1.Guben Kechuan Granules (固本咳喘颗粒) for the Treatment of Chronic Bronchitis with Lung Qi Weakness Pattern:A Multi-Centre Randomised Controlled Trial
Daowen YANG ; Xiaofeng SHANG ; Er HONG ; Hongchun ZHANG
Journal of Traditional Chinese Medicine 2025;66(3):262-267
ObjectiveThis study aimed to evaluate the clinical effectiveness and safety of Guben Kechuan Granules (固本咳喘颗粒) in treating chronic bronchitis (CB) with lung qi weakness pattern. MethodsA multicenter, randomized controlled trial was conducted, and 180 patients with CB of lung qi weakness pattern were randomly divided into 120 cases in the treatment group and 60 cases in the control group according to a 2∶1 ratio. The control group received health education for 24 weeks, while conventional symptomatic treatment was given when acute exacerbation of CB occurred. Treatment group was treated with the oral administration of Guben Kechuan Granules, 2 g each time, 3 times a day, for a total of 24 weeks on the basis of treatment of the control group. Both groups were followed up for 24 weeks after 24 weeks of treatment. Primary effectiveness indicators included the number of CB acute exacerbations occurence during the treatment and follow-up period, and the total number of CB acute exacerbations from the start of treatment to the end of follow-up. Secondary effectiveness indicators included the details of CB acute exacerbations, i.e., time to first acute exacerbation, time between acute exacerbations, duration of each time of acute exacerbation, and acute exacerbation symptom severity scores, and lung function indices. The scores of cough, sputum, and wheeze and total symptom scores were compared prior to treatment, at 4, 8, 12, 16, 20, and 24 weeks of treatment, and at 24 weeks of follow-up. The occurrence of adverse events during the study period was recorded and safety indices including blood routine, liver function, kidney function, and urine routine were tested. ResultsA total of 179 participants completed the trial including 119 in the treatment group and 60 in the control group. Compared to pre-treatment scores within the group, the treatment group showed reductions in cough, sputum, and wheeze scores, and total symptom scores at weeks 4, 8, 12, 16, 20, and 24 of treatment, as well as at 24 weeks of follow-up; in the control group, cough scores decreased at weeks 16, 20, and 24, sputum and wheeze scores decreased at week 24 of treatment and at 24 weeks of follow-up, and total symptom scores decreased at weeks 20, 24 of treatment, and at 24 weeks of follow-up (P<0.05). Compared with the control group, the treatment group showed reductions in the number of CB acute exacerbations occurence during the treatment and follow-up period, and the total number of CB acute exacerbations from the start of treatment to the end of follow-up, the duration of acute exacerbations, the acute exacerbation symptom severity scores, and the scores for cough, sputum, wheeze, and total symptoms at weeks 8, 12, 16, 20, 24 of treatment, and at 24 weeks of follow-up; while the time to the first acute exacerbation of CB was significantly prolonged in the treatment group (P<0.05 or P<0.01). There were no statistically significant differences in lung function indicators between groups before treatment and at 24 weeks after treatment (P>0.05). Safety indicators showed no significant abnormalities before or after treatment in either group, and the incidence of adverse events during the treatment period showed no significant differences between the groups (P>0.05). ConclusionGuben Kechuan Granules can reduce the risk of acute exacerbations in CB patients with lung qi weakness pattern, improve clinical symptoms such as cough, sputum, and wheeze, and show good safety.
2.LIM and calponin homology domains 1 may function as promising biological markers to aid in the prognostic prediction of oral squamous cell carcinoma.
Li XU ; Wen SHI ; Yuehua LI ; Yajun SHEN ; Shang XIE ; Xiaofeng SHAN ; Zhigang CAI
Journal of Peking University(Health Sciences) 2025;57(1):19-25
OBJECTIVE:
To explore the function of LIM and calponin homology domains 1 (LIMCH1) in the development and progression of oral squamous cell carcinoma (OSCC), along with their potential clinical applications.
METHODS:
By utilizing transcriptome sequencing data from two groups of oral squamous cell carcinoma patients, along with bioinformatics analytical techniques such as Gene Ontology (GO) and gene co-expression networks, we identified genes that might play a pivotal role in the pathogenesis of oral squamous cell carcinoma. We employed real-time quantitative PCR and Western blotting to validate the expression patterns of these genes across twelve patient tissue samples. Furthermore, we conducted CCK-8 assays, flow cytometry analyses, and scratch wound healing assays to assess the impact of key genes on the biological behaviors of both the Cal27 oral squamous cell carcinoma cell line and the potentially malignant DOK oral lesion cell line. Additionally, we examined correlations between these key genes and clinical disease parameters in 214 oral squamous cell carcinoma patients using The Cancer Genome Atlas (TCGA) data; gene set enrichment analysis (GSEA) analysis results were also incorporated to enhance our findings from real-time quantitative PCR and Western blotting regarding potential mechanisms underlying the action of these key genes.
