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.Dosimetric comparison of the heart and its substructures between two hybrid radiotherapy plans following breast-conserving surgery for left-sided breast cancer
Lin GUO ; Hongrong REN ; Meng CHEN ; Chengjun WU ; Yun ZHOU ; Xiaobo RUAN ; Ji DING ; Weiyuan WU
Chinese Journal of Radiological Health 2025;34(2):174-178
Objective To compare the dosimetric differences in the heart and its substructures between two hybrid plans for hypofractionated whole-breast radiotherapy after breast-conserving surgery in patients with early-stage left-sided breast cancer. Methods A total of 46 patients with early-stage left-sided breast cancer who underwent hypofractionated whole-breast radiotherapy were randomly selected. Two hybrid radiotherapy plans were used, including hybrid intensity-modulated radiotherapy (H_IMRT) and hybrid volumetric-modulated arc therapy (H_VMAT). The heart and its substructures were contoured, including left anterior descending (LAD), left ventricle (LV), right coronary artery (RCA), and right ventricle (RV). The heart and substructure doses, as well as monitor units, were compared between H_IMRT and H_VMAT. Results Both hybrid plans met the clinical requirements. H_IMRT significantly outperformed H_VMAT for the heart (V10, V30, and Dmean), LAD (V30, V40, Dmax and Dmean), LV (V10, V20 and Dmean), RCA (Dmax, Dmean), and RV (V5, V10, Dmean) (P < 0.001). Additionally, H_IMRT was significantly superior to H_VMAT for heart V5, LAD V20, and RV V20 (P = 0.005, 0.035 and 0.037). For LAD (V15, V40) and LV (V5, V25), H_IMRT was slightly better than H_VMAT, and the difference was not statistically significant. Conclusion Both H_IMRT and H_VMAT hybrid radiotherapy plans are suitable for hypofractionated whole-breast radiotherapy after breast-conserving surgery in patients with early-stage left-sided breast cancer. H_IMRT is slightly better than H_VMAT in dose sparing for the heart and its substructures.
4.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.
5.Establishment of a risk prediction model for cerebrogenic multiple organ dysfunction syndrome in patients with acute cerebral hemorrhage
Huaibiao WU ; Hao ZHANG ; Chengjun GUO
Chinese Critical Care Medicine 2024;36(9):966-971
Objective:To construct and validate a predictive model for the risk of cerebrogenic multiple organ dysfunction syndrome (CMODS) in patients with acute cerebral hemorrhage.Methods:Clinical data of 93 patients with acute cerebral hemorrhage admitted to Wannan Rehabilitation Hospital from January 2019 to June 2023 were retrospectively analyzed. Data included baseline information, disease severity score, laboratory examination indicators, cerebral hemorrhage status, treatment status, etc. Patients were divided into CMODS group and non-CMODS group according to whether CMODS occurred during hospitalization. The clinical data of the two groups were compared. Multivariate Logistic regression was used to analyze the risk factors of CMODS in patients with acute cerebral hemorrhage. A nomogram model was constructed to predict the risk of CMODS in patients with acute cerebral hemorrhage, and the model was validated. Receiver operator characteristic curve (ROC curve) was used to evaluate the predictive efficiency of nomogram model for CMODS in patients with acute cerebral hemorrhage.Results:A total of 93 patients with acute cerebral hemorrhage were enrolled, including 26 patients in CMODS group and 67 patients in non-CMODS group. Compared with the non-CMODS group, the ratio of diabetes, acute physiological and chronic health evaluationⅡ(APACHEⅡ)≥35 score, cerebral hemorrhage volume ≥30 mL, endotoxemia, and national institutes of health stroke scale (NIHSS) and intracranial pressure of patients in the CMODS group were significantly higher, while the Glasgow coma score (GCS) was significantly lower and the length of hospital stay was significantly longer, with statistically significant differences (all P < 0.05). Multivariate Logistic regression analysis showed that diabetes mellitus [odds ratio ( OR) = 3.615, 95% confidence interval (95% CI) was 1.487-8.785, P = 0.000], APACHEⅡscore ( OR = 4.697, 95% CI was 1.933-11.416, P = 0.000), endotoxemia ( OR = 4.577, 95% CI was 1.883-11.123, P = 0.000), and cerebral hemorrhage volume ( OR = 4.039, 95% CI was 1.662-9.816, P = 0.000) were the risk factors for CMODS in patients with acute cerebral hemorrhage. Taking the above risk factors as predictive variables, a nomogram prediction model was established. The verification results of the nomogram model showed that the C index was 0.804 (95% CI was 0.768-0.841), and the calibration curve was close to the ideal curve with good fit ( P > 0.05). ROC curve results showed that the sensitivity and specificity of the nomogram model in predicting CMODS in patients with acute cerebral hemorrhage were 76.92%, 86.57%, respectively, and the area under the ROC curve (AUC) was 0.855 (95% CI was 0.776-0.935). Conclusions:Diabetes mellitus, APACHEⅡscore, endotoxemia and intracerebral hemorrhage are risk factors for CMODS in patients with acute cerebral hemorrhage. The risk prediction model based on these risk factors is effective in evaluating the risk of CMODS in patients with acute cerebral hemorrhage.
