Abstract
OBJECTIVE: To evaluate the clinical efficacy and safety of Dongtian Changchun ointment (, DTCO) for the treatment of patients with stable moderate-to-severe chronic obstructive pulmonary disease (COPD). METHODS: This was a multicenter, prospective, open-label, randomized controlled trial. Patients with COPD who met the inclusion and exclusion criteria were randomly divided into a DTCO group and a control group in a 1∶1 ratio. Both groups were treated with Symbicort Turbuhaler (320 μg / 9 μg twice daily) for 48 weeks. The DTCO group was given additional DTCO (15 g twice daily) for the first 12 weeks. Outcome assessments were conducted at five time points: 0, 12, 24, 36, and 48 weeks. Primary outcome measures included frequency and duration of acute exacerbation of COPD (AECOPD). Secondary outcomes included St. George's Breathing Questionnaire, pulmonary function, 6-min walk test, and modified Medical Research Council (mMRC) scores. RESULTS: A total of 84 patients were randomly divided into the DTCO group (n = 42) and the control group (n = 42). The results showed that in the DTCO group, 23 patients had AECOPD for a total duration of 166 d compared with 31 patients in the control group for a total duration of 307 d. Compared with the control group, the DTCO group showed a significant reduction in the median (interquartile range) frequency and duration of AECOPD (P < 0.05). The incidence of AECOPD significantly reduced in the DTCO group to 0.539 [95% confidence interval (0.347, 0.836), P = 0.006]. In the DTCO group, a significant improvement in forced vital capacity was observed at 12 and 48 weeks (P < 0.05), and a reduction in mMRC was noted at 36 and 48 weeks (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups. CONCLUSIONS: DTCO significantly reduced the frequency and duration of AECOPD in patients with moderate-to-severe COPD, and demonstrated satisfactory safety.