1.Treatment based on meridian differentiation and its application in clinical acupuncture research: reflections and recommendations.
Jing HE ; Cong CHE ; Ying ZHOU ; Xueqi TENG ; Hongxiu CHEN ; Jialin JIA ; Tie LI
Chinese Acupuncture & Moxibustion 2025;45(5):708-712
Treatment based on meridian differentiation is a characteristic method in clinical acupuncture diagnosis and treatment. Accurately defining and explaining its main content and core concepts is essential for effective clinical guidance. This paper reviews the historical and contemporary understanding, concepts, and primary content of treatment based on meridian differentiation. It proposes a four-step process for clinical application: meridian examination, treatment based on meridian differentiation, acupoint selection, and appropriate treatment methods, with TCM syndrome differentiation applied throughout. Constructing a diagnostic and treatment system which is based on meridian differentiation and suited to clinical acupuncture is significant for enhancing therapeutic efficacy and maximizing the benefits of acupuncture in disease treatment.
Humans
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Meridians
;
Acupuncture Therapy/methods*
;
Acupuncture Points
;
Medicine, Chinese Traditional
2.Biological characteristics of pathogen causing damping off on Aconitum kusnezoffiii and inhibitory effect of effective fungicides.
Si-Yi GUO ; Si-Yao ZHOU ; Tie-Lin WANG ; Ji-Peng CHEN ; Zi-Bo LI ; Ru-Jun ZHOU
China Journal of Chinese Materia Medica 2025;50(7):1727-1734
Aconitum kusnezoffii is a perennial herbaceous medicinal plant of the family Ranunculaceae, with unique medicinal value. Damping off is one of the most important seedling diseases affecting A. kusnezoffii, occurring widely and often causing large-scale seedling death in the field. To clarify the species of the pathogen causing damping off in A. kusnezoffii and to formulate an effective control strategy, this study conducted pathogen identification, research on biological characteristics, and evaluation of fungicide inhibitory activity. Through morphological characteristics, cultural traits, and phylogenetic tree analysis, the pathogen causing damping off in A. kusnezoffii was identified as Rhizoctonia solani, belonging to the AG5 anastomosis group. The optimal temperature for mycelial growth of the pathogen was 25-30 ℃, with OA medium as the most suitable medium, pH 8 as the optimal pH, and sucrose and yeast as the best carbon and nitrogen sources, respectively. The effect of light on mycelial growth was not significant. In evaluating the inhibitory activity of 45 chemical fungicides, including 30% hymexazol, and 4 biogenic fungicides, including 0.3% eugenol, it was found that 30% thifluzamide and 50% fludioxonil had significantly better inhibitory effects on R. solani than other tested agents, with EC_(50) values of 0.129 6,0.220 6 μg·mL~(-1), respectively. Among the biogenic fungicides, 0.3% eugenol also showed an ideal inhibitory effect on the pathogen, with an EC_(50) of 1.668 9 μg·mL~(-1). To prevent the development of resistance in the pathogen and to reduce the use of chemical fungicides, it is recommended that the three fungicides above be used in rotation during production. These findings provide a theoretical basis for the accurate diagnosis and effective control strategy for R. solani causing damping off in A. kusnezoffii.
