1.Ethical considerations of using the deceased as medical research subjects
Zhaolong LU ; Xiaoyun CHEN ; Yongchuan CHEN ; Mengjie YANG ; Qiang LIU ; Hui JIANG ; Zhonglin CHEN
Chinese Medical Ethics 2025;38(11):1447-1452
The relevant laws and regulations regarding the utilization of the deceased as medical research subjects are not yet fully developed in China nowadays. Taking the deceased as research subjects as a starting point, this paper discussed the definition of the deceased and the scope of their interest protection from multiple perspectives. It posited that the scope of interest protection for the deceased encompassed two components: spiritual personality interests and material personality interests represented by the remains. The spiritual personality interests of the deceased included identification information such as name, portrait, reputation, honor, privacy, and personal information, as well as medical and health information. The personal information of the deceased was not directly affected by the individual’s life and death status and remained relatively independent. In terms of ethical review, the research team approached from two perspectives: the remains and the personal information of the deceased. Based on the standard of whether the research subjects involve a human body, research with the remains of the deceased as the medical research subjects was classified as non-clinical research. According to the standard of whether a human body is clinically operated, research with the personal information of the deceased (including medical and health information) as the medical research subjects was recognized as clinical research without human research operation. This approach provided evidence for the application of existing laws and regulations in ethical review and record management. The ethical review of investigator-initiated clinical research conducted in medical and health institutions, as well as the regulatory conditions for exemption from ethical review, were examined. The forms, content, and acquisition of informed consent were summarized, and the risk-benefit characteristics of the research activity were evaluated, with a view to providing a basis for the smooth and compliant implementation of research activities involving the deceased as medical research subjects.
2.Analysis of the effect of fudosteine on induced sputum components in patients with stable neutrophil-dominated COPD
Zhanbo LI ; Kaifeng DU ; Zhilong JIANG ; Jiameng GAO ; Mengjie CHEN ; Yuan MA ; Zhihong CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):362-369
AIM:To observe the effect of fudostei-ne on induced sputum cell components and lung function in patients with stable neutrophil-dominat-ed COPD.METHODS:From October 2019 to Octo-ber 2022,53 patients with stable COPD were select-ed and divided into fudosteine group and placebo group.The placebo group was treated with routine treatment,and the fudosteine group was treated with fudosteine on the basis of routine treatment.The two groups were treated for 6 months.The clinical symptoms[Saint George's Respiratory Questionnaire(SGRQ),COPD Assessment Test(CAT)and Modified British Medical Research Council Dys-pnea scale(MMRC),Breathlessness,Cough,and Sputum Scale(BCSS)],lung function index,induced sputum cytology analysis and other related exami-nation results were recorded in detail before and after treatment.RESULTS:(1)Compared with the baseline,the forced expiratory volume in one sec-ond(FEV1),forced vital capacity(FVC),and the ra-tio of FEV1 to FVC(FEV1/FVC)of the two groups were improved after treatment,and the differenc-es were statistically significant(P<0.05).However,after treatment,there was no significant difference in pulmonary function between the two groups ex-cept for the percentage of carbon monoxide diffu-sion in the predicted value(DLCO%pre)(DLCO%pre in the fudosteine group was higher than that in the placebo group).(2)After treatment,the total num-ber of induced sputum cells and neutrophil counts in the fudosteine group were lower than those in the placebo group.Compared with the number of cells in each component at baseline,the total num-ber of induced sputum cells and neutrophil count in the fudosteine group were significantly lower(P<0.05).CONCLUSION:Fudosteine treatment in pa-tients with stable neutrophil-dominated COPD can improve lung function,reduce the total number of induced sputum cells and the total number of neu-trophils,thereby improving airway inflammation.
