1.Short- to medium-term safety and efficacy of the implantable Corheart 6 left ventricular assist system in patients with end-stage heart failure
Zhibing QIU ; Xiaochun SONG ; Liangpeng LI ; Hongwei SHI ; Liqiong XIAO ; Yunzhang WU ; Xiaosong RONG ; Jidan FAN ; Liang WEI ; Xin CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(05):639-645
Objective To investigate the efficacy and safety of the Corheart 6 left ventricular assist system in patients with end-stage heart failure. Methods A retrospective study was conducted on patients with end-stage heart failure who were treated with Corheart 6 left ventricular assist system from March 2022 to June 2024 in 4 hospitals in Jiangsu Province. The efficacy of the device was evaluated by comparing changes in clinical indicators at preoperative, discharge, 3-month postoperative, and 6-month postoperative timepoints, including the New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), and left ventricular end-diastolic diameter (LVEDD). The safety of the device was assessed by analyzing the intraoperative position and orientation of the blood pump inlet cannula, as well as the incidence of adverse events. Results In this study, 39 patients were collected, including 34 males and 5 females with a mean age of (56.4±12.5) years, ranging from 20 to 75 years. There was no operative death. There was no death in postoperative 3 months with a survival rate of 100.0%. There were 3 deaths in 6 months postoperatively, with a survival rate of 92.3%. All patients had a preoperative NYHA cardiac function classification of class Ⅳ. The NYHA cardiac function class of the patients improved (P<0.05) at discharge, 3 and 6 months after surgery when compared to the preoperative period. LVEF was significantly higher at 3 months after surgery than that during the preoperative period (P<0.05). LVEDD was significantly smaller at discharge, 3 and 6 months after surgery than that during the preoperative period (P<0.05). The safety evaluation's findings demonstrated that all 39 patients' intraoperative blood pump inlet tubes were oriented correctly, the artificial blood vessel suture sites were appropriate, there were no instances of device malfunction or pump thrombosis, or instances of bleeding or hemolysis, and the rate of the remaining adverse events was low. Conclusion With a low rate of adverse events and an excellent safety profile, the Corheart 6 left ventricular assist system can efficiently enhance cardiac function in patients with end-stage heart failure. It also has considerable clinical uses.
2.Xianling Lianxia formula improves the efficacy of trastuzumab by enhancing NK cell-mediated ADCC in HER2-positive BC
Li FEIFEI ; Shi YOUYANG ; Ma MEI ; Yang XIAOJUAN ; Chen XIAOSONG ; Xie YING ; Liu SHENG
Journal of Pharmaceutical Analysis 2024;14(10):1450-1467
Trastuzumab has improved survival rates in human epidermal growth factor receptor 2(HER2)-positive breast cancer(BC),but drug resistance leads to treatment failure.Natural killer(NK)cell-mediated antibody-dependent cell cytotoxicity(ADCC)represents an essential antitumor immune mechanism of trastuzumab.Traditional Chinese medicine(TCM)has been used for centuries to treat diseases because of its capacity to improve immune responses.Xianling Lianxia formula(XLLXF),based on the principle of"strengthening body and eliminating toxin",exhibits a synergistic effect in the trastuzumab treatment of patients with HER2-positive BC.Notably,this synergistic effect of XLLXF was executed by enhancing NK cells and ADCC,as demonstrated through in vitro co-culture of NK cells and BC cells and in vivo inter-vention experiments.Mechanistically,the augmented impact of XLLXF on NK cells is linked to a decrease in cytokine inducible Src homology 2(SH2)containing protein(CISH)expression,which in turn activates the Janus kinase 1(JAK1)/signal transducer and activator of transcription 5(STAT5)pathway.Collectively,these findings suggested that XLLXF holds promise for enhancing NK cell function and sensitizing pa-tients with HER2-positive BC to trastuzumab.