RESULTS:
The integrated analysis of sequencing data and bioinformatics revealed that LIMCH1 exhibited significantly reduced mRNA (P < 0.001) and protein levels (P < 0.01) in the oral squamous cell carcinoma tissues compared with normal control tissues. In the Cal27 cells, the low LIMCH1 level group demonstrated a larger wound healing area within 24 hours than the control group (P < 0.01), enhanced proliferation capacity over 72 hours relative to the control group (P < 0.01), and an increased apoptosis rate within 24 hours compared with the high expression group (P < 0.05). However, no significant differences were observed between the low and high level groups in DOK cells. Furthermore, it was determined that low LIMCH1 level correlated with poor prognosis in the patients (P=0.013) and a higher lymph node metastasis rate (P < 0.05). Investigations into the potential mechanisms of action indicated that LIMCH1 did not influence the onset or progression of oral squamous cell carcinoma via the epithelial-mesenchymal transition pathway.
CONCLUSION
LIMCH1 level may function as a promising biomarker to aid in the prognostic assessment of oral squamous cell carcinoma; however, its precise mechanistic role requires further investigation.
Humans
;
Mouth Neoplasms/metabolism*
;
Prognosis
;
Carcinoma, Squamous Cell/metabolism*
;
Biomarkers, Tumor/metabolism*
;
LIM Domain Proteins/metabolism*
;
Cell Line, Tumor
;
Cell Proliferation
;
Male
;
Female
3.One-stage mandibular reconstruction combining iliac flap with immediate implant-based denture.
Yifan KANG ; Yanjun GE ; Xiaoming LV ; Shang XIE ; Xiaofeng SHAN ; Zhigang CAI
Journal of Peking University(Health Sciences) 2025;57(1):78-84
OBJECTIVE:
To evaluate the clinical outcomes and define the indications for a one-stage mandibular reconstruction technique that combines iliac bone flaps with immediate implant-based dentures, and to assess both the accuracy of surgical planning and the long-term success of the procedure.
METHODS:
A total of ten patients underwent the procedure at Peking University Hospital of Stomatology between June 2020 and August 2023. The preoperative biopsy pathology of all the patients confirmed a benign tumor. In this technique, iliac bone flaps were used for mandibular reconstruction, and immediate implant-based dentures were placed during the same surgical session. Various outcome measures were evaluated, including the accuracy of the surgical reconstruction, implant placement deviations (entry point, apical point, depth, and angle), and long-term outcomes, such as cervical bone resorption, implant survival, and the cumulative survival rate.
RESULTS:
Thirty-eight implants were successfully inserted into the iliac flaps of the ten patients. The median follow-up duration was 23.5 months, and no significant complications occurred during the follow-up period, such as infections, titanium plate exposure, implant loosening, or damage to the implants and dentures. The accuracy of preoperative virtual surgical planning (VSP) was highly reliable. The repeatability of the VSP model compared to the postoperative reconstructed mandible was as follows: 67.82% ±10.16% within 1 mm, 82.14% ±6.58% within 2 mm, and 90.61% ±4.62% within 3 mm. The average maximum deviation from the plan was (6.10±0.89) mm, with an average overall deviation of (1.14±0.31) mm. For the implants, deviations in critical parameters were as follows: entry point deviation was (2.02±0.58) mm, apical point deviation was (2.25± 0.66) mm, depth deviation was (1.26±0.51) mm, and angular deviation was 1.84°±1.10°. The implant survival rate remained 100% during the follow-up, with a cumulative survival rate of 97.37% from 1 to 4 years. Average cervical bone resorption was 0.94 mm.
CONCLUSION
The combination of iliac bone flaps with immediate implant-based dentures for one-stage mandibular reconstruction demonstrated pro-mising clinical outcomes, including high implant survival and minimal complications. This technique proved to be safe and reliable for mandibular reconstruction. However, further studies with larger sample sizes and longer follow-up periods are necessary to confirm the long-term efficacy and optimal indications for this procedure.
