目的 系統(tǒng)評(píng)價(jià)百令膠囊治療慢性阻塞性肺疾病(COPD)穩(wěn)定期患者的臨床療效和安全性。方法 檢索 PubMed、Embase、Web of Science、Cochrane Library、中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)(CNKI)、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM)、維普中文期刊全文數(shù)據(jù)庫(kù)(VIP)、萬(wàn)方數(shù)據(jù)庫(kù)等數(shù)據(jù)庫(kù),篩選并納入 2022 年 9 月 20 日以前發(fā)表的百令膠囊聯(lián)合常規(guī)療法治療COPD 穩(wěn)定期患者的隨機(jī)對(duì)照試驗(yàn)(RCT),采用 Cochrane 風(fēng)險(xiǎn)評(píng)價(jià)對(duì)納入研究進(jìn)行質(zhì)量評(píng)價(jià),然后用 RevMan 5.4 軟件對(duì)臨床療效指標(biāo)進(jìn)行 Meta 分析。結(jié)果 共納入 14 項(xiàng) RCTs,1 082 例患者。Meta 分析結(jié)果顯示,與對(duì)照組比較,常規(guī)治療加用百令膠囊可提高患者 1 秒鐘用力呼氣容積(FEV₁)[MD=0.37,95%CI(0.19,0.56),P<0.000 01]、肺活量(FVC)[MD=0.32,95%CI(0.14,0.49),P=0.000 4]、FEV₁/FVC[MD=5.33,95%CI(3.36,7.29),P<0.000 01],延長(zhǎng) 6 分鐘步行距 離[MD=57.05, 95%CI (45.91, 68.18), P<0.000 01], 降低1年內(nèi)COPD急性發(fā)作次數(shù)[MD=-1.12,95%CI(-1.54,-0.70),P<0.000 01]。所納入的研究均未報(bào)道嚴(yán)重不良反應(yīng)。結(jié)論 百令膠囊聯(lián)合常規(guī)治療可以改善COPD 穩(wěn)定期患者的肺功能、提高患者活動(dòng)能力,減少急性發(fā)作次數(shù),且安全性較高。

Objective To systematically evaluate the clinical efficacy and safety of Bailing Capsule in the treatment of patients with stable chronic obstructive pulmonary disease (COPD). Methods The databases of PubMed, Embase, Web of Science, Cochrane Library, CNKI, CBM, VIP and Wanfang Database were searched, and the randomized controlled trials published before September 20, 2022 of Bailing Capsule combined with conventional therapy in the treatment of stable patients with COPD were screened and included. The quality of the included studies was evaluated by Cochrane risk assessment, and then the clinical efficacy indexes were analyzed by RevMan 5.4 software. Results A total of 14 RCTs involving 1 082 patients were included. Meta-analysis results showed that compared with the control group, the routine treatment plus Bailing Capsule could improve the FEV₁[MD=0.37, 95%CI (0.19,0.56), P<0.000 01], FVC[MD=0.32, 95%CI (0.14, 0.49), P=0.0004], FEV₁/FVC[MD=5.33, 95%CI (3.36, 7.29), P<0.000 01], prolong the 6-minute walking distance[MD=57.05, 95%CI (45.91, 68.18), P<0.000 01], reduce the number of COPD acute attacks within one year[MD=-1.12, 95%CI (-1.54, -0.70), P<0.000 01]. No serious adverse reactions were reported in the included studies. Conclusion Bailing Capsule combined with routine treatment can improve pulmonary function, improve patient's activity ability, reduce the number of acute attacks, and has high safety.

R286.4

國(guó)家自然科學(xué)基金面上項(xiàng)目(82074367);中日友好醫(yī)院橫向課題(2018-HX-96)