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Guaranteeing the rights and safety of subjects is an important responsibility of all participants in the medical devices clinical trial, including medical institutions, sponsors and researchers. The legal disputes caused by serious adverse events in the clinical trial of medical devices are characterized by complex legal relationships, great difficulty in handling, and many points of dispute. Based on a typical case of medical device clinical trials, this paper discussed the litigation subject qualification, the treatment of contract breach and tort in medical device clinical trial, analyzed the responsibility of different subjects, and provided constructive suggestions on the risk management of medical device clinical trial.
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Objective:To explore the association between serum high density lipoprotein subtype 3 cholesterol (HDL3-C) levels and the severity and in-stent restenosis of patients with coronary artery disease.Methods:124 patients with coronary artery diseases and 62 healthy controls were included in this clinical case-control retrospective study. Participants were hospitalized from November 2020 to November 2021 at Jinling Hospital, Medical School of Nanjing University were enrolled. Patients with coronary artery disease were as follows: 28 patients with acute coronary syndrome and 96 patients with stable coronary heart disease. Serum HDL3-C levels as well as total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) levels were determined. According to the coronary artery angiography results of all patients at the time of admission, Gensini scores were calculated and patients were divided into in-stent restenosis group ( n=22), no in-stent stenosis group ( n=23) and non-stent implantation group ( n=79). The correlation between HDL3-C levels and other parameters was analyzed by Pearson or Spearman correlation analyses. Multivariate Logistic regression analyses were used to determine the impact of HDL3-C on the in-stent restenosis of coronary artery diseases. Results:Compared with controls, serum levels of HDL3-C and HDL-C were significantly decreased in patients with coronary artery diseases (all P<0.05). There was a significantly negative correlation between HDL3-C levels and Gensini scores ( r=-0.201, P=0.043). Among patients with coronary artery disease, serum levels of HDL3C, TC and TG in the in-stent restenosis group were significantly lower than in no in-stent stenosis group as well as than in the non-stent implantation group (all P<0.05). Multivariate Logistic regression analyses showed that after adjusting for age, sex, lipid-lowering drugs and TC, TG, LDLC parameters, HDL3-C ( OR=0.885, 95% CI 0.791-0.990, P=0.033) and HDL-C ( OR=0.018, 95% CI 0.001-0.426, P=0.013) levels were both independently associated with the occurrence of coronary artery disease; only HDL3-C levels (no in-stent stenosis group as the reference: OR=0.833, 95% CI 0.698-0.994, P=0.042; non-stent implantation group as the reference: OR=0.812, 95% CI 0.685-0.963, P=0.017) were independently associated with the presence of in-stent restenosis ( P<0.05). Conclusions:Serum HDL3-C levels are decreased in patients with coronary artery disease, especially in patients with in-stent restenosis. HDL3-C levels are associated with the severity of coronary artery lesions and the presence of in-stent restenosis of coronary arteries.
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Objective:To investigate the clinical efficacy of amoxicillin combined with metronidazole in the treatment of peri-implantitis and its effect on serum matrix metalloproteinase-8 (MMP-8), tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) levels.Methods:Sixty-four patients with peri-implantitis who received treatment from January 2017 to December 2019 in Xiasha Hospital, SiR Run Run Shaw Hospital, Zhejiang University School of Medicine were included in this study. They were randomly assigned to receive treatment with metronidazole (control group, n = 32) or amoxicillin combined with metronidazole (observation group, n = 32). Clinical efficacy, periodontal pocket depth (PD), clinical attachment level (CAL), sulcus bleeding index (SBI), plaque index (PLI), matrix metalloproteinase-8 (MMP-8), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) levels and the incidence of adverse reactions were compared between the control and observation groups. PD, CAL, SBI and PLI were correlated with MMP-8, TNF-α and IL-1β levels. Results:The clinical efficacy in the observation group was significantly higher than that in the control group [93.75% (30/32) vs. 75.00% (24/32), χ2 = 4.267, P < 0.05]. After treatment, PD [(3.02 ± 0.24) mm], CAL [(1.70 ± 0.14) mm], SBI [(11.54 ± 3.26)%], PLI (0.87 ± 0.11) in the observation group were significantly lower than those in the control group [(4.47 ± 1.37) mm, (3.77 ± 1.06) mm, (18.84 ± 5.11)%, (1.12 ± 0.15), t = 5.897, 10.952, 6.813, 7.603, all P < 0.01]. After treatment, serum MMP-8 [(0.78 ± 0.23) μg/L], TNF-α [(71.24 ± 10.33) μg/L], IL-1β [(1.20 ± 0.14) μg/L] levels in the observation group were significantly lower compared with the control group [(1.12 ± 0.35) μg/L, (113.28 ± 15.73) μg/L, (2.55 ± 1.02) μg/L, t = 4.592, 12.637, 7.417, all P < 0.01]. Spearman correlation coefficient analysis showed that PD, CAL, SBI and PLI were positively correlated with serum MMP-8, TNF-α and IL-1β levels (all P < 0.01). Conclusion:Amoxicillin combined with metronidazole is highly effective in the treatment of peri-implantitis because it can promote plaque regression, reduce inflammatory reaction, and has a certain clinical promotion value.