Fungicides, Industrial/pharmacology*
;
Plant Diseases/microbiology*
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Rhizoctonia/growth & development*
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Aconitum/microbiology*
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Phylogeny
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Mycelium/growth & development*
3.Physicochemical Processes of Biofilm Formation on The Surface of Structures in Water
Kai SHEN ; Fei GAO ; Xu-Qiang HUANG ; Xiao-Peng LU ; Hui-Min ZHOU ; Wei-Rong LI ; Di TIE
Progress in Biochemistry and Biophysics 2024;51(1):145-157
Microorganisms can form biofilms, complex, heterogeneous, multicellular communities that adhere to surfaces. Biofilm formation on the surface of structures in water will accelerate structures’ corrosion, seriously affect their service efficiency and life, and significantly impact the growth of animals, plants, and human life. Hence, clarifying the mechanism of biofilm formation contributes to developing new strategies to control biofilm formation on surface and then reduce infections, biofouling, and contaminations. Biofilm-targeting strategies include the regulation of established biofilms or the modulation of single-cell attachment. In most studies, physicochemical mechanism is frequently applied to explain the initial bacterial adhesion phenomena but rarely to explain other stages of biofilm formation. This review presents a five-step comprehensive description of the physicochemical process from film formation to biofilm maturation: (1) period of film formation; (2) period of bacterial adhesion; (3) period of extracellular-polymeric-substances (EPSs) membrane formation; (4) period of regulating biofilm by quorum sensing (QS); (5) period of biofilm maturation. We first clarify how the film formed by compound molecules affects the surface’s physicochemical properties and initial adhesion, summarizing many factors that affect bacterial adhesion. We then review the types of EPSs and signal molecules secreted by bacteria after irreversible adhesion, as well as their role and QS mechanism in biofilm maturation. Finally, we discuss how bacteria or microcolonies separate from the mature biofilm by physicochemical action and summarize the morphology and adhesion characterization methods after the biofilm matures. This review redefines the role of physicochemical in the whole process of biofilm formation and provides a theoretical basis for the prevention, removal, and utilization of biofilm and other related research fields.
4.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
5.Cerebral oxygen metabolism and brain electrical activity of healthy full-term neonates in high-altitude areas:a multicenter clinical research protocol
Bi ZE ; Jin GAO ; Xiao-Fen ZHAO ; Yang-Fang LI ; Tie-Song ZHANG ; Xiao-Mei LIU ; Hui MAO ; Ming-Cai QIN ; Yi ZHANG ; Yong-Li YANG ; Chun-Ye HE ; Yan ZHAO ; Kun DU ; Lin LIU ; Wen-Hao ZHOU ; Chinese High Altitude Neonatal Medicine Alliance
Chinese Journal of Contemporary Pediatrics 2024;26(4):403-409
Further evidence is needed to explore the impact of high-altitude environments on the neurologic function of neonates.Non-invasive techniques such as cerebral near-infrared spectroscopy and amplitude-integrated electroencephalography can provide data on cerebral oxygenation and brain electrical activity.This study will conduct multiple cerebral near-infrared spectroscopy and amplitude-integrated electroencephalography monitoring sessions at various time points within the first 3 days postpartum for healthy full-term neonates at different altitudes.The obtained data on cerebral oxygenation and brain electrical activity will be compared between different altitudes,and corresponding reference ranges will be established.The study involves 6 participating centers in the Chinese High Altitude Neonatal Medicine Alliance,with altitude gradients divided into 4 categories:800 m,1 900 m,2 400 m,and 3 500 m,with an anticipated sample size of 170 neonates per altitude gradient.This multicenter prospective cohort study aims to provide evidence supporting the impact of high-altitude environments on early brain function and metabolism in neonates.[Chinese Journal of Contemporary Pediatrics,2024,26(4):403-409]
6.A prospective study on the safety and efficacy of excimer laser coronary angioplasty for the treatment of degenerated great saphenous vein graft.
Guang Yao ZHAI ; Tie Nan SUN ; Xiang LI ; Ming YE ; Cheng Gang WANG ; Xiao Lin ZU ; Duo YANG ; Hao FU ; Shu Ying QI ; Yu Jie ZHOU ; Hai GAO
Chinese Journal of Cardiology 2023;51(5):490-496
Objective: To explore the safety and efficacy of excimer laser coronary angioplasty (ELCA) for the treatment of degenerated great saphenous vein graft (SVG). Methods: This is a single-center, prospective, single-arm study. Patients, who were admitted to the Geriatric Cardiovascular Center of Beijing Anzhen Hospital from January 2022 to June 2022, were consecutively enrolled. Inclusion criteria were recurrent chest pain after coronary artery bypass surgery (CABG), and coronary angiography confirmed that the SVG stenosis was more than 70% but not completely occluded, and interventional treatment for SVG lesions was planned. Before balloon dilation and stent placement, ELCA was used to pretreat the lesions. Optical coherence tomography (OCT) examination was performed and postoperative index of microcirculation resistance (IMR) were assessed after stent implantation. The technique success rate and operation success rate were calculated. The technique success was defined as the successful passage of the ELCA system through the lesion. Operation success was defined as the successful placement of a stent at the lesion. The primary