1.Ethical issues and countermeasures of off-label drug use in children
Limin LI ; Haipeng HU ; Xiaoqin CAO ; Xiaohong LIU
Chinese Medical Ethics 2025;38(2):227-231
Children, as a special group, frequently experience of off-label drug use worldwide. Common reasons for off-label drug use in children include the lack of data on pediatric patients during the clinical trial stage of drug development, delayed updates to drug instructions, and the non-standard professional behavior of some doctors. Off-label drug use in children is a double-edged sword. It could save lives and provide a way to explore additional functions of drugs, while it may also lead to the phenomenon of hyper-indication abuse, increasing the risk of adverse drug events. Regulating off-label drug use in children can safeguard the best treatment rights and interests of children. It is recommended to encourage pharmaceutical enterprises to conduct research and development of pediatric new drugs, simplify the approval process for drug instructions amendments, accumulate evidence-based medical evidence for off-label drug use in children, standardize the process of off-label drug use in children in medical institutions, continuously improve the standardized diagnosis and treatment capabilities of pediatricians, and actively cooperate with the families of pediatric patients in diagnosis and treatment, so as to comprehensively safeguard the rights and interests of both doctors and patients.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
3.Exploring the pathogenesis of "internal heat leading to zheng" in diabetic kidney disease from the perspective of "glucose toxicity" and its differential diagnosis and treatment
Yuxin HU ; Boning CAO ; Lin WANG ; Ziheng GAO ; Maoxuan LIN ; Zeyu XUE ; Weijing LIU ; Yaoxian WANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):386-391
Diabetic kidney disease (DKD) is a common microvascular complication of diabetes. "Internal heat leading to zheng" is the core pathogenesis of DKD, while "glucose toxicity" is transformed from subtle substances through "internal heat" and the cementation of various pathological products, which is pivotal to the transformation of diabetes to DKD. "Glucose toxicity" is characterized by deep and widespread heat, caused by various pathological factors, and its sticky nature makes it difficult to resolve, which can cause severe damage to the kidney collaterals. In the early stage of "glucose toxicity", it is yang pathogen, which can be transformed into yin pathogen in the later stage with disease progression. In clinical practice, treatment should be based on disease staging, with attention on grasping the pathogenesis of "internal heat leading to zheng" and identifying the nature of "glucose toxicity". During the diabetic period, clearing heat is the primary method, often using modified Yueju Pill and Dachaihu Decoction. In the early stage of DKD, treatment primarily focuses on clearing and penetrating latent heat to treat DKD, aiming to prevent toxic heat from transitioning from qi to blood. The approach emphasizes clearing heat and re-penetrating, detoxification, and re-clearing, often using a self-made modified Qingre Xiaozheng Decoction. In the middle and late stages of DKD, the focus shifts to clearing heat, eliminating zheng, strengthening vital qi, and dispelling turbidity, with commonly used treatments including the self-made modified Xiezhuo Xiaozheng Formula, Jingui Shenqi Pill, and Zhenwu Decoction.
4.Academic connotation of the "three phases and three methods" theory in preventing and treating radiation-induced lung injury
Kangdi CAO ; Dandan WANG ; Shuaihang HU ; Jiawei WANG ; Wei HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):412-417
Radiation-induced lung injury is a prevalent side effect of radiotherapy for chest cancer. The "three phases and three methods "is an innovative theory based on the evolution of the core pathogenesis of radiation-induced lung injury. Its formation also considers the understanding of radiation-induced lung injury by ancient and modern medical practitioners, pathological characteristics, clinical manifestations, and the development patterns of radiation-induced lung injury. The "three phases and three methods" refers to the three phases of the course and the three treatment methods. The core pathogenesis of radiation-induced lung injury from the beginning, middle and late stages is heat toxicity, yin deficiency, and blood stasis. Therefore, the course of radiation-induced lung injury is divided into three phases: blazing heat toxin, yin deficiency and heat accumulation, and static blood obstruction. The method of clearing the lung and resolving toxins, enriching yin and venting heat, invigorating blood and dissolving stasis are used respectively. Traditional Chinese medicines commonly used in each phase include Flos Lonicerae, Atrina Glass, heartleaf houttuynia herb, Radix Ophiopogonis, American Ginseng, Forsythiae Fructus, Radix Salviae Miltiorrhizae, Rhizoma Ligustici chuanxiong, Scorpio, etc. This article presents the theoretical origins of the "three phases and three methods" concept by reviewing of ancient literature, inheriting experience, and summarizing disease pathogenesis, as well as elaborating on the academic connotations of the "three phases and three methods". The scientific validity of the "three phases and three methods" is verified by literature, clinical, and basic research. The "three phases and three methods" interprets the core characteristics of each stage of radiation-induced lung injury, improves the traditional Chinese medicine prevention and treatment system for radiation-induced lung injury, and provides theoretical basis for achieving complete process management.
