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Under the national policy background of traditional Chinese medicine（TCM）registration review and approval reform， TCM preparations in medical institutions（hereinafter referred to as medical institution preparations） have human use experience， conform to the characteristics of TCM clinical practice， and have advantages in the research and development of innovative Chinese medicines. Therefore， the research and development mode based on clinical experience prescription-medical institution preparations-innovative Chinese medicines has attracted widespread attention from the industry. However， in the process of development and use of medical institution preparations， there are generally clinical problems that restrict their transformation into innovative Chinese medicines， resulting in a relatively weak collection basis of human use experience and insufficient clinical evidence for supporting the research and development of new TCM medicines. In this paper， on the basis of sorting out the supporting regulations and relevant technical requirements of human use experience， and analyzing the clinical problems restricting the transformation of medical institution preparations， it provides suggestions for medical institutions to carry out high-quality research on human use experience of preparations in the process of TCM clinical practice from the aspects of continuously exploring clinical value， improving the construction of information system， focusing on the TCM clinical practice and giving full play to the advantages of discipline cooperation. By realizing the whole life cycle management of medical institution preparations based on three-combination evaluation evidence system， we can promote the transformation of medical institution preparations into innovative Chinese medicines.
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Objective:To investigate the risk factors of infarct growth rate of elderly acute ischemic stroke(AIS)patients with endovascular treatment(EVT)and its influence on prognosis.Methods:Elderly AIS patients who underwent EVT at Beijing hospital from June 2016 to October 2020 were retrospectively included.Infarct growth rate(ml/h)=infarct core volume(ml)/time from stroke onset to CTP examination(h).Based on the rate of infarct growth and the patient's clinical severity, ROC curve was established, and the cut-off value of the ROC curve was obtained.By the cut-off value of the rate of infarct growth, the patients were divided into cerebral infarct slow-growth group and rapid-growth group.Predictors of rapid growth in infarct were analyzed by univariate and multivariate analysis.The patients were divided into good prognosis group(mRS score 0-2)and poor prognosis group(mRS score 3-6)according to the mRS score at the day 90 and the predictors of poor prognosis were analyzed separately.Results:A total of 67 elderly AIS patients were included with age ranging from 65-96 years and an average of(78.8±7.6)years.(1)The cut-off value of the optimal infarct growth rate for patients with good and poor prognosis was 8.89 ml/h.The patients were divided into fast-growth group(26 patients)and slow-growth group(41 patients)according the cut-off value.(2)Multivariate logistic regression showed that only poor collateral circulation was an independent predictor for fast infarct growth( OR=0.162, 95% CI: 0.053-0.489).(3)Faster infarct growth rate( OR=1.173, 95% CI: 1.044-1.318)and high NIHSS score( OR=1.146, 95% CI: 1.018-1.291)were predictors of poor prognosis. Conclusions:Collateral circulation status is a major influencing factor for the infarct growth rate, and a faster infarct growth rate is a predictor of poor prognosis for elderly AIS patients after endovascular treatment.
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Objective:To serially characterize the myocardial perfusion, myocardial hibernation and left ventricular (LV) function as well as LV remodeling in progressive coronary artery stenosis in Chinese mini-pigs.Methods:In 8 Chinese mini-pigs (5 males, 3 females; age: 10 months), chronic progression of coronary stenosis and finally occlusion was established using Ameroid constrictor implantation at the 1 cm below the bifurcation of the first diagonal branch of the left anterior descending (LAD) artery. Serial gated 99Tc m-methoxyisobutylisonitrile(MIBI) SPECT/CT, gated 18F-FDG PET/CT imaging and coronary angiography (CAG) were performed before surgery and at the 1st, 4th and 8th week after surgery. Longitudinally, total perfusion defect (TPD), LV ejection fraction (LVEF), LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), summed motion score (SMS), summed thickening score (STS) and hibernating myocardium (HM) were analyzed. Repeated measures analysis of variance, Kruskal-Wallis rank sum test and Bonferroni correction method were used to analyze data. Results:One mini-pig died of infection after the Ameroid constrictor implantation. In the remaining 7 mini-pigs, TPD was progressively increased with time prolonged (0, 12.0%(0, 33.0%), (41.1±23.7)% and (49.3±24.5)%; H=17.03, P=0.001); Compared with HM before the surgery (100%), HM was gradually reduced from the 1st (21.0%(6.0%, 100%)) to the 4th (18.0%(3.0%, 33.0%)) week after surgery, and then increased to the 8th week after surgery ((23.0±15.4)%; H=13.09, P=0.004), but there was no significant difference between the 1st and 4th week, or between the 4th and 8th week after surgery (both P>0.05 (Bonferroni correction method)). Accordingly, LVEF gradually decreased ((73.7±8.4)%, (63.7±19.1)%, (53.7±14.6)% and (49.9±15.4)%; F=6.22, P=0.004). LVEDV (9.0(6.0, 21.0), (31.4±16.3), (32.9±17.4) and (36.4±17.5) ml; H=8.58, P=0.035)and LVESV ((3.8±3.2), (15.9±15.3), 12.0(10.0, 17.0)and (19.3±10.9) ml; H=10.51, P=0.015) gradually increased. SMS and STS continuously increased as well ( H values: 16.49, 13.33, P values: 0.001, 0.004). Conclusions:With the progression of coronary artery stenosis to occlusion, myocardial perfusion is gradually decreased, while the global and regional LV function, LV remodeling are gradually aggravated, and HM is gradually reduced. After the chronic coronary artery occlusion, myocardial perfusion has a trend to be improved and HM is gradually recovered.
