鹿瓜多肽注射液治疗3071例骨关节炎真实世界疗效分析

Efficacy Analysis of 3071 Patients with Osteoarthritis Treated by Cervus and Cucumis Polypeptide Injection Based on Real World Study

目的:比较骨关节炎患者使用或不使用鹿瓜多肽注射液的疗效(好转率)是否存在差异。方法:本研究数据来自全国多家三甲综合医院信息管理系统(Hospital Information System,HIS),共纳入骨关节炎患者信息22855例,最终纳入3071例使用鹿瓜多肽注射液的患者为鹿瓜多肽观察组,3071例未使用鹿瓜多肽注射液的患者为对照组。采用倾向性评分法平衡2组混杂因素,通过3种Logistic回归方法比较2组疗效是否存在差异。结果:在未控制混杂因素的情况下,2组有效率差异有统计学意义(P<0.05)。分别通过3种Logistic回归分析方法进行分析,均显示回归系数大于0,且差异有统计学意义(P<0.05)。结论:使用鹿瓜多肽注射液的骨关节炎患者与不使用鹿瓜多肽注射液的患者治疗结果差异有统计学意义,且观察组的治疗结果优于对照组。但鉴于回顾性研究可能存在大量未知的混杂因素,因此该结果仍有待于前瞻性研究进一步验证。

Objective:To compare the curative effect(improvement rate)of patients with osteoarthritis with or without cervus and cucumis polypeptide injection(CCPI).Methods:The study extracted data from the information management systems(hospital information system,HIS)of gradeⅢA hospital across the country.A total of 22,855 patients with osteoarthritis were collected.A total of 3071 patients were treated by CCPI as the experimental group while patients of the same number who did not use CCPI were assigned to the control group.The propensity score method was used to balance the confounding factors,and the 3 logistic regression methods were used to judge whether there was statistical difference.Results:The effect difference between the groups was statistically significant(P<0.05)when the confounding factors were not controlled.The result showed that the regression coefficient was greater than zero and the difference was statistically significant(P<0.05)through the 3 logistic regression analyses.Conclusion:The clinical effect of patients with arthritis who used CCPI is better than that of the patients who did not receive CCPI.However,considering the retrospective study may be a large number of unknown confounding factors,and the result remain to be confirmed through prospective studies.