Objective: To analyze the correlation between ABO blood group compatibility and the risk of early complications after liver transplantation, and to identify risk factors for clinical intervention. Methods: Clinical data of 404 liver transplant recipients and donors were collected. Based on donor-recipient ABO matching, patients were divided into three groups: ABO-Identical (ABO-Id, n=313), ABO-compatible (ABO-c, n=68), ABO-incompatible (ABO-i, n=23). Clinical data, early complications, and associated risk factors were compared. Results: Compared with the ABO-Id, ABO-c and ABO-i recipients were younger, had a higher proportion of primary biliary atresia, and more frequently received living-donor transplantation from relatives (P<0.05). Overall complication rates were: ABO-c 47.1% (32/68), ABO-i 43.5% (10/23), ABO-Id 39.3% (123/313), with no significant intergroup difference (P>0.05). Infection was the most common complication [ABO-c 30.9% (21/68), ABO-i 21.7% (5/23), ABO-Id 17.9% (56/313)]. No significant differences were found in infection, vascular/biliary or acute kidney injury/renal failure among the three groups (P>0.05). However, ABO-c group had significantly higher rates of ascites/abscess (20.6% vs 8.9%, P<0.05) and pleural effusion (14.7% vs 7.0%, P<0.05) than ABO-Id group. There was no significant difference in the incidence of complications and ABO blood group between ABO non-Identical (ABO-c and ABO-i) and Identical groups. Logistic regression analysis showed that the risk of ascites/abscess in ABO non-Identical was higher than that in ABO-Id liver transplantation (P<0.05), and the risk of ascites/abscess after ABO-c liver transplantation was 2.246 times higher than that of ABO-Id liver transplantation. The primary biliary atresia were a risk factor for postoperative ascites/abscess. Conclusion: Enhanced postoperative management is critical for ABO-nonidentical (especially ABO-compatible) recipients, and those with biliary atresia to reduce complication risks.

OBJECTIVE: To investigate the safety and prognostic factors influencing the treatment of upper urinary tract urothelial carcinoma (UTUC) combined with bladder cancer (BCa) by laparoscopic simultaneous radical cystectomy and nephroureterectomy (RCNU). METHODS: The clinical data of patients admitted to Peking University Third Hospital for laparoscopic RCNU surgery from January 2009 to September 2023 were analyzed retrospectively. Based on the same gender, age (±5 years), history of uroepithelial tumors, underlying diseases, T-stage, N-stage, M-stage, American Society of Anesthesiologists (ASA) score, Charlson comorbidity index, and body mass index (BMI) (±5), 34 patients with RCNU were matched 1 ∶1 with patients with bladder cancer who underwent laparoscopic radical cystectomy (RC) alone. Kaplan-Meier survival analysis was used to calculate patient survival, and Cox proportional regression risk model was used to analyze clinical factors affecting prognosis. RESULTS: Of the 68 patients enrolled, the follow-up rate was 100% with a median follow-up time of 27.0 (11.7, 60.2) months. Comparison of intraoperative conditions (including operation time, estimated intraoperative bleeding, intra-operative blood transfusion, etc.) between the two groups of patients showed no significant difference (P>0.05). Comparison of preoperative creatinine and postoperative creatinine between the two groups of patients showed significant differences (P < 0.05). The perioperative Clavien grade Ⅲ-Ⅳ complication rates were 2.9% (1/34) in the RC group and 5.9% (2/34) in the RCNU group. There was no significant difference in terms of perioperative complications between the two groups. Overall survival was significantly lower in the patients receiving RCNU compared with the matched group receiving RC alone (P < 0.05). Cox regression analysis suggested that two factors, high N stage and high postoperative creatinine, were independent risk factors affecting the prognosis of patients in the 2 groups (P < 0.05). CONCLUSION The overall survival prognosis of patients undergoing RCNU surgery was worse compared with laparoscopic RC surgery alone during the same period. There was no clinically significant difference between the two groups in terms of operation time, intraoperative bleeding, and perioperative complications, and there were clinically significant differences in preoperative renal function and post-operative renal function.
Humans ; Laparoscopy/methods* ; Nephroureterectomy/methods* ; Cystectomy/methods* ; Prognosis ; Male ; Retrospective Studies ; Female ; Urinary Bladder Neoplasms/mortality* ; Middle Aged ; Aged

