1.Tacrolimus once daily (Advagraf) vs twice daily (Prograf) in De Novo renal transplantation: a multicentre, randomized, open label, parallel control phase Ⅲ study
Jianhua AO ; Weizhen WU ; Liming WANG ; Lixin YU ; Zhishui CHEN ; Ye TIAN ; Jianghua CHEN ; Yinfu ZHANG ; Longkai PENG ; Tongyu ZHU ; Lizhong CHEN
Chinese Journal of Organ Transplantation 2011;32(7):399-402
Objective To compare the efficacy and safety of twice-daily tacrolimus (Tacrolimus BID; Prograf) vs once-daily prolonged release tacrolimus (Tacrolimus QD; Advagraf), combined with steroids and mycophenolate mofetil in preventing acute rejection in De Novo renal transplantation patients. Methods 241 patients from 11 centers were randomized into two groups with 3 months observation period post-transplantation. Advagraf was administered as a single oral dose in the morning (initially 0. 1-0. 15 mg/kg every day) and Prograf was administered in two equal oral doses 12h apart (initially 0. 1-0. 15 mg/kg). Study visits were scheduled for days 1, 3, 7, 14, 28, 56, 84post-transplantion. The efficacy, safety, compliance and adverse effects were compared between two groups. Results Totally 223 patients completed the study. The two groups were comparable in age,gender and primary disease. There were 12 episodes of acute rejection in each group. There was no graft loss or patient death in both groups. The incidence of drug related adverse events was 32. 1 %and 33. 3% respectively in the control and experimental groups. Dosage was decreased in both groups and there was significant difference in each group. The trough level was similar at the initiate period.Twenty-eight days post-transplantation the trough level in the Advagraf group was lower than in the Prograf group. Conclusion Advagraf has the same efficacy, safety and drug related adverse effects as Prograf. It is practical and feasible for Advagraf substitute for Prograf in clinical practice.
2.A multicenter randomized controlled trial of HC-A Ⅱ solution in kidney preservation
Wenyu ZHAO ; Youhua ZHU ; Li ZENG ; Lulin MA ; Xiaodong ZHANG ; Jianhua AO ; Bingyi SHI ; Ye TIAN ; Jianghua CHEN ; Zhishui CHEN ; Long LIU
Chinese Journal of Organ Transplantation 2012;33(8):474-476
ObjectiveTo evaluate the efficacy and safety of HC-A Ⅱsolution in kidney preservation.Methods A multicenter,randomized,double-blind and controlled clinical trial was conducted.Between Jan.2008 and Dec.2010,kidney recipients from 9 transplant centers were randomly divided into two groups.Grafts in each group were perfused and stored in HC-A Ⅱ or HTK solutions respectively.Results277 patients were included in the Full Analysis Set (FAS),137 of whom were inHC-A Ⅱgroup and 140inHTK group. Demographic andbaseline medical characteristics were similar between the two groups.262 patients were included in the Per Protocol Set (PPS),133 of whom were in HC-A Ⅱ group and129 in HTK group.The percentages of patients with a serum creatinine level that returned to normal within 28 days postoperation were 86.9% in HC-A Ⅱ group and 85.0% in HTK group respectively (P>0.05 ).The results from PPS analysis were consistent with those from FAS analysis The incidence of test-related adverse events was 2.9% in HC-AⅡ group and 0.7% in HTK group respectively (P>0.05).No test-related serious adverse events occurred throughout the study.ConclusionHC-A Ⅱ solution,the same as HTK solution,is safe and effective in kidney preservation.
3.Contrast-enhanced ultrasonography in diagnosis of inflammatory pseudotumor of liver.
Yan CHEN ; Tian-an JIANG ; Jian-yang AO ; Min HUANG ; Fen CHEN ; Qi-yu ZHAO
Journal of Zhejiang University. Medical sciences 2010;39(6):634-637
OBJECTIVETo evaluate the application of contrast-enhanced ultrasonography (CEUS) in diagnosis of inflammatory pseudotumor of liver (IPL).
METHODSThe contrast-enhanced untrasonography was performed in 32 cases of IPL and the results were retrospectively analyzed.
RESULTAmong total 32 cases, 21 had absent contrast enhancement (type I); 6 had rimlike or stringlike enhancement during arterial phase and presented hypoechoic lesions during the late phase (type II); 2 had diffuse and homogeneous enhancement during early arterial phase,persisting hyperechoic during the late phase (type III); 3 had enhancement during arterial phases and washed out more quickly than liver parenchymal (type IV).
