1.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
;
Drug Monitoring/methods*
;
Humans
;
Organ Transplantation
;
Immunosuppressive Agents/administration & dosage*
;
Delphi Technique
2.A clinical study of electrocochleography monitoring for residual hearing retention during minimally invasive cochlear implant.
Ruijie WANG ; Jianfen LUO ; Qinglei DAI ; Xiuhua CHAO ; Yifei NI ; Fangxia HU ; Yueran CAO ; Haibo WANG ; Xiaohui ZHOU ; Lei XU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(5):425-432
Objective:To investigate the application value of intraoperative electrocochleography(ECochG) monitoring technique and insertion techniques in cochlear implant(CI) and analyze its relationship with postoperative residual hearing(RH) preservation. Methods:Thirty-one patients(35 ears) who received CI in our hospital from June 2022 to July 2024 were enrolled. The Advanced Bionics Active Insertion Monitoring(AIM) system was used for real-time ECochG monitoring during surgery. Intraoperative cochlear microphonics (CM) waveform changes were recorded and analyzed in relation to postoperative RH preservation. Results:①ECochG recordings were successfully obtained in 34 of 35 ears (97.1%). ②According to Harris classification, there were 7 ears(20.6%) of Type A(rising), 7 ears(20.6%) of Type C(declining), 8 ears(23.5%) of Type CC(fluctuating), and 12 ears(35.3%) of Type D(no response). ③The total CM amplitude decrease was significantly moderately correlated with postoperative low-mid frequency hearing loss(r=0.67, P=0.017). The total CM amplitude decrease was significantly moderately correlated with postoperative low frequency hearing loss(r=0.65, P=0.023). ④For the mean amplitude variation, the Amax was 30.70 μV, the Amin was 8.64 μV, and the Aend was 18.27 μV. ⑤Sixteen cases completed postoperative follow-up, with an average low-mid frequency(125-1 000 Hz) residual hearing loss of 15.25 dB HL and a RH preservation rate of 87.5%. Conclusion:Intraoperative ECochG monitoring can effectively predict postoperative residual hearing changes, effectively guide surgical manipulation, and improve residual hearing preservation rate.
Humans
;
Cochlear Implantation/methods*
;
Audiometry, Evoked Response
;
Cochlear Implants
;
Male
;
Female
;
Adult
;
Middle Aged
;
Monitoring, Intraoperative
;
Adolescent
;
Young Adult
;
Minimally Invasive Surgical Procedures
;
Child
;
Aged
;
Postoperative Period
3.Case report of robot-assisted resection of benign parotid gland tumor via hairline incision under facial nerve monitoring.
Xijun LIN ; Fang LIAO ; Xiaoming HUANG ; Faya LIANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(11):1053-1056
A 30-year-old female patient with a benign tumor in the superficial lobe of the left parotid gland underwent tumor resection via a 5 cm intra-hairline incision, using the da Vinci Xi surgical robot combined with the NIM-Response 3.0 facial nerve monitoring system. During the operation, facial nerve branches were located and protected through facial nerve monitoring, and the robotic arms were used for precise tumor dissection. Postoperatively, the facial nerve function, incision healing, and tumor recurrence were observed. duration of the procedure was 120 minutes, and the tumor(2.0 cm×1.5 cm) was completely resected. Postoperative pathological examination indicated a pleomorphic adenoma. During the 3-month postoperative follow-up, the patient's facial nerve function remained normal, no salivary fistula occurred, the incision was hidden within the hairline, no tumor recurrence was found in the ultrasound reexamination, and the patient was highly satisfied with the appearance. The surgical approach of robot-assisted resection of benign parotid gland tumor via a hairline incision under facial nerve monitoring has significant advantages in facial nerve protection and cosmetic effect, and is suitable for patients with benign parotid gland tumors meeting specific conditions.
Humans
;
Female
;
Adult
;
Parotid Neoplasms/surgery*
;
Facial Nerve
;
Robotic Surgical Procedures/methods*
;
Adenoma, Pleomorphic/surgery*
;
Parotid Gland/surgery*
;
Monitoring, Intraoperative
5.Research on intelligent fetal heart monitoring model based on deep active learning.
