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【medical-news】研究表明，保妥适（A型肉毒毒素）可有效改善特发性逼尿肌过度活动症

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First-of-Its-Kind Study Shows BOTOX(R) (Botulinum Toxin Type A) Significantly Improves Idiopathic Detrusor Overactivity (IDO)
16 May 2007

Researchers from Guy's Hospital and King's College London School of Medicine have announced the results from the first randomized, double-blind, placebo-controlled study evaluating botulinum toxin type A (BTX-A, BOTOX(R)) as a treatment for idiopathic detrusor overactivity (IDO) in patients with symptoms of overactive bladder (OAB). The trial results which are published in the June 2007 issue of The Journal of Urology show that BTX-A is safe and effective for this use and that the beneficial effects -- including improved quality of life -- persist for at least 24 weeks.

"The findings of this study are important because there is a need for new treatments for OAB patients who have unsatisfactory responses to therapies which are currently available and who do not want to consider invasive surgery," said Mr. Arun Sahai, who was a principal investigator of the study during his time as a research fellow at Guy's Hospital, London. "This study demonstrated that botulinum toxin type A may be a promising treatment option for patients with OAB symptoms."

OAB is characterized by feelings of urgency to urinate, with or without incontinence, and is usually accompanied by increased urination frequency and nocturia (excessive urination at night). A large proportion of OAB patients have what is referred to as idiopathic detrusor overactivity or IDO -- excessive activity of the muscles that contract the bladder, due to an unknown cause -- and are treated with drugs called anticholinergics (e.g., tolterodine). However, many OAB patients discontinue medication due to insufficient relief of symptoms or intolerable side effects that can include dry mouth, dry eyes, constipation and headache.

"This study showed that this treatment had real benefits for patients for whom previous treatments had not worked," said Mr. Prokar Dasgupta, consultant urologist at Guy's Hospital, honorary senior lecturer at King's College London, and a co-principal investigator of the study. "These were patients who were seriously affected by their OAB symptoms. At basline, 81 percent of patients in the botulinum toxin type A treatment group and 67 percent in the placebo treatment group were experiencing urge urinary incontinence daily."

OAB is more common than osteoarthritis or diabetes(1,2) and is estimated to affect 16-17% of the population in the U.S. and Western Europe.(3) In addition, the economic burden of OAB is substantial. In the U.S., for example, the total economic cost of OAB has been estimated at $12 billion in 2000 (including costs incurred in the community and institutions).

About the Study

The double-blind trial included 34 patients with OAB and confirmed IDO who had failed on a trial of anticholinergic therapy for six weeks or more due to either poor efficacy or tolerability. They were randomly assigned to treatment with BTX-A 200 U (BOTOX(R)) (16 patients) or placebo (18 patients). The primary outcome measure was change in maximum cystometric capacity (MCC), a measure of urinary bladder capacity. Secondary outcome measures included changes in OAB symptoms, other measures related to urinary bladder filling and pressure, symptoms of urgency and incontinence, and quality of life (QoL). Patients were assessed at 4 and 12 weeks post-injection, at which point the study was unblinded; BTX-A patients were further followed until 24 weeks.

BTX-A treatment significantly increased MCC vs. baseline at 4 weeks (by about 72%) and 12 weeks (by about 45%), compared to a 15 percent decrease in placebo patients at both time points. The differences between MCC changes for the BTX-A and placebo groups were significant at both time points (p<0.0001 and p<0.0011, respectively). Likewise, at 4 and 12 weeks compared to baseline, BTX-A also significantly improved all secondary endpoints, including measures of bladder filling and pressure; urination frequency, urgency urinary incontinence episodes, and urgency (at 4 weeks only); and QoL. All these improvements were significantly greater than with placebo vs. baseline.

The extension study lasting until week 24 suggested that most of these beneficial effects of BTX-A were maintained for at least 24 weeks. At baseline, 81% of patients in the BTX-A group were experiencing urgent urinary incontinence daily, but urinary frequency normalized in 57% at 4 weeks, and 36% maintained this benefit at 24 weeks; further, 50% were continent at follow-up, and the improvement lasted 24 weeks. Complete resolution of detrusor overactivity was observed in 44% of BTX-A patients at 4 weeks, though this dropped to 25% by 24 weeks.