6.Exploring the Integrated Traditional Chinese and Western Medicine Treatment for Acute Respiratory Distress Syndrome from the Perspective of State Differentiation and Treatment
Yikun GUO ; Miao CHENG ; Jun YAN ; Bei XUE ; Linwen CHEN ; Shujiao LI ; Shangshang JIANG ; Liangduo JIANG ; Chengjun BAN
Journal of Traditional Chinese Medicine 2024;65(6):577-581
From the perspective of state differentiation and treatment, it is believed that the pathogenesis of acute respiratory distress syndrome (ARDS) is that evil poisons injured the lungs, and the lung qi suddenly collapsed, then blocked and exhausted, and the qi failure to control blood and liquid, then the fluids overflow outside the vessels, and damp phlegm, stasis, and toxins became knotted up in the body, which ultimately leads to qi dysfunction, and a series of symptom arise, so qi impairment is the principal mechanism of ARDS. A combination of Chinese and Western medicine was proposed to treat ARDS by combining tangible qi and intangible qi, using Chinese herbal medicine to boost qi and relieve collapse, percolate and drain dampness with bland medicinals, resolve toxins and dissolve stasis, and regulate qi, and combining with Western medicine to assist qi circulation to improve qi's consolidation, propulsion, and transformation, so as to make the evil qi go away, the positive qi restored, the viscera qi circulated, qi, blood, yin, and yang connected, and the activities of life maintained, and thus to achieve the goal of treating ARDS by integrated Chinese medicine and Western medicine.
7.Three-year survival status of 664 older patients with acute exacerbation of chronic obstructive pulmonary disease and the prognostic factors of traditional Chinese and western medicine
Shujiao LI ; Yuanrun GUO ; Mingzhe WANG ; Miao CHENG ; Fengyuan LIANG ; Yiqiu LI ; Chengjun BAN
Journal of Beijing University of Traditional Chinese Medicine 2024;47(9):1288-1296
Objective Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of hospitalization and death in patients with chronic obstructive pulmonary disease (COPD). Exploring the prognostic factors of AECOPD patients will assist in optimizing treatment strategies and standardizing disease management. Methods This study retrospectively collected the clinical data of 664 patients with AECOPD admitted to the Respiratory Department of Dongzhimen Hospital of Beijing University of Chinese Medicine from January 2013 to September 2019. The 3-year survival rate and treatment of the patients were investigated. According to whether the patients died,they were divided into a non-survivors group and a survivors group,and clinical data such as basic information,comorbidities,and auxiliary examination results were compared between the two groups. Incorporating clinical experience of researchers and previous research evidence,a secondary screening of variables was conducted to ultimately determine the covariates to be included in the multifactorial Cox proportional hazards regression model,and the factors affecting the 3-year survival rate of the patients were analyzed. Results A total of 664 cases were included in this study,including 362 males and 302 females,with an average age of (77.25±6.89) years old. The 3-year all-cause mortality rate of older hospitalized patients with AECOPD was 20.48%(136 patients). Older age (HR:1.071,95%CI:1.040-1.102,P<0.001);smoking history (HR:1.788,95%CI:1.173-2.723,P=0.007);Charlson comorbidity index (HR:1.209,95%CI:1.029-1.421,P=0.022);lower arterial partial pressure of oxygen (HR:1.014,95%CI:1.006-1.022,P<0.001);higher brain natriuretic peptide(HR:1.001,95%CI:1.000-1.001,P=0.025);cor pulmonale(HR:1.896,95%CI:1.235-2.908,P=0.004);respiratory failure (HR:2.437,95%CI:1.378-4.311,P=0.003);TCM syndrome differentiation elements,including kidney (HR:1.639,95%CI:1.055-2.546,P=0.028) and fluid retention (HR:2.512,95%CI:1.653-3.816,P<0.001),were independent risk factors for 3-year all-cause death of older hospitalized patients with AECOPD. Long-term regular use of bronchiectasis (HR:0.474,95%CI:0.324-0.695,P<0.001) was an independent protective factor for 3-year all-cause death. Conclusion The 3-year survival rate of elderly hospitalized patients with AECOPD is relatively low,with the TCM syndrome elements manifested as lung-kidney qi deficiency,yang deficiency with water retention,and blood stasis obstruction. Patients with moderate to severe impairment of lung function due to COPD have an increased risk of death within 3 years. Therefore,for such patients,nourishing lung-kidney qi,resolving phlegm and water retention,activating blood circulation to remove blood stasis and dredging collaterals,combined with regular use of bronchodilators,may help improve their 3-year survival rate.
