1.Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin CUI ; Hongchun ZHANG ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xuefeng YU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):218-224
As an exclusive Miao medicine of Honwing Pharma (Guizhou) Co. Ltd., Yifei Zhike capsules are both a prescription drug and an over-the-counter (OTC) drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs, as well as relieving cough and reducing phlegm, Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis, pulmonary tuberculosis, and other diseases. However, there is insufficient understanding of their efficacy, suitable syndromes, and safety in clinical practice, with a lack of relevant expert consensus on clinical application. To standardize their clinical application, 30 experts from the fields of respiratory medicine, pharmacy, and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules (Consensus for short) through evidence-based medicine methods. The Consensus clarified the syndrome characteristics, disease stages, dosages, treatment courses, combined medication, and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis, it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients, increase the sputum smear conversion rate, and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections, Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile, recommendations for specific usage, dosages, and treatment courses were given for different diseases, and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety, the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions, and pregnant women and women during menstruation were prohibited from using it. In addition, modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However, further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules, which helps to improve clinical efficacy and reduce medication risks.
2.Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin CUI ; Hongchun ZHANG ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xuefeng YU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):218-224
As an exclusive Miao medicine of Honwing Pharma (Guizhou) Co. Ltd., Yifei Zhike capsules are both a prescription drug and an over-the-counter (OTC) drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs, as well as relieving cough and reducing phlegm, Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis, pulmonary tuberculosis, and other diseases. However, there is insufficient understanding of their efficacy, suitable syndromes, and safety in clinical practice, with a lack of relevant expert consensus on clinical application. To standardize their clinical application, 30 experts from the fields of respiratory medicine, pharmacy, and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules (Consensus for short) through evidence-based medicine methods. The Consensus clarified the syndrome characteristics, disease stages, dosages, treatment courses, combined medication, and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis, it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients, increase the sputum smear conversion rate, and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections, Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile, recommendations for specific usage, dosages, and treatment courses were given for different diseases, and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety, the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions, and pregnant women and women during menstruation were prohibited from using it. In addition, modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However, further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules, which helps to improve clinical efficacy and reduce medication risks.
3.Compilation Instructions for Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin LI ; Hongchun ZHANG ; Xuefeng YU ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):143-148
The compilation instructions for the Expert Consensus on Clinical Application of Yifei Zhike Capsules systematically expound the development background, methodological framework, and core achievements of this consensus. In view of the problems existing in the clinical application of Yifei Zhike Capsules, such as insufficient efficacy evidence and lack of standardized syndrome differentiation, the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences took the lead and collaborated with 21 tertiary grade-A hospitals and research institutions across China to form a multidisciplinary expert group (comprising 30 experts in clinical medicine, pharmacy, and methodology). The compilation work was carried out in strict accordance with the World Health Organization (WHO) guidelines, the GB/T 1.1-2020 standard, and the writing specifications for the explanatory notes of expert consensus on clinical application of Chinese patent medicines. Through systematic literature retrieval (including 32 studies, with 24 clinical studies), Grading of Recommendations Assessment, Development and Evaluations (GRADE)-based evidence grading, and multiple rounds of discussions using the nominal group method (25 experts voted to determine 17 clinical questions), 5 evidence-based recommendations and 11 expert consensus suggestions were formed. It is clarified that this medicine (Yifei Zhike Capsules) is applicable to the treatment of expectoration/hemoptysis in acute and chronic bronchitis and the adjuvant treatment of pulmonary tuberculosis. It is recommended that it can be used alone or in combination with anti-tuberculosis drugs. The safety evaluation shows that this medicine mainly induces the following adverse reactions: mild gastrointestinal reactions (such as nausea and abdominal pain) and rashes. The contraindicated populations include pregnant women and women during menstruation. The compilation process of the consensus underwent three rounds of expert letter reviews, two rounds of peer reviews, and quality control assessments to ensure methodological rigor and clinical applicability. In addition, through policy alignment, academic promotion, and a dynamic revision mechanism, the standardization of clinical application was promoted, providing a demonstration for the evidence-based transformation of characteristic therapies of Miao medicine.
