Abstract

Background: Acute exacerbation is an important factor in the progression of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD). Recently, many studies have suggested that Suhuang Zhike capsule (SZC) combined with western medicine can suppress the inflammatory response efficiently and quickly, and shorten the course of the disease. Therefore, the treatment with SZC has important implications for the prognosis of the patients. However, the effectiveness and safety of SZC in the treatment to acute exacerbations of CB or COPD have not been systematically reviewed. Purpose: In order to evaluate the effectiveness of Traditional Chinese Patent Medicine-SZC in the treatment of patients with CB or COPD. Methods: We searched and reviewed the relevant publications by August 2022, in the following databases: EMBASE, PubMed, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Chinese Vip database, China Biomedical Literature Database, and Wanfang. The risk bias was assessed for the included studies according to the Cochrane Handbook. Lung function was used as the primary outcome indicator, including the ratio of exertional expiratory volume in one second to exertional spirometry (FEV1/FVC), exertional expiratory volume in one second (FEV1), exertional spirometry (FVC). The secondary outcomes included tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8), and adverse events (AEs). Results: A total of 20 randomized controlled trials (RCTs) meet the inclusion criteria (including 1956 patients) and the results of the meta-analysis showed that the treatment of SZC combined with western medicine routine significantly improved the lung function of patients with CB or COPD compared to the western medicine routine alone: (FEV1/FVC [MD = -7.18, 95%CI (5.43,8.95), P < 0.01], FEV1[ MD= 0.37, 95%CI (0.19, 0.54), P < 0.01] and FVC [MD= 0.59, 95%CI (0.31, 0.86), P < 0.01, I2 = 94%]), significantly reduced the levels of inflammatory factors: TNF-α [MD= -6.86, 95% CI (-9.73,-3.99), P < 0.01, I2 = 94%], IL-6 [MD= -1.77, 95%CI (-2.81, 39-0.73),P < 0.01, I2 = 86.7%], and IL-8 [MD= -1.50, 95% CI (-2.25, -0.76), P < 0.01, I2 = 92%], and shorten cough duration [MD = -1.51, 95%CI (-2.15, -0.86), P < 0.01, I2 = 86%].There was no significant difference in the incidence of adverse events between the two groups. There was no publication bias in the statistics, according to begge test (z = 0.34 (p = 0.732)) and egger tests (t =0.46 (p = 0.653)) respectively. Conclusions: The current review suggest that the adjunctive therapy with SZC can safely and effectively improve lung function, reduce the levels of inflammatory factors, and shorten the

duration of symptoms for the patients with acute exacerbations of CB or COPD.

Keywords: Suhuang zhike capsule; COPD; CB; RCTs; Meta-analysis.