1.Effects of Huangqi Bushen Huoxue Decoction on osteoclast activity in a mouse osteoporosis model induced by aromatase inhibitors
Dongqing PU ; Dandan FENG ; Mengdi ZHANG ; Bingwei LIU ; Guangxi SHI ; Hanhan CHEN ; Jingwei LI
Chinese Journal of Tissue Engineering Research 2025;29(14):2861-2867
BACKGROUND:Although aromatase inhibitors significantly improve the clinical benefit of patients with hormone receptor-positive breast cancer,its associated adverse event-osteoporosis seriously affects the quality of life of patients.Huangqi Bushen Huoxue Decoction can effectively prevent the occurrence of aromatase inhibitor-induced osteoporosis,but its mechanism of action is unclear.OBJECTIVE:To investigate the effects of Huangqi Bushen Huoxue Decoction on osteoclast activity in a mouse model of osteoporosis induced by aromatase inhibitors and relevant mechanisms.METHODS:Sixty 8-week-old female C57BL/6J mice were randomly divided into sham operation group,model group,high-,medium-and low-dose Huangqi Bushen Huoxue Decoction,and positive control group,with 10 mice in each group.Bilateral ovaries were removed to establish postmenopausal animal models in all the groups except for the sham operation group.After 1 week of recovery,letrozole was injected subcutaneously to establish postmenopausal osteoporosis models via subcutaneous injection of letrozole(an aromatase inhibitor).The high-,medium-and low-dose Huangqi Bushen Huoxue Decoction groups were intragastrically given 19.24,9.62 and 4.81 g/kg/d Huangqi Bushen Huoxue Decoction(once a day),respectively.The positive control group was given alendronate 5mg/kg once a week.After 3 months of administration,Micro-CT was used to detect tibial bone mineral density and bone microstructure.Hematoxylin-eosin staining and tartrate-resistant acid phosphatase staining of the femur were performed.Immunohistochemistry was used to detect the protein expression of receptor activator of nuclear factor-κB ligand and osteoprotectin in the femur.ELISA was used to detect the serum levels of carboxyterminal cross-linked telopeptides of type I collagen and tartrate-resistant acid phosphatase 5b.RESULTS AND CONCLUSION:(1)Compared with the sham operation group,the model group showed a significant decrease in bone mineral density,sparse and fractured trabecular morphology,and a significant increase in serum levels of carboxyterminal cross-linked telopeptides of type I collagen and tartrate-resistant acid phosphatase 5b,indicating that the model of aromatase inhibitor-induced osteoporosis was successfully constructed.(2)Compared with the model group,the high-,medium-,and low-dose Huangqi Bushen Huoxue Decoction groups showed significant improvement in bone mineral density and bone microstructure,thickening and densification of trabecular morphology,significantly decreased serum levels of carboxyterminal cross-linked telopeptides of type I collagen and tartrate-resistant acid phosphatase 5b,a decrease in the number of osteoclasts and the expression of receptor activator of nuclear factor-κB ligand proteins,and an increase in the expression of osteoprotegerin.To conclude,Huangqi Bushen Huoxue Decoction may regulate the receptor activator of nuclear factor-κB ligand/receptor activator of nuclear factor-κB/osteoprotegerin signaling pathway,inhibit osteoclast activity,improve trabecular morphology and bone microstructure,and increase bone mineral density,thus preventing the occurrence and development of aromatase inhibitor-induced osteoporosis.
2.Distribution characteristics of polymorphonuclear neutrophil pulmonary infiltration and the mechanism of neutrophil elastase in promoting lung injury in the early stages of severe burns.
Xin ZHANG ; Chunfang ZHENG ; Jiahui CHEN ; Zaiwen GUO ; Linbin LI ; Jiamin HUANG ; Bingwei SUN
Chinese Critical Care Medicine 2025;37(5):431-437
OBJECTIVE:
To investigate the distribution characteristics of polymorphonuclear neutrophil (PMN) in the lungs during the early stage of severe burns and the mechanism of neutrophil elastase (NE) promoting lung injury.