3.Analysis of the effect of fudosteine on induced sputum components in patients with stable neutrophil-dominated COPD
Zhanbo LI ; Kaifeng DU ; Zhilong JIANG ; Jiameng GAO ; Mengjie CHEN ; Yuan MA ; Zhihong CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):362-369
AIM:To observe the effect of fudostei-ne on induced sputum cell components and lung function in patients with stable neutrophil-dominat-ed COPD.METHODS:From October 2019 to Octo-ber 2022,53 patients with stable COPD were select-ed and divided into fudosteine group and placebo group.The placebo group was treated with routine treatment,and the fudosteine group was treated with fudosteine on the basis of routine treatment.The two groups were treated for 6 months.The clinical symptoms[Saint George's Respiratory Questionnaire(SGRQ),COPD Assessment Test(CAT)and Modified British Medical Research Council Dys-pnea scale(MMRC),Breathlessness,Cough,and Sputum Scale(BCSS)],lung function index,induced sputum cytology analysis and other related exami-nation results were recorded in detail before and after treatment.RESULTS:(1)Compared with the baseline,the forced expiratory volume in one sec-ond(FEV1),forced vital capacity(FVC),and the ra-tio of FEV1 to FVC(FEV1/FVC)of the two groups were improved after treatment,and the differenc-es were statistically significant(P<0.05).However,after treatment,there was no significant difference in pulmonary function between the two groups ex-cept for the percentage of carbon monoxide diffu-sion in the predicted value(DLCO%pre)(DLCO%pre in the fudosteine group was higher than that in the placebo group).(2)After treatment,the total num-ber of induced sputum cells and neutrophil counts in the fudosteine group were lower than those in the placebo group.Compared with the number of cells in each component at baseline,the total num-ber of induced sputum cells and neutrophil count in the fudosteine group were significantly lower(P<0.05).CONCLUSION:Fudosteine treatment in pa-tients with stable neutrophil-dominated COPD can improve lung function,reduce the total number of induced sputum cells and the total number of neu-trophils,thereby improving airway inflammation.
4.Analysis of the effect of fudosteine on induced sputum components in patients with stable neutrophil-dominated COPD
Zhanbo LI ; Kaifeng DU ; Zhilong JIANG ; Jiameng GAO ; Mengjie CHEN ; Yuan MA ; Zhihong CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):362-369
AIM:To observe the effect of fudostei-ne on induced sputum cell components and lung function in patients with stable neutrophil-dominat-ed COPD.METHODS:From October 2019 to Octo-ber 2022,53 patients with stable COPD were select-ed and divided into fudosteine group and placebo group.The placebo group was treated with routine treatment,and the fudosteine group was treated with fudosteine on the basis of routine treatment.The two groups were treated for 6 months.The clinical symptoms[Saint George's Respiratory Questionnaire(SGRQ),COPD Assessment Test(CAT)and Modified British Medical Research Council Dys-pnea scale(MMRC),Breathlessness,Cough,and Sputum Scale(BCSS)],lung function index,induced sputum cytology analysis and other related exami-nation results were recorded in detail before and after treatment.RESULTS:(1)Compared with the baseline,the forced expiratory volume in one sec-ond(FEV1),forced vital capacity(FVC),and the ra-tio of FEV1 to FVC(FEV1/FVC)of the two groups were improved after treatment,and the differenc-es were statistically significant(P<0.05).However,after treatment,there was no significant difference in pulmonary function between the two groups ex-cept for the percentage of carbon monoxide diffu-sion in the predicted value(DLCO%pre)(DLCO%pre in the fudosteine group was higher than that in the placebo group).(2)After treatment,the total num-ber of induced sputum cells and neutrophil counts in the fudosteine group were lower than those in the placebo group.Compared with the number of cells in each component at baseline,the total num-ber of induced sputum cells and neutrophil count in the fudosteine group were significantly lower(P<0.05).CONCLUSION:Fudosteine treatment in pa-tients with stable neutrophil-dominated COPD can improve lung function,reduce the total number of induced sputum cells and the total number of neu-trophils,thereby improving airway inflammation.
