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*
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Drug Monitoring/methods*
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Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
2.Early clinical outcomes of 3D-printed individualised customised prostheses in hip revision combined severe bone defect.
Hong-Ping WANG ; Ming-You WANG ; Xiao-Qin YANG ; Zhuo-Dong TANG ; Xun-Zhou SONG ; Yu-Ping LAN
China Journal of Orthopaedics and Traumatology 2025;38(2):163-169
OBJECTIVE:
To explore the early clinical outcomes of 3D printed individualised customised prostheses for in hip revision in patients with combined severe bone defects.
METHODS:
Twenty-two patients from January 2021 to May 2023 underwent hip revision using 3D printed personalised customised prostheses were retrospective analyzed, including 10 males and 12 females, age 28 to 78 with a mean of (58.9±12.8) years old. All of patients were combined with severe bone defects (Parprosky type Ⅲ). Among of them, 9 patients had periprosthetic infections and 13 patients had aseptic prosthesis loosening. All patients were treated with a 3D printed personalised prosthesis protocol, patients with the periprosthetic infection received a second stage revision after infection control. The operation time, preoperative waiting time, intraoperative and postoperative complications were recorded, and the clinical efficacy were evaluated at the final follow-up using the visual analogue scale (VAS) for pain, the Harris hip score.
RESULTS:
One patient was lost to follow-up and the remaining 21 patients were followed up for 10 to 15 with a mean of (12.91±1.44) months after surgery. All patients completed surgery as planned, with an operative time of 135 to 390 with a mean of (165.4±39.3) minutes and a preoperative waiting time of 7 to 16 with a mean of (10.5±3.3) days. Regarding patient complications:one patient had a severe intraoperative periprosthetic femoral fracture due to the combination of severe osteoporosis; one patient had an intraoperative greater trochanteric femur fracture. At the latest follow-up, all patients had good position of the custom-made prosthesis and no loosening of the prosthesis;all patients had good wound healing and no local redness or swelling. The total Harris score at the final follow-up (85.86±7.04) was significantly improved compared to the preoperative (44.86±2.36), P<0.001. The VAS at the last follow-up (2.19±0.87) was significantly improved compared with preoperative (7.41±0.96), P<0.001.
CONCLUSION
The clinical efficacy of 3D-printed personalised customised prosthesis in combined severe bone defect hip revision is satisfactory, but due to the increased preoperative waiting time of the patients and certain risks, certain indications should be mastered when applying in the clinic.
Humans
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Male
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Female
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Printing, Three-Dimensional
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Middle Aged
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Aged
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Adult
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Retrospective Studies
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Hip Prosthesis
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Arthroplasty, Replacement, Hip
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Reoperation
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Prosthesis Design
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Treatment Outcome
3.Predictive value of preoperative inflammatory response indicators for incisional infection after spinal surgery.
Wei LIANG ; Rui-Li ZHUO ; Shao-Dong SUN
China Journal of Orthopaedics and Traumatology 2025;38(2):183-187
OBJECTIVE:
To explore the clinical significance of preoperative neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and C-reactive protein (CRP) to albumin (ALB) ratio in spinal surgery patients with postoperative incision infection.
METHODS:
A total of 373 patients who underwent spinal surgery were collected and devided into two groups according to the postoperative incision infection situation. Among them, 65 cases in the incision infection group included 34 males and 31 females with a mean age of (56.01±9.78) years old;308 cases in the non incision infection group included 157 males and 151 females with a mean age of (55.54±10.19) years old. Blood cell analyzer was applied to detect neutrophils, lymphocytes, and platelets, and calculate NLR and PLR;immunoturbidimetry was applied to measure serum CRP and ALB levels and calculate CRP/ALB ratio;receiver operating characteristic (ROC) curve was applied to analyze the predictive value of preoperative NLR, PLR, and CRP/ALB ratio for postoperative spinal incision infection;Logistic multivariate regression was applied to analyze the influencing factors of incision infection after spinal surgery.