3.Efficacy of arthroscopic modified anatomic glenoid reconstruction with Enden-Hybinette procedure in the treatment of recurrent anterior dislocation of shoulder combined with severe glenoid bone loss
Keyi ZHAO ; Congcong CHEN ; Gan ZHANG ; Lyu WU ; Xiaosong CHEN
Chinese Journal of Trauma 2024;40(5):446-453
Objective:To investigate the clinical efficacy of arthroscopic modified anatomic glenoid reconstruction with Enden-Hybinette procedure combined with loop plate fixation in the treatment of recurrent anterior dislocation of shoulder combined with severe glenoid bone loss.Methods:A retrospective case series study was conducted to analyze 36 patients with recurrent anterior dislocation of the shoulder combined with severe glenoid bone loss who were admitted to 901st Hospital of the Joint Logistics Support Force of PLA from January 2019 to January 2021, including 28 males and 8 females, aged 18-33 years [(29.5±3.0)years]. All the patients had injury history. The dislocation frequency range was 2-40 times [(20.5±6.5)times]. Beighton scale scores were 3-9 points [(4.0±0.8)points]. All the patients underwent anatomic reconstruction of the glenoid bone with arthroscopic modified Enden-Hybinette procedure using iliac autograft and loop plate elastic fixation. Posterior glenoid version angle, the breadth of the glenoid cavity and the A-P glenoid cavity depth were measured and osseous anatomy of the reconstructed glenoid bone was evaluated. Union of the Iliac bone block and glenoid bone loss was observed and the absorption rate of the bone block was evaluated at 6 months after surgery. The shoulder stability score, functional activity score, joint range of motion score and total Rowe score of shoulder function were used to evaluate the shoulder stability, functional activity and movement before surgery, at 3, 6 months after surgery and at the last follow-up. The incidence of complications was observed.Results:All the patients were followed up for 12-24 months [(18.8±3.5)months]. At 1, 3, 6 months after surgery and at the last follow-up, posterior glenoid version angle was (11.3±1.7)°, (10.6±1.2)°, (9.1±2.0)° and (9.2±1.9)° respectively; the breadth of the glenoid cavity was (34.2±1.3)mm, (33.2±1.0)mm, (32.2±1.0)mm and (31.3±1.1)mm respectively; the A-P glenoid cavity depth was (2.6±0.1)mm, (2.4±0.1)mm, (2.3±0.2)mm and (2.2±0.2)mm respectively, which were all significantly improved compared with those before surgery [(-5.9±1.0)°, (24.3±1.2)mm and (0.6±0.1)mm respectively] ( P<0.01), with no significant differences among those at different postoperative time points ( P>0.05). Bony union was observed in the iliac bone block and glenoid bone loss after bone grafting in all the patients at 6 months after surgery and the iliac bone block resorption rate was (20.5±4.1)%. At 3, 6 months after surgery and at the last follow-up, the shoulder stability score was (41.5±6.1)points, (43.9±6.3)points and (44.7±5.0)points respectively; the functional activity score was (26.9±2.5)points, (27.1±2.5)points and (28.6±2.3)points respectively; the joint range of motion score was (13.9±1.0)points, (14.9±1.2)points and (15.8±1.5)points respectively; the total Rowe score of shoulder function was (81.4±11.5)points, (85.8±12.3)points and (86.4±9.8)points respectively, which were significantly improved compared with those before surgery [(6.1±1.5)points, (11.9±1.5)points, (8.5±1.4)points and (27.4±7.5)points respectively] ( P<0.01), with no significant differences among those at different postoperative time points ( P>0.05). At the follow-up, no complications such as incision infection, neurological injuries, implant failure of displacement, recurrent re-dislocation of the shoulder or osteoarthritis were observed. Conclusion:Arthroscopic modified anatomic glenoid reconstruction with Enden-Hybinette procedure combined with loop plate fixation in the treatment of recurrent anterior dislocation of shoulder combined with severe glenoid bone loss has the advantages of better osseous anatomy of the reconstructed glenoid bone, better bony union, satisfactory shoulder stability, functional restoration, etc.
4.Mechanism and prevention progress of receptor desensitization induced by β2-AR agonists in the treatment of asthma
Junya DUAN ; Yan ZHANG ; Guihua SONG ; Xiaosong CHEN ; Yanrong GUO ; Xuan ZHOU ; Xinying CHEN
China Pharmacy 2024;35(15):1910-1914
β2-adrenergic receptor (β2-AR) agonists are widely used as first-line drugs in the treatment of bronchial asthma (hereinafter referred to as “asthma”), but long-term use can lead to β2-AR desensitization and reduce its clinical efficacy, resulting in poor symptom control of some asthma patients. The mechanism of β2-AR desensitization induced by β2-AR agonists mainly includes slow hyposensitization (related to the decrease of β2-AR density in airway mucosa) and rapid hyposensitization (related to the mechanism of stimulatory G protein decoupling). Cyclic adenosine monophosphate(cAMP)-protein kinase A and cAMP- exchange protein activated by cAMP signaling pathways are closely related to β2-AR desensitization. Glucocorticoids, peroxisome proliferator-activated receptor-gamma agonists, ASM-024, Chinese medicine monotherapies and formulations, when combined with β2-AR agonists, can improve the sensitivity of β2-AR, so as to better control asthma symptoms.
