1.Construction of a full-cycle management model for T2DM patients led by clinical pharmacists
Yuanyuan JIANG ; Guimei ZHENG ; Yaohua CAO ; Zeyu XIE ; Weiling CAO
China Pharmacy 2026;37(1):92-98
OBJECTIVE To establish a full-cycle management model for type 2 diabetes mellitus (T2DM) patients led by clinical pharmacists. METHODS Based on literature research, a basic framework and items of full-cycle management model led by clinical pharmacists were initially formulated. The Delphi method was adopted to conduct questionnaire inquiries among 26 experts to determine the specific implementation items of the model. The analytic hierarchy process (AHP) method was used to determine the weight values of items at all levels, and the reliability and validity of the model items were analyzed. RESULTS The recovery rates of the two rounds of expert consultation questionnaires were 86.67% and 100%, respectively, and the expert authority coefficient was 0.88. Kendall’s concordance coefficients of the tertiary-level items were 0.064 and 0.084, respectively, and the P values from the χ 2 tests were all less than 0.05; the consistent ratios of the judgment matrices for all levels of AHP model were all less than 0.1. The established full-cycle management led by clinical pharmacists comprised three primary-level items (pharmacy service pathway for T2DM patients during hospitalization, pharmacy management pathway for hypoglycemia in T2DM inpatients, and the pharmacy follow-up pathway for T2DM discharged patients, with weights of 0.098, 0.568 and 0.334, respectively), twelve secondary-level items (e.g. pharmaceutical care during hospitalization for 1 to 2 days, admission assessment and education, with weights ranging from 0.143 to 0.333) and thirty-seven tertiary-level items (e.g. assessment of medication compliance, verification of the medication plan for discharge, with weights ranging from 0.068 to 0.750). Cronbach’s α coefficients for primary-level items and the overall questionnaire were 0.762, 0.879, 0.928 and 0.951, respectively. The item-level and scale-level content validity indexes were 0.967 and 0.808, respectively. CONCLUSIONS A full-cycle management model for T2DM patients led by clinical pharmacists has been constructed successfully, demonstrating high scientificity and reliability.
2.Rapid health technology assessment of tirzepatide for diabetes mellitus type 2 and long-term weight management
Zeyu XIE ; Yinuo LIU ; Zhuoru LIANG ; Yaohua CAO ; Guimei ZHENG ; Weiling CAO
China Pharmacy 2025;36(9):1141-1146
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of tirzepatide for diabetes mellitus type 2 (T2DM) and long-term weight management, and provide evidence-based basis for clinical drug treatment and health insurance policy formulation. METHODS Computer searches were conducted in Embase, PubMed, the Cochrane Library, CNKI and health technology assessment (HTA) official website from their inception to October 1st 2024 to collect HTA report, systematic review/ meta-analysis and pharmacoeconomic study on tirzepatide for the treatment of T2DM or for weight management. After data extraction and quality evaluation, descriptive analysis was performed on the research results. RESULTS Totally 18 papers were included, including 14 systematic reviews/meta-analyses and 4 pharmacoeconomics studies, and no HTA report was retrieved. In terms of efficacy, most results showed that the tirzepatide 10 mg and 15 mg were significantly better than other glucagon-like peptide-1 (GLP-1) receptor agonists in reducing glycosylated hemoglobin, body weight, and waist circumference (P<0.05). In terms of safety, compared with other GLP-1 receptor agonists, tirzepatide did not increase the incidence of gastrointestinal-related adverse events (AE), the incidence of AE of grade ≥3, or the incidence of severe hypoglycemia (P>0.05). However, tirzepatide 15 mg may significantly increased the incidence of hypoglycemia and the rate of discontinuation due to adverse reactions (P< 0.05). In terms of cost-effectiveness, based on the background of foreign pharmacoeconomic studies, tirzepatide was more cost- effective compared to semaglutide and liraglutide in the treatment of T2DM or for weight management. CONCLUSIONS Tirzepatide at doses of 10 mg and 15 mg has good efficacy and safety for the treatment of T2DM and for long-term weight management. However, when using the 15 mg dose of tirzepatide, close monitoring is required due to the risk of hypoglycemia and discontinuation due to adverse reactions it may pose. Based on pharmacoeconomic studies conducted abroad results, tirzepatide exhibits economic advantages.