RESULTS:
The NLR(4.92±1.13), PLR (119.32±22.74), CRP/ALB ratio (10.19±2.51), operation time (3.02±0.64) h, history of diabetes 38.46%(25/65), and the proportion of patients with implant 32.31%(21/65) in the incision infection group were higher than those in the non incision infection group 3.72±0.81, 90.58±20.16, 7.23±2.21, (2.26±0.51) h, 16.88%(53/308), 11.69%(36/308), there were statistical differences(P<0.05). The AUC of preoperative NLR, PLR, and CRP/ALB ratio alone and in combination for predicting postoperative incision infection after spinal surgery was 0.786, 0.806, 0.839, and 0.926, respectively. Preoperative NLR, PLR, and CRP/ALB ratio were independent risk factors for postoperative incision infection in spinal surgery(P<0.05).
CONCLUSION
The determination of preoperative NLR, PLR, and CRP/ALB ratio is beneficial for early prediction of postoperative spinal incision infection, and the combined detection of the three can further improve the accuracy of the prediction results.
Humans
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Male
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Female
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Middle Aged
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Aged
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C-Reactive Protein/metabolism*
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Surgical Wound Infection/etiology*
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Adult
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Spine/surgery*
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Inflammation
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Preoperative Period
4.Comparison of application and efficacy of domestic HURWA and imported Smith & Nephew Cori robots in total knee arthroplasty.
Ming-You WANG ; Zhuo-Dong TANG ; Yu-Ping LAN ; Heng XIAO ; Ming-Li WANG ; Xun-Zhou SONG ; Hong-Ping WANG
China Journal of Orthopaedics and Traumatology 2025;38(10):1027-1036
OBJECTIVE:
Investigation on the clinical application of HURWA robot and Smith & Nephew Cori robot in total knee arthroplasty(TKA).
METHODS:
A retrospective analysis was performed on 84 patients with knee osteoarthritis who underwent robotic-assisted TKA (RATKA) between June 2023 and March 2025. According to the different robotic systems used, the patients were divided into the domestic HUARUN robotic-assisted total knee arthroplasty group (HRATKA group) and the Smith & Nephew Cori robotic-assisted total knee arthroplasty group (CRATKA group). There were 42 patients in the HRATKA group, including 16 males and 26 females; the age ranged from 56 to 73 years old, with an average of (64.70±8.30) years old;the body mass index (BMI) was (25.10±2.30) kg·m-2;21 cases were on the right side and 21 cases on the left side;in terms of Kellgren-Lawrence(K-L) classification, there were 15 cases of Grade Ⅲ and 27 cases of Grade Ⅳ;the disease duration ranged from 3 to 25 years, with an average of (15.5±7.5) years. The CRATKA group also included 42 patients, with 14 males and 28 females;the age ranged from 58 to 74 years old, with an average of (65.60±7.50) years old;the BMI was (24.50±2.70) kg·m-2; 20 cases were on the right side and 22 cases on the left side;regarding K-L classification, there were 11 cases of Grade Ⅲ and 31 cases of Grade Ⅳ;the disease duration ranged from 2 to 26 years, with an average of (16.5±8.8) years. Collect general data of all patients, including age, gender, height, weight, surgical site, K-L classification, incision length, and operation time. To evaluate prosthesis position, compare the frontal tibia component (FTC) angle, lateral femoral component (LFC) angle, lateral tibia component (LTC) angle, and frontal femoral component angle between the two groups of patients after surgery. Measure the deviation of the hip-knee-ankle (HKA) angle to assess lower limb alignment. Additionally, compare the following indicators between the two groups:Knee Society Score (KSS), Visual Analogue Scale (VAS) for pain, knee range of motion (ROM), hemoglobin (HB) level, hematocrit (HCT) level, complication rate, and in-hospital satisfaction.
