1.Expert Consensus on Clinical Application of Qidong Yixin Oral Liquid
Changkuan FU ; Xiaochang MA ; Mingjun ZHU ; Yue DENG ; Hongxu LIU ; Mingxue ZHANG ; Ying CHEN ; Yan ZHOU ; Ling ZHANG ; Jianhua FU ; Wei YANG ; Yu'er HU ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):147-158
The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis (VMC). It has the functions of tonifying Qi, nourishing the heart,calming the mind, and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However,the understanding of its efficacy evidence, advantageous aspects, dosage and administration, and medication safety remains insufficient in clinical practice. Therefore,the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid (hereinafter referred to as consensus) was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine,successively completing multiple tasks such as the consensus project initiation,determination of clinical problems,evidence search and evaluation,formation of recommendation opinions and consensus suggestions,solicitation of opinions,peer review, submission for review and release, and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions,clarifying the clinical positioning,efficacy advantages,syndrome differentiation,dosage and administration,combination therapy,timing of medication,adverse reactions,contraindications, and precautions of Qidong Yixin oral liquid,indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease,providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23, 2024. Standard number:GSCACM-376-2024.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
4.Expert Consensus on Clinical Application of Ruyi Zhenbaowan
Ming CHEN ; Jingling CHANG ; Shangquan WANG ; Gejia ZHONG ; Qiang DENG ; Hongxia CHEN ; Qien LI ; Yaming LIN ; Zujian XU ; Changkuan FU ; Yuer HU ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):173-183
Osteoarthritis (OA) and stroke are common clinical diseases that reduce patients' quality of life and place a burden on families and society. Ruyi Zhenbaowan, a classic prescription in Tibetan medicine, have the functions of clearing heat, awakening the brain and opening orifices, relaxing tendons and promoting meridian circulation, and eliminating yellow water. Clinically, they are used to treat osteoarthritis, post-stroke sequelae, neuropathic pain, and other related conditions. Modern pharmacological studies have demonstrated their anti-inflammatory, analgesic, and nerve-repairing effects. However, current research remains insufficient regarding the appropriate indications, timing, and efficacy of this medicine in treating relevant diseases. To enhance clinicians' understanding of this medicine and promote its standardized and rational clinical use, a panel of national experts, including clinical specialists, Tibetan medicine practitioners, pharmacologists, and methodologists, formulated this consensus based on clinical experience and evidence-based practice. The Cochrane systematic review framework, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, and the nominal group method were employed to generate seven graded recommendations and 19 consensus-based suggestions. These recommendations clearly define the key points in the clinical application of Ruyi Zhenbaowan, including therapeutic indications, dosage and administration, treatment duration, and medication safety. The consensus specifically addresses the clinical efficacy, appropriate timing of administration, dosage strategies, treatment cycles, and combination medication strategies for treating osteoarthritis and stroke and provides an overview of safety considerations. The aim is to provide standardized guidance for hospitals and healthcare institutions nationwide to ensure the rational application of Ruyi Zhenbaowan in the treatment of osteoarthritis and stroke, reduce medication-related risks, and further leverage its clinical advantages. This consensus has been approved and issued by the China Association of Chinese Medicine, with the standard number GS/CACM 369-2024.