METHODS:
6-8-week-old male C57BL/6J mice were selected for the experiments. A 30% total body surface area (TBSA) III degree burn mouse model was established (severe burn group); the Sham-injury group was treated with 37 centigrade water. In the sodium sivelestat intervention group (SV intervention group), NE competitive inhibitor, sivelestat, 100 mg/kg, was injected via tail vein immediately after injury, while other groups received an equal volume of saline. Ten mice were harvested from each group to observe survival for 72 hours. Respiratory function tests were tested at 0 (immediate), 3, 6, 12, and 24 hours after molding. hematoxylin-eosin (HE) and immunohistochemical staining were used to observe lung tissue structure, inflammatory changes and PMN infiltration. The PMN absolute count in mice lung tissue was detected buy flow cytometry. At 6, 12, and 24 hours after molding, PMN counts and the concentration of NE [enzyme linked immunosorbent assay (ELISA)] in peripheral blood plasma, lung tissue, and bronchoalveolar lavage fluid (BALF) were detected.
RESULTS:
(1) HE staining results showed that compared with the Sham-injury group, the lungs of mice in the severe burn group showed inflammatory changes and PMN infiltration, with more significant changes at 6 hours. Immunohistochemistry results also confirmed that the expression of NE protein released from PMN significantly increased after 6 hours of severe burn injury [(3.79±0.62)% vs. (0.18±0.05)%, t = 11.56, P < 0.01]. (2) Compared with the Sham-injury group, the number of PMN and the concentration of NE in the peripheral blood and lung tissues in the severe burn group were significantly increased (F values were 13.709, 55.350 and 29.890, 13.286, respectively, all P < 0.01), peaking at 6 hours [plasma PMN count (×109/L): 2.92±1.01 vs. 0.92±0.29, lung tissue PMN absolute count (cells): 48 788.03±11 833.91 vs. 1 516.72±415.35, plasma NE (ng/L): 24 522.71±3 842.92 vs. 7 009.34±4 067.86, lung tissue NE (ng/L): 262 189.04±9 695.13 vs. 65 026.03± 16 016.31, all P < 0.01]. The number of PMN in the lung of severely burned mice was highly correlated with NE concentration (r = 0.892, P < 0.001). There was no significantly difference in the PMN absolute count in the BALF of mice between the Sham-injury group and severe burn group (F = 1.403, P > 0.05). The Sham-injury group and severe burn group contained a small amount of NE in the BALF, and the concentration of NE in the BALF of the severely burned 6 hours and 12 hours groups were significantly higher than those of the Sham-injury group (ng/L: 328.58±158.10, 415.30±240.89 vs. 61.95±15.80, both P < 0.05). (3) Kaplan-Meier survival curve showed that the 72-hour survival rate of mice in the SV intervention group was significantly higher than that in the severe burn group (100% vs. 10%, Log-Rank test: χ2 = 19.12, P < 0.001). (4) Compared with the Sham-injury group, all lung function indices of the severe burn group decreased significantly. All lung function indices of SV intervention group improved gradually over time, which were significantly better than those of the severe burn group. (5) Compared with the Sham-injury group, the PMN absolute count in lung tissue and the concentration of NE in plasma and lung tissue were significantly higher in the SV intervention group (F values were 46.709, 3.535, 32.701, respectively, all P < 0.05), with a peak at 6 hours. Compared with the severe burn group, the SV intervention group had a higher PMN absolute count in lung tissue (cells: 8 870.80±7 013.89 vs. 25 974.92±22 240.8, P < 0.05), and higher plasma and lung tissue NE concentrations (ng/L: 14 955.94±3 944.41 vs. 21 972.75±4 573.05, 81 956.87±38 658.35 vs. 168 182.30±83 513.91, both P < 0.01) were significantly decreased.
CONCLUSIONS
In the early stage of severe burns, there is a significant infiltration of PMN into the lungs. The NE promotes lung injury in the early stage of severe burn, and improve lung injury by inhibiting the action of NE.
