1.Ethical Review on Placebo Control in Ophthalmic New Drug Clinical Trials
Yifeng JIANG ; Lei MA ; Shuya ZHANG ; Erjun GONG ; Yanhong ZHU
Chinese Medical Ethics 2014;(2):189-190
In China , some ophthalmic new drug clinical trials used placebo as control .Two principles should be con-sidered in ethical review when placebo was used in these ophthalmic new drug clinical trials .Firstly, using placebo couldn't lead to irreversible or permanent vision loss .Secondly , there should be proper risk management in protocol and risk dis-closure in consent process .There are several important factors , including effects of standard treatment , risks of using pla-cebo, risk management in protocol and risk information in informed consent form , which should be used to assess the ra-tionality of placebo in ethical review .
2.Effects of three surgical modalities on ovarian reserve by assessing the serum level of anti-Mullerian hormone for uterine fibroids
Hua YUAN ; Shaojie ZHAO ; Hua GONG ; Xi LIANG ; Yifeng WANG
Chinese Journal of General Practitioners 2015;14(5):377-380
To compare the effects of laparoscopic total or subtotal hysterectomy and myomectomy on ovarian reserve by measuring the serum level of anti-Mullerian hormone (AMH).A total of 96 patients with uterine fibroids underwent total laparoscopic hysterectomy (TLH group,n =32),laparoscopic subtotal hysterectomy (LSH group,n =31) and laparoscopic myomectomy (LM group,n =33).Changes in ovarian reserve were examined by measuring the level of AMH pre-operation and at 1 and 4 months post-operation.No significant differences existed in AMH in LM group[(1.42 ±0.65),(1.31 ±0.53) & (1.33 ±0.61) μg/L,P > 0.05].The levels of AMH in both groups were significantly lower than those at pre-operation [(1.17 ± 0.11),(1.01 ±0.10),(0.48±0.54) & (1.18±0.93),(0.45 ±0.39),(0.14±0.0) μg/L,P<0.001].The mean percentage decrease in AMH was lower in TLH group than that in LSH group at 4-month follow-up [(-37.4 ± 37.6) % vs.(-27.0 ± 23.0) %,P =0.017].The results showed that LM had no effect on ovarian reserve.Both LSH and TLH had adverse effects on ovarian reserve and TLH was more marked.
3.Analysis on the Utilization of Drug Included in the Army Rational Medicine Directory in a Military Sanatorium in 2009
Shuguang GONG ; Chengwei ZHANG ; Yifeng SUN ; Fangfang LU
China Pharmacy 2001;0(08):-
OBJECTIVE:To analyze the utilization of drug included in the army of rational medicine directory in a military sanatorium in 2009.METHODS:To extrac convalescent medication data from a military sanatorium "military sanatorium information system",and analyze the drug use situation.RESULTS:The first 6-bit key role of drug consumption was the circulatory system drugs,anti-microbial drugs,a major role in the central nervous system drugs,clinical subjects medication,a major role in the respiratory system drugs,a major role in the digestive system drugs.CONCLUSION:The drug use of the military sanatorium for the convalecents basically matches the spectrum of convalecent disease.
4.Clinical significance of differential expression of inflammatory factors in chronic non-bacterial prostati-tis/chronic pelvic pain syndrome
Qing ZHOU ; Xuefei TIAN ; Yifeng YUAN ; Bo YUAN ; Shuohuang PI ; Xiuying GONG ; Shuxiang WANG ; Hua XU
Chinese Journal of Urology 2009;30(6):386-389
Objective To investigate the role of inflammatory cytokines in the pathogenesis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome (CAP/CPPS) patients. Methods The 38 cases with CAP/CPPS patients (18 cases of CAP and 20 cases of CPPS) and 20 cases of healthy controls were selected. The differential expressions of 40 kinds of inflammatory cytokines were detec-ted by antibody arrays in prostate fluid. Results The inflammatory cytokines which increased more than 1.5 times expression have been found. There were seven kinds in CAP including monocyte che-moattractant protein (MCP)-1, solution tumor necrosis factor receptor Ⅱ(s TNF R Ⅱ), platelet-de-rived growth faetor-BB (PDGF-BB), interleukin (IL)-β, IL-11、IL-6、MCP-2 and five kinds in CPPS groups including MCP-1、PDGF-BB、MCP-2、s TNF R Ⅱ、It-11 respectively, compared with healthy control group. The cluster analysis results showed that protein expression of Monocyte chemoattrac-tant protein 1 (MCP-1)and platelet-derived growth factor BB (PDGF-BB) were significantly increased in CAP (3.47 and 2.07 times) and CPPS (2.25 and 2.19 times) compared with healthy control group and were the final polymerization of inflammatory cytokines. The protein expression of interleukin 1 β (IL-1 β), MCP-1 and soluble tumor necrosis factor Ⅱ (s TNF R Ⅱ) in CAP group was increased more than 1.85,1.55,1.67 times compared with CPPS group. Conclusions Elevated expression of inflammatory cytokines may play an important role in the course of CAP/CPPS disease. The extent of the inflammatory response of CAP was higher than CPPS. The inflammatory factors of MCP-1 and PDGF-BB could serve as a novel diagnostic marker.