5.Immunogenicity, safety and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years
Dingyan YAO ; Yingping CHEN ; Fan DING ; Xiaosong HU ; Zhenzhen LIANG ; Bo XING ; Yifei CAO ; Tianqi ZHANG ; Xilu WANG ; Yuting LIAO ; Juan YANG ; Huakun LYU
Chinese Journal of Preventive Medicine 2024;58(1):25-32
Objective:To evaluate the immunogenicity, safety, and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years.Methods:An open-label, multi-center trial was conducted in October 2021. The eligible healthy individuals, aged 18-84 years who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, were recruited from Shangyu district of Shaoxing and Kaihua county of Quzhou, Zhejiang province. All participants were divided into three groups based on the differences in prime-boost intervals: Group A (3-4 months), Group B (5-6 months) and Group C (7-9 months), with 320 persons per group. All participants received the recombinant COVID-19 vaccine (CHO cell). Blood samples were collected before the vaccination and after receiving the booster at 14 days, 30 days, and 180 days for analysis of GMTs, antibody positivity rates, and seroconversion rates. All adverse events were collected within one month and serious adverse events were collected within six months. The incidences of adverse reactions were analyzed after the booster.Results:The age of 960 participants was (52.3±11.5) years old, and 47.4% were males (455). The GMTs of Groups B and C were 65.26 (54.51-78.12) and 60.97 (50.61-73.45) at 14 days after the booster, both higher than Group A′s 44.79 (36.94-54.30) ( P value<0.05). The GMTs of Groups B and C were 23.95 (20.18-28.42) and 27.98 (23.45-33.39) at 30 days after the booster, both higher than Group A′s 15.71 (13.24-18.63) ( P value <0.05). At 14 days after the booster, the antibody positivity rates in Groups A, B, and C were 91.69% (276/301), 94.38% (302/320), and 93.95% (295/314), respectively. The seroconversion rates in the three groups were 90.37% (272/301), 93.75% (300/320), and 93.31% (293/314), respectively. There was no significant difference among these rates in the three groups (all P values >0.05). At 30 days after the booster, antibody positivity rates in Groups A, B, and C were 79.60% (238/299), 87.74% (279/318), and 90.48% (285/315), respectively. The seroconversion rates in the three groups were 76.92% (230/299), 85.85% (273/318), and 88.25% (278/315), respectively. There was a significant difference among these rates in the three groups (all P values <0.001). During the sequential booster immunization, the incidence of adverse events in 960 participants was 15.31% (147/960), with rates of about 14.38% (46/320), 17.50% (56/320), and 14.06% (45/320) in Groups A, B, and C, respectively. The incidence of adverse reactions was 8.02% (77/960), with rates of about 7.50% (24/320), 6.88% (22/320), and 9.69% (31/320) in Groups A, B, and C, respectively. No serious adverse events related to the booster were reported. Conclusion:Healthy individuals aged 18-84 years, who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, have good immunogenicity and safety profiles following the sequential booster with the recombinant COVID-19 vaccine (CHO cell).