Bin QUAN ; Yajing HUANG ; Yanfang LI ; Qinqun CHEN ; Honglai ZHANG ; Li LI ; Guiqing LIU ; Hang WEI
Journal of Biomedical Engineering 2025;42(1):57-64
Cardiotocography (CTG) is a non-invasive and important tool for diagnosing fetal distress during pregnancy. To meet the needs of intelligent fetal heart monitoring based on deep learning, this paper proposes a TWD-MOAL deep active learning algorithm based on the three-way decision (TWD) theory and multi-objective optimization Active Learning (MOAL). During the training process of a convolutional neural network (CNN) classification model, the algorithm incorporates the TWD theory to select high-confidence samples as pseudo-labeled samples in a fine-grained batch processing mode, meanwhile low-confidence samples annotated by obstetrics experts were also considered. The TWD-MOAL algorithm proposed in this paper was validated on a dataset of 16 355 prenatal CTG records collected by our group. Experimental results showed that the algorithm proposed in this paper achieved an accuracy of 80.63% using only 40% of the labeled samples, and in terms of various indicators, it performed better than the existing active learning algorithms under other frameworks. The study has shown that the intelligent fetal heart monitoring model based on TWD-MOAL proposed in this paper is reasonable and feasible. The algorithm significantly reduces the time and cost of labeling by obstetric experts and effectively solves the problem of data imbalance in CTG signal data in clinic, which is of great significance for assisting obstetrician in interpretations CTG signals and realizing intelligence fetal monitoring.
Humans
;
Pregnancy
;
Female
;
Cardiotocography/methods*
;
Deep Learning
;
Neural Networks, Computer
;
Algorithms
;
Fetal Monitoring/methods*
;
Heart Rate, Fetal
;
Fetal Distress/diagnosis*
;
Fetal Heart/physiology*
6.A review of deep learning methods for non-contact heart rate measurement based on facial videos.
Shuyue GUAN ; Yimou LYU ; Yongchun LI ; Chengzhi XIA ; Lin QI ; Lisheng XU
Journal of Biomedical Engineering 2025;42(1):197-204
Heart rate is a crucial indicator of human health with significant physiological importance. Traditional contact methods for measuring heart rate, such as electrocardiograph or wristbands, may not always meet the need for convenient health monitoring. Remote photoplethysmography (rPPG) provides a non-contact method for measuring heart rate and other physiological indicators by analyzing blood volume pulse signals. This approach is non-invasive, does not require direct contact, and allows for long-term healthcare monitoring. Deep learning has emerged as a powerful tool for processing complex image and video data, and has been increasingly employed to extract heart rate signals remotely. This article reviewed the latest research advancements in rPPG-based heart rate measurement using deep learning, summarized available public datasets, and explored future research directions and potential advancements in non-contact heart rate measurement.
Humans
;
Deep Learning
;
Heart Rate/physiology*
;
Photoplethysmography/methods*
;
Video Recording
;
Face
;
Monitoring, Physiologic/methods*
;
Signal Processing, Computer-Assisted
7.A signal sensing system for monitoring the movement of human respiratory muscle based on the thin-film varistor.
Yueyang YUAN ; Zhongping ZHANG ; Lixin XIE ; Haoxuan HUANG ; Wei LIU
Journal of Biomedical Engineering 2025;42(4):733-738
In order to accurately capture the respiratory muscle movement and extract the synchronization signals corresponding to the breathing phases, a comprehensive signal sensing system for sensing the movement of the respiratory muscle was developed with applying the thin-film varistor FSR402 IMS-C07A in this paper. The system integrated a sensor, a signal processing circuit, and an application program to collect, amplify and denoise electronic signals. Based on the respiratory muscle movement sensor and a STM32F107 development board, an experimental platform was designed to conduct experiments. The respiratory muscle movement data and respiratory airflow data were collected from 3 healthy adults for comparative analysis. In this paper, the results demonstrated that the method for determining respiratory phase based on the sensing the respiratory muscle movement exhibited strong real-time performance. Compared to traditional airflow-based respiratory phase detection, the proposed method showed a lead times ranging from 33 to 210 ms [(88.3 ± 47.9) ms] for expiration switched into inspiration and 17 to 222 ms [(92.9 ± 63.8) ms] for inspiration switched into expiration, respectively. When this system is applied to trigger the output of the ventilator, it will effectively improve the patient-ventilator synchrony and facilitate the ventilation treatment for patients with respiratory diseases.