Quality of life was assessed using the IIQ-7 and UDI-6 and was significantly better in the BTX-A group compared with placebo at both 4 and 12 weeks post-injections.

Treatment with BTX-A was well tolerated and there were no major complications. Six patients in the BTX-A group had symptomatic post void residual (PVR) at follow-up requiring clean intermittent self catheterization (CISC). Seven patients developed symptomatic urinary tract infection, six of whom were performing CISC. Mr. Sahai's and Mr. Dasgupta's co-researcher was Mohammad S. Khan, FRCS (urol) FEBU, consultant urologist at Guy's Hospital, London. BTX-A is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of any form of OAB, nor is it currently approved for this use by regulatory agencies in Europe. This research was funded by Allergan, Inc and through a project grant from the British Urological Foundation.

References

(1) National Diabetes Information Clearinghouse, a service of the National Institute of Diabetes and Digestive and Kidney Disease (DIDDK), NIH, http://diabetes.niddk.nih.gov/dm/pubs/statistics/#7

(2) National Institute of Arthritis and Musculoskeletal and Skin Disease, National Institute of Health (NIH), http://www.niams.nih.gov/hi/topics/arthritis/oahandout.htm#1

(3) Sahai A, Khan M, Fowler CJ, Dasgupta P. Botulinum toxin for the treatment of lower urinary tract symptoms: a review. Neurourology and Urodynamics 2005;24:2-12

Guy's and St Thomas' NHS Foundation Trust
http://www.guysandstthomas.nhs.uk

Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=71031

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2007-05-17 11:57

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初译：

First-of-Its-Kind Study Shows BOTOX(R) (Botulinum Toxin Type A) Significantly Improves Idiopathic Detrusor Overactivity (IDO)

16 May 2007

研究表明，保妥适（A型肉毒毒素）可有效改善特发性逼尿肌过度活动

Researchers from Guy's Hospital and King's College London School of Medicine have announced the results from the first randomized, double-blind, placebo-controlled study evaluating botulinum toxin type A (BTX-A, BOTOX(R)) as a treatment for idiopathic detrusor overactivity (IDO) in patients with symptoms of overactive bladder (OAB). The trial results which are published in the June 2007 issue of The Journal of Urology show that BTX-A is safe and effective for this use and that the beneficial effects -- including improved quality of life -- persist for at least 24 weeks.
来自Guy医院和King伦敦大学医学院的研究人员宣布了一项随机双盲安慰剂对照研究，该研究评估了A型肉毒毒素(BTX-A, BOTOX(R))治疗膀胱过度活动症患者特发性逼尿肌过度活动的疗效。《泌尿外科杂志》2007年6月发表的该试验研究结果表明，使用BTX-A是安全有效的，其疗效（包括改善生活质量）至少可维持24 周。

"The findings of this study are important because there is a need for new treatments for OAB patients who have unsatisfactory responses to therapies which are currently available and who do not want to consider invasive surgery," said Mr. Arun Sahai, who was a principal investigator of the study during his time as a research fellow at Guy's Hospital, London. "This study demonstrated that botulinum toxin type A may be a promising treatment option for patients with OAB symptoms."
主要研究者Arun Sahai先生在伦敦Guy 医院研究时提到“对于不满意现行的治疗疗效而又不想考虑手术的OAB病人而言，这项研究发现对于新治疗手段的提出很重要。研究表明A型肉毒毒素对于OAB症状病人可能是一种有前景的治疗选择。”

OAB is characterized by feelings of urgency to urinate, with or without incontinence, and is usually accompanied by increased urination frequency and nocturia (excessive urination at night). A large proportion of OAB patients have what is referred to as idiopathic detrusor overactivity or IDO -- excessive activity of the muscles that contract the bladder, due to an unknown cause -- and are treated with drugs called anticholinergics (e.g., tolterodine). However, many OAB patients discontinue medication due to insufficient relief of symptoms or intolerable side effects that can include dry mouth, dry eyes, constipation and headache.
OAB定义为尿急伴有或无尿失禁，常有尿频和夜尿（夜间排尿次数增多）。一大部分OAB患者存在所谓的特发性逼尿肌过度活动（IDO）－即控制膀胱排尿逼尿肌不明原因的过度活动－可通过抗胆碱类药物得以治疗(如托特罗定)。但是，许多病人由于症状缓解不明显或难以耐受副反应（包括口、眼干燥，便秘以及头痛）而停止了用药。

