1.A comparative study on the conversion treatment of the sirolimus quadruple regimen for expanded criteria donor kidney transplantation versus the control group from the same donors
Hua YANG ; Rui XIONG ; Lisong WAN ; Tongzhang CHEN ; Jinran YANG ; Wenfeng LUO ; Xinzhang LI
Organ Transplantation 2026;17(2):243-249
Objective To explore the efficacy and safety of converting the triple immunosuppressive regimen of tacrolimus (Tac) + mycophenolate mofetil (MMF) + prednisone (Pred) to a quadruple regimen of low-dose sirolimus (SRL) + low-dose Tac + MMF + Pred at 3 to 6 months after expanded criteria donor (ECD) kidney transplantation. Methods A single-center, retrospective, donor-matched controlled study included 22 ECD kidney transplant recipients from September 2021 to June 2024. Two recipients from the same donor kidneys were respectively assigned to the SRL group and the conventional triple regimen control group. The main outcome measures were the differences in serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and adverse events before the regimen conversion and after conversion during the 1, 3, 6, and 12-month follow-up. Results There were no statistically significant differences in baseline characteristics between the two groups. In the SRL group, Scr decreased and eGFR increased starting from 3 months after conversion, and this was superior to the control group starting from 6 months(all P < 0.05). There were no statistically significant differences in the incidence of rejection reactions, pulmonary infections, hyperlipidemia and proteinuria between the two groups after conversion and during the 12-month follow-up (all P > 0.05). Conclusions For ECD kidney transplant recipients, converting the triple regimen to the SRL quadruple regimen at 3 to 6 months after transplantation may improve the function of the transplanted kidney without increasing the risk of adverse events.
2.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
3.Study on changes and correlations of color,components and anti-tumor activity of processed products of Gelsemium elegans at different sand-frying durations
Hao WU ; Lisong CHEN ; Chenglong HUANG ; Yueling WANG ; Lirong CHEN ; Wenyi WANG ; Yinghao WANG ; Desen LI ; Shuisheng WU ; Ying CHEN
China Pharmacy 2026;37(17):2258-2263
OBJECTIVE To explore the changes and correlations of color, components and anti-tumor activity of Gelsemium elegans during sand-frying processing, so as to provide a reference for the toxicity-attenuating and efficacy-preserving processing as well as quality control of sand-fried G. elegans decoction pieces.METHODS Raw G.elegans and its processed products prepared by sand-frying for 15, 30, 75, 105 and 120 s were taken as test samples. The chromatic values, contents of total alkaloids and seven main active components (gelsemine, humantenine, koumine, gelsenicine, etc.) were determined. Their in vitro anti-tumor activity was investigated. The correlations between color and component contents, as well as between total alkaloid content and anti-tumor activity were analyzed.RESULTS The color of G.elegans samples generally darkened after sand-frying, and the total color difference (Δ E * ) of samples sand-fried for 75 s was greater than 20. At the initial stage of sand-frying (15-30 s), the total alkaloid content in processed products decreased sharply compared with the raw material; at the later-stage of sand-frying (75-105 s), the declining rate of total alkaloid content slowed down and tended to be stable. The contents of gelsenicine and humantenidine in processed products dropped drastically at 30 s of sand-frying, while the contents of koumine and sempervirine decreased substantially (by about 80%) after 75 s of sand-frying and then gradually tended to be stable. The anti-HepG2 cell proliferation activity of each processed product decreased with the extension of frying time. Correlation analysis demonstrated that color brightness and yellow-blue chromaticity were significantly positively correlated with the contents of total alkaloids and all determined active components except gelsemine ( P <0.05 or P <0.01); red-green chromaticity was significantly positively correlated with the contents of koumine, sempervirine, gelsemivirine and humantenidine ( P <0.05 or P <0.01); Δ E * was significantly negatively correlated with the contents of total alkaloids and all determined active components except gelsemine. Besides, total alkaloid content was significantly negatively correlated with the half maximal inhibitory concentration of the samples on HepG2 cells ( P <0.05 or P <0.01).CONCLUSIONS With the prolongation of sand-frying time, the color of sand-fried G.elegans decoction pieces gradually turned brownish-brown, the contents of seven active components and total alkaloids decreased progressively, and its anti-HepG2 cell activity showed an overall downward trend. Sand-frying for 75 s serves as a critical turning-point for the above-mentioned changes.