RESULTS:
All patients successfully completed the surgery as scheduled, and all were followed up after the operation. The follow-up period ranged from 5 to 17 months with an average of (11.2±6.1) months. There were 4 cases of venous thrombosis in the HRATKA group and 3 cases in the CRATKA group;each group had 2 cases of wound exudation. No mechanical-related complications, pulmonary embolism, or other severe complications occurred. Comparison of the incision length and hospital stay between the HRATKA group and the CRATKA group showed no statistically significant difference (P>0.05). The operation time in the HRATKA group was (96.80±7.10) minutes, which was longer than that in the CRATKA group (90.10±8.80) minutes, and the difference was statistically significant (P<0.05). In the HRATKA group, the HKA angle was (178.93±1.11) degree, the FFC angle was (89.00±0.91)°, and the LFC angle was (7.31±2.17) degree;the corresponding values in the CRATKA group were (178.05±1.34)°, (87.88±1.74)°, and (10.60±2.84) degree respectively. The differences in these three indicators between the two groups were all statistically significant (P<0.05). However, there were no statistically significant differences in the FTC angle or LTC angle between the two groups (P>0.05). There was also no statistically significant difference in the total perioperative blood loss between the two groups (P>0.05). At 3 days after surgery, the VAS score for movement in the HRATKA group (5.95±1.45) points was higher than that in the CRATKA group (4.50±0.97) points, with a statistically significant difference (P<0.05);at 90 days after surgery, there was no statistically significant difference in the movement VAS score between the two groups (P>0.05). Additionally, no statistically significant differences were observed between the two groups in the KSS, ROM at 3 and 90 days after surgery, or satisfaction degree during hospitalization (all P>0.05).
CONCLUSION
The domestic HURWA robot demonstrates excellent performance in osteotomy efficiency and lower limb alignment recovery. The Smith & Nephew Cori robot has a significant advantage in soft tissue assessment and joint stability optimization. Both robotic systems offer high-quality surgical treatments that significantly improve short-term knee function.
Humans
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Male
;
Female
;
Arthroplasty, Replacement, Knee/instrumentation*
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Aged
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Middle Aged
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Retrospective Studies
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Robotic Surgical Procedures/methods*
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Osteoarthritis, Knee/surgery*
5.Immunophenotypic Characteristics of Bone Marrow Granulocytes and Their Clinical Significance in Patients with Multiple Myeloma.
Ning-Fang WANG ; Chong-Shan ZHAO ; Dong-Dong ZHANG ; Zhuo-Wen CAI ; Fang-Fang CAI ; Fang LIU ; Peng-Hao ZHAO
Journal of Experimental Hematology 2025;33(2):447-454
OBJECTIVE:
To explore the immunophenotypic characteristics of bone marrow granulocytes (G) and their clinical significance in patients with multiple myeloma (MM).
METHODS:
The granulocyte immunophenotypes of bone marrow in 70 MM patients (MM group) and 40 anemia patients (control group) were detected by flow cytometry, and its correlation with clinical characteristics was further analyzed. Univariate and multivariate regression analysis were used to screen factors that affected prognosis.
RESULTS:
The CD56+G%, CD13+G%, CD22+G% and CD117+G% in MM group were higher than those in the control group (all P <0.05). CD56+G% and CD117+G% in CR+VGPR group were significantly lower than those in PR+MR+PD group (both P <0.05). The CD10+G% in RISS Ⅲ stage and Ca2+ ≥2.65 mmol/L groups were increased (both P <0.05). The CD56+G% in elevated lactate dehydrogenase, β2-microglobulin≥5.5 mg/L and hemoglobin <85 g/L groups were increased (all P <0.05), while the CD117+G% in high-risk cytogenetic positive group was decreased (P <0.05). The expression rate of CD molecules on granulocytes was divided into low (L) and high (H) groups according to the median value. The overall survival (OS) of the LCD56+G%, LCD13+G% and LCD22+G% groups was significantly prolonged (all P <0.05). CD13+G% and CD22+G% were independent risk factors for OS in MM patients (HR=0.443, 0.410, both P <0.05).
CONCLUSION
The CD56+G%, CD10+G% and CD117+G% are closely correlated with clinical features in MM patients, while CD13+G% and CD22+G% are closely correlated with prognosis. Detection of CD molecules expression on granulocytes may be used to evaluate prognosis and guide treatment.