5.Research and application progress on recognition components of surface plasmon resonance sensors in the pharmaceutical field
Xiaofei WANG ; Ying ZHANG ; Jiayu GU ; Xiner HU ; Hai ZHANG ; Yan CAO
Journal of Pharmaceutical Practice and Service 2025;43(5):205-212
Surface plasmon resonance (SPR) sensor is an optical detection technique enables real-time and dynamic monitoring of biological samples. SPR-based biosensors have remarkable characteristics such as label-free detection and high sensitivity, making them important tools for studying molecular interactions. The recognition element, which plays a critical role in SPR sensors,which could specifically identify and capture of target analytes, closely influencing the selectivity performance of the sensor. The progress on SPR sensors in pharmaceutical research were reviewed, which focused on the application of recognition elements such as antibodies, aptamers, molecularly imprinted polymers, and metal nanoparticles.
6.LC-MS-based phosphoproteomic profiling of the acute phase of myocardial infarction in mice
Yang GAO ; Jian ZHANG ; Shiyu HU ; Jingpu WANG ; Yiwen WANG ; Jiatian CAO ; Feng ZHANG
Chinese Journal of Clinical Medicine 2025;32(3):392-402
Objective To investigate dynamic changes in myocardial protein phosphorylation during the acute phase of myocardial infarction (MI) in mice. Methods Six 8-week-old C57BL/6J mice were randomly assigned to MI model (n=3) or sham-operated control (n=3) groups. Cardiac tissues were harvested 72 hours post-intervention for proteomic analysis. Phosphorylation modifications were systematically characterized using liquid chromatography-mass spectrometry (LC-MS). Bioinformatics analyses included differential phosphorylation screening, functional enrichment, hierarchical clustering, and protein-protein interaction network. Results LC-MS identified 1 921 differentially phosphorylated sites (20 tyrosine and 1 901 serine/threonine sites) across 851 proteins. Compared with controls, MI hearts exhibited significant phosphorylation upregulation at 1 545 sites and downregulation at 376 sites (P<0.05). Conclusions This study delineates MI-associated phosphorylation dynamics, providing mechanistic insights and potential therapeutic targets for acute MI intervention.
7.Efficacy of laparoscopic radical cystectomy with indocyanine green fluorescence imaging versus standard lymph node dissection: a randomized comparative study
Lifeng LIU ; Na CAO ; Yansong GUO ; Hao WANG ; Xiaopeng WANG ; Fengshuo YANG ; Yuepeng HU ; Longjiang TIAN ; Dawei TIAN
Journal of Modern Urology 2025;30(3):212-214
Objective: To investigate the efficacy,safety and feasibility of regional lymph node dissection in laparoscopic radical surgery for bladder cancer under the guidance of indocyanine green fluorescence imaging. Methods: A total of 30 patients with muscle invasive bladder cancer (T2/T3NxM0) who volunteered to enter the clinical trial were randomly divided into the indocyanine green imaging guided laparoscopic regional lymph node dissection group (n=15) and the standard pelvic lymph node dissection group (n=15).The number of positive lymph nodes,operation time,intraoperative bleeding volume,incidence of lymph leakage,and tumor recurrence and metastasis rate 2-year after surgery were collected. Results: The number of positive lymph nodes was (4.20±1.66) and (4.60±1.72) respectively in the indocyanine green and standard groups,with no statistically significant difference (P>0.05).There were no statistically significant difference in the tumor recurrence and metastasis rates 2-year after surgery between the two groups (P>0.05).However,the indocyanine green group had shorter operation time,less intraoperative bleeding volume,and lower incidence of lymphatic leakage than the standard group (P<0.05). Conclusion: Indocyanine green fluorescence imaging guided laparoscopic lymph node dissection has comparable clinical efficacy to standard lymph node dissection,but with fewer complications.
