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.Correlation analysis between SUV index in 18F-FDG PET/CT imaging and invasiveness of early lung adenocarcinoma
Rong NIU ; Yuetao WANG ; Xiaoliang SHAO ; Jianfeng WANG ; Zhenxing JIANG ; Mei XU ; Yunmei SHI ; Peiqi LU ; Xiaosong WANG ; Xiaonan SHAO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2022;42(5):257-262
Objective:To investigate the correlation between the SUV index (SUV max of the lesion/SUV mean of the liver) in 18F-FDG PET/CT imaging and the invasiveness of early lung adenocarcinoma presenting as ground-glass nodule (GGN). Methods:From January 2012 to March 2020, 167 GGN patients (49 males, 118 females; age: (61.5±9.0) years) with early lung adenocarcinoma who underwent PET/CT imaging in Changzhou First People′s Hospital were retrospectively enrolled. The image parameters including the GGN number, location, type, edge, shape, abnormal bronchus sign, vacuole sign, pleural depression, vessel convergence sign, GGN diameter ( DGGN), solid component diameter ( Dsolid), consolidation to tumor ratio (CTR, Dsolid/ DGGN), CT values (CT value of ground-glass opacity (CT GGO), CT value of lung parenchyma (CT LP), ΔCT GGO-LP (CT GGO-CT LP)) and SUV index were analyzed. Single and multivariate logistic regressions were used to analyze the correlation between SUV index and infiltration. The generalized additive model was used for curve fitting, and the piece-wise regression model was used to further explain the nonlinearity. Results:In 189 GGNs, invasive adenocarcinoma accounted for 85.2% (161/189). Single logistic regression showed that the GGN number, type, shape, edge, abnormal bronchus sign, pleural depression, vessel convergence sign, DGGN, Dsolid, CTR, CT GGO, ΔCT GGO-LP and SUV index were related factors of infiltration (odds ratio ( OR) values: 0.396-224.083, P<0.001 or P<0.05). After fully adjusting for confounding factors, SUV index was significantly correlated with increased risk of invasion ( OR=2.162 (95% CI: 1.191-3.923), P=0.011). Curve fitting showed that the SUV index was non-linearly related to the risk of infiltration, and the risk of infiltration increased significantly only when the SUV index was greater than 0.43 ( OR=3.509 (95% CI: 1.429-8.620), P=0.006). The correlation between SUV index and infiltration had no interaction between age, vacuoles, pleural depression and CTR subgroups (all P>0.05). Conclusions:SUV index is an independent factor related to the invasiveness of early lung adenocarcinoma. The higher the SUV index, the greater the risk of invasion; but the two are not simply linearly correlated.
4.Value of 18F-FDG PET/CT metabolic parameters of primary lesions for predicting occult lymph node metastasis in non-small cell lung cancer
Yunmei SHI ; Rong NIU ; Yuetao WANG ; Xiaoliang SHAO ; Feifei ZHANG ; Xiaonan SHAO ; Jianfeng WANG ; Xiaosong WANG ; Bao LIU ; Wenji YU
Chinese Journal of Nuclear Medicine and Molecular Imaging 2021;41(6):327-333
Objective:To investigate the predictive value of 18F-fluorodeoxyglucose (FDG) PET/CT metabolic parameters for occult lymph node metastasis (OLM) in non-small cell lung cancer (NSCLC). Methods:A total of 183 patients (72 males, 111 females; age (61.5±8.4) years) who underwent 18F-FDG PET/CT and preoperatively diagnosed with clinical N0 stage (cN0) in Third Affiliated Hospital of Soochow University from January 2013 to December 2018 were retrospectively enrolled. All patients underwent anatomical pulmonary resection with systematic lymph node dissections within 3 weeks after 18F-FDG PET/CT examinations. According to the presence or absence of lymph node metastasis, patients were divided into OLM positive (OLM+ ) group and OLM negative (OLM-) group. Parameters of primary lesions, such as the maximum diameter (D max), tumor sites, morphological features, maximum standardized uptake value (SUV max), mean standardized uptake value (SUV mean), metabolic total volume (MTV), total lesion glycolysis (TLG), tumor SUV max to liver SUV mean (TLR max), tumor TLG to liver SUV mean (TLR TLG) were analyzed. Mann-Whitney U test and χ2 test were used to compare the parameters between groups. Multivariable logistic regression