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Objective:To assess the value of 4-dimensional CT angiography (4D CTA) to predict hemorrhagic transformation (HT) with a new nomogram model in acute ischemic stroke (AIS) patients after endovascular treatment (EVT).Methods:Imaging and clinical data of 101 AIS patients with internal carotid artery and/or middle cerebral artery occlusion who underwent "one-stop" CTA-CT perfusion and EVT in green channel of Beijing Hospital from March 2016 to November 2020 were analyzed retrospectively. The patients were divided into HT group (45 patients) and non-HT group (56 patients). Multivariate logistic regression analysis was used to select relevant clinical and imaging variables, such as age, initial National Institute of Health stroke scale (NIHSS) score, 4D CTA collateral circulation score, Alberta stroke program early CT score (ASPECTS), clot burden score, and a predictive nomogram model were developed. The receiver operating characteristic (ROC) curve and area under the curve (AUC) were used to evaluate the efficacy of predictive nomogram model for diagnosing HT.Results:Univariate analysis showed that there were significant difference of age[79.00(68.00, 85.00) years, 73.00(62.75, 80.00) years, Z=-2.20, P=0.028], NIHSS score [16.00(12.00, 21.00), 9.50(6.00, 14.00), Z=-4.44, P<0.001], ASPECTS score [5.00(3.00, 8.00), 8.00(7.00, 9.00), Z=-4.23, P<0.001], 4D CTA collateral circulation score [2.00(0, 3.00), 3.00(3.00, 4.00), Z=-5.39, P<0.001], clot burden score [4.00(1.00, 7.00), 7.50(6.00, 9.00), Z=-3.42, P=0.001], location of the occlusion(internal carotid artery/middle cerebral artery occlusion was 23/22, 11/45 cases, χ2=9.70, P=0.002), and atrial fibrillation (27 and 19 cases respectively, χ2=5.83, P=0.016) between HT group and non-HT group. Multivariate logistic regression analysis showed that ASPECTS score (OR=0.64, 95%CI 0.47-0.87), NIHSS score (OR=1.13, 95%CI 1.01-1.26), 4D CTA collateral circulation score (OR=0.40,95%CI 0.22-0.76) were independent predictors of HT in AIS patients ( P<0.05). The AUC of the nomogram based on the ASPECTS score, NIHSS score and 4D CTA collateral circulation score to predict HT of AIS patients was 0.876 (95%CI 0.807-0.945), with a sensitivity of 77.8% and specificity of 87.5%. Conclusions:Patients with low ASPECTS score, high NIHSS score and low 4D CTA collateral circulation score have a higher risk of HT after EVT. The nomogram model may predict the probability of HT of AIS patients and provide effective assistance for clinical decision-making.