"This study showed that this treatment had real benefits for patients for whom previous treatments had not worked," said Mr. Prokar Dasgupta, consultant urologist at Guy's Hospital, honorary senior lecturer at King's College London, and a co-principal investigator of the study. "These were patients who were seriously affected by their OAB symptoms. At basline, 81 percent of patients in the botulinum toxin type A treatment group and 67 percent in the placebo treatment group were experiencing urge urinary incontinence daily."
这项研究的共同主要研究者，伦敦King学院的荣誉高级讲师，Guy 医院泌尿外科的顾问医生，Prokar Dasgupta先生提到“这项研究表明，此种疗法对于既往疗效欠佳的患者真正有效。这些病人已经被OAB症状严重困扰。在试验初始时，81%的A型肉毒毒素组患者以及67%安慰剂组患者每天都会出现急迫性尿失禁。”

OAB is more common than osteoarthritis or diabetes(1,2) and is estimated to affect 16-17% of the population in the U.S. and Western Europe.(3) In addition, the economic burden of OAB is substantial. In the U.S., for example, the total economic cost of OAB has been estimated at $12 billion in 2000 (including costs incurred in the community and institutions).
OAB较骨关节病和糖尿病更为常见，据评估在美国和西欧的16~17%人群中流行。另外，OAB导致大量经济负担。比如在美国，据估计2000年OAB所带来的总经济成本达12 亿美元。

About the Study 相关研究

The double-blind trial included 34 patients with OAB and confirmed IDO who had failed on a trial of anticholinergic therapy for six weeks or more due to either poor efficacy or tolerability. They were randomly assigned to treatment with BTX-A 200 U (BOTOX(R)) (16 patients) or placebo (18 patients). The primary outcome measure was change in maximum cystometric capacity (MCC), a measure of urinary bladder capacity. Secondary outcome measures included changes in OAB symptoms, other measures related to urinary bladder filling and pressure, symptoms of urgency and incontinence, and quality of life (QoL). Patients were assessed at 4 and 12 weeks post-injection, at which point the study was unblinded; BTX-A patients were further followed until 24 weeks.
这项双盲试验纳入34例OAB具有IDO的患者，这些患者曾行6 周以上的抗胆碱能药物治疗后由于疗效不佳或耐受性差而告失败。病例随机分为BTX-A 200 U (BOTOX(R))治疗组（16例）和安慰剂组（18例）。测定最大膀胱容量（MCC）的改变和膀胱容量作为主要结果。次要结果包括OAB症状改善，其他相关的有膀胱充盈压，尿急和尿失禁症状以及生活质量（QoL）。在注射给药后第4和12 周对病人进行评估，研究为非盲。行BTX-A治疗的患者一直随访24 周。

BTX-A treatment significantly increased MCC vs. baseline at 4 weeks (by about 72%) and 12 weeks (by about 45%), compared to a 15 percent decrease in placebo patients at both time points. The differences between MCC changes for the BTX-A and placebo groups were significant at both time points (p<0.0001 and p<0.0011, respectively). Likewise, at 4 and 12 weeks compared to baseline, BTX-A also significantly improved all secondary endpoints, including measures of bladder filling and pressure; urination frequency, urgency urinary incontinence episodes, and urgency (at 4 weeks only); and QoL. All these improvements were significantly greater than with placebo vs. baseline.
BTX-A治疗患者中的MCC对比其试验初始值在第4 周增加了72%，在第12周增加了45%，而安慰剂对照组患者的MCC在这两个时点上增加了15%。在两个时点上BTX-A和安慰剂组间的MCC改变差异具有统计学意义(p分别 <0.0001 以及 p<0.0011)。而且，在4 周和12周时对比试验初始值中，BTX-A组的所有次要结果包括膀胱充盈压，尿频、急迫性尿失禁的发生，尿急（仅测第4周）情况以及生活质量都显著改善。相对于试验初始值，所有的这些改善较安慰剂组更显著。