CONCLUSIONThe perfusion pattern of IPL with CEUS varies, the predominant type is no contrast enhancement; type IV may be confused with atypical hepatic carcinoma, in that case the needle biopsy is necessary.
Adult ; Female ; Granuloma, Plasma Cell ; diagnostic imaging ; Humans ; Liver ; diagnostic imaging ; Liver Diseases ; diagnostic imaging ; Male ; Middle Aged ; Retrospective Studies ; Ultrasonography ; Young Adult
4.Clinical outcomes in renal allograft recipients switched to long-term immunosuppressive therapy with mycophenolate mofetil after renal transplantation
Lizhong CHEN ; Zhihong LIU ; Bingyi SHI ; Jianghua CHEN ; Jianyu LING ; Wei ZHANG ; Genfu ZHANG ; Jianhua AO ; Yiping LU ; Xiaodong ZHANG ; Yu FAN ; Ye TIAN ; Lulin MA ; Liming WANG ; Shunliang YANG ; Wujun XUE ; Changsheng MING ; Tongyu ZHU ; Da XU ; Xiangtie LI
Chinese Journal of Organ Transplantation 2012;(12):716-720
Objective To document the impact of conversion to mycophenolate mofetil (MMF)at different time points after transplantation on the renal function of renal function.Methods A longterm,multicenter,non-interventional and observational study was done.Two cohorts were included:One was Switch cohort (340 cases) including renal allograft recipients who switched to MMF at least 6 months after renal transplantation and followed up for 4 years after switch; The other was Stay cohort (123 cases),including renal allograft recipients who received MMF treatment after transplantation and followed up for 4 years after enrollment.Results GFR values of patients in Switch cohort was significantly increased after switch,and the change in GFR slope was 3.1 mL· min-1 · year-1 (P<0.01).GFR values of patients in Stay cohort kept steady before and after enrollment,and the change in GFR slope was 0.44 mL·min-1 ·year-1 (P>0.05).Statistically significant difference in the onset time of GFR decline (defined as 20% decline from the baseline) was observed among subgroups within Switch cohort (P<0.01),but there was no significant difference among subgroups within Stay cohort (P>0.05).Stay cohort was 12% higher than in Switch cohort every year.Conclusion Conversion to MMF >6 months or even many years after transplantation can obviously improve the renal function of recipients.The earlier conversion can benefit improvement of the renal function.
5.Modified docetaxel regimen for prostate cancer patients who got poor tolerance to chemotherapy
Linjun HU ; Changling LI ; Jianzhong SHOU ; Jun TIAN ; Dong WANG ; Zhendong XIAO ; Zejun XIAO ; Xingang BI ; Kaopeng GUAN ; Hongsong BAI ; Chengming XIE ; Xingli SHAN ; Dehu LU ; Xiang AO ; Yonghai CHEN
Chinese Journal of Urology 2017;38(8):615-618
Objective To evaluate the efficacy and safety of the modified docetaxel plus prednisone scheme for the metastatic castration resistant prostate cancer patients who got poor tolerance to chemotherapy.Method The clinical data of 50 metastatic castration resistant prostate cancer who received docetaxel + prednisone chemotherapy from March 2010 to October 2015 were analyzed retrospectively.23 cases received the modified DP regimen (modified group),27 cases received the standard DP regimen (standard group).The median age of the modified group and the standard group were 69 years (47-80 years) and 63 years (52-77 years) (P =0.005).There were 19 and 24 cases with pain in modified group and standard group respectively;10 and 19 cases with lymph node metastasis respectively;3 and 4 cases of visceral metastasis respectively;all of the 50 patients were complicated with bone metastasis.For the pathological Gleason score,there were 7 cases scored ≤7 points,13 cases scored ≥ 8 points and 3 cases unscored in the modified group;7 cases scored ≤7 points,15 cases scored ≥8 points and 5 cases unscored in standard group.There was no significant difference of the pain,metastasis,and Gleason score between the two groups (P > 0.05).Progression free survival (PFS),overall survival (OS)and adverse events were analyzed using Kaplan-Meier curves,and the differences were assessed using the log-rank test.Results In the modified group and standard group,the median follow-up times were 11.0 months and 14.0 months respectively,the median chemotherapy cycles were 4.5 cycles and 5.0 cycles respectively;OS were 18.0 months and 27.5 months respectively (P =0.746).The PFS of the two groups were 6.0 months and 5.2 months,respectively (P =0.822).The PSA response were 13 cases and 17 cases in the modified group and standard group respectively (P =0.615),and the pain response were 8 cases and 7 cases (P =0.927),grade 3 to 4 adverse events were 3 cases and 14 cases (P =0.003).The main adverse events were blood toxicity,neutrophils,gastrointestinal reaction,edema,fatigue and oral mucositis etc.Conclusions Compared with the standard DP scheme,the modified DP scheme had no significant difference in OS,PFS,pain response rate and PSA response rate,while the incidence of grade 3 to 4 adverse events was significantly reduced.Modified DP scheme may be a better choice for patients with metastatic castration resistant prostate cancer who get poor tolerance to chemotherapy.