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Objective:To compare the clinical effects between cannulated screwing and plating in combination with interlocking intramedullary nailing for the treatment of ipsilateral discontinuous fractures of the tibial shaft and plateau.Methods:A retrospective analysis was performed of the clinical data of 34 patients who had been treated for ipsilateral discontinuous fractures of the tibial shaft and plateau at Department of Orthopedics and Trauma, Honghui Hospital Affiliated to Xi′an Jiaotong University from January 2015 to January 2020. There were 17 males and 17 females, aged from 26 to 60 years (average, of 43.6 years). The left side was affected in 18 cases and the right side in 16. The patients were divided into 2 groups according to their internal fixation methods: a cannulated screw group of 16 cases treated with cannulated screwing and intramedullary nailing and a plate group of 18 cases treated with plating and intramedullary nailing. The 2 groups were compared in terms of operation time, intraoperative blood loss, incision length, tibial plateau collapse, consumables cost, hospital stay, fracture healing time, weight-bearing time, range of knee motion, reduction of tibial plateau fracture by Rasmussen radiology, Lysholm knee function score at the last follow-up and complications.Results:There was no significant difference in the preoperative general data between the 2 groups, showing the 2 groups were comparable ( P>0.05). All the 34 patients were followed up for 12 to 28 months (average, 17.4 months). There was no significant difference either in operation time, hospital stay, tibial plateau healing time, tibial fracture healing time, weight-bearing time or range of knee motion between the 2 groups ( P>0.05). In the cannulated screw group, the intraoperative blood loss [(89.4 ± 14.5) mL] and consumables cost [(2.0 ± 0.2) ten thousand yuan] were significantly less than those in the plate group [(120.8 ± 22.1) mL and (2.6 ± 0.4) ten thousand yuan], the incision length [(4.1 ± 0.8) cm] was significantly shorter than that in the plate group [(7.1 ± 0.9) cm], and the Lysholm knee function score at the last follow-up [(89.8 ± 4.5) points] was significantly lower than that in the plate group [(93.0 ± 4.2 points] (all P<0.05). The difference was statistically significant between the 2 groups in the quality of tibial plateau reduction ( P<0.05). The postoperative tibial plateau collapse in the plate group [0.5 (0, 2) mm] was insignificantly less than that in the cannulated screw group [1.0 (0, 2) mm] ( P>0.05). In the cannulated screw group, one tibial shaft fracture did not achieve union after operation and deep vein thrombosis occurred in 2 cases after operation; in the plate group, 2 cases suffered from delayed wound healing, one from delayed fracture healing, one from deep venous thrombosis of lower extremity, and one from knee discomfort which was relieved after removal of internal fixation. Conclusions:In the treatment of ipsilateral discontinuous fractures of tibial shaft and plateau, both cannulated screwing and plating in combination with interlocking intramedullary nailing can achieve good clinical effects. Although plating in combination with intramedullary nailing lead to more severe trauma and higher costs, it is conducive to improving the reduction quality of the tibial plateau and postoperative functional recovery of the knee joint.
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At present, vitreoretinal surgery has gradually entered the era of minimally invasive surgery, and high-speed vitrectomy, micro-incision approach and wide-angle illumination have also pushed it to a higher level. Minimally invasive vitreoretinal surgery has become one of the key and difficult points in the teaching of ophthalmic microsurgery. The three-dimensional (3D) surgical display system can provide high-resolution, multi-level magnification, and stereoscopic images for surgery teachers and multiple observers at the same time, breaking the traditional "one-to-one" teaching of the main surgeon and assistant mirrors, realizing "one-to-more" and "head-up" surgery teaching, and thereby improving the teaching effect of vitreoretinal surgery.
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ObjectiveTo identify Dendrobium flexicaule and its related species， and analyze the differences in polysaccharide composition and D-mannose content， so as to provide theoretical basis for the accurate identification and quality control of Dendrobium medicinal materials. MethodNine samples of Dendrobium （S1-S9） were identified by DNA barcoding and infrared spectroscopy， and the contents of polysaccharides and D-mannose were determined by ultraviolet spectrophotometry （UV） and high performance liquid chromatography （HPLC）， respectively. UV detection condition was 488 nm， HPLC detection conditions were the mobile phase of 20 mmol·L-1 ammonium acetate solution-acetonitrile （81.5∶18.5） and the detection wavelength at 250 nm. ResultDNA barcoding results showed that samples S1-S3 were D. nobile， samples S4-S5 were D. officinale， sample S6 was D. huoshanense， and S7-S9 were D. flexicaule. One-dimensional infrared spectroscopy showed that only D. nobile had stable characteristics at the wavenumber of 1 570-1 467 cm-1， showing a "W" shape， while no absorption peak was found at the wavenumber of 842-740 cm-1， but the other Dendrobium samples had stable absorption peaks at the wavenumber of 842-740 cm-1. In the first derivative spectrum， at the wavenumber of 785 cm-1， D. huoshanense presented a "V" shape， while the rest of Dendrobium presented a "W" shape. At the wavenumber of 1 110 cm-1， D. flexicaule had a stable characteristic peak. In the second derivative spectrum， at the wavenumber of 1 125 cm-1， D. officinale presented an "M" shape， and the rest of Dendrobium was approximately "W" shape. The results of determination showed that the contents of polysaccharides in samples S1-S9 were 9.35%， 9.12%， 32.78%， 49.38%， 48.97%， 32.48%， 32.95%， 39.41% and 25.32%， and their contents of D-mannose were 1.39%， 0.47%， 13.57%， 3.04%， 33.85%， 23.57%， 16.64%， 17.47% and 19.49%， respectively. Among them， D. flexicaule had high polysaccharide and D-mannose contents. ConclusionBoth DNA barcoding and infrared spectroscopy can be used to identify D. flexicaule and its related species， and infrared spectroscopy is cost-effective and easy to operate. At the same time， D. flexicaule has high contents of polysaccharides and D-mannose， which can provide a scientific basis for rapid identification of D. flexicaule and its relatives， and provides a reference for its quality control， and resource development and utilization.