5.Radiofrequency ablation of intra-articular venous malformations of the knee joint
Junbo QIAO ; Junjie LIN ; Junhua LI ; Dexin ZHANG ; Bin FANG ; Xiaodi LI ; Changkuan CHEN ; Hongye YU
Chinese Journal of Plastic Surgery 2021;37(2):166-170
Objective:To investigate the outcomes of therapeutic radiofrequency ablation (RFA) in unilateral intra-articular venous malformations (IAVMs) of the knee.Methods:The clinical data of 15 patients with intravascular venous malformation in the Third Affiliated Hospital of Zhengzhou University from February 2018 to May 2019 were retrospectively analyzed. There were 7 males and 8 females with an average age of 16 years (range, 5—25 years). All patients had unilateral knee involvement, ranging from localized lesions to diffuse extensive lesions. The radiofrequency ablation electrode needle with a diameter of 0.5 mm was selected and the power was adjusted to 25 W. Under the guidance of color ultrasound monitoring, the whole operation was carried out. The RFA electrode needle was inserted into the deepest site of the lesion and extracted by 1-mm graded movements until a point 1 mm from the surface of the lesion. Each ablation point was ablated for 10 to 30 seconds and multi-point ablation was done until the lesions were completely eliminated. Patients were followed up for 6 months to 1 year. Treatment outcomes were evaluated by functional activity, including extension, flexion, abduction, and adduction at the knee joint, and MRI findings, including intensity, shape, boundary, and degree of aggressiveness in the intra- and extraarticular cavities.Results:Included 15 patients; 12 had VMs in the knee joint cavity, and 3 had VMs involving both the intraarticular and extraarticular cavities (1 from the joint cavity to the calf, 1 from the joint cavity to the lower femur, and 1 from the intraarticular to the extraarticular cavity). All subjects underwent RFA, and the lesions were completely ablated and eradicated in a single operation. No recurrence was reported in the 6 months to 1 year follow-up. The knee joint remained symmetrical with the contralateral knee joint, without scarring, after the RFA.Conclusions:Radiofrequency ablation for the treatment of intra-articular venous malformation of the knee joint is a valuable minimally invasive surgical method with complete ablation, no complications, good prognosis and aesthetic appearance.
6.Minimally invasive radiofrequency ablation for Kasabach-Merritt phenomenon
Junbo QIAO ; Junjie LIN ; Haoran ZHANG ; Wenqiu WANG ; Dexin ZHANG ; Junhua LI ; Bin FANG ; Yujiao WANG ; Changkuan CHEN ; Hongye YU
Chinese Journal of Plastic Surgery 2021;37(12):1345-1349
Objective:To evaluate the therapeutic effect of radiofrequency ablation in the treatment of severe hemangioma with thrombocytopenia and coagulation abnormality (Kasabach-Merritt phenomenon, KMP).Methods:From April 2018 to April 2021, 11 cases of KMP in our department were retrospectively analyzed. The patients underwent MRI, color ultrasound and hematology examination. Radiofrequency ablation was performed for all patients under general anesthesia. The comprehensive, multi-level and multi-point ablation was accurately implemented under the whole-process intraoperative monitoring of color ultrasound. Postoperative ice pad was applied for the treatment area, and dressing change was carried out every day.Results:All 11 cases of KMP were treated with radiofrequency ablation, including 5 males and 6 females, aged 1 d to 2 months, with a median age of 15 d. Intraoperative color Doppler ultrasound monitoring showed that the tumor was completely ablated in the single operation. All patients were followed up for 0.5 to 2 years. The tumor was cured without recurrence. The local function was unaffected. The local scar formation was mild and the appearance was satisfactory.Conclusions:Radiofrequency ablation has great clinical value in the treatment of KMP. It makes up the shortcomings and avoids the disadvantages of traditional surgery and other conservative treatment methods. Good clinical results can be achieved by radiofrequence ablation with satifactory function and appearance.