3.Prediction model for transformation of chronic atrophic gastritis to high-grade intraepithelial neoplasia based on traditional Chinese medicine syndrome patterns.
Xiangying LIN ; Jingyao SHI ; Xiaoyan HUANG ; Zeyu ZHENG ; Xiaofeng HUANG ; Minghan HUANG
Journal of Zhejiang University. Medical sciences 2025;54(3):297-306
OBJECTIVES:
To develop a risk prediction model for the transformation of chronic atrophic gastritis to high-grade intraepithelial neoplasia (HGIN) based on traditional Chinese medicine (TCM) syndrome patterns.
METHODS:
Clinical data of 201 chronic atrophic gastritis patients who visited the Second People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine and Dong'erhuan Branch between January 2022 and March 2023 were retrospectively analyzed, including 32 patients with HGIN (HGIN group) and 169 patients with moderate and severe chronic atrophic gastritis (non-HGIN group). The information of demographic characteristics, dietary habits, lifestyle factors, social and psychosocial factors, family history of tumors, medical history and comorbidities, long-term medication, endoscopic findings, histopathological examination results, as well as TCM syndrome types were collected. Potential HGIN risk factors were screened using LASSO regression, and the significant risk factors for establishing an HGIN risk prediction model were identified using logistic regression analysis. The final model was visually presented using a nomogram, and its diagnostic performance was evaluated through receiver operating characteristic curve analysis.
RESULTS:
Spleen-stomach Qi deficiency was the most common TCM syndrome in both HGIN and non-HGIN groups. LASSO-logistic regression model analysis showed that heavy alcohol consumption (X1), syndrome of static blood in stomach collaterals (X2), low-grade intraepithelial neoplasia (X3), high-salt diet (X4), and age (X5) were independent risk factors related to the occurrence of HGIN, and the predictive model was ln[P/(1-P)]=2.159X1+2.230X2+1.664X3+2.070X4+0.122X5- 11.096. The model demonstrated good discriminative ability, calibration, and goodness-of-fit, with area under the curve values of 0.940 and 0.891 in the training and validation sets, respectively.
CONCLUSIONS
The TCM syndrome of static blood in stomach collaterals shows correlation with the transformation from chronic atrophic gastritis to HGIN. The HGIN prediction model based on TCM syndrome patterns developed in the study demonstrates potential value in clinical application.
Humans
;
Gastritis, Atrophic/diagnosis*
;
Medicine, Chinese Traditional
;
Retrospective Studies
;
Female
;
Male
;
Middle Aged
;
Stomach Neoplasms/diagnosis*
;
Adult
;
Risk Factors
;
Carcinoma in Situ/diagnosis*
;
Aged
;
Nomograms
;
Chronic Disease
;
Logistic Models
4.Clinical study of intracranial hypotension targeted body posture combined with pharmacotherapy in the treatment of chronic subdural hematoma
Jiayu CHEN ; Zhe WANG ; Di ZANG ; Ruizhe ZHENG ; Xiangru YE ; Zengxin QI ; Zeyu XU ; Zhiqiang LI ; Chengfeng SUN ; Liangjun SHEN ; Luoping SHENG ; Fulin XU ; Ruyong YE ; Kaiyu ZHOU ; Weijun TANG ; Yueqing HU ; Dapeng SHI ; Yuquan WANG ; Xizhen WU ; Ying WANG ; Qilin ZHANG ; Feili LIU ; Guo YU ; Yiping LU ; Yirui SUN ; Ning ZHANG ; Feng HUANG ; Xialong GU ; Han ZHANG ; Jian DING ; Yongyan BI ; Haolan DU ; Jing ZHANG ; Hailong JI ; Ding DING ; Wei ZHANG ; Xuehai WU
Chinese Journal of Surgery 2025;63(3):212-218