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AIM: Meta-analysis was performed to systematically evaluate the macular vessel density(VD)and foveal avascular zone(FAZ)areas in patients with no diabetic retinopathy(NDR)by using optical coherence tomography angiography(OCTA). This study aimed to investigate the microcirculatory characteristics of the retina in the early stage of diabetes.METHODS: PubMed, Embase, Web of Science and Cochrane Library databases were searched for publications from 1 January, 2011 to 5 January, 2021 on OCTA analysis of VD in different regions of the macular area in diabetic patients with NDR. Compare the differences in the superficial parafoveal VD(spafVD), superficial perifoveal VD(spefVD), deep parafoveal VD(dpafVD), deep perifoveal vessel density(dpefVD), superficial FAZ area and best corrected visual acuity(BCVA)between NDR group and the normal control group(healthy population matched for the age at the same time and gender with patients in the NDR group).RESULTS: Thirteen publications with a total of 1 227 eyes(558 eyes in normal control group and 669 eyes in NDR group)were included in the study. Meta-analysis showed that compared with the control group, NDR group displayed a significant decrease in spafVD(MD=-1.90, 95%CI: -2.43--1.37, P<0.00001), spefVD(MD=-1.29, 95%CI: -2.14--0.44, P=0.003), dpafVD(MD=-2.18, 95%CI: -2.69--1.67, P<0.00001)and dpefVD(MD=-2.37, 95%CI: -3.27--1.46, P<0.00001), with a more significant reduction in dpefVD, and superficial FAZ area(MD=0.04, 95%CI: 0.03-0.06, P<0.00001)was increased. There was no difference in BCVA(MD=0.00, 95%CI: -0.01-0.02, P=0.44)between the two groups.CONCLUSION:Capillary injury in the deep perifoveal region of the macular area is the earliest manifestation of retinal microcirculation disturbance in diabetic patients, and is also a key indicator for clinical follow-up of diabetic retinopathy.
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Objective:To assess the prognostic value of the collateral status and clot burden score based on four-dimensional computed tomography angiography(4D CTA)in anteriorcir culation is chemics troke patients with large ischemic core after endovascular treatment.Methods:Clinical and imaging data of 36 anterior circulation ischemic stroke patients with large infarct core (infarct core≥50.0 ml) after endovascular treatment at our institution from March 2016 to September 2020 were retrospectively reviewed. According to the modified Rankin Scale (mRS) score, patients were divided into the good outcome (mRS score 0-2) and poor outcome (mRS score 3-6) groups. Mann-Whitney U and Fisher tests were used to compare the 4D CTA collateral circulation score, clot burden score, and baseline clinical data between the good and poor outcome groups. Multivariate logistic regression was used to analyze the risk factors associated with the poor outcome (mRS score 3-6) and mortality in patients with large infarct core stroke. Finally, based on the 90-day outcome, a ROC curve was used to obtain the cut-off values for poor prognosis (mRS 3-6) and death, respectively. Results:Ten patients (27.8%) had good outcome and 26 (72.2%) had poor outcome. The patients in the poor outcome group had older median age, higher blood glucose, lower 4D CTA collateral circulation score, lower clot burden score, larger infarct core volume, and higher hemorrhagic transformation and brain hernia (all P<0.05). Multivariate logistic regression showed that the poor collateral circulation score on 4D CTA( OR=0.18, 95% CI: 0.03-0.99, P<0.05)and clot burden score( OR=0.64, 95% CI: 0.44-0.93, P<0.05) were independent predictors of the poor prognosis. The ROC curves revealed that the cut-off value of infarct core for distinguishing between good prognosis and poor prognosis was 63.7 ml, while that for distinguishing between survival and death was 130.3 ml. Conclusions:Endovascular treatment may improve the prognosis of patients with large infarct core of anterior circulation is chemic stroke if the patients have good 4D CTA collateral circulation score and high clot burden score.