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Objective:To explore the predictive value of fractional excretion of IgG (FE IgG) on drug responsiveness and remission in patients with idiopathic membranous nephropathy (IMN).Methods:Retrospective analysis of 82 patients with IMN diagnosed by clinical and pathological data and regularly followed up from April 2014 to August 2017. Receiver operating characteristic (ROC) curve was used to determine the FE IgG threshold. Comparing the difference of remission time under different baseline levels of FE IgG, and analyzing the effect of different levels of FE IgG on the drug responsiveness of immunosuppressive therapy (tacrolimus or cyclophosphamide) and supportive therapy.Results:Areas under the curve (AUC) of estimated glomerular filtration rate (eGFR), 24-hour urinary protein quantity and FE IgG were 0.509, 0.701 and 0.948, respectively. Before treatment, there was no significant difference in gender, age, mean arterial pressure and eGFR between the high FE IgG group (FE IgG>0.029) and low FE IgG group (FE IgG<0.029) ( P>0.05). The remission time of high FE IgG group was (18.75±6.81)months, while it was (8.46±3.74)months in low FE IgG group, with significant difference ( P<0.01). There was no difference in remission time of immunosuppressive therapy and supportive therapy in low FE IgG group ( P=0.265), bo-th of which were lower than the high-level immunosuppressive therapy group ( P<0.001). The remission time of tacrolimus was shorter than that of cyclophosphamide in high FE IgG group, but with no significant difference ( P=0.131). There was significant difference in the remission time of tacrolimus between the high and low level groups of FE IgG ( P<0.01). Under electron microscope, the ratio of foot process fusion and podocyte diffuse vacuolar degeneration in the high level group of FE IgG was higher than that in the low level group ( P<0.01). Conclusions:FE IgG can be used as a clinical indicator for predicting drug responsiveness and remission in patients with IMN, and is essential for early identification of high-risk patients and for making clinical decisions. Patients with high FE-IgG may benefit from early initiation of immunosuppressive therapy.
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[Objective]To study doctor LEI Feng's life story from Zhejiang Province in late Qing Dynasty from the point of view of the social history. [Methods]With the research methods of history and philology, collect relevant historical materials, to study LEI Feng 's life story from the view of social history. [Results]LEI Feng was born in the nineteenth year of the Daoguang Emperor of the Qing Dynasty(1839), died in the fourteenth year of the Guangxu Emperor of the Qing Dynasty(1888), at the age of 49. LEI Feng had a daughter named GONG Yuyun(about 1870-1899), a son named LEI Dazheng(?-1899), two students named ChENG Xi and JIANG Cheng, LEI Feng's father named LEI Huanran(?-about 1862), LEI Huanran's medical teacher was CHENG Zhitian. [Conclusion]LEI's medical family in Quzhou city of Zhejiang Province inherited from father to son and teacher to student, they both had their own medical literatures, the academic origin of LEI's medical family was Xin'an medicine;though LEI Feng called himself an ordinary person, he was good at writing poem, calligraphy and painting even music, he played a special role in traditional Chinese medicine 's social history.
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It has always been considered that() printed byis the earliest version. In comparative study, it is found that there are two versions in thedynasty, one is the original, stored in the Library of China Academy of Sciences and another one is the revision, stored in the Library of Tianjin University of TCM, Zhejiang Provincial Library and the Library of China Academy of Chinese Medical Sciences. The last item, Chengjiang (CV 24) in thein volume 7 is included in the revised edition, but not covered in the original one, which is the difference between the two versions. Both of the versions were in thedynasty, rather than the block-printed one in thedynasty.
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Objective To investigate immunological changes in the serum of elderly patients with primary nephrotic syndrome (PNS).Methods We made a retrospective analysis of clinically relevant immunological parameters and pathological data of PNS patients 60 years old and above (elderly group)in our hospital for kidney biopsy between September 2010 and November 2013.The data of similar patients but younger than 60 years old (control group)were collected for comparison.Results ① The average levels of IgG in serum of the two groups were both lower than the normal level.And the patients with a decreased level accounted for 59.3% in the elderly group and 78.2% in the control group.The results exhibited a significant difference (P 0.05).③ IgG had a negative correlation with urinary protein and cholesterol in serum (the values of r were-0.107,-0.238,respectively,P <0.05).However,there was a positive correlation between IgG and albumin (r=0.252,P <0.05).The results in both groups were consistent.④ Membranous nephropathy was the most common pathological type in aged patients while in control group IgA nephropathy was the most common.Conclusion ① The level of IgG in the serum decreases in most aged patients with PNC.The serum IgA and IgG/IgM ratio are elevated while concentrations of C3 and C4 change little.②The change of IgG is correlated with urinary protein, serum albumin and cholesterol in aged patients with PNS.