was used to analyze the independent risk factors for OLM. Receiver operating characteristic (ROC) curve analysis was used to evaluate the diagnostic value of different parameters. Results:Among 183 patients, 25 (13.7%, 25/183) of them were diagnosed as OLM. In OLM+ group, 46 lymph nodes were pathologically positive for metastasis, including 15 N1 disease and 31 N2 disease. D max (2.9(2.3, 3.7) vs 2.3(1.7, 2.8) cm), lobulation ((76.0%(19/25) vs 37.3%(59/158)), SUV max (11.1(7.9, 17.7) vs 4.7(2.3, 9.2)), TLG (41.5(10.2, 91.1) vs 15.6(6.5, 23.8) ml), TLR max (4.7(3.5, 7.6) vs 2.1(0.9, 4.0)) and TLR TLG (18.1(5.0, 44.3) vs 6.1(3.0, 11.4) ml) of the primary lesions in OLM+ group were significantly higher than those in OLM-group ( z values: from -4.709 to -3.247, χ2=13.190, all P<0.05). Multivariable logistic regression analysis showed that TLR max (odds ratio ( OR)=15.145, 95% CI: 3.381-67.830, P<0.001) and D max ( OR=3.220, 95% CI: 1.192-8.701, P=0.021) were independent risk factors for OLM. TLR max yielded the highest area under curve (AUC; AUC=0.794) with the threshold of 3.12, and the sensitivity, specificity, accuracy, positive predictive value and negative predictive value for predicting OLM were 92.0%(23/25), 63.3%(100/158), 67.2%(123/183), 28.4%(23/81) and 98.0%(100/102), respectively. Conclusions:TLR max of tumor is the independent risk factor for OLM in NSCLC patients. TLR max can sensitively predict OLM preoperatively in patients with NSCLC.
5.Preliminary results of multicenter studies on ABO-incompatible kidney transplantation
Hongtao JIANG ; Tao LI ; Kun REN ; Xiaohua YU ; Yi WANG ; Shanbin ZHANG ; Desheng LI ; Huiling GAN ; Houqin LIU ; Liang XU ; Zhigang LUO ; Peigen GUI ; Xiangfang TAN ; Bingyi SHI ; Ming CAI ; Xiang LI ; Junnan XU ; Liang XU ; Tao LIN ; Xianding WANG ; Hongtao LIU ; Lexi ZHANG ; Jianyong WU ; Wenhua LEI ; Jiang QIU ; Guodong CHEN ; Jun LI ; Gang HUANG ; Chenglin WU ; Changxi WANG ; Lizhong CHEN ; Zheng CHEN ; Jiali FANG ; Xiaoming ZHANG ; Tongyi MEN ; Xianduo LI ; Chunbo MO ; Zhen WANG ; Xiaofeng SHI ; Guanghui PEI ; Jinpeng TU ; Xiaopeng HU ; Xiaodong ZHANG ; Ning LI ; Shaohua SHI ; Hua CHEN ; Zhenxing WANG ; Weiguo SUI ; Ying LI ; Qiang YAN ; Huaizhou CHEN ; Liusheng LAI ; Jinfeng LI ; Wenjun SHANG ; Guiwen FENG ; Gang CHEN ; Fanjun ZENG ; Lan ZHU ; Jun FANG ; Ruiming RONG ; Xuanchuan WANG ; Guisheng QI ; Qiang WANG ; Puxun TIAN ; Yang LI ; Xiaohui TIAN ; Heli XIANG ; Xiaoming PAN ; Xiaoming DING ; Wujun XUE ; Jiqiu WEN ; Xiaosong XU
Chinese Journal of Organ Transplantation 2020;41(5):259-264
Objective:To summarize the patient profiles and therapeutic efficacies of ABO-incompatible living-related kidney transplantations at 19 domestic transplant centers and provide rationales for clinical application of ABOi-KT.Methods:Clinical cases of ABO-incompatible/compatible kidney transplantation (ABOi-KT/ABOc-KT) from December 2006 to December 2009 were collected. Then, statistical analyses were conducted from the aspects of tissue matching, perioperative managements, complications and survival rates of renal allograft or recipients.Results:Clinical data of 342 ABOi-KT and 779 ABOc-KT indicated that (1) no inter-group differences existed in age, body mass index (BMI), donor-recipient relationship or waiting time of pre-operative dialysis; (2) ABO blood type: blood type O recipients had the longest waiting list and transplantations from blood type A to blood type O accounted for the largest proportion; (3) HLA matching: no statistical significance existed in mismatch rate or positive rate of PRA I/II between two types of surgery; (4) CD20 should be properly used on the basis of different phrases; (5) hemorrhage was a common complication during an early postoperative period and microthrombosis appeared later; (6) no difference existed in postoperative incidence of complications or survival rate of renal allograft and recipients at 1/3/5/10 years between ABOi-KT and ABOc-KT. The acute rejection rate and serum creatinine levels of ABOi-KT recipients were comparable to those of ABOc-KT recipients within 1 year.Conclusions:ABOi-KT is both safe and effective so that it may be applied at all transplant centers as needed.