4.Establishment and Implementation of Post-marketing Benefit-risk Assessment Strategy for Traditional Chinese Medicine
Meng QIAO ; Wenxi PENG ; Qiang ZHANG ; Chao LEI ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):253-260
The field of post-marketing benefit-risk assessment for traditional Chinese medicine(TCM) is still in its nascent stage, lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM, and explored the critical techniques and specific implementation steps involved in the assessment process. Initially, appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently, key technologies were outlined, including the establishment of a benefit-risk indicator system, the assignment of indicator weights, and the definition of criteria attributes. Furthermore, the implementation steps were elaborated, which involved defining decision-making issues, data collection, evaluation methodologies, variability factors, and sensitivity analysis. Finally, a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM.
5.Anti-pancreatic cancer effect of recombinant mouse peroxidase reductase-5 in vivo
Lin YANG ; Huiping XIE ; Miao WANG ; Jianing FENG ; Yuanyuan JIN ; Zhifei ZHANG ; Zhaoyong YANG
Chinese Journal of Immunology 2024;40(5):905-909
Objective:To investigate whether murine peroxidase reductase-5(mPRDX5)has anti-tumor activity in mice,so as to further confirm the anti-tumor activity and mechanism of recombinant peroxidase reductase-5.Methods:High purity mPRDX5 was obtained by heterologous expression and purification in vitro.Pancreatic cancer Pan02 cells were inoculated subcutaneously on the left axillary back of mice to establish a tumor bearing mouse model.Mice were randomly divided into PBS(solvent control)group,GEM(gemcitabine)50.0 mg/kg group and mPRDX5 10.0 mg/kg group,with 10 mice in each group,and the tumor related indexes were detected in mice.Results:Compared with PBS group,weight of tumor-bearing mice in GEM group was decreased obviously,while weight of mPRDX5 group was increased to a certain extent.Tumor growth was good in PBS group,according to tumor volume,com-pared with PBS group,tumor growth inhibition rates in D7 were 87.07%in GEM group and 52.82%in mPRDX5 10.0 mg/kg group,re-spectively;according to tumor weight,compared with PBS group,GEM group and mPRDX5 10.0 mg/kg group had tumor growth inhibi-tion rates of 95.39%and 48.33%in D7,respectively.Polarization state of macrophages in tumor tissues of mice in PBS group and mPRDX5 group was analyzed,and it was found that compared with PBS group,M1 macrophages expressing CD86 in tumor tissues of mice in mPRDX5 group were significantly increased,while M2 macrophages expressing CD206 were significantly decreased.Conclu-sion:mPRDX5 has significant anti-pancreatic cancer activity in mice,and the activity is exerted by promoting M1-type polarization of macrophages in the tumor microenvironment.
6.Sporadic medullary thyroid carcinoma: prognostic value of pathological grading and whole exome sequencing analysis
Shanshan SHEN ; Qin YANG ; Su MENG ; Yan HOU ; Lixiong SHUAI ; Wei XIA ; Zhifei CAO ; Yongsheng ZHANG
Chinese Journal of General Surgery 2024;39(8):593-597
Objective:To explore the clinicopathological and genetic characteristics of sporadic medullary thyroid carcinoma (MTC) and new therapeutic targets for sporadic MTC.Methods:Based on family and personal disease history, we identified 32 sporadic MTC who underwent surgical resection from Jan 2010 to Dec 2022. Clinicopathological and immunohistochemical features were analyzed in all patients, while 6 of them were subject to the whole exome sequencing (WES).Results:Compared with those of low-grade sporadic MTC, patients with high-grade tumors were more likely to have lymph node metastasis at presentation ( χ2=4.428, P=0.040); less likely to be cured by biochemical treatment ( χ2=4.072, P=0.044). Pathological grading scheme, biochemical cure, and TNM stage were independent risk factors of disease free survival. WES was performed on 6 pairs of normal tissues. We screened RET and RAS as driver mutations, and the mutation ratio was 3/6 respectively. Patients with RET or RAS mutations had no recurrence. In addition, we detected PDGFRA somatic mutation, with a mutation ratio of 1/6. Conclusions:For sporadic MTC cases, the pathological grading system has important prognostic value, and RET and RAS somatic mutations are the main driver mutations. PDGFRA are potential therapeutic targets for sporadic MTC.