Humans
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Multiple Myeloma/immunology*
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Granulocytes/immunology*
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Prognosis
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Immunophenotyping
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Male
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Bone Marrow
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Female
;
Flow Cytometry
;
Middle Aged
;
Aged
;
Clinical Relevance
6.Clinical Effect and Imaging Evaluation of Tendon-Management and Patella-Movement Therapeutic Manipulation for Patellofemoral Arthritis:A Randomised Controlled Trial
Jinguang GU ; Guangcheng WEI ; Yong ZHAO ; Yongli DONG ; Zechuan ZHUO ; Aolin SUN ; Weikai QIN
Journal of Traditional Chinese Medicine 2025;66(13):1350-1356
ObjectiveTo evaluate the therapeutic effect and mechanism of tendon-management and patella-movement therapeutic manipulation in the treatment of patellofemoral arthritis based on imaging evaluation. MethodsTotally 126 patients with patellofemoral arthritis were recruited and divided into a treatment group and a control group according to a randomised numerical table. The control group received routine sodium hyaluronate injection once a week for a total of 5 times; the treatment group received tendon-management and patella-movement therapeutic manipulation three times a week for four weeks. We compared the Western Ontario and McMaster University osteoarthritis index score (WOMAC), visual analogue scale (VAS), imaging indicators including patellar external displacement distance, patellofemoral fit angle, lateral patellofemoral angle, and patellofemoral index, and overall effectiveness evaluation between the two groups before and one week after treatment. ResultsThe total effective rate of the treatment group (45/54, 83.33%) was significantly higher than that of the control group (36/54, 66.67%,P<0.05). One week after the end of treatment, the VAS scores and WOMAC scores of both groups were lower than those before treatment in the same group (P<0.01), and the patellofemoral index and patellofemoral fit angle of the treatment group decreased compared with that of the control group (P<0.05). Compared with the pre-treatment, the distance of patellar external displacement, patellofemoral index, and patellofemoral fit angle decreased in the treatment group 1 week after the end of treatment, and the patellofemoral fit angle decreased in the control group (P<0.05). ConclusionThe therapeutic manipulation of tendon-management and patella-movement can correct the degree of patellar external displacement, alleviate joint pain symptoms, improve joint function, and achieve the goal of treating patellofemoral arthritis.
8.Analysis on the Current Status of Outcome Indicators in Randomized Controlled Trials of Manual Treatment for Knee Osteoarthritis
Jinguang GU ; Guangcheng WEI ; Yong ZHAO ; Yongli DONG ; Zechuan ZHUO ; Chengzhi HOU ; Weikai QIN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(4):58-64
Objective To provide suggestions for the clinical efficacy evaluation method of manual therapy for knee osteoarthritis(KOA)by analyzing the current status of the use of outcome indicators in randomized controlled trials(RCTs)of manual therapy for KOA.Methods RCTs about manual treatment of KOA were retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,Scopus and Web of Science from March 2014 to March 2024.Two researchers screened literature,extracted literature features,analyzed the RCT indicator domain,measurement tools,and measurement time points for manual treatment of KOA.Results A total of 134 articles were included,with a sample size of 17 659.A total of 138 outcome indicators were used to classify the outcome indicators:64 symptoms and signs(46.4%),54 physical and chemical examinations(39.1%),11 quality of life(8.0%),2 psychological status indicators(1.4%),2 safety indicators(1.4%),2 muscle strength testing indicators(1.4%)and 3 other indicators(2.2%).Among 134 articles,there were a total of 36 measurement time points,with a research time span of 1 hour to 1 year after treatment;91 articles(67.9%)used"clinical efficacy"as the outcome measure;27 articles(20.1%)were evaluated for safety and reported adverse events.Conclusion The RCT outcome indicators of manual therapy for KOA lack representativeness,integrality,objectivity and specificity.The rigorism of the outcome indicators should be improved from the aspects of representativeness,integrality,objectivity and specificity,in order to achieve a complete evaluation effect on disease research.