6.Lymph node dissection along the left gastroepiploic vessels region in 4K laparoscopic radical gastrectomy with the surgeon on left position
Yan SHI ; Xiaosong WANG ; Qing FENG ; Ping′ang LI ; Ziyan LUO ; Chenjun TAN ; Jun CHEN ; Yongliang ZHAO ; Feng QIAN ; Peiwu YU
Chinese Journal of Digestive Surgery 2020;19(S1):62-67
Minimally invasive surgery experienced a rapid development in the past thirty years, of which the laparoscopy has been widely used in gastrointestinal surgery. Lymph node dissection is one of the difficulties of laparoscopic radical resection of gastric cancer. The lymph node dissection along the left gastroepiploic vessels is a difficult part, which usually causes bleeding and splenic injury. This article mainly introduce the indications, contraindications, surgical preparations, the difficulties and techniques during the lymph nodes dissection when the operator stood on the left side of the patients, and perioperative complications of lymph nodes dissection along the left gastroepiploic vessels.
7. Minimal invasive subcutaneous internal fixator in treatment of anterior pelvic ring instability-analysis of effects and complications
Haiwei YAN ; Juzheng HU ; Ying YANG ; You XIE ; Zhanzhu HUANG ; Xiaosong CHENG ; Lu WEI ; Yansong FENG ; Boyu LIU ; Zhanying SHI
Chinese Journal of Orthopaedics 2019;39(13):826-832
Objective:
To investigate the incidence of complications following minimal invasive subcutaneous internal fixator (INFIX) for the treatment of anterior pelvic ring instability, and to analyze control measures.
Methods:
Data of 42 patients with anterior pelvic ring instability who were treated by anterior subcutaneous internal fixation in our hospital from January 2016 to December 2017 were retrospectively analyzed. There were 15 females and 27 males with an average age of 45.4 years (range, 18-67 years). There were 26 traffic injuries, 10 falling injuries, 3 crush injuries and 3 low energy injuries. According to Tile classification, 24 cases of B2 type, 16 cases of B3 type, 1 case of C1 type and 1 case of C2 type. According to Young-Burgess classification, there were 20 cases of LCI, 18 cases of LCII, 1 case of LCIII, 1 case of APCI, 1 case of APCII, and 1 case of VS. Fourteen cases were combined with limb fractures, and 11 cases were combined with thoracic or abdominal injuries requiring surgical treatment, while 16 cases were with brain injuries. For type APC2, LC1, and some LC2 fractures, fixation for the anterior pelvic ring is enough with INFIX technique alone. For some LC2, LC3, or VS fractures, the anterior and posterior ring were both fixed. Postoperative reduction was evaluated by Matta radiological criteria. Lateral thigh numbness and pain, quadriceps muscle power were recorded during follow-up, and clinical efficacy was evaluated by Majeed score at 6 months after operation.
Results:
All the 42 patients were followed up for 6 to 12 months, with an average of 9.3 months. Matta standard evaluation for fracture reduction showed that 28 cases were excellent, 14 cases good, and the excellent and good rate was 100%. The early complication rate (within 3 month after operation) was 23.8% (10/42) including 6 cases of lateral femoral cutaneous nerve injury and 2 cases of femoral nerve injury. The symptoms were obviously relieved after the treatment of nutrient nerve and hyperbaric oxygen; 1 case had incision infection which was healed after anti-infection therapy and internal plant removal; 1 case suffered from superior gluteal artery injury which was controlled by pressure hemostasis. Six months after surgery, no case had lost reduction. At 6 months follow-up, the Majeed score was 72-96, with an average of 84.96, of which 32 were excellent and 10 were good, thus the excellent and good rate was 100% (42/42).
