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.Multidimensional analysis and scientific prospect of expected value setting for signal detection by vaccine marketing authorization holders
Chinese Journal of Biologicals 2026;39(02):251-256
In order to effectively ensure the effectiveness and scientific nature of vaccine safety monitoring, it is necessary to deeply explore the reference data sources, key elements to be considered and future development trends that vaccine marketing authorization holders rely on to set signal detection expected values in pharmacovigilance. By systematically sorting out various data types for reference in expected value setting, multiple elements that affect expected value setting can be deeply analyzed, the dimensions and methods of considering these data and elements during the setting process can be explored, and the future development direction of expected value setting can be analyzed. The setting of expected values of signal detection requires a comprehensive consideration of various data and elements, keep up with the forefront of technological development, and flexibly apply advanced technologies, so as to achieve precision, personalization and dynamism in expected value setting and ensure vaccine safety. This paper clarifies the advantages and disadvantages of clinical trial data,real-world usage data and data of similar products as reference for expected value setting, expounds the effects of differences in factors such as vaccine and vaccination population characteristics, monitoring system characteristics, policy and environmental characteristics on the setting of expected values, and puts forward the deve-lopment trends of expected value setting in the future.
3.Current application status of stem cell therapy in the field of lung transplantation
Mingyu GU ; Xiangyun ZHENG ; Ji’er MA ; Xiaohan JIN ; Zhiqiang DENG ; Haoji YAN ; Dong TIAN
Organ Transplantation 2026;17(2):311-318
In recent years, research on stem cell therapy in the field of lung transplantation has gradually increased, demonstrating its potential in improving the outcomes of lung transplantation. As a treatment option for end-stage lung diseases, lung transplantation faces challenges such as scarcity of donor organs, postoperative complications and rejection. Stem cells, with their self-renewal and multi-directional differentiation capabilities, have emerged as strong candidates for alternative or adjunctive treatments. Current studies show that embryonic stem cells and umbilical cord mesenchymal stem cells play significant roles in lung tissue regeneration and immune regulation. However, stem cell therapy still needs to overcome issues such as the selection of cell sources, low survival rates after transplantation and unclear long-term efficacy in clinical applications. Future research should focus on exploring new stem cell sources, improving transplantation techniques and establishing efficacy evaluation systems.
4.Exploring the Relationship Between Liver and Executive Function Decline Based on "the Liver Governs the Designing of Strategy"
Lei HUO ; Yanan DENG ; Jinchai DENG ; Yan ZHANG ; Xueyuan DU ; Xianghong ZHAN
Journal of Traditional Chinese Medicine 2025;66(2):201-204
The concept of "spirit" in traditional Chinese medicine (TCM) aligns closely with "the liver governs the designing of strategy". By exploring the relationship between the liver and executive function decline, it is proposed that prolonged liver constraint leads to indecisiveness in strategy designing, which is the initiating factor for executive function decline; liver blood deficiency causes difficulties in executing strategy, which forms an essential foundation for the progression of executive function decline; obstruction in the "liver-du mai-brain" pathway leads to unclear strategy designing, which accelerates executive function decline. This relationship is examined from the perspectives of TCM, modern medicine, and cognitive psychology, aiming to provide insights into addressing executive function decline through treatments focused on the liver.
5.Adverse reaction analysis of drug-induced liver injury
Yan ZHANG ; Yanjun LI ; Jiahui LIU ; Jiao DENG ; Yuan YUAN ; Jingyi ZHANG
Journal of Pharmaceutical Practice and Service 2025;43(1):26-29
Objective To analyze the adverse reaction reports (ADRs) of drug-induced liver injury in recent ten years, explore the characteristics and related rules of drug-induced liver injury, and provide reference for clinical safe drug use. Methods ADRs in our hospital from 2011 to 2021 which belonged to drug-induced liver injuries were collected, and Pareto analysis was carried on. Results In 259 ADR reports, the most common type of drug-induced liver injury was hepatocellular injury (37.84%). The age of drug-induced liver injury was mainly over 46 years, totaling 195 (75.28%). Drugs were mainly distributed in cardiovascular system medicine (44.02%), anti-infective medicine (23.94%)and anti-tumor medicine (11.58%). Among the cardiovascular drugs, atorvastatin calcium 40mg and over 40mg were the highest proportion, with 53 cases (46.49%). The main anti-infectious drugs were cephalosporins (29.03%), carbapenem (19.35%), antifungal (17.74%)and quinolones (11.29%). Adverse reactions occurred within 6 days (69.88%), the duration of adverse reactions was 1-2 weeks (31.66%), and most patients were improved (47.88%) or cured (37.07%). Conclusion For middle-aged and elderly patients, when the application of cardiovascular system drugs, anti-infective drugs or anti-tumor drugs, it is necessary to monitor the liver function changes of patients for at least 6 days. If there are abnormalities, the drugs should be stopped or given treatment in time, to avoid the progress of drug-induced liver injury.
