目的 系統(tǒng)評價疏風(fēng)解毒膠囊治療慢性阻塞性肺疾病急性加重期（AECOPD）的臨床有效性、安全性。方法 檢索中文學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）、萬方數(shù)據(jù)庫（WanFang Data）、維普中文期刊全文數(shù)據(jù)庫（VIP）、PubMed、Cochrane Library等數(shù)據(jù)庫已發(fā)表的疏風(fēng)解毒膠囊治療AECOPD的臨床隨機(jī)對照試驗（RCT），時限從建庫至2021年1月，使用Cochrane手冊對納入文獻(xiàn)進(jìn)行質(zhì)量評價，使用Review Manager 5.3進(jìn)行Meta分析。結(jié)果 最終納入16篇RCTs，包括1 753例患者。Meta分析結(jié)果顯示：疏風(fēng)解毒膠囊聯(lián)合西醫(yī)常規(guī)治療（試驗組）有效率優(yōu)于單純西醫(yī)常規(guī)治療（對照組），組間比較差異具有統(tǒng)計學(xué)意義［RR=1.20，95% CI=（1.15，1.26），P<0.000 01］；試驗組患者血氣分析，二氧化碳分壓［MD=-3.65，95% CI=（-10.79，3.50），P=0.32］、氧分壓［MD=6.80，95% CI=（5.40，8.20），P<0.000 01］改善優(yōu)于對照組；試驗組患者肺功能指標(biāo)，第1秒用力呼氣容積［MD=1.35，95% CI=（0.68，2.03），P<0.000 1］、第1秒用力呼氣容積占用力肺活量百分比［MD=0.83，95% CI=（0.66，1.00），P<0.000 01］改善優(yōu)于對照組；試驗組炎癥指標(biāo)，C反應(yīng)蛋白［MD=-4.81，95% CI=（-7.41，-2.20），P<0.000 01］改善優(yōu)于對照組，降鈣素原［MD=-0.51，95% CI=（-0.79，-0.23），P=0.000 4］改善優(yōu)于對照組。不良反應(yīng)少且無嚴(yán)重不良反應(yīng)發(fā)生。結(jié)論 西醫(yī)常規(guī)治療聯(lián)用疏風(fēng)解毒膠囊治療AECOPD，可以提高臨床療效，改善患者血氣、肺功能、炎癥指標(biāo)，安全性好，但部分結(jié)局指標(biāo)有異質(zhì)性，可能存在發(fā)表偏倚，因此未來仍需更大樣本、高質(zhì)量、多中心RCT研究以進(jìn)一步評價其療效及安全性。

Objective To systematically evaluate the clinical effectiveness and safety of Shufeng Jiedu Capsule in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods Search the Chinese Academic Journals Full-text Database (CNKI), China Biomedical Literature Database (CBM), WanFang Data, VIP Chinese Journal Full-text Database (VIP), PubMed, Cochrane Library and other databases that have published Shufeng Jiedu Capsules Clinical randomized controlled trials (RCTs) for the treatment of AECOPD, the time frame is from the establishment of the database to January 2021, the quality of the included literature is evaluated using the Cochrane manual, and the Meta analysis is performed using Review Manager 5.3. Results A total of 16 RCTs were finally included, including 1 753 patients. Meta-analysis results show that: Shufeng Jiedu Capsule combined with Western medicine conventional treatment is more effective than conventional treatment alone, and the difference between the groups is statistically significant [RR = 1.20, 95%CI = (1.15, 1.26), P < 0.000 01]; The blood gas analysis of the patients in the test group showed that the partial pressure of carbon dioxide [MD = -3.65, 95%CI = (-10.79, 3.50), P = 0.32], the partial pressure of oxygen [MD = 6.80, 95%CI = (5.40, 8.20), P < 0.000 01] improved better than the control group; the lung function index of the test group patients, the forced expiratory volume in the first second (FEV1) [MD = 1.35, 95%CI = (0.68, 2.03), P < 0.000 1], FEV1/FVC [MD = 0.83, 95%CI = (0.66, 1.00), P < 0.000 01] improved better than the control group; the inflammatory index of the test group, C-reactive protein [MD = - 4.81, 95%CI = (- 7.41, - 2.20), P < 0.000 01] improved better than the control group, procalcitonin [MD = -0.51, 95%CI = (-0.79, -0.23), P = 0.000 4] Improvement is better than the control group. There were few adverse reactions and no serious adverse reactions occurred. Conclusion The combination of conventional western medicine treatment and Shufeng Jiedu capsule in the treatment of AECOPD can improve the clinical efficacy, improve the blood gas, lung function, and inflammation indexes of patients, and have good safety. However, some outcome indexes are heterogeneous, and there may be publication bias. Therefore, it is still in the future. More large-sample, high-quality, multi-center RCT studies are needed to further evaluate its efficacy and safety.

陜西省科技廳重點研發(fā)計劃（2020SF-351）