1.Predictive model for severe adverse reaction associated with bevacizumab based on the global trigger tool and machine learning
Yongfei FU ; Xin LONG ; Hongzhen XU ; Jian TANG ; Xiangqing LI ; Yucheng LONG ; Dong QIN
China Pharmacy 2026;37(4):497-503
OBJECTIVE To confirm trigger items for adverse drug reaction (ADR) induced by bevacizumab, to identify and analyze the occurrence of related ADR, and to establish a predictive model for severe adverse reaction (SAR) caused by this drug. METHODS Based on the global trigger tool (GTT) theory, and referencing the GTT White Paper, drug package inserts and relevant literature, trigger items for bevacizumab-related ADR were confirmed using a single-round Delphi method. Utilizing these established items, electronic medical records of relevant patients at Guilin People’s Hospital from January 2020 to September 2024 were actively screened via the China Hospital Pharmacovigilance System. Pharmacists then identified and tallied the occurrence of bevacizumab-induced ADR. Data from patients with any positive trigger item served as the study subjects (divided into training and test sets at a ratio of 7∶3), candidate feature variables were selected from 39 related variables using the Boruta algorithm, and the multivariable Logistic regression analysis was performed with the occurrence of SAR as the dependent variable. Based on these candidate features, Logistic Regression, Extreme Gradient Boosting, Light Gradient Boosting Machine, Random Forest, and Categorical Boosting models were constructed. Model performance was evaluated using metrics including the area under the curve (AUC) of receiver operating characteristic curve and recall rate. The Shapley Additive exPlanations (SHAP) method was applied to analyze and interpret the contribution of each variable. A nomogram was constructed based on the optimal model. RESULTS A total of 38 trigger items for active monitoring of bevacizumab-related ADR were determined, comprising 17 laboratory indicators, 13 clinical manifestations, and 8 intervention measures. In total, 483 patients with positive trigger items were included, and 318 patients with bevacizumab-induced ADR were identified, including 83 SARs. The positive predictive values for the trigger items and cases were 43.57% (708/1 625) and 63.84% (318/483), respectively. Bevacizumab-induced ADR involved 7 systems/organs, with the hematological system being the most frequently involved (64.15%). The Boruta algorithm selected 7 vari ables: serum potassium, hematocrit, albumin-to-globulin ratio, prealbumin, hypertension history, age and red blood cell count. Multivariable Logistic regression showed that elevated serum potassium levels were associated with a decreased risk of bevacizumab-induced SAR (OR=0.234, P =0.002), while a history of hypertension (OR=2.642, P =0.006) and increased age (OR=1.040, P =0.025) were associated with an increased risk. The Logistic Regression model demonstrated superior performance with higher AUC, F1 score and recall rate (0.761, 0.447, 0.607), compared to other models. SHAP evaluation results indicated that variables such as serum potassium, hematocrit, and age ranked highest in importance. CONCLUSIONS Totally 38 trigger entries have been successfully identified for active screening of bevacizumab-related ADR. Elevated serum potassium levels are a protective factor against bevacizumab-induced SAR, whereas the hypertension history and increased age are risk factors. The Logistic Regression model is the optimal predictive model.
2.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
3.Application of 22G needle-guided suture to transcutaneous orbital septum fat release and transposition over the orbital rim
Qinghua LI ; Qiong GAO ; Guangwei ZENG ; Xinjian HUANG ; Yongfei XU ; Shuang CHEN ; Yongqiang REN
Chinese Journal of Plastic Surgery 2025;41(1):32-37
Objective:To explore and analyze the feasibility and efficacy of the 22G needle-guided suture for orbital septum fat flap fixation on the periosteum.Methods:The retrospective study was conducted. From January 2022 to November 2023, patients with tear trough deformity and eyelid bags underwent surgery of releasing the orbicularis retaining ligament (ORL) complex, orbital septum fat pad combined with 22G needle-guided suture in Department of Burn and Plastic Surgery, the First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology. Postoperative follow-up was conducted to observe the occurrence of complications. The lacrimal depression deformity was classified according to the Hirmand standard and the degree of lower eyelid bags was graded to evaluate the surgical outcome. Patients were evaluated their satisfaction using the visual analogue scale (very dissatisfied, dissatisfied, average, satisfied, very satisfied).Results:A total of 32 patients (30 females and 2 males) were included in this study. The age range was 31-62 years old with an average of 50.2 years. All patients were followed up for 6 months postoperatively. None of the patients had any severe complications, such as inferior eyelid ectropion, inferior eyelid retraction, scar hyperplasia, and diplopia. Four patients showed mild eyelid-eyeball separation, two patients had conjunctival edema, and all recovered in 1 month. The orbital fat protrusion, tear trough depression deformity, and lower eyelid skin laxity were significantly improved compared to before the operation. Postoperative satisfaction was 22 cases, very satisfied 10 cases, and patient satisfaction rate was 100% (32/32) after surgery.Conclusion:The method of 22G needle-guided suture to fix orbital septum fat pad represents a technically feasible, easy, and suitable for promotion.
