罗红霉素缓释胶囊治疗细菌性上呼吸道感染的安全性及经济性评价

目的：评价罗红霉素缓释胶囊治疗细菌性上呼吸道感染的安全性与经济性。方法：基于中国卫生体系角度，采用决策树模型模拟中国细菌性上呼吸道感染患者接受5种不同剂型罗红霉素治疗的直接医疗成本与临床收益。直接医疗费用为药品费用，来源于米内网。临床收益为安全性收益，不良反应发生率通过相关数据库研究测算，相关治疗成本来源于专家咨询。采用单因素敏感性分析和概率敏感性分析验证模型结果的稳健性。结果：安全性上，罗红霉素缓释胶囊总不良反应发生率最低(2.66%)。经济性上，罗红霉素缓释胶囊组相比于罗红霉素片组，成本低18.41元，净收益为7.66元，具有成本效益；罗红霉素缓释胶囊组相比于罗红霉素分散片组，成本高2.45元，净收益为45.35元，具有成本效益。罗红霉素缓释胶囊组分别与罗红霉素软胶囊组、罗红霉素胶囊组相比，干预成本分别高出10.24元、8.17元，净效益分别为3.18元、4.40元，增量效益-成本比分别为0.31、0.54，不具有成本效益。敏感性分析结果稳健。结论：常见罗红霉素剂型中，罗红霉素缓释胶囊安全性最高。在现有的模型和参数下，当罗红霉素缓释胶囊组药品成本降低幅度大于19.36%，在治疗上呼吸道感染时，相比其他常见剂型的罗红霉素均具有经济性优势。

Safety and Economic Evaluation of Roxithromycin Sustained-release Capsules in the Treatment of Bacterial Upper Respiratory Tract Infections

Objective: To evaluate the safety and cost-eff ectiveness of common formulations of roxithromycin in the treatment of bacterial upper respiratory tract infections. Methods: From the perspective of health care system in China, a decision tree mode was built to simulate the direct medical costs and clinical benefits of roxithromycin of fi ve diff erent formulations for patients with bacterial upper respiratory tract infections. Direct medical expenses were cost of medicine, which were obtained from MiNet Database. The incidence of adverse events was estimated through the relevant database, while the cost was derived from questionnaire survey. Oneway and probability sensitivity analysis were conducted to validate the robustness of the model results. Results: In terms of safety, the adverse events incidence of roxithromycin sustained-release capsules was the lowest among these fi ve diff erent formulas. As for economic results, roxithromycin sustained-release capsules group yielded an additional cost tablets and dispersible tablets, RMB -18.41 and RMB 2.45, respectively, while yielded the net benefi ts, RMB 7.66 and RMB 45.35, respectively. Therefore, roxithromycin sustained-release capsules were cost-eff ective strategy compared with tablets and dispersible tablets. The roxithromycin sustained-release capsule group was causing an additional cost compared with soft capsules group and capsules, RMB 10.24 and RMB 8.17, respectively, and yielded an net benefi ts, RMB 3.18 and RMB 4.40, respectively. The benefi t-cost ratio was 0.31 and 0.54, respectively. Therefore, roxithromycin sustained-release capsule was not a cost-eff ective alternative. The sensitivity analysis results were robust. Conclusion: Among common diff erent formulas, the safety of roxithromycin sustained-release capsules was signifi cantly better than the others. Based on the current model and parameters, roxithromycin sustained-release capsules was more cost-eff ective than other commonly used formula in treating upper respiratory tract infections when the price of it could be reduced by over 19.36%.