evaluation index of the study was IMR immediately after PCI. Secondary evaluation indexes included thrombolysis in myocardial infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), minimal stent area and stent expansion measured by OCT after PCI, and procedural complications (Ⅳa myocardial infarction, no reflow, perforation). Results: A total of 19 patients aged (66.0±5.6) years were enrolled, including 18 males (94.7%). The age of SVG was 8 (6, 11) years. The length of the lesions was greater than 20 mm, and they were all SVG body lesions. The median stenosis degree was 95% (80%, 99%), and the length of the implanted stent was (41.7±16.3)mm. The operation time was 119 (101, 166) minutes, and the cumulative dose was 2 089 (1 378, 3 011)mGy. The diameter of the laser catheter was 1.4 mm, the maximum energy was 60 mJ, and the maximum frequency was 40 Hz. The technique success and the operation success rate were both 100% (19/19). The IMR after stent implantation was 29.22±5.95. The TIMI flow grade of patients after ELCA and stent implantation was significantly improved (all P>0.05), and the TIMI flow grade of all patients after stent implantation was Grade Ⅲ. The cTFC decreased significantly after ELCA (33.2±7.8) and after stent placement (22.8±7.1) than preoperative level (49.7±13.0) (both P<0.001). The minimum stent area was (5.53±1.36)mm2, and the stent expansion rate was (90.0±4.3)%. Perforation, no reflow, type Ⅳa myocardial infarction and other complications were not observed. However, postoperative high-sensitivity troponin level was significantly increased ((67.937±33.839)ng/L vs. (5.316±3.105)ng/L, P<0.001). Conclusion: ELCA is safe and effective in the treatment of SVG lesions and could improve microcirculation and ensure full expansion of stent.
Male
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Humans
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Aged
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Prospective Studies
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Percutaneous Coronary Intervention
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Lasers, Excimer/therapeutic use*
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Saphenous Vein/transplantation*
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Constriction, Pathologic
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Atherectomy, Coronary/methods*
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Myocardial Infarction
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Coronary Angiography
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Stents
;
Treatment Outcome
7.Clinical characteristics and prognostic analysis of female patients with Stanford type B aortic dissection.
Tie Nan ZHOU ; Mei Cen LI ; Ya Song WANG ; Hai Wei LIU ; Quan Min JING ; Xiao Zeng WANG ; Ya Ling HAN
Chinese Journal of Cardiology 2023;51(2):172-179
Objective: To explore the clinical characteristics and prognostic factors of female patients with Stanford type B aortic dissection. Methods: This is a single-centre retrospective study. Consecutive patients diagnosed with Stanford type B aortic dissection in General Hospital of Northern Theater Command from June 2002 to August 2021 were enrolled, and grouped based on sex. According to the general clinical conditions and complications of aortic dissection tear, patients were treated with thoracic endovascular aortic repair, surgery, or optimal medication. The clinical characteristics and aortic imaging data of the patients at different stages were collected, adverse events including all-cause deaths, stroke, and occurrence of aortic-related adverse events were obtained during hospitalization and within 30 days and at 1 and 5 years after discharge. According to the time of death, death was classified as in-hospital death, out-of-hospital death, and in-hospital death was divided into preoperative death, intraoperative death and postoperative death. According to the cause of death, death was classified as aortic death, cardiac death and other causes of death. Aortic-related adverse events within 30 days after discharge included new paraplegia, post-luminal repair syndrome, and aortic death; long-term (≥1 year after discharge) aortic-related adverse events included aortic death, recurrent aortic dissection, endoleak and distal ulcer events. The clinical characteristics, short-term and long-term prognosis was compared between the groups. Logistic regression analysis was used to explore the association between different clinical factors and all-cause mortality within 30 days in female and male groups separately. Results: A total of 1 094 patients with Stanford type B aortic dissection were enrolled, mean age was (53.9±12.1) years, and 861 (78.7%) were male and 233 (21.3%) were female. (1) Clinical characteristics: compared with male patients, female patients were featured with older average age, higher proportion of aged≥60 years old, back pain, anemia, optimal medication treatment, and higher cholesterol level; while lower proportion of smoking and drinking history, body mass index, calcium antagonists use, creatine kinase level, and white blood cell count (all P<0.05). However, there was no significant difference in dissection tear and clinical stage, history of coronary heart disease, diabetes, hypertension, and cerebrovascular disease between female and male patients (all P>0.05). (2) Follow-up result: compared with male patients, female patients had a higher rate of 30-day death [6.9% (16/233) vs. 3.8% (33/861), P=0.047], in-hospital death (5.6% (13/233) vs. 2.7% (23/861), P=0.027), preoperative death (3.9% (9/233) vs. 1.5% (12/861), P=0.023) and aorta death (6.0% (14/233) vs. 3.1% (27/861), P=0.041). The 1-year