穴位贴敷治疗慢性阻塞性肺疾病疗效的Meta分析和Grade评价

Meta analysis and Grade evaluation of therapeutic effect of acupoint application on chronic obstructive pulmonary disease

关键词:  穴位贴敷  慢性阻塞性肺疾病  Meta分析  Grade评价

Key words:  acupoint application  chronic obstructive pulmonary diseases  Meta analysis  Grade evaluation

摘要:

[目的] 运用循证医学的方法对穴位贴敷疗法治疗慢性阻塞性肺疾病（COPD）的临床疗效和安全性进行系统分析和Grade评价。[方法] 计算机检索国内外中英文数据库，检索从各数据库建库至2022年9月31日发表的关于穴位贴敷治疗COPD的随机对照研究（RCT），由两名研究员背对背根据纳入标准及排除标准进行筛查，应用Revman 5.3软件做偏倚风险评估及Meta分析，应用Grade系统进行证据质量评价。[结果] 共纳入16篇文献、1 500例患者，包括治疗组751例，对照组749例，Meta分析结果显示：与单纯西医治疗相比，穴位贴敷提高总有效率（TE）[OR=4.68，95%CI（3.36，6.53），P＜0.000 01]，改善第1秒用力呼气量占预计值的百分比（FEV1%）[MD=3.04，95%CI（1.76，4.33），P＜0.000 01]、第一秒用力呼气量/最大肺活量比值（FEV1/FVC）[MD=2.38，95%CI（0.84，3.92），P=0.002]，改善动脉血氧分压（PaO₂）[MD=7.27，95%CI（4.60，9.95），P＜0.000 01]、动脉血二氧化碳分压（PaCO2）[MD=-8.68，95%CI（-10.28，-7.09），P＜0.000 01]，圣乔治呼吸问卷（SGRQ）、呼吸相关量表（BODE指数、CAT评分）均有明显降低[MD= -7.36，95%CI（-13.22，-1.51），P=0.01；MD=-0.74，95%CI（-0.80，-0.69），P＜0.000 01；MD=-1.92，95%CI（-2.73，-1.10），P＜0.000 01]，减少急性加重次数[MD=-1.85，95%CI（-2.67，-1.03），P＜0.000 01]，增加不良反应发生率[OR=2.89，95%CI（1.57，5.33），P=0.000 7]，中医证候积分组间无差异[MD=-0.87，95%CI（-1.84，0.09），P=0.08]，Grade证据分级结果显示：FEV1/FVC、PaCO2、不良反应发生率3项结局指标为中质量证据，临床总有效率、FEV1%、CAT评分、急性加重次数4项结局指标为低质量证据，中医证候总积分、PaO₂、SGQR评分、BODE指数4项结局指标为极低质量证据。[结论] 穴位贴敷联合西医治疗COPD比单纯西医治疗有明显优势，但所纳入研究的证据质量不高，尚需高质量研究为临床提供指导。

Abstract:

[Objective] To systematically analyze and evaluate Grade on the clinical efficacy and safety of acupoint application therapy in chronic obstructive pulmonary disease（COPD） by using evidence-based medicine. [Methods] A computer search of Chinese and English databases at home and abroad was conducted to retrieve randomized controlled trials（RCTs） on acupoint application in the treatment of COPD published from the establishment of each database to September 31，2022. Screening was performed by two researchers back-to-back according to the inclusion criteria and exclusion criteria. Review Manager 5.3 software was used for bias risk assessment and Meta-analysis，and Grade system was used for evidence quality evaluation. [Results] A total of 16 references with 1 500 patients were included（751 patients in the treatment group and 749 patients in the control group）. The results of Metaanalysis showed that compared with conventional western medicine，acupoint application was more effective in total response efficiency（TE） [OR=4.68，95%CI（3.36，6.53），P＜0.000 01]，with a superior advantage in increasing the forced expiratory volume in the first second as a percentage of the expected value（FEV1%） [MD=3.04，95%CI（1.76，4.33），P＜0.000 01] and the first-second forced expiratory volume/maximum vital capacity ratio（FEV1/FVC） [MD=2.38，95%CI（0.84，3.92），P=0.002]，improving arterial blood oxygen partial pressure（PaO₂）[MD=7.27，95%CI（4.60，9.95），P＜0.000 01] and reducing arterial blood carbon dioxide partial pressure（PaCO2）[MD=-8.68，95%CI（-10.28，-7.09），P＜0.000 01]，and decreasing the St. George’s Respiratory Questionnaire（SGRQ），Respiratory correlation scale（the BODE index and the CAT score） [MD=-7.36，95%CI（-13.22，-1.51），P=0.01；MD=-0.74，95%CI（-0.80，-0.69），P＜0.000 01；MD=-1.92，95%CI（-2.73，-1.10），P＜0.000 01]. Acupoint application could also reduce the number of acute exacerbation [MD=-1.85，95%CI（-2.67，-1.03），P＜0.000 01]，but in a degree increase the incidence of adverse effects [OR=2.89，95%CI（1.57，5.33），P=0.000 7]. There was no differentiation between traditional Chinese medicine syndrome integration groups [MD=-0.87，95%CI（-1.84，0.09），P=0.08]. The Grade evidence classification results showed that three outcome indicators of FEV1/FVC，PaCO2 and the incidence of adverse reactions were moderate quality evidence，four outcome measures which were including in clinical total response rate，FEV1%，CAT score and number of acute exacerbation were the low-quality evidence，four outcome indicators including TCM total syndrome score，PaO₂，SGQR score，and BODE index were very low quality evidence. [Conclusion] Acupoint application combined with conventional western medicine in the treatment of COPD has obvious advantages over western medicine treatment alone，but the evidence quality of the included studies is not high，and good-quality research is still needed to provide guidance for clinical practice.