Humans
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Mandibular Reconstruction/methods*
;
Male
;
Ilium/surgery*
;
Female
;
Middle Aged
;
Surgical Flaps
;
Adult
;
Mandible/surgery*
;
Aged
;
Dental Implantation, Endosseous/methods*
;
Immediate Dental Implant Loading/methods*
;
Bone Transplantation/methods*
;
Dental Implants
4.Construction and application of oral squamous cell carcinoma organoid bank.
Shang XIE ; Luming WANG ; Xinyuan ZHANG ; Qiushi FENG ; Yangyang XIA ; Ziwei DAI ; Xiaofeng SHAN ; Zhigang CAI
Journal of Peking University(Health Sciences) 2025;57(5):847-851
Oral squamous cell carcinoma (OSCC) accounts for over 90% of oral malignancies, with more than 370 000 new cases and approximately 188 000 deaths annually worldwide. In China, there are roughly 65 000 new cases and 35 000 deaths each year, showing a significant upward trend compared with 2015 statistics. Despite continuous advancements in treatment modalities, the 5-year survival rate remains stagnant at 50%-60%, where tumor heterogeneity and therapy resistance persist as fundamental barriers to precision oncology. To address these critical challenges, this study established a standardized bioban-king protocol for OSCC patient-derived organoids (PDOs) (Patent: Method for constructing an oral squamous cell carcinoma organoid bank, ZL202311378598.3). Through groundbreaking optimization of culture media, enzymatic digestion kinetics, and stepwise cryopreservation, we achieved a biobanking success rate exceeding 95% and pioneered synchronous cultivation of matched primary tumors, lymph node metastases, and adjacent normal mucosa from individual patients, preserving spatial heterogeneity and stromal interactions. Leveraging this platform, we developed high-throughput drug screening: Quantified heterogeneity-driven differential chemoresponse using adenosine triphosphate (ATP)-based viability assays; We discovered resistance mechanisms: Identified sialylated cancer IgG (SIA-cIgG)-mediated cis-platin resistance (primary/secondary) through PTPN13 suppression, with anti-SIA-cIgG combination therapy demonstrating synergistic efficacy. Besides, we elucidated metastatic drivers: CRISPR-Cas9-edited organoids revealed WDR54 promoted metastasis via H3K4me3/H4K16ac epigenetic reprogramming, activating epithelial-mesenchymal plasticity (EMP) and inducing partial epithelial-mesenchymal transition (pEMT). This "holographic patient-mirroring" platform provided unprecedented resolution for OSCC precision therapy and had been formally incorporated into the Chinese Stomatological Association Technical Guidelines (Technical guideline for establishing patient-derived oral squamous cell carcinoma organoid banks, CHSA 2024-08). Future integration of immune-competent organoids, 3D-bioprinted vasculature, and multi-omics-AI systems will accelerate personalized oncology. These innovations will accelerate clinical translation of personalized therapeutic regimens, ultimately bridging the gap between bench research and bedside application.
Humans
;
Organoids/pathology*
;
Mouth Neoplasms/genetics*
;
Carcinoma, Squamous Cell/pathology*
;
Tissue Banks
;
Biological Specimen Banks
5.Expert consensus on surgical treatment of oropharyngeal cancer
China Anti-Cancer Association Head and Neck Oncology Committee ; China Anti-Cancer Association Holistic Integrative Oral Cancer on Preventing and Screen-ing Committee ; Min RUAN ; Nannan HAN ; Changming AN ; Chao CHEN ; Chuanjun CHEN ; Minjun DONG ; Wei HAN ; Jinsong HOU ; Jun HOU ; Zhiquan HUANG ; Chao LI ; Siyi LI ; Bing LIU ; Fayu LIU ; Xiaozhi LV ; Zheng-Hua LV ; Guoxin REN ; Xiaofeng SHAN ; Zhengjun SHANG ; Shuyang SUN ; Tong JI ; Chuanzheng SUN ; Guowen SUN ; Hao TIAN ; Yuanyin WANG ; Yueping WANG ; Shuxin WEN ; Wei WU ; Jinhai YE ; Di YU ; Chunye ZHANG ; Kai ZHANG ; Ming ZHANG ; Sheng ZHANG ; Jiawei ZHENG ; Xuan ZHOU ; Yu ZHOU ; Guopei ZHU ; Ling ZHU ; Susheng MIAO ; Yue HE ; Jugao FANG ; Chenping ZHANG ; Zhiyuan ZHANG
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(11):821-833