8.Progress in clinical application of anti-CD20 monoclonal antibody in refractory nephrotic syndrome in children
Jinbo XIANG ; Guanguo SHEN ; Zheng LI ; Xiaoyan HU ; Tingting CAO ; Ziran XU ; Ting DING ; Jingbo LI
China Pharmacy 2025;36(16):2078-2084
Anti-CD20 monoclonal antibodies for the treatment of refractory nephrotic syndrome (RNS) in children. The first- generation rituximab is the most widely used in clinical practice; it shows definite efficacy in children with RNS, is recommended by guidelines, particularly for achieving a high remission rate in minimal change nephrosis, and can significantly reduce the cumulative use of glucocorticoids and immunosuppressants. The second-generation ofatumumab has potential as an alternative treatment for patients who are intolerant or resistant to rituximab, while the third-generation obinutuzumab has shown efficacy in complex cases such as rituximab resistance or post-transplant recurrence. However, there is still controversy regarding the optimization of rituximab treatment dosage and whether ofatumumab and obinutuzumab offer greater advantages than rituximab for the treatment of RNS in children. The most common adverse reaction induced by anti-CD20 monoclonal antibodies is infusion reactions, and long-term adverse events mainly include increased risks of sustained immunosuppression and infections. Rituximab has significant economic advantages for the treatment of RNS, but additional pharmacoeconomic research based on China’s healthcare environment is needed to evaluate the cost-effectiveness of ofatumumab and obinutuzumab in this population. Given that the current use of ofatumumab and obinutuzumab in this field is considered off-label use, clinical application should only proceed after a rigorous evaluation of the patient’s benefits and risks.
9.Exploration of the comprehensive management practice pathway for long-term prescription medications in psychiatry
Mengxi NIU ; Pengfei LI ; Xue WANG ; Shanshan LIU ; Yanxiang CAO ; Hongyan ZHUANG ; Hu WANG ; Li BAI ; Huawei LI ; Fei PAN ; Sha SHA ; Qing’e ZHANG
China Pharmacy 2025;36(19):2366-2371
OBJECTIVE To explore comprehensive management and potential issues associated with long-term prescriptions medications of psychiatry, in order to provide a reference for the comprehensive management of long-term prescriptions of psychiatry in psychiatric hospitals and other medical institutions’ pharmacies. METHODS Starting from the applicable principles for long-term prescriptions of psychiatry, this study introduced the standardized assessment and precautions before issuing long-term prescriptions, the formulation and adjustment of the drug list, as well as the rational management of the long-term prescriptions. It also analyzed potential issues that may arise in the comprehensive management of long-term prescription medications and proposed corresponding countermeasures and suggestions. RESULTS & CONCLUSIONS Prior to initiating long-term prescriptions, a standardized assessment should be conducted on patients from the aspects of their psychiatric condition and long-term potential risk factors, pharmacological treatment plans and other non-pharmacological therapies, physical illnesses. Additionally, healthcare providers should fulfill their obligation to inform patients or their family members. The comprehensive management of long-term prescription medications should be jointly established and improved by multiple departments, and the formulation of drug catalogs should avoid including drugs with potential social harm or medication risks while complying with policy requirements. Furthermore, measures such as adding special identifiers to long-term prescriptions, providing patients with reminders about (No.YGLX202537) prescription expiration, or offering online consultations can also effectively enhance the rationality of medication use under long-term prescriptions. Currently, the implementation of long-term prescriptions in psychiatry remains challenged by inconsistencies in prescription duration, incomplete coverage of diagnostic categories, poor patient adherence, and the risk of deviation in clinical assessments. In this regard, measures such as collaborating with multiple departments to strengthen long-term prescription information management, providing matching pharmaceutical services, ensuring the quality and rationality of long-term prescription implementation, and using modern methods to screen high-risk patients can be taken to improve patient medication compliance and safety.
