刘兴兴 黎元元 魏戌

摘要 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22 855例，最终纳入3 071例使用鹿瓜多肽注射液的患者为鹿瓜多肽观察组，3 071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。

关键词 鹿瓜多肽;骨关节炎;真实世界;倾向性评分;Logistic回归分析;混杂因素;效应量;疗效

Abstract 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 grade ⅢA hospital across the country.A total of 22，855 patients with osteoarthritis were collected.A total of 3 071 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.

Keywords Cervus and cucumis polypeptide injection; Osteoarthritis; Real world; Propensity score; Logistic regression analysis; Mixed factors; Effect size; Efficacy

中圖分类号：R274.9;R684.3文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.07.020

骨关节炎（Osteoarthritis，OA）是一种以软骨退行性改变为特征的慢性关节疾病，常伴有疼痛、功能障碍和残疾[1]，严重威胁人类健康和影响人们的生命质量，给社会带来沉重的负担[2-4]。《素问·痹论》指出：“风寒湿三气杂至，合而为痹也。”[5]OA特点为“本虚标实”，肾虚为本，外感风寒湿邪为标，临床上常以补肝肾、强筋骨、补益气血治其本，祛风散寒除湿、活血通络止痛治其标[6]。

鹿瓜多肽注射液是一种复方制剂[7]，主要成分是鹿骨和甜瓜的干燥种子，提取后可改善微循环和调节骨代谢。本品中的鹿骨可以诱导多肽类生物因子，继而有效促进骨形成和骨源性生长因子合成[8];甜瓜籽提取物可使骨折局部组织的毛细血管通透性下降，减轻局部疼痛，改善局部组织血供，还可以降低全血黏度，为新骨形成提供稳定的供血环境[9]。……