1.A randomized trial on the efficacy and safety of Advagraf vs tacrolimus in prevention of acute liver allograft rejection
Guangming LI ; Shushen ZHENG ; Yongfeng LIU ; Zhijun ZHU ; Qiang XIA ; Jian ZHOU ; Zhiren FU ; Lei HUANG ; Jiye ZHU ; Xisheng LENG
Chinese Journal of Organ Transplantation 2011;32(4):217-220
Objective To evaluate the efficacy and safety of tacrolimus exposure in stable liver transplant recipients converted from FK506 twice a day to Advagraf (tacrolimus extended-release capsules) once daily. Methods This was an open-label, random, control and multi-center study.Eligible patients were 19 to 70 years of age, 6 months post-transplant with stable renal and hepatic function and receiving stable doses of tacrolimus twice a day for 2 weeks prior to enrollment. There were 86 patients in the experimental group and the control group, separately. The average age of experimental group and control group was 46 ± 10 and 49 ± 9, respectively. Patients in experimental group received Advagraf, once daily, and the dose was adjusted according to the drug concentration,and the drug concentration was between 2 to 10 μg/L. The control group given tacrolimus, twice daily, and the drug concentration was between 2 to 10 μg/L. Results The incidence of acute rejection reaction was 1.20 % and 1.18 % respectively in experimental group and control group, and the 95 %confidence interval was -3.25% ~3.31 % and -3.26% ~ 3.34 %, individually. There was 1 case of acute rejection reaction in experimental group and control group, respectively. The patient and organ survival rate was 100%. Sixteen adverse events occurred in 15 patients (17.65 %) of the experimental group, and 10 adverse events occurred in 10 patients (11.63 %) of control group. Severe adverse events relating to the test drug in experimental group occurred in 4 patients (4. 71 %). and 2 patients (2. 33) in control group.Conclision Clinical trials indicated that Advagraf has efficacy and safety profiles similar to those of tacrolimus. The drug is safe and may improve patient compliance.
2.Transmission chains of clusters of COVID-19 associated with a market in Beijing
Yamin SUN ; Feng LIU ; Wei CAI ; Lei WANG ; Fangyao LIU ; Yulian LI ; Juguang WANG ; Huaqing YING ; Jiye FU
Chinese Journal of Epidemiology 2021;42(3):427-432
Objective:To investigate the clusters of COVID-19 associated with a market (market Y) in Haidian District, Beijing, and analyze the chain of transmission and provide reference for effective prevention and control of COVID-19.Methods:The investigation of field epidemiology and cluster epidemic was used to describe the distributions of all COVID-19 cases. The time sequence diagram of the cases, disease onset was drawn and transmission chains were analyzed. Real-time RT-PCR assay was conducted for SARS-CoV-2 nucleic acid test by using the respiratory samples of the cases.Results:The COVID-19 epidemic, originated from a wholesale farm produce market (market X) in Fengtai District, Beijing, was introduced by a marketer in the market Y who had exposed to market X, causing 8 clusters of 20 confirmed cases of COVID-19 and one asymptomatic case, including 8 men and 13 women, in market Y, surrounding communities, food plaza, companies,families and other places. The incidence peaked during June 10-14, 2020; the median age of the cases was 45 years, ranging from 5 years to 87 years. The initial symptoms of the cases included fever (10/20) and pharynx discomfort (7/20). The median of incubation period was 5 days ( IQR:3-8). The median of serial interval between primary case and secondary cases was 5 days with a secondary attack rate of 3.7%(20/538), and the secondary attack rate in household close-contacts was 14.0% (7/50). Conclusions:The clusters of COVID-19 associated with market Y were caused by several modes of transmission, including human-to-human, contaminated material-to-human, etc. The combined public-health response measures were effective to control the COVID-19 epidemic in Haidian district of Beijing.