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Objective:To investigate the effects of mycophenolate mofetil combined with prednisone and hydroxychloroquine on immune function, renal function, erythrocyte sedimentation rate and C-reactive protein in patients with systemic lupus erythematosus.Methods:A total of 64 patients with systemic lupus erythematosus who received treatment in Zhoushan Hospital from March 2018 to March 2021 were included in this study. These patients were divided into control and observation groups according to different treatment drugs. The control group ( n = 33) was given prednisone and hydroxychloroquine treatment. The observation group ( n = 31) was given mycophenolate mofetil treatment based on prednisone and hydroxychloroquine treatment. Before and after treatment, the number of T cell subsets, renal function, erythrocyte sedimentation rate and C-reactive protein level were determined in each group. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) was compared between the two groups. Results:Before and after treatment, there was no significant difference in CD 3+ cells between the two groups [control group: (58.23 ± 9.74)%, (59.12 ± 10.59)%; observation group: (57.33 ± 10.27)%, (58.85 ± 9.74)%, t = -0.34, -0.60, both P > 0.05]. After treatment, CD 4+ cells and CD 4+/CD 8+ cells in each group were significantly increased compared with those before treatment (both P < 0.05). After treatment, CD 4+ cells and CD 4+/CD 8+ cells in the observation group were significantly higher than those in the control group [(34.11 ± 5.37)% vs. (30.95 ± 6.65)%, (1.42 ± 0.33) vs. (1.23 ± 0.33), t = -2.08, -2.30, both P < 0.05]. After treatment, serum creatinine, urea nitrogen and 24-hour urine protein in each group were significantly decreased compared with those before treatment (all P < 0.05). After treatment, serum creatinine, urea nitrogen and 24-hour urine protein in the observation group were significantly lower than those in the control group [(65.36 ± 16.28) μmol/L vs. (91.88 ± 18.74) μmol/L, (5.19 ± 0.94) mmol/L vs. (8.57 ± 1.27) mmol/L, (0.12 ± 0.04) g/L vs. (0.22 ± 0.06) g/L, t = -6.02, -12.03, -7.79, all P < 0.05]. After treatment, erythrocyte sedimentation rate in each group was significantly decreased compared with that before treatment (both P < 0.05). After treatment, erythrocyte sedimentation rate in the observation group was significantly lower than that in the control group [(26.36 ± 11.29) mm/h vs. (39.89 ± 13.74) mm/h, t = -4.28, P < 0.05]. After treatment, C-reactive protein level in each group was significantly decreased compared with that before treatment (both P < 0.05), and C-reactive protein level in the observation group was significantly lower than that in the control group [(7.52 ± 3.23) mg/L vs. (12.83 ± 5.72) mg/L, t = -4.53, P < 0.05]. After treatment, SLEDAI in each group was significantly decreased compared with that before treatment (both P < 0.05), and SLEDAI in the observation group was significantly lower than that in the control group [(5.52 ± 1.25) points vs. (8.25 ± 2.42) points, t = -5.61, P < 0.05]. Conclusion:Mycophenolate mofetil combined with prednisone and hydroxychloroquine for systemic lupus erythematosus can improve patient's immune function and renal function, reduce the body's inflammatory response, and better lower disease activity.
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Objective:To compare the efficacy of double mini locking plate and anatomical locking plate in the treatment of comminuted olecranon fracture.Methods:The clinical data of 46 patients who underwent comminuted olecranon fracture in the Xi′an Honghui Hospital Affiliated to Xi′an Jiaotong University from March 2017 to May 2020 were analyzed retrospectively. Among them, 21 cases were treated with double mini locking plate (double plate group) and 25 cases with anatomical locking plate (single plate group). The operation time, patient satisfaction, range of motion, return to work time, soft tissue stimulation to remove internal fixation, Mayo elbow performance score (MEPS), disabilities of arm, shoulder and hand score (DASH) of the two fixation methods were statistically compared. Measurement data with normal distribution were represented as ( ± s), and comparison between groups was conducted using the t test. Comparison between groups of count data was conducted using the chi-square test or Fisher exact probability. Results:All 46 patients were followed up for to (19.17±2.79) months. All fractures healed after operation. There was no significant difference in operation time, range of motion, patient satisfaction, MEPS and DASH scores among the two groups( P>0.05). The time of returning to work was (8.47±2.13) weeks in the double plate group and (9.78±1.98) weeks in the single plate group, and the difference was statistically significant ( P< 0.05). There were 9 cases of internal fixation due to soft tissue stimulation, 1 cases in double plate group and 8 cases in single plate group, and the difference was statistically significant ( P<0.05). Conclusions:Compared with anatomical locking plate, the treatment of olecranon fracture with double mini locking plate can effectively reduce soft tissue stimulation and promote patients to return to work early, and the operation time is not significantly prolonged, and the biomechanical advantage is obvious, the clinical effect is satisfactory and the postoperative function is good, so it is an effective treatment.
