1.Yunchang Capsule in treatment of functional constipation: a randomized, double-blinded controlled, multicenter trial.
Jia GUO ; Ruiming ZHANG ; Zongwen HUANG ; Lei WANG ; Songshan LIU ; Juncheng DIAO ; Siyuan HU ; Binghui LIN
Journal of Integrative Medicine 2009;7(12):1123-9
Background: Although there are some Chinese herbal medicines in treatment of constipation, but no multi-center randomized controlled trials have been carried out to prove their effectiveness. Objective: To evaluate the safety and efficacy of Yunchang Capsule in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome, and to explore the clinical dosage. Design, setting, participants and interventions: A randomized, double-blinded controlled, multicenter trial was conducted. A total of 240 patients with functional constipation from West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine and Fujian Academy of Traditional Chinese Medicine were randomly divided into three groups: low dose group (80 cases), high dose group (80 cases) and control group (80 cases). Patients in the low dose group were treated with two pills (0.35 g/pill) of Yunchang Capsule and one pill of Yunchang Capsule simulant for three times daily; patients in the high dose group were treated with three pills (0.35 g/pill) of Yunchang Capsule for three times daily; and patients in the control group were treated with three pills (0.35 g/pill) of Biantong Capsule for three times daily. The therapeutic course was 14 days. Main outcome measures: Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment, and blood, urine and stool tests, hepatorenal function and electrocardiogram were also examined. Results: Two cases were excluded, eleven cases were lost to follow-up, and there were 234 patients entered to intention-to-treat (ITT) analysis. After the treatment, the therapeutic effects were calculated by full analysis set (FAS) and per-protocol population set (PPS) analysis respectively. The effects on functional constipation in FAS showed the response rates in the low dose, high dose and control groups were 86.25% (69/80), 82.90% (63/76), and 70.52% (55/78) respectively, and PPS analysis showed the response rates were 85.71% (66/77), 83.56% (61/73), and 70.13% (54/77) respectively. There were no significant differences among the three groups (P>0.05). The effects on traditional Chinese medicine syndrome in FAS showed the response rates in the low dose, high dose and control groups were 78.75% (63/80), 69.74% (53/76), and 67.95% (53/78) respectively, and PPS analysis showed the response rates were 77.92% (60/77), 69.87%(51/73), and 67.53% (52/77) respectively. There were also no significant differences among the three groups (P>0.05). No severe adverse events were observed. Conclusion: Both low dose and high dose of Yunchang Capsule are effective and safe in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome.
2.Hematological adverse events of sunitinib in treatment of advanced renal cell carcinoma
Xiaoyi HU ; Guomin WANG ; Jianming GUO ; Zongming LIN ; Lian SUN ; Ming XU ; Zhibing XU ; Hang WANG ; Ruiming RONG ; Chen CANG
Chinese Journal of Urology 2012;33(8):627-630
Objective To evaluate the hematological adverse events of sunitinib in treatment of advanced renal cell carcinoma.Methods Forty-four male patients and 18 female patients were included in this study.They were all with metastatic renal cell carcinoma and received sunitinib treatment at the dose of 50 mg daily in repeated 6 weeks cycle (4 weeks on and 2 weeks off).Toxicity was assessed every cycle with tumor assessments every 2 cycles via CT or PET-CT.Results Fifty patients (80.6%) had experienced treatment-related hematotoxicity,including leucocytopenia,anemia and thrombocytopenia.Severe hematological adverse events ( grade 3 -4 ) occured in 18 patients ( 29.0% ) and slight events ( grade 1 - 2 ) in others (51.6%).Most of the hematological adverse events were manageable and reversible and treatment-changes (dose reduction,interruption) were necessary in severe cases.Almost half of the dose reduction (9/21,42.9% ) were owing to hematotoxicity.Conclusions Sunitinib of 50 mg dose on schedule 4/2 is effective and well-tolerated in advanced renal carcinoma patients.Hematological adverse events are frequent in Chinese patients and can be controlled well.