7.Radiofrequency ablation of intra-articular venous malformations of the knee joint
Junbo QIAO ; Junjie LIN ; Junhua LI ; Dexin ZHANG ; Bin FANG ; Xiaodi LI ; Changkuan CHEN ; Hongye YU
Chinese Journal of Plastic Surgery 2021;37(2):166-170
Objective:To investigate the outcomes of therapeutic radiofrequency ablation (RFA) in unilateral intra-articular venous malformations (IAVMs) of the knee.Methods:The clinical data of 15 patients with intravascular venous malformation in the Third Affiliated Hospital of Zhengzhou University from February 2018 to May 2019 were retrospectively analyzed. There were 7 males and 8 females with an average age of 16 years (range, 5—25 years). All patients had unilateral knee involvement, ranging from localized lesions to diffuse extensive lesions. The radiofrequency ablation electrode needle with a diameter of 0.5 mm was selected and the power was adjusted to 25 W. Under the guidance of color ultrasound monitoring, the whole operation was carried out. The RFA electrode needle was inserted into the deepest site of the lesion and extracted by 1-mm graded movements until a point 1 mm from the surface of the lesion. Each ablation point was ablated for 10 to 30 seconds and multi-point ablation was done until the lesions were completely eliminated. Patients were followed up for 6 months to 1 year. Treatment outcomes were evaluated by functional activity, including extension, flexion, abduction, and adduction at the knee joint, and MRI findings, including intensity, shape, boundary, and degree of aggressiveness in the intra- and extraarticular cavities.Results:Included 15 patients; 12 had VMs in the knee joint cavity, and 3 had VMs involving both the intraarticular and extraarticular cavities (1 from the joint cavity to the calf, 1 from the joint cavity to the lower femur, and 1 from the intraarticular to the extraarticular cavity). All subjects underwent RFA, and the lesions were completely ablated and eradicated in a single operation. No recurrence was reported in the 6 months to 1 year follow-up. The knee joint remained symmetrical with the contralateral knee joint, without scarring, after the RFA.Conclusions:Radiofrequency ablation for the treatment of intra-articular venous malformation of the knee joint is a valuable minimally invasive surgical method with complete ablation, no complications, good prognosis and aesthetic appearance.
8.Minimally invasive radiofrequency ablation for Kasabach-Merritt phenomenon
Junbo QIAO ; Junjie LIN ; Haoran ZHANG ; Wenqiu WANG ; Dexin ZHANG ; Junhua LI ; Bin FANG ; Yujiao WANG ; Changkuan CHEN ; Hongye YU
Chinese Journal of Plastic Surgery 2021;37(12):1345-1349
Objective:To evaluate the therapeutic effect of radiofrequency ablation in the treatment of severe hemangioma with thrombocytopenia and coagulation abnormality (Kasabach-Merritt phenomenon, KMP).Methods:From April 2018 to April 2021, 11 cases of KMP in our department were retrospectively analyzed. The patients underwent MRI, color ultrasound and hematology examination. Radiofrequency ablation was performed for all patients under general anesthesia. The comprehensive, multi-level and multi-point ablation was accurately implemented under the whole-process intraoperative monitoring of color ultrasound. Postoperative ice pad was applied for the treatment area, and dressing change was carried out every day.Results:All 11 cases of KMP were treated with radiofrequency ablation, including 5 males and 6 females, aged 1 d to 2 months, with a median age of 15 d. Intraoperative color Doppler ultrasound monitoring showed that the tumor was completely ablated in the single operation. All patients were followed up for 0.5 to 2 years. The tumor was cured without recurrence. The local function was unaffected. The local scar formation was mild and the appearance was satisfactory.Conclusions:Radiofrequency ablation has great clinical value in the treatment of KMP. It makes up the shortcomings and avoids the disadvantages of traditional surgery and other conservative treatment methods. Good clinical results can be achieved by radiofrequence ablation with satifactory function and appearance.
