1.Case analysis of hospitals′s infringement on patients′ right to informed consent from the perspective of the Civil Code of the People′s Republic of China
Linshan TANG ; Mengli TANG ; Lizhen YANG ; Xuejuan GAO
Chinese Journal of Hospital Administration 2024;40(8):640-646
Objective:To analyze the problems existing in the cases of hospitals infringing upon patients′ informed consent right after the promulgation of the Civil Code of the People′ s Republic of China, and to provide reference for improving the legal system of informed consent. Methods:Search for judgment documents published from January 1, 2021 to June 30, 2023 on the China Judgment Document Network using the keyword " liability dispute for infringing on patients′ informed consent rights", and conduct descriptive and textual analysis on the cases in the judgment documents.Results:68 judgment documents were included in total.There were 11 judgment documents on infringement of patients′ right to informed consent, and all related cases have undergone appraisal. The content of infringement mainly included infringement of patients′ right to know their condition (12/20), infringement of patients′ right to access their medical records (6/20), infringement of patients′ right to bodily integrity without consent (2/20). There were 15 judgment documents which judge that the right of informed consent of patients wasn′t infringed, and only one case in the document has been appraised. The main focus of controversy was the issue of the priority of the exercise of the right to informed consent (2/15), the fulfillment of the obligation to inform the right to informed consent (5/15), the issue of surgery without notification (1/15), and the issue of determining the authenticity of medical records and providing medical materials (7/15).Conclusions:The legal protection of patients′ right to informed consent still faces judicial difficulties such as unclear order of the exercise of rights subject, insufficient specificity of the scope of the exercise of the right, conflicts between the right to informed consent and medical intervention, and lack of unified identification methods for infringement liability. It is suggested to standardize the order of the exercise subject of the right to informed consent, clarify the content of the obligation of the medical party to inform, construct a system for medical intervention, and unify the identification methods for disputes related to the right to informed consent.
2.Research advances in immunotherapy for hepatocellular carcinoma
Lizhen ZHU ; Xiaolei XU ; Xiaojuan WANG ; Hu ZHOU ; Rui TANG ; Haining FAN ; Qian LU
Journal of Clinical Hepatology 2023;39(5):1197-1203
Hepatocellular carcinoma (HCC) has an insidious onset, and most patients are in the advanced stage when attending the hospital and thus lose the opportunity for radical surgical resection, which results in the poor prognosis of patients. With the development of clinical treatment, the treatment of advanced HCC has gradually transitioned from the relatively single and limited treatment options in the past to the new model of comprehensive treatment. In recent years, immunotherapy, represented by immune checkpoint inhibitors (ICIs), has become widely used in clinical practice. At present, a number of clinical studies have been conducted for immunotherapy combined with local and targeted antitumor therapy, and in particular, ICIs combined with targeted therapy have become a research hotspot in the field of HCC treatment. This article reviews the research advances in immunotherapy for the treatment of HCC.