Cleaning process validation is an important guarantee for implantable medical devices to ensure product cleanliness. In the manufacturing process, implantable devices usually need to control pollution through cleaning process to achieve a certain cleanliness to ensure the effectiveness of sterilization and product safety. This paper discusses the cleaning process validation of the manufacturing process of the implantable devices based on relevant regulations and technical standards, and proposes the influencing factors and principles to be considered in the cleaning process validation, so as to provide technical reference for the design of the cleaning process validation.
Prostheses and Implants ; Sterilization ; Equipment and Supplies

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Biodegradable heart occluder uses a biodegradable medical polymer material to replace or completely replace the metal material.After completing the repair function of the heart defect,the device is gradually degraded and safely absorbed by the human tissue.So it may minimize the risk of long-term complications that traditional metal heart occluder causing in the body after implantation.Based on the quality management concept of the entire lifecycle of medical device,this article briefly introduces design and development,as well as the product realization of biodegradable heart occluder.It analyzes the main risk points in design and production,and corresponding suggestions have been put forward.These suggestions are combined with the medical device good manufacturing practice and the appendix of implantable medical equipment to provide a reference for regulators and industry professionals.

Objective:To explore the application effect of the daytime neuroimmunotherapy bed model in patients with autoimmune diseases of the nervous system.Methods:The quasi-experiment research method was adopted, with the implementation time of the new procedure as the dividing point, 96 patients from November 1, 2020 to October 31, 2022 were selected as the control group, and routine management procedures was adopted.64 patients from November 1, 2022 to October 31, 2023 were selected as the experimental group, and the optimized management process was applied, the intervention effects of the two groups were compared.Results:There were 69 females and 27 males with (39.5 ± 1.4) years old in the control group, 44 females and 20 males with (39.9 ± 1.4) years old in the experimental group. Waiting time for bed, admission time to start medication, length of hospital stay, incidence of adverse drug reactions, timely follow-up rate and patient satisfaction in the experimental group were (24.3 ± 10.6) h, (4.5 ± 1.4) h, (18.9 ± 17.2) h, 4.7%(3/64), 96.9%(62/64) and (99.50 ± 1.14) points, while the control group were (105.3 ± 35.2) h, (36.1 ± 18.7) h, (78.3 ± 63.8) h, 14.6%(14/96), 82.3%(79/96) and (95.74 ± 2.39) points, there were statistical significance between the two groups ( t=2.41-21.17, χ2=7.80, 3.96, all P<0.05). Conclusions:The optimized daytime neuroimmunotherapy bed model can effectively shorten the patients′ bed waiting time, admission time to start medication, and length of hospital stay, reduce the incidence of adverse drug reactions, and improve the timely follow-up rate and patient satisfaction.

Objective:To analyze the clinicopathological features,prognostic value and surgical treat-ment experience in patients with adrenocortical carcinoma with venous tumor thrombus.Methods:We collected relevant data of the patients with adrenocortical carcinoma who had undergone surgery in Peking University Third Hospital from 2018 to 2023.The patients were divided into venous tumor thrombus group and non-tumor thrombus group.The Wilcoxon rank sum test was used to compare the quantitative varia-bles.The chi-squared test and Fisher's exact test were used to compare the categorical variables.The Kaplan-Meier method was used to estimate the survival rate.Results:A total of 27 patients with adreno-cortical carcinoma were included,of whom 11 cases(40.7％)had venous tumor thrombus.In the pa-tients with venous tumor thrombus,8 patients were female and 3 were male.The median age was 49(36,58)years.The median body mass index was 26.0(24.1,30.4)kg/m2.Seven patients presented with symptoms at their initial visit.Six patients had a history of hypertension.Elevated levels of cortisol were observed in 2 cases.Three tumors were found on the left side,while 8 were found on the right side.Median tumor diameter was 9.4(6.5,12.5)cm.On the left,there was a case of tumor thrombus limit-ed to the central vein of the left adrenal gland without invasion into the left renal vein,and two cases of tumor thrombus growth extending into the inferior vena cava below the liver.One case of tumor thrombus on the right adrenal central vein did not invade the inferior vena cava.Four cases of tumor thrombus inva-ded the inferior vena cava below the liver and three cases extended to the posterior of the liver.Ten pa-tients were in European Network for the Study of Adrenal Tumors(ENSAT)stage Ⅲ and one was in ENSAT stage Ⅳ.Open surgery was performed in 6 cases,laparoscopic surgery alone in 4 cases and ro-bot-assisted laparoscopic surgery in 1 case.Two patients underwent ipsilateral kidney resection.Median operative time was 332(261,440)min.Median intraoperative bleeding was 900(700,2 200)mL.Median hospital stay was 9(5,10)days.Median survival time for the patients with tumor thrombus was 24.0 months and median time to recurrence was 7.0 months.The median survival and recurrence time of 16 patients without tumor thrombus were not reached.The patients with tumor thrombus had worse 3-year overall survival(OS)rate(40.9％vs.71.4％;Log-rank,P=0.038)and 2-year recurrence-free sur-vival(RFS)(9.1％vs.53.7％;Log-rank,P=0.015)rates compared with the patients with non-tumor thrombus.Conclusion:Patients with adrenocortical carcinoma with venous tumor thrombus have poor prognosis.Different adrenal tumor resections and venous tumor thrombus removal procedures based on different tumor thrombus locations are safe and effective in treating this disease.