4.Therapeutic effects of piperacillin/tazobactam combined with acetylcysteine solution on severe pneumonia after cerebral infarction
Yongfei ZHU ; Qinqin WANG ; Wenzheng XU ; Haichang LI
Chinese Journal of Nosocomiology 2025;35(15):2258-2262
OBJECTIVE To explore the effects of piperacillin/tazobactam combined with acetylcysteine solution on severe pneumonia after cerebral infarction,and to analyze its impact on cardiopulmonary and neurological function.METHODS A total of 86 patients with severe pneumonia after cerebral infarction admitted to Yulin Xingyuan Hos-pital from Jan.2022 to Jun.2024 were selected and divided into a control group and a study group using the ran-dom number table method(single blind),with 43 cases in each group.The control group was treated with intrave-nous drip of piperacillin/tazobactam,while the study group received additional inhalation of acetylcysteine solution based on the control group's treatment.The levels of inflammatory factors[C-reactive protein(CRP),interleukin-6(IL-6)and procalcitonin(PCT)],lung function indicators[forced vital capacity(FVC),peak expiratory flow rate(PEF),forced expiratory volume in one second(FEV1)and mean maximal expiratory flow rate(MMEF)],cardiac function indicators[left ventricular ejection fraction(LVEF),cardiac output(CO),cardiac index(CI)and stroke volume(SV)],NIH Stroke Scale(NIHSS)score,clinical efficacy,and the occurrence of adverse reactions were compared before and after treatment.RESULTS Compared with the control group,the study group had low levels of CRP,IL-6,PCT and NIHSS scores after treatment(P<0.05),and high levels of FVC,PEF,FEV1,MMEF,LVEF,CO,CI,and SV after treatment(P<0.05).The overall response rate in the study group was 95.35%,higher than 81.40%in the control group(χ2=4.074,P=0.044).There was no statistically significant difference in the incidence of adverse reactions between the control group and the study group during treatments(χ2=0.179,P=0.672).CONCLUSION Piperacillin/tazobactam combined with inhaled acetylcysteine solution for the treatment of severe pneumonia after cerebral infarction can improve clinical efficacy,reduce levels of inflamma-tory factors,and enhance cardiopulmonary and neurological functions in patients,which has a high safety profile.
5.Research progress on promoting infection prevention and control based on the chemotactic characteristics of microorganisms
Zhiyi LIAO ; Yongfei WANG ; Xisheng XU
Journal of Chinese Physician 2025;27(6):957-960
Infection has brought huge disasters and heavy economic burdens to human health. With the continuous expansion of the global antimicrobial resistance crisis, more people will face threats to their lives. Considering the numerous problems existing in traditional antibiotic anti-infection strategies and the many challenges faced by the new non-antibiotic anti-infection strategies under development, it is urgent to explore a new approach to deal with the current situation now. Based on the results of previous research, some scholars have made significant progress in the field of antibacterial by taking advantage of the chemotactic tendency characteristics of bacteria, and proposed that chemotactic sterilization will be a new strategy. As an active inducement strategy, it does not cause bacteria to develop drug resistance and can completely eliminate bacteria while avoiding tissue damage. It will be an effective means for future anti-infection research. This article reviews the existing strategies for infection prevention and control and the latest research progress of chemotaxis and sterilization, aiming to provide a reference for wound anti-infection and systemic anti-infection research throughout the body, and offer new directions and ideas for future infection prevention and control strategies.