With the increasing proportion of human papilloma virus(HPV)infection in the pathogenic factors of oro-pharyngeal cancer,a series of changes have occurred in the surgical treatment.While the treatment mode has been im-proved,there are still many problems,including the inconsistency between diagnosis and treatment modes,the lack of popularization of reconstruction technology,the imperfect post-treatment rehabilitation system,and the lack of effective preventive measures.Especially in terms of treatment mode for early oropharyngeal cancer,there is no unified conclu-sion whether it is surgery alone or radiotherapy alone,and whether robotic minimally invasive surgery has better func-tional protection than radiotherapy.For advanced oropharyngeal cancer,there is greater controversy over the treatment mode.It is still unclear whether to adopt a non-surgical treatment mode of synchronous chemoradiotherapy or induction chemotherapy combined with synchronous chemoradiotherapy,or a treatment mode of surgery combined with postopera-tive chemoradiotherapy.In order to standardize the surgical treatment of oropharyngeal cancer in China and clarify the indications for surgical treatment of oropharyngeal cancer,this expert consensus,based on the characteristics and treat-ment status of oropharyngeal cancer in China and combined with the international latest theories and practices,forms consensus opinions in multiple aspects of preoperative evaluation,surgical indication determination,primary tumor re-section,neck lymph node dissection,postoperative defect repair,postoperative complication management prognosis and follow-up of oropharyngeal cancer patients.The key points include:① Before the treatment of oropharyngeal cancer,the expression of P16 protein should be detected to clarify HPV status;② Perform enhanced magnetic resonance imaging of the maxillofacial region before surgery to evaluate the invasion of oropharyngeal cancer and guide precise surgical resec-tion of oropharyngeal cancer.Evaluating mouth opening and airway status is crucial for surgical approach decisions and postoperative risk prediction;③ For oropharyngeal cancer patients who have to undergo major surgery and cannot eat for one to two months,it is recommended to undergo percutaneous endoscopic gastrostomy before surgery to effectively improve their nutritional intake during treatment;④ Early-stage oropharyngeal cancer patients may opt for either sur-gery alone or radiation therapy alone.For intermediate and advanced stages,HPV-related oropharyngeal cancer general-ly prioritizes radiation therapy,with concurrent chemotherapy considered based on tumor staging.Surgical treatment is recommended as the first choice for HPV unrelated oropharyngeal squamous cell carcinoma(including primary and re-current)and recurrent HPV related oropharyngeal squamous cell carcinoma after radiotherapy and chemotherapy;⑤ For primary exogenous T1-2 oropharyngeal cancer,direct surgery through the oral approach or da Vinci robotic sur-gery is preferred.For T3-4 patients with advanced oropharyngeal cancer,it is recommended to use temporary mandibu-lectomy approach and lateral pharyngotomy approach for surgery as appropriate;⑥ For cT1-2N0 oropharyngeal cancer patients with tumor invasion depth>3 mm and cT3-4N0 HPV unrelated oropharyngeal cancer patients,selective neck dissection of levels ⅠB to Ⅳ is recommended.For cN+HPV unrelated oropharyngeal cancer patients,therapeutic neck dissection in regions Ⅰ-Ⅴ is advised;⑦ If PET-CT scan at 12 or more weeks after completion of radiation shows intense FDG uptake in any node,or imaging suggests continuous enlargement of lymph nodes,the patient should undergo neck dissection;⑧ For patients with suspected extracapsular invasion preoperatively,lymph node dissection should include removal of surrounding muscle and adipose connective tissue;⑨ The reconstruction of oropharyngeal cancer defects should follow the principle of reconstruction steps,with priority given to adjacent flaps,followed by distal pedicled flaps,and finally free flaps.The anterolateral thigh flap with abundant tissue can be used as the preferred flap for large-scale postoperative defects.