4.A novel anchor-loop internal fixation system in coracoclavicular ligament reconstruction for acromioclavicular dislocation: a biomechanical study
Chen WANG ; Na YANG ; Lisong HENG ; Wei FAN ; Yangjun ZHU ; Kun ZHANG ; Zhe SONG
Chinese Journal of Orthopaedic Trauma 2024;26(2):125-129
Objective:To explore the biomechanical stability of a novel anchor-loop internal fixation system in the treatment of acromioclavicular joint dislocation using cadaveric specimens.Methods:The acromioclavicular ligaments were severed in 12 complete shoulder joint specimens, in which the quasi-static non-destructive cycle experiment was performed until the coracoclavicular ligaments failed. The failure intensities of the coracoclavicular ligaments were recorded. Next, the 12 specimens were randomly divided into groups A, B, C and D ( n=3), in which 4 different internal fixation materials were used respectively to reduce and fix the acromioclavicular joint. Group A was subjected to 3.5 mm clavicular hook locking compression plate, group B to 5 mm soft tissue with wire anchor, group C to 10 mm Endobutton steel plate, and group D to the novel anchor-loop internal fixation system (5 mm soft tissue with wire anchor + 10 mm Endobutton steel plate). An X-ray machine was used to evaluate the reduction and internal fixation of the acromioclavicular joint. After the shoulder specimens were securely fastened by a homemade fixation jig to a 100 KN electronic universal mechanical testing machine, each experimental specimen was subjected to a destructive static tensile mechanic determination in the vertical direction at a loading speed of 100 mm/min. The load-displacement curves were recorded and drawn by a computer connected with the biomechanical testing machine. The failure strength and failure causes were recorded for each internal fixation. Results:The fracture strength of the coracoclavicular ligament in 12 cadaver specimens was (374.6±0.8) N. The mechanical load of internal fixation failure was (409.5±2.6) N in group A, (297.8±3.4) N in group B, (375.2±3.1) N in group C and (376.2±3.1) N in group D. The internal fixation failure was due to clavicular fracture in 2 specimens and to acromial fracture in 1 specimen in group A, to anchor protrusion in all the 3 specimens in group B, to coracoid base fracture in all the 3 specimens in group C, and to anchor protrusion in all the 3 specimens in group D. The mechanical loads of internal fixation failure were significantly different among the 4 experimental groups ( P<0.05). The mechanical load of internal fixation failure in group D was significantly different from that in groups A and B ( P<0.05). Conclusions:Our self-developed novel anchor-loop internal fixation system can effectively reposit the acromioclavicular joint to treat acromioclavicular joint dislocation, because it conforms to the biomechanical characteristics of the acromioclavicular joint, and is easy to handle. Therefore, its feasibility is high.