3.Difference analysis of somatic mutations between deficient mismatch repair and proficient mismatch repair gene related with colorectal cancer
Xiujun TANG ; Mengyuan YANG ; Lizhen ZHU ; Dong XU ; Ying YUAN
Chinese Journal of Oncology 2021;43(10):1088-1093
Objective:To analyze the difference of somatic mutation of DNA mismatch repair (MMR) protein deletion (dMMR) /integrity (pMMR) in colorectal cancer (CRC).Methods:A total of 93 cases of paraffin pathological tissue derived from CRC patients underwent surgical treatment and postoperative routine immunohistochemical diagnosed as dMMR in the Second Affiliated Hospital of Zhejiang University Medical College from January 2015 to January 2017 were collected and conducted the second-generation sequencing test. The expressions of 4 MMR proteins (MLH1, MSH2, MSH6 and PMS2) in CRC tissue were detected by immunohistochemistry method, and the immunohistochemistry results were re-interpreted according to the American Association of Pathologists (CAP) standard. Second-generation sequencing technology was used to detect somatic mutations of 41 genes in 93 cases of paraffin pathological CRC tissue, and Fisher′s exact test was used to analyze the gene mutation differences between groups.Results:After re-evaluation according to CAP standard, 31 cases were divided into pMMR group and 62 cases in dMMR group among the 93 CRC patients. The medium number of gene mutations in the dMMR group was 9.5, higher than 3.0 of the pMMR group ( P<0.001). Somatic mutation differences were found in 17 genes between the dMMR and pMMR groups, including breast cancer susceptibility genes 1 (BRCA1), BRCA2, MLH1, PDGFRA, PIK3CA, APC, ATM, KIT, MET, PMS2, MSH6, POLE, MSH2, PTCH1, epidermal growth factor receptors (EGFR), TP53 and ERBB2 genes. The pathogenic somatic mutation rates of BRAF, MLH1, MSH2 and MSH6 in the dMMR group were higher than those in the pMMR group [21.0% (13/62) vs 9.7% (3/31), 9.7% (6/62) vs 0 (0/31), 21.0% (13/62) vs 0 (0/31), 22.6% (14/62) vs 0 (0/31), P<0.05]. The mutation rate differences of BLM N515fs, BRAF V600E, PTCH1 R1308fs and KRAS G13D sites were statistically different between the dMMR group and the pMMR group [22.6% (14/62) vs 0 (0/31), 19.4% (12/62) vs 3.2% (1/31), 11.3% (7/62) vs 0 (0/31), 16.1% (10/62) vs 3.2% (1/31), P<0.05]. The mutation rates of 3 uncommon sites including BLM N515fs, MSH6 F1088fs and PTCH1 R1308fs were 28.2% (11/39), 15.4% (6/39) and 15.4% (6/39) in patients with dMMR who were missing MLH1 and PMS2 together, statistically different from all of 0 (0/31) in pMMR patients ( P<0.05). Conclusions:CRC Patients with dMMR have more related gene somatic mutations. The BRAF V600E mutation is closely related to dMMR. KRAS G13D, BLM N515fs and PTCH1 R1308fs mutation sites are also associated with the expression of MMR proteins.