6.The application and effect of bispherical augment in acetabular defects reconstruction
Guoyuan LI ; Xiaoqi ZHANG ; Min CHEN ; Zhengliang LUO ; Daijie FU ; Xiaofeng JI ; Zhe NI ; Xifu SHANG
Chinese Journal of Surgery 2024;62(9):828-835
Objective:To evaluate the clinical effect of bispherical augment in acetabular defects reconstruction in hip revision.Methods:This is a retrospective case series study. A retrospective analysis of 119 patients (124 hips) patients who underwent hip revision surgery and reconstructed with bispherical augment for acetabular bone defects from January 2019 to December 2023 was performed. There were 57 males (58 hips) and 62 females (66 hips), aged (65.0±11.8) years (range:40 to 102 years). The body mass index was (23.9±3.5) kg/m 2 (range:16.1 to 32.2 kg/m 2). Acetabular bone defects were typed as follows: 2 hips in Paprosky type ⅡA, 29 hips in type ⅡB, 34 hips in type ⅡC, 31 hips in type ⅢA, and 28 hips in type ⅢB, of which 9 patients (9 hips) were combined with pelvic discontinuity. Differences in Harris hip score (HHS) and lower limb discrepancy (LLD) were compared between preoperatively and final follow-up. The height of the hip center of rotation and the horizontal distance from the center of rotation to the teardrop were measured by radiographs before and after surgery, and prothesis stability and the occurrence of postoperative complications were evaluated. Data were compared using the paired sample t test. Results:All patients successfully completed the operation. The operation time was (167.0±53.4) minutes (range:90 to 380 minutes) and the intraoperative bleeding was (345.3±124.2) ml (range:100 to 1 200 ml). The height of the hip center of rotation decreased from (39.7±13.0) mm preoperatively to (21.8±7.1) mm postoperatively and the horizontal distance from the center of rotation to the teardrop increased from (34.0±10.1) mm preoperatively to (38.5±5.9) mm postoperatively, and the differences were statistically significant ( t=15.859, P<0.01; t=5.266, P<0.01). All the patients were followed up for (26.1±15.4) months (range:6 to 60 months). At the last follow-up, HHS improved from (35.2±10.0) points preoperatively to (85.5±9.5) points, and the difference was statistically significant ( t=50.723, P<0.01). LLD decreased from (2.1±1.1) cm preoperatively to (0.5±0.5) cm, and the difference was statistically significant ( t=13.767, P<0.01). All acetabular components were stable and free of displacement on imaging during follow-up. Three patients suffered dislocation and received closed reduction, all prosthesis were in good position during follow-up. No dislocation, loosening, fracture, recurrence of infection and vascular nerve injury occurred in other patients. Conclusion:Bispherical augment can effectively reconstruct acetabular bone defects, restore the hip center of rotation, and improve hip joint function scores at short and mid-term follow-up.
7.The application and effect of bispherical augment in acetabular defects reconstruction
Guoyuan LI ; Xiaoqi ZHANG ; Min CHEN ; Zhengliang LUO ; Daijie FU ; Xiaofeng JI ; Zhe NI ; Xifu SHANG
Chinese Journal of Surgery 2024;62(9):828-835
Objective:To evaluate the clinical effect of bispherical augment in acetabular defects reconstruction in hip revision.Methods:This is a retrospective case series study. A retrospective analysis of 119 patients (124 hips) patients who underwent hip revision surgery and reconstructed with bispherical augment for acetabular bone defects from January 2019 to December 2023 was performed. There were 57 males (58 hips) and 62 females (66 hips), aged (65.0±11.8) years (range:40 to 102 years). The body mass index was (23.9±3.5) kg/m 2 (range:16.1 to 32.2 kg/m 2). Acetabular bone defects were typed as follows: 2 hips in Paprosky type ⅡA, 29 hips in type ⅡB, 34 hips in type ⅡC, 31 hips in type ⅢA, and 28 hips in type ⅢB, of which 9 patients (9 hips) were combined with pelvic discontinuity. Differences in Harris hip score (HHS) and lower limb discrepancy (LLD) were compared between preoperatively and final follow-up. The height of the hip center of rotation and the horizontal distance from the center of rotation to the teardrop were measured by radiographs before and after surgery, and prothesis stability and the occurrence of postoperative complications were evaluated. Data were compared using the paired sample t test. Results:All patients successfully completed the operation. The operation time was (167.0±53.4) minutes (range:90 to 380 minutes) and the intraoperative bleeding was (345.3±124.2) ml (range:100 to 1 200 ml). The height of the hip center of rotation decreased from (39.7±13.0) mm preoperatively to (21.8±7.1) mm postoperatively and the horizontal distance from the center of rotation to the teardrop increased from (34.0±10.1) mm preoperatively to (38.5±5.9) mm postoperatively, and the differences were statistically significant ( t=15.859, P<0.01; t=5.266, P<0.01). All the patients were followed up for (26.1±15.4) months (range:6 to 60 months). At the last follow-up, HHS improved from (35.2±10.0) points preoperatively to (85.5±9.5) points, and the difference was statistically significant ( t=50.723, P<0.01). LLD decreased from (2.1±1.1) cm preoperatively to (0.5±0.5) cm, and the difference was statistically significant ( t=13.767, P<0.01). All acetabular components were stable and free of displacement on imaging during follow-up. Three patients suffered dislocation and received closed reduction, all prosthesis were in good position during follow-up. No dislocation, loosening, fracture, recurrence of infection and vascular nerve injury occurred in other patients. Conclusion:Bispherical augment can effectively reconstruct acetabular bone defects, restore the hip center of rotation, and improve hip joint function scores at short and mid-term follow-up.