Animals
;
Burns/metabolism*
;
Leukocyte Elastase/metabolism*
;
Male
;
Mice, Inbred C57BL
;
Mice
;
Neutrophils/metabolism*
;
Lung/metabolism*
;
Disease Models, Animal
;
Neutrophil Infiltration
;
Lung Injury/metabolism*
;
Glycine/analogs & derivatives*
;
Sulfonamides
3.Effects of Huangqi Bushen Huoxue Decoction on osteoclast activity in a mouse osteoporosis model induced by aromatase inhibitors
Dongqing PU ; Dandan FENG ; Mengdi ZHANG ; Bingwei LIU ; Guangxi SHI ; Hanhan CHEN ; Jingwei LI
Chinese Journal of Tissue Engineering Research 2025;29(14):2861-2867
BACKGROUND:Although aromatase inhibitors significantly improve the clinical benefit of patients with hormone receptor-positive breast cancer,its associated adverse event-osteoporosis seriously affects the quality of life of patients.Huangqi Bushen Huoxue Decoction can effectively prevent the occurrence of aromatase inhibitor-induced osteoporosis,but its mechanism of action is unclear.OBJECTIVE:To investigate the effects of Huangqi Bushen Huoxue Decoction on osteoclast activity in a mouse model of osteoporosis induced by aromatase inhibitors and relevant mechanisms.METHODS:Sixty 8-week-old female C57BL/6J mice were randomly divided into sham operation group,model group,high-,medium-and low-dose Huangqi Bushen Huoxue Decoction,and positive control group,with 10 mice in each group.Bilateral ovaries were removed to establish postmenopausal animal models in all the groups except for the sham operation group.After 1 week of recovery,letrozole was injected subcutaneously to establish postmenopausal osteoporosis models via subcutaneous injection of letrozole(an aromatase inhibitor).The high-,medium-and low-dose Huangqi Bushen Huoxue Decoction groups were intragastrically given 19.24,9.62 and 4.81 g/kg/d Huangqi Bushen Huoxue Decoction(once a day),respectively.The positive control group was given alendronate 5mg/kg once a week.After 3 months of administration,Micro-CT was used to detect tibial bone mineral density and bone microstructure.Hematoxylin-eosin staining and tartrate-resistant acid phosphatase staining of the femur were performed.Immunohistochemistry was used to detect the protein expression of receptor activator of nuclear factor-κB ligand and osteoprotectin in the femur.ELISA was used to detect the serum levels of carboxyterminal cross-linked telopeptides of type I collagen and tartrate-resistant acid phosphatase 5b.RESULTS AND CONCLUSION:(1)Compared with the sham operation group,the model group showed a significant decrease in bone mineral density,sparse and fractured trabecular morphology,and a significant increase in serum levels of carboxyterminal cross-linked telopeptides of type I collagen and tartrate-resistant acid phosphatase 5b,indicating that the model of aromatase inhibitor-induced osteoporosis was successfully constructed.(2)Compared with the model group,the high-,medium-,and low-dose Huangqi Bushen Huoxue Decoction groups showed significant improvement in bone mineral density and bone microstructure,thickening and densification of trabecular morphology,significantly decreased serum levels of carboxyterminal cross-linked telopeptides of type I collagen and tartrate-resistant acid phosphatase 5b,a decrease in the number of osteoclasts and the expression of receptor activator of nuclear factor-κB ligand proteins,and an increase in the expression of osteoprotegerin.To conclude,Huangqi Bushen Huoxue Decoction may regulate the receptor activator of nuclear factor-κB ligand/receptor activator of nuclear factor-κB/osteoprotegerin signaling pathway,inhibit osteoclast activity,improve trabecular morphology and bone microstructure,and increase bone mineral density,thus preventing the occurrence and development of aromatase inhibitor-induced osteoporosis.