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Objective:To compare the early clinical efficacy between reaming after distal tibia cortical fenestration combined with antibiotic-loaded calcium sulphate and trench grooving combined with polymethyl methacrylate (PMMA) for the treatment of chronic tibial osteomyelitis after intramedullary nail fixation.Methods:A retrospective analysis was conducted in the 20 patients who had been surgically treated for chronic tibial osteomyelitis after intramedullary nail fixation at Department of Trauma Orthopaedics, Honghui Hospital from January 2019 to January 2021. According to the surgical methods, they were divided into a reaming group and a grooving group. In the reaming group, there were 6 males and 3 females with an age of (47.6±11.4) years; in the grooving group, there were 9 males and 2 females with an age of (49.2±13.9) years. The 2 groups were compared in terms of duration of infection, operation time, intraoperative blood loss, bacterial culture results, total hospital stay, time for inflammatory indexes to return to normal, time for weight-bearing, complication rate, infection control rate, and good to excellent rate by Johner-Wruhs joint function scoring.Results:There was no significant difference in the preoperative general data between the 2 groups, showing they were comparable ( P > 0.05). All patients were followed up for 12 to 25 months after operation. There were no significant differences in the duration of infection, operation time, intraoperative blood loss, bacterial culture results, time for inflammatory indexes to return to normal, complication rate, infection control rate, or Johner-Wruhs scoring between the 2 groups ( P > 0.05). The total hospital stay [(11.7 ± 4.7) d] and weight-bearing time [(5.8 ± 1.6) weeks] for the reaming group were significantly shorter than those for the grooving group [(16.8 ± 4.6) d and (8.1 ± 2.9) weeks] ( P < 0.05). Conclusion:In the treatment of chronic tibial osteomyelitis after intramedullary nail fixation, compared with conventional trench grooving combined with PMMA, reaming after distal tibia cortical fenestration combined with antibiotic-loaded calcium sulphate can not only obtain satisfactory outcomes by infection control but also shorten the treatment cycle by allowing the patients to start early weight bearing.
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Objective To investigate the clinical features and autoantibody characteristics of patients with drug-induced liver injury (DILI). Methods A retrospective analysis was performed for the patients with abnormal liver function who were admitted to Beijing Ditan Hospital, Capital Medical University, from September 2014 to September 2018 and were diagnosed with DILI based on RUCAM score, and related data on admission were collected, including baseline liver function, renal function, routine blood test results, five immune indices, autoantibody, and liver biopsy results. The t -test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used to compare the detection rate of autoantibody between the patients with different sexes or types of liver injury. A logistic regression analysis was used to investigate whether autoantibody had a regression relationship with sex, age, and type of injury, and an ordinal logistic regression analysis was performed with baseline laboratory results as independent variables and anti-nuclear antibody (ANA) titer as the dependent variable. Results A total of 419 patients with DILI were enrolled in the study, with a median age of 47 (35-55) years, among whom male patients accounted for 32.5% (136/419) and female patients accounted for 67.5% (283/419). Among these 419 patients, 88 (21.5%) had hepatocellular-type liver injury, 87 (21.2%) had mixed-type liver injury, and 235 (57.3%) had cholestasis-type liver injury. The detection rate of autoantibodies was 50.6% (212/419), and the detection rate of ANA was 42.9% (180/419), with a titer of mainly 1∶ 100 (104/180). There was no significant difference in the detection rate of autoantibodies between the patients with different sexes ( χ 2 =2.658, P =0.103) or different types of injury ( χ 2 =0.859, P =0.651). The binary logistic regression analysis showed that autoantibody did not have a regression relationship with sex, age, and type of injury (all P > 0.05) There were significant differences in prothrombin time activity (PTA) and international normalized ratio (INR) between the positive autoantibody group and the negative autoantibody group ( t =2.161, P =0.031; Z =-3.010, P =0.003). The ordinal logistic regression analysis showed that INR (odds ratio [ OR ]=3.101, P =0.040) and IgG ( OR =1.043, P =0.014) were associated with ANA grade. Conclusion There is a relatively high detection rate of autoantibodies in patients with DILI, and the detection rate of autoantibodies is not associated with sex, age, or type of injury. There are differences in PTA and INR between autoantibody-positive patients and autoantibody-negative patients, and the levels of INR and IgG are correlated with antibody titer.