5.Analysis of the effect of fudosteine on induced sputum components in patients with stable neutrophil-dominated COPD
Zhanbo LI ; Kaifeng DU ; Zhilong JIANG ; Jiameng GAO ; Mengjie CHEN ; Yuan MA ; Zhihong CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):362-369
AIM:To observe the effect of fudostei-ne on induced sputum cell components and lung function in patients with stable neutrophil-dominat-ed COPD.METHODS:From October 2019 to Octo-ber 2022,53 patients with stable COPD were select-ed and divided into fudosteine group and placebo group.The placebo group was treated with routine treatment,and the fudosteine group was treated with fudosteine on the basis of routine treatment.The two groups were treated for 6 months.The clinical symptoms[Saint George's Respiratory Questionnaire(SGRQ),COPD Assessment Test(CAT)and Modified British Medical Research Council Dys-pnea scale(MMRC),Breathlessness,Cough,and Sputum Scale(BCSS)],lung function index,induced sputum cytology analysis and other related exami-nation results were recorded in detail before and after treatment.RESULTS:(1)Compared with the baseline,the forced expiratory volume in one sec-ond(FEV1),forced vital capacity(FVC),and the ra-tio of FEV1 to FVC(FEV1/FVC)of the two groups were improved after treatment,and the differenc-es were statistically significant(P<0.05).However,after treatment,there was no significant difference in pulmonary function between the two groups ex-cept for the percentage of carbon monoxide diffu-sion in the predicted value(DLCO%pre)(DLCO%pre in the fudosteine group was higher than that in the placebo group).(2)After treatment,the total num-ber of induced sputum cells and neutrophil counts in the fudosteine group were lower than those in the placebo group.Compared with the number of cells in each component at baseline,the total num-ber of induced sputum cells and neutrophil count in the fudosteine group were significantly lower(P<0.05).CONCLUSION:Fudosteine treatment in pa-tients with stable neutrophil-dominated COPD can improve lung function,reduce the total number of induced sputum cells and the total number of neu-trophils,thereby improving airway inflammation.
6.Analysis of the effect of fudosteine on induced sputum components in patients with stable neutrophil-dominated COPD
Zhanbo LI ; Kaifeng DU ; Zhilong JIANG ; Jiameng GAO ; Mengjie CHEN ; Yuan MA ; Zhihong CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):362-369
AIM:To observe the effect of fudostei-ne on induced sputum cell components and lung function in patients with stable neutrophil-dominat-ed COPD.METHODS:From October 2019 to Octo-ber 2022,53 patients with stable COPD were select-ed and divided into fudosteine group and placebo group.The placebo group was treated with routine treatment,and the fudosteine group was treated with fudosteine on the basis of routine treatment.The two groups were treated for 6 months.The clinical symptoms[Saint George's Respiratory Questionnaire(SGRQ),COPD Assessment Test(CAT)and Modified British Medical Research Council Dys-pnea scale(MMRC),Breathlessness,Cough,and Sputum Scale(BCSS)],lung function index,induced sputum cytology analysis and other related exami-nation results were recorded in detail before and after treatment.RESULTS:(1)Compared with the baseline,the forced expiratory volume in one sec-ond(FEV1),forced vital capacity(FVC),and the ra-tio of FEV1 to FVC(FEV1/FVC)of the two groups were improved after treatment,and the differenc-es were statistically significant(P<0.05).However,after treatment,there was no significant difference in pulmonary function between the two groups ex-cept for the percentage of carbon monoxide diffu-sion in the predicted value(DLCO%pre)(DLCO%pre in the fudosteine group was higher than that in the placebo group).(2)After treatment,the total num-ber of induced sputum cells and neutrophil counts in the fudosteine group were lower than those in the placebo group.Compared with the number of cells in each component at baseline,the total num-ber of induced sputum cells and neutrophil count in the fudosteine group were significantly lower(P<0.05).CONCLUSION:Fudosteine treatment in pa-tients with stable neutrophil-dominated COPD can improve lung function,reduce the total number of induced sputum cells and the total number of neu-trophils,thereby improving airway inflammation.