Conclusion
INFIX is an effective internal fixation method for the treatment of unstable anterior pelvic ring injury. However, it has a high rate of early complications, among which nerve injury has the highest incidence.
8.Short-term clinical efficacies of Da Vinci robotic surgical system-assisted and laparoscopy-assisted radical gastrectomy for locally advanced gastric cancer
Xuqi SHEN ; Yongliang ZHAO ; Chongyu SU ; Xiaosong WANG ; Wei DUAN ; Xiaolong FU ; Feng QIAN ; Yingxue HAO ; Yan SHI ; Peiwu YU
Chinese Journal of Digestive Surgery 2018;17(6):581-587
Objective To compare the short-term clinical efficacies of Da Vinci robotic surgical systemassisted and laparoscopy-assisted radical gastrectomy for locally advanced gastric cancer (GC).Methods The retrospective cohort study was conducted.The clinicopathological data of 162 patients who underwent minimally invasive radical gastrectomy for locally advanced GC in the First Affiliated Hospital of Army Medical University between September 2016 and September 2017 were collected.Of 162 patients,65 undergoing Da Vinci robotic surgical system-assisted radical gastrectomy were allocated into the robotic group and 97 undergoing laparoscopyassisted radical gastrectomy were allocated into the laparoscopic group.According to Japanese gastric cancer treatment guidelines,patients with upper GC and with middle or lower GC underwent respectively total gastrectomy + D2 lymph node dissection and distal subtotal gastrectomy + D2 lymph node dissection,and then Billroth Ⅱ or Roux-en-Y digestive tract reconstruction.Observation indicators:(1) surgical and postoperative situations;(2) detection of lymph node;(3) follow-up and survival situations.Measurement data with normal distribution were represented as x±s,and comparisons between groups were analyzed using the t test.Comparisons of count data were done using the chi-square test.Ordinal data were analyzed by the nonparametric test.Results (1) Surgical and postoperative situations:all 162 patients underwent successful surgery,without conversion to laparoscopic or open surgery,and pathological resection margins were confirmed as R0.Volume of intraoperative blood loss,levels of amylase in peritoneal drainage fluid at day 1,2 and 3 postoperatively,levels of serum amylase fluid at day 1,2 and 3 postoperatively were respectively (123±39) mL,(557± 181) U/L,(357± 127) U/L,(183±86) U/L,(181±47)U/L,(123±29)U/L,(85±22)U/L in the robotic group and (142±40)mL,(793±284)U/L,(497±199)U/L,(279±157) U/L,(218±45) U/L,(162±37) U/L,(120±31) U/L in the laparoscopic group,with statistically significant differences between groups (t =-3.015,-2.817,-2.364,-2.132,-2.372,-3.338,-3.720,P<0.05).Cases with distal subtotal gastrectomy + D2 lymph node dissection and with total gastrectomy + D2 lymph node dissection,cases with Billroth Ⅱ and Roux-en-Y of digestive tract reconstruction,time of distal subtotal gastrectomy + D2 lymph node dissection,time of total gastrectomy + D2 lymph node dissection,cases with anastomotic leakage,pulmonary infection,wound infection or liquefaction and delayed gastric emptying,cases in grading Ⅱ,Ⅲ,Ⅳ and Ⅴ of postoperative complications,time of postoperative drainage-tube removal and duration of postoperative hospital stay were respectively 47,18,40,25,(222±37) minutes,(274±43) minutes,1,1,1,1,2,1,0,0,(6.5-± 1.5) days,(10.0±4.0) days in the robotic group and 74,23,69,28,(213±40) minutes,(262±39)minutes,2,4,1,0,4,1,0,1,(6.9±1.7)days,(10.0±5.0)days in the laparoscopic group,with no statistically significant difference between groups (x2=0.326,1.628,t =1.272,0.960,x2=2.501,Z=-1.342,t=-1.142,-0.115,P>0.05).One and 1 patients in the robotic and laparoscopic groups who were complicated with esophagus-jejunum anastomotic leakage after total gastrectomy + Roux-en-Y anastomosis were cured by nutrition support therapy using feeding tube placement under gastroscopy,and 1 patient in the laparoscopic group who were complicated with gastrojejunal anastomosis leakage after distal subtotal gastrectomy +Billroth Ⅱ anastomosis received the second surgical exploration and jejunal feeding tube placement.Patients with pulmonary infection,wound infection or liquefaction and delayed gastric emptying were cured by conservative treatment.Levels of amylase in peritoneal drainage fluid and serum amylase fluid at day 1,2 and 3 postoperatively were not higher than 3 times of upper limit of normal,without treatment interventions.