6.Effect of sorafenib and donafenib on the pharmacokinetics of ertugliflozin in rats
Yanru DENG ; Gexi CAO ; Bin YAN ; Ying LI ; Zhanjun DONG
Journal of Clinical Hepatology 2025;41(1):92-98
ObjectiveTo investigate the effect of sorafenib and donafenib on the pharmacokinetics of ertugliflozin in rats, and to provide a theoretical basis for drug combination in clinical practice. MethodsA total of 24 male Sprague-Dawley rats were randomly divided into groups A, B, C, and D, with 6 rats in each group. The rats in groups A and B were given sorafenib control solvent and sorafenib (100 mg/kg), respectively, by gavage for 7 consecutive days, followed by ertugliflozin (1.5 mg/kg) by gavage on day 7. Blood samples were collected from the angular vein plexus at different time points, and ultra-performance liquid chromatography-tandem mass spectrometry was used to determine the mass concentration of ertugliflozin and plot the plasma concentration-time curves, while the non-compartment model in DAS 2.1.1 software was used to calculate related pharmacokinetic parameters. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups. ResultsCompared with group A, group B had significant increases in the AUC0-t and AUC0-∞ of the plasma concentration-time curve of ertugliflozin (both P<0.05), significant prolongation of t1/2, MRT0-t, and MRT0-∞ (all P<0.05), and a significant reduction in CLZ/F (P<0.05). Compared with group C, group D had significant increases in the AUC0-t and AUC0-∞ of ertugliflozin (both P<0.05), significant prolongation of Tmax, t1/2, MRT0-t, and MRT0-∞ (all P<0.01), and significant reductions in VZ/F and CLZ/F (both P<0.05). ConclusionBoth sorafenib and donafenib can affect the pharmacokinetics of ertugliflozin in rats and significantly increase the plasma exposure of ertugliflozin. The efficacy and adverse drug reactions of ertugliflozin should be closely monitored during combined use in clinical practice and the dose should be adjusted when necessary to avoid the potential risk of drug interaction.
7.Risk assessment of human Spirometra mansoni infections and cross-sectional study on knowledge, attitude and practice towards sparganosis in endemic areas of Henan Province
Yalan ZHANG ; Tiantian JIANG ; Xiaohui MA ; Yan DENG ; Weiqi CHEN ; Yankun ZHU ; Zhenqiang TANG ; Xi-meng LIN ; Hongwei ZHANG
Chinese Journal of Schistosomiasis Control 2025;37(2):190-195
Objective To assess the risk of human Spirometra mansoni infections and investigate the knowledge, attitude and practice (KAP) towards sparganosis mansoni among residents in Henan Province, so as to provide insights into formulation of the sparganosis mansoni control measures. Methods Qinling Village in Fugou County of Zhoukou City, Bali Village in Yancheng District of Luohe City, Duzhai Village in Puyang County of Puyang City and Doushan Village in Luoshan County of Xinyang City were sampled as survey sites in Henan Province from July to August 2023, and more than 40 frogs were sampled from ponds or streams in each survey site for detection of Sparganum mansoni infections. At least 150 residents were sampled using a cluster sampling method from each survey site, and the sero-prevalence of anti-S. mansoni IgG antibody was estimated. In addition, a questionnaire survey was conducted on the KAP towards sparganosis mansoni among participants, and the proportion of eligible KAP, rate of correct KAP and KAP scores were calculated. Results A total 229 frogs were collected from 4 survey sites in 2023, and the overall prevalence of S. mansoni infection was 4.37% (10/229) in frogs, with 7.75% (10/129) prevalence in wild frogs and 0 in farm-bred frogs. A questionnaire survey was performed among 649 residents sampled from 4 survey sites, and 649 serum samples were collected. The seroprevalence of anti-S.mansoni IgG antibody was 0.15% (1/649) and the overall proportion of eligible KAP was 23.73% (154/649) among participants. There were age- (χ2 = 30.905, P = 0.000), educational level- (χ2 = 41.011, P = 0.000), and occupation-specific proportions of eligible KAP among participants (χ2 = 10.721, P = 0.005), and the proportion of eligible KAP decreased with age (χ2 trend = 22.717, P = 0.000) and increased with education levels (χ2 trend = 40.025, P = 0.000). The rates of correct KAP towards sparganosis mansoni were 40.81% (2 119/5 192), 96.66% (1 882/1 947) and 63.81% (3 727/5 841) (χ2 = 1 913.731, P = 0.000) among residents, respectively. The rates of correct KAP towards sparganosis mansoni varied significantly among survey sites (χ2 = 136.872, 42.347 and 255.157; all P values= 0.000, with the highest rate of correct knowledge (51.94%, 748/1 440) and practices (75.86%, 1 229/1 620) in Yancheng District of Luohe City and the highest rate of correct attitudes in Puyang County of Puyang City (99.11%, 446/450) (all P values< 0.05). Conclusions There is still a high transmission risk of sparganosis mansoni in Henan Province, and the KAP towards sparganosis mansoni is required to be improved among residents.