7.Analysis of the effect of fudosteine on induced sputum components in patients with stable neutrophil-dominated COPD
Zhanbo LI ; Kaifeng DU ; Zhilong JIANG ; Jiameng GAO ; Mengjie CHEN ; Yuan MA ; Zhihong CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):362-369
AIM:To observe the effect of fudostei-ne on induced sputum cell components and lung function in patients with stable neutrophil-dominat-ed COPD.METHODS:From October 2019 to Octo-ber 2022,53 patients with stable COPD were select-ed and divided into fudosteine group and placebo group.The placebo group was treated with routine treatment,and the fudosteine group was treated with fudosteine on the basis of routine treatment.The two groups were treated for 6 months.The clinical symptoms[Saint George's Respiratory Questionnaire(SGRQ),COPD Assessment Test(CAT)and Modified British Medical Research Council Dys-pnea scale(MMRC),Breathlessness,Cough,and Sputum Scale(BCSS)],lung function index,induced sputum cytology analysis and other related exami-nation results were recorded in detail before and after treatment.RESULTS:(1)Compared with the baseline,the forced expiratory volume in one sec-ond(FEV1),forced vital capacity(FVC),and the ra-tio of FEV1 to FVC(FEV1/FVC)of the two groups were improved after treatment,and the differenc-es were statistically significant(P<0.05).However,after treatment,there was no significant difference in pulmonary function between the two groups ex-cept for the percentage of carbon monoxide diffu-sion in the predicted value(DLCO%pre)(DLCO%pre in the fudosteine group was higher than that in the placebo group).(2)After treatment,the total num-ber of induced sputum cells and neutrophil counts in the fudosteine group were lower than those in the placebo group.Compared with the number of cells in each component at baseline,the total num-ber of induced sputum cells and neutrophil count in the fudosteine group were significantly lower(P<0.05).CONCLUSION:Fudosteine treatment in pa-tients with stable neutrophil-dominated COPD can improve lung function,reduce the total number of induced sputum cells and the total number of neu-trophils,thereby improving airway inflammation.
8.Report of six cases with mast cell leukemia and a literature review
Feng ZHU ; Yuan YU ; Chunyan CHEN ; Wenbing DUAN ; Qian JIANG ; Rui YAN ; Yu SUN ; Yanqiu HAN ; Jing ZHANG ; Huan WANG ; Qiurong ZHANG ; Suning CHEN ; Wanhui YAN ; Mengjie CAI ; Zhibo ZHANG ; Jia YIN ; Qian WANG
Chinese Journal of Internal Medicine 2024;63(10):996-1000
From October 2021 to February 2023, we retrospectively analyzed the clinical and laboratory data of six patients (three male and three female, median age: 54 years, age range: 29-73 years) with mast cell leukemia (MCL) diagnosed in the First Affiliated Hospital of Soochow University (The Mastocytosis Collaborative Network of China). All patients had acute MCL, with at least one C-finding present. The main clinical presentations were hypoalbuminemia ( n=4), fatigue ( n=3), fever ( n=2), abdominal discomfort ( n=2), osteolytic lesions ( n=2), dizziness ( n=1), skin flushing ( n=1), and weight loss ( n=1). Splenomegaly and lymphadenopathy were noted in six and three patients, respectively. Six patients were strongly positive for CD117, five were positive for CD30 and CD25, and four were positive for CD2. Four patients had a normal karyotype and two patients had an abnormal karyotype. Gene mutations were detected in 4/6 cases. The median serum tryptase level was 24.9 (range: 20.1-171.9) μg/L. Two patients were treated with venetoclax and azacitidine for induction (one patient achieved partial remission by combination with afatinib, while there was no remission after combination with dasatinib in the other patient). Two patients did not achieve complete remission despite treatment with cladribine and imatinib, respectively. One patient treated with interferon combined with glucocorticoids was lost to follow-up, and one patient abandoned treatment. The follow-up time ranged from 1.1 to 21.7 months. Three patients died and two survived. Overall, MCL is a rare subtype of systemic mastocytosis with heterogeneous clinical course, and these patients have poor outcome. A better understanding of the clinical characteristics, treatment, and prognosis of MCL is urgently needed.
