关键词:

鼻外科手术, 云南白药胶囊, 有效性

Abstract:

Objective  To evaluate the efficacy and safety of Yunnan Baiyao Capsule in reducing bleeding during sinusitis/nasal polyps endoscopic surgery and promoting the healing of nasal mucosa.

Methods  A multicenter, double-blind, randomized, placebo-controlled study was used. A total of 200 patients who met the inclusion criteria were enrolled and randomly divided into the experimental group(n=100) and the control group(n=100). They were given Yunnan Baiyao Capsule and placebo(500 mg/time, 4 times a day)respectively which were initiated at 3 d before surgery, and continued at 6 h after surgery until 28 d after surgery. The intraoperative bleeding volume and bleeding volume per unit of the two groups, the healing of the nasal mucosal epithelium were observed, and the safety was evaluated.

Results  Intention-to-treat(ITT) population analysis showed that intraoperative bleeding volume and bleeding volume per unit in the experimental group were less than those in the control group, and the difference was statistically significant(P＜0.05). PP population analysis showed that the intraoperative bleeding volume and bleeding volume per unit in the experimental group were less than those in the control group, and the difference was statistically significant(P＜0.05). In ITT population, the coverage rate of nasal mucosa epithelium in the experimental group and the control group at 8 weeks after operation was 56.12% in the experimental group and 38.14% in the control group, and there was significant difference between two groups(P=0.008). The total effective rate was 92.86% in the experimental group and 76.29% in the control group, and there was significant difference between  two groups(P=0.001). In PP population, the coverage rate of nasal mucosa epithelium in the experimental group and the control group at 8 weeks after operation was 56.67% in the experimental group and 41.86% in the control group, and there was significant difference between  two groups(P=0.041). The total effective rate was 95.56% in the experimental group and 82.56% in the control group, and there was significant difference between two groups(P=0.008). In ITT and PP population, Lund Kennedy endoscopic mucosal morphology score decreased at 2, 4, 6 and 8 weeks after operation in the experimental group and the control group, but the decrease was more significant in the experimental group. There were significant differences in the interaction between groups, time points, time points between groups(P＜0.05). There was no significant difference in the incidence of adverse events/adverse reactions between the two groups(P＞0.05).

Conclusion  Yunnan Baiyao Capsules used in endoscopic sinus surgery can effectively reduce intraoperative bleeding volume and bleeding volume per unit, promote the healing of nasal mucosa, and have no obvious adverse effects.