Evaluation of clinical evidence and value of <italic style="font-style: italic">Compound Danzhi Tablets</italic> in treatment of cerebral infarction with <italic style="font-style: italic">qi</italic> deficiency and blood stasis syndrome

LI Fei; WANG Fengchen; WANG Yaxing; DU Ying; XIE Yanming; LI Yuanyuan

doi:10.16025/j.1674-1307.2025.09.024

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Evaluation of clinical evidence and value of Compound Danzhi Tablets in treatment of cerebral infarction with qi deficiency and blood stasis syndrome

更新时间：2025-11-25

- Evaluation of clinical evidence and value of Compound Danzhi Tablets in treatment of cerebral infarction with qi deficiency and blood stasis syndrome
- Beijing Journal of Traditional Chinese Medicine Vol. 44, Issue 9, Pages: 1199-1206(2025)
- 作者机构：
  
  1.中国中医科学院广安门医院济南医院济南市中医医院脑病科，济南 250012
  2.中国中医科学院中医临床基础医学研究所，北京 100700
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2025.09.024
  CLC：
- Received：08 December 2024，
  
  Published：25 September 2025
- 稿件说明：
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李菲，王凤晨，王雅星，等.复方丹蛭片治疗脑梗死气虚血瘀证的临床证据评价与价值评估［J］.北京中医药，2025，44（9）：1199-1206.

LI Fei,WANG Fengchen,WANG Yaxing,et al.Evaluation of clinical evidence and value of Compound Danzhi Tablets in treatment of cerebral infarction with qi deficiency and blood stasis syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(09):1199-1206.
李菲，王凤晨，王雅星，等.复方丹蛭片治疗脑梗死气虚血瘀证的临床证据评价与价值评估［J］.北京中医药，2025，44（9）：1199-1206. DOI： 10.16025/j.1674-1307.2025.09.024.

LI Fei,WANG Fengchen,WANG Yaxing,et al.Evaluation of clinical evidence and value of Compound Danzhi Tablets in treatment of cerebral infarction with qi deficiency and blood stasis syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(09):1199-1206. DOI： 10.16025/j.1674-1307.2025.09.024.

摘要

目的

评估复方丹蛭片治疗脑梗死气虚血瘀证的临床证据与价值，明确其临床优势。

方法

以循证医学证据为主，综合卫生技术评估、真实世界研究、药物经济学评价等多种研究方法，围绕安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色“6+1”维度进行数据采集，经定性及定量相结合的证据整合分析，应用多准则决策分析（MCDA）模型与CSC v2.0软件综合评价其临床价值。

结果

①安全性：根据不良反应中心自发呈报系统数据、文献研究、临床研究等资料，复方丹蛭片的不良反应主要表现为口干、恶心、腹痛等消化系统不良反应，未见明显严重不良反应，已知风险小，临床应用相对安全。②有效性：复方丹蛭片能改善中风后综合功能，提高患者生活质量，联合常规疗法治疗脑梗死后遗症的临床疗效方面优于常规治疗。③经济性：经成本-效果分析表明，复方丹蛭片联合常规治疗方案成本较高，但在脑梗死气虚血瘀证治疗方面，临床应用复方丹蛭片联合常规治疗方案更具有经济性，经济性证据支持充分。④创新性：复方丹蛭片在活血化瘀的基础上，又兼益气通络之功，且在综合工艺、奖项和产业创新等方面，创新性较好。⑤适宜性：复方丹蛭片储运方便，基本满足临床用药需求，适宜性好。⑥可及性：药品价格水平偏低，可负担性较好，但可获得性一般，总体可及性较好。⑦中医药特色：复方丹蛭片处方来源于名老中医姚学善的临床有效经验方，基于经典名方“补阳还五汤”变方加减，具备中医药理论特色，但人用经验研究不足，总体中医药特色较突出。

结论

复方丹蛭片治疗脑梗死气虚血瘀证具有较高的临床价值，且临床证据充足。

Abstract

Objective

To evaluate the clinical evidence and value of

Compound Danzhi Tablets

in the treatment of cerebral infarction with

deficiency and blood stasis syndrome， and to clarify its clinical advantages.

Method

This study primarily relied on evidence-based medicine and integrated multiple research methods， including health technology assessment， real-world research， and pharmacoeconomic evaluation. Data were collected across the "6+1" dimensions： safety， effectiveness， economy， innovation， suitability， accessibility， and characteristics of traditional Chinese medicine （TCM）. Data were analyzed using qualitative and quantitative evidence integration， and clinical value was comprehensively evaluated using the Multi-Criteria Decision Analysis （MCDA） model and CSC v2.0 software.

Result

① Safety： According to the Spontaneous Reporting System （SRS）， literature studies， clinical research， and other sources， adverse reactions of

Compound Danzhi Tablets

mainly involved the digestive system， including dry mouth， nausea， and abdominal pain. No significant serious adverse reactions were observed， and known risks were low， indicating relative clinical safety. ② Effectiveness：

Compound Danzhi Tablets

can improve post-stroke comprehensive function and enhance patients' quality of life. When combined with conventional therapy， their clinical efficacy in treating the sequelae of cerebral infarction is superior to

conventional therapy alone. ③ Economy： Cost-effectiveness analysis showed that while the cost of combining

Compound Danzhi Tablets

with conventional therapy is higher， this combination is more economical for treating cerebral infarction with

deficiency and blood stasis， and economic evidence is well supported. ④ Innovation： In addition to promoting blood circulation and removing blood stasis，

Compound Danzhi Tablets

also benefit

and dredge collaterals. Innovation is notable in terms of comprehensive production process， awards， and industrial advancement. ⑤ Suitability：

Compound Danzhi Tablets

are convenient for storage and transportation， meet clinical medication needs， and show good suitability. ⑥ Accessibility： The drug has a relatively low price with good affordability. Overall accessibility is favorable， though availability is average. ⑦ Characteristics of TCM： The prescription is derived from the clinical empirical formula of YAO Xueshan， based on modifications of the classical

Buyang Huanwu Decoction

. It retains the theoretical characteristics of TCM， although human experience studies are limited.

Conclusion

Compound Danzhi Tablets

demonstrate high clinical value in the treatment of cerebral infarction with

deficiency and blood stasis syndrome， with sufficient clinical evidence supporting their use.

关键词

Keywords

references

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Evaluation of clinical evidence and value of Compound Danzhi Tablets in treatment of cerebral infarction with qi deficiency and blood stasis syndrome

DOI：10.16025/j.1674-1307.2025.09.024

摘要

Abstract

关键词

Keywords

references