and 5-year follow-up results demonstrated that there were no significant differences in death, cerebrovascular disease, and aorta-related adverse events between the two groups (all P>0.05). (3) Prognostic factors: the results of the univariate logistic regression analysis showed that body mass index>24 kg/m2 (HR=1.087, 95%CI 1.029-1.149, P=0.013), history of anemia (HR=2.987, 95%CI 1.054-8.468, P=0.032), hypertension (HR=1.094, 95%CI 1.047-1.143, P=0.040) and troponin-T>0.05 μg/L (HR=5.818, 95%CI 1.611-21.018, P=0.003)were associated with an increased risk of all-cause mortality within 30 days in female patients. Conclusions: Female patients with Stanford type B aortic dissection have specific clinical characteristics, such as older age at presentation, higher rates of anemia and combined back pain, and higher total cholesterol levels. The risk of death within 1 month is higher in female patients than in male patients, which may be associated with body mass index, hypertension, anemia and troponin-T, but the long-term prognosis for both female and male patients is comparable.
Humans
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Male
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Female
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Adult
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Middle Aged
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Aged
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Prognosis
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Hospital Mortality
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Retrospective Studies
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Troponin T
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Aortic Aneurysm, Thoracic/surgery*
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Blood Vessel Prosthesis Implantation/adverse effects*
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Treatment Outcome
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Endovascular Procedures/adverse effects*
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Aortic Dissection
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Hypertension/complications*
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Cholesterol
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Risk Factors
8.Effect of out-hospital blood pressure management on prognosis of patients with acute aortic syndrome complicated with hypertension after TEVAR.
Mei Cen LI ; Ya Song WANG ; Tie Nan ZHOU ; Quan Yu ZHANG ; Lei ZHANG ; Xiao Zeng WANG
Chinese Journal of Cardiology 2023;51(3):303-309
Objective: To investigate the influence of blood pressure control after discharge on prognosis of patients with acute aortic syndrome (AAS) complicated with hypertension who underwent thoracic endovascular aortic repair (TEVAR). Methods: This is a retrospective case analysis. Patients diagnosed with AAS complicated with hypertension and undergoing TEVAR in Northern Theater Command General Hospital from June 2002 to December 2021 were consecutively enrolled. Average systolic blood pressure (SBP) and the occurrence of endpoint events were recorded at one month, one year and every 2 years after TEVAR. According to the patients' average SBP, patients with average SBP<140 mmHg (1 mmHg=0.133 kPa) or<150 mmHg were divided into the target blood pressure achievement group, and the others were divided into target blood pressure non-achievement group. Endpoint events included all-cause death, aortic death, stroke, renal insufficiency, aortic related adverse events and a composite of these events (overall clinical adverse events), and re-accepting TEVAR. The incidence of endpoint events was compared between the two groups at each follow-up period. Results: A total of 987 patients were included, aged (55.7±11.7) years, including 779 male (78.9%). When the cutoff value was 140 mmHg, the rate of average target SBP achievement was 71.2% (703/987) at one month, 66.7% (618/927) during 1st to 12th month and 65.1% (542/832) from the first year to the third year after TEVAR. The proportion of patients taking≥2 antihypertensive agents was higher in the group of target blood pressure non-achievement group than the target blood pressure achievement group after TEVAR at 1 month (74.3% (211/284) vs.65.9% (463/703), P=0.010) and during 1st to 12th month (71.5% (221/309) vs. 63.6% (393/618), P=0.016). There were no statistical differences in the all-cause deaths, stroke, aortic related adverse events, and repeat TEVAR between the two groups (All P>0.05) during above follow-up periods. When the cutoff value was 150 mmHg, the rate of target SBP achievement was 89.3% (881/987) at one month, 85.2% (790/927) during 1st to 12th month and 85.6%(712/832) from the first year to the third year after TEVAR. The incidence of clinical total adverse events (8.8% (12/137) vs. 4.2% (33/790), P=0.021) and repeat TEVAR (4.4% (6/137) vs. 1.0% (8/790), P=0.003) in target blood pressure non-achievement group were significantly higher than the target blood pressure achievement group during 1st to 12th month after TEVAR. The incidence of all-cause deaths (5.8% (7/120) vs. 2.4% (17/712), P=0.037) in the target blood pressure non-achievement group was significantly higher than the target blood pressure achievement group from the first year to the third year follow-up period, but there were no statistical differences in the incidence of clinical total adverse events between the two group (P>0.05). Conclusion: Among TEVAR treated AAS patients complicated with hypertension, the average SBP more than 150 mmHg post discharge is associated with increased risk of adverse events. Ideal blood pressure control should be encouraged to improve the outcome of these patients.