5.Potential of new self-crosslinked hyaluronic acid gel on the recovery of endometrium after artificial abortion: a multicenter, prospective randomized controlled trial
Chunying LI ; Lirong TENG ; Qing LIN ; Liping ZHAO ; Yunxia ZHU ; Xin MI ; Zhenna WANG ; Xiaoye WANG ; Lisong ZHANG ; Dan HAN ; Lili MA ; Wenpei BAI ; Jianmei WANG ; Jun NI ; Huiping SHEN ; Qinfang CHEN ; Hongmei XU ; Chenchen REN ; Jing JIANG ; Guanyuan LIU ; Ping PENG ; Xinyan LIU
Chinese Journal of Obstetrics and Gynecology 2024;59(11):864-870
Objective:To evaluate the impact of self-crosslinked hyaluronic acid (SCH) gel on endometrium recovery after artificial abortion.Methods:A multicenter, prospective randomized controlled trial was conducted across 18 hospitals from December 2021 to February 2023, involving 382 women who underwent artificial abortion. Participants were randomly allocated to receive either treatment with SCH gel (SCH group) or no treatment (control group) in a 1∶1 ratio. The primary outcome was endometrium thickness in 14 to 18 days after the first postoperative menstruation. Secondary outcomes included changes in menstrual volume during the first postoperative menstruation, menstruation resumption within 6 postoperative weeks, time to menstruation resumption, duration of the first postoperative menstruation, and incidence of dysmenorrhea.Results:Baseline characteristics of participants were comparable between the two groups (all P>0.05), with 95.3% (182/191) in SCH group and 92.7% (177/191) in the control group completed the study. The postoperative endometrial thickness in SCH group was significantly greater than that in the control group [(9.78±3.15) vs (8.95±2.32) mm; P=0.005]. SCH group also had significantly fewer participants with reduced menstrual volume [23 cases (12.6%, 23/182) vs 31 cases (17.5%, 31/177); P=0.038]. Although SCH group experienced less dysmenorrhea during the first postoperative menstrual period, this difference was not statistically significant [28.5% (51/179) vs 37.1% (65/175); P=0.083]. Outcomes were similar between SCH group and the control group regarding the proportion of participants who resumed menstruation within 6 weeks postoperatively, time to menstruation resumption, and duration of the first postoperative menstruation ( P=0.792, 0.485, and 0.254, respectively). No serious adverse events were observed during the study period, and no adverse events were attributed to SCH gel treatment. Conclusion:The application of SCH gel after artificial abortion is safe and might aid in the recovery of the endometrium.
6.Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.
Binghe XU ; Qingyuan ZHANG ; Xichun HU ; Qing LI ; Tao SUN ; Wei LI ; Quchang OUYANG ; Jingfen WANG ; Zhongsheng TONG ; Min YAN ; Huiping LI ; Xiaohua ZENG ; Changping SHAN ; Xian WANG ; Xi YAN ; Jian ZHANG ; Yue ZHANG ; Jiani WANG ; Liang ZHANG ; Ying LIN ; Jifeng FENG ; Qianjun CHEN ; Jian HUANG ; Lu ZHANG ; Lisong YANG ; Ying TIAN ; Hongyan SHANG
Acta Pharmaceutica Sinica B 2023;13(5):2250-2258
Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR + ABC that relapsed/progressed after ≥1 endocrine therapy. Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint was the independent radiographic committee (IRC)-assessed progression-free survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline characteristics were comparable between the entinostat and placebo groups. The median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), respectively. Grade ≥3 adverse events (AEs) occurred in 154 (65.5%) patients in the entinostat group versus 23 (19.3%) in the placebo group, and the most common grade ≥3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly improved PFS compared with exemestane, with generally manageable toxicities in HR + ABC (ClinicalTrials.gov #NCT03538171).
7.Optimization of formulation and preparation technology of Neuritic acid oral emulsion
Wenjing CHEN ; Jialei FU ; Dandan SUN ; Beibei YU ; Lisong SHENG ; Xuesheng YAN
China Pharmacy 2022;33(4):458-464
OBJECTIVE To prepare Neuritic acid oral emulsion ,to optimize its formulation and preparation technology ,and to investigate its stability. METHODS Neuritic acid oral emulsion was prepared by mechanical method. On the basis of single factor experiment ,the appearance ,centrifugal stability ,centrifugal stability constant (Ke)and particle size of the emulsion as indexes,the formulation was optimized by orthogonal design ,taking the dosage of oleic acid ,octylphenol polyoxyethylene ether-10 and propylene glycol as factors ,the preparation technology was optimized by taking emulsification temperature ,shear time,pressure of high-pressure homogenization and cycle times of high-pressure homogenization as factors. The content of neuritic acid was determined by high performance liquid chromatography. The stability of Neuritic acid oral emulsion was investigated by high temperature test ,accelerated test and long-term test. RESULTS The optimal formulation and preparation technology were as follows:neuritic acid of 1 g,oleic acid of 5% ,octylphenol polyoxyethylene ether- 10 of 4% ,propylene glycol of 2% , emulsification temperature of 60 ℃ ,shear time of 2 min,homogenization pressure of 40 MPa and cycle times of twice. After three experiments ,the average particle size of Neuritic acid oral emulsion was 158.05 nm(RSD=1.58%,n=3),the average Ke was 0.39(RSD=1.49%,n=3),and the appearance was uniform milky white ,there was no stratification. The results of high temperature test showed that Neuritic acid oral emulsion was prone to stratification in high temperature environment ,and the content of neuritic acid increased. The results of accelerated test and long-term test showed that there was no significant change in the appearance or the content of neuritic acid when Neuritic acid oral emulsion was placed at room temperature for 6 months. CONCLUSIONS The formulation and preparation technology are stable and feasible ,and can be used for the preparation of Neuritic acid oral emulsion. Neuritic acid oral emulsion should not be placed in high temperature environment. It has good stability at room temperature for 6 months.