9.Hepatic arterial infusion chemotherapy combined with carrelizumab and sorafenib for the treatment of advanced hepatocellular carcinoma:its clinical efficacy and safety
Mengjie YIN ; Shouzhong FU ; Feng DAI ; Bin WANG ; Xiaowei WANG ; Wei DING ; Fengchen JIANG ; Jiandong SHEN
Journal of Interventional Radiology 2024;33(11):1212-1217
Objective To discuss the clinical efficacy and safety of hepatic arterial infusion chemotherapy(HAIC)combined with carrelizumab and sorafenib in treating advanced hepatocellular carcinoma(HCC).Methods The clinical data of 36 HCC patients,who were admitted to the Affiliated Nantong Third Hospital of Nantong University of China to receive HAIC combined with carrelizumab and sorafenib from August 2019 to August 2020,were collected.According to modified Response Evaluation Criteria in Solid Tumors(mRECIST),the objective response rate(ORR)and disease control rate(DCR)of the combination therapy were evaluated.The Common Terminology Criteria Adverse Events Version 5.0 developed by American National Cancer Institute was used to evaluate the clinical safety.Results After receiving 4 cycles of FOLFOX-HAIC,the ORR and DCR of the patients were 38.9%and 77.8%respectively.The patients were followed up for 30 months.The median progression-free survival(mPFS)was 306 days(95%CI:242.7-369.3),and the median overall survival(mOS)was 515 days(95%CI:2 482.5-547.5).After HAIC treatment,one patient was successfully changed to surgical operation.The overall incidence of adverse events were 100%.There were 9 adverse events(25%)above grade m,including severe abdominal pain(n=2,5.6%),nausea(n=1,2.8%),vomiting(n=1,2.8%),elevated alanine aminotransferase(n=3,8.3%),elevated aspartate aminotransferase(n=1,2.8%),and death due to pulmonary failure caused by severe immune-induced pneumonia(n=1,2.8%).Conclusion For the treatment of advanced HCC,HAIC combined with carrelizumab and sorafenib has better ORR and DCR with controllable safety,which provides a new option for the treatment of advanced HCC.However,studies with large sample size need to be conducted before its long-term survival benefit of patients can be further validated.
10.Establishment of a method for detecting propofol concentration in plasma and its application in patients with lymphedema
Jingfeng LI ; Zhengyuan SHI ; Mengjie ZHANG ; Lei GUAN ; Dechun JIANG
China Pharmacy 2024;35(4):476-480
OBJECTIVE To establish a method for the determination of propofol concentration in human plasma and apply it in patients with lymphedema. METHODS The concentration of propofol was determined by UPLC-MS/MS after protein precipitation of plasma samples using thymol as internal standard. The sample was eluted on a Kinetex C18 column with a mobile phase consisting of acetonitrile (A)-water (B) for gradient elution at the flow rate of 200 μL/min. The sample size was 5 μL, and the column temperature was set at 40 ℃. The sample chamber temperature was 15 ℃. Using multi-reaction monitoring mode, the ion pairs for quantitative analysis were m/z 177.0→161.2 (propofol) and m/z 149.0→133.1 (internal standard), respectively. The above method was used to determine the plasma concentration of propofol in 6 patients with lymphedema. RESULTS The linear range of propofol was 50-5 000 ng/mL (r=0.995 0). RSDs of within- and between-batch precision were not more than 8.08%; no endogenous interference, carryover effect, or dilution effect was observed in blank plasma. The extraction recovery ranged from 89.80% to 93.73%, and matrix effects were within the range of 97.93%-101.73%. RSDs of the stability test were all lower than 3.27%. During intraoperative TCI 2-30 min, the plasma concentration of propofol in 6 patients was maintained in the range of 1 865.3-6 056.2 ng/mL, and the propofol was almost excreted within 4-8 h after operation. CONCLUSIONS The established UPLC-MS/MS method in this study can achieve the determination of propofol and a simple and fast sample pretreatment process without derivatization; it is proved to be suitable for the concentration monitoring of propofol in plasma samples of patients with lymphedema.

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