4.Correlation between clinical phenotypes and genotypes among 46 children with SCN1A-related developmental epileptic encephalopathy
Bingwei PENG ; Haixia ZHU ; Yang TIAN ; Xiaojing LI ; Xiuying WANG ; Yuanyuan GAO ; Yani ZHANG ; Huiling SHEN ; Wenxiong CHEN
Chinese Journal of Medical Genetics 2024;41(4):426-431
Objective:To explore the correlation between clinical phenotypes and genotypes among 46 children with SCN1A-related developmental epileptic encephalopathy (DEE). Methods:Clinical data of 46 children with DEE and SCN1A variants identified at the Guangzhou Women and Children′s Medical Center between January 2018 and June 2022 were collected. The children were grouped based on their age of onset, clinical manifestations, neurodevelopmental status, and results of genetic testing. The correlation between SCN1A genotypes and clinical phenotypes was analyzed. Results:Among the 46 patients, 2 children (4.35%) had developed the symptoms before 3 months of age, 42 (91.30%) were between 3 to 9 months, and 2 cases (4.35%) were after 10 months. Two cases (4.35%) presented with epilepsy of infancy with migrating focal seizures (EIMFS), while 44 (95.7%) had presented with Dravet syndrome (DS), including 28 cases (63.6%) with focal onset (DS-F), 13 cases (29.5%) with myoclonic type (DS-M), 1 case (2.27%) with generalized type (DS-G), and 2 cases (4.55%) with status epilepticus type (DS-SE). Both of the two EIMFS children had severe developmental delay, and among the DS patients, 7 cases had normal development, while the remaining had developmental delay. A total of 44 variants were identified through genetic sequencing, which included 16 missense variants and 28 truncating variants. All EIMFS children had carried the c. 677C>T (p.Thr226Met) missense variant. In the DS group, there was a significant difference in the age of onset between the missense variants group and the truncating variants group ( P < 0.05). Missense variants were more common in D1 (7/15, 46.7%) and pore regions (8/15, 53.3%), while truncating variants were more common in D1 (12/28, 42.9%). Children with variants outside the pore region were more likely to develop myoclonic seizures. Conclusion:The clinical phenotypes of DEE are diverse. There is a difference in the age of onset between individuals with truncating and missense variants in the SCN1A gene. Missense variants outside the pore region are associated with a higher incidence of myoclonic seizures.
5.Differential analysis of circadian rhythm pathway gene polymorphisms in patients with depression and bipolar disorder
Lei CHEN ; Zimu CHEN ; Tian SHEN ; Tingting TAN ; Chenjie GAO ; Suzhen CHEN ; Bingwei CHEN ; Yonggui YUAN ; Zhijun ZHANG ; Zhi XU
Chinese Journal of Psychiatry 2024;57(8):495-501
Objective:To explore the differences of the circadian rhythm gene polymorphisms between patients with major depressive disorder and those with bipolar disorder, providing a genetic basis for differential diagnosis.Methods:70 patients who were still diagnosed with major depressive disorder after 5 years and 68 patients who were still diagnosed with bipolar disorder from Zhongda Hospital affiliated to Southeast University from 2012 to 2018 were included in this study. Single nucleotide polymorphisms (SNPs) of circadian rhythm gene were selected for genetic testing. And the differences in genotype frequency, allele frequency, and haplotypes of each SNP between major depressive disorder and bipolar disorder were analyzed using UNPHASED 3.1.7.Results:The analysis of genotype frequency revealed statistically significant differences in genotype frequency of PER1rs2253820, PER1rs2735611, PER3rs12566042, PER3rs17031614, and PER3rs79372391 between the two groups ( OR(95% CI)=2.386(1.173-4.854), 2.357(1.166-4.764), 0.351(0.176-0.703), 0.389(0.196-0.773), 0.389(0.196-0.773) respectively; all P<0.05). Haplotype analysis showed that the T-C-C-T-G haplotype, in CLOCK loci (rs12505266, rs2272073, rs3817444, rs11133389 and rs12505265) was significantly different between major depressive disorder group and bipolar disorder group ( OR(95% CI)=0.108(0.010-1.185), P=0.027). Conclusion:There are significant differences in circadian rhythm gene polymorphisms between patients with major depressive disorder and bipolar disorder. Carrying the PER1rs2253820TT and PER1rs2735611GG genotypes is a risk factors for bipolar disorder.