8.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
9.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
10.Clinical efficacy of Da Vinci robot-assisted superior mediastinum lymph node dissection around recurrent laryngeal nerve
Xiaofeng DUAN ; Jie YUE ; Xiaobin SHANG ; Zhao MA ; Chuangui CHEN ; Chen ZHANG ; Zuoyu CHEN ; Hongjing JIANG
Chinese Journal of Digestive Surgery 2023;22(S1):1-6
Objective:To investigate the clinical efficacy of Da Vinci robot-assisted superior mediastinum lymph node dissection around recurrent laryngeal nerve.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 404 patients with esophageal cancer who underwent Da Vinci robot-assisted esophagectomy in Tianjin Medical University Cancer Hospital and Institute from June 2017 to June 2022 were collected. There were 349 males and 55 females, aged (62±8)years. Observation indicators: (1) intraoperative conditions; (2) postoperative conditions; (3) comparison of clinical features in patients who were admitted in different time periods. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the one way ANOVA. Measurement data with skewed distribution were represented as M(IQR), and comparison among multiple groups was conducted using the Kruskal-Wallis H test. Count data were described as absolute numbers or percentages, and com-parison between groups was conducted using the chi-square test or Fisher exact probability. Results:(1) Intraoperative conditions. The operation time, volume of intraoperative blood loss, the total number of lymph node dissected, the number of thoracic lymph node dissected, left recurrent laryngeal nerve lymph node dissection rate, the number of left recurrent laryngeal nerve lymph node dissected, left recurrent laryngeal nerve lymph node metastasis rate, right recurrent laryngeal nerve lymph node dissection rate, the number of right recurrent laryngeal nerve lymph node dissected, right recurrent laryngeal nerve lymph node metastasis rate were (306±56)minutes,200(100)mL, 29.9±13.1, 18.5±9.7, 78.47%(317/404), 4.0(3.0), 17.35%(55/317), 94.55%(382/404), 3.0(2.0), 21.20%(81/382). (2) Postoperative conditions. The tumor histopathological type (squamous cell carcinoma, neuroendocrine carcinoma, adenocarcinoma, carcinosarcoma, adenosquamous carcinoma, malignant melanoma), incidence rate of overall complications, cases with recurrent laryngeal nerve paralysis, cases with pulmonary complications, cases with anastomotic fistula, cases with incision infection, cases with chylothorax, cases with arrhythmia, cases with deep vein thrombosis, cases with other complications, incidence of re-admission to the intensive care unit, duration of postoperative hospital stay, 90-day mortality were 377, 11, 7, 5, 3, 1, 27.48%(111/404), 8.91%(36/404), 10.64%(43/404), 6.93%(28/404), 0.99%(4/404), 2.48%(10/404), 1.73%(7/404), 0.50%(2/404), 1.98%(8/404), 6.93%(28/404), 16(11)days, 0.50%(2/404). (3) Comparison of clinical features in patients who were admi-tted in different time periods. The number of patients who were admitted from June 2017 to May 2018, from June 2018 to May 2019, from June 2019 to May 2020, from June 2020 to May 2021, from June 2021 to June 2022 was 40, 56, 57, 116, 135, respectively. There were significant differences in age, tumor histopathological type, pT staging, neoadjuvant therapy, operation time, volume of intra-operative blood loss, the total number of lymph node dissected, the number of thoracic lymph node dissected, left recurrent laryngeal nerve lymph node dissection rate, the number of left recurrent laryngeal nerve lymph node dissected, the number of right recurrent laryngeal nerve lymph node dissected, incidence rate of overall complications among patients who were admitted in different time periods ( P<0.05). Conclusion:The Da Vinci robot-assisted superior mediastinum lymph node dissection around recurrent laryngeal nerve is safe and feasible, which can achieve good short-term efficacy.


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