米拉贝琼与索利那新治疗膀胱过度活动综合征的疗效和药物不良反应比较

Megha O. Raj, Jinish Jose, Fredrick Paul, Syam Sreedharan, Nithya Uthaman
{"title":"米拉贝琼与索利那新治疗膀胱过度活动综合征的疗效和药物不良反应比较","authors":"Megha O. Raj, Jinish Jose, Fredrick Paul, Syam Sreedharan, Nithya Uthaman","doi":"10.4103/picr.picr_166_23","DOIUrl":null,"url":null,"abstract":"\n \n \n Overactive bladder (OAB) syndrome is a chronic disease characterized by urinary urgency with or without urge incontinence, frequency, and nocturia and antimuscarinic drugs such as solifenacin have been the mainstay of treatment. Mirabegron a beta 3 adrenoreceptor agonist has recently gained importance in the management of OAB. The rationale of the study is that mirabegron improves the storage function without affecting voiding which increases the therapeutic effectiveness. The objective was to determine the therapeutic effectiveness of mirabegron versus solifenacin.\n \n \n \n A prospective observational study was conducted on 298 patients with OAB syndrome attending the urology outpatient department of government medical college after obtaining institutional review board clearance. Patients of both genders, belonging to the 18–65 years of age group, attending the urology outpatient department were selected for the study. Patients were evaluated using the OAB-validated 8-question awareness tool (OAB-V8 score) before and after receiving drugs by direct questionnaire method after receiving informed consent. Patients were prescribed either solifenacin 5 mg or mirabegron 25 mg once daily by the urologist. Follow-up was done after 4 and 12 weeks. Adverse drug reactions of the drugs were assessed using the Central Drug Standard Control Organization suspected adverse reaction (ADR) form, and ADRs were notified to the nearest ADR monitoring center.\n \n \n \n The mirabegron group showed maximum improvement in the mean OAB-V8 score values from baseline at 4 weeks (12.82 ± 5.86, P < 0.001) and 12 weeks (5.74 ± 3.31, P < 0.001) when compared to solifenacin. OAB-V8 scores of the solifenacin group also showed significant improvement from the baseline at 4 weeks (15.30 ± 5.54, P < 0.001) and 12 weeks (8.05 ± 4.59, P < 0.001). Heart rate, systolic, and diastolic blood pressures did not show significant changes during the follow-up in both the study groups. Thirteen patients developed ADRs such as dry mouth (four patients) and constipation (nine patients) in the solifenacin group. No ADRs were noted in the mirabegron group.\n \n \n \n Mirabegron showed maximum improvement in the OAB-V8 scores in patients with OAB syndrome, although the solifenacin group also showed improvement. Adverse effects were less in the mirabegron group when compared to the solifenacin group.\n","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":" 582","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Therapeutic effectiveness and adverse drug reactions of mirabegron versus solifenacin in the treatment of overactive bladder syndrome\",\"authors\":\"Megha O. Raj, Jinish Jose, Fredrick Paul, Syam Sreedharan, Nithya Uthaman\",\"doi\":\"10.4103/picr.picr_166_23\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n \\n \\n Overactive bladder (OAB) syndrome is a chronic disease characterized by urinary urgency with or without urge incontinence, frequency, and nocturia and antimuscarinic drugs such as solifenacin have been the mainstay of treatment. Mirabegron a beta 3 adrenoreceptor agonist has recently gained importance in the management of OAB. The rationale of the study is that mirabegron improves the storage function without affecting voiding which increases the therapeutic effectiveness. The objective was to determine the therapeutic effectiveness of mirabegron versus solifenacin.\\n \\n \\n \\n A prospective observational study was conducted on 298 patients with OAB syndrome attending the urology outpatient department of government medical college after obtaining institutional review board clearance. Patients of both genders, belonging to the 18–65 years of age group, attending the urology outpatient department were selected for the study. Patients were evaluated using the OAB-validated 8-question awareness tool (OAB-V8 score) before and after receiving drugs by direct questionnaire method after receiving informed consent. Patients were prescribed either solifenacin 5 mg or mirabegron 25 mg once daily by the urologist. Follow-up was done after 4 and 12 weeks. Adverse drug reactions of the drugs were assessed using the Central Drug Standard Control Organization suspected adverse reaction (ADR) form, and ADRs were notified to the nearest ADR monitoring center.