4.Difference analysis of somatic mutations between deficient mismatch repair and proficient mismatch repair gene related with colorectal cancer
Xiujun TANG ; Mengyuan YANG ; Lizhen ZHU ; Dong XU ; Ying YUAN
Chinese Journal of Oncology 2021;43(10):1088-1093
Objective:To analyze the difference of somatic mutation of DNA mismatch repair (MMR) protein deletion (dMMR) /integrity (pMMR) in colorectal cancer (CRC).Methods:A total of 93 cases of paraffin pathological tissue derived from CRC patients underwent surgical treatment and postoperative routine immunohistochemical diagnosed as dMMR in the Second Affiliated Hospital of Zhejiang University Medical College from January 2015 to January 2017 were collected and conducted the second-generation sequencing test. The expressions of 4 MMR proteins (MLH1, MSH2, MSH6 and PMS2) in CRC tissue were detected by immunohistochemistry method, and the immunohistochemistry results were re-interpreted according to the American Association of Pathologists (CAP) standard. Second-generation sequencing technology was used to detect somatic mutations of 41 genes in 93 cases of paraffin pathological CRC tissue, and Fisher′s exact test was used to analyze the gene mutation differences between groups.Results:After re-evaluation according to CAP standard, 31 cases were divided into pMMR group and 62 cases in dMMR group among the 93 CRC patients. The medium number of gene mutations in the dMMR group was 9.5, higher than 3.0 of the pMMR group ( P<0.001). Somatic mutation differences were found in 17 genes between the dMMR and pMMR groups, including breast cancer susceptibility genes 1 (BRCA1), BRCA2, MLH1, PDGFRA, PIK3CA, APC, ATM, KIT, MET, PMS2, MSH6, POLE, MSH2, PTCH1, epidermal growth factor receptors (EGFR), TP53 and ERBB2 genes. The pathogenic somatic mutation rates of BRAF, MLH1, MSH2 and MSH6 in the dMMR group were higher than those in the pMMR group [21.0% (13/62) vs 9.7% (3/31), 9.7% (6/62) vs 0 (0/31), 21.0% (13/62) vs 0 (0/31), 22.6% (14/62) vs 0 (0/31), P<0.05]. The mutation rate differences of BLM N515fs, BRAF V600E, PTCH1 R1308fs and KRAS G13D sites were statistically different between the dMMR group and the pMMR group [22.6% (14/62) vs 0 (0/31), 19.4% (12/62) vs 3.2% (1/31), 11.3% (7/62) vs 0 (0/31), 16.1% (10/62) vs 3.2% (1/31), P<0.05]. The mutation rates of 3 uncommon sites including BLM N515fs, MSH6 F1088fs and PTCH1 R1308fs were 28.2% (11/39), 15.4% (6/39) and 15.4% (6/39) in patients with dMMR who were missing MLH1 and PMS2 together, statistically different from all of 0 (0/31) in pMMR patients ( P<0.05). Conclusions:CRC Patients with dMMR have more related gene somatic mutations. The BRAF V600E mutation is closely related to dMMR. KRAS G13D, BLM N515fs and PTCH1 R1308fs mutation sites are also associated with the expression of MMR proteins.