6.Intermittent abdominal pain and abdominal distension with fatigue and massive ascites in a 13-year-old boy.
Tian ZHANG ; Hui ZHANG ; Tao FANG ; Ao XU ; Ming-Wu CHEN
Chinese Journal of Contemporary Pediatrics 2019;21(3):277-281
A 13-year-old boy was admitted due to intermittent abdominal pain for one year with massive ascites. The purified protein derivative (PPD) test after admission yielded positive results (3+), and ascites examination revealed a yellow color. There were 634×10 nucleated cells/L in the ascites, among which 82.2% were mononuclear cells and 17.8% were multinuclear cells. The Rivalta test yielded a positive result and revealed that the ascites was exudate, suggesting the possibility of tuberculosis infection. The symptoms were not relieved after isoniazid-rifampicin anti-tuberculosis therapy and symptomatic/supportive treatment. Plain CT scan of the abdomen and contrast-enhanced CT showed that the lesion was located at the left wall of the transverse colon, with uneven thickening of the peritoneum and heterogeneous enhancement. Colonoscopic biopsy found signet ring cells in the mucosa and immunohistochemical examination revealed Syn (-), CgA (-), CD56 (-), CK(pan) (+), CDX-2 (+), CK20 (+), Muc-1 (+) and Ki-67 (+, about 80%). PET-CT scan showed an abnormal increase in fluorodeoxyglucose metabolism, which was shown as a mass near the splenic flexure of the transverse colon, with a maximum standard uptake value of 9.9, indicating a highly active lesion; this was consistent with the metabolic changes of malignant tumors. Surgical operation was performed and intraoperative exploration revealed massive ascites, a hard mass located at the hepatic flexure of the colon, involvement of the serous coat and surrounding tissues, stenosis of the bowel, lymph node enlargement around the superior mesenteric vessels and the gastrocolic ligament, and multiple metastatic nodules in the greater omentum, the abdominal wall and the pelvic cavity. The results of postoperative pathology were consistent with those of colonoscopic biopsy, i.e., poorly differentiated mucinous adenocarcinoma of the transverse colon and partly signet-ring cell carcinoma. Therefore, the boy was diagnosed with colon signet-ring cell carcinoma with peritoneal metastasis and tuberculosis infection. When a child is suffering from intractable abdominal pain, unexplained intestinal obstruction and massive intractable ascites, the possibility of malignancy should be considered. Abdominal plain CT scan as well as contrast-enhanced CT scan should be performed as early as possible, and enteroscopy should be performed when necessary.
Abdomen
;
Abdominal Pain
;
etiology
;
Adolescent
;
Ascites
;
complications
;
Fatigue
;
etiology
;
Humans
;
Male
;
Positron Emission Tomography Computed Tomography
;
Tomography, X-Ray Computed
7.S100A4 Gene is Crucial for Methionine-Choline-Deficient Diet-Induced Non-Alcoholic Fatty Liver Disease in Mice.