3.Expression and significance of peripheral T helper type 9 cells and their related cytokines in patients with alopecia areata
Ying ZHAO ; Youyu SHENG ; Ruiming HU ; Jun ZHAO ; Wenlong RUI ; Sisi QI ; Qinping YANG
Chinese Journal of Dermatology 2019;52(1):20-24
Objective To investigate the relationship of the expression of peripheral T helper type 9 (Th9) cells and their related cytokines with the severity and clinical course of alopecia areata,and to explore their significance in the occurrence of alopecia areata.Methods From May to December in 2017,74 outpatients with alopecia areata enrolled from Department of Dermatology,Huashan Hospital,Fudan University served as the alopecia areata group,and 57 health checkup examinees in Huashan Hospital served as the control group.Peripheral blood samples were obtained from the patients and controls.Enzyme-linked immunosorbent assay (ELISA) was performed to detect the serum levels of interleukin (IL)-9,IL-4,transforming growth factor (TGF)-β1 and interferon (IFN)-γ,flow cytometry to determine the proportion of Th9 cells (CD4+IL-9+ T helper cells) in peripheral blood mononuclear cells (PBMC),and real-time fluorescence-based quantitative PCR to measure the mRNA expression of IL-9 and PU.1 in the PBMCs.Data were recorded in Microsoft Excel 2017 software,and statistically analyzed with SPSS17.0 software using two-sample t test and Spearman rank correlation analysis.Statistical charts were drawn with Graphpad prism 6 software.Results Compared with the control group,the alopecia areata group showed significantly decreased serum level of IL-9 (190.40 ± 12.33 ng/L vs.288.10 ± 17.38 ng/L,t =4.71,P < 0.01),but significantly increased serum levels of TGF-β1 (6 191.00 ± 355.50 ng/L vs.4 026.00 ± 258.00 ng/L,t =4.41,P < 0.05) and IFN-γ(15.71 ± 3.00 ng/L vs.8.79 ± 0.60 ng/L,t =2.001,P < 0.05).However,there was no significant difference in the serum level of IL-4 between the alopecia areata group and control group (P > 0.05).The serum level of IFN-γ was significantly lower in the patients with severe alopecia areata than in the patients with mild alopecia areata (P =0.02),and the serum level of IFN-γ in the patients with alopecia areata was negatively correlated with the severity of alopecia tool (SALT) score (ru =-0.298,P =0.010).There were no significant differences in the serum levels of IL-9,IL-4 and TGF-β1 between the patients with severe alopecia areata and those with mild alopecia areata (all P > 0.05).The serum levels of IL-9,IL-4,TGF-β1 and IFN-γdid not differ between the patients with active alopecia areata and those with stable alopecia areata,as well as between the patients with clinical course of < 6 months and those with clinical course of > 6 months (P > 0.05).The alopecia areata group showed significantly decreased proportion of Th9 cells in the PBMCs (t =2.04,P =0.045) and mRNA expression of IL-9 and PU.1 (t =2.12,2.178,both P < 0.05) compared with the control group.Condusion The serum level of IL-9 and proportion of peripheral blood Th9 cells both decrease in patients with alopecia areata,and Th9 cells and their related cytokines may be involved in the occurrence of alopecia areata.
4.Cluster characteristics of physical activities among children inside and outside kindergartens and its relationship with athletic abilities
Chinese Journal of School Health 2023;44(10):1560-1563
Objective:
Based on physical activity (PA) and sedentary behavior (SB) variables on weekdays and weekends, the study aims to cluster the physical activities inside and outside kindergartens and to explore the cluster characteristics of different children using physical fitness indicators, so as to provide new strategies and methods for early childhood education and health.
Methods:
From March to June 2019, 291 children aged 3-6 years from 6 kindergartens in Nanchang were recruited by a stratified cluster random sampling method. The ActiGraph GT3X-BT triaxial accelerometer was used to measure and analyze the PA and SB levels inside and outside the kindergarten. A twostep clustering algorithm model was employed for cluster analysis. Physical fitness were measured and evaluated according to the "National Physical Fitness Measurement Standard Manual (Preschool Section)". Differences in physical fitness among different clusters of children were compared, and the cluster characteristics of different children were analyzed.