7.Clinical and molecular genetic analysis of 18 cases of cerebrotendinous xanthomatosis
Cong TIAN ; Zhifei CHU ; Tongxia ZHANG ; Bing ZHAO ; Xiuhe ZHAO ; Cuiping ZHAO ; Chuanzhu YAN ; Yuying ZHAO
Chinese Journal of Neurology 2024;57(11):1217-1226
Objective:To analyze the clinical and molecular genetic characteristics of patients with cerebrotendinous xanthomatosis (CTX) to increase the awareness of the disease among clinicians.Methods:The clinical data, including the age of onset and diagnosis, clinical manifestations, neuroimaging and neuroelectrophysiology and the genetic data of patients diagnosed with CTX in the Department of Neurology, Qilu Hospital of Shandong University from March 2017 to December 2023 were retrospectively collected and analyzed.Results:A total of 18 patients were enrolled in this study, including 12 males and 6 females.The onset age was 10 (6, 29) years, with a minimum onset age of 3 years and a maximum onset age of 32 years; the period from onset to diagnosis was 19.00 (8.75, 24.25) years, with the shortest being 6 months and the longest being 35 years. Among the 18 patients, 16 patients had symptoms and signs of spastic paralysis, 9 patients had cognitive impairment and peripheral neuropathy, 8 patients had cerebellar ataxia, 3 patients had mental disorders, 3 patients had autonomic nervous dysfunction, and only 2 patients had seizures. Among the non-neurological symptoms, 9 patients had Achilles tendon xanthoma, of whom 1 patient was accompanied by patellar tendon xanthoma; 8 patients had adolescent cataracts, 6 patients had chronic diarrhea since childhood. All patients underwent brain MRI examination, among whom 15 patients had cerebellar dentate nucleus involvement, 10 patients had corticospinal tract involvement and 2 patients had normal brain MRI. Fourteen patients underwent nerve conduction and electromyography examinations, among whom 9 patients presented with multiple peripheral neuropathy characterized by motor or motor sensory demyelination. A total of 17 CYP27A1 gene variants were detected in 18 patients. The c.1420C>T and c.1263+1G>A were the hot-spot mutations in this cohort. Conclusions:Spastic paralysis, cerebellar ataxia, tendon xanthoma and adolescent cataracts are typical manifestations of CTX. The cerebellar dentate nucleus and corticospinal tract are mainly involved on the neuroimaging. It should be noted that some patients lack the typical characteristics mentioned above. The c.1420C>T and c.1263+1G>A are the hot-spot mutations in this cohort.
8.Treatment strategy refinement and long-term outcome assessment based on the magnetic resonance imaging features of gynecomastia
Zenan XIA ; Xinran ZHANG ; Yuanbo KANG ; Wenchao ZHANG ; Nanze YU ; Zhifei LIU ; Lin ZHU
Chinese Journal of Medical Aesthetics and Cosmetology 2024;30(3):202-207
Objective:To improve and optimize the modified surgical strategies for patents with Simon Ⅰ and Simon Ⅱ type of gynecomastia, based on their magnetic resonance imaging (MRI) features.Methods:Clinical data of 190 patients aged 12 to 56 years (mean age 26.7±8.6) with gynecomastia who underwent modified surgeries in the Department of Plastic Surgery of Peking Union Medical College Hospital from January 2017 to January 2023 were retrospectively analyzed. The study measured breast MRI images of 44 male patients to calculate the area ratio of the glands on the transverse plane via nipple. This provided insight into the physiological structure and the tissue distribution of gynecomastia for improving the modified surgical strategies. All 190 patients were treated with enhanced liposuction and " Pull-Through and Bottom-Up" techniques. The duration of operation, amount of liposuction and amount of glandular resection, postoperative complications were recorded, and postoperative satisfaction was investigated by questionnaire surveys.Results:MRI images of the 87-side male breast showed that the average area ratio of the glands on the transverse plane via nipple was (10.9±12.5) %. The most prevalent subtype of gynecomastia was branch pattern, accounting for 46.0%. The median surgical duration of 190 patients was 95 (65-210) minutes, the median liposuction volume was 300 (50-1 400) ml, and the median glandular removal was 19.9 (1.5-157.0) g. Eighty-eight patients (46.3%) went through followed up for more than 6 months post-posterative with an overall satisfaction score of 4.68±0.53. Postoperative complications occurred in 19 sides (5.1%), and the reoperation rate was 1.3%.Conclusions:The MRI imaging of gynecomastia shows that the component of patients′ breasts are mainly fat, with a small amount of glandular tissue and the dominant subtype is branch pattern. Enhanced liposuction combined with " Pull-Through and Bottom-Up" stab incision technique can be an effective treatment for Simon grades Ⅰ and Ⅱ gynecomastia. The method results in high patient satisfaction with fewer postoperative complications.
