Do Repeat Intradetrusor Botulinum Toxin Type A Injections Yield Valuable Results? Clinical and Urodynamic Results after Five Injections in Patients with Neurogenic Detrusor Overactivity

OBJECTIVES: To study repeat intradetrusor botulinum toxin injections for the treatment of neurogenic detrusor overactivity in terms of safety and improvement of continence status and urodynamic parameters. MATERIAL AND METHODS: This study was based on 20 consecutive patients (13 males, 7 females; median age, 41.1 yr) who received at least five intradetrusor injections of botulinum toxin and who were followed by clinical and urodynamic evaluation after at least four injections. The results of 100 injections and corresponding follow-ups were analyzed and compared with baseline. RESULTS: No toxin-related side effects were observed after the first or repeat injections. All patients had a baseline urodynamic study and at least four urodynamic studies after botulinum toxin injections. Clinical continence improved significantly after the first injection and then remained constant after repeat injections. The median reflex volume increased significantly from a median of 200 ml at baseline to values between 440 and 500 ml at follow-up studies. The presence of neurogenic detrusor overactivity decreased significantly by 60-75%. Maximum cystometric capacity increased significantly 2.3-fold. Maximum detrusor pressure during cystometry decreased significantly 5.8-fold from a median of 70 cm H(2)O to values of about 20 cm H(2)O. Median compliance at baseline (60 ml/cm H(2)O) did not change significantly. CONCLUSION: Repeat intradetrusor botulinum toxin A injections are a safe and valuable treatment option for neurogenic detrusor overactivity over a period of several years. The beneficial effect of the toxin on clinical and urodynamic parameters remains constant after repeat injections.     

艾普拉唑治疗十二指肠溃疡及CYP2C19代谢型对疗效影响的多中心临床研究

目的确证每日10mg艾普拉唑肠溶片治疗十二指肠溃疡的疗效和安全性,评价不同细胞色素氧化酶P450CYP2C19代谢型对药物疗效的影响。方法采用多中心、随机、双盲双模拟、阳性药物平行对照设计,入选患者按2：1随机进入艾普拉唑组（10mg／d,321例）或对照奥美拉唑组（20mg／d,159例）,疗程4周。同时检测患者CYP2C19的代谢型。结果艾普拉唑和奥美拉唑均可快速缓解患者疼痛、烧心、反酸、恶心呕吐、嗳气、腹胀等临床症状,除2周艾普拉唑对腹胀的改善情况优于奥美拉唑（P=0．0344）,2周两组综合症状改善显效率和有效率、其余单一症状改善有效率差异均无统计学意义。艾普拉唑组和奥美拉唑组2周溃疡愈合率分别为77．88％和75．00％;4周愈合率分别为93．03％和90．85％,两组间差异亦无统计学意义。两组同一代谢型之间以及组内不同代谢型之间的4周溃疡痊愈率无统计学差异（P〉0．05）。艾普拉唑组不良反应发生率为8．46％,对照组为11．52％。主要不良反应包括腹泻、头痛头晕、ALT／AST升高等,未发生严重不良事件。结论每日10mg艾普拉唑肠溶片能安全、有效地治疗十二指肠溃疡,且不受CYP2C19代谢型的影响。     

造影剂碘普罗胺在妇科盆腔CT检查中的效果及其安全性

目的 探究与分析造影剂碘普罗胺在妇科盆腔CT检查中的效果及其安全性.方法 运用回顾性研究方法,选取我院2018年2月-2021年1月收治的78例接受妇科盆腔CT增强检查者作为研究对象,观测全部患者的影像质量、全身及局部耐受性和相关不良反应.结果 在78例检查中,影像质量优良率为97.44％,患者耐受度为97.44％.患...     

GAD65 vaccination: 5?years of follow-up in a randomised dose-escalating study in adult-onset autoimmune diabetes

Aims/hypothesis  The aim of this study was to ascertain whether treatment of GAD65 autoantibody (GADA)-positive diabetic patients with alum-formulated recombinant GAD65 (GAD-alum) is safe and does not compromise beta cell function. Methods  This Phase 2, placebo-controlled, dose-escalation clinical trial, which was randomized through a central office, was performed in 47 GADA-positive type 2 diabetic patients, who received subcutaneous injections of GAD-alum (4 [n = 9], 20 [n = 8], 100 [n = 9] or 500 [n = 8] μg) or placebo (n = 13) at weeks 1 and 4 of the trial. Participants and caregivers were blinded to group assignments. The primary outcome was safety as assessed by neurological tests, medications and beta cell function evaluated over 5 years, representing the end of the trial. Results  No severe study-related adverse events occurred during the 5 year follow-up. None of the dose groups was associated with an increased risk of starting insulin treatment compared with the placebo group. The use of oral hypoglycaemic agents did not differ between the dose groups. After 5 years, fasting C-peptide levels declined in the placebo group (−0.24; 95% CI −0.41 to −0.07 log₁₀ nmol/l; p = 0.01) and the 500 μg dose group (−0.37; 95% CI −0.57 to −0.17 log₁₀ nmol/l; p = 0.003), but not in the 4 μg (−0.10; 95% CI −0.28 to 0.07 log₁₀ nmol/l; p = 0.20), 20 μg (0.04; 95% CI −0.12 to 0.19 log₁₀ nmol/l; p = 0.58) and 100 μg (0.00; 95% CI −0.20 to −0.20 log₁₀ nmol/l; p = 0.98) dose groups. Conclusions/interpretation  The primary outcome of safety was achieved, since no severe study-related adverse events occurred. Trial registration  Because the study was initiated before 1 July 2005, the protocol was not registered in a registry. Funding  This trial was funded by the National Institutes of Health (grant numbers DK26190 and DK53004), the Swedish Research Council (grant number 72X-14064) and Diamyd Therapeutics (Stockholm, Sweden). Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorised users.     