6.Analysis of the relationship between KRAS,NRAS,BRAF,HER2 gene mutations and MSI status and clinical features in colorectal cancer patients
Jie ZHAO ; Shan JIANG ; Xin LIAO ; Xiaofeng WANG ; Xueping CHEN ; Jiang WU ; Xiaosong LI ; Yifan SHEN
International Journal of Laboratory Medicine 2024;45(19):2360-2365,2371
Objective To investigate the relationship between Kirsten rat sarcoma viral oncogene homolog(KRAS),neuroblastoma viral oncogene RAS homolog(NRAS),V-raf murine sarcoma viral oncogene homo-log B(BRAF),human epidermal growth factor receptor 2(HER2)gene mutations and microsatellite instabili-ty(MSI)status and clinicopathological features in patients with colorectal cancer.Methods The clinical data of 226 patients with colorectal cancer treated in the hospital from October 2019 to March 2022 were collected.Next-generation sequencing technology was used to detect KRAS,NRAS,BRAF,HER2 gene mutations and MSI status.Immunohistochemistry was used to evaluate the mismatch repair system(MMR)status.Multiva-riate Logistic regression analysis was used to analyze the relationship between KRAS,NRAS,BRAF,HER2 gene mutations and clinicopathological features.Results Among 226 colorectal cancer patients,the mutation frequencies of KRAS,NRAS,BRAF and HER2 were 54.89%,5.3%,8.4%and 1.8%,respectively.The fre-quency of KRAS mutation in mucinous adenocarcinoma was higher than that in common adenocarcinoma(P<0.05).The risk of KRAS mutation in right colon cancer was increased(OR=2.145,P=0.012).NR AS gene mutation was more frequent in left colon and rectal cancer(P<0.05).The frequency of BRAF gene mu-tation was higher in poorly differentiated and microsatellite instability-high(MSI-H)colorectal cancer(P<0.05),and the risk of BRAF gene mutation in the right colon was increased(OR=2.844,P=0.042).HER2 gene amplification mutation showed distant metastasis(P<0.05).KRAS mutations were mutually exclusive with NRAS,BRAF and HER2 amplification mutations(P<0.05).MSI-H was more frequent in the right co-lon(P<0.05).Of the 226 cases,10 cases were defective mismatch repair(dMMR)/MSI-H,8 cases were dM-MR/microsatellite stable,and 5 cases were proficient mismatch repair/MSI-H.There was a moderate agree-ment between dMMR and MSI-H(Kappa=0.575).Conclusion KRAS,NRAS,BRAF,HER2 and MSI sta-tus are associated with clinicopathological features in patients with colorectal cancer.Combined detection of KRAS,NRAS,BRAF,HER2 and MSI can provide more accurate and effective data to guide the treatment and prognosis of patients.
7.The 21-Gene Recurrence Score Assay Improved Multidisciplinary Treatment Compliance in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Patients: An Analysis of 2,323 Patients
Liangqiang LI ; Jing YU ; Kunwei SHEN ; Xiaosong CHEN
Journal of Breast Cancer 2024;27(3):163-175
Purpose:
The 21-gene recurrence score (RS) can guide adjuvant chemotherapy decisions in the multidisciplinary treatment (MDT) of patients with early breast cancer. This study aimed to evaluate the influence of the 21-gene RS assay on patient’ compliance with MDT and its association with disease outcomes.
Methods:
Patients diagnosed with pN0-1, hormone receptor-positive, human epidermal growth factor receptor-2-negative breast cancer between January 2013 and June 2019 were enrolled. A logistic regression model was used to identify parameters associated with treatment adherence. Prognostic indicators were evaluated using the Cox proportional hazard models.
Results:
After the assay, patients were less likely to violate the treatment plan (14.9% vs. 23.1%, p < 0.001), and higher compliance rates were observed for chemotherapy (p = 0.042), radiotherapy (p = 0.012), and endocrine therapy (p < 0.001). Multivariable analysis demonstrated that the 21-gene RS assay (odds ratio [OR], 1.43; 95% confidence interval [CI], 1.09–1.88; p = 0.009) was independently associated with MDT compliance. Moreover, compliance with MDT was independently associated with better disease-free survival (hazard ratio, 0.43; 95% CI, 0.29–0.64; p < 0.001), regardless of the 21-gene RS assay (interaction p = 0.842).
Conclusion
The 21-gene RS assay improved the MDT compliance rate in patients with early breast cancer. Adherence to MDT is associated with a better prognosis.