6.Application of 22G needle-guided suture to transcutaneous orbital septum fat release and transposition over the orbital rim
Qinghua LI ; Qiong GAO ; Guangwei ZENG ; Xinjian HUANG ; Yongfei XU ; Shuang CHEN ; Yongqiang REN
Chinese Journal of Plastic Surgery 2025;41(1):32-37
Objective:To explore and analyze the feasibility and efficacy of the 22G needle-guided suture for orbital septum fat flap fixation on the periosteum.Methods:The retrospective study was conducted. From January 2022 to November 2023, patients with tear trough deformity and eyelid bags underwent surgery of releasing the orbicularis retaining ligament (ORL) complex, orbital septum fat pad combined with 22G needle-guided suture in Department of Burn and Plastic Surgery, the First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology. Postoperative follow-up was conducted to observe the occurrence of complications. The lacrimal depression deformity was classified according to the Hirmand standard and the degree of lower eyelid bags was graded to evaluate the surgical outcome. Patients were evaluated their satisfaction using the visual analogue scale (very dissatisfied, dissatisfied, average, satisfied, very satisfied).Results:A total of 32 patients (30 females and 2 males) were included in this study. The age range was 31-62 years old with an average of 50.2 years. All patients were followed up for 6 months postoperatively. None of the patients had any severe complications, such as inferior eyelid ectropion, inferior eyelid retraction, scar hyperplasia, and diplopia. Four patients showed mild eyelid-eyeball separation, two patients had conjunctival edema, and all recovered in 1 month. The orbital fat protrusion, tear trough depression deformity, and lower eyelid skin laxity were significantly improved compared to before the operation. Postoperative satisfaction was 22 cases, very satisfied 10 cases, and patient satisfaction rate was 100% (32/32) after surgery.Conclusion:The method of 22G needle-guided suture to fix orbital septum fat pad represents a technically feasible, easy, and suitable for promotion.
7.Therapeutic effects of piperacillin/tazobactam combined with acetylcysteine solution on severe pneumonia after cerebral infarction
Yongfei ZHU ; Qinqin WANG ; Wenzheng XU ; Haichang LI
Chinese Journal of Nosocomiology 2025;35(15):2258-2262
OBJECTIVE To explore the effects of piperacillin/tazobactam combined with acetylcysteine solution on severe pneumonia after cerebral infarction,and to analyze its impact on cardiopulmonary and neurological function.METHODS A total of 86 patients with severe pneumonia after cerebral infarction admitted to Yulin Xingyuan Hos-pital from Jan.2022 to Jun.2024 were selected and divided into a control group and a study group using the ran-dom number table method(single blind),with 43 cases in each group.The control group was treated with intrave-nous drip of piperacillin/tazobactam,while the study group received additional inhalation of acetylcysteine solution based on the control group's treatment.The levels of inflammatory factors[C-reactive protein(CRP),interleukin-6(IL-6)and procalcitonin(PCT)],lung function indicators[forced vital capacity(FVC),peak expiratory flow rate(PEF),forced expiratory volume in one second(FEV1)and mean maximal expiratory flow rate(MMEF)],cardiac function indicators[left ventricular ejection fraction(LVEF),cardiac output(CO),cardiac index(CI)and stroke volume(SV)],NIH Stroke Scale(NIHSS)score,clinical efficacy,and the occurrence of adverse reactions were compared before and after treatment.RESULTS Compared with the control group,the study group had low levels of CRP,IL-6,PCT and NIHSS scores after treatment(P<0.05),and high levels of FVC,PEF,FEV1,MMEF,LVEF,CO,CI,and SV after treatment(P<0.05).The overall response rate in the study group was 95.35%,higher than 81.40%in the control group(χ2=4.074,P=0.044).There was no statistically significant difference in the incidence of adverse reactions between the control group and the study group during treatments(χ2=0.179,P=0.672).CONCLUSION Piperacillin/tazobactam combined with inhaled acetylcysteine solution for the treatment of severe pneumonia after cerebral infarction can improve clinical efficacy,reduce levels of inflamma-tory factors,and enhance cardiopulmonary and neurological functions in patients,which has a high safety profile.
8.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
9.Research progress on promoting infection prevention and control based on the chemotactic characteristics of microorganisms
Zhiyi LIAO ; Yongfei WANG ; Xisheng XU
Journal of Chinese Physician 2025;27(6):957-960
Infection has brought huge disasters and heavy economic burdens to human health. With the continuous expansion of the global antimicrobial resistance crisis, more people will face threats to their lives. Considering the numerous problems existing in traditional antibiotic anti-infection strategies and the many challenges faced by the new non-antibiotic anti-infection strategies under development, it is urgent to explore a new approach to deal with the current situation now. Based on the results of previous research, some scholars have made significant progress in the field of antibacterial by taking advantage of the chemotactic tendency characteristics of bacteria, and proposed that chemotactic sterilization will be a new strategy. As an active inducement strategy, it does not cause bacteria to develop drug resistance and can completely eliminate bacteria while avoiding tissue damage. It will be an effective means for future anti-infection research. This article reviews the existing strategies for infection prevention and control and the latest research progress of chemotaxis and sterilization, aiming to provide a reference for wound anti-infection and systemic anti-infection research throughout the body, and offer new directions and ideas for future infection prevention and control strategies.