The extension study lasting until week 24 suggested that most of these beneficial effects of BTX-A were maintained for at least 24 weeks. At baseline, 81% of patients in the BTX-A group were experiencing urgent urinary incontinence daily, but urinary frequency normalized in 57% at 4 weeks, and 36% maintained this benefit at 24 weeks; further, 50% were continent at follow-up, and the improvement lasted 24 weeks. Complete resolution of detrusor overactivity was observed in 44% of BTX-A patients at 4 weeks, though this dropped to 25% by 24 weeks.
24周延长研究表明BTX-A的大部分效应可至少维持24周。BTX-A组81%的患者试验初始时每天急迫性尿失禁，而在4周时57%的患者尿频改善到正常，36%的患者在24周时仍保持得到改善。此外，随访中50%的患者可控尿，改善保持到24周。在4周时BTX-A组患者中可观察到44%的患者逼尿肌过度活动完全消失，尽管在24周时这个比率降至25%。

Quality of life was assessed using the IIQ-7 and UDI-6 and was significantly better in the BTX-A group compared with placebo at both 4 and 12 weeks post-injections.
通过IIQ-7以及UDI-6对生活质量进行评估，给药后BTX-A组的生活质量在4周和12周时点显著优于安慰剂组。

Treatment with BTX-A was well tolerated and there were no major complications. Six patients in the BTX-A group had symptomatic post void residual (PVR) at follow-up requiring clean intermittent self catheterization (CISC). Seven patients developed symptomatic urinary tract infection, six of whom were performing CISC. Mr. Sahai's and Mr. Dasgupta's co-researcher was Mohammad S. Khan, FRCS (urol) FEBU, consultant urologist at Guy's Hospital, London. BTX-A is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of any form of OAB, nor is it currently approved for this use by regulatory agencies in Europe. This research was funded by Allergan, Inc and through a project grant from the British Urological Foundation.
病人使用BTX-A治疗具有耐受性且无主要并发症出现。BTX-A组中6 例患者在随访期间出现残余尿症状（PVR)而需行清洁间断自行导尿术（CISC)；7例患者出现泌尿系感染症状，其中的6例行CISC。Sahai先生和Dasgupta先生的共同研究员是Mohammad(穆罕默德)S. Khan，其是FRCS（皇家外科医师学会会员） (urol) FEBU，伦敦Guy医院的泌尿外科顾问医生。BTX-A目前尚未被美国食品和药物管理局批准治疗任何OAB患者，其在欧洲代理机构也不能通过。这项研究由Allergan, Inc资助，并由英国泌尿外科基金会给予项目奖励。

References 参考文献

(1) National Diabetes Information Clearinghouse, a service of the National Institute of Diabetes and Digestive and Kidney Disease (DIDDK), NIH, http://diabetes.niddk.nih.gov/dm/pubs/statistics/#7

(2) National Institute of Arthritis and Musculoskeletal and Skin Disease, National Institute of Health (NIH), http://www.niams.nih.gov/hi/topics/arthritis/oahandout.htm#1

(3) Sahai A, Khan M, Fowler CJ, Dasgupta P. Botulinum toxin for the treatment of lower urinary tract symptoms: a review. Neurourology and Urodynamics 2005;24:2-12

Guy's and St Thomas' NHS Foundation Trust
http://www.guysandstthomas.nhs.uk

Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=71031

编译投稿（1283字）

【据《今日医学新闻》在线2007年5月16日刊出了一则消息】题为：研究表明，保妥适（A型肉毒毒素）可有效改善特发性逼尿肌过度活动

新闻报道了《泌尿外科杂志》2007年6月发表了一项随机双盲安慰剂对照研究表明，使用BTX-A是安全有效的，其疗效（包括改善生活质量）至少可维持24 周。

此项研究是针对膀胱过度活动症（OAB）中的特发性逼尿肌过度活动进行药物研究，OAB定义为尿急伴有或无尿失禁，常有尿频和夜尿（夜间排尿次数增多）。一大部分OAB患者存在所谓的特发性逼尿肌过度活动（IDO）－即控制膀胱排尿逼尿肌不明原因的过度活动－可通过抗胆碱类药物得以治疗(如托特罗定)。但是，许多病人由于症状缓解不明显或难以耐受副反应（包括口、眼干燥，便秘以及头痛）而停止了用药。流行病学研究，OAB较骨关节病和糖尿病更为常见，据评估在美国和西欧的16~17%人群中流行。另外，OAB导致大量经济负担。比如在美国，据估计2000年OAB所带来的总经济成本达12 亿美元。

