1.Application of highly selective alpha 1-blockers after extracorporeal shock wave lithotripsy for ureteral stone
Kelin DU ; Jun OUYANG ; Caibin FAN ; Duangai WEN
Chinese Journal of Postgraduates of Medicine 2011;34(8):6-9
Objective To investigate the application of highly selective alpha 1-blockers in treatment of ureteral stone after extracorporeal shock wave lithotripsy (ESWL). Methods One hundred and twenty patients with ureteral stone who accepted ESWL were divided into three groups by random digits table,each 40 cases. Tamsulosin group received tamsulosin (0.4 mg,once daily) after ESWL,doxazosin group received doxazosin (4 mg,once daily) ,control group were given no ureteral smooth musclar relaxant served. All patients were observed for 2 weeks. Results During the 2 weeks, only 4 patients withdrew due to adverse drug reactions. In tamsulosin group and doxazosin group, the stones expulsion rate [89.7%(35/39), 83.8%(31/37) respectively] were significantly higher than control group [65.0%(26/40)] (P<0.05), the expulsion time [(3.1-1.2), (3.7 ± 1.4) d] were significantly lower than control group [(6.5 ±1.1) d] (P <0.05),the incidence of renal colic [12.8%(5/39), 21.6%(8/37)] and the stone street formation rate [7.7% (3/39), 13.5% (5/37)] were significantly lower than control group [45.0% (18/40) and 40.0% (16/40)] (P < 0.05). But there was no significant difference between tamsulosin group and doxazosin group (P > 0.05). Orthostatic hypotension occurred in 1 patient in tamsulosin group, but 7 patients experienced orthostatic hypotension in doxazosin group,the difference was significant (P < 0.05).Conclusions Highly selective alpha 1-blockers can improve the stone-free rate of ureteral stone after ESWL,reduce expulsion time,decrease renal colic rate,and it is safe and tolerated. It can be regarded as an auxiliary clearance method after ESWL for ureteral stone.
2.Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study
Huiyun ZHU ; Xue PAN ; Li ZHANG ; Hongxin SUN ; Huizhen FAN ; Zhongwei PAN ; Caibin HUANG ; Zhenwang SHI ; Jin DING ; Qi WANG ; Yiqi DU ; Nonghua LYU ; Zhaoshen LI
Chinese Medical Journal 2022;135(24):2941-2949
Background::The pharmacokinetic and clinical behaviors of many proton pump inhibitors (PPIs) in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms. This non-inferiority study evaluated the efficacy and safety of the novel PPI anaprazole compared with rabeprazole. We also explored the influence of Helicobacter pylori ( H. pylori) infection status and CYP2C19 polymorphism on anaprazole. Methods::In this multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, phase III study, Chinese patients with duodenal ulcers were randomized 1:1 to receive rabeprazole 10 mg + anaprazole placebo or rabeprazole placebo + anaprazole 20 mg once daily for 4 weeks. The primary efficacy endpoint was the 4-week ulcer healing rate assessed by blinded independent review. Secondary endpoints were the proportion of patients with improved overall and individual duodenal ulcer symptoms at 4 weeks. Furthermore, exploratory subgroup analysis of the primary endpoint by H. pylori status and CYP2C19 polymorphism was conducted. Adverse events were monitored for safety. Non-inferiority analysis was conducted for the primary endpoint. Results::The study enrolled 448 patients (anaprazole, n = 225; rabeprazole, n = 223). The 4-week healing rates were 90.9% and 93.7% for anaprazole and rabeprazole, respectively (difference, -2.8% [95% confidence interval, -7.7%, 2.2%]), demonstrating non-inferiority of anaprazole to rabeprazole. Overall duodenal ulcer symptoms improved in 90.9% and 92.5% of patients, respectively. Improvement rates of individual symptoms were similar between the groups. Healing rates did not significantly differ by H. pylori status or CYP2C19 genotype for either treatment group. The incidence of treatment-emergent adverse events was similar for anaprazole (72/220, 32.7%) and rabeprazole (84/219, 38.4%). Conclusions::The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers.Registration::ClinicalTrials.gov, NCT04215653.