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1.中国科学技术大学附属第一医院(安徽省立医院)创伤骨科,合肥;230001
2.南京医科大学附属逸夫医院骨科,南京 211198
3.扬州市中医院创伤中心,江苏 扬州 225100
4.深圳市宝安中医院骨伤科,广东 深圳 518100
5.咸阳中心医院医学检验科,陕西 咸阳 712000
6.杭州市富阳中医骨伤医院骨伤科,杭州 311499
7.中国药科大学国际医药商学院,南京 211100
Received:27 June 2024,
Revised:2024-11-18,
Accepted:06 December 2024,
Published:30 December 2024
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方诗元,覃健,张利勇,等.盘龙七片治疗骨折的真实世界研究[J].中国药房,2024,35(24):3046-3051.
FANG Shiyuan,QIN Jian,ZHANG Liyong,et al.Real-world research on Panlongqi tablets in the treatment of fractures[J].ZHONGGUO YAOFANG,2024,35(24):3046-3051.
方诗元,覃健,张利勇,等.盘龙七片治疗骨折的真实世界研究[J].中国药房,2024,35(24):3046-3051. DOI: 10.6039/j.issn.1001-0408.2024.24.14.
FANG Shiyuan,QIN Jian,ZHANG Liyong,et al.Real-world research on Panlongqi tablets in the treatment of fractures[J].ZHONGGUO YAOFANG,2024,35(24):3046-3051. DOI: 10.6039/j.issn.1001-0408.2024.24.14.
目的
2
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
2
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、14 d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
2
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
2
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。
OBJECTIVE
2
To evaluate the effectiveness and safety of Panlongqi tablets in the treatment of fractures based on real-world research.
METHODS
2
From September 2021 to September 2023, fracture patients admitted to 33 medical institutions were collected retrospectively. Patients who received conventional treatment wer
e 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
2
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
2
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.
乔洪杰 , 郝延科 , 李学锋 , 等 . 骨科学 [M ] . 北京 : 中医古籍出版社 , 2009 : 1 - 3 .
QIAO H J , HAO Y K , LI X F , et al . Orthopedics [M ] . Beijing : Ancient Books of Traditional Chinese Medicine Publishing House , 2009 : 1 - 3 .
崔爽爽 , 赵丽坤 , 马信龙 . 中国老年髋部骨折流行病学和疾病经济负担研究现状 [J ] . 中国中西医结合外科杂志 , 2020 , 26 ( 3 ): 567 - 570 .
CUI S S , ZHAO L K , MA X L . Research status of epidemiology and economic burden of hip fracture in the elderly in China [J ] . Chin J Surg Integr Tradit West Med , 2020 , 26 ( 3 ): 567 - 570 .
阿里木江·玉素甫 , 阿孜姑·玉素甫 , 阿不都拉·阿不来提 , 等 . 非甾体抗炎药应用于骨愈合期的疗效及安全性的Meta分析 [J ] . 实用临床医药杂志 , 2023 , 27 ( 21 ): 17 - 24 .
Alimujiang Yusufu , Azigu Yusufu , Abudula Abulahati , et al . Meta-analysis of the efficacy and safety of non-steroidal anti-inflammatory drugs in bone healing period [J ] . J Clin Med Pract , 2023 , 27 ( 21 ): 17 - 24 .
姜泉 , 王海隆 , 巩勋 , 等 . 类风湿关节炎病证结合诊疗指南:T/ CACM 1042—2017 [S/OL ] .( 2017-07-12 )[ 2021-02-03 ] . https://www.ttbz.org.cn/StandardManage/Detail/37253/ https://www.ttbz.org.cn/StandardManage/Detail/37253/ .
JIANG Q , WANG H L , GONG X , et al . Guidelines for the diagnosis and treatment of rheumatoid arthritis syndromes:T/ CACM 1042—2017 [S/OL ] .( 2017-07-12 )[ 2021-02-03 ] . https://www.ttbz.org.cn/StandardManage/Detail/37253/ https://www.ttbz.org.cn/StandardManage/Detail/37253/ .