Objective To investigate the clinical efficacy of preoperative therapeutic plasma exchange(TPE)in pre-venting acute rejection after ABO incompatible kidney transplantation(ABOi-KT).Methods Nine patients with ABOi-KT who were admitted to the renal transplant department of our hospital from April 2022 to April 2024 were retrospectively ana-lyzed.They received a total of 28 TPEs before kidney transplantation,and the treatment plan was summarized as follows:The proportion of the substitute fluid,as well as the frequency and volume of TPE were determined based on the patient′s ABO blood group system antibody titer,gender,height,weight,hematocrit and other indicators upon admission.The pa-tient′s relevant laboratory indicators,including hemoglobin,platelets,leukocytes,coagulation function,total protein,albu-min,globulin,A/G,creatinine and urea nitrogen upon admission and after TPE were monitored and statistically analyzed.After transplantation,changes in renal function indicators such as ABO blood group system antibody titers,creatinine and u-rinary excretion were observed,and clinical symptoms of acute rejection,such as swelling,pain and edema in the transplan-ted kidney area were observed.Results Nine ABOi-KT patients had an average of about 3 TPEs before transplantation sur-gery,with an average total volume of approximately 2 500 mL to 3 500 mL per TPE,or approximately about 1.01 to 1.16 plasma volume(PV).After multiple TPEs,pre-transplantation antibody titers decreased by an average of 3 times compared to before TPE.There were no statistically significant differences in Hb,PLT,PT,PTA,INR,TBil,ALB,Cr and BUN(P＞0.05),while statistically significant differences were found in WBC,APTT,Fbg,TP,GLB and A/G(P＜0.05).After surgery,the creatinine level of 9 patients dropped to approximately 100 to 140 μmol/L,the urine output was normal,and the urine protein dropped to weakly positive or negative values.None of the nine patients experienced acute rejection.Con-clusion TPE can effectively reduce the level of ABO blood group antibody and prevent the occurrence of acute rejection in ABOi-KT patients.

