连花清瘟制剂的临床疗效与安全性评价

- 廖欣婷

Lianhuaqingwen (莲花清瘟) is an ancient Traditional Chinese Medicine (TCM) formula that has gained much attention during the Coronavirus Disease-19 (COVID-19) pandemic.

It consists of Maxingshigan Decoction (麻杏石甘汤) and Yinqiaosan (银翘散), which have the combined effects of clearing plague, detoxifying, and clearing lung heat. The prescription consists of forsythia suspensa, honeysuckle, Ephedra, almond, gypsum, isatis root, cyrtomium fortunei, houttuynia cordata, patchouli, rhubarb, rhodiola rosea, menthol, and licorice. This formula contains active ingredients such as iridoids, lignans, anthraquinones, phenolic acids, and flavonoids.

Studies have shown that the main components of Forsythia suspensa in Lianhuaqingwen are hyperoside, rutin, and lignoside E, which are important inhibitors of the main protease of the SARS-CoV-2 virus. Lianhua Qingwen can inhibit the infiltration of inflammatory cells, improve the expression of junction proteins in alveolar epithelial cells and pulmonary vascular endothelial cells, and reduce lung damage caused by lipopolysaccharide (LPS) by inhibiting the IKK/IB/NF-kB signaling pathway. In addition, animal experiments have confirmed that Lianhuaqingwen has an immunomodulatory effect on the body’s infection with viruses, by increasing the expression levels of CD4+ and CD4+/CD8+ T cells after infection with the influenza virus type A mouse lung-adapted strain (FM1), and increasing the interferon (IFN) levels in the mice’s lung tissue after influenza virus infection.

In February 2020, Lianhuaqingwen preparations were officially included in the “New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Version 6)” published by the National Health Commission of China, which can be used for mild cases of COVID-19, with symptoms of fever, cough, and fatigue. A randomized controlled trial showed that Lianhuaqingwen capsules can significantly suppress the main symptoms of COVID-19 (fever, cough), and shorten the course of the disease, with no reported adverse events. Another randomized controlled trial showed that Lianhuaqingwen capsules can significantly control the main symptoms of influenza A (fever, cough, sore throat, and fatigue) and reduce the severity of the disease, with no reported adverse events. The results of another randomized controlled trial proved that Lianhuaqingwen granules can significantly reduce the clinical symptoms and signs of children with Mycoplasma pneumonia, and reduce the degree of pulmonary inflammation and inflammatory exudation, thereby improving pulmonary ventilation function.

A systematic review showed that the general safety of Lianhuaqingwen preparations is good, and the occurrence of adverse events is relatively lesser than that of Western medications. The most common adverse reactions of Lianhuaqingwen preparations mostly involve the digestive system, which includes nausea, vomiting, and diarrhea. Adverse reactions on skin and laboratory test results were rare in clinical practice. The adverse reactions of the combined use of Lianhuaqingwen preparations were higher than those of Lianhuaqingwen preparations solely, so it can be speculated that the adverse reactions were caused by the combined use of Western medications. Nevertheless, more large-sample, multi-center randomized controlled clinical trials need to be conducted in the future to evaluate the efficacy of this prescription more scientifically and objectively.

References

  1. 成蕾, 刘洪, 王婷婷, 等. 连花清瘟制剂化学成分、药理作用、临床应用的研究进展.中成药. 2021,43(12):3409-3416.
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  3. Hu K, Guan WJ, Bi Y, et.al. Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial. Phytomedicine: international journal of phytotherapy and phytopharmacology.2021,85,153242.
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