来自Guy医院和King伦敦大学医学院的研究人员在这项研究中评估了A型肉毒毒素(BTX-A, BOTOX(R))治疗膀胱过度活动症患者特发性逼尿肌过度活动的疗效。其中，主要研究者Arun Sahai先生在伦敦Guy 医院研究时提到“对于不满意现行的治疗疗效而又不想考虑手术的OAB病人而言，这项研究发现对于新治疗手段的提出很重要。研究表明A型肉毒毒素对于OAB症状病人可能是一种有前景的治疗选择。”这项研究的共同主要研究者，伦敦King学院的荣誉高级讲师，Guy 医院泌尿外科的顾问医生，Prokar Dasgupta先生提到“这项研究表明，此种疗法对于既往疗效欠佳的患者真正有效。这些病人已经被OAB症状严重困扰。在试验初始时，81%的A型肉毒毒素组患者以及67%安慰剂组患者每天都会出现急迫性尿失禁。”

这项双盲试验纳入34例OAB具有IDO的患者，这些患者曾行6 周以上的抗胆碱能药物治疗后由于疗效不佳或耐受性差而告失败。病例随机分为BTX-A 200 U (BOTOX(R))治疗组（16例）和安慰剂组（18例）。测定最大膀胱容量（MCC）的改变和膀胱容量作为主要结果。次要结果包括OAB症状改善，其他相关的有膀胱充盈压，尿急和尿失禁症状以及生活质量（QoL）。在注射给药后第4和12 周对病人进行评估，研究为非盲。行BTX-A治疗的患者一直随访24 周。结果显示，BTX-A治疗患者中的MCC对比其试验初始值在第4 周增加了72%，在第12周增加了45%，而安慰剂对照组患者的MCC在这两个时点上增加了15%。在两个时点上BTX-A和安慰剂组间的MCC改变差异具有统计学意义(p分别 <0.0001 以及 p<0.0011)。而且，在4 周和12周时对比试验初始值中，BTX-A组的所有次要结果包括膀胱充盈压，尿频、急迫性尿失禁的发生，尿急（仅测第4周）情况以及生活质量都显著改善。相对于试验初始值，所有的这些改善较安慰剂组更显著。24周延长研究表明BTX-A的大部分效应可至少维持24周。BTX-A组81%的患者试验初始时每天急迫性尿失禁，而在4周时57%的患者尿频改善到正常，36%的患者在24周时仍保持得到改善。此外，随访中50%的患者可控尿，改善保持到24周。在4周时BTX-A组患者中可观察到44%的患者逼尿肌过度活动完全消失，尽管在24周时这个比率降至25%。病人使用BTX-A治疗具有耐受性且无主要并发症出现。BTX-A组中6 例患者在随访期间出现残余尿症状（PVR)而需行清洁间断自行导尿术（CISC)；7例患者出现泌尿系感染症状，其中的6例行CISC。

药物BTX-A治疗OAB的相关背景及相关研究进展：（1234字）

1 BTX-A目前尚未被美国食品和药物管理局批准治疗任何OAB患者，其在欧洲代理机构也不能通过。

2 BTX是厌氧梭状芽孢杆菌产生的一种神经毒素。BTX根据抗原性不同可分为A、B、C、D、E、F、G七型。BTX－A是最早制成的结晶毒素，由19种氨基酸组成的最简单的结晶毒素，分子量约为900000。BTX由神经毒素和非神经毒素的血凝素成份组成。神经毒素是分子量约为150000的单链蛋白质；非毒性成分即血凝素部分使神经毒素能够抵御胰蛋白酶的消化作用。神经毒素由单链结构构成，然后由蛋白分解酶分解成包含两个不对称亚单位的双链结构即重链和轻链。重链结构BTX对运动神经末梢突触前膜的结合及内化有关；轻链结构与BTX抑制神经递质的释放有关。