8.Study of quantitative flow ratio-guided surgical coronary artery revascularization strategy
Cong CHEN ; Yang ZHAO ; Kui ZHANG ; Pengyun YAN ; Haiming DANG ; Taoshuai LIU ; Yue SONG ; Jubing ZHENG ; Yang LI ; Lisong WU ; Jian CAO ; Ran DONG
Chinese Journal of Thoracic and Cardiovascular Surgery 2022;38(5):272-276
Objective:To explore the feasibility of applying quantitative flow ratio(QFR) to assess the degree of coronary artery functional stenosis before surgery, and to guide coronary artery bypass grafting(CABG) revascularization strategy.Methods:The study prospectively included a total of 154 patients who were electively treated with CABG in the 11th ward of the Department of Cardiac Surgery of Beijing Anzhen Hospital from January 2019 to September 2020, and their coronary angiography visually showed stenosis of the coronary artery to perform QFR analysis to know the diseased blood vessels. For functional stenosis, the surgeon was blinded to the results of QFR analysis before surgery. Collect its baseline data, perioperative data and recent clinical outcomes for summary analysis.Results:One year later, the coronary artery CTA showed that the occlusion rate of functionally significant disease(QFR<0.8) was 5.5%, and that of non-functionally significant disease(QFR≥0.8) was 15.6%. There was no difference in angina class or repeat interventions between patients with or without occluded bypass grafts.Conclusion:According to QFR analysis, coronary arteries with functional non-significant disease have a higher risk of grafts failure than those with functionally significant disease. For coronary arteries with negative QFR lesions, the risk of occlusion of arterial grafts is higher than that of venous. However, this finding is not significantly related to clinical prognosis, because patients with patency or occlusion of the grafts in non-significant lesions have not found excessive angina pectoris or repeated coronary interventions. QFR-guided selection of coronary surgery strategies is safe and feasible.
9.Deep vein thrombosis after closed fracture of lower extremity and blood types ABO
Shuhao LI ; Kun ZHANG ; Zhe SONG ; Wei FAN ; Xiaolong WANG ; Chen WANG ; Dongxu FENG ; Lisong HENG ; Fan XU ; Xiao CAI ; Pengfei WANG ; Yangjun ZHU
Chinese Journal of Orthopaedic Trauma 2021;23(1):81-87
Objective:To investigate the differences in incidence of deep vein thrombosis (DVT) after closed fracture of lower extremity between patients with different blood types ABO.Methods:A retrospective study was conducted in the 1, 951 patients who had been admitted to Department of Orthopaedics Trauma, Honghui Hospital Affiliated to Xi'an Jiaotong University for lower extremity fractures from August 2014 to June 2018. They were 924 males and 1,027 females with a mean age of 63 (46, 78) years (range, from 16 to 102 years). Of them, 572 were type O, 564 type A, 609 type B and 206 type AB. Venous ultrasonography was performed on both lower extremities within 12 hours after admission. The incidences of DVT after fracture were compared between different blood types in all the patients, patients with proximal fracture of the knee, peri-knee fracture and distal fracture of the knee, and patients<60 years old and ≥60 years old.Results:The incidences of DVT were, respectively, 26.75% (153/572), 28.72% (162/564), 34.32% (209/609) and 29.61% (61/206) for patients with blood type O, type A, type B and type AB. The DVT incidence for type B was significantly higher than that for type O ( P< 0.008). The incidences of DVT were, respectively, 28.74% (98/341), 28.99% (100/345), 39.45% (144/365) and 30.97% (35/113) for blood type O, type A, type B and type AB in the patients with proximal fracture of the knee. The DVT incidence for blood type B was significantly higher than those for blood type O and blood type A ( P< 0.008). There were no significant differences in the DVT incidence between different blood types ABO in the patients with peri-knee fracture, distal fracture of the knee,<60 years old or ≥60 years old( P>0.05). The incidences of DVT were, respectively, 30.99% (97/313), 33.33% (108/324), 45.22% (156/345), 34.74% (33/95) for blood type O, type A, type B and type AB in the patients ≥60 years old. The DVT incidence for blood type B was significantly higher than those for blood type O and blood type A ( P< 0.008). Conclusions:The incidence of DVT varied with different blood types ABO after lower extremity fracture. The highest DVT incidence was found in patients with blood type B. The impact of blood type on the DVT incidence after lower extremity fracture was mainly observed in the patients with proximal fracture of the knee or an age of ≥ 60 years old.