Results:
The clustering algorithm model indicated that based on six indicators, including PA and SB inside the kindergarten on weekdays, and PA and SB outside the kindergarten on both weekdays and weekends, children could be divided into three categories:active inside (high PA, low SB inside), active outside (high PA outside), and inactive (low PA, high SB both inside and outside). The average silhouette coefficient of the model was 0.3, indicating good clustering results. Both the active inside and active outside children showed significantly higher PA inside on weekdays, PA outside on weekdays and weekends, daily low intensity physical activity (LPA) and moderate-to-vigorous physical activity (MVPA) than the inactive children ( F=157.91, 80.79 , 95.86, 95.52, 124.74, P <0.05). After adjusting for gender and age, the physical fitness scores of both active outside ( 19.03 ±0.47) and active inside (19.11±0.40) were significantly higher than those of the inactive children (17.94±0.31). Additionally, active inside children (3.91±0.14) also showed significantly better performance in continuous double-leg jumps, compared to inactive children (3.45±0.11) ( P <0.05).
Conclusion
Children active inside and those active outside perform well in PA. Future research should focus on the proportion of structured and unstructured PA time to enhance the overall physical fitness of children.
5.Conversion from mycophenolic acid to mizoribine in renal transplant recipients with gastrointestinal tract symptoms: a prospective observational multi-center study
Bingyi SHI ; Jianxin QIU ; Weiguo SUI ; Jun TIAN ; Youhua ZHU ; Chunbo MO ; Changxi WANG ; Yingzi MING ; Zhishui CHEN ; Yaowen FU ; Zheng CHEN ; Longkai PENG ; Zhilin HU ; Tao LIN ; Xuyong SUN ; Hang LIU ; Ruiming RONG ; Ye TIAN ; Wujun XUE ; Ming ZHAO ; Guiwen FENG ; Ronghua CAO ; Decheng DENG ; Minzhuan LIN ; Xiaodong ZHANG
Chinese Journal of Organ Transplantation 2017;38(12):708-713
Objective To evaluate the effect of conversion from mycophenolic acid (MPA) to mizoribine (MZR) in renal transplant recipients with gastrointestinal tract (GI) symptoms.Methods A total of 355 renal transplant recipients with GI symptoms caused by MPA administration were enrolled from April 2015 to March 2017 in 25 different renal transplant centers in China.The symptomatic improvement of GI before (baseline) and after conversion to MZR (1,2,4 weeks) was assessed by each item of GI symptoms indication.In addition,the efficacy and safety of the conversion therapy during 12 months were determined.Results Patients showed improvement in GI symptoms including diarrhea,abdominal pain,abdominal distention and stomachache after conversion to MZR 1,2,4 weeks (P<0.05).In patients with different severity of diarrhea,conversion to MZR therapy significantly improved diarrhea (P<0.05).During 12 months,no patient experienced clinical immune rejection.We did not observe any infections,leucopenia and other serious side effects.Conclusion MZR could markedly improve GI symptoms caused by MPA administration in renal transplant recipients.
6.Renal transplantationplus hematopoietic stem cell transplantation as Induction therapy :a single-center 10-year experience
Xuanchuan WANG ; Linkun HU ; Zheng WEI ; Qunye TANG ; Bing CHEN ; Zhaochong ZENG ; Yuan JI ; Ming XU ; Ruiming RONG ; Tongyu ZHU
Chinese Journal of Organ Transplantation 2019;40(5):284-288
Objective To explore the efficacy of renal transplantation plus hematopoietic stem cell transplantation on inducing immune tolerance and summarize its long-term follow-up outcomes . Methods From 2009 to 2018 ,a total of 11 cases of living related donor kidney transplantation plus hematopoietic stem cell transplantation were performed .Two of them were HLA-matched and the remainder were mismatched for one HLA haplotype . The donor hematopoietic stem cells were mobilized using granulocyte colony-stimulating factor at 5 days pre-transplantation and collected at 1 day pre-operation .The recipients received total lymphoid irradiation for 3 days pre-transplantation and received anti-thymocyte globulin induction during transplantation .The donor hematopoietic stem cells were infused at 2 ,4 and 6 postoperative day .Postoperative regulatory T cells ,chimerism ,B cell activating factor and mixed lymphocyte culture and other parameters were detected and long-term follow-up outcomes tracked .Results The immune tolerance-inducible recipients had a significant increase in activated Treg .One HLA-matched recipient achieved 30%-50% of chimerism and lost after 6 months .However ,other recipients did not achieve mixed chimerism .The BAFF of recipient spiked sharply after transplantation .Mixed lymphocyte culture indicated that a donor-specific low response was induced .The recipients were followed up for 717 to 3612 days .The first recipient lost renal function and another ten recipients had stable renal function . None of the recipients had myelosuppression or graft-versus-host disease .Allograft biopsy confirmed only one case of mild acute rejection . The dose of immunosuppressive agents was lowered in 5 patients .Conclusions Hematopoietic stem cell transplantation for inducing tolerance is safe during renal transplantation . And chimerism is essential for inducing immune tolerance .