5.Analysis of risk factors for death in patients with corona virus disease 2019
Hu TUO ; Baozhen YAO ; Bing HE ; Wenjing LI ; Lizhen TANG ; Ping MAO ; Chengxue XIA ; Qizhu TANG
Chinese Journal of Infectious Diseases 2020;38(11):696-700
Objective:To investigate the risk factors for death in patients with corona virus disease 2019 (COVID-19).Methods:The clinical data of 141 cases of patients diagnosed with COVID-19 at Renmin Hospital of Wuhan University from February 1 to February 26, 2020 were included in this retrospective analysis. The gender, age, time of hospitalization after the onset, clinical manifestations, underlying diseases, laboratory examination indicators (inculding white blood cell counts, neutrophil counts, lymphocyte counts, lymphocyte subsets, immunoglobulin, complement 3, complement 4, D-dimer, fibrinogen), and short term prognosis were compared between the death group and the survival group. Logistic regression was used to analyze the factors influencing the death of COVID-19 patients. The t test, Mann Whitney U test or chi-square test were used for comparison between groups. Results:Of the 141 COVID-19 patients, 52 died and 89 survived. The age, hypertension, chronic respiratory diseases, cardiovascular and cerebrovascular diseases, fever and wheeze of patients in the death group were all higher than those in the survival group, which were (70.7±13.3) years old vs (50.4±15.3) years old, 51.9%(27/52) vs 14.6%(13/89), 15.4%(8/52) vs 4.5%(4/89), 30.8%(16/52) vs 7.9%(7/89), 80.8%(42/52) vs 61.8%(55/89) and 50.0%(26/52) vs 25.8%(23/89), respectively. The differences were all statistically significant ( t=7.972, χ2=22.104, 3.615, 12.392, 5.503 and 8.447, respectively, all P<0.05). The white blood cell count, neutrophil count, CD4 + /CD8 + T lymphocyte, immunoglobulin E, D-dimer, fibrinogen, CD19 + T lymphocyte proportion and CD19 + T lymphocyte count of patients in the death group were all higher than those in the survival group, which were 8.20(5.26, 13.01)×10 9/L vs 5.29(3.96, 7.04)×10 9/L, 7.40(4.54, 11.46)×10 9/L vs 3.16(2.20, 5.01)×10 9/L, 2.32(1.77, 3.11) vs 1.63(1.25, 2.08), 125.0(42.6, 275.0) IU/mL vs 66.8(38.3, 143.0) IU/mL, 7.27(2.11, 16.21) mg/L vs 0.95(0.38, 2.54) mg/L, 4.37(2.72, 6.78) g/L vs 4.10(2.78, 4.97) g/L, (23.19±13.43)% vs (15.38±6.38)%, and (181.5±115.4)/μL vs (98.89±77.64)/μL, respectively. The differences were all statistically significant ( Z=3.944, 4.210, 2.834, 1.190, 5.497, 1.180, t=3.987, 3.411, respectively, all P<0.05). The lymphocyte count, CD3 + T lymphocyte proportion, CD3 + T lymphocyte count, CD8 + T lymphocyte proportion, CD8 + T lymphocyte count, CD16 + CD56 + T lymphocyte count and CD4 + T lymphocyte count were all lower than those in survival group, which were 0.47(0.37, 0.96)×10 9/L vs 1.33(0.90, 1.55)×10 9/L, 48.72%(42.31%, 76.92%) vs 69.91%(65.05%, 75.36%), 223.0(100.0, 403.0)/μL vs 761.0(499.0, 1 092.0)/μL, 13.82%(10.32%, 19.82%) vs 24.90%(20.87%, 29.57%), 55.5(30.5, 106.0)/μL vs 318.0(162.5, 443.5)/μL, 63.0(29.0, 99.5)/μL vs 140.0(69.5, 195.5)/μL and (209.74±140.13)/μL vs (487.61±232.02)/μL, respectively. The differences were all statistically significant ( Z=6.937, 3.944, 5.883, 3.924, 5.703, 3.517 and t=7.558, respectively, all P<0.01). Age, history of hypertension, white blood cell count, D-dimer, and fibrinogen were the risk factors for death of COVID-19 (odds ratio ( OR)=1.170, 10.405, 3.055, 1.128 and 1.343, respectively, all P<0.05). Conclusion:Age, underlying hypertension, white blood cell count, D-dimer and fibrinogen are independent prognostic factors for COVID-19.
6.Effects from Fiber Orientations of Bovine Pericardium on its Compression Performance
Zebin WU ; Chang JIN ; Lizhen WANG ; Xiaolan TANG ; Shengping ZHONG ; Yubo FAN
Journal of Medical Biomechanics 2019;34(1):E021-E026
Objective To investigate the mechanical behavior of bovine pericardium with different orientations after compression and evaluate its effects on the duration of transcatheter aortic valve. Methods According to the fiber directions, the pericardial strips were divided into 12 groups of transverse, longitudinal and oblique pericardial strips, and each group included 3 strips of pericardium. One strip maintained the original state, and the other two strips were under 12.5 N and 25 N compression, respectively for 1 h. The mechanical properties of compressed samples were tested and analyzed subsequently in uniaxial tension test. Results The samples with different orientations showed obvious anisotropy before and after compression. The secant modulus, elastic modulus and ultimate tensile strength of the longitudinal pericardium were generally greater than those of the oblique pericardium, while the oblique pericardium was larger than the transverse pericardium. For longitudinal and oblique bovine pericardium under 25 N compression, the average tensile strength ratio was 0.92 and 0.87, respectively, and the ratio of tensile strength before and after compression had a significant difference (P<0.05). The average tensile strength ratio of transverse bovine pericardium after 25 N compression was 0.97, and there was no significant difference in the ratio of tensile strength before and after compression (P>0.05). Conclusions The compressive damage of the pericardia with different fiber orientations was very small under low stresses at transitory time. For design and production of transcatheter aortic valves, the orientations of the pericardium and the changes of strength after compression should be taken into consideration.