Humans
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Male
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Blood Pressure
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Acute Aortic Syndrome
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Retrospective Studies
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Aftercare
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Treatment Outcome
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Blood Vessel Prosthesis Implantation/adverse effects*
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Aortic Dissection
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Aortic Aneurysm, Thoracic/surgery*
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Endovascular Procedures/adverse effects*
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Patient Discharge
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Hypertension
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Prognosis
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Stroke
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Hospitals
9.Surgical efficacy and prognosis influencing factors of hilar cholangiocarcinoma based on multi-disciplinary diagnosis and treatment
Liang MAO ; Yifei YANG ; Alexer ABAYDULLA ; Tie ZHOU ; Xu FU ; Hao CHENG ; Jing ZHANG ; Youjun LIANG ; Yinyin FAN ; Wentao KONG ; Jian HE ; Aimei LI ; Min TANG ; Qun ZHOU ; Qibin HE ; Yi WANG ; Lei WANG ; Weiwei KONG ; Jie SHEN ; Baorui LIU ; Jun CHEN ; Jiong SHI ; Qi LI ; Zhao LIU ; Yudong QIU
Chinese Journal of Digestive Surgery 2023;22(7):873-883
Objective:To investigate the surgical efficacy and prognosis influencing factors of hilar cholangiocarcinoma based on multidisciplinary diagnosis and treatment.Methods:The retrospective cohort study was conducted. The clinicopathological data of 91 patients with hilar cholangiocarcinoma who underwent surgery in Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from April 2004 to April 2021 were collected. There were 59 males and 32 females, aged (61±10)years. Patients who were admitted from April 2004 to March 2014 underwent traditional surgical diagnosis and treatment, and patients who were admitted from April 2014 to April 2021 underwent multidisciplinary diagnosis and treatment. Observation indica-tors: (1) surgical situations; (2) postoperative situations; (3) postoperative pathological examina-tions; (4) postoperative prognosis analysis; (5) influencing factors of postoperative prognosis. Follow-up was conducted using telephone interview and outpatient examination. Patients were followed up once every 6 months after surgery to detect survival. The follow-up was up to April 2023. Measure-ment data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Comparison of ordinal data was conducted using the rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. The Kaplan-Meier method was used to draw survival curve and calculate survival rate. The Log-Rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the COX proportional hazard model. Results:(1) Surgical situations. Of the 91 patients, there were 65 cases receiving hemi- or expanded hemi-hepatectomy, 13 cases receiving tri-hepatectomy, 9 cases receiving partial hepatectomy, 4 cases receiving extrahepatic bile duct resection. There were 24 cases receiving combined vein resection and reconstruction, 8 cases receiving combined pancreaticoduodenectomy, 6 cases receiving com-bined hepatic artery resection and reconstruction, including 24 cases receiving extended radical surgery (tri-hepatectomy, hepatic artery resection and reconstruction, hepatopancreaticoduodenec-tomy). The operation time, volume of intraoperative blood loss and intraoperative blood transfusion rate of 91 patients was (590±124)minutes, 800(range, 500?1 200)mL and 75.8%(69/91), respectively. Of the 91 patients, cases receiving extended radical surgery, the volume of intraoperative blood loss were 4, 650(range, 300?1 000)mL in the 31 patients who were admitted from April 2004 to March 2014, versus 20, 875 (range, 500?1 375)mL in the 60 patients who were admitted from April 2014 to April 2021, showing significant differences