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Objective:To study the influence of anticoagulation timing on incidence of perioperative deep venous thrombosis (DVT) in elderly patients with hip fracture.Methods:A retrospective analysis was made of the 179 elderly patients with hip fracture who had been admitted to Department of Orthopedics and Traumaology, Hong-Hui Hospital from July 2017 to December 2018. They were 78 males and 101 females, aged from 62 to 91 years (mean, 79.5 years). There were 79 femoral neck fractures and 100 intertrochanteric fractures, 109 of which were treated by internal fixation and 70 by hip replacement. The patients were divided into 3 groups depending on the timing of anticoagulation after injury. In group 1 of 74 cases, anticoagulation started <24 h after injury; in group 2 of 36 cases, anticoagulation started 24 to 48 h after injury; in group 3 of 69 cases, anticoagulation started >48 h after injury. Anticoagulation continued until 12 h before surgery in all patients but was resumed 8 to 12 h after surgery. The 3 groups were compared in incidence of perioperative DVT.Results:The 3 groups were comparable due to insignificant differences between them in their pre-operative general data ( P>0.05). DVT occurred perioperatively in 84 patients, yielding an incidence of 46.9% (84/179). The incidences of perioperative DVT were 27.0% (20/74), 47.2% (17/36) and 68.1% (47/69) in groups 1, 2 and 3, respectively, showing significant differences ( χ2=24.206, P<0.001), between any 2 groups ( P<0.05). Conclusion:Since the earlier anticoagulation starts after injury the lower incidence of perioperative DVT in elderly patients with hip fracture, early standardized prophylactic anticoagulation after injury can effectively reduce incidence of perioperative DVT.
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@#Drug transportation is impeded by various barriers in the hypoxic solid tumor, resulting in compromised anticancer efficacy. Herein, a solid lipid monostearin (MS)-coated CaO2/MnO2 nanocarrier was designed to optimize doxorubicin (DOX) transportation comprehensively for chemotherapy enhancement. The MS shell of nanoparticles could be destroyed selectively by highly-expressed lipase within cancer cells, exposing water-sensitive cores to release DOX and produce O2. After the cancer cell death, the core-exposed nanoparticles could be further liberated and continue to react with water in the tumor extracellular matrix (ECM) and thoroughly release O2 and DOX, which exhibited cytotoxicity to neighboring cells. Small DOX molecules could readily diffuse through ECM, in which the collagen deposition was decreased by O2-mediated hypoxia-inducible factor-1 inhibition, leading to synergistically improved drug penetration. Concurrently, DOX-efflux-associated P-glycoprotein was also inhibited by O2, prolonging drug retention in cancer cells. Overall, the DOX transporting processes from nanoparticles to deep tumor cells including drug release, penetration, and retention were optimized comprehensively, which significantly boosted antitumor benefits.
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OBJECTIVE@#To evaluate the effect and safety of Kangfuyan Capsules () for treating pelvic inflammatory disease (PID) in patients with chronic pelvic pain (CPP) in a multicenter, randomized, controlled, double-blind, parallel-group clinical trial.@*METHODS@#Totally, 240 PID patients with CPP were randomized into 2 groups using a computer generated random number at a 1:1 ratio from 10 hospitals in China between September 2014 and November 2015. Patients received either oral Kangfuyan Capsules or Gongyanping Capsules (, control); the regimen for both groups comprised 4 capsules (3 times daily) for 12 weeks, with follow-up visit 4 weeks after treatment. The visual analogue scale (VAS) scores, clinical responses, remarkable cure rates for each symptom, and quality of life scores were assessed at baseline, and after 1, 2, and 3 months. Adverse events were also recorded.@*RESULTS@#The VAS scores were significantly lower (P<0.05), whereas the clinical responses, remarkable cure rates for lower abdominal pain, uterine tenderness, adnexal mass, and adnexal tenderness, and Health-related quality of life (EQ-5D) scores were higher in the Kangfuyan group than in the control group at 3 months (P<0.05). Common treatment-related adverse events included high hepatic enzyme levels, reduced hemoglobin levels, and elevated platelet counts, although all the adverse events were either mild or moderate in severity.@*CONCLUSION@#Compared with Gongyanping therapy, Kangfuyan therapy yielded markedly better analgesia effects for CPP caused by PID, with obvious long-term efficacy and good safety. (Registration No. ChiCTR190022732).
Subject(s)
Humans , Capsules , Chronic Pain/drug therapy , Double-Blind Method , Pelvic Pain/drug therapy , Quality of Life , Treatment OutcomeABSTRACT
Different fragments of SARS-CoV-2 nucleocapsid (N) protein were expressed and purified, and a fluorescence immunochromatography method for detection of SARS-CoV-2 total antibody was established. The effect of different protein fragments on the performance of the method was evaluated. The N protein sequence was analyzed by bioinformatics technology, expressed in prokaryotic cell and purified by metal ion affinity chromatography column. Different N protein fragments were prepared for comparison. EDC reaction was used to label fluorescence microsphere on the synthesized antigen to construct sandwich fluorescence chromatography antibody detection assay, and the performance was systemically evaluated. Among the 4 prepared N protein fragments, the full-length N protein (N419) was selected as the optimized coating antigen, N412 with 0.5 mol/L NaCl was used as the optimal combination; deleting 91-120 amino acids from the N-terminal of N412 reduced non-specific signal by 87.5%. the linear range of detection was 0.312-80 U/L, the limit of detection was 0.165 U/L, and the accuracy was more than 95%. A fluorescence immunochromatographic detection method for analysis of SARS-CoV-2 total antibody was established by pairing N protein fragments. The detection result achieved 98% concordance with the commercially available Guangzhou Wanfu test strip, which is expected to be used as a supplementary approach for detection of SARS-CoV-2. The assay could also provide experimental reference for improving the performance of COVID-19 antibody detection reagents.