7.The clinical significance of combined heart lung ultrasound on severe left heart failure with pulmonary hypertension
Gang LIU ; Tongliang HAN ; Lizhen DU ; Rui LI ; Tingting LEI ; Guozhang TANG ; Simin ZHANG ; Xishun MA
Chinese Journal of Medical Ultrasound (Electronic Edition) 2017;14(12):927-932
Objective To investigate the clinical significance of combined heart and lung ultrasound in patients with severe left heart failure and pulmonary hypertension. Methods From March 2016 to June 2017, 75 patients with grade Ⅲ and Ⅳ heart failure and dyspnea were enrolled in Qingdao Municipal Hospital Affiliated to Qingdao University. Thirty-three patients had normal pulmonary artery pressure (normal pulmonary arterial pressure group), 25 patients had mild pulmonary hypertension (mild pulmonary hypertension group), and 17 patients had moderate to severe pulmonary hypertension (moderate to severe pulmonary hypertension group). The patient′s plasma B-type natriuretic peptide (BNP) was measured. Left ventricular diameter (LVD), right ventricular diameter (RVD), and left ventricular ejection fraction (LVEF) were measured by echocardiography. The patient′s lungs were observed by lung ultrasonography, and its number was recorded. One-way analysis of variance was used to compare the differences of LVD, RVD, and LVEF in three groups of patients with severe left heart failure. Further comparison between groups was performed using LSD-t test. Kruskal-wallis H test was used to compare the plasma BNP concentration and B-line number in three groups of patients with severe left heart failure. The Mann-Whitney U test was used to further compare the groups. The receiver operating characteristic (ROC) curve of pulmonary hypertension diagnosed by plasma BNP concentration and B line number in patients with severe left heart failure were drwan. Results The concentrations of BNP in patients with normal pulmonary arterial pressure, mild pulmonary hypertension, and moderate to severe pulmonary hypertension were 890 (614, 1516), 1460 (1245, 1950), and 2660 (1670, 3279) ng/L, respectively. The number of B line was 12 (9, 16), 17 (14, 18), 26 (20, 28), and the RVD was (22.1±1.7), (24.9±2.0), (26.3±2.8) mm, respectively. The number of B-line and RVD in the moderate-severe pulmonary hypertension group were both lager than those in the mild pulmonary hypertension group, and the number of B-line and RVD in the mild pulmonary hypertension group were both lager than those in the normal pulmonary artery pressure group. There was significant difference between any two groups (BNP concentration: U=210.500, P < 0.05; U=47.000, 73.000, both P < 0.001;B line number:U=189.000,P < 0.05;U=38.5000,64.000,both P < 0.001;RVD:t=0.553, 0.623, both P<0.001; t=0.656, P<0.05). There was no significant difference in LVD and LVEF between the three groups of patients. The ROC curve showed that the optimal threshold for the diagnosis of pulmonary hypertension in patients with severe left heart failure with BNP concentration was 1225 ng/L. The sensitivity was 85.7%,the specificity was 69.7%,the area under the curve was 0.814,and the 95% CI was 0.717 to 0.911. The optimal threshold for diagnosis of pulmonary hypertension in patients with severe left heart failure was B line number 14, the sensitivity was 88.1%, specificity was 66.7%, the area under the curve was 0.836, and 95%CI was 0.747 to 0.925.Conclusion Patients with severe left heart failure at different pulmonary artery pressure levels have different B-line findings, and the number of B-line increases with the severity of pulmonary hypertension, which warrants further study and application.
8.Analgesic and Anti-inflammatory Effects of the Water Extract of Glycosmis citrifolia (Willd.) Lindl
Lizhen HUANG ; Ningning HOU ; Wenfang MA ; Haijing WU ; Xiuzhen DENG ; Biao TANG
Herald of Medicine 2016;(3):233-236
Objective To observe the analgesic and anti-inflammatory effects of the water extract of Glycosmis citrifolia (Willd.) Lindl.on mice and explore the mechanism. Methods The analgesic and anti-inflammatory effects were evaluated by 0.7% acetic acid-induced writhing test,the hot plate test,tests of dimethylbenzene-induced ear swelling,1% carrageenan-induced paw edema,determination of PGE2 in inflammatory feet,0.6% acetic acid-induced increase in peritoneal capillary permeability and cotton ball granuloma. Results The water extract of Glycosmis citrifolia (Willd.) Lindl.at low,medium and high doses can reduce the acetic acid-induced writhing times (P<0.01 or P<0.05),increase the pain threshold of mice (P<0.01 or P<0.05), inhibit dimethylbenzene-induced ear swelling (P<0.01 or P<0.05),1% carrageenan-induced paw edema (P<0.01 or P<0.05) and PGE2 production (P<0.01),0.6% acetic acid-induced increase of peritoneal capillary permeability (P<0.05),and the de-velopment of cotton ball granuloma (P<0.01 or P<0.05). Conclusion The water extract of Glycosmis citrifolia (Willd.) Lindl.shows analgesic and anti-inflammatory effects on mice.
