘可治穴位注射治疗慢性阻塞性肺疾病稳定期80例临床观察[J].浙江中医杂志,2013,48(7):528.
[12]段玉香,杨海峰,胡峰,等.穴位注射喘可治和胸腺肽对稳定期COPD患者作用的研究[J].临床肺科杂志,2014,19(7):1335-1337.
[13]陈代平,伍朝霞,赵婕,等.温补脾肾汤结合穴位注射治疗稳定期脾肾阳虚型COPD临床观察[J].上海中医药杂志,2014,48(10):43-44.
[14]潘金波,陈晔.喘可治注射液治疗慢性阻塞性肺疾病稳定期脾肾阳虚证的临床研究[J].中华中医药学刊,2016,34(1):57-59.
[15]黄立搜,王世强,陈素珍,等.喘可治注射液穴位注射为主对慢性阻塞性肺疾病患者免疫功能的影响[J].浙江中医杂志,2016,51(3):166-167.
[16]黄约诺,石亚莉,宋李桃,等.“冬病夏治”对长期糖皮质激素治疗COPD稳定期患者免疫功能影响的观察[J].黑龙江中医药,2016,45(6):52-53.
[17]张一乐,史苗颜,张炜.穴位注射喘可治联合舒利迭治疗慢性阻塞性肺疾病稳定期的临床观察[J].中国中医急症,2017(10):1817-1819.
[18]温秀梅,赵峻峰,陈中明.人参蛤蚧散加味联合穴位注射治疗对稳定期COPD患者免疫功能、IL-2及sIL-2R的影响[J].中华全科医学,2018,16(4):630-633.
[19]FUJITA J,YAMADORI I,SUEMITSU I,et al.Clinical features of non-specific interstitial pneumonia[J].Respiratory Medicine,1999,93(2):113-118.
[20]邓炜,郑民强,张静,等.2种黔产淫羊藿总黄酮对免疫功能影响的比较研究[J].中国中药杂志,2011,36(4):511-513.
[21]张玲娟,沈自尹,蔡定芳,等.淫羊藿对大鼠下丘脑-垂体-肾上腺-胸腺轴抑制模型的影响[J].中医杂志,1996,37(10):620-621.
[22]饶鸿宇,陈滔彬,何彦,等.南药巴戟天化学成分与药理研究进展[J].中南药学,2018,16(11):1567-1574.
[23]龚梦鹃,叶文华,谢媛媛,等.巴戟天补肾阳作用的血清代谢组学研究[J].中国中药杂志,2012,37(11):1682-1685.
[24]王佳,史辑,魏晓峰,等.巴戟天不同炮制品对肾阳虚不育大鼠改善作用研究[J].中药材,2017,40(8):1826-1832.
[25]吕世静,黄槐莲.巴戟天对淋巴细胞增殖及产生细胞因子的调节作用[J].中医药研究,1997,13(5):48-50.
[2]Global Strategy for the Diagnosis,Management and Prevention of COPD.http://goldcopd.org.
[3]陈诗琪,杨欣宇,唐潇旖,等.喘可治注射液治疗慢性阻塞性肺疾病急性加重期的系统评价[J].中国中药杂志,2017,42(14):2789-2795.
[4]中华中医药学会内科分会肺系病专业委员会.慢性阻塞性肺疾病中医证候诊断标准(2011版)[J].中医杂志,2012,53(2):177-178.
[5]慢性阻塞性肺疾病诊治指南(2013年修订版)[J].中国医学前沿杂志(电子版),2014,6(2):67-80.
[6]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002.
[7]国家中医药管理局.ZY/T001.1~001.9-94中医病证诊断疗效标准[S].南京:南京大学出版社,1994:1-2.
[8]HIGGINS JPT,GREEN S.Cochrane handbook for systematic reviews of interventions version 5.1.0[Z/OL].(2011-03)[2017-10-27].http://www.cochrane-handbook.org.
[9]毕蓉蓉,张惠勇,耿佩华,等.冬病夏治穴位疗法对慢性阻塞性肺疾病患者肺通气功能的影响[J].上海中医药大学学报,2011,25(3):32-35.
[10]卓俊涛,曾仕富,左明晏.喘可治注射液穴位注射治疗慢性阻塞性肺疾病肺肾阳虚证临床研究[J].中国中医急症,2013,22(1):145-146.
[11]刘军,吴国伟,徐军英,等.喘可治穴位注射治疗慢性阻塞性肺疾病稳定期80例临床观察[J].浙江中医杂志,2013,48(7):528.
[12]段玉香,杨海峰,胡峰,等.穴位注射喘可治和胸腺肽对稳定期COPD患者作用的研究[J].临床肺科杂志,2014,19(7):1335-1337.
[13]陈代平,伍朝霞,赵婕,等.温补脾肾汤结合穴位注射治疗稳定期脾肾阳虚型COPD临床观察[J].上海中医药杂志,2014,48(10):43-44.
[14]潘金波,陈晔.喘可治注射液治疗慢性阻塞性肺疾病稳定期脾肾阳虚证的临床研究[J].中华中医药学刊,2016,34(1):57-59.
[15]黄立搜,王世强,陈素珍,等.喘可治注射液穴位注射为主对慢性阻塞性肺疾病患者免疫功能的影响[J].浙江中医杂志,2016,51(3):166-167.
[16]黄约诺,石亚莉,宋李桃,等.“冬病夏治”对长期糖皮质激素治疗COPD稳定期患者免疫功能影响的观察[J].黑龙江中医药,2016,45(6):52-53.
[17]张一乐,史苗颜,张炜.穴位注射喘可治联合舒利迭治疗慢性阻塞性肺疾病稳定期的临床观察[J].中国中医急症,2017(10):1817-1819.
[18]温秀梅,赵峻峰,陈中明.人参蛤蚧散加味联合穴位注射治疗对稳定期COPD患者免疫功能、IL-2及sIL-2R的影响[J].中华全科医学,2018,16(4):630-633.
[19]FUJITA J,YAMADORI I,SUEMITSU I,et al.Clinical features of non-specific interstitial pneumonia[J].Respiratory Medicine,1999,93(2):113-118.
[20]邓炜,郑民强,张静,等.2种黔产淫羊藿总黄酮对免疫功能影响的比较研究[J].中国中药杂志,2011,36(4):511-513.
[21]张玲娟,沈自尹,蔡定芳,等.淫羊藿对大鼠下丘脑-垂体-肾上腺-胸腺轴抑制模型的影响[J].中医杂志,1996,37(10):620-621.
[22]饶鸿宇,陈滔彬,何彦,等.南药巴戟天化学成分与药理研究进展[J].中南药学,2018,16(11):1567-1574.
[23]龚梦鹃,叶文华,谢媛媛,等.巴戟天补肾阳作用的血清代谢组学研究[J].中国中药杂志,2012,37(11):1682-1685.
[24]王佳,史辑,魏晓峰,等.巴戟天不同炮制品对肾阳虚不育大鼠改善作用研究[J].中药材,2017,40(8):1826-1832.
[25]吕世静,黄槐莲.巴戟天对淋巴细胞增殖及产生细胞因子的调节作用[J].中医药研究,1997,13(5):48-50.
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