10.Efficacy evaluation of combined anterior and posterior elbow approach and posterior median elbow approach for treatment of O'Driscoll type III b fracture of ulnar coronoid process
Chen XIONG ; Kun ZHANG ; Xiao HE ; Jiarui YANG ; Changjun HE ; Chen WANG ; Zhengwei SHI ; Yangjun ZHU ; Lisong HENG
Chinese Journal of Trauma 2021;37(5):437-442
Objective:To compare the clinical effect of combined anterior and posterior approach and posterior median approach to treat O'Driscoll type III b fracture of ulnar coronoid process.Methods:A retrospective case control study was made on 67 patients with O'Driscoll type III b fracture of ulnar coronoid process treated in Honghui Hospital, Xi'an Jiaotong University from January 2015 to January 2019, including 35 males and 32 females, aged from 21 to 61 years [(38.0±9.4)years]. Among them, 31 patients were treated with combined anterior and posterior approach for reduction and internal fixation (combined approach group), and 36 patients with median posterior elbow approach group for reduction and internal fixation (posterior elbow approach group). The operation time, amount of intraoperative blood loss and fracture healing time were compared between groups. The visual analogue score (VAS), elbow joint range of motion and Mayo elbow performance score (MEPS) were assessed for pain and function evaluation at postoperative 1, 3, 6 months and at the last follow-up. The occurrence of complications were observed as well.Results:All patients were followed up for 12 to 28 months [(20.1±4.2)months]. There was no significant difference in operation time and VAS between the two groups ( P>0.05). The intraoperative blood loss [(133.6±20.3)ml] and fracture healing time [(12.3±1.7)months] in combined approach group were less or shorter than those in posterior elbow approach group [(144.4±22.1)ml, (13.2±2.0)months] ( P<0.05). The range of flexion and extension of elbow joint in combined approach group [(88.7±10.8)°, (111.1±13.9)°, (121.3±14.1)°, (127.1±13.3)°] was higher than that in posterior elbow approach group [(74.5±11.8)°, (97.6±12.6)°, (111.3±13.0)°, (115.2±12.7)°] at postoperative 1, 3, 6 months and at the last follow-up ( P<0.05). The MEPS in combined approach group [(31.7±8.6)points, (55.6±9.3)points, (84.6±10.5)points, (85.0±10.3)points] was higher than that in posterior elbow approach group [(27.2±8.2)points, (50.7±8.7)points, (77.4±11.2)points, (80.1±9.4)points] at postoperative 1, 3, 6 months and last follow-up ( P<0.05). The incidence of complications in combined approach group [10%(3/31)] was lower than that in posterior elbow approach group [31%(11/36)]( P<0.05). Conclusion:Compared with the simple posterior elbow median approach, the combined anterior and posterior elbow approach for treatment of O'Driscoll type IIIb fracture of ulnar coronoid process has lower intraoperative blood loss, faster fracture healing, lower incidence of complications and better elbow function.


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