Subject(s)
Humans , Antibodies, Viral , COVID-19 , Chromatography, Affinity , Fluorescent Antibody Technique , Microspheres , SARS-CoV-2 , Sensitivity and SpecificityABSTRACT
OBJECTIVES@#This study aims to evaluate the endo-sinus bone remodeling of dental implants placed via osteotome sinus floor elevation (OSFE) after 6 months and using different implant protrusion lengths and bone grafts through cone beam computed tomography (CBCT).@*METHODS@#Ninety-six patients with 124 implants were included and assigned into four groups. Group 1: implant protrusion length4 mm with bone graft; group 3: implant protrusion length4 mm without bone graft. Apical bone gain (ABG), cortical bone gain (CBG), bone density gain (BDG), and marginal bone loss (MBL) were observed and analyzed at baseline and 6 months after implant surgery.@*RESULTS@#The CBG in grafted groups 1 and 2 was higher than that in non-grafted groups. The ABG and BDG were higher in non-grafted groups 3 and 4 than in grafted groups, and the levels in group 3 were higher than those in group 4. The CBG in grafted group 2 was higher than that in group 1. No significant difference was observed in MBL analysis.@*CONCLUSIONS@#The BDG of IPL4 mm implant when bone grafts were not applied. No relevance was observed between IPL and CBG. Bone grafts can accelerate endo-sinus bone remodeling by increasing CBG and dissipating the influence of IPL on BDG.
Subject(s)
Humans , Dental Implantation, Endosseous , Dental Implants , Maxilla/surgery , Retrospective Studies , Sinus Floor Augmentation , Treatment OutcomeABSTRACT
Objective@#In the present study, the ABCA1 was used as a label to capture specific exosomes, the level of ABCA1-labeled exosomal microRNA-135a (miR-135a) was evaluated for the diagnosis of Alzheimer's disease (AD), especially in patients with early stages of AD.@*Methods@#This is a preliminary research focused on the levels of ABCA1 in WBCs, RBCs, HT-22 cells, and neuron cells. The diagnostic value of ABCA1-labeled exosomal miR-135a was examined using the CSF and serum of APP/PS1 double transgenic mice, and 152 patients with SCD, 131 patients with MCI, 198 patients with DAT, and 30 control subjects.@*Results@#The level of ABCA1 exosomes harvested from HT-22 cells and neuron culture medium was significantly higher compared to that of RBCs and WBCs ( @*Conclusion@#This study outlines a method to capture specific exosomes and detect them using immunological methods, which is more efficient for early diagnosis of AD.
Subject(s)
Aged , Aged, 80 and over , Animals , Female , Humans , Male , ATP Binding Cassette Transporter 1/cerebrospinal fluid , Alzheimer Disease/cerebrospinal fluid , Biomarkers/cerebrospinal fluid , Cell Line , Cognitive Dysfunction/cerebrospinal fluid , Erythrocytes/metabolism , Exosomes , Leukocytes/metabolism , Mice, Transgenic , MicroRNAs/blood , Neurons/metabolismABSTRACT
Objective:Proposed suggestions to improve the quality of investigator-initiated trials follow-up management under the normalization of COVID-19.Methods:Analyzed current status and challenges of follow-up management in China investigator initiated trial through a combination of literature review and previous work reflection, in the context of normalization of COVID-19.Results:Follow-up management of investigator initiated trial had shown variations in follow-up contents, methods, personnel and auxiliary tools. The insufficient research funding and lacking of professional clinical research team support have led to the challenges of low follow-up visits, insufficient follow-up personnel, lack of electronic follow-up platforms, and unknown follow-up time windows for investigator-initiated trials, which became more prominent in the context of COVID-19.Conclusions:In order to improve the quality of follow-up management during the normalization of COVID-19, appropriate amendment of the investigator-initiated trials follow up should be carefully considered. For instance, taking into account of the characteristics of the research disease, the main research endpoints, the content of the key indicators of the research key follow-up, follow-up methods, follow-up frequency, and follow-up tools to make sure the scientific validity and feasibility, as well as the mandate of clinical research related laws, regulations and ethical requirement. The possible amendments may include follow content, method, mode, frequency, time window. At the same time, re-consent or sufficient disclosure of information should be carried out with compliance of the updated protocols to assure the quality of clinical research follow up.