Objective:To compare the efficacy of body posture combined with pharmacotherapy and pharmacotherapy alone in the treatment of chronic subdural hematoma(CSDH).Methods:Firstly, retrospective case series study was conducted. Thirty cases of CSDH that had received body posture combined with pharmacotherapy at Department of Neurosurgery, Huashan Hospital Affiliated to Fudan University from December 2016 to October 2020 were studied retrospectively. Twenty-seven patients were male, and 3 patients were female. The age of patients ( M(IQR)) was 66(16) years (range:28 to 84). Nineteen patients had unilateral hematoma, and 11 patients had bilateral hematoma. All patients received pharmacotherapy and body posture therapy that was to raise their lower limbs 20 to 30 cm with leg lift pad and get abdominal compressed with customized abdominal belt in supine position. Patients were required to maintain the body posture as much as possible, with the maximum to 16 to 18 hours per day. Patients with unilateral hematoma should tilt the head to the affected side and avoid tilting it to the opposite side. For patients with bilateral hematoma, there was no need for head lateralization. Patient were treated with oral dexamethasone and atorvastatin simultaneously. The preliminary efficacy of body posture combined with pharmacotherapy was determined by hematoma improvement rate which was analyzed by Clopper-Pearson method. Then, the multi-center, prospective, randomized controlled trial had carried out in 9 medical centers from August 2020 to November 2021. The stratified block randomization method was adopted. Patients were randomized in a ratio of 1∶1 to either receive pharmacotherapy alone(the control group) or body posture combined with pharmacotherapy(the experiment group) for 3 months and followed up for 6 months. Effective treatment was defined as complete absorption of hematoma, or the hematoma volume decreased by more than 10 ml and Markwalder grading scale score had improved by more than 1 point compared to the baseline. The efficacy rate and surgery conversion rate at 3 months and recurrence at 6 months were observed. Comparison between groups was performed with paired sample t test, Mann-Whitney U test, χ2 test, corrected χ2 test, or Fisher exact probability method. Logistic regression was used to compare the effective rate and operation rate between the two groups. Results:In the respective study, 30 patients completed follow-up 13 to 353 days after treatment. At the last follow-up, the incidence of almost complete absorption or significantly absorption of hematoma (hematoma volume was significantly reduced accompanied by symptom improvement) was 93.3%. The 95% CI for the incidence that analyzed by the Clopper-Pearson method was 77.9% to 99.2%. One hundred and six patients were enrolled in the multicenter study. Fifty-five patients underwent body posture combined with pharmacotherapy. The age was 74(17) years (range:26 to 92). Thirty-nine patients were males and 16 were females. Fifty-one patients underwent pharmacotherapy alone. The age was 69(12) years (range:48 to 84). Thirty-seven patients were males and 14 were females. The length of body posture recorded in diary card was (15.7±2.3) hours(range:7.6 to 19.3 hours). The efficacy rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 83.6% (46/55) and 56.9% (29/51), respectively at 3 months. The result of the logistic regression analysis showed that the efficacy of body posture combined with pharmacotherapy group was better than that of pharmacotherapy alone group ( OR=3.88,95% CI:1.57 to 9.58, P=0.003). Surgery rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 5.5% (3/55) and 21.6% (11/51) respectively. The result of Logistic regression showed that the pharmacotherapy alone group was more likely to be converted to surgery ( OR=0.21,95% CI:0.05 to 0.80, P=0.023). At the 6 months, no recurrence of cases was found in the body posture combined with pharmacotherapy group. However, the recurrence rate of pharmacotherapy alone group was 6.3% (3/48), there was no significant difference between the two groups ( P>0.05). Conclusion:The effect of body posture combined with pharmacotherapy for chronic subdural hematoma is better than that of pharmacotherapy alone.
