摘要
跌打活血胶囊源于1995年版《中华人民共和国药典》收载的跌打活血散,为江西远超医药科技有限公司独家品种,属医保乙类中成药,具有舒筋活血、散瘀止痛功效,临床用于跌打损伤、瘀血疼痛、闪腰岔气等。鉴于其临床应用的中医证候、疗效及安全性证据尚不充分,且缺乏相应的临床专家共识,该研究遵循循证医学原则,组织全国33名循证医学、骨伤科及药学专家,采用名义组法、问卷调查等方法,依据推荐分级的评估、制定与评价(GRADE)分级标准制定《跌打活血胶囊临床应用专家共识》(以下简称《共识》)。该《共识》明确了跌打活血胶囊临床应用的疾病分期、证候特点、疗程、剂量、合并用药、使用建议、用药禁忌和注意事项等的规范,适用于医疗卫生机构的相关人员。针对19个临床问题形成3条推荐意见和16条共识建议,涵盖:①适应证与证候:中医主治跌打损伤等,对应西医软组织挫伤、急性腰扭伤等,中医证候为血瘀证;②用法用量:口服每次6粒、每日2次,外用需与黄酒/醋调敷(闭合性损伤),轻、重症疗程分别为2~4周和4~6周,老年人需间隔停药;③联合用药:中重症可联合非甾体抗炎药、糖皮质激素等,需监测不良反应;④安全性:常见皮疹、胃肠不适等,禁用于孕妇、严重胃溃疡及皮肤破损者,避免与抗凝药联用。现代研究显示,该药可减轻气滞血瘀型老年骨质疏松性骨折疼痛,促进骨折愈合,改善骨代谢;对骨折后疼痛及骨关节炎的肿、痛消除亦有良好效果。该《共识》为促进临床合理使用跌打活血胶囊,提高疗效及降低用药风险提供了科学依据,后续将根据研究进展动态修订。
Dieda Huoxue capsules are derived from Dieda Huoxue powder,as recorded in the Pharmacopoeia of the People's Republic of China.Developed exclusively by Jiangxi Yuanchao Medical Technology Co.,Ltd.,they are classified as a Class B Chinese patent medicine covered by medical insurance.The capsules possess the effects of soothing the tendons and promoting blood circulation,dispersing blood stasis,and relieving pain.Clinically,they are used for the treatment of traumatic injuries,pain due to blood stasis,acute lumbar sprains,and chest qi stagnation.Given the current lack of sufficient clinical evidence regarding the traditional Chinese medicine(TCM)syndromes,efficacy,and safety of this product,and in the absence of corresponding expert consensus,this study was conducted in accordance with the principles of evidence-based medicine.A panel of 33 national experts in evidence-based medicine,orthopedics and traumatology,and pharmacy was organized.Using methods such as the nominal group technique and questionnaire surveys,and based on the Grading of Recommendations Assessment,Development,and Evaluation(GRADE)system,the Expert Consensus on the Clinical Application of Dieda Huoxue capsules(hereinafter referred to as the"Consensus")was developed.The Consensus clearly defines the standardized clinical application of Dieda Huoxue capsules,including disease staging,syndrome characteristics,treatment duration,dosage,combination therapy,usage recommendations,contraindications,and precautions.It is intended for relevant personnel in medical and health institutions.Based on 19 clinical questions,the Consensus proposes 3 graded recommendations and 16 consensus-based suggestions,covering the following aspects.①Indications and syndromes:In TCM,it is mainly used for traumatic injuries,corresponding to soft tissue contusions,acute lumbar sprains,etc.,in Western medicine.The primary TCM syndrome is blood stasis.②Administration and dosage:For oral administration,the recommended dosage is 6 capsules per dose,twice daily.For external application(limited to closed injuries),the capsule contents may be mixed with yellow rice wine or vinegar(1∶2 ratio)and applied as a topical paste.The treatment course is 2-4 weeks for mild cases and 4-6 weeks for severe cases.In elderly patients,drug holidays between treatment cycles are recommended.③Combination therapy:For moderate to severe cases,Dieda Huoxue capsules can be combined with non-steroidal anti-inflammatory drugs(NSAIDs),glucocorticoids,etc.,with monitoring for adverse reactions.④Safety:Common adverse reactions include rash and gastrointestinal discomfort.The capsules are contraindicated in pregnant women,individuals with severe gastric ulcers,and patients with open wounds.Concurrent use with anticoagulants should be avoided.Modern research has shown that this medicine can alleviate pain from osteoporotic fractures in elderly patients with Qi stagnation and blood stasis syndromes,promote fracture healing,and improve bone metabolism.They have also demonstrated good efficacy in relieving swelling and pain associated with post-fracture conditions and osteoarthritis.This consensus provides a scientific foundation for promoting the rational clinical use of Dieda Huoxue capsules,improving therapeutic outcomes,and reducing medication-related risks.It will be dynamically revised in accordance with future research advancements.
作者
崔鑫
高景华
纪泉
金今
程桯
李永耀
黎元元
冯敏山
谢雁鸣
CUI Xin;GAO Jinghua;JI Quan;JIN Jin;CHENG Ting;LI Yongyao;LI Yuanyuan;FENG Minshan;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China;Beijing Hospital,Beijing 100005,China;Peking Union Medical College Hospital,Beijing 100006,China)
出处
《中国实验方剂学杂志》
北大核心
2025年第19期54-61,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家中医药管理局2021歧黄学者支持项目(国家中医药人教函[2022]6)
谢雁鸣全国名老中医药专家传承工作室建设项目(国家中医药人教函[2022]75)
国家重点研发计划项目(2018YFC1707400)。
关键词
专家共识
跌打活血胶囊
临床应用
骨伤科
expert consensus
Dieda Huoxue capsules
clinical application
orthopedics and traumatology department
