Kalsi Vinay, Popat Roshni B, Apostolidis Apostolos, Kavia Rajesh, Odeyemi Isaac A O, Dakin Helen A, Warner Juliet, Elneil Soheir, Fowler Clare J, Dasgupta Prokar
The National Hospital for Neurology and Neurosurgery, London, UK.
Eur Urol. 2006 Mar;49(3):519-27. doi: 10.1016/j.eururo.2005.11.006. Epub 2005 Dec 22.
OBJECTIVE(S): This study aimed to assess the resource utilisation, health benefits and cost-effectiveness of intra-detrusor injections of botulinum neurotoxin-A (BoNT/A) in patients with overactive bladder (OAB).
101 patients with urodynamically-proven detrusor overactivity of either neurogenic (NDO; n = 63) or idiopathic (IDO; n = 38) origin received intra-detrusor injections of 200-300 units of BoNT/A in 20-30 ml saline as part of a research protocol. Twenty-nine patients received repeat injections after 7-26 months. Symptom severity and urodynamic parameters were assessed at 0, 4 and 16 weeks. The cost of therapy was quantified based on the NHS resources used by typical patients and was used to calculate the cost-effectiveness of BoNT/A compared with standard care from the perspective of the UK NHS.
In an intent-to-treat analysis, 82% of patients showed a 25% or greater improvement in at least two out of five parameters (urinary frequency, urgency, urgency incontinence episodes, maximum cystometric capacity and maximum detrusor pressure) four weeks after treatment, reducing to 65% after 16 weeks. A 50% or greater improvement in the frequency of micturition, urgency or urgency incontinence was seen in 73% of patients at four weeks and 54% at 16 weeks. There were no significant differences between IDO and NDO patients in the proportion meeting these endpoints. Therapy cost pounds 826 per patient, with a cost-effectiveness ratio of pounds 617 per patient-year with > or = 25% clinical improvement.
CONCLUSION(S): This study demonstrates that intra-detrusor BoNT/A is an effective treatment for OAB that is highly likely to be cost-effective in both idiopathic and neurogenic disease.
本研究旨在评估膀胱逼尿肌内注射A型肉毒杆菌神经毒素(BoNT/A)对膀胱过度活动症(OAB)患者的资源利用情况、健康效益及成本效益。
101例经尿动力学证实为神经源性(NDO;n = 63)或特发性(IDO;n = 38)逼尿肌过度活动的患者,作为研究方案的一部分,接受了在20 - 30毫升生理盐水中注射200 - 300单位BoNT/A的膀胱逼尿肌内注射。29例患者在7 - 26个月后接受了重复注射。在0、4和16周时评估症状严重程度和尿动力学参数。基于典型患者使用的英国国家医疗服务体系(NHS)资源对治疗成本进行量化,并从英国NHS的角度计算BoNT/A与标准护理相比的成本效益。
在意向性分析中,82%的患者在治疗后4周时,五项参数(尿频、尿急、急迫性尿失禁发作次数、最大膀胱测压容量和最大逼尿肌压力)中至少两项有25%或更大程度的改善,16周后降至65%。73%的患者在4周时排尿频率、尿急或急迫性尿失禁有50%或更大程度的改善,16周时为54%。达到这些终点的比例在IDO和NDO患者之间无显著差异。治疗费用为每位患者826英镑,临床改善≥25%时成本效益比为每位患者每年617英镑。
本研究表明,膀胱逼尿肌内注射BoNT/A是治疗OAB的有效方法,在特发性和神经源性疾病中极有可能具有成本效益。