5.Study on the Mechanism of Regulating miR-532-3p in Improving Adriamycin Cardiotoxicity with Yiqi Huayu Decoction
Rongrong CHEN ; Ping ZHENG ; Deqing LI ; Hua YANG ; Zeyu ZHENG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):128-133
Objective To explore the mechanism of regulating miR-532-3p with Yiqi Huayu Decoction to improve adriamycin cardiotoxicity.Methods Totally 25 rats were randomly divided into control group,model group and Yiqi Huayu Decoction low-,medium-and high-dosage groups,with 5 rats in each group.Myocardial injury model was established by intraperitoneal injection of adriamycin 2.5 mg/kg once a week for 8 weeks in model group and Yiqi Huayu Decoction low-,medium-and high-dosage groups.At the same time,Yiqi Huayu Decoction low-,medium-and high-dosage groups were given 2,4,8 g/kg Yiqi Huayu Decoction by gavage respectively,once a day for consecutive 8 weeks.Cardiac function of rats was detected by echocardiography,serum NT-proBNP content was detected by ELISA,morphology of myocardial tissue were observed by HE staining,apoptosis of myocardial tissue was detected by TUNEL staining,miR-532-3p gene expression was detected by RT-qPCR,Western blot was used to detect the expressions of GATA4 and CARP protein.Results Compared with the control group,the left ventricular end systolic diameter(LVESD)and left ventricular end diastolic diameter(LVEDD)of the model group increased significantly,the left ventricular ejection fraction(LVEF)and left ventricular fractional shortening(LVFS)significantly decreased(P<0.05),and the serum NT-proBNP content significantly increased(P<0.05),with severe hypertrophy and disordered arrangement of myocardial cells,fibroblast proliferation accompanied by necrosis,and significantly increased apoptosis rate of myocardial cells(P<0.05),the expression of miR-532-3p gene in myocardial tissue significantly increased(P<0.05),and the expressions of GATA4 and CARP proteins in myocardial tissue significantly increased(P<0.05).Compared with the model group,Yiqi Huayu Decoction high-dosage group showed a significant decrease in LVESD and LVEDD(P<0.05),with LVEF and LVFS significantly increased(P<0.05),the content of serum NT-proBNP in Yiqi Huayu Decoction low-,medium-and high-dosage groups were significantly decreased(P<0.05),and myocardial cell damage and fibrosis were improved to varying degrees,the apoptosis rate of myocardial cells was significantly decreased(P<0.05),the expression of miR-532-3p gene in myocardial tissue decreased(P<0.05),and the expressions of GATA4 and CARP proteins in myocardial tissue decreased(P<0.05).Conclusion Yiqi Huayu Decoction can antagonize doxorubicin cardiotoxicity,and its possible mechanism may be related to regulating miR-532-3p to inhibit myocardial fibrosis.
6.A multicenter clinical study on intramedullary vancomycin injection for preventing periprosthetic joint infection in total knee arthroplasty
Te LIU ; Jun FU ; Shiguang LAI ; Zhuo ZHANG ; Chi XU ; Lei GENG ; Yang LUO ; Peng REN ; Xin ZHI ; Quanbo JI ; Heng ZHANG ; Runkai ZHAO ; Haichao REN ; Ye TAO ; Qingyuan ZHENG ; Zeyu FENG ; Jianfeng YANG ; Yiming WANG ; Pengcheng LI ; Shuai LIU ; Wei CHAI ; Xiang LI ; Huiwu LI ; Xiaogang ZHANG ; Baochao JI ; Xianzhe LIU ; Xinzhan MAO ; Jianbing MA ; Xiangxiang SUN ; Jiying CHEN ; Yonggang ZHOU ; Jinliang WANG ; Weijun WANG ; Guoqiang ZHANG ; Ming NI
Chinese Journal of Orthopaedics 2025;45(12):803-811
Objective:To explore the safety and efficacy of intraosseous regional administration (IORA) of vancomycin for preventing infection in primary total knee arthroplasty (TKA).Methods:A total of 124 patients with knee osteoarthritis undergoing TKA between February 2024 and May 2024 at nine hospitals were enrolled. Preoperative infection prophylaxis involved either IORA (0.5 g vancomycin administered via intraosseous regional infusion before incision) or intravenous infusion (1 g vancomycin via peripheral vein). The IORA group included 15 males and 47 females with a median age of 66.5 years (range, 60.0-70.0 years), while the intravenous group included 14 males and 48 females with a median age of 66.0 years (range, 61.8-70.3 years) years. Intraoperative samples were collected including fat and synovium tissues after incision, before prosthesis placement, and after tourniquet release; distal femoral cancellous bone during femoral osteotomy; proximal tibial cancellous bone during tibial osteotomy; proximal intercondylar cancellous bone before prosthesis placement; and peripheral blood from non-infused arms at surgery initiation and after tourniquet release. Vancomycin concentrations were measured using liquid chromatography-tandem mass spectrometry. Vital sign changes were recorded from admission to 5~10 minutes post-IORA (IORA group) or post-incision (intravenous group). Follow-ups were conducted on postoperative day 1 and 3, and at 1 and 3 