9.Comparison of suction blister transplantation and noncultured autologous suspension of epidermal cells in treatment of stable vitiligo in the face and neck region
Yong TAO ; Zhifei LIU ; Mingzi ZHANG ; Xiaohan HU ; Nanze YU ; Fei LONG ; Zenan XIA ; Lan MO ; Xiaojun WANG
Chinese Journal of Medical Aesthetics and Cosmetology 2024;30(3):208-212
Objective:To evaluate the differences and aesthetic meaning of stable vitiligo treatment in the face and neck region using suction blister transplantation or noncultured autologous suspension of epidermal cells.Methods:Sixty-four stable vitiligo patients (25 males and 39 females with age ranges from 10 to 46 years, average 25 years) in the face and neck region were randomly divided into two groups (32 patients in each group): one group received suction blister transplantation, while other group received noncultured autologous suspension of epidermal cells. Patients′treatment effectiveness, pigmentation and piecing deformity were evaluated in postoperative 3 months and 6 months.Results:In the postoperative 3 months and 6 months, the effectiveness of suction blister transplantation group was 68.75% (22/32) and 90.63% (29/32), respectively, while the effectiveness of noncultured autologous suspension of epidermal cells group was 59.37% (19/32) and 87.50% (28/32), respectively, in which no significant differences were found between two groups ( P>0.05). No obvious pigmentation and piecing deformity were found in noncultured autologous suspension of epidermal cells group, which were much better than the suction blister transplantation group in postoperative 3 months and 6 months. Conclusions:Both suction blister transplantation and noncultured autologous suspension of epidermal cells could bring good treatment effectiveness for patients of stable vitiligo in the face and neck region. Compared with suction blister transplantation, noncultured autologous suspension of epidermal cells could offer better aesthetic appearance.
10.Development of an experience scale for patients with chronic wound debridement and dressing
Yanping SHI ; Ling TIAN ; Zhifei LIU ; Wei ZHANG ; Tianqi LIU ; Jinna WANG ; Siming JIANG ; Yanan CUI ; Zirong LI
Chinese Journal of Medical Aesthetics and Cosmetology 2024;30(3):213-217
Objective:To develop and evaluate a medical experience assessment scale for debridement and dressing change in chronic wound patients in China, and to provide a reference for improving hospital service quality.Methods:Based on the framework of hospital consumer assessment of healthcare providers and systems survey (HCAHPS) in the United States, a preliminary draft of the scale was formed through a literature review and qualitative interviews with 12 chronic wound patients (7 males and 5 females aged 58.1±12.3 years). Five experts were invited for content validity testing, and 191 chronic wound patients (111 males and 80 females aged 53.5±19.1 years) were selected to evaluate the internal consistency reliability, half reliability, retest reliability, and structural validity of the scale.Results:The Chronic Wound Patient Debridement and Dressing Experience Scale covered 5 dimensions with 30 sub-items and 2 comprehensive evaluation items, including demand response, good and friendly communication, professional trust, optimization of the medical treatment process, and encouragement of patient participation. The scale Cronbach′s α coefficient was 0.967 and ranged from 0.890 to 0.962 for each dimension. The overall retest reliability of the scale was 0.940 and ranged from 0.895 to 0.940 for each dimension. The overall half reliability of the scale was 0.923 and ranged from 0.834 to 0.935 for each dimension. 5 factors were extracted, with a cumulative variance contribution rate of 82.061%.Conclusions:Based on the HCAHPS framework in the United States, the Chronic Wound Debridement and Dressing Experience Scale developed has high reliability and validity, and can be used to evaluate the dressing change experience of patients with chronic wounds. It has clinical practice significance for dressing change in chronic wounds.

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