摘要
目的 基于真实世界数据评价盘龙七片治疗骨折的有效性和安全性.方法 回顾性收集全国33家医疗机构2021年9月至2023年9月期间收治的骨折患者,将接受常规治疗的患者纳入对照组(n=3 750),将在常规治疗基础上联用盘龙七片的患者纳入观察组(n=3 706).通过电话回访收集治疗0、4、7、14d的患者自报告指标,比较两组患者的疼痛评分改善值、肿胀评分改善值、生命质量效用值改善值、有效率和安全性.使用倾向评分匹配法对患者的年龄、性别、骨折部位、骨折严重程度、手术类型、医院类型等指标进行基线匹配,对各疗效指标进行统计分析.结果 匹配后,共纳入患者6 425例,其中观察组3 055例,对照组3 370例.治疗14 d后,观察组患者在疼痛评分(4.768 vs.4.353)、肿胀分级评分(2.979 vs.2.391)、生命质量效用值(0.430 vs.0.363)和有效率(87.20％vs.75.99％)的改善方面均显著优于对照组(P＜0.05).按性别、年龄、医院类型和骨折部位进行的亚组分析结果与上述结果一致.安全性方面,观察组未见严重不良反应,共有29例头晕、胃痛、过敏等轻微不良反应,发生率为0.78％.结论 盘龙七片联合常规治疗在改善骨折患者疼痛、肿胀、生命质量和有效率方面均显著优于常规治疗,安全性较好.
Abstract
OBJECTIVE To evaluate the effectiveness and safety of Panlongqi tablets in the treatment of fractures based on real-world research.METHODS From September 2021 to September 2023,fracture patients admitted to 33 medical institutions were collected retrospectively.Patients who received conventional treatment were divided into control group(n=3 750),and patients who received combination of Panlongqi tablets on the basis of conventional treatment were divided into observation group(n=3 706).Self-reported indicators of patients were collected through telephone follow-up at 0,4,7 and 14 days after treatment.The improvement values of pain score,swelling score and health utility value,as well as effective rate and adverse drug reactions were compared between 2 groups.The propensity matching score(PSM)method was adopted to perform baseline matching on patient's age,gender,fracture site,fracture severity,surgical type,type of hospital,and other indicators.Statistical analysis was performed on each therapeutic effect indicator.RESULTS After PSM,a total of 6 425 patients were included,of which 3 055 were in the observation group and 3 370 were in the control group.After 14 days of treatment,the observation group showed significant improvement in pain score(4.768 vs.4.353),swelling grading score(2.979 vs.2.391),and life quality utility value(0.430 vs.0.363),as well as effective rate(87.20％vs.75.99％)compared to the control group(P＜0.05).The results of subgroup analyses conducted by gender,age,hospital type,and fracture site were consistent with the aforementioned results.In terms of safety,the observation group had no serious adverse reactions,with a total of 29 cases of mild adverse reactions such as dizziness,stomach pain,and allergies,with an incidence rate of 0.78％.CONCLUSIONS Panlongqi tablets combined with conventional treatment are significantly better than conventional treatment in improving pain,swelling,quality of life,and effective rate in patients with fractures,and have good safety.
维普
万方数据