王承德 . 中成药临床应用指南:风湿病分册 [M ] . 北京 : 中国中医药出版社 , 2017 : 261 - 273 .
WANG C D . Guidelines for the clinical application of proprietary Chinese medicines: rheumatological diseases [M ] . Beijing : China Publishing House of Traditional Chinese Medicine , 2017 : 261 - 273 .
毕胜 . 疼痛康复指南 [M ] . 北京 : 人民卫生出版社 , 2020 : 15 - 24 .
BI S . Guidelines for pain rehabilitation [M ] . Beijing : People’s Medical Publishing House , 2020 : 15 - 24 .
张力伟 . 临床路径释义:神经外科分册 [M ] . 北京 : 中国协和医科大学出版社 , 2015 : 64 - 65 .
ZHANG L W . Interpretation of clinical pathways:neurosurgery fascicle [M ] . Beijing : Peking Union Medical College Press , 2018 : 64 - 65 .
彭昊 , 汪喆 , 方洪松 . 盘龙七片治疗骨折的临床疗效观察 [J ] . 中国中医骨伤科杂志 , 2006 , 14 ( Suppl. 2 ): 154 - 155 .
PENG H , WANG Z , FANG H S . Clinical observation on treatment of fracture with Panlongqi tablets [J ] . Chin J Tradit Med Traumatol Orthop , 2006 , 14 ( Suppl. 2 ): 154 - 155 .
郑筱萸 . 中药新药临床研究指导原则:试行 [M ] . 北京 : 中国医药科技出版社 , 2002 : 338 - 356 .
ZHENG X Y . The guiding principles for clinical research of new traditional Chinese medicine: trial [M ] . Beijing : China Medical Science and Technology Press , 2002 : 338 - 356 .
国家中医药管理局 . 中医骨伤科病证诊断疗效标准 : ZY/T 001.9-1994 [S ] . 北京 : 国家中医药管理局 , 1994 : 1 .
National Administration of Traditional Chinese Medicine . Criteria of diagnosis and therapeutic effect of orthopaedic and traumatologic diseases and syndromes in traditional Chinese medicine : ZY/T 001.9-1994 [S ] . Beijing : National Administration of Traditional Chinese Medicine , 1994 : 1 .
中华医学会骨质疏松和骨矿盐疾病分会 . 中国骨质疏松症流行病学调查及“健康骨骼” 专项行动结果发布 [J ] . 中华骨质疏松和骨矿盐疾病杂志 , 2019 , 12 ( 4 ): 317 - 318 .
The Osteoporosis and Bone Mineral Salt Disease Branch of the Chinese Medical Association . Epidemiological investigation of osteoporosis in China and the release of the results of the special action of “healthy bones” [J ] . Chin J Osteoporos Bone Miner Res , 2019 , 12 ( 4 ): 317 - 318 .
徐展望 . 盘龙七片治疗Colles骨折复位后肿痛的临床观察 [J ] . 中国中医骨伤科杂志 , 2009 , 17 ( 8 ): 58 - 59 .
XU Z W . Clinical observation on treatment of swelling and pain after Colles fracture reduction with Panlongqi tablets [J ] . Chin J Tradit Med Traumatol Orthop , 2009 , 17 ( 8 ): 58 - 59 .
韦世钦 , 甘干达 . 盘龙七片治疗外伤性四肢骨折疗效观察 [J ] . 现代中西医结合杂志 , 2012 , 21 ( 34 ): 3802 - 3803 .
WEI S Q , GAN G D . Observation on therapeutic effect of Panlongqi tablets on traumatic limb fractures [J ] . Mod J Integr Tradit Chin West Med , 2012 , 21 ( 34 ): 3802 - 3803 .
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