(2) Detection of lymph node:overall number of lymph nodes detected in the robotic and laparoscopic groups were respectively 36.82±13.41 and 35.21 ± 11.52,with no statistically significant difference between groups (t =0.786,P> 0.05).Results of further analysis showed that numbers of lymph node dissected in the 2nd station and upper region of pancreas in patients undergoing distal subtotal gastrectomy + D2 lymph node dissection were respectively 6.04±3.98,13.51±6.53 in the robotic group and 4.45±3.12,11.40±5.30 in the laparoscopic group,with statistically significant differences between groups (t=2.461,1.986,P<0.05).Numbers of lymph node dissected in No 7 and 8 groups and upper region of pancreas in patients undergoing total gastrectomy + D2 lymph node dissection were respectively 5.44±2.63,2.92±1.87,10.81±4.78 in the robotic group and 3.11±1.82,1.62±1.33,7.76±3.34 in the laparoscopic group,with statistically significant differences between groups (t =3.340,2.689,2.522,P<0.05).(3) Follow-up and survival situations:of 162 patients,148 were followed up for 2-14 months,with a median time of 8 months.During the follow-up,patients in the 2 groups had tumor-free survival.Conclusions Da Vinci robotic surgical system-assisted radical gastrectomy is safe and feasible.Compared with laparoscopy-assisted radical gastrectomy for locally advanced GC,it has advantages of clear vision of the local anatomy,less intraoperative bleeding,more numbers of lymph nodes dissected in the upper region of pancreas and lighter pancreatic injure,meanwhile,it has also certain operating advantages around the great vessels and in the deep and narrow spaces.
9. Progress of individualized treatment in Waldenström macroglobulinemia
Jun HOU ; Yiwen ZHANG ; Xiaosong WU ; Jumei SHI
Journal of Leukemia & Lymphoma 2018;27(4):193-197
Waldenström macroglobulinemia (WM) is a rare lymphoma without a curable treatment method, which is characterized by MYD88 and CXCR4 gene mutations. The study on clinical manifestations, the pathological and genomic features has led to a series of promising clinical protocols. This article reviews the safety and efficacy of drugs including alkylating agents, proteasome inhibitors, monoclonal antibodies, and Bruton tyrosine kinase (BTK) inhibitors in WM patients combined with the latest research of the individualized treatment for WM at the 59th American Society of Hematology (ASH) Annual Meeting, so as to analyze the feasibility of basic genomic treatment and current integrated regimens for WM.
10.Formula Optimization of Bromhexine Hydrochloride Dry Powder Inhalations by Central Composite Design-response Surface Methodology
Yinke LI ; Xiaosong YANG ; Zihao ZHOU ; Qiongzhi SHI ; Chen CHEN ; Xiangru LIAO ; Ying CHEN ; Xiangyang XIE
China Pharmacist 2018;21(6):1010-1015
Objective: To optimize the formula of bromhexine hydrochloride dry powder inhalations (BH DPIs). Methods: BH DPIs were prepared by freezing-drying combined with an air-jet milling method. Three factors, including the weights of mannitol (X1), leucine (X2) and poloxamer 188 (X3) in the formula were known to be associated with the quality of BH DPIs. A central composite design was used to investigate the effects of the three factors on the response angle (Y1), fine particle fraction (FPF, Y3) and aerody-namic diameter (Y4). Response surface and overlay contour plot were delineated according to the best-fit mathematic models. Opti-mum formula was selected by overlay contour plot. Results: The quantitative relationships between the three factors and the three re-sponses were obtained. The optimal formula was mannitol﹕leucine﹕poloxamer 188 (2. 4: 2. 22: 0. 05) in the excipients. The pre-dicted and observed values of the optimum formula were similar. Conclusion: The multi-objective simultaneous optimization of the for-mula of BH DPIs is achieved by central composite design-response surface methodology.

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