3.Efficacy and complications of intravesical instillation of BCG for prevention of recurrence of moderate and high-risk non muscle invasive bladder cancer
Weibing SUN ; Zhiyu LIU ; Quanlin LI ; Xishuang SONG ; Xiangbo KONG ; Chunxi WANG ; Qifu ZHANG ; Qingguo ZHU ; Changfu LI ; Wanhai XU ; Guanghai YU ; Cheng ZHANG ; Jinyi YANG ; Tianjia SONG ; Jiye ZHAO ; Qizhong FU ; Lixin WANG ; Quanzhong DING ; Xuehui CAI ; Chuize KONG
Chinese Journal of Urology 2019;40(1):14-19
Objective To assess the efficacy and side effects of intravesical instillation of BCG after transurethral resection of the bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC) patients.Methods The clinical data of patients treated with BCG 120 mg per course induced perfusion or more after TURBT from December 2013 to October 2016 in 18 hospitals of northeast China region,were analyzed retrospectively.The first part,data of 106 patients with moderate,high-risk NMIBC were collected.A total of 83 patients were male,while the other 23 patients were female.The average age was 66.7 years old.The clinical staging were T1 in 86(81.1%) cases,Ta in 20(18.9%) cases and carcinoma in situ in 6 (5.7%) patients.Intravesical instillation of BCG was executed after transurethral resection of the bladder tumor.The incidence rate of recurrence and progression during more than 6 months' follow-up time were observed.Multivariate analyses were done by using logistic analysis and Cox proportional hazards regression model with Kaplan-Meier method.The second part,treatment compliance of 276 patients with bladder cancer,including moderate/high-risk NMIBC in 263 cases,moderate/high-risk NMIBC followed with renal pelvis/ureteral carcinoma in 8 cases were and moderate/high-risk NMIBC with renal pelvis/ureteral carcinoma in 5 cases who treated with BCG after the surgeries,were observed.Patients consisted of 211 males and 65 females with average age of 68.3 years.Results With a median follow-up of 12 months,9 (8.5%) patients experienced tumor recurrence and 2 (1.9%) patients were found progression in the first part.The one-year cancer free recurrence rate of the patients was 91.5%.Statistically significant prognostic factors for recurrence identified by multivariable analyses were prior recurrence of the tumors (OR =3.214,95%CI0.804-12.845,P =0.099).In the second port,an incidence rate of adverse effects was 64.1% (177/276).The Ⅲ/Ⅳ degree complications were occurred in 11 patients and satisfactory outcomes achieved with active treatment.A total of 36 patients withdrawal with the major causes were recurrence and progression of bladder tumor in 12 cases (4.4 %),9 cases (3.3 %) with economic reasons and 11 cases (4.0%) with serious complications.Conclusions NMIBC patients treated with intravesical BCG therapy have approving cancer free recurrence rates and acceptable adverse effects.Prior recurrence may be prognostic factor of recurrence after intravesical BCG therapy.
4.Epidemiological characteristics of an epidemic of 2019-nCoV Omicron variant infection in Beijing
Yamin SUN ; Feng LIU ; Wei CAI ; Lina JIN ; Li GUO ; Run CAI ; Rujing SHI ; Fangyao LIU ; Chu JIANG ; Jiye FU ; Yang PAN ; Xiangfeng DOU ; Shuangsheng WU
Chinese Journal of Epidemiology 2022;43(12):1881-1886
Objective:To analyze the epidemiological characteristics and transmission chain of an epidemic of COVID-19 in Haidian district, Beijing.Methods:Descriptive epidemiological method was used to analyze the epidemiological characteristics of the epidemic, and field investigation and big data technology were used to analyze the transmission chain of the epidemic.Results:From April 27 to May 13, 2022, an epidemic of COVID-19 occurred in Haidian district. The strains isolated from the cases were identified by whole genome sequencing as Omicron variant (BA.2.2 evolutionary branch). A total of 38 infection cases were detected, including 34 confirmed cases and 4 asymptomatic cases. Most cases were mild ones (88.2%), no severe, critical or death cases occurred. The early clinical symptoms were mainly sore throat (50.0%) and cough (29.4%). The epidemic lasted for 17 days, resulting in 7 generations of the cases and involving 3 community transmissions, 2 working place transmissions and 8 family transmissions; the main infection routes were co-residence (47.6%) and co-space exposure (31.6%). The intergenerational interval M( Q1, Q3)was 3 (1, 6) days. The overall secondary attack rate was 1.5% (37/2 482), and the family secondary attack rate was 36.7% (18/49). Conclusions:The cases in this COVID-19 epidemic caused by Omicron variant had mild clinical symptoms, but the case clustering in families and communities was obvious, the transmission was rapid, and the risk for co-space exposure was high. It is necessary to use information technology to identify close contacts in the local population for the rapid and effective blocking of the epidemic spread.