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金水宝胶囊治疗新型冠状病毒肺炎恢复期心肺气虚证患者的有效性和安全性:一项前瞻性、随机、双盲、安慰剂对照的临床试验。

Effectiveness and safety of Jinshuibao capsules in treatment of residual cardiopulmonary symptoms in convalescent patients of coronavirus disease 2019: a pilot randomized, double-blind, placebo-controlled clinical trial.

机构信息

Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.

Department of Infectious Diseases, Wuhan No.7 Hospital, Wuhan 430071, China.

出版信息

J Tradit Chin Med. 2023 Feb;43(1):134-139. doi: 10.19852/j.cnki.jtcm.2023.01.012.

Abstract

OBJECTIVE

: To evaluate the effectiveness and safety of Jinshuibao capsules (金水宝胶囊), a Traditional Chinese Medicine (TCM), in the treatment of residual cardiopulmonary symptoms in convalescent corona virus disease 2019 (COVID-19) patients.

METHODS

: A total of 200 participants with COVID-19 in convalescence phase were randomly assigned into two groups at a 1:1 ratio in this multicenter randomized, double-blind, placebo-controlled trial. One group received Jinshuibao capsules, and the other received placebo. The patients were followed up at one and two weeks of treatment. Five symptoms (dry cough, shortness of breath, sweating, chest tightness and palpitation) improvement rates and full recovery rates were compared.

RESULTS

: All baseline characteristics were comparable between the two groups. After two weeks of treatment, symptom improvement rates for dry cough (74.00% 50.00%, = 0.015), shortness of breath (78.95% 46.15%, < 0.001), sweating (80.00% 57.75%, = 0.004), chest tightness (87.06% 60.47%, < 0.001) and palpitation (82.50% 64.56%, = 0.010) were significantly higher in the Jinshuibao group compared with the control group. Meanwhile, Jinshuibao capsules treatment also displayed more satisfactory full recovery rates of all five symptoms (dry cough 58.00% vs 19.57%, shortness of breath 18.95% 7.69%, sweating 36.00% 19.72%, chest tightness 32.94% 13.95%, and palpitation 48.75% 29.11%) in participants with COVID-19 in convalescence phase compared with the control group ( < 0.05). No severe adverse events were reported in either group.

CONCLUSIONS

: Jinshuibao capsules have the potential to improve residual cardiopulmonary symptoms in convalescent COVID-19 patients, with few adverse events.

摘要

目的

评估金水宝胶囊(一种中药)治疗恢复期 2019 冠状病毒病(COVID-19)患者心肺残留症状的疗效和安全性。

方法

本多中心、随机、双盲、安慰剂对照试验采用 1:1 比例将 200 名 COVID-19 恢复期患者随机分为两组。一组服用金水宝胶囊,另一组服用安慰剂。两组患者均在治疗后 1 周和 2 周进行随访。比较两组患者 5 种症状(干咳、呼吸急促、出汗、胸闷和心悸)的改善率和完全缓解率。

结果

两组患者的所有基线特征均无统计学差异。治疗 2 周后,干咳(74.00%比 50.00%,=0.015)、呼吸急促(78.95%比 46.15%,<0.001)、出汗(80.00%比 57.75%,=0.004)、胸闷(87.06%比 60.47%,<0.001)和心悸(82.50%比 64.56%,=0.010)的改善率均显著高于对照组。同时,金水宝胶囊组的 5 种症状(干咳、呼吸急促、出汗、胸闷和心悸)完全缓解率也显著高于对照组(分别为 58.00%比 19.57%、18.95%比 7.69%、36.00%比 19.72%、32.94%比 13.95%和 48.75%比 29.11%)(<0.05)。两组均未报告严重不良事件。

结论

金水宝胶囊可能有助于改善恢复期 COVID-19 患者的心肺残留症状,且不良反应少。

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