补肺活血胶囊治疗新型冠状病毒感染后恢复期患者的有效性和安全性：一项多中心、双盲、随机对照临床试验。
Efficacy and safety of Bufei Huoxue capsules in the management of convalescent patients with COVID-19 infection: A multicentre, double-blind, and randomised controlled trial.
机构信息
State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangdong-Hong Kong-Macao Joint Laboratory for respiratory infectious disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Department of Out-patient and Emergency, Wuhan Institute for Tuberculosis Control, Wuhan Pulmonary Hospital, Wuhan, Hubei, China.
出版信息
J Ethnopharmacol. 2022 Feb 10;284:114830. doi: 10.1016/j.jep.2021.114830. Epub 2021 Nov 9.
BACKGROUND
As of September 17, 2021, coronavirus disease 2019 (COVID-19) has infected more than 226 million people in a worldwide pandemic, with conservative estimates suggesting that there are more than 204 million convalescent patients with COVID-19. Previous studies have indicated that patients in the recovery phase exhibit decreased function of multiple organs. In China, traditional Chinese medicine (TCM) treatment is recommended in the rehabilitation period of COVID-19; however, the safety and efficacy of such treatment remain to be confirmed.
AIM OF STUDY
The present study aimed to evaluate the efficacy and safety of Bufei Huoxue (BFHX) in restoring the functional status and exercise tolerance of patients recovering from COVID-19.
METHODS
A total of 131 patients in the rehabilitation period of COVID-19 infection were randomly divided into a Bufei Huoxue (BFHX) group (n = 66) and a placebo group (n = 65). BFHX or placebo was given orally three times a day (1.4 g/dose) for 90 days. The primary outcomes was to evaluate improvements in exercise tolerance and imaging manifestations on chest computed tomography (CT).
RESULTS
After the exclusion of two patients who withdrew prior to receiving any medications, 129 patients were recruited, including 64 patients in the BFHX group and 65 patients in the placebo group. After 3 months of treatment, the BFHX group exhibited greater attenuation of pneumonia lesions on chest CT than the placebo group (P<0.05). Improvements in 6-min walk distance (6MWD) relative to baseline were also significantly better in the BFHX group than in the placebo group (P<0.01). Scores on the Fatigue Assessment Inventory (FAI) were lower in the BFHX group than in the placebo group (P<0.05). Although the rate of adverse events was higher in the BFHX group than in the placebo group (9.38% vs. 4.62%), the difference was not significant (P=0.3241).
CONCLUSIONS
BFHX may exert strong rehabilitative effects on physiological activity in patients recovering from COVID-19, which may in turn attenuate symptoms of fatigue and improve exercise tolerance.
背景
截至 2021 年 9 月 17 日，全球大流行导致超过 2.26 亿人感染了 2019 年冠状病毒病（COVID-19），保守估计有超过 2.04 亿例 COVID-19 康復患者。先前的研究表明，恢復期的患者多個器官功能下降。在中国，COVID-19 恢復期推薦使用中醫藥治療；然而，這種治療的安全性和有效性仍有待確定。
研究目的
本研究旨在評估補肺活血（BFHX）恢復 COVID-19 康復患者功能狀態和運動耐量的療效和安全性。
方法
共招募了 131 例 COVID-19 感染恢復期患者，隨機分為補肺活血（BFHX）組（n=66）和安慰劑組（n=65）。BFHX 或安慰劑每天口服 3 次（1.4g/劑），共 90 天。主要觀察指標是評估運動耐量和胸部計算機斷層掃描（CT）的影像表現的改善。
結果
在排除了兩名在接受任何藥物治療前退出的患者後，共入組 129 例患者，其中 BFHX 組 64 例，安慰劑組 65 例。治療 3 個月後，BFHX 組患者胸部 CT 肺炎病灶的吸收明顯好於安慰劑組（P<0.05）。與基線相比，6 分鐘步行距離（6MWD）的改善也顯著好於安慰劑組（P<0.01）。BFHX 組的疲勞評估量表（FAI）評分低於安慰劑組（P<0.05）。雖然 BFHX 組不良事件的發生率高於安慰劑組（9.38%比 4.62%），但差異無統計學意義（P=0.3241）。
結論
BFHX 可能對 COVID-19 恢復患者的生理活動產生強有力的康復作用，從而緩解疲勞症狀，提高運動耐量。
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