8.On acceleration and alienation in medicine: based on Hartmut Rosa’s critical theory of social acceleration
Chinese Medical Ethics 2025;38(3):357-363
The accelerated development of modern medicine is a key force in safeguard human health, but there has also been a phenomenon of alienation. Interpreting the development of modern medicine from the perspective of Hartmut Rosa’s socially accelerated critical thought is a powerful explanatory framework for profoundly dissecting the development of medicine in the post-medical era and an entry point for diagnosing medical ailments. The development of medicine follows a “dynamic stability” model from three aspects, including technology, structure, and the pace of subjective life, entering a self-accelerating cycle system. In the infinite acceleration cycle, there are new manifestations of alienation, such as the abstraction of medical space, the subjectification of medical technology, the retreat of the humanistic spirit, the increasing poverty of life experience, and the elimination of doctor-patient identity. According to Rosa’s path of realizing the “good life”, the solution to medical alienation lies in establishing a “resonance” relationship, fostering the concept of medical humanization, constructing rational communication in medical language, and exploring new development concepts in medicine. These are effective ways to reconcile the relationship between medical development and other social factors.
9.Effect and mechanism of ertugliflozin on pharmacokinetic of sorafenib and donafenib in rats
Yanru DENG ; Zhi WANG ; Gexi CAO ; Bin YAN ; Ying LI ; Zhanjun DONG
China Pharmacy 2025;36(7):826-831
OBJECTIVE To investigate the effects of ertugliflozin on pharmacokinetic of sorafenib and donafenib in rats and explore the mechanism. METHODS Twenty-four male SD rats were randomly divided into four groups, with 6 rats in each group. Groups A and B were respectively gavaged with 0.5% sodium carboxymethyl cellulose solution and ertugliflozin (1.5 mg/kg) for 7 consecutive days, and both were given sorafenib (100 mg/kg) on the 7th day. Groups C and D were administered intragastrically in the same way as those in Groups A and B, respectively, for the first 7 days; after the drug administration on the 7th day, all rats in Groups C and D were further gavaged with donafenib (40 mg/kg). Blood samples were collected at different time points before and after administration of sorafenib or donafenib, the concentrations of sorafenib in plasma of rats in groups A and B and donafenib in groups C and D were determined by UPLC-MS/MS method. The pharmacokinetic parameters were calculated by DAS 2.1.1 software. Six additional rats were randomly divided into blank control group and ertugliflozin group, with three rats in each group. Blank control group was given 0.5% sodium carboxymethyl cellulose intragastrically, while rats in ertugliflozin group were given ertugliflozin (1.5 mg/kg) once a day for 7 consecutive days. After the last administration, the mRNA expression levels of uridine diphosphate glucuronosyl transferase 1A7 (UGT1A7), breast cancer resistance protein (BCRP), and P-glycoprotein (P-gp) in the liver and small intestine tissues of the rats were detected. RESULTS Compared with group A, the AUC0-t, AUC0-∞, cmax, tmax, MRT0-t and MRT0-∞ of sorafenib in group B were decreased significantly, while CL and V were increased significantly. Compared with group C, the AUC0-t, AUC0-∞ , tmax, cmax and MRT0-t of Δ donafenib in group D were decreased significantly, while V and CL were increased significantly (P<0.05). mRNA expression of UGT1A7, P-gp and BCRP in the liver tissue and small intestine of rats were not significantly affected after intragastric administration of ertugliflozin for 7 consecutive days. CONCLUSIONS Ertugliflozin can affect the pharmacokinetics of sorafenib and donafenib in rats and decrease the plasma exposure of them significantly. However, its mechanism of action may not be through the regulation of related metabolic enzymes and transporters. When using drugs in combination clinically, one should be vigilant about the potential for disease progression due to poor therapeutic effects.
10.Effect analysis of endolymphatic sac surgery on Meniere’s disease based on propensity score matching
Yu SI ; Shipei ZHUO ; Yan HUANG ; Wuhui HE ; Jingman DENG ; Jintao LOU ; Zhigang ZHANG
Chinese Journal of Clinical Medicine 2025;32(2):165-170
Objective To analyse the clinical efficiency of endolymphatic sac surgery (ESS) in the management of Meniere’s disease (MD). Methods A retrospective analysis was conducted on 274 patients with MD who were hospitalized for treatment in Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University from January 2009 to August 2023. All patients received lifestyle management and drug treatment such as diuretics. For those whose conditions were not well controlled 3 to 6 months after the initial treatment, intratympanic glucocorticoid (ITG) or ESS treatment was carried out. Six months after the treatment, the classes of vertigo relief and hearing changes in the patients were evaluated. After adjusting the confounding factors through propensity score matching (PSM), the impact of ESS on the prognosis of MD patients was evaluated. Results Among 274 patients, 194 and 80 patients underwent ITG and ESS, respectively. Eighty patients were enrolled into each group after PSM. Before and after PSM, the rate of patients reaching vertigo relief class A in ESS group was higher than that in the ITG group (P=0.004); there was no significant difference in hearing preservation between the two groups. Kaplan-Meier curve analysis showed that vertigo relief in the ESS group was better than that in the ITG group (P=0.029); there was no statistically significant difference in hearing preservation between the two groups. Conclusion When the initial treatment for patients with MD is ineffective, choosing ESS is more beneficial than ITG for controlling vertigo.


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