8.Chinese expert consensus on emergency surgery for severe trauma and infection prevention during corona virus disease 2019 epidemic (version 2023)
Yang LI ; Yuchang WANG ; Haiwen PENG ; Xijie DONG ; Guodong LIU ; Wei WANG ; Hong YAN ; Fan YANG ; Ding LIU ; Huidan JING ; Yu XIE ; Manli TANG ; Xian CHEN ; Wei GAO ; Qingshan GUO ; Zhaohui TANG ; Hao TANG ; Bingling HE ; Qingxiang MAO ; Zhen WANG ; Xiangjun BAI ; Daqing CHEN ; Haiming CHEN ; Min DAO ; Dingyuan DU ; Haoyu FENG ; Ke FENG ; Xiang GAO ; Wubing HE ; Peiyang HU ; Xi HU ; Gang HUANG ; Guangbin HUANG ; Wei JIANG ; Hongxu JIN ; Laifa KONG ; He LI ; Lianxin LI ; Xiangmin LI ; Xinzhi LI ; Yifei LI ; Zilong LI ; Huimin LIU ; Changjian LIU ; Xiaogang MA ; Chunqiu PAN ; Xiaohua PAN ; Lei PENG ; Jifu QU ; Qiangui REN ; Xiguang SANG ; Biao SHAO ; Yin SHEN ; Mingwei SUN ; Fang WANG ; Juan WANG ; Jun WANG ; Wenlou WANG ; Zhihua WANG ; Xu WU ; Renju XIAO ; Yang XIE ; Feng XU ; Xinwen YANG ; Yuetao YANG ; Yongkun YAO ; Changlin YIN ; Yigang YU ; Ke ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Gang ZHAO ; Xiaogang ZHAO ; Xiaosong ZHU ; Yan′an ZHU ; Changju ZHU ; Zhanfei LI ; Lianyang ZHANG
Chinese Journal of Trauma 2023;39(2):97-106
During coronavirus disease 2019 epidemic, the treatment of severe trauma has been impacted. The Consensus on emergency surgery and infection prevention and control for severe trauma patients with 2019 novel corona virus pneumonia was published online on February 12, 2020, providing a strong guidance for the emergency treatment of severe trauma and the self-protection of medical staffs in the early stage of the epidemic. With the Joint Prevention and Control Mechanism of the State Council renaming "novel coronavirus pneumonia" to "novel coronavirus infection" and the infection being managed with measures against class B infectious diseases since January 8, 2023, the consensus published in 2020 is no longer applicable to the emergency treatment of severe trauma in the new stage of epidemic prevention and control. In this context, led by the Chinese Traumatology Association, Chinese Trauma Surgeon Association, Trauma Medicine Branch of Chinese International Exchange and Promotive Association for Medical and Health Care, and Editorial Board of Chinese Journal of Traumatology, the Chinese expert consensus on emergency surgery for severe trauma and infection prevention during coronavirus disease 2019 epidemic ( version 2023) is formulated to ensure the effectiveness and safety in the treatment of severe trauma in the new stage. Based on the policy of the Joint Prevention and Control Mechanism of the State Council and by using evidence-based medical evidence as well as Delphi expert consultation and voting, 16 recommendations are put forward from the four aspects of the related definitions, infection prevention, preoperative assessment and preparation, emergency operation and postoperative management, hoping to provide a reference for severe trauma care in the new stage of the epidemic prevention and control.
10.Chitosan Nerve Grafts Incorporated with SKP-SC-EVs Induce Peripheral Nerve Regeneration
Xinyang ZHOU ; Miaomei YU ; Daiyue CHEN ; Chunyan DENG ; Qi ZHANG ; Xiaosong GU ; Fei DING
Tissue Engineering and Regenerative Medicine 2023;20(2):309-322
BACKGROUND:
Repair of long-distance peripheral nerve defects remains an important clinical problem. Nerve grafts incorporated with extracellular vesicles (EVs) from various cell types have been developed to bridge peripheral nerve defects. In our previous research, EVs obtained from skin-derived precursor Schwann cells (SKP-SC-EVs) were demonstrated to promote neurite outgrowth in cultured cells and facilitate nerve regeneration in animal studies.
METHODS:
To further assess the functions of SKP-SC-EVs in nerve repair, we incorporated SKP-SC-EVs and Matrigel into chitosan nerve conduits (EV-NG) for repairing a 15-mm long-distance sciatic nerve defect in a rat model. Behavioral analysis, electrophysiological recording, histological investigation, molecular analysis, and morphometric assessment were carried out.
RESULTS:
The results revealed EV-NG significantly improved motor and sensory function recovery compared with nerve conduits (NG) without EVs incorporation. The outgrowth and myelination of regenerated axons were improved, while the atrophy of target muscles induced by denervation was alleviated after EVs addition.
CONCLUSION
Our data indicated SKP-SC-EVs incorporation into nerve grafts represents a promising method for extended peripheral nerve damage repair.

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