毛细管气相色谱法测定酒石酸托特罗定中有机溶剂的残留量

摘 要 目的： 建立毛细管气相色谱法测定酒石酸托特罗定中8种有机溶剂残留量的方法。 方法: 采用CP sil 5CB色谱柱（60.0 m×0.32 mm,5 μm）;进样口温度为200℃;FID检测器温度为250℃;载气流速为1.2 ml·min^-1;柱温120℃;顶空瓶平衡温度85℃,时间30 min,以二甲基甲酰胺 水（1∶4）混合溶液为溶解介质,测定酒石酸托特罗定中甲醇,乙醇,乙腈,丙酮,乙酸乙酯,三氯甲烷和四氢呋喃的残留量;采用HP 1色谱柱（30.0 m×0.53 mm,5 μm）,进样口温度为220℃;FID检测器温度为250℃;载气流速为3.0 ml·min^-1;柱温80℃;顶空瓶平衡温度85℃,时间30 min,以二甲亚砜 氢氧化钠溶液（17∶13）混合溶液为溶解介质,测定酒石酸托特罗定中吡啶的残留量。结果:在各色谱条件下,被测溶剂峰之间均分离良好,8种溶剂的标准曲线线性良好,相关系数均大于0.999;平均回收率为86.0%～100.2%,RSD为1.7%～3.5%(n=9);甲醇,乙醇,乙腈,丙酮,乙酸乙酯,三氯甲烷,四氢呋喃和吡啶的检测限分别为0.63,0.43,0.30,0.18,0.079,0.36,0.18,0.89 μg·ml^-1。结论: 该法适用于酒石酸托特罗定中这8种有机溶剂残留量的测定。     

Efficacy and Safety of Tol Terodine in People With Neurogenic Detrusor Overactivity

Abstract

Objective: To compare tolterodine with oxybutynin and placebo in people with neuragenie detrusor overactivity.

Design: Prospective, randomized, double-blind, crossover trial plus open-label comparative stage.

Participants: Ten participants with neuragenie detrusor overactivity due to spinal cord injury or multiple sclerosis who usedintermittent catheterization.

Methods: Bladder capacity on cystometrogram, a 10-day record of catheterization volumes, number of incontinent episodes perday, and perceived dry mouth using a visual analog scale (VAS) were measured for the following: (a) a blinded comparison:tolterodine, 2 mg twice daily, vs placebo, twice daily; and (b) an unblinded comparison: oxybutynin vs tolterodine, each atself-selected doses (SSDs).

Results: Tolterodine, 2 mg twice daily, was superior to placebo in enhancing catheterization volumes (P<0.0005) and reducingincontinence (P<0.001 ), but was comparable with placebo in cystometric bladder capacity. Efficacy of tolterodine SSD wascomparable with oxybutynin SSD with regard to catheterization volumes, degree of incontinence, and cystometric bladder capacity.The side effect profile (dry mouth) was comparable between tolterodine, 2 mg twice daily, and placebo, but differed significantlywhen comparing tolterodine SSD with oxybutynin SSD (P<0.05).

Conclusion: T olterodine, when used at SSDs, is comparable with oxybutynin at SSDs in enhancing bladder volume and improvingcontinence, but with less dry mouth. T olterodine at the recommended dosage of 2 mg twice daily improves incontinence and bladdervolumes compared with placebo, and without significant dry mouth. Larger doses of tolterodine may be needed to achieve best effectin this population, but further studies are required.     

托特罗定联合坦索罗辛治疗输尿管结石临床价值

目的探讨托特罗定联合坦索罗辛治疗输尿管结石的临床效果和安全性。方法将解放军11医院自2012年2月至2014年5月收治的219例输尿管结石患者,按随机数字表法分为两组。其中,观察组110例患者,使用托特罗定联合坦索罗辛进行治疗;对照组109例患者,仅使用坦索罗辛治疗。治疗4周后,比较两组患者的结石排石率、结石排出时间、肾绞痛发生率及疼痛视觉模拟评分(VAS)等指标并记录不良反应发生情况。结果观察组患者的总结石排石率为76.4%(84/110),对照组的结石排除率为57.8%(63/109),两组比较,差异有显著统计学意义(P<0.01)。观察组平均结石排出时间和VAS评分均低于对照组,差异有显著统计学意义(P<0.01)。观察组输尿管下段结石组肾绞痛发生率为13.2%(9/68),对照组为27.9%(17/61),两组比较,差异有统计学意义(P<0.05)。观察组的不良反应发生率为8.2%(9/110),对照组为5.5%(6/109),两组比较,差异无统计学意义(P>0.05),两组均无严重不良反应发生。结论托特罗定联合坦索罗辛治疗输尿管结石安全有效,尤其可提高输尿管中下段结石的清除率,缩短结石排出时间,减轻疼痛。     

