1.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.
2.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.
3.Betulinic Acid Induces Autophagy and Apoptosis of Human Colorectal Cancer SW620 Cells by Regulating PI3K/Akt/mTOR Signaling Pathway
Qingyuan ZHUO ; Meixian CHEN ; Lingli WANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(14):99-106
ObjectiveTo investigate the effect of betulinic acid (BA) on apoptosis and autophagy of human colorectal cancer SW620 cells and the regulatory role of phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway. MethodCell viability was detected by methyl thiazolyl tetrazolium (MTT) colorimetry to determine the optimal administration time and dosage for subsequent experiments. Four groups were designed, including blank group and low-, medium-, and high-dose BA groups. Hematoxylin-eosin (HE) staining was conducted for the observation of SW620 cell morphology, and annexin-V/propidium iodide double staining for the determination of apoptosis rate in SW620 cells. Hoechst33258 staining and MDC staining were used for the observation of apoptosis and autophagy, respectively. Western blotting was employed to determine the protein levels of B-cell lymphoma/leukemia-2(Bcl-2)-associated X protein (Bax), aspartate proteolytic enzyme-9 (Caspase-9), activated aspartate proteolytic enzyme-3 (cleaved Caspase-3), microtubule-associated protein 1 light chain 3 (LC3), the mammalian homolog of yeast Atg6 (Beclin-1), p62, phosphorylated PI3K (p-PI3K), phosphorylated Akt (p-Akt), and phosphorylated mTOR (p-mTOR) in SW620 cells. ResultBA inhibited the activity of SW620, HT29, and HCT116 cells in a concentration- and time-dependent manner. The cells treated with BA for 48 h had lower viability than those treated for 24 h (P<0.05, P<0.01). The half maximal inhibitory concentration (IC50) value of BA at the time point of 48 h was also lower than that at the time point of 24 h (P<0.01), and that for SW620 cells was the minimum. BA induced the apoptosis in a concentration-dependent manner and increased the autophagosomes. Compared with the blank group, BA increased the apoptosis rate (P<0.01), up-regulated the protein levels of Bax, Caspase-9, cleaved Caspase-3, and LC3 Ⅱ (P<0.05, P<0.01), and down-regulated the protein levels of p62, p-Akt, p-PI3K, and p-mTOR (P<0.01). Additionally, medium- and high-dose BA up-regulated the protein level of beclin-1 (P<0.01). ConclusionBA may inhibit the activity of SW620 cells by hindering the PI3K/Akt/mTOR signaling pathway to induce cell apoptosis and autophagy.
4.Research on the regulation system and registration path of Traditional Chinese Medicine products in Ghana
Xin ZHANG ; Huanxin CHEN ; Qingyuan ZHUO ; Zhanwang GAO ; Lingli WANG
International Journal of Traditional Chinese Medicine 2022;44(4):366-370
Ghana attaches great importance to the use of traditional medicine. Over the years, Ghana has successively promulgated laws and policies on traditional medicine, which has laid a legal foundation for the research, registration and sales of its herbal products. This article briefly describes the regulation system of herbal and food supplements in Ghana, and sorts out the registration path of Traditional Chinese Medicine (TCM) products as herbal and food supplements. We also briefly analyze the registration information. We believe that TCM products can open the Ghanaian market as food supplements, so as to promote the registration of herbal medicines. TCM enterprise should controlling TCM registration risks, and strengthening the cooperation between the Chinese and Ghana governments. TCM enterprise can leveraging on the advantages of TCM theory and experience, and strengthening cooperation with Ghana's traditional medicine. This article provide advices for the registration and listing of TCM products in Ghana, expanding the market of TCM in Ghana which finally expands to West Africa and the entire African countries.
5.Research on the registration path and strategy of Traditional Chinese Medicine products in South Africa
Huanxin CHEN ; Xin ZHANG ; Qingyuan ZHUO ; Zhanwang GAO ; Lingli WANG
International Journal of Traditional Chinese Medicine 2022;44(5):493-497
This paper analyzes the registration regulations and guidelines of Traditional Chinese Medicine (TCM) products in South Africa, summarizes the registration path of TCM products in South Africa, analyzes the Common Technical Document (CTD) data required for registration from the aspects of quality control, safety and effectiveness, and discusses the registration strategy of TCM products in South Africa. This paper suggests that the strategies could include effective management and control of the registration risk of TCM and steady promotion of the products; TCM enterprises can first register low-risk TCM products, then open the South African TCM market, and promote the registration of high-risk TCM products after accumulating some experience; TCM enterprises need to have the awareness of promoting the inheritance, innovation and development of TCM, increase the investment in clinical trials of TCM products, and supplement the clinical effectiveness and safety data of TCM products; Strengthen the quality control of TCM and build an international brand of TCM.
6.Efficacy of hypofractionated radiotherapy combined with docetaxel for treatment of bone metastasis of lung cancer.
Zheng-Fu FENG ; Xin LIU ; Zhuo-Mei LIU ; Hui-Sheng SONG ; Rui-Ming TANG
Journal of Southern Medical University 2009;29(7):1442-1444
OBJECTIVETo evaluate the efficacy of hypofractionated radiotherapy combined with docetaxel for treatment of bone metastasis of lung cancer and explore the factors related to the prognosis.
METHODSSeventy-two patients with bone metastasis of lung cancer were divided into group A with hypofractionated radiotherapy at 3.0 Gy /fraction (once a day, 5 days per week for 30 Gy) and weekly docetaxel treatment at 60 mg for 2 weeks, and group B with radiotherapy alone at 2.0 Gy/fraction (once a day, 5 days per week for 40 Gy).
RESULTSThe total effective rate was 93.1% (67/72) in these patients, with a non-response rate of 6.9% (5/72). The total effective rate was 97.2% (35/36) in group A and 88.9% (32/36) in group B. After the radiotherapy, the analgesic effect showed no significant difference between the two groups, but the onset of the effect was faster in group B than in group A.
CONCLUSIONLocal radiotherapy provides effective pain relief in patients with bone metastasis of lung cancer. High-dose fractionated irradiation can rapidly achieve the analgesic effect.
Adult ; Aged ; Bone Neoplasms ; drug therapy ; radiotherapy ; secondary ; Combined Modality Therapy ; Dose Fractionation ; Female ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; radiotherapy ; Male ; Middle Aged ; Prognosis ; Taxoids ; therapeutic use ; Treatment Outcome

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