3 BTX的药理作用：BTX与副交感神经末梢神经肌肉接头处的突触前膜受体结合后进入细胞内，影响钙离子介导的神经囊泡排出，阻滞乙酰胆碱(Acetylcholine, Ach)释放，从而产生可逆性肌肉麻痹和萎缩。临床上将其用于治疗肌肉过度或异常收缩引起的疾病。BTX发挥作用涉及到三个步骤：①结合到突触前膜。②内化及转运。结合到突触前膜后，其重链结构的氨基端在低pH环境下表现为疏水性,从而与突触前膜的脂质层结合，形成pH依赖的转运通道。该通道能够使轻链结构通过细胞膜进入细胞质内，进而被溶酶体所吞噬,称为内化。③细胞内的毒性作用可能降低细胞对钙离子的敏感性，从而损害钙离子诱导的细胞分泌功能,使Ach囊泡的释放受阻。

4 1999年，Stohrer等首先提出采用BTX－A治疗逼尿肌反射亢进症。BTX－A治疗OAB的机制可能是与逼尿肌内胆碱能神经末梢突触前膜结合，阻断神经递质Ach的释放和传递，使其无法与M受体结合，导致逼尿肌麻痹、松弛，有效抑制其收缩，缓解症状，从而达到治疗的目的。

5 匹兹堡大学的研究人员曾在美国泌尿科学会年会上报告，应用A 型肉毒杆菌毒素(BTX) 治疗包括膀胱过度活动症(OAB) 在内的各种下尿道功能障碍显示出良好的前景。匹兹堡大学医学院泌尿科和妇科学教授Chancellor 医师说：“在世界范围内，罹患膀胱功能障碍的患者的数字是惊人的。注射BTX 为这些患者解决这一令人窘困的问题提供了一个暂时、但安全的方法。”在这项研究中，研究人员向50 例患者的膀胱或尿道中注射了A 型肉毒杆菌毒素。这些患者罹患由多种原因导致的排空功能障碍，病因包括多发性硬化、脊髓损伤、卒中、OAB 和间质性膀胱炎。每例患者都经历过膀胱肌的非自主性收缩,后者常导致尿潴留或由于尿液非自主性排空引起的尿失禁。在注射治疗之后,50例患者中有41 例(82 %) 尿失禁症状减轻或消失。患者在注射治疗后7天内即获得症状减轻，症状减轻可持续6 个月左右。50 例患者中没有人因治疗引起的远期并发症，如压力性尿失禁或尿潴留。BTX通过结合到控制肌肉运动的神经末梢，阻断引起肌肉收缩的化学因子的释放。将BTX注射到特定的肌肉中，既可观察到此部分肌肉麻痹或肌力减弱，而周围的肌肉则不受影响，能够保持正常的功能。神经源性逼尿肌反射亢进和过动性膀胱是常见的泌尿科病例，通常由控制膀胱的逼尿肌非自主性收缩引起的。BTX 注射疗法减少了膀胱的非自主性收缩,从而恢复膀胱的正常功能。－摘自《中国医学论坛报》2002 年06 月

2007-05-19 11:57

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谍影重重编辑于 2007-05-19 12:59

• 落枕诊治

楼主

anmb1

丁香园准中级站友

4楼

谢谢谍影重重战友的精彩翻译和提供背景知识。

有几处翻译尚待修改：

1. $12 billion 12亿/120亿

2. The primary outcome measure was change in maximum cystometric capacity (MCC), a measure of urinary bladder capacity. 测定最大膀胱容量（MCC）的改变和膀胱容量作为主要结果。

a measure of urinary bladder capacity用来解释change in maximum cystometric capacity (MCC)，并非两个测量指标。

3. BTX-A treatment significantly increased MCC vs. baseline at 4 weeks (by about 72%) and 12 weeks (by about 45%), compared to a 15 percent decrease in placebo patients at both time points. BTX-A治疗患者中的MCC对比其试验初始值在第4 周增加了72%，在第12周增加了45%，而安慰剂对照组患者的MCC在这两个时点上增加了15%。

4. BTX-A is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of any form of OAB, nor is it currently approved for this use by regulatory agencies in Europe. BTX-A目前尚未被美国食品和药物管理局批准治疗任何OAB患者，其在欧洲代理机构也不能通过。

BTX-A目前尚未被美国食品和药物管理局批准用于治疗任何OAB患者，欧洲药品管理机构也没有批准该治疗用途。

regulatory agencies in Europe是指欧洲的药品监督管理机构，即European Medicines Agency（EMEA），其职能相当于美国的FDA。

2007-05-21 08:22

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