酒石酸托特罗定治疗双极等离子前列腺剜除术后膀胱不适症状临床研究

Tolterodine for Prevention of Bladder Discomfort after Itraluminal Enucleation of the Prostate Using Plasma Kinetic Energy

目的评估酒石酸托特罗定治疗双极等离子前列腺剜除术后膀胱不适症状的疗效和安全性.方法采用前瞻双盲随机对照的临床研究,376例行双极等离子前列腺剜除术后的前列腺增生症患者被随机分入试验组(n=172)和对照组(n=204),试验组术后服用酒石酸托特罗定片,对照组术后服用安慰剂,均为2mg,Bid,连续6d.记录术后6d内患者的膀胱不适症状,并将膀胱不适症状分为轻、中、重度.结果对照组膀胱不适症状发生率为52.0%(106/204),高于试验组的41.3%(71/172)(P<0.05);并且试验组的膀胱不适症状的严重程度也低于对照组,但是试验组(10.5%)的尿潴留发生率高于对照组(2.0%);61.0%试验组患者有口干等不良反应.结论Tolterodine能安全有效的降低双极等离子前列腺剜除术后的膀胱不适症状的发生率和严重程度,但可能增加的尿潴留的风险.

Objective To evaluate the efficacy and safety of tolterodine for prevention of bladder discomfort after itraluminal enucleation of the prostate using plasma kinetic energy. Methods A prospective, randomized, double-blind, placebo-controlled study was adopted. The 376 patients who underwent itraluminal enucleation of the prostate for benign prostates hyperplasia were randomly divided into toherodine group （Group T, n = 172） and control group （Group C, n = 204）. The patients in Group T received tolterodine 2 mg twice daily after surgery, the patients in Group C received placebo, The bladder discomfort was assessed after 6 days,severity of bladder discomfort was graded as mild, moderate and severe. Results The incidence of bladder discomfort in the Group C was higher, i.e. 52.0% （106/204） , compared with Group T where it was 41.3% （71/172 ）（P 〈 0.05 ）. Significant reduction in the severity of bladder discomfort was also observed after tolterodine therapy compared with control （P 〈 0.05）. But the incidence of urinary retention in the Group T （10.5%） was higher than that in Group C （2.0%）. The incidence of side effects in the Group T was 61.0%. Conclusion Tolterodine can reduce the incidence and severity of bladder discomfort after itraluminal enucleation of the prostate using plasma kinetic energy ; but it can increase the risk of urinary retention.