OBJECTIVETo explore the effect of Tanreqing Injection (TRQI) on the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with Chinese medicine syndrome of retention of phlegm and heat in Fei (RPHF).

METHODSIn a prospective randomized controlled clinical trial, 90 patients with AECOPD of RPHF syndrome were randomly assigned to 3 groups, TRQI and controls A and B, each with 30 cases. The TRQI group was administered with the intravenous injections of 20 mL TRQI once a day and conventional Western medicine treatment. Control group A was administered with the intravenous injection of 15 mg ambroxol hydrochloride twice a day and conventional Western medicine treatment, and control group B was administered with conventional Western medicine treatment only. The treatments were administered for 10 days. Chinese medical symptoms and signs were scored, and plasma concentrations of interleukin (IL)-8 and neutrophil elastase (NE) were recorded.

RESULTS(1) The Chinese medical symptoms (cough, sputum amount, expectoration, dyspnea and fever) and signs (tongue and pulse) improved significantly in the TRQI group (P<0.05 or P<0.01), and improvements in cough, sputum amount and expectoration were better in the TRQI group than control group B (P<0.05); there was no significant difference between the TRQI group and control group A (P>0.05). The sign of tongue was also improved significantly in the TRQI group (P<0.05). (2) The overall effects in the TRQI group and control group A were significantly better than in control group B (P<0.05), with no significant differences between the TRQI group and control group A (P>0.05). There was no significant difference in the total effective rate among the three groups (P>0.05). (3) After treatment, the plasma concentrations of IL-8 and NE decreased in the TRQI group and control group A (P<0.05), and the concentration of IL-8 in control group B decreased (P<0.05). The difference in IL-8 was greater in the TRQI group than in control group A and B before and after treatment, and the change in NE was greater in control group A than in the TRQI group and control group B, but there was no statistical significance among the three groups with regards to the change in IL-8 or NE (P>0.05).

CONCLUSIONTRQI could improved the Chinese medical signs and symptoms in the patients with AECOPD, possibly because of the decreasing plasma levels of IL-8 and NE which could improve response to airway inflammation and mucus hypersecretion.