10.Effect of perioperative transcutaneous electrical acupoint stimulation on postoperative fatigue syndrome in elderly patients.
Jing CHENG ; Shiyi HU ; Yuru FANG ; Guixia CAO ; Tao JIANG ; Yiqiao WANG
Chinese Acupuncture & Moxibustion 2025;45(8):1071-1077
OBJECTIVE:
To observe the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative fatigue syndrome (POFS) in elderly patients undergoing laparoscopic radical gastrectomy.
METHODS:
A total of 80 elderly patients scheduled for laparoscopic radical gastrectomy were randomized into a TEAS group and a sham TEAS group, 40 cases in each one. In the TEAS group, TEAS intervention was applied at bilateral Hegu (LI4), Neiguan (PC6), Zusanli (ST36) and Sanyinjiao (SP6) from 30 min before anesthesia induction until surgery completion, and at 18:00 on 1st, 2nd and 3rd days after surgery, once a day, 30 min a time. In the sham TEAS group, the same acupoints were selected and connected to the electroacupuncture device at the same time, without electrical stimulation. One day before surgery and 1, 3, 7 days after surgery, the 10-item short form of identity consequence fatigue scale (ICFS-10) score was observed, and the POFS incidence rate of 1, 3, 7 days after surgery was assessed in the two groups. One day before surgery, surgery completion, and 1, 3 days after surgery, the serum levels of superoxide dismutase (SOD), β-endorphin (β-EP) were detected; 1 day before surgery and 1, 3, 7 days after surgery, the serum level of tumor necrosis factor-α (TNF-α) was detected in the two groups. The pain visual analog scale (VAS) score was observed at 24, 48 and 72 h after surgery; the intraoperative dosage of propofol and remifentanil, and the incidence rate of postoperative nausea and vomiting, itching, respiratory depression were recorded in the two groups.
RESULTS:
In the TEAS group, on 1, 3, 7 days after surgery, except for the scores of item 8-10, the item scores and the total scores of ICFS-10 were lower than those in the sham TEAS group (P<0.001); on 3 and 7 days after surgery, the POFS incidence rates were lower than those in the sham TEAS group (P<0.05). In the TEAS group, on 1 and 3 days after surgery, the serum levels of SOD were higher than those in the sham TEAS group (P<0.05, P<0.01); at surgery completion, and on 1, 3 days after surgery, the serum levels of β-EP were higher than those in the sham TEAS group (P<0.001, P<0.01); on 1, 3, 7 days after surgery, the serum levels of TNF-α were lower than those in the sham TEAS group (P<0.01, P<0.001). In the TEAS group, at 24, 48 and 72 h after surgery, the pain VAS scores were lower than those in the sham TEAS group (P<0.001, P<0.01, P<0.05); the intraoperative dosage of remifentanil was lower than that in the sham TEAS group (P<0.001); the incidence rate of postoperative nausea and vomiting was lower than that in the sham TEAS group (P<0.01).
CONCLUSION
Perioperative TEAS intervention can effectively reduce the incidence rate of POFS, improve fatigue symptom and mental state in elderly patients undergoing laparoscopic radical gastrectomy, its mechanism may related to enhancing endogenous β-EP release, inhibiting inflammatory response, and reducing central oxidative stress, thereby promoting postoperative recovery.
Humans
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Acupuncture Points
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Male
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Female
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Aged
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Transcutaneous Electric Nerve Stimulation
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Postoperative Complications/therapy*
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Middle Aged
;
Fatigue/etiology*
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Gastrectomy/adverse effects*
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beta-Endorphin/blood*
;
Tumor Necrosis Factor-alpha/blood*


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