6.Differential analysis of circadian rhythm pathway gene polymorphisms in patients with depression and bipolar disorder
Lei CHEN ; Zimu CHEN ; Tian SHEN ; Tingting TAN ; Chenjie GAO ; Suzhen CHEN ; Bingwei CHEN ; Yonggui YUAN ; Zhijun ZHANG ; Zhi XU
Chinese Journal of Psychiatry 2024;57(8):495-501
Objective:To explore the differences of the circadian rhythm gene polymorphisms between patients with major depressive disorder and those with bipolar disorder, providing a genetic basis for differential diagnosis.Methods:70 patients who were still diagnosed with major depressive disorder after 5 years and 68 patients who were still diagnosed with bipolar disorder from Zhongda Hospital affiliated to Southeast University from 2012 to 2018 were included in this study. Single nucleotide polymorphisms (SNPs) of circadian rhythm gene were selected for genetic testing. And the differences in genotype frequency, allele frequency, and haplotypes of each SNP between major depressive disorder and bipolar disorder were analyzed using UNPHASED 3.1.7.Results:The analysis of genotype frequency revealed statistically significant differences in genotype frequency of PER1rs2253820, PER1rs2735611, PER3rs12566042, PER3rs17031614, and PER3rs79372391 between the two groups ( OR(95% CI)=2.386(1.173-4.854), 2.357(1.166-4.764), 0.351(0.176-0.703), 0.389(0.196-0.773), 0.389(0.196-0.773) respectively; all P<0.05). Haplotype analysis showed that the T-C-C-T-G haplotype, in CLOCK loci (rs12505266, rs2272073, rs3817444, rs11133389 and rs12505265) was significantly different between major depressive disorder group and bipolar disorder group ( OR(95% CI)=0.108(0.010-1.185), P=0.027). Conclusion:There are significant differences in circadian rhythm gene polymorphisms between patients with major depressive disorder and bipolar disorder. Carrying the PER1rs2253820TT and PER1rs2735611GG genotypes is a risk factors for bipolar disorder.
7.Analysis of the diagnosis and treatment of 68 cases of iatrogenic ureteral stricture
Peng ZHANG ; Bingwei HUANG ; Guicao YIN ; Shengqi ZHENG ; Zhe LI ; Shuo QIAO ; Xuesong LI
Journal of Modern Urology 2023;28(7):613-618
【Objective】 To investigate the common etiology, characteristics and treatment of iatrogenic ureteral stricture. 【Methods】 The clinical data of 226 patients with ureteral stricture repaired during May 2019 and Mar. 2022 were retrospectively analyzed, including 68 cases of iatrogenic ureteral stricture. According to the etiology, the patients were divided into urinary group and non-urinary group. 【Results】 There were 42 females and 26 males, aged 25 to 67 (average 49.0±10.4) years. Upper ureteral stricture was detected in 24 (35.3%) cases, who received oral mucosal repair of the ureter. Middle ureteral stricture was detected in 12 (17.6%) cases, who underwent ileal ureterography. Lower ureteral stricture was observed in 24 (35.3%) cases, who were treated with vesical wall flap ureteroplasty. Full-length stricture was observed in 8 (11.8%) cases,who were treated with ileal ureterography. There were significant differences in age, gender, stenosis side, stenosis location and length, surgical methods and types between patients in the urinary group and non-urinary group (P<0.05). During the follow-up of 8 to 20 (average 12.3±5.6) months, the symptoms and renal function of all patients improved, and no recurrence occurred. 【Conclusion】 Invasive endourological surgery is the most common cause of iatrogenic ureteral stenosis. Different treatment strategies should be adopted according to patients’ condition, time of diagnosis and location and length of ureteral injury.