months, to document complications including IORA-related adverse events, periprosthetic joint infections, surgical site infections, red man syndrome, acute kidney injury, deep vein thrombosis and so on.Results:Vancomycin concentrations in bone, fat, and synovial tissue samples were significantly higher in the IORA group than in the intravenous group ( P<0.05), while vancomycin concentrations in blood samples were significantly lower in the IORA group than in the intravenous group ( P<0.05). Only 7.3%(41/558) of tissue samples in the IORA group had vancomycin concentrations below 2.0 μg/g (the minimum inhibitory concentration of vancomycin against coagulase-negative staphylococcus), compared to 59.3%(331/558) in the intravenous group (χ 2=11.285, P<0.001). In the intravenous group, 16.9%(21/124) of blood samples had vancomycin concentrations exceeding 15.0 mg/L (the threshold associated with a significantly increased risk of nephrotoxicity), while all concentrations in the IORA group were below this threshold, the difference was statistically significant (χ 2=22.943, P<0.001). There were no statistically significant difference ( P>0.05) in vital signs changes before and after vancomycin administration between the two groups. Two patients in the intravenous group experienced incision exudate, while no other related complications occurred in either group. Conclusions:Compared to the traditional intravenous infusion of 1 g vancomycin, intraosseous injection of a low dose (0.5 g) of vancomycin achieves higher local tissue concentrations in the knee joint with a lower incidence of adverse reactions and is safe for infection prophylaxis. Despite guidelines not recommending the routine use of vancomycin for preventing infection after primary TKA, intraosseous injection of 0.5 g vancomycin may be considered intraoperatively for primary TKA in the following scenarios: patients in medical institutions with a high prevalence of methicillin-resistant staphylococcus aureus (MRSA) infections, patients with potential preoperative MRSA colonization, or patients with cephalosporin allergy.
7.Study on the Mechanism of Regulating miR-532-3p in Improving Adriamycin Cardiotoxicity with Yiqi Huayu Decoction
Rongrong CHEN ; Ping ZHENG ; Deqing LI ; Hua YANG ; Zeyu ZHENG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):128-133
Objective To explore the mechanism of regulating miR-532-3p with Yiqi Huayu Decoction to improve adriamycin cardiotoxicity.Methods Totally 25 rats were randomly divided into control group,model group and Yiqi Huayu Decoction low-,medium-and high-dosage groups,with 5 rats in each group.Myocardial injury model was established by intraperitoneal injection of adriamycin 2.5 mg/kg once a week for 8 weeks in model group and Yiqi Huayu Decoction low-,medium-and high-dosage groups.At the same time,Yiqi Huayu Decoction low-,medium-and high-dosage groups were given 2,4,8 g/kg Yiqi Huayu Decoction by gavage respectively,once a day for consecutive 8 weeks.Cardiac function of rats was detected by echocardiography,serum NT-proBNP content was detected by ELISA,morphology of myocardial tissue were observed by HE staining,apoptosis of myocardial tissue was detected by TUNEL staining,miR-532-3p gene expression was detected by RT-qPCR,Western blot was used to detect the expressions of GATA4 and CARP protein.Results Compared with the control group,the left ventricular end systolic diameter(LVESD)and left ventricular end diastolic diameter(LVEDD)of the model group increased significantly,the left ventricular ejection fraction(LVEF)and left ventricular fractional shortening(LVFS)significantly decreased(P<0.05),and the serum NT-proBNP content significantly increased(P<0.05),with severe hypertrophy and disordered arrangement of myocardial cells,fibroblast proliferation accompanied by necrosis,and significantly increased apoptosis rate of myocardial cells(P<0.05),the expression of miR-532-3p gene in myocardial tissue significantly increased(P<0.05),and the expressions of GATA4 and CARP proteins in myocardial tissue significantly increased(P<0.05).Compared with the model group,Yiqi Huayu Decoction high-dosage group showed a significant decrease in LVESD and LVEDD(P<0.05),with LVEF and LVFS significantly increased(P<0.05),the content of serum NT-proBNP in Yiqi Huayu Decoction low-,medium-and high-dosage groups were significantly decreased(P<0.05),and myocardial cell damage and fibrosis were improved to varying degrees,the apoptosis rate of myocardial cells was significantly decreased(P<0.05),the expression of miR-532-3p gene in myocardial tissue decreased(P<0.05),and the expressions of GATA4 and CARP proteins in myocardial tissue decreased(P<0.05).Conclusion Yiqi Huayu Decoction can antagonize doxorubicin cardiotoxicity,and its possible mechanism may be related to regulating miR-532-3p to inhibit myocardial fibrosis.
