Deflux 可以更有效降低小孩泌尿道感染的次数


  October 9, 2006 -- 根据一篇孩童方面的新研究,内视镜注射一种葡萄聚醣/玻尿酸(Dx/HA) 共聚物(Deflux) ,比预防性抗生素更可以降低和膀胱输尿管回流(VUR)有关的泌尿道感染(UTI)次数。
  
  纽约长老会儿童医院的Grace Hyun医师和同事在昨天的美国小儿科学会国际会议与展览中发表他们的研究发现。
  
  根据研究者所述, VUR发生在约1%的婴儿和小孩,且约有三分之一的小孩症状表现为有发烧的泌尿道感染;对VUR现有的第一线治疗包括内视镜注射、手术和预防性抗生素。
  
  作者在研究摘要中指出,这些研究发现提出将并用Deflux作为VUR病患第一线治疗选择之建议。
  
  Hyun医师和同事主导一项回溯分析,评估PharMetrics National Administrative Claims资料库;研究目标是比较孩童接受Dx/HA或者预防性抗生素的使用资源。
  
  在6783位有VUR纪录的孩童中,监别出有140位曾接受抗生素,48位曾接受Dx/HA,全部病患的年纪都小于11 岁。
  
  Hyun医师在发表中指出,这些病患以六个月治疗前期的抗生素总量、年纪、性别和使用特别照顾等加以配对;因为缺乏VUR严重度的明显识别方法,无法以病患的VUR等级配对;治疗后一年追踪病患的治疗结果。
  
  以Dx/HA治疗的孩童有25%发生泌尿道感染,以抗生素治疗的有45%发生 (P = .009),控制共同因子后,研究者发现接受抗生素的病患比接受的Dx/HA病患多出79%发生泌尿道感染的机会(P = .028)。
  
  研究者也报告了Dx/HA相较于预防性抗生素的经济效益,不过之间的差异并没有统计上的显著意义。
  
  他们指出,研究限制包括了属于回溯设计,此外,副作用、并发症、双亲对治疗的满意度并未发表。
  
  Hyun医师向Medscape表示,我们的发现或许可鼓舞开业医师更早使用Deflux治疗病患,而不是持续使用预防抗生素来观察病童的状况。
  
  不过,她指出有些病患仍应持续服用预防性抗生素;Hyun医师表示,Deflux不适用于逆流程度高的病患,但对逆流程度低的病患看来效果颇优。
  
  她也强调,一般开业医师应将采用现有的更有效方法治疗VUR病童谨记在心,这些病患应被转诊到小儿泌尿科,以便即早介入治疗;她补充道,提高抗生素的服药顺从性也是重要的。
  
  宾州大学医学院泌尿科主任Douglas A. Canning医师是该段VUR会议的主持人指出目前的VUR治疗计画正在改变,他向Medscape表示,我们尚不清楚是否每个患了VUR小孩都需要预防性抗生素,而此研究评估了预防性抗生素以外的治疗方式,使我们对此议题有更深入的了解。
  
  Canning医师表示,以历史观点看来,我们总是假设最不具侵入式的治疗方式是预防性抗生素,但本研究显示,对某些病患而言,内视镜注射Deflux 可以比另两种方法(预防性抗生素和手术)更有效。
  
  本研究接受 Deflux的制造商 Q-Med的赞助。
  
  AAP 2006 年会:摘要455。发表于October 8, 2006。

Deflux More Effective in Reduc

By Emma Hitt, PhD
Medscape Medical News

October 9, 2006 — Endoscopic injection with a dextranomer/hyaluronic acid (Dx/HA) copolymer (Deflux) appears to reduce the number of urinary tract infections (UTIs) related to vesicoureteral reflux (VUR) compared with a regimen of prophylactic antibiotics, according to a new study in children.

Grace Hyun, MD, from the Children's Hospital of New York–Presbyterian in New York, and colleagues presented the findings here yesterday at the American Academy of Pediatrics National Conference and Exhibition.

According to the researchers, VUR occurs in approximately 1% of infants and children and as many as a third of children presenting with a febrile urinary tract infection. Current first-line treatment for VUR includes endoscopic injection, surgery, and prophylactic antibiotics.

These findings “suggest the need to incorporate Deflux as a first-line treatment option for patients with VUR,” the study authors write in the study abstract.

Dr. Hyun and colleagues conducted a retrospective analysis evaluating the PharMetrics National Administrative Claims Database. The goal of the study was to compare resource use for children receiving Dx/HA vs prophylactic antibiotics.

Of 6783 records of children with VUR, they identified 140 patients who had received antibiotics and 48 patients who had received Dx/HA. All patients were younger than 11 years.

Patients were matched with regard to the total amount of antibiotic costs in a 6-month pretreatment period, age, sex, and use of specialty care. It was not possible to match patients for grade of VUR due to a lack of distinct coding for VUR severity, Dr. Hyun noted during the presentation. Patients’ outcomes were followed for 1 year after treatment.

Urinary tract infections were observed in 25% of patients being treated with Dx/HA compared with 45% of patients treated with antibiotics (P = .009). After controlling for confounding factors, the researchers found that patients receiving antibiotics were 79% more likely to develop a urinary tract infection than patients receiving Dx/HA (P = .028).

The researchers also reported an economic benefit for Dx/HA