益气健脾法联合西医常规治疗对稳定期慢性阻塞性肺疾病疗效的系统评价

Efficacy of Boosting Qi and Fortifying the Spleen combined with Western Medicine on Chronic Obstructive Pulmonary Disease at Stable Stage: A Systematic Review

目的系统评价临床运用中医益气健脾法联合西医常规治疗对稳定期慢性阻塞性肺疾病的疗效。方法经计算机对Wanfang、CNKI、VIP、PubMed等中英文数据库进行综合检索,检索时间均设定为建库至2020年2月28日,由2名研究员独立检索、筛选文献,以Cochrane手册针对临床随机对照研究的工具进行风险评估和质量评价,然后纳入Stata 12.0软件和RevMan5.3软件进行荟萃分析。结果最终经过严格的纳排标准共纳入13项研究,均为临床随机对照试验。其中益气健脾组联合常规治疗分别在肺功能FEV1/FVC(MD=6.31,95%CI:2.03-10.59,P=0.004)、FEV1%(MD=6.21,95%CI:2.50-9.93,P=0.001)、FEV1(MD=0.15,95%CI:0.03-0.27,P=0.01);临床有效率(RR=0.17,95%CI:0.06-0.29,P=0.003)等指标明显优于单纯西医治疗或常规治疗联合安慰剂。但是在肺功能FVC(MD=0.19,95%CI:-0.10-0.47,P=0.19)和身体质量指数(MD=1.53,95%CI:-0.44-3.50,P=0.13)两项指标益气健脾组未发现明显优势。本研究也通过亚组分析发现不同剂型中药运用益气健脾法治疗慢阻肺的临床疗效具有明显差异,中药饮片治疗效果明显优于中药颗粒剂等非饮片剂型。此外,我们运用敏感性分析和亚组分析尝试寻找纳入研究存在较大异质性的可能来源。结论中医益气健脾法联合常规治疗相较于单纯西医常规治疗或常规治疗联合安慰剂治疗稳定期慢性阻塞性肺疾病在改善肺功能、临床症状和提高临床治疗有效率等方面优势明显,且临床疗效在不同中药剂型之间存在差异。

Objective To systematically evaluate the clinical efficacy of the method of boosting qi and fortifying the spleen in traditional Chinese medicine(TCM) combined with Western medicine in the treatment of chronic obstructive pulmonary disease(COPD) at a stable period. Methods Publications from the establishment of the database to February28, 2020 were retrieved from several databases, including Wanfang, CNKI, VIP, and PubMed, by two researchers. The Cochrane handbook for clinical randomized controlled research tools was consulted for risk assessment and quality evaluation. Stata 12.0 software and RevMan5.3 software were used to conduct a meta-analysis. Results A total of 13 studies were included in the study, all of which were randomized controlled clinical trials. In the aspects of FEV1/FVC(MD = 6.31, 95%CI: 2.03-10.59, P = 0.004), FEV1%(MD = 6.21, 95%CI: 2.50-9.93, P = 0.001), FEV1(MD = 0.15,95%CI: 0.03-0.27, P = 0.01), FEV1(RR = 0.17, 95%CI: 0.06-0.29, P = 0.003), the clinical efficacy of boosting qi and fortifying the spleen combined with Western medicine was significantly better than that of Western medicine to be used alone or conventional treatment combined with placebo. However, no significant advantage was found in FVC(MD =0.19, 95%CI:-0.10-0.47, P = 0.19) and body mass index(MD = 1.53, 95%CI:-0.44-3.50, P = 0.13). Through subgroup analysis, this study also found that there were significant differences in the clinical efficacy of different preparations of TCM in the treatment of COPD with the method of boosting qi and fortifying the spleen. The therapeutic effect of prepared drugs in pieces was significantly better than that of TCM granules and other non-pieces drugs.Besides, we used sensitivity analysis and subgroup analysis to identify possible sources of greater heterogeneity in the included studies. Conclusion The combination of TCM method of boosting qi and fortifying the spleen combined with conventional therapy has obvious advantages in improving pulmonary function, clinical symptoms, and clinical therapeutic efficiency compared with Western medicine used alone or conventional treatment combined with placebo in the treatment of stable COPD, and the clinical efficacy is different among different TCM preparations.