8.Research on the Current Situation and Influencing Factors of Digitalized Medical and Health Service Space for the Elderly from the Perspective of Healthy Aging
Qiaoqiao REN ; Kai ZHENG ; Chaoyi CHEN ; Zeyu YAN ; Yanhua HAO
Chinese Hospital Management 2025;45(7):38-42
Objective To study the current situation and influencing factors of the digitalized medical and health service space for the elderly,it provides a reference for solving the dilemma of digital medical treatment for the elderly,sharing the dividend of digital medical development,and achieving the goal of healthy aging.Methods Using stratified cluster sampling method,a questionnaire survey was conducted among the elderly in Jiamusi City and Daqing City of Heilongjiang Province in August 2024,and 800 valid questionnaires were collected.Multiple linear regression was used to analyze the influencing factors of the spatial level of digitalized medical and health services for the elderly.Results The score of digitalized medical and health service space for the elderly was(2.05±1.90).The results of multiple linear regression analysis showed that digital health literacy,long-term residence and digital literacy were the main influencing factors of digitalized medical and health service space for the elderly the differences were statistically significant(P<0.05).Conclusion The government,hospitals,enterprises,society,families and other multi-subjects should pay attention to the integration of digitalized medical and health service space for the elderly,and cooperate with the improvement of the digital ability of the elderly by creating an external digital medical environment,so as to reduce the occurrence of adverse outcomes in the digitalized medical and health service space of the elderly,eliminate the dilemma of digital medical treatment for the elderly,improve the medical well-being of the elderly in the digital society,and promote healthy aging.
9.Research on the Current Situation and Influencing Factors of Digitalized Medical and Health Service Space for the Elderly from the Perspective of Healthy Aging
Qiaoqiao REN ; Kai ZHENG ; Chaoyi CHEN ; Zeyu YAN ; Yanhua HAO
Chinese Hospital Management 2025;45(7):38-42
Objective To study the current situation and influencing factors of the digitalized medical and health service space for the elderly,it provides a reference for solving the dilemma of digital medical treatment for the elderly,sharing the dividend of digital medical development,and achieving the goal of healthy aging.Methods Using stratified cluster sampling method,a questionnaire survey was conducted among the elderly in Jiamusi City and Daqing City of Heilongjiang Province in August 2024,and 800 valid questionnaires were collected.Multiple linear regression was used to analyze the influencing factors of the spatial level of digitalized medical and health services for the elderly.Results The score of digitalized medical and health service space for the elderly was(2.05±1.90).The results of multiple linear regression analysis showed that digital health literacy,long-term residence and digital literacy were the main influencing factors of digitalized medical and health service space for the elderly the differences were statistically significant(P<0.05).Conclusion The government,hospitals,enterprises,society,families and other multi-subjects should pay attention to the integration of digitalized medical and health service space for the elderly,and cooperate with the improvement of the digital ability of the elderly by creating an external digital medical environment,so as to reduce the occurrence of adverse outcomes in the digitalized medical and health service space of the elderly,eliminate the dilemma of digital medical treatment for the elderly,improve the medical well-being of the elderly in the digital society,and promote healthy aging.