8.Clinical value of lymph node dissection for intrahepatic cholangiocarcinoma
Junwu GUO ; Binghua DAI ; Kunpeng FANG ; Yijun ZHAO ; Zhitao DONG ; Hengmei ZHU ; Chengjun SUI ; Feng XIE ; Li GENG
Chinese Journal of Hepatobiliary Surgery 2022;28(3):202-205
Objective:To evaluate the clinical value of lymph node dissection (LND) for intrahepatic cholangiocarcinoma (ICC) after surgical resection.Methods:A retrospective study was conducted on the clinical data of 156 patients who underwent surgery for ICC in Eastern Hepatobiliary Surgery Hospital of Naval Military Medical University from November 2010 to December 2017, including 94 males and 62 females, aged (60.0±9.5) years. Curative surgery was performed in 114 cases. Of 64 cases were in stage Ⅰ according to American Joint Committee on Cancer (AJCC), including 38 cases of non-lymph node dissection (NLND) and 26 cases of LND; 21 cases were in AJCC stage Ⅱ, including 11 cases of NLND and 10 cases of LND; 22 cases were in AJCC stage Ⅲb, including 14 cases of LND and 8 cases of lymph node resection (LNR); 5 cases were in AJCC stage Ⅲa, 2 cases were in AJCC stage Ⅳ. Univariate and multivariate Cox regression analysis were used for the risk factors of ICC prognosis. The log-rank test compared the survival rates of the two groups.Results:Cox multivariate analysis indicated that lymph node metastasis was independent risk factors for prognosis in patients with ICC ( HR=1.96, 95% CI: 1.09-3.55, P=0.026). A total of 114 patients were included in the curative surgery group. The 1-, 3-, and 5-year overall survival (OS) rates of the negative lymph node group ( n=91) were 65.9%, 47.3% and 35.6%, respectively, which were significantly better than those of the positive lymph node group ( n=23) who had 1-, 3-, 5-year OS rates of 56.5%, 17.7% and 0, respectively (χ 2=8.11, P=0.004 ). In stage Ⅰ and Ⅱ patients, there were no significant differences in 1-, 3-, 5-year OS rates between the NLND group and the LND group (both P>0.05 ). In stage Ⅲb patients, the LND group had 1-, 3-, 5-year OS rates of 71.4%, 29.8% and 0, respectively, significantly better than those of the LNR group who had 1-, 3-, 5-year OS rates of 37.5%, 0 and 0, respectively (χ 2=6.45, P=0.011). Conclusions:Lymph node metastasis is an independent risk factor affecting the prognosis of ICC. Lymph node dissection should be performed cautiously in ICC with AJCC stage Ⅰ and Ⅱ, while routine lymph node dissection is recommended in ICC with AJCC stage Ⅲb.