9.Minimally invasive radiofrequency ablation for severe lymphatic vascular malformations in tongue
Junbo QIAO ; Junjie LIN ; Dexin ZHANG ; Junhua LI ; Bin FANG ; Xiaodi LI ; Changkuan CHEN ; Hongye YU
Chinese Journal of Plastic Surgery 2020;36(4):398-402
Objective:To investigate the effect of radiofrequency ablation in the treatment of severe tongue′s lymphatic vascular malformation, and evaluate the value and aesthetics of the operation.Methods:The 33 cases′ data of lingual lymphatic vascular malformation from February 2018 to February 2019 in Department of Hemangioma Surgery of Third Affiliated Hospital of Zhengzhou University were analyzed retrospectively. There were 18 males and 15 females, aged from 1 month to 50 years old, with a median age of 5 years. From unilateral lesions to diffuse and extensive lesions, 33 of them received radiofrequency ablation.24 cases were unilateral and 9 cases were bilateral. 18G radiofrequency ablation needle was selectedwithworking tip diameter of 1mm and heating 5 mm tip , and the power was adjusted to 25 W. Monitoring by color Doppler ultrasound, the working tip was inserted into the bottom of the lesion part which is about 1 mm from the deepest part. The ablation was performed for 5-20 s after being electrified. Then the electrode needle was withdrawn 1 mm in turn until it was 1 mm from the lesion surface, and respectively performed multi-point ablation withinterval of 5 mm.Results:One-stage radiofrequency ablation was performed in 24 patients with unilateral lesions and 9 patients with bilateral lesions. One-stage radiofrequency ablation was performed in one side of the lesions. After three to six months later, two-stage radiofrequency ablation was performed in most of the lesions. 33 cases were followed up from 6 months to 2 years.18 cases of unilateral lesions and 6 cases of bilateral lesions had no recurrence, and the tongue was symmetrical on both sides; 9 cases of full-thickness involvement of the tongue (6 cases on one side and 3 cases on both sides) had a small amount of lesions near the lingual artery, which were asymptomatic, nearly cured, without obvious scars, and satisfactory in appearance.Conclusions:Radiofrequency ablation is an important supplement for the treatment of lingual lymphatic vascular malformation, which makes up for the shortcomings of traditional surgery. Clinically, it can primarily achieve the treatment′s goal, with unobvious complication and aesthetical outcome.
10.Minimally invasive radiofrequency ablation for severe lymphatic vascular malformations in tongue
Junbo QIAO ; Junjie LIN ; Dexin ZHANG ; Junhua LI ; Bin FANG ; Xiaodi LI ; Changkuan CHEN ; Hongye YU
Chinese Journal of Plastic Surgery 2020;36(4):398-402
Objective:To investigate the effect of radiofrequency ablation in the treatment of severe tongue′s lymphatic vascular malformation, and evaluate the value and aesthetics of the operation.Methods:The 33 cases′ data of lingual lymphatic vascular malformation from February 2018 to February 2019 in Department of Hemangioma Surgery of Third Affiliated Hospital of Zhengzhou University were analyzed retrospectively. There were 18 males and 15 females, aged from 1 month to 50 years old, with a median age of 5 years. From unilateral lesions to diffuse and extensive lesions, 33 of them received radiofrequency ablation.24 cases were unilateral and 9 cases were bilateral. 18G radiofrequency ablation needle was selectedwithworking tip diameter of 1mm and heating 5 mm tip , and the power was adjusted to 25 W. Monitoring by color Doppler ultrasound, the working tip was inserted into the bottom of the lesion part which is about 1 mm from the deepest part. The ablation was performed for 5-20 s after being electrified. Then the electrode needle was withdrawn 1 mm in turn until it was 1 mm from the lesion surface, and respectively performed multi-point ablation withinterval of 5 mm.Results:One-stage radiofrequency ablation was performed in 24 patients with unilateral lesions and 9 patients with bilateral lesions. One-stage radiofrequency ablation was performed in one side of the lesions. After three to six months later, two-stage radiofrequency ablation was performed in most of the lesions. 33 cases were followed up from 6 months to 2 years.18 cases of unilateral lesions and 6 cases of bilateral lesions had no recurrence, and the tongue was symmetrical on both sides; 9 cases of full-thickness involvement of the tongue (6 cases on one side and 3 cases on both sides) had a small amount of lesions near the lingual artery, which were asymptomatic, nearly cured, without obvious scars, and satisfactory in appearance.Conclusions:Radiofrequency ablation is an important supplement for the treatment of lingual lymphatic vascular malformation, which makes up for the shortcomings of traditional surgery. Clinically, it can primarily achieve the treatment′s goal, with unobvious complication and aesthetical outcome.

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