10.A multicenter clinical study on intramedullary vancomycin injection for preventing periprosthetic joint infection in total knee arthroplasty
Te LIU ; Jun FU ; Shiguang LAI ; Zhuo ZHANG ; Chi XU ; Lei GENG ; Yang LUO ; Peng REN ; Xin ZHI ; Quanbo JI ; Heng ZHANG ; Runkai ZHAO ; Haichao REN ; Ye TAO ; Qingyuan ZHENG ; Zeyu FENG ; Jianfeng YANG ; Yiming WANG ; Pengcheng LI ; Shuai LIU ; Wei CHAI ; Xiang LI ; Huiwu LI ; Xiaogang ZHANG ; Baochao JI ; Xianzhe LIU ; Xinzhan MAO ; Jianbing MA ; Xiangxiang SUN ; Jiying CHEN ; Yonggang ZHOU ; Jinliang WANG ; Weijun WANG ; Guoqiang ZHANG ; Ming NI
Chinese Journal of Orthopaedics 2025;45(12):803-811
Objective:To explore the safety and efficacy of intraosseous regional administration (IORA) of vancomycin for preventing infection in primary total knee arthroplasty (TKA).Methods:A total of 124 patients with knee osteoarthritis undergoing TKA between February 2024 and May 2024 at nine hospitals were enrolled. Preoperative infection prophylaxis involved either IORA (0.5 g vancomycin administered via intraosseous regional infusion before incision) or intravenous infusion (1 g vancomycin via peripheral vein). The IORA group included 15 males and 47 females with a median age of 66.5 years (range, 60.0-70.0 years), while the intravenous group included 14 males and 48 females with a median age of 66.0 years (range, 61.8-70.3 years) years. Intraoperative samples were collected including fat and synovium tissues after incision, before prosthesis placement, and after tourniquet release; distal femoral cancellous bone during femoral osteotomy; proximal tibial cancellous bone during tibial osteotomy; proximal intercondylar cancellous bone before prosthesis placement; and peripheral blood from non-infused arms at surgery initiation and after tourniquet release. Vancomycin concentrations were measured using liquid chromatography-tandem mass spectrometry. Vital sign changes were recorded from admission to 5~10 minutes post-IORA (IORA group) or post-incision (intravenous group). Follow-ups were conducted on postoperative day 1 and 3, and at 1 and 3 months, to document complications including IORA-related adverse events, periprosthetic joint infections, surgical site infections, red man syndrome, acute kidney injury, deep vein thrombosis and so on.Results:Vancomycin concentrations in bone, fat, and synovial tissue samples were significantly higher in the IORA group than in the intravenous group ( P<0.05), while vancomycin concentrations in blood samples were significantly lower in the IORA group than in the intravenous group ( P<0.05). Only 7.3%(41/558) of tissue samples in the IORA group had vancomycin concentrations below 2.0 μg/g (the minimum inhibitory concentration of vancomycin against coagulase-negative staphylococcus), compared to 59.3%(331/558) in the intravenous group (χ 2=11.285, P<0.001). In the intravenous group, 16.9%(21/124) of blood samples had vancomycin concentrations exceeding 15.0 mg/L (the threshold associated with a significantly increased risk of nephrotoxicity), while all concentrations in the IORA group were below this threshold, the difference was statistically significant (χ 2=22.943, P<0.001). There were no statistically significant difference ( P>0.05) in vital signs changes before and after vancomycin administration between the two groups. Two patients in the intravenous group experienced incision exudate, while no other related complications occurred in either group. Conclusions:Compared to the traditional intravenous infusion of 1 g vancomycin, intraosseous injection of a low dose (0.5 g) of vancomycin achieves higher local tissue concentrations in the knee joint with a lower incidence of adverse reactions and is safe for infection prophylaxis. Despite guidelines not recommending the routine use of vancomycin for preventing infection after primary TKA, intraosseous injection of 0.5 g vancomycin may be considered intraoperatively for primary TKA in the following scenarios: patients in medical institutions with a high prevalence of methicillin-resistant staphylococcus aureus (MRSA) infections, patients with potential preoperative MRSA colonization, or patients with cephalosporin allergy.

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