1.Risks and prevention for ethical review of drug clinical trials
Chen WANG ; Tienan YAO ; Caizhen BAI
Chinese Journal of Hospital Administration 2011;27(9):684-688
The authors presented in the paper the following subjects: a description of risk exposures commonly found in drug clinical trials; risk types in terms of the personnel organization of ethical review boards, and the composition of the ethical review board members, as well as ethical training, ethical review procedures and supervising of the ethical review. To avoid these risks, an analysis is made on the causes of ethical review risks, and recommendations are proposed on international certification, reform of ethical review board setup, greater efforts on training, introduction of ethical supervision and ethical acceptance procedure.
2.Expression of extracellular signal-regulated kinase in intraepithelial neoplasi
Tienan BAI ; Yucheng LI ; Shumin ZHANG
Chinese Journal of Urology 2001;0(04):-
Objective To study expression of extracellular signal-regualated kinase in intraepithelial neoplasia,prostatic cancer and BPH tissue. Methods Expression of extracellular signal-regualated kinase (ERK) was determined in 12 prostatic intraepithelial neoplasia (PIN),11 prostate cancer and 16 benign prostatic hyperplasia specimens.ERK expression was determined by immunohistochemistry. Results ERK expression was positive in all the 12 PIN specimens,6 of which being overexpressed.In the 11 prostate cancer specimens,overexpression was observed in only one while the other 10 under expressed.Overexpreassion was not observed in all the BPH specimens whereas 12 of the 16 showed underexpression. Conclusions ERK expression is obviously higher in PIN tissue (P
3.Submucosal tunnel ureteroileostomy in detenia ceacal-colon continent urinary diversion using ileovalvular segment as afferent loop
Tienan BAI ; Fengkuan LI ; Weili MA
Chinese Journal of Urology 2001;0(07):-
Objective To evaluate the usefulness of the submucosal tunnel ureteroileostomy using ileovalvular segment as afferent loop in preventing ureteral refluxes and upper urinary tract infection in detenia ceacal-colon continent urinary diversion. Methods Ten patients underwent submucosal tunnel ureteroileostomy in detenia ceacal-colon continent reservior and detenia coloneobladder and the follow up for ureteral reflux and upper urinary tract infection was carried out from 1998 to 2001. Results The patients were followed up for 6 to 36 months.No evidence of ureteral reflux and upper urinary tract infection was observed.Unilateral hydronephrosis was found in one patient caused by the ureteroileal anastomotic stricture. Conclusions Submucosal tunnel ureteroileostomy is an effective fashion for detenia ceacal-colon continent urinary diversion in preventing the postoperative complications of ureteral reflux and upper urinary tract infection.
4.A comparative study of transurethral plasmakinetic resection versus transurethral resection of the prostate for benign prostatic hyperplasia
Bo CHENG ; Ruifa HAN ; Tienan BAI ; Chunyu LIU ; Yong XU ; Guang SUN
Chinese Journal of Postgraduates of Medicine 2008;31(z1):4-7
Objective To compare the efficacy and safety of transurethral plasmakinetic resection of prostate (PKRP) and transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH). Methods The clinical and follow-up data of 186 patients with BPH were analyzed retrospectively. Two groups of BPH patients (90 patients in PKRP group,96 patients in TURP group) were treated by PKRP and TURP,respectively. The clinical date and therapeutic result were measured and compared for both in-tra-and inter-groups. Results In PKRP group,the operative time,intraoperative bleeding,the rates of damage of prostate surgical membranes,secondary hemorrhage (within 1 month),the rates of postoperative temporary urinary incontinence (within 2 months) were (65.3 ± 12.8)min,(213.6 ± 78.2)ml,5.6%(5/90),2.2% (2/90)and 21.1% (19/90),respectively,while in TURP group,these parameters were (83.6 ± 17.5) min,( 397.4 ± 142.7 )ml,17.7%( 17/96 ),11.5% ( 11/96 )and 36.5% ( 35/96 ),respectively. There were signif-icant differences between the 2 groups (P < 0.05 ). In PKRP group,the international prostate symptom score (IPSS),quality of life(QOL),Qmax and PVR were (4.7 ± 1.3 )scores,(1.1 ± 0.4)scores,( 18.7 ± 5.6)ml/s,(8.9 ± 2.5)ml,respectively,while in TURP group,these parameters were (5.3 ± 1.0)scores,(1.2 ± 0.5) scores,(20.4 ± 4.3 )ml/s,(11.2 ± 3.2)ml,respehively. These parameters were significantly improved after both procedures(P < 0.05),but there was no significant difference in the above parameters between the 2 groups (P > 0.05). Conclusions PKRP and TURP have similar efficacy in the treatment of BPH,but PKRP ap-pears to have an advantage of more safety and easier blood controls with less physical damage and complica-lion than those in TURP. PKRP is a better treatment option for BPH.
5.Clinical efficacy of plasma exchange in 47 patients with severe bullous dermatoses or drug eruption
Tienan LI ; Xiaojie SUN ; Qingyan CHEN ; Lingyun LI ; Yan LIU ; Xin ZHANG ; Qiang WANG ; Yinghua BAI ; Yue LIU
Chinese Journal of Dermatology 2010;43(8):565-567
Objective To estimate the therapeutic value of plasma exchange (PE) in severe bullous dermatoses and drug eruption. Methods Plasma exchange was carried out to treat 47 patients with severe dermatoses including 15 cases of pemphigus, 17 cases of bullous pemphigoid and 15 cases of drug eruption who were intolerant or unresponsive to glucocorticosteroids and or immunosuppressants. Cobe Spectra blood cell separator was utilized to collect plasma and cell components from patients' blood, and the replacement fluid and cell components were infused back into patients. Patients received 1 to 3 sessions of plasma exchange. Results Of the 47 patients, 44 (93.62%) achieved satisfactory efficacy with relief of clinical symptoms and improvement of laboratory parameters 2 to 3 days after the plasma exchange. Side effects occurred in 11 (23.4%) patients, which included fever, shivering, numbness of limbs, pruritus and convulsion. Conclusion Plasma exchange is beneficial for the control of severe drug eruption and bullous dermatoses.