屈他维林联合托特罗定治疗经尿道前列腺电切术后膀胱痉挛的疗效观察

目的探讨屈他维林联合托特罗定治疗经尿道前列腺电切术后膀胱痉挛的临床疗效。方法选取2016年6月—2017年6月在河北省沧州中西医结合医院治疗的经尿道前列腺电切术后后膀胱痉挛患者82例,随机将患者分为对照组(41例)和治疗组(41例)。对照组口服酒石酸托特罗定片,2 mg/次,2次/d。治疗组在对照组基础上口服盐酸屈他维林片,80 mg/次,3次/d。两组均在拔出尿管3 d后停药。观察两组患者临床疗效,比较治疗前后两组患者膀胱痉挛次数和持续时间以及膀胱过度活动症评分(OABSS)评分、膀胱状况感知量表(PPBC)评分、视觉模拟评分法(VAS)评分和生活质量(QOL)评分。结果治疗后,对照组和治疗组临床有效率分别为80.49%和97.56%,两组比较差异具有统计学意义(P0.05)。治疗2、3 d后,两组膀胱痉挛次数和持续时间均较治疗前显著减少,同组治疗前后比较差异具有统计学意义(P0.05);治疗后,治疗组膀胱痉挛次数和持续时间比同时期对照组均显著减少,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者OABSS评分、PPBC评分、VAS评分和QOL评分均明显降低;同组比较差异具有统计学意义(P0.05);且治疗组上述相关评分明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论屈他维林联合托特罗定治疗经尿道前列腺电切术后膀胱痉挛可显著改善患者临床症状,减轻患者疼痛,具有一定的临床推广应用价值。     

坦索罗辛联合托特罗定治疗前列腺增生合并膀胱逼尿肌不稳定的效果观察

目的为了探究临床有效治疗前列腺增生合并膀胱逼尿肌不稳定的可靠方法,从而为临床相关研究提供一些借鉴和参考。方法本次研究入选对象均为我院2009年1月—2012年1月期间收治的前列腺增生合并膀胱逼尿肌不稳定患者,共计132例,随机将患者分成两组,分别为观察组和对照组,每组66例,对照组患者服用坦索罗辛治疗,观察组患者服用坦索罗辛和托特罗定联合治疗。观察并且比较两组患者实施不同临床治疗措施前后国际前列腺症状评分结果、最大尿流率以及膀胱残余尿量。结果在国际前列腺症状评分结果[（10.34±5.38）VS（18.32±5.49）分]、最大尿流率[（17.99±3.28）VS（14.02±4.33）mL/s]以及膀胱残余尿量[（22.34±4.32）VS（29.30±4.87）mL]等三项指标上,组间比较,实施治疗后观察组各项指标水平均显著的优于对照组,并且组间数据差异具有统计学意义。结论与单纯采用坦索罗辛治疗的方法相比较,采用坦索罗辛联合托特罗定的治疗方法治疗前列腺增生合并膀胱逼尿肌不稳定患者的临床效果较好,是临床上的可靠选择。     

托特罗定防治经尿道前列腺切除术后膀胱过度活动症疗效观察

目的:评价托特罗定对前列腺切除术后膀胱过度活动症(OAB)的防治效果。方法:将49例行经尿道前列腺切除术(TURP)的前列腺增生症(BPH)患者随机分为托特罗定治疗组25例,对照组24例。观察患者膀胱痉挛的发生率,每天发生频率,持续天数;拔尿管后急迫性尿失禁的发生率,持续天数。结果:治疗组膀胱痉挛发生率较对照组无差异性(P>0.05)。但膀胱痉挛发生频率、持续时间较对照组明显减少(P<0.01);拔尿管后急迫性尿失禁发生率及持续时间较对照组明显减少(P<0.01)。结论:围手术期应用托特罗定可有效缓解前列腺增生症患者经尿道前列腺切除术后膀胱过度活动症的发生。     

A cost-utility analysis of once daily solifenacin compared to tolterodine in the treatment of overactive bladder syndrome

ABSTRACT

Objective: To evaluate the cost-utility of solifenacin, a new generation antimuscarinic, compared with tolterodine in the treatment of overactive bladder syndrome (OAB), from the perspective of the UK National Health Service (NHS).

Research design and methods: A 1-year Markov model was constructed using data from a 12-week, randomised, double-blind study that compared flexible dosing with solifenacin (5?mg and 10?mg) with tolterodine (IR 2?mg bd/ER 4?mg) in adults with OAB. The model incorporated five discrete health states that were based on disease severity (micturitions/day and incontinence episodes/day). A ‘drop out’ state was also used in the model to account for patients that discontinued treatment in the first year. UK-specific costs for drug treatment and pad use as well as utilities were assigned to each health state.

Results: Solifenacin was a less costly and more effective treatment strategy compared with tolterodine. During the course of 1 year, the estimated cost per patient was £509 for patients treated with solifenacin and £526 for those given tolterodine, a cost saving of £17 per patient. Treatment with solifenacin was also associated with a small incremental gain of 0.004 quality-adjusted-life-years (QALYs) over tolterodine. Sensitivity analysis suggests that the incremental cost effectiveness of solifenacin relative to tolterodine does not appear to exceed £30?000/QALY with even large variations in key model parameters.

Conclusion: Flexible dosing with solifenacin is likely to be cost-effective versus tolterodine in the treatment of OAB. Further studies are needed to confirm these results.     

Different responses to drugs against overactive bladder in detrusor muscle of pig,guinea pig and mouse

Direct comparison of experimental data for drugs commonly used in the treatment of overactive bladder is difficult because of possible species differences. In this study, we compare the effects of atropine, propiverine, oxybutynin and tolterodine in strips of pig, guinea pig and mouse detrusor muscle. In the three species, we observed slight differences in potency of carbachol-induced biphasic contractile responses between the species (guinea pig>pig>mouse). Cumulative concentration-response curves for carbachol were shifted to the right by atropine, propiverine, oxybutynin and tolterodine. However, at higher concentrations of the latter three antagonists, the maximum response to carbachol was also reduced. Therefore, propiverine, oxybutynin and tolterodine must have additional pharmacological actions beyond competitive antagonism at muscarinic receptors. Electric field stimulation (30 Hz) of detrusor strips led to contraction amplitudes, which remained constant over time (210 min) in pig, decreased by 17+/-5% in guinea pig, and increased by 28+/-9% in mouse detrusor muscle. Electric field stimulation-evoked contractions were suppressed to 18% of pre-drug control by high concentrations of atropine (10 microM) in pig, but to a much lesser extent in guinea pig and mouse (to 46% and 70%, respectively). In all three species, a myogenic component of contraction was observed in the presence of tetrodotoxin (1 microM). Compared to atropine, the bladder spasmolytic agents propiverine, oxybutynin and tolterodine also reduced electrically evoked contractions in the three species, though higher concentrations were required. The differences in the reported effects of the spasmolytic agents commonly used for treating overactive bladder suggest that drug action is strongly dependent on the species. Thus, a comparison of drug effects is only feasible in the same animal model and the results cannot easily be transferred to humans.     

托特罗定防治良性前列腺增生患者围手术期膀胱痉挛的临床疗效

目的 探讨良性前列腺增生(BPH)患者围手术期膀胱痉挛的有效防治方法.方法 BPH患者112例,随机分为2组,每组56例.治疗组应用酒石酸托特罗定治疗,术前4～5 d,术后3～4 d,2 mg,2次/d.对照组不服用任何对膀胱痉挛有影响的药物.观察比较2组患者经尿道前列腺切除术后膀胱痉挛发生频率、持续时间等.结果 对照组56例患者麻醉效应过后未发生膀胱痉挛7例(12.5%)、轻度膀胱痉挛(偶感耻骨上膀胱区及尿道疼痛不适)8例(14.3%)、膀胱痉挛(膀胱区阵发性疼痛伴尿液自尿管周围溢出)41例(73.2%).治疗组56例患者麻醉效应过后未发生膀胱痉挛49例(87.5%)、轻度膀胱痉挛5例(8.9%)、膀胱痉挛2例(3.6%).2组膀胱痉挛发生率比较差异有统计学意义(P相似文献   

舍尼亭联合α受体阻滞剂对逼尿肌过度活动患者尿动力学的影响

目的探讨舍尼亭联合α受体阻滞剂治疗良性前列腺增生伴逼尿肌过度活动尿动力学的影响及疗效。方法 108例良性前列腺增生伴逼尿肌过度活动患者随机分为观察组和对照组,各54例,分别给予舍尼亭联合可多华和可多华单用治疗。结果治疗前两组Qmax、Pdet、VV、PVR、24 h排尿次数之间差异无统计学意义(P>0.05),治疗后两组Pdet、PVR、24 h排尿次数均较治疗前显著降低,VV则显著升高(P均<0.05),Qmax与治疗前差异无统计学意义(P>0.05),两组各指标之间差异有统计学意义(P<0.05)。治疗后均显著下降,观察组均显著低于对照组(P<0.05),观察组6例(11.11%)、对照组5例(9.26%)出现轻度不良反应,两组差异无统计学意义。结论舍尼亭联合α受体阻滞剂能有效改善尿动力学,缓解良性前列腺增生患者的逼尿肌过度活动,安全有效。