前列欣胶囊治疗慢性前列腺炎的多中心真实世界研究

A multicenter,real-world study on the treatment of chronic prostatitis with Qianliexin capsules

目的采用多中心、真实世界研究方法,探究前列欣胶囊在真实医疗环境下治疗慢性前列腺炎的有效性、安全性与经济性,为临床应用提供指导。方法通过全国22个中心共纳入慢性前列腺炎患者3399例,患者单独服用前列欣胶囊或在其常规治疗基础上服用前列欣胶囊。观察和记录患者治疗前后NIH-CPSI评分,分析评分总有效率、评分减半率、症状消失率与单项症状积分变化情况,同时观察不良反应并记录肝肾功能(ALT/AST/Cr)异常率,以及治疗周期内成本效果比与增量成本效果比。结果治疗后患者NIH-CPSI总积分较治疗前下降,总有效率为89.79%,差异具有统计学意义(P<0.001);疼痛或不适症状评分的总体减半率为76.21%,排尿症状评分的总体减半率为78.26%;疼痛或不适症状评分的总体消失率为23.36%,排尿症状评分的总体消失率为21.77%;不良反应发生率为0.47%,发生频率属于偶见,无严重不良反应;药物经济学评估中,前列欣胶囊单独使用的成本效果比最小,为3.42元/%。结论前列欣胶囊在真实医疗场景中能显著改善慢性前列腺炎患者疼痛不适症状以及排尿症状,且安全性良好,经济性较高。

Objective To investigate the effectiveness,safety and economy of Qianliexin capsule in the treatment of chronic prostatitis using multi-center and real world research method for providing the guidance for clinical application.Methods A total of 3399 patients with chronic prostatitis were enrolled from 22 centers across the country.The patients received Qianliexin capsule alone or in addition to their conventional treatment.NIH-CPSI scores were observed and recorded before and after treatment,and changes in total response rate,score halving rate,symptom disappearance rate and single symptom score were analyzed.Adverse reactions were observed and abnormal rate of liver and kidney function(ALT/AST/Cr),as well as cost-effectiveness ratio and incremental cost-effectiveness ratio during treatment cycle were recorded.Results After treatment,the total NIH-CPSI score decreased compared with that before treatment,and the total effective rate was 89.79%,the difference was statistically significant(P<0.001).The overall halving rate of pain or discomfort symptom score was 76.21%,and the overall halving rate of urination symptom score was 78.26%.The overall disappearance rate of pain or discomfort symptom score was 23.36%,and the overall disappearance rate of urination symptom score was 21.77%.The incidence of adverse reactions was 0.47%,and the frequency was rare.No serious adverse reactions were found.In the economic evaluation,the cost-effectiveness ratio of Qianliexin capsule used alone(3.42 yuan/%)was the smallest.Conclusion Qianliexin capsule can significantly improve the pain and discomfort symptoms and urination symptoms of chronic prostatitis patients in real medical scenes,with good safety and high economy.