Yin Hua ZHANG ; De Qiang MA ; De Ping DING ; Juan LI ; Lin Li CHEN ; Kang Jian AO ; You You TIAN
Yonsei Medical Journal 2018;59(9):1064-1071
PURPOSE: To explore the influence of S100 calcium binding protein A4 (S100A4) knockout (KO) on methionine-choline-deficient (MCD) diet-induced non-alcoholic fatty liver disease (NAFLD) in mice. MATERIALS AND METHODS: S100A4 KO mice (n=20) and their wild-type (WT) counterparts (n=20) were randomly divided into KO/MCD, Ko/methionine-choline-sufficient (MCS), WT/MCD, and WT/MCS groups. After 8 weeks of feeding, blood lipid and liver function-related indexes were measured. HE, Oil Red O, and Masson stainings were used to observe the changes of liver histopathology. Additionally, expressions of S100A4 and proinflammatory and profibrogenic cytokines were detected by qRT-PCR and Western blot, while hepatocyte apoptosis was revealed by TUNEL staining. RESULTS: Serum levels of aminotransferase, aspartate aminotransferase, triglyceride, and total cholesterol in mice were increased after 8-week MCD feeding, and hepatocytes performed varying balloon-like changes with increased inflammatory cell infiltration and collagen fibers; however, these effects were improved in mice of KO/MCD group. Meanwhile, total NAFLD activity scores and fibrosis were lower compared to WT+MCD group. Compared to WT/MCS group, S100A4 expression in liver tissue of WT/MCD group was enhanced. The expression of proinflammatory (TNF-α, IL-1β, IL-6) and profibrogenic cytokines (TGF-β1, COL1A1, α-SMA) in MCD-induced NAFLD mice were increased, as well as apoptotic index (AI). For MCD group, the expressions of proinflammatory and profibrogenic cytokines and AI in KO mice were lower than those of WT mice. CONCLUSION: S100A4 was detected to be upregulated in NAFLD, while S100A4 KO alleviated liver fibrosis and inflammation, in addition to inhibiting hepatocyte apoptosis.
Animals
;
Apoptosis
;
Aspartate Aminotransferases
;
Blotting, Western
;
Calcium
;
Carrier Proteins
;
Cholesterol
;
Collagen
;
Cytokines
;
Fibrosis
;
Hepatocytes
;
In Situ Nick-End Labeling
;
Inflammation
;
Liver
;
Liver Cirrhosis
;
Mice*
;
Non-alcoholic Fatty Liver Disease*
;
Triglycerides
8.Study on the acupoints belonging to the three yin meridians of foot reflecting the variation pattern of uterine qi and blood in women with moderate constitution
Xiao-Dan SONG ; Fei YANG ; Yan-Fen SHE ; Ya-Yu GAO ; Hao CHEN ; Xi-Sheng FAN ; Ao-Tian YU ; Man ZHANG ; Zhi-Fang ZHANG ; Li-Jia PAN ; Bing-Cheng WANG ; Xu-Liang SHI
Journal of Acupuncture and Tuina Science 2020;18(6):411-417
Objective: To observe the blood perfusion volume variation pattern in the body surface microcirculation at the Yuan-Primary and the Xi-Cleft points during the menstrual cycle in female college students with moderate constitution under normal physiological state of the uterus; to explore the specific laws of the body surface microcirculation at the Yuan-Primary and Xi-Cleft points in response to the uterine qi and blood changes under normal physiological conditions, and to provide the experimental basis for the specificity of acupoints reflecting the uterine function. Methods: Forty-three healthy and moderate constitution female college students with regular menstrual cycles, without dysmenorrhea and not yet giving birth were recruited. Bilateral Yuan-Primary points [Taichong (LR 3), Taibai (SP 3) and Taixi (KI 3)] and Xi-Cleft points [Zhongdu (LR 6), Diji (SP 8) and Shuiquan (KI 5)], belonging to the three yin meridians of foot and adjacent to the spinal cord segment of the uterus, were selected as the detection acupoints; the crossing point of the three yin meridians of foot [Sanyinjiao (SP 6)], the uterus-related meridian acupoint [Xuehai (SP 10)], the uterus-non-related meridian acupoint [Xuanzhong (GB 39)], and the non-meridian non-acupoint point were selected as the control points. The laser speckle blood flow imaging technique was used to monitor the blood perfusion volume in skin microcirculation at the above points at the menstrual, follicular, ovulatory, and luteal phases of the subjects. Results: The blood perfusion volume in the body surface microcirculation at the right Zhongdu (LR 6) at the ovulatory phase was higher than that at the menstrual, follicular and luteal phases (all P<0.05); there was no significant difference in the microcirculation blood perfusion volume at the other points among different phases (all P>0.05). Conclusion: The blood perfusion volume in the body surface microcirculation at Zhongdu (LR 6), the Xi-Cleft point of the Liver Meridian, shows a specific response to qi and blood changes in the uterus of women with moderate constitution.
