盘龙七片治疗骨折早期的真实世界研究  

Real-World Study on the Treatment of Early Fractures with Panlongqi Tablets

作　　者：方诗元 覃健 张利勇 吴泽荣 郭团茂 董婷 徐玮 杨家赵 张春闩 王伟伟 何斌 冯琴琴 李程 夏泉 方先骏 蔡和平[13] 贾长军 徐喜卿 于明伟 黄承夸 孙超[18] 张红 张艳丽 陈磊[21] 刘斌[1] FANG Shiyuan;QIN Jian;ZHANG Liyong;WU Zerong;GUO Tuanmao;DONG Ting;XU Wei;YANG Jiazhao;ZHANG Chunshuan;WANG Weiwei;HE Bin;FENG Qinqin;LI Cheng;XIA Quan;FANG Xianjun;CAI Heping;JIA Changjun;XU Xiqing;YU Mingwei;HUANG Chengkua;SUN Chao;ZHANG Hong;ZHANG Yanli;CHEN Lei;LIU Bin(First Affiliated Hospital of University of Science and Technology of China,Hefei 230001,China;Sir Run Run Hospital Affiliated to Nanjing Medical University,Nanjing 211198,China;Yangzhou Traditional Chinese Medicine Hospital,Yangzhou 225100,Jiangsu China;Shenzhen Baoan Traditional Chinese Medicine Hospital,Shenzhen 518100,Guangdong China;Xianyang Central Hospital,Xianyang 712000,Shaanxi China;Fuyang Traditional Chinese Medicine Orthopedic Hospital,Hangzhou 311400,China;Lujiang County Hospital of Traditional Chinese Medicine,Hefei 231501,China;Nanjing Traditional Chinese Medicine Hospital,Nanjing 210022,China;Second Affiliated Hospital of Nanjing Medical University,Nanjing 210003,China;W521 Hospital of the Ordnance Industry,Xi'an 710065,China;The Affiliated Hospital of Northwest University(Xi'an No.3 Hospital),Xi'an 710018,China;First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Anhui Children's Hospital,Hefei 230011,China;The Second People's Hospital of Huludao,Huludao 125060,Liaoning China;Zibo Central Hospital,Zibo 255020,Shandong China;Yuhuangding Hospital,Yantai 264000,Shandong China;The Southwest Hospital Affiliated to Youjiang Medical University for Nationalities and Baise People's Hospital,Baise 533000,Guangxi China;Second Hospital of Shandong University,Jinan 250013,China;Gaochun People's Hospital,Nanjing 211300,China;Songjiang Central Hospital,Shanghai 201600,China;China Pharmaceutical University,Naniing 211198,China)

机构地区：[1]中国科学技术大学附属第一医院,合肥230001 [2]南京医科大学附属逸夫医院 [3]扬州市中医院 [4]深圳宝安中医院 [5]咸阳中心医院 [6]杭州市富阳中医骨伤医院 [7]庐江县中医院 [8]南京市中医院 [9]南京医科大学第二附属医院 [10]兵器工业五二一医院 [11]西北大学附属医院(西安市第三医院) [12]安徽医科大学第一附属医院 [13]安徽省儿童医院 [14]葫芦岛市第二人民医院 [15]淄博中心医院 [16]烟台毓璜顶医院 [17]右江民族医学院附属西南医院暨百色市人民医院 [18]山东大学第二医院 [19]南京市高淳人民医院 [20]上海市松江中心医院 [21]中国药科大学

出　　处：《中国中医骨伤科杂志》2025年第3期48-55,63,共9页Chinese Journal of Traditional Medical Traumatology & Orthopedics

摘　　要：目的:基于真实世界研究评价盘龙七片对比接骨七厘片治疗骨折的有效性和安全性。方法:研究纳入20余家入组医院2021年9月至2023年9月期间6 654例骨折早期患者,依据中西医骨折诊断标准分为观察组患者3 706例,对照组患者2 948例。观察组在常规治疗础上联用盘龙七片,对照组在常规治疗基础上联用接骨七厘片。通过电话回访收集骨折后第1,4,7,14天的患者自报告指标,将疼痛评分改善值、肿胀评分改善值、EQ-5D评分改善值作为疗效指标,将药物不良反应作为安全性指标。采用倾向匹配得分法(PSM)对患者年龄、性别、骨折部位、骨折严重程度、手术类型、联合用药等指标进行基线匹配,最后对各疗效指标进行统计分析。结果:观察组(A组)患者的疼痛评分差异有统计学意义(PSM后4.761比4.617,P<0.01),降低效果显著;肿胀分级评分差异有统计学意义(PSM后2.984比2.697,P<0.01),降低效果显著;效用值改善效果显著,差异有统计学意义(PSM后0.430比0.406,P<0.01);有效率改善效果显著,差异有统计学意义(PSM后87.20%比80.57%,P<0.01)。安全性方面,两组均无严重不良反应,不良反应率都低于1%,差异无统计学意义(P>0.01)。结论:盘龙七片在改善骨折患者疼痛、肿胀、效用值和有效率方面均显著优于接骨七厘片,安全性较好。Objective:To evaluate the effectiveness and safety of Panlongqi tablets and Jiegu Qili tablets in the treatment of fractures based on real-world research.Methods:The study enrolled 6 654 early-stage fracture patients across more than 20 participating hospitals from September 2021 to September 2023.According to the diagnostic criteria for fractures in both traditional Chinese and Western medicine,3 706 patients were assigned to the observation group,while 2 948 patients were assigned to the control group.The control group received routine care combined with Jiegu Qili tablets,whereas the observation group received routine care combined with Panlongqi tablets.Patient-reported outcomes were collected via telephone follow-up at 1,4,7,and 14 d post-fracture.Improvement in pain scores,swelling scores,and EQ-5D scores served as efficacy indicators,while adverse drug reactions were monitored as safety indicators.The propensity score matching(PSM) method was utilized to ensure baseline comparability among patients based on age,gender,fracture location,fracture severity,surgical type,and concomitant therapies.Subsequently,statistical analyses were conducted on each efficacy indicator.Results:The observation group showed a significant decrease in pain score(4.761 vs 4.617 after PSM,P<0.01),swelling grading score(2.984 vs 2.697 after PSM,P<0.01),improvement in utility value(0.430 vs 0.406 after PSM,P<0.01),and effective improvement of the effect(87.20% vs 80.57% after PSM,P<0.01) compared to the control group.In terms of safety,there were no serious adverse reactions in the two groups,and the adverse reaction rate was less than 1%,and the difference was not statistically significant.Conclusion:Panlongqi tablets is significantly better than Jiegu Qili tablets in improving pain,swelling,utility value,and effective rate in patients with fractures,and has good safety.

关 键 词：真实世界研究 早期骨折 倾向匹配得分法 患者报告结局 健康相关生命质量 

分 类 号：R683[医药卫生—骨科学]