Humans
;
Respiratory Muscles/physiology*
;
Signal Processing, Computer-Assisted
;
Movement/physiology*
;
Respiration
;
Monitoring, Physiologic/methods*
;
Adult
8.Research progress on the early warning of heart failure based on remote dynamic monitoring technology.
Ying SHI ; Mengwei LI ; Lixuan LI ; Wei YAN ; Desen CAO ; Zhengbo ZHANG ; Muyang YAN
Journal of Biomedical Engineering 2025;42(4):857-862
Heart failure (HF) is the end-stage of all cardiac diseases, characterized by high prevalence, high mortality, and heavy social and economic burden. Early warning of HF exacerbation is of great value for outpatient management and reducing readmission rates. Currently, remote dynamic monitoring technology, which captures changes in hemodynamic and physiological parameters of HF patients, has become the primary method for early warning and is a hot research topic in clinical studies. This paper systematically reviews the progress in this field, which was categorized into invasive monitoring based on implanted devices, non-invasive monitoring based on wearable devices, and other monitoring technologies based on audio and video. Invasive monitoring primarily involves direct hemodynamic parameters such as left atrial pressure and pulmonary artery pressure, while non-invasive monitoring covers parameters such as thoracic impedance, electrocardiogram, respiration, and activity levels. These parameters exhibit characteristic changes in the early stages of HF exacerbation. Given the clinical heterogeneity of HF patients, multi-source information fusion analysis can significantly improve the prediction accuracy of early warning models. The results of this study suggest that, compared with invasive monitoring, non-invasive monitoring technology, with its advantages of good patient compliance, ease of operation, and cost-effectiveness, combined with AI-driven multimodal data analysis methods, shows significant clinical application potential in establishing an outpatient management system for HF.
Humans
;
Heart Failure/physiopathology*
;
Monitoring, Physiologic/methods*
;
Wearable Electronic Devices
;
Remote Sensing Technology
;
Early Diagnosis
;
Electrocardiography
;
Hemodynamics
9.Relevance of intra-abdominal pressure monitoring in non-operative management of patients with blunt liver and splenic injuries.
Vivek KUMAR ; Ramesh VAIDYANATHAN ; Dinesh BAGARIA ; Pratyusha PRIYADARSHINI ; Abhinav KUMAR ; Narendra CHOUDHARY ; Sushma SAGAR ; Amit GUPTA ; Biplab MISHRA ; Mohit JOSHI ; Kapil Dev SONI ; Richa AGGARWAL ; Subodh KUMAR
Chinese Journal of Traumatology 2025;28(4):307-312
PURPOSE:
Non-operative management (NOM) has been validated for blunt liver and splenic injuries. Literature on continuous intra-abdominal pressure (IAP) monitoring as a part of NOM remains to be equivocal. The study aimed to find any correlation between clinical parameters and IAP, and their effect on the NOM of patients with blunt liver and splenic injury.
METHOD:
A prospective cross-sectional study conducted at a level I trauma center from October 2018 to January 2020 including 174 patients who underwent NOM following blunt liver and splenic injuries. Hemodynamically unstable patients or those on ventilators were excluded, as well as patients who suffered significant head, spinal cord, and/or bladder injuries. The study predominantly included males (83.9%) with a mean age of 32.5 years. IAP was monitored continuously and the relation of IAP with various parameters, interventions, and outcomes were measured. Data were summarized as frequency (percentage) or mean ± SD or median (Q1, Q3) as indicated. χ2 or Fisher's exact test was used for categorical variables, while for continuous variables parametric (independent t-test) or nonparametric tests (Wilcoxon rank sum test) were used as appropriate. Clinical and laboratory correlates of IAP < 12 with p < 0.200 in the univariable logistic regression analysis were included in the multivariable analysis. A p < 0.05 was used to indicate statistical significance.