between them ( χ2=4.39, Z=0.31, P<0.05). (2) Post-operative situations. The postoperative duration of hospital stay and cases with postoperative infectious complications were (27±17)days and 50 in the 91 patients. Cases with abdominal infection, cases with infection of incision, cases with bacteremia and cases with pulmonary infection were 43, 7, 5, 8 in the 91 patients. One patient might have multiple infectious complications. Cases with bile leakage, cases with delayed gastric emptying, cases with chylous leakage, cases with liver failure, cases with pancreatic fistula, cases with intraperitoneal hemorrhage, cases with reoperation, cases dead during the postoperative 90 days were 30, 9, 9, 6, 5, 3, 6, 3 in the 91 patients. Cases with abdominal infection was 10 in the 31 patients who were admitted from April 2004 to March 2014, versus 33 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=4.24, P<0.05). Cases dead during the postoperative 90 days was 3 in the 31 patients who were admitted from April 2004 to March 2014, versus 0 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( P<0.05). (3) Post-operative pathological examinations. Of the 91 patients, cases with Bismuth type as type Ⅰ?Ⅱ, type Ⅲ, type Ⅳ, cases with T staging as Tis stage, T1 stage, T2a?2b stage, T3 stage, T4 stage, cases with N staging as N0 stage, N1 stage, N2 stage, cases with M staging as M0 stage, M1 stage, cases with TNM staging as 0 stage, Ⅰ stage, Ⅱ stage, Ⅲ stage, ⅣA stage, ⅣB stage, cases with R 0 radical resection, cases with R 1 or R 2 resection were 15, 46, 30, 1, 9, 25, 30, 26, 49, 36, 6, 85, 6, 1, 7, 13, 58, 6, 6, 63, 28. Cases with R 0 radical resection, cases with R 1 or R 2 resection were 15, 16 in the 31 patients who were admitted from April 2004 to March 2014, versus 48, 12 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=9.59, P<0.05). (4) Postoperative prognosis analysis. Of the 91 patients, 3 cases who died within 90 days after surgery were excluded, and the 5-year overall survival rate and median overall survival time of the rest of 88 cases were 44.7% and 55 months. The 5-year overall survival rate was 33.5% in the 28 patients who were admitted from April 2004 to March 2014, versus 50.4% in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=5.31, P<0.05). Results of further analysis showed that the corresponding 5-year overall survival rate of cases without lymph node metastasis was 43.8% in the 16 patients who were admitted from April 2004 to March 2014, versus 61.6% in the 31 patients who were admitted from April 2014 to April 2021. There was a significant difference in the 5-year overall survival rate between these patients without lymph node metastasis ( χ2=3.98, P<0.05). The corresponding 5-year overall survival rate of cases with lymph node metastasis was 18.5% in the 12 patients who were admitted from April 2004 to March 2014, versus 37.7% in the 29 patients who were admitted from April 2014 to April 2021. There was no significant difference in the 5-year overall survival rate between these patients with lymph node metastasis ( χ2=2.25, P>0.05). (5) Influencing factors of postoperative prognosis. Results of multivariate analysis showed that poorly differentiated tumor and R 1 or R 2 resection were inde-pendent risk factors influencing prognosis after surgical treatment of hilar cholangiocarcinoma ( hazard ratio=2.62, 2.71, 95% confidence interval as 1.30?5.29, 1.30?5.69, P<0.05). Conclusions:Compared with traditional surgical diagnosis and treatment, treatment of hilar cholangiocarcinoma based on multidisciplinary diagnosis and treatment can expand surgical indications, reduce proportion of dead patients within 90 days after surgery, improve proportation of radical resection and long-term survival rate. Poorly differentiated tumor and R 1 or R 2 resection are independent risk factors influencing prognosis after surgical treatment of hilar cholangiocarcinoma.
10.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
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East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*

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