9.Evaluation of CRISPR-Based Assays for Rapid Detection of SARS-CoV-2: A Systematic Review and Meta-Analysis
Pei-Ying HUANG ; Xin YIN ; Yue-Ting HUANG ; Qi-Qing YE ; Si-Qing CHEN ; Xun-Jie CAO ; Tian-Ao XIE ; Xu-Guang GUO
Yonsei Medical Journal 2022;63(5):480-489
Purpose:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen of coronavirus disease 2019. Diagnostic methods based on the clustered regularly interspaced short palindromic repeats (CRISPR) have been developed to detect SARSCoV-2 rapidly. Therefore, a systematic review and meta-analysis were performed to assess the diagnostic accuracy of CRISPR for detecting SARS-CoV-2 infection.
Materials and Methods:
Studies published before August 2021 were retrieved from four databases, using the keywords “SARS-CoV-2” and “CRISPR.” Data were collected from these publications, and the sensitivity, specificity, negative likelihood ratio (NLR), positive likelihood ratio (PLR), and diagnostic odds ratio (DOR) were calculated. The summary receiver operating characteristic curve was plotted for analysis with MetaDiSc 1.4. The Stata 15.0 software was used to draw Deeks’ funnel plots to evaluate publication bias.
Results:
We performed a pooled analysis of 38 independent studies shown in 30 publications. The reference standard was reverse transcription-quantitative PCR. The results indicated that the sensitivity of CRISPR-based methods for diagnosis was 0.94 (95% CI 0.93–0.95), the specificity was 0.98 (95% CI 0.97–0.99), the PLR was 34.03 (95% CI 20.81–55.66), the NLR was 0.08 (95% CI 0.06– 0.10), and the DOR was 575.74 (95% CI 382.36–866.95). The area under the curve was 0.9894.
Conclusion
Studies indicate that a diagnostic method based on CRISPR has high sensitivity and specificity. Therefore, this would be a potential diagnostic tool to improve the accuracy of SARS-CoV-2 detection.
10.Effect of Shenkang injection on the cytochrome 2C9 enzyme activity in rats
Ze-Na CHANG ; USMAN MUHAMMAD ; Zhen-Han ZHU ; Jun-Ping HAN ; Tian-Ao CHEN ; Chang-Qing YANG
The Chinese Journal of Clinical Pharmacology 2017;33(13):1240-1243,1247
Objective Diclofeanc as probe drug to investigate the influence of Shenkang injection on the activity of CYP2C9 enzyme in rats.Methods A total of 24 SD male rats were randomly divided into control group (0.9% NaCl),low dose (6.7 mL · kg-1),middle dose (13.3 mL· kg-1),high dose (26.6 mL · kg-1) Shenkang injection group,each group 6 rats.The relevant injection was administered by intraperitoneal injection,twice a day for 7 d.On the eighth day before collected the blood plasma samples each group were given relevant injection and all rats were injected with diclofenac (15 mg · kg-1,iv) 1 h after last administration.The orbital blood samples were collected before and 5,15,30,45 min and 1,1.5,2,3,4,6,8,10,12,24 h after diclofenac administration through femoral venous.A sensitive high-performance liquid chromatography method was established to characterize and validate for the determination of plasma concentration of diclofenac and 4'-hydroxy-diclofenac in rats.Pharmacokinetic parameters were calculated with WinNolin 6.1 pharmacokinetic software.Results The area under the concen-tration-time curve (AUC0-24 h) of diclofenac in control group,low,middle and high-dose Shenkang injection group were (21.12±2.88),(25.13 ±8.13),(31.11 ± 11.19),(32.32 ±6.18) mg · h · L-1(P >0.05).The AUC0→24h of 4'-hydroxy-diclofenac were (9.79 ±1.12),(7.84 ±2.67),(9.97 ±3.85),(10.39 ±3.38)mg · h · L-1 (P>0.05).The t1/2 of diclofenac in control group,low,middle and high-dose Shenkang injection group were (6.21 ± 1.78),(7.46 ±2.20),(6.40 ± 1.50),(6.13 ±2.19) h(P >0.05).The t1/2 of 4'-hydroxy-diclofenac in control group,low,middle and high-dose Shenkang injection group were (11.53 ±4.31),(30.85 ± 10.52),(23.29 ± 13.09),(22.53 ± 10.95)h(P >0.05).There was no statistical significant difference in other pharmacokinetic parameters (P > 0.05).Conclusion Consecutive administration of Shenkang injection may not have an effect on the pharmacokinetic of diclofenac and 4'-hydroxy-diclofenac of typical probe substrates of CYP2C9 in rats.The present study would provide some reference on Shenkang injection have no influence on CYP2C9.