9.Impact of antimicrobial resistance on sustainable development goals and countermeasures
Mengqing YU ; Dandan DONG ; Chao ZHUO ; Zhongyue HUANG ; Guanyang ZOU
Chinese Journal of Infection Control 2025;24(6):868-875
Antimicrobial resistance(AMR)has become a global public health crisis,posing a serious threat to the achievement of sustainable development goals(SDGs)of the United Nations.This article explores the potential con-sequences and far-reaching impacts of AMR on the global health system,economic development,and social well-being from the perspective of SDGs.This article analyzes the current situation and challenges of AMR prevention and control globally and domestically,proposes comprehensive response suggestions,such as establishing a global collaborative governance mechanism for AMR,deepening the"One Health"practice framework,perfecting survei-llance as well as infection prevention and control system on AMR,accelerating the development of new vaccines,ex-ploring AMR innovative response technologies,and strengthening AMR literacy education for all people.The re-search findings can provide reference globally,especially for developing countries to comprehensively respond to the threat of AMR and promote the SDGs process.
10.The value of total volume response and total mass response in the therapeutic evaluation of lung metastasis of hepatocarcinoma
Jun-cheng WAN ; Cai-hong YU ; Chang-yu LI ; Yong-jie ZHOU ; Wei ZHANG ; Jian-hua WANG ; Zhi-ping YAN ; Guo-wei YANG ; Zhuo-yang FAN ; Xu-dong QU
Fudan University Journal of Medical Sciences 2025;52(2):201-208,231
Objective To analyze the correlation between lesion volume,lesion mass,and maximum lesion diameter in the assessment of advanced hepatocarcinoma with lung metastasis,and to evaluate the application value of total volume response and total mass response of lung metastatic lesions in efficacy assessment.Methods A retrospective analysis was conducted on the CT imaging data of 20 patients clinically confirmed with hepatocarcinoma and lung metastases,followed by subsequent follow-up to monitor their survival outcomes.Volume measurement software was used to measure the volume of lesions before and after treatment.We recored lesion diameter,volume measurements and CT values,calculated the mass of the lesions.The correlation between lesion volume,mass and diameter was analyzed,as well as the correlation between the change rates of volume,mass and lesion diameter.Additionally,the total volume and total mass of all lesions were calculated.The correlation between the change rates of total volume/total mass and the change rate of pulmonary lesion diameter under the RECIST 1.1 criteria,as well as the correlation with changes in patients'tumor markers,were analyzed.Furthermore,the overall volume response and overall mass response of lesions were evaluated based on changes in total volume and total mass,and their consistencies with the RECIST 1.1 criteria for efficacy evaluation were analyzed.Finally,univariate Cox regression analysis was performed to explore the association between these variables and patient survival outcomes.Results There was strong correlation between lesion volume,mass and tumor diameter(r=0.771,0.775),between the rate of change in mass and the rate of change in lesion diameter(r=0.846),and between the rates of change in total volume/total mass and the rate of change in pulmonary lesion diameter under the RECIST 1.1 criteria(r=0.800,0.896).The correlation between the rates of change in total volume/total mass and patients'tumor markers was not statistically significant.There was moderate correlation between the rate of change in volume and the rate of change in lesion diameter(r=0.692).The evaluation results of total volume response and total mass response for pulmonary lesions in advanced hepatocarcinoma with lung metastasis were generally consistent with the RECIST 1.1 criteria(Kappa=0.486,0.426).Univariate Cox regression analysis revealed that total lesion volume(P=0.047)and total lesion mass(P=0.049)were independent prognostic factors for survival outcomes.Conclusion Lesion volume,mass,and diameter,as well as their respective change rates,were found to be interrelated.Furthermore,total lesion volume and total lesion mass were identified as independent prognostic factors for survival outcomes.The total volume response and total mass response are promising evaluation methods in evaluating the efficacy of lung metastasis of hepatocarcinoma,which are different from the RECIST 1.1 evaluation criteria.

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