9.AITC induces MRP1 expression by protecting against CS/CSE-mediated DJ-1 protein degradation via activation of the DJ-1/Nrf2 axis
Lingling XU ; Jie WU ; Nini LI ; Chengjun JIANG ; Yan GUO ; Peng CAO ; Dianlei WANG
The Korean Journal of Physiology and Pharmacology 2020;24(6):481-492
The present study aimed to examine the effect of allyl isothiocyanate (AITC) on chronic obstructive pulmonary disease and to investigate whether upregulation of multidrug resistance-associated protein 1 (MRP1) associated with the activation of the PARK7 (DJ-1)uclear factor erythroid 2-related factor 2 (Nrf2) axis.Lung function indexes and histopathological changes in mice were assessed by lung function detection and H&E staining. The expression levels of Nrf2, MRP1, heme oxygenase-1 (HO-1), and DJ-1 were determined by immunohistochemistry, Western blotting and reverse transcription-quantitative polymerase chain reaction. Next, the expression of DJ-1 in human bronchial epithelial (16HBE) cells was silenced by siRNA, and the effect of DJ-1 expression level on cigarette smoke extract (CSE)-stimulated protein degradation and AITC-induced protein expression was examined. The expression of DJ-1, Nrf2, HO-1, and MRP1 was significantly decreased in the wild type model group, while the expression of each protein was significantly increased after administration of AITC. Silencing the expression of DJ-1 in 16HBE cells accelerated CSE-induced protein degradation, and significantly attenuated the AITC-induced mRNA and protein expression of Nrf2 and MRP1. The present study describes a novel mechanism by which AITC induces MRP1 expression by protecting against CS/CSEmediated DJ-1 protein degradation via activation of the DJ-1/Nrf2 axis.
10.Study on the Fingerprint of Crude/vinegar-processed Corydalis yanhusuo Decoction Pieces and Their Dispen- sing Granules and Content Determination of Five Alkaloids
Pingping SUN ; Zhenghong GUO ; Wude YANG ; Bo YANG ; Chengjun SHEN ; Xiangchun SHEN ; Ling TAO ; Ting XIAO
China Pharmacy 2020;31(20):2462-2468
OBJECTIVE:To establish the fingerprint of crude/vinegar-processed Corydalis yanhusuo decoction pieces and their dispensing granules,and to determine the contents of five alkaloids (protopine,tetrahydropalmatine,corydaline,berberine hydrochloride,palmatine hydrochloride ). METHODS :HPLC method was adopted. The determination was performed on Agilent TC-C18 column with mobile phase consisted of 0.1% phosphoric acid solution-methanol (gradient elution )at the flow rate of 1.0 mL/min. The detection wavelength was set at 280 nm,and the column temperature was 30 ℃. The sample size was 10 μL. Using palmatine hydrochloride as reference , Similarity Evaluation System of TCM Chromatographic Fingerprint (2012 edition) was used to establish the fingerprint of 11 059) batches of C. yanhusuo decoction pieces ,7 batches of crude . yanhusuo dispensing granules , 12 batches of vinegar- processed C. yanhusuo decoction pieces and 11 batches of vinegar-processed C. yanhusuo dispensing granules. The same HPLC method was adopted to determine the contents of protopine, tetrahydropalmatine, corydaline, berberine hydrochloride and palmatine hydrochloride in 41 batches of crude/ vinegar-processed C. yanhusuo decoction pieces and their dispensing granules. RESULTS :There were 12 and 20 common peaks for crude C. yanhusuo decoction pieces and its dispensing granules ,and 14 and 16 common peaks for vinegar-processed C. yanhusuo decoction pieces and its dispensing granules. The similarity of each batch of same type were 0.529-0.981,0.342-0.985, 0.711-0.999,0.437-0.998,respectively. The linear range of protopine ,tetrahydropalmatine,corydaline,berberine hydrochloride and palmatine hydrochloride were 1.9-38.0,2.0-40.0,2.2-44.0,2.6-52.0,2.3-46.0 μg/mL(R2>0.999 0). The recoveries were 100.12%-100.98%(RSD=1.05%-1.90%,n=9). RSDs of precision ,reproducibility,stability(24 h)and durability tests were all lower than 2.0%. The average contents of five alkaloids in different batches of crude/vinegar-processed C. yanhusuo decoction pieces and its dispensing granules were 0.24-0.46,0.37-0.82,0.24-0.58,0.07-0.75,0.24-0.76 mg/g. RSDs were 12.27%-147.48%. CONCLUSIONS:The fingerprint of crude/vinegar-processed C. yanhusuo decoction pieces and its dispensing granules is established successfully. The similarities of fingerprint are different before and after processing with vinegar ,and the contents of five alkaloids in C. yanhusuo decoction pieces and its dispensing granules are greatly different.

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