8.Changes and clinical significance of multiple cytokines in exhaled breath condensate in patients with severe inhalation injury
Yunfeng LIU ; Yong ZHANG ; Sheng DING ; Ran SUN ; Xiaojun LIU ; Jiandong SU ; Bingwei SUN
Chinese Critical Care Medicine 2023;35(8):818-822
Objective:To investigate the changes and clinical significance of multiple cytokine levels in exhaled breath condensate (EBC) in patients undergoing tracheotomy with severe inhalation injury.Methods:A prospective study was conducted. A total of 32 patients with severe burn combined with severe inhalation injury admitted to the department of burns and plastic surgery of Affiliated Suzhou Hospital of Nanjing Medical University from May 2021 to August 2022 were enrolled. Twenty healthy volunteers from the same period were served as controls. EBC of patients at 12 hours after burn and the samples of healthy controls were collected. The levels of 27 cytokines in EBC, including tumor necrosis factor-α (TNF-α) and interleukins (IL-1β, IL-6, IL-8, IL-10, and IL-17), were determined by liquid phase chip technology. Meanwhile, plasma of patients at 12 hours after burn and the plasma of volunteers were collected, and the levels of inflammatory cytokines were detected by liquid chip technology, and the differences between the levels in plasma and those in EBC were analyzed. Plasma and EBC of patients with aspiration injury were collected at 12 hours and 3, 7, 14 and 21 days after burn, and TNF-α levels were determined by enzyme-linked immunosorbent assay (ELISA).Results:Finally, 32 patients were enrolled, and the total burned area was (40±16)% of total body surface area (TBSA). The time of admission was (4.2±2.3) hours after injury. ① Twenty-seven cytokines in EBC: 18 kinds of cytokines including macrophage inflammatory protein-1β (MIP-1β), IL-6, IL-5, IL-2, IL-1β, IL-8, IL-10, IL-15, IL-9, interferon-γ (IFN-γ), IL-1 receptor antagonist (IL-1ra), TNF-α, chemotactic factor for eosinophil (Eotaxin), basic fibroblast growth factor (bFGF), platelet derived growth factor-BB (PDGF-BB), interferon-inducible protein-10 (IP-10), monocyte chemoattractant protein-1 (MCP-1), granulocyte colony-stimulating factor (G-CSF) were significantly increased in patients with severe aspiration injury compared with health controls. Eotaxin was not detected in EBC of healthy controls. Five cytokines, granulocyte-macrophage colony-stimulating factor (GM-CSF), chemokine ligand 5 (CCL5/RANTES), IL-13, IL-4 and MIP-1α, were not detected in EBC of severe inhalation injury patients and healthy controls. Vascular endothelial growth factor (VEGF) and IL-12 p70 in EBC of severe aspiration injury patients were slightly decreased as compared with healthy controls, while IL-7 and IL-17 were slightly increased, but the differences were not statistically significant. ② Six inflammatory cytokines in plasma: the levels of IL-6 and IL-8 in the severe aspiration injury group were significantly increased as compared with healthy controls [IL-6 (ng/L): 18.51 (10.87, 26.21) vs. 0.22 (0.10, 0.36), IL-8 (ng/L): 10.75 (8.58, 18.79) vs. 1.06 (0.81, 2.14), both P < 0.01]. The plasma levels of TNF-α, IL-1β and IL-10 were slightly increased in patients with severe aspiration injury as compared with healthy controls, and IL-17 was slightly decreased, but the difference was not statistically significant. In the EBC collected during the same period, five inflammatory cytokines, including TNF-α, IL-1β, IL-6, IL-8 and IL-10, in patients with severe inhalation injury were significantly increased as compared with healthy controls [TNF-α (ng/L): 16.42 (12.57, 19.21) vs. 7.34 (6.11, 8.69), IL-1β (ng/L): 15.57 (10.53, 20.25) vs. 0.99 (0.67, 1.41), IL-6 (ng/L): 13.36 (9.76, 16.54) vs. 0.70 (0.42, 0.85), IL-8 (ng/L): 1 059.29 (906.91, 1 462.37) vs. 10.36 (8.40, 12.37), IL-10 (ng/L): 2.69 (1.54, 3.33) vs. 1.54 (1.18, 2.06), all P < 0.05]. ③ Dynamic changes