RESULTS:
Intra-abdominal hypertension (IAH) was seen in 19.0% of the study population. IAH was strongly associated with a high injury severity score (p < 0.001), and other physiological parameters like respiratory rate (p < 0.001), change in abdominal girth (AG) (p < 0.001), and serum creatinine (p < 0.001). IAH along with the number of solid organs involved, respiratory rate, change in AG, and serum creatinine was associated with the intervention, either operative or non-operative (p = 0.001, p = 0.002, p < 0.001, p < 0.001, p = 0.013, respectively). On multivariable analysis, IAP (p = 0.006) and the mean change of AG (p = 0.004) were significantly associated with the need for intervention.
CONCLUSION
As a part of NOM, IAP should be monitored as a continuous vital. However, the decision for any intervention, either operative or non-operative cannot be guided by IAP values alone.
Humans
;
Male
;
Adult
;
Female
;
Wounds, Nonpenetrating/physiopathology*
;
Spleen/injuries*
;
Prospective Studies
;
Cross-Sectional Studies
;
Liver/injuries*
;
Middle Aged
;
Monitoring, Physiologic/methods*
;
Pressure
;
Abdominal Injuries/physiopathology*
;
Intra-Abdominal Hypertension
;
Young Adult
10.Real-world Study of Icotinib in EGFR Mutant Non-small Cell Lung Cancer Based on the Therapeutic Drug Monitoring.
Sen HAN ; Lan MI ; Jian FANG ; Xu MA
Chinese Journal of Lung Cancer 2025;28(1):33-39
BACKGROUND:
In the real world, the plasma drug concentration range of Icotinib treated with epidermal growth factor receptor (EGFR) gene mutant non-small cell lung cancer (NSCLC) is not yet clear, and there may be a correlation between drug concentration and its efficacy, as well as adverse reactions. This study conducted therapeutic drug monitoring (TDM) of Icotinib. The aim of this study was to analyze the drug exposure of Icotinib in targeted therapy for NSCLC, and to investigate the relationship between Icotinib drug concentration and its efficacy and safety.
METHODS:
Prospective blood samples were collected from NSCLC patients with EGFR-sensitive mutations who received treatment with Icotinib in Peking University Cancer Hospital from April 2022 to July 2024. The drug trough concentration of Icotinib in plasma was detected, and the correlation between drug concentration and efficacy, as well as the toxic side effects, were further analyzed based on the patient's clinical medical records.
RESULTS:
22 patients who were treated with Icotinib underwent TDM, but one of them did not acquire the data due to prolonged discontinuation. The remaining 21 patients, each with 1-7 blood draws, obtained a total of 32 plasma drug concentration data. The drug concentration of icotinib is a range of 126.9-2317.1 ng/mL. Among the 21 patients, 18 cases were female (85.7%), and 3 cases were male (14.3%), with an age range of 44-85 years old. The pathological types are all lung adenocarcinoma. Except for 5 patients receiving postoperative adjuvant therapy, 16 patients had assessable tumors. The objective response rate was 43.8% (7/16), and the disease control rate reached 100.0% (16/16). The median value of drug concentration is 805.5 ng/mL among those 21 patients. Compared with the patients who achieved stable disease, the median value of drug concentrations of Icotinib in patients who achieved partial response were 497.2 and 1195.5 ng/mL, respectively (P=0.017). The median value of drug concentrations for patients who did not experience adverse reactions during treatment and those who experienced adverse reactions were 997.0 and 828.6 ng/mL, respectively (P=0.538).
CONCLUSIONS
Icotinib demonstrates good therapeutic effect and tolerable toxicity on the EGFR gene mutant NSCLC. There is a certain negative correlation between the plasma drug concentration of Icotinib and its efficacy, while there seems no significant correlation with safety.
Humans
;
Carcinoma, Non-Small-Cell Lung/genetics*
;
ErbB Receptors/metabolism*
;
Lung Neoplasms/genetics*
;
Male
;
Female
;
Crown Ethers/blood*
;
Middle Aged
;
Drug Monitoring
;
Aged
;
Quinazolines/blood*
;
Mutation
;
Adult
;
Aged, 80 and over
;
Antineoplastic Agents/blood*
;
Prospective Studies

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