BACKGROUND:Glucocorticoid-induced osteoporosis is a common complication of systemic glucocorticoid therapy,which is mainly characterized by its inhibitory effect on osteoblasts.Eriodictyol inhibits osteoclast differentiation and osteoporosis-induced by ovariectomy.However,it is unclear whether eriodictyol regulates glucocorticoid-induced osteoblasts. OBJECTIVE:To explore whether eriodictyol plays a role in glucocorticoid-induced osteoblast apoptosis and its potential regulatory mechanisms. METHODS:Dexamethasone-pretreated osteoblasts MC3T3-E1 were treated with the different concentrations(0,0.5,1,2.5,5,10 μmol/L)of eriodictyol or 5 μmol/L 3-methyladenine,an autophagy inhibitor,and then transfected with heme oxygenase 1 overexpression vector(pcDNA-HMOX1)and empty vector(pcDNA vector).Cell proliferation and apoptosis were assessed by using cell counting kit-8 assay and flow cytometry,respectively.The activity of caspase-3 was detected with ELISA.Western blot assay was used to detect the protein expression of autophagy-related proteins LC3-Ⅱ/LC3-Ⅰ,p62,Atg5 and Atg12,the expression of apoptotic related proteins Bax and Bcl-2,as well as the protein expression of AMPK and p-AMPK. RESULTS AND CONCLUSION:Low concentrations of eriodictyol were non-toxic to MC3T3-E1 cells and promoted cell proliferation,as well as increased the expression of autophagy related proteins LC3-Ⅱ/LC3-Ⅰ,p62,Atg5 and Atg12,decreased caspase-3 enzyme activity,inhibited Bax protein expression,promoted Bcl-2 protein expression and reduced dexamethasone-induced apoptosis in MC3T3-E1 cells in a dose-dependent manner.Moreover,eriodictyol significantly promoted heme oxygenase 1 expression in osteoblasts,whereas overexpression of heme oxygenase 1 promoted AMPK phosphorylation,activated autophagy,and inhibited dexamethasone-induced osteoblast apoptosis.While 3-methyladenine treatment counteracted the effects of heme oxygenase 1 overexpression on MC3T3-E1 cells.To conclude,low concentration of Eriodictyol is non-toxic to osteoblasts and activates AMPK signaling pathway by upregulating the expression of heme oxygenase 1,thereby promoting autophagy and inhibiting dexamethasone-induced osteoblast apoptosis.Eriodictyol has great potential for the treatment of glucocorticoid-induced osteoporosis.

BACKGROUND:Acupotomy is an effective method for the clinical treatment of osteoarthritis,with affirmed clinical outcomes,but the specific mechanisms remain unclear OBJECTIVE:To investigate the role of acupotomy in modulating chondrocyte autophagy to promote chondrocyte homeostasis in osteoarthritis. METHODS:Twenty-eight New Zealand rabbits were randomly divided into control group,osteoarthritis group,acupotomy group,and hyaluronic acid group,with seven rabbits in each group.The knee osteoarthritis rabbit model was prepared using the Videman method in the latter three groups.After modeling,the control group and osteoarthritis group received no interventions.The acupotomy group received acupotomy treatment 15 minutes per time,once a week,while the hyaluronic acid group received intra-articular injection of hyaluronic acid once a week,with a continuous treatment duration of 5 weeks.The day after the final intervention,knee joint macrostructure was observed using DR imaging,chondrocyte ultrastructure was examined through transmission electron microscopy,apoptosis of chondrocytes was assessed using Tunel staining,and western blot analysis was used to detect the expression of proteins related to the PI3K/Akt/mTOR pathway. RESULTS AND CONCLUSION:The DR imaging results revealed that the osteoarthritis group exhibited narrowed knee joint spaces and the formation of periarticular osteophytes,while the hyaluronic acid group and acupotomy group showed widened knee joint spaces with a reduction in periarticular osteophytes.Transmission electron microscopy results demonstrated a decreased number of autophagosomes in chondrocytes in the osteoarthritis group,along with nuclear shrinkage,nuclear membrane rupture,incomplete organelle morphology,and a clear tendency towards cell death.In contrast,both the hyaluronic acid group and acupotomy group exhibited a significant increase in autophagosomes,intact nuclear membranes,and a well-preserved cellular state.Tunel staining results indicated a considerable decrease in the number of apoptotic cells in the hyaluronic acid group and acupotomy group compared with the osteoarthritis group.Western blot results revealed that,compared with the control group,the expression levels of Beclin1,Cath D,and LC3II/LC3I were significantly decreased in the osteoarthritis group(P<0.05),while the expression levels of p-Akt/Akt and p-mTOR/mTOR were significantly increased(P<0.05);compared with the osteoarthritis group,the expression levels of Beclin1,Cath D,and LC3II/LC3I were significantly increased in both the hyaluronic acid group and acupotomy group(P<0.05),while the expression levels of p-Akt/Akt and p-mTOR/mTOR were significantly decreased(P<0.05).To conclude,acupotomy intervention can modulate the PI3K/Akt/mTOR signaling pathway to enhance the autophagic level in chondrocytes,thereby maintaining chondrocyte homeostasis.This ultimately leads to a slowdown in cartilage degeneration.