of TNF-α in plasma and EBC: the level of TNF-α in EBC of patients with severe aspiration injury was lower than that in plasma. Plasma TNF-α level was increased gradually with the extension of time after injury, and was significantly higher than that of healthy controls on day 3 [ng/L: 30.38 (24.32, 39.19) vs. 22.94 (17.15, 30.74), P < 0.05], and reached the peak on day 14, then fell back. The level of TNF-α in EBC at 12 hours after injury was significantly higher than that in healthy controls [ng/L: 15.34 (11.75, 18.14) vs. 6.99 (6.53, 7.84), P < 0.01], and reached the peak on 3 days after injury, and then gradually decreased. Conclusion:There are changes in the expression of multiple cytokines in EBC of patients with severe inhalation injury, and the changes of many inflammatory cytokines including TNF-α are more sensitive than those in plasma, which can be used to monitor and evaluate the condition of patients with inhalation injury.
9.Exploration and practice of clinical research hospital transformation based on structure-conduct-performance model
Liang MA ; Bingwei WANG ; Ruoyan HAN ; Wenjie MA ; Yanyan LIU ; Jiangong ZHANG
Chinese Journal of Hospital Administration 2022;38(12):909-914
Strengthening clinical research is an inevitable requirement for expediting the development of the medical and healthcare services, as well as enhancing the capability of the hospitals in China. On the basis of sufficient argumentation of the significance and the internal and external environment of developing clinical research according to structure-conduct-performance analysis model, Henan Cancer Hospital set the aim of transforming from clinical hospital to clinical research hospital. By constructing a high-level phase Ⅰ clinical trials center, establishing the department of clinical research management, promoting the collaborative innovation and cooperation among medical institutions, research institutions, and enterprises, and developing the accessory clinical trial management system, Henan Cancer Hospital has turned abundant patient resources into advantages of clinical research. The quality and quantity of clinical trials have been elevated significantly, which could provide strong impetus for hospital′s discipline construction and high-quality development.
10.Prognostic analysis of robotic and open pancreatoduodenectomy for pancreatic cancer
Haoda CHEN ; Chao WANG ; Bingwei SU ; Xiuqi ZHANG ; Yuxuan YANG ; Yuchen JI ; Yusheng SHI ; Yuanchi WENG ; Chenghong PENG ; Baiyong SHEN ; Xiaxing DENG
Chinese Journal of Digestive Surgery 2022;21(5):609-615
Objective:To investigate the prognosis of robotic pancreatoduodenectomy after the learning curve and open pancreatoduodenectomy for pancreatic cancer.Methods:The propensity score matching and retrospective cohort study was conducted. The clinicopathological data of 396 patients who underwent curative pancreatoduodenectomy for pancreatic duct adenocar-cinoma in Ruijin Hospital of Shanghai Jiaotong University School of Medicine from January 2017 to December 2018 were collected. There were 244 males and 152 females, aged 64(range, 36?92)years. Of 396 patients, 86 cases undergoing robotic pancreatoduodenectomy were divided into robotic group, 310 cases undergoing open pancreatoduodenectomy were divided into open group. Observa-tion indicators: (1) propensity score matching and comparison of general data between the two groups after matching; (2) follow-up and survival analysis. Follow-up was conducted by telephone interview or outpatient examinations including tumor markers and abdominal imaging examina-tions to detect survival of patients up to March 2022. Overall survival was defined as the time from the surgery date to death or the last follow-up. Disease-free survival was defined as the time from the surgery date to tumor recurrence or the last follow-up. The propensity score matching was conducted by 1∶1 