5.Application of contrast-enhanced ultrasound in preoperative diagnosis of anal fistula
Dazhong ZOU ; Yifeng YU ; Danping YAN ; Li LIU ; Qin XUE ; Yufang XU ; Yuying TANG ; Hai GONG
Chinese Journal of Ultrasonography 2010;19(12):1051-1053
Objective To evaluate the clinical value of contrast-enhanced ultrasound (CEUS) in preoperative diagnosis of anal fistula. Methods Forty-five patients with fistula in ano were evaluated by physical examination, then CEUS were peformed by injecting SonoVue through the external opening to enhance the detection of the fistulous track and the internal opening. The results of CEUS were matched with surgical features to establish their accuracy in preoperative assessment of anal fistula. Results Simple typing fistula was found in 19 of 45 patients and 26 patients had complex fistulas. The accurate diagnostic rates by conventional ultrasound of simple typing fistula and complex fistulas were 89. 5% and 61.5%,respectively,the accurate diagnostic rates by CEUS of simple typing fistula and complex fistulas were 94. 7% and 92.3%, respectively, there was no significant difference between conventional ultrasound and CEUS about simple typing fistula( P >0.05), and there was significant difference about complex fistulas ( P <0. 05). Conclusions CEUS has a good visibility and accurate rate for diagnosis of anal fistula,It plays an important role for operation.
6.Clinical features of pulmonary infection at different stages after renal transplantation
Yan QIN ; Fang ZHANG ; Yong LIU ; Yu FAN ; Erdun BAO ; Jianxin QIU ; Yifeng GUO ; Jie ZHU ; Zhihong LIU ; Bing SHEN ; Hua GONG ; Yong WANG
Chinese Journal of Infection and Chemotherapy 2009;09(4):260-263
Objective To investigate the clinical features and prognosis of pulmonary infection at different stages after renal transplantation.Methods Medical records of 61 patients with pulmonary infection after renal transplantation from January 2003 to July 2008 in our hospital were reviewed in this retrospective study. According to stages of infection onset, we divided all patients into two groups, early onset group (43/61, 70.5%, ≤12 months after transplantation) and late onset group (18/61, 29.5%, >12 months after transplantation). Clinical manifestations and prognosis were compared between the two groups.Results In the early onset group, the radiographic manifestation suggested diffuse interstitial changes of bilateral lungs. Combination of anti-infective therapy and early mechanical ventilation was preferred. While in the late onset group, unilateral pulmonary lesions were seen in most cases. More patients showed cardiac and gastrointestinal complications in this group, the mortality of which was much higher. Conclusions Pulmonary infection is a major complication of renal transplantation. The etiology, clinical characteristics and prognosis of infection varies with the stage after transplantation. Effective preventive and therapeutic measures should be applied more vigorously in patients with pulmonary infection, especially early onset ones.
7.A clikical study on kidney transplantation patients with a survival time over 10 years and long-term administration of cyclosporine
Yan QIN ; Yu FAN ; Xingyu MU ; Fang ZHANG ; Yong LIU ; Erdun BAO ; Jianxin QIU ; Jie ZHU ; Zhihong LIU ; Bing SHEN ; Yifeng GUO ; Hua GONG ; Mingyue TAN ; Yong WANG
Chinese Journal of Organ Transplantation 2010;31(11):661-664
Objective To investigate the effect of cyclosporine blood level at first year after kidney transplantation on patients with a survival time over 10 years. Methods 380 patients with functional allograft, a survival time over 10 years and long-term administration of cyclosporine A (CsA) were studied, and received CsA-based treatments. According to the blood CsA level at the first year after kidney transplantation, patients were divided into five groups: group 1, blood CsA level was above 0. 208 μmol/L (1 μmol/L = 1201.9 μg/L), group 2, blood CsA level between 0. 166-0. 208μmol/L; group 3, blood CsA blood level between 0. 125-0. 166 μmol/L; group 4, blood CsA blood level between 0. 083-0. 125 μmol/L; group 5, blood CsA level less than 0. 083 μmol/L. Systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine(SCr), uric acid (UA), cholesterol (CH), triglyceride (TG), alanine aminotransferase (ALT), direct bilirubin (DBil) and total bilibubin (TBil), albumin (Alb), hemoglobin (Hb), count of white blood cells and positive rate of proteinuria in 5 groups at the 1st, 5th and 10th year after kidney transplantation were analyzed. Results At the 5th year SBP in groups 1 and 2 was higher than in groups 3, 4 and 5. UA level in group 5 was lower than other groups, and Alb level in group 5 was higher than other 4 groups. Proteinuria positive rate in groups 4 and group was lower than other groups. At the 10th year after kidney transplantation,indexes among 5 groups had no statistically significant difference, except for SBP, DBP, DBil and CH in some groups. There was also no significant difference in SCr level among 5 groups at the 5th or 10th year after transplantation. Conclusion Blood CsA levels at the first year after kidney transplantation has no significant effect on long-term allograft function. But higher level of CsA (>0. 166μmol/L) at the first year maybe predict high rate of hypertension, high blood UA and proteinuria at the 5th and 10th year after transplantation.