9.Cyclin D1 as a potential predictive biomarker for TPF induction chemotherapy in cN2 patients with oral squamous cell carcinoma
Wenwen SUN ; Xiao TANG ; Dongwang ZHU ; Jie MA ; Hailong MA ; Ying LIU ; Yiran TAN ; Yaoyao TU ; Lizhen WANG ; Jiang LI ; Laiping ZHONG ; Chenping ZHANG ; Zhiyuan ZHANG
Chinese Journal of Clinical Oncology 2015;42(16):791-795
Objective:To investigate the potential prognostic value of cyclin D1 expression in patients with locally advanced oral squamous cell carcinoma (OSCC) and its relationship with taxol (Docetaxel)/cisplatin plus 5-fluorouracil (TPF) induction chemothera-py. Methods:A total of 256 patients with locally advanced OSCC were selected from Shanghai Ninth People's Hospital of Shanghai Ji-ao Tong University School of Medicine between March 2008 and December 2010 as the objects of study in this prospective randomized clinical trial. The effect of TPF induction chemotherapy was investigated. Immunohistochemical staining against cyclin D1 was per-formed in the pretreatment biopsy specimen of the patients. The relationship between cyclin D1 expression and prognostic data of the TPF induction arm and control arm was analyzed. Results:Cyclin D1 expression was detected in 232 out of the 256 patients. Patients with low cyclin D1 expression showed significantly better overall survival (OS) (P=0.001), disease-free survival (DFS) (P=0.003), lo-coregional recurrence-free survival (LRFS) (P=0.004), and distant metastasis-free survival (DMFS) (P=0.001) than those with high cy-clin D1 expression. No significant differences existed in OS, DFS, LRFS, or DMFS between the patients with TPF induction chemother-apy and the control. Cyclin D1 expression levels were not predictive of the benefit from TPF induction chemotherapy in the overall pop-ulation. However, patients with nodal stage cN2 and high cyclin D1 expression, who were undergoing TPF chemotherapeutic regimen, showed significantly higher OS (P=0.024) and DMFS (P=0.024) than cN2 patients with high cyclin D1 expression but undergoing stan-dard surgical treatment. Conclusion:Cyclin D1 can be used as a prognostic biomarker for patients with locally advanced OSCC. Fur-thermore, cN2 OSCC patients with high cyclin D1 expression can receive long-term benefit from the addition of TPF induction chemo-therapy to standard surgical treatment.
10.Biomechanical analysis of different ProDisc-C arthroplasty design parameters after implanted: a numerical sensitivity study based on finite element method.
Qiaohong TANG ; Zhongjun MO ; Jie YAO ; Qi LI ; Chenfei DU ; Lizhen WANG ; Yubo FAN
Journal of Biomedical Engineering 2014;31(6):1265-1271
This study was aimed to estimate the effect of different ProDisc-C arthroplasty designs after it was implanted to C5-C6 cervicalspine. Finite element (FE) model of intact C5-C6 segments including the vertebrae and disc was developed and validated. Ball-and-socket artificial disc prosthesis model (ProDisc-C, Synthes) was implanted into the validated FE model and the curvature of the ProDisc-C prosthesis was varied. All models were loaded with compressed force 74 N and the pure moment of 1.8 Nm along flexion-extension and bilateral bending and axial torsion separately. The results indicated that the variation in the curvature of ball and socket configuration would influence the range of motion in flexion/extension, while there were not apparently differences under other conditions of loads. The method increasing the curvature will solve the stress concentration of the polyethylene, but it will also bring adverse outcomes, such as facet joint force increasing and ligament tension increasing. Therefore, the design of artificial discs should be considered comprehensively to reserve the range of motion as well as to avoid the adverse problems, so as not to affect the long-term clinical results.
Arthroplasty
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Biomechanical Phenomena
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Finite Element Analysis
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Humans
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Intervertebral Disc
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Pressure
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Prostheses and Implants
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Range of Motion, Articular
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Spine
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Zygapophyseal Joint

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