7.Preliminary results of multicenter studies on ABO-incompatible kidney transplantation
Hongtao JIANG ; Tao LI ; Kun REN ; Xiaohua YU ; Yi WANG ; Shanbin ZHANG ; Desheng LI ; Huiling GAN ; Houqin LIU ; Liang XU ; Zhigang LUO ; Peigen GUI ; Xiangfang TAN ; Bingyi SHI ; Ming CAI ; Xiang LI ; Junnan XU ; Liang XU ; Tao LIN ; Xianding WANG ; Hongtao LIU ; Lexi ZHANG ; Jianyong WU ; Wenhua LEI ; Jiang QIU ; Guodong CHEN ; Jun LI ; Gang HUANG ; Chenglin WU ; Changxi WANG ; Lizhong CHEN ; Zheng CHEN ; Jiali FANG ; Xiaoming ZHANG ; Tongyi MEN ; Xianduo LI ; Chunbo MO ; Zhen WANG ; Xiaofeng SHI ; Guanghui PEI ; Jinpeng TU ; Xiaopeng HU ; Xiaodong ZHANG ; Ning LI ; Shaohua SHI ; Hua CHEN ; Zhenxing WANG ; Weiguo SUI ; Ying LI ; Qiang YAN ; Huaizhou CHEN ; Liusheng LAI ; Jinfeng LI ; Wenjun SHANG ; Guiwen FENG ; Gang CHEN ; Fanjun ZENG ; Lan ZHU ; Jun FANG ; Ruiming RONG ; Xuanchuan WANG ; Guisheng QI ; Qiang WANG ; Puxun TIAN ; Yang LI ; Xiaohui TIAN ; Heli XIANG ; Xiaoming PAN ; Xiaoming DING ; Wujun XUE ; Jiqiu WEN ; Xiaosong XU
Chinese Journal of Organ Transplantation 2020;41(5):259-264
Objective:To summarize the patient profiles and therapeutic efficacies of ABO-incompatible living-related kidney transplantations at 19 domestic transplant centers and provide rationales for clinical application of ABOi-KT.Methods:Clinical cases of ABO-incompatible/compatible kidney transplantation (ABOi-KT/ABOc-KT) from December 2006 to December 2009 were collected. Then, statistical analyses were conducted from the aspects of tissue matching, perioperative managements, complications and survival rates of renal allograft or recipients.Results:Clinical data of 342 ABOi-KT and 779 ABOc-KT indicated that (1) no inter-group differences existed in age, body mass index (BMI), donor-recipient relationship or waiting time of pre-operative dialysis; (2) ABO blood type: blood type O recipients had the longest waiting list and transplantations from blood type A to blood type O accounted for the largest proportion; (3) HLA matching: no statistical significance existed in mismatch rate or positive rate of PRA I/II between two types of surgery; (4) CD20 should be properly used on the basis of different phrases; (5) hemorrhage was a common complication during an early postoperative period and microthrombosis appeared later; (6) no difference existed in postoperative incidence of complications or survival rate of renal allograft and recipients at 1/3/5/10 years between ABOi-KT and ABOc-KT. The acute rejection rate and serum creatinine levels of ABOi-KT recipients were comparable to those of ABOc-KT recipients within 1 year.Conclusions:ABOi-KT is both safe and effective so that it may be applied at all transplant centers as needed.