10.Application effect of acellular allogeneic dermal matrix combined with autologous razor-thin scalp grafts in scar rehabilitation
Jiangbo KUANG ; Yongfei WANG ; Xisheng XU ; Botong LI
Chinese Journal of Plastic Surgery 2024;40(6):641-650
Objective:To investigate the efficacy of acellular allogeneic dermal matrix (ADM) combined with autologous razor-thin scalp grafts in scar rehabilitation.Methods:A retrospective study was conducted on patients who underwent skin grafts transplantation to repair scar in the Department of Burns and Plastic Surgery of the First People’s Hospital of Chenzhou from July 2015 to December 2021. All the patients were divided into the observation group and the control group according to surgical methods. The observation group was treated with ADM combined with autologous razor-thin scalp grafts to repair the wound after scar resection, and the control group was treated with split-thickness skin grafts (STSGs) to repair the wound. Efficacy evaluation: On the 1st, 7th and 14th day after surgery, the patients in the two groups scored the pain degree of the donor sites through the visual analogue scale (VAS), with a score of 0 indicating no pain and a score of 10 indicating severe pain. The grid method was used to measure the surviving area of the skin and calculate the surviving proportion of the skin grafts. The wound healing time in donor and recipient sites were recorded. The postoperative complication was recorded, and the incidence of complications was calculated. Scars in donor and recipient sites were observed at the 3rd, 6th, 9th and 12th month after surgery, and the scars in recipient sites were scored by the Vancouver scar scale (VSS), with a total score of 0-13 points, and the higher the score, the more serious the scars were. SPSS 22.0 software was used for statistical analysis of the data. The normally distributed continuous data were represented as Mean±SD, and analyzed by t-test, and the non-normally distributed continuous data were represented as M ( Q1, Q3), and the Wilcoxon rank-sum test was used for comparison between groups. Enumeration data were expressed as examples and (or) percentages, and chi-square test was used for comparison between groups. The differences were considered statistically significant for probability values P<0.05. Results:A total of 50 patients, including 28 males and 22 females, aged (38.5±13.9) years, were enrolled in the observation group, and the wound area caused by scar resection and release was (70.4±17.7) cm 2. The scars were on upper limb in 16 cases, lower limb in 15 cases, trunk in 11 cases, neck in 8 cases. The control group included 50 patients, 30 males and 20 females, aged (34.8±14.6) years, and the wound area caused by scar resection and release was (66.2±16.5) cm 2. The scars were on upper limb in 15 cases, lower limb in 11 cases, trunk in 13 cases, neck in 11 cases. There was no significant difference in gender composition, age, skin graft site and the wound area caused by scar resection and release between these two groups ( P > 0.05). On the 1st, 7th and 14th day after surgery, the VAS scores of the observation group were 6.35 (5.11, 7.67) points, 4.95 (3.63, 6.46) points and 0.73 (0.18, 1.39) points, while the control group were 8.25 (7.14, 9.19) points, 7.00 (5.45, 8.06) points and 0.80(0.20, 1.55)points, respectively. The VAS score of the observation group was lower than that of the control group on the 1st and 7th day after surgery ( Z=-4.53, -3.86, both P < 0.001), and there was no significant difference in VAS score between the two groups on the 14th day after surgery ( P > 0.05). There was no significant difference between the two groups in terms of the survival ratio of skin grafts [(95.6±2.1) % vs. (95.8±2.3) %] ( P>0.05) and the postoperative incidence of complications [18% (9/50) vs. 10% (5/50)] ( P>0.05). The wound healing time in the donor sites in both groups were (6.80±0.88) days, (13.30±1.83) days ( t=-22.70, P<0.001), while the wound healing time in the recipient sites in both groups were 14.33 (12.73, 15.76) days and 8.91 (7.76, 10.67) days ( Z=-7.31, P<0.001). The average follow-up time was 21.8 months, the observation group had no scar formation at the donor site, while the control group had different degrees of scar hyperplasia. There was no significant difference in VSS scores between the two groups at the 3rd and 6th month after surgery ( P>0.05), while the VSS scores of the observation group at 9th and 12th month after surgery were 5.96 (4.81, 7.15) points and 5.85 (4.81, 6.75) points, which were significantly lower than those of in the control group [7.04(5.93, 8.14)points, 6.92(5.81, 8.06)points] ( Z=-2.82, P=0.005; Z=-3.54, P<0.001). Conclusion:The use of ADM combined with autologous razor-thin scalp graft to repair the wound after scar resection can effectively improve the appearance and function of the repair area, and reduce the pain and avoid scar hyperplasia in the donor sites.

Result Analysis
Print
Save
E-mail