matching using the nearest neighbor method. Normality of measurement data was examined using the Shapiro-Wilk test. Measurement data with skewed distribution were described as M(range), and comparison between groups was analyzed using the Mann-Whitney rank-sum test. Count data were represented as absolute numbers, and comparison between groups was analyzed using the chi-square test. Kaplan-Meier method was used to calculate survival rates and draw survival curves, and Log-Rank test was used for survival analysis. An intent-to-treat analysis was performed in this study, patients who were converted to laparotomy from robotic surgery were still divided into the robotic group. Results:(1) Propensity score matching and comparison of general data between the two groups after matching: 164 of 396 patients had successful matching, including 82 cases in robotic group and open group, respectively. Before propensity score matching, the body mass index, cases in stage T1, T2, T3, T4, cases in N0, N1, N2 were 23.4(range, 21.4?25.3)kg/m 2,24, 41, 10, 11, 52, 27, 7 for the robotic group, versus 22.4(range,20.3?23.9)kg/m 2,57, 144, 22, 87, 131, 132, 47 for the open group, showing significant differences in the above indicators between the two groups ( Z=3.01, 2.63, 3.03, P<0.05). After propensity score matching, cases of males, age, body mass index, cases with American Society of Anesthesiologists (ASA) score as 1, 2, 3, CA19-9, cases with preoperative biliary drainage, cases with portal vein resection, cases with pancreatic resection margin <1 mm, cases in stage T1, T2, T3, T4, cases in stage N0, N1, N2, cases with nerve invasion, cases with tumor differentiation as high-medium differentiation, medium-low differentiation, low differentiation, cases with adjuvant chemotherapy were 51, 65(range, 59?69)years, 23.0(range, 21.0?25.2)kg/m 2, 32, 41, 9, 160.4(range, 46.7?377.2)U/mL, 21, 9, 8, 21, 40, 10, 11, 48, 27, 7, 76, 26, 47, 9, 53 for the robotic group, versus 58, 65(range, 58?69)years, 23.3(range, 21.4?25.3)kg/m 2, 35, 39, 8, 172.0(range, 69.7?402.9)U/mL, 26, 9, 10, 24, 40, 7, 11, 49, 28, 5, 76, 22, 49, 11, 57 for the open group, showing no significant difference in the above indicators between the two groups ( χ2=1.34, Z=0.18, 0.34, 0.49, 0.51, χ2=0.75, 0.00,0.25, Z=0.59, 0.27, χ2=0.00, Z=0.76, χ2=0.44, P>0.05). (2) Follow-up and survival analysis: after propensity score matching, 164 patients were followed up for 54(range, 1?67)months. The follow-up time of patients was 55(range, 51?59)months for the robotic group, versus 54(range, 50?58)months for the open group, respectively, showing no significant difference between the two groups ( Z=0.48, P>0.05). During the follow-up, the 1-year overall survival rate, 3-year overall survival rate, the median survival time, 1-year disease-free survival rate, 3-year disease-free survival rate, the median disease-free survival time, tumor recurrence rate, cases with recurrence pattern as local recurrence, liver recurrence, other distant recurrence, local and distant recurrence were 81.7%, 39.0%, 27 months(95% confidence interval as 19?33 months), 61.0%, 34.2%, 15 months(95% confidence interval as 12?18 months), 54.9%(45/82), 12, 16, 9, 8 for the robotic group. The above indicators were 79.3%, 36.0%, 24 months(95% confidence interval as 19?31 months), 59.8%, 27.5%, 15 months(95% confidence interval as 10?20 months), 58.5% (48/82), 10, 22, 6, 10 for the open group. There was no significant difference in overall survival or disease-free survival between the two groups ( χ2=0.39, 0.47, P>0.05). There was no significant difference in tumor recurrence rate or tumor recurrence site between the two groups either ( χ2=0.22, 1.86, P>0.05). Conclusion:After the learning curve, robotic pancreato-duodenectomy has non-inferior prognosis compared with open pancreatoduodenectomy.

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