9.Application and development of stabilizers in coronary artery bypass grafting
Ke GONG ; Xiaobo LIAO ; Yifeng YANG ; Li XIE
Journal of Chinese Physician 2023;25(4):618-621
The first robotic heart surgery was performed more than two decades ago. Less invasive cardiac surgical techniques have become increasingly popular in recent years. The integration of emerging materials, computers and engineering technologies has provided the conditions for the application of robotic surgery in various cardiac procedures. Coronary artery bypass grafting (CABG), mitral valvuloplasty/valvuloplasty and radiofrequency/cryoablation for atrial fibrillation are some of the most common surgical procedures. Currently, only a few international cardiac centers have teams specializing in total endoscopic coronary artery bypass grafting. Although some studies have shown good results in robot-assisted heart surgery, questions remain about its safety, cost-benefit ratio, and long-term clinical outcomes. Robotic heart surgery poses higher challenges to myocardial protection and precise anastomosis. The role of stabilizers is to provide a relatively stable field of vision for heart surgery, which is the basis of all non-stop heart surgery. Because of their importance, researchers around the world are constantly exploring how to develop new, more sophisticated stabilizers. This review focuses on the research and development status and development trend of the stabilizer, summarizes the advantages and disadvantages of the current commonly used stabilizer, closely follows the clinic, makes in-depth analysis, and puts forward the key points of the future development of the stabilizer in coronary artery bypass surgery.
10.Midterm follow-up results of implantation of a fully biodegradable ventricular septal defect occluder
Xueyang GONG ; Yifeng YANG ; Tianli ZHAO ; Shijun HU ; Weizhi ZHANG
Journal of Central South University(Medical Sciences) 2024;49(5):795-801
Objective:Ventricular septal defect(VSD)is a prevalent congenital cardiac anomaly.By enhancing the occluder design and optimizing procedural approaches,the indications for VSD closure can be broadened while minimizing associated complications.The utilization of fully biodegradable occluder holds promising potential in resolving conduction block issues encountered during VSD closure.This study aims to compare the results of the fully biodegradable occluder with the metal occluder in transoesophageal echocardiography-guided VSD closure via lower sternal level minor incision at the interim follow-up,and to find risk factors for the occurrence of electrocardiographic and valvular abnormalities postoperatively. Methods:We reviewed the postoperative and 3-year follow-up data of all patients who underwent the randomized controlled study of VSD closure from January 1 to November 7,2019 in the Second Xiangya Hospital of Central South University.The safety and efficacy of the procedure were assessed and compared between the 2 groups by electrocardiogram and echocardiography results,and the risk factors for the occurrence of postoperative electrocardiogram and valve abnormalities were studied with Logistic regression analysis. Results:Twelve and fifteen patients underwent VSD closure with the metallic occluder and the fully biodegradable occluder,respectively.All patients survived during the follow-up period without major complications such as atrioventricular block,significant residual shunt,too rapid absorption of the occluder,and significant valvular regurgitation.There were no significant differences in the results of electrocardiograph and color Doppler ultrasonography the metal occluder group and the fully biodegradable occluder group 1,2,and 3 years after operation(all P>0.05).The size of the occluder were risk factors for tricuspid regurgitation at 2 and 3 years postoperatively,and the difference between the occluder size and the VSD defect size were risk factors for tricuspid regurgitation at 2 years postoperatively(P<0.05). Conclusion:This study adequately demonstrates the safety and efficacy of fully biodegradable occluders in small VSD closure and shows the same postoperative effects as conventional nitinol occluders.