\\n \\n \\n \\n The mirabegron group showed maximum improvement in the mean OAB-V8 score values from baseline at 4 weeks (12.82 ± 5.86, P < 0.001) and 12 weeks (5.74 ± 3.31, P < 0.001) when compared to solifenacin. OAB-V8 scores of the solifenacin group also showed significant improvement from the baseline at 4 weeks (15.30 ± 5.54, P < 0.001) and 12 weeks (8.05 ± 4.59, P < 0.001). Heart rate, systolic, and diastolic blood pressures did not show significant changes during the follow-up in both the study groups. Thirteen patients developed ADRs such as dry mouth (four patients) and constipation (nine patients) in the solifenacin group. No ADRs were noted in the mirabegron group.\\n \\n \\n \\n Mirabegron showed maximum improvement in the OAB-V8 scores in patients with OAB syndrome, although the solifenacin group also showed improvement. Adverse effects were less in the mirabegron group when compared to the solifenacin group.\\n\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":\" 582\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-05-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.picr_166_23\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_166_23","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

膀胱过度活动症(OAB)是一种慢性疾病,以尿急为特征,伴有或不伴有急迫性尿失禁、尿频和夜尿症。Mirabegron 是一种 beta 3 肾上腺素受体激动剂,最近在治疗 OAB 方面越来越受到重视。这项研究的基本原理是米拉贝琼能改善储尿功能而不影响排尿,从而提高治疗效果。研究的目的是确定米拉贝琼与索利那新的治疗效果。 在获得机构审查委员会批准后,我们对在公立医学院泌尿科门诊就诊的 298 名 OAB 综合征患者进行了前瞻性观察研究。研究选择了在泌尿科门诊就诊的 18-65 岁男女患者。在征得知情同意后,采用直接问卷调查法对患者用药前后的OAB-V8评分进行评估。泌尿科医生为患者开具了索利那新 5 毫克或米拉贝琼 25 毫克的处方,每日一次。4 周和 12 周后进行随访。使用中央药品标准控制组织的疑似不良反应(ADR)表评估药物的不良反应,并将不良反应通报给最近的ADR监测中心。 与索利那新相比,米拉贝琼组在4周(12.82±5.86,P<0.001)和12周(5.74±3.31,P<0.001)时的OAB-V8平均评分值与基线相比改善最大。在4周(15.30 ± 5.54,P < 0.001)和12周(8.05 ± 4.59,P < 0.001)时,索非那新组的OAB-V8评分与基线相比也有显著改善。两组患者的心率、收缩压和舒张压在随访期间均无明显变化。索利芬那新组的 13 名患者出现了口干(4 名)和便秘(9 名)等不良反应。米拉贝琼组没有出现不良反应。 在OAB综合征患者的OAB-V8评分中,米拉贝琼的改善幅度最大,但索非那新组也有改善。与索利那新组相比,米拉贝琼组的不良反应较少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Therapeutic effectiveness and adverse drug reactions of mirabegron versus solifenacin in the treatment of overactive bladder syndrome
Overactive bladder (OAB) syndrome is a chronic disease characterized by urinary urgency with or without urge incontinence, frequency, and nocturia and antimuscarinic drugs such as solifenacin have been the mainstay of treatment. Mirabegron a beta 3 adrenoreceptor agonist has recently gained importance in the management of OAB. The rationale of the study is that mirabegron improves the storage function without affecting voiding which increases the therapeutic effectiveness. The objective was to determine the therapeutic effectiveness of mirabegron versus solifenacin. A prospective observational study was conducted on 298 patients with OAB syndrome attending the urology outpatient department of government medical college after obtaining institutional review board clearance. Patients of both genders, belonging to the 18–65 years of age group, attending the urology outpatient department were selected for the study. Patients were evaluated using the OAB-validated 8-question awareness tool (OAB-V8 score) before and after receiving drugs by direct questionnaire method after receiving informed consent. Patients were prescribed either solifenacin 5 mg or mirabegron 25 mg once daily by the urologist. Follow-up was done after 4 and 12 weeks. Adverse drug reactions of the drugs were assessed using the Central Drug Standard Control Organization suspected adverse reaction (ADR) form, and ADRs were notified to the nearest ADR monitoring center. The mirabegron group showed maximum improvement in the mean OAB-V8 score values from baseline at 4 weeks (12.82 ± 5.86, P < 0.001) and 12 weeks (5.74 ± 3.31, P < 0.001) when compared to solifenacin. OAB-V8 scores of the solifenacin group also showed significant improvement from the baseline at 4 weeks (15.30 ± 5.54, P < 0.001) and 12 weeks (8.05 ± 4.59, P < 0.001). Heart rate, systolic, and diastolic blood pressures did not show significant changes during the follow-up in both the study groups. Thirteen patients developed ADRs such as dry mouth (four patients) and constipation (nine patients) in the solifenacin group. No ADRs were noted in the mirabegron group. Mirabegron showed maximum improvement in the OAB-V8 scores in patients with OAB syndrome, although the solifenacin group also showed improvement. Adverse effects were less in the mirabegron group when compared to the solifenacin group.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
期刊最新文献
Evaluation of student-led “Association for Support and Propagation of Innovation, Research, and Education” (A.S.P.I.R.E) in empowering undergraduate medical students in research: A 2-year longitudinal study Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial Efficacy and safety of quick penetrating solution heparin, quick penetrating solution diclofenac, and heparin gel in the prevention of infusion-associated superficial thrombophlebitis: A randomized controlled trial Bio-entrepreneurs’ bugbear: Regulatory rigmarole Experience of participating in community-based clinical trials from rural Maharashtra: Analysis of over 4000 participant feedback forms
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1