临床药师对阿司匹林安全性干预研究

目的：通过临床药师宣教,研究临床药师对药品不良反应的影响。方法：从高血压、糖尿病、冠心病、脑卒中、高血脂的患者中抽取服用阿司匹林者262例,制作《阿司匹林用药手册》及宣教幻灯片,向患者传播阿司匹林用药知识及减轻、减少药品不良反应措施。选取的患者在宣教、随访、讲课等干预前后,分别进行B超检查并测定出凝血时间、血常规、肝功能、肾功能。结果：干预前后胃肠道反应、出血倾向、血栓形成倾向、肝功能异常发生率降低显著,肾功能异常、神经系统反应、凝血障碍发生率也有所降低。临床药师干预前不良反应发生率约12.21%,干预后降低到3.82%。患者用药依从性从干预前的23.48%提升到干预后的69.05%。结论：临床药师可以减少、减轻药品不良反应,提高患者用药安全性和用药依从性。     

基于总处方量的不良反应报告分析对盐酸伐地那非安全性评估研究

目的：基于盐酸伐地那非（艾力达）上市以来总处方量的不良反应报告分析,评估其安全性,旨在对临床规范用药提供有益借鉴。方法：查阅WHO药品不良反应数据库,检索并分析比较药品不良反应报告。结果：药品不良反应报告主要集中在心血管等系统。各个系统不良反应表现形式各异,但都比较轻微,基于总处方量来讲,不良反应报告率极低。严重不良反应如心肌梗塞、异常勃起的报告率极少。结论：枸橼酸西地那非治疗勃起功能障碍的安全性比较高;应继续规范药物的临床应用,尽量减少死亡、异常勃起等严重不良反应的发生。     

重组人脑利钠肽治疗急性失代偿性心力衰竭的临床研究

目的：探讨冻干重组人脑利钠肽（rhBNP）对急性失代偿性心力衰竭的治疗效果和安全性。方法：选取40例急性失代偿性心力衰竭患者随机分为rhBNP组（n=20）和对照组（n=20）。rhBNP组以rhBNP1.5μg／kg静脉注射后,再以0.0075μg／kg持续静脉泵入：对照组持续静脉泵入硝普钠。观察治疗前、治疗48h后心肌酶水平、心脏超声指标、每小时尿量的变化。安全性评估采用用药过程中及用药后定期测量血压、心率．并记录用药过程中的不良事件。结果：治疗48h后rhBNP组心肌酶水平、LVEF、每小时尿量均显著优于常规对照组（P〈0.05或P〈0.01）。rhBNP组的不良事件与对照组相比无差异。结论：rhBNP能显著改善急性失代偿性心力衰竭患者的血流动力学及全身临床状况．其安全性与硝普钠相似。     

罗格列酮的安全性评价

目的：介绍当前临床广泛应用但又长期富有争议的胰岛素增敏剂罗格列酮的安全性评价情况。方法：检索并综合近期国外发表的有关文献进行分析与综述。结果：罗格列酮与心功能不全有一定关联。结论：依据循证资料．罗格列酮的总体评价是利稍大于弊．对其弊应予重视,为此．医师必须在知情同意下．严格掌握适应征：即只能用于其他降糖药无效的2型糖尿病患者．或一直使用此药有效且无严重不良反应者。     

法莫替丁注射液的研制

目的：制备法莫替丁注射液,建立其质量控制方法,并考察其稳定性和安全性。方法：优化处方组成与制备工艺,并进行性状、鉴别、检查等质量研究,采用高效液相色谱法测定有关物质和含量,影响因素试验、加速试验和长期试验考察其稳定性,血管刺激性试验、溶血性试验以及过敏性试验评价其用药的安全性。结果：样品经酸、碱、氧化、热、光照破坏后所产生的杂质峰均能与主峰有效分离,最低检测限为1.0ng。法莫替丁在80.32～120.48μg/ml的浓度范围内与峰面积成良好的线性关系,平均回收率为99.76%,RSD为0.73%。恒温加速试验6个月和长期留样试验12个月,其性状、pH值、有关物质、可见异物、含量等均未见明显改变。结论：该制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。     

我院医务人员接种H1N1流感疫苗安全性调查分析

目的：调查我院医务人员接种H1N1流感疫苗的安全性。方法：对我院2009年11-12月接种H1N1流感疫苗的249名医务人员进行问卷调查,包括接种人员一般情况、注射疫苗后不良反应发生率、出现时间、持续时间、转归等,并对其进行统计分析。结果：249例接种者中发生不良反应64例,发生率为25.70%。不良反应表现以全身反应为主,主要有发热、头晕、头痛、乏力、肌肉酸痛。男女接种者发生率分别为17.31%（9/52）和27.92%（55/197）（χ2=2.4303,P〉0.05）,差异无显著统计学意义;各年龄组间不良反应发生率差异无显著统计学意义（χ2=4.6563,P〉0.05）。不良反应症状普遍较轻或中等,大多数患者均能自愈（59/64）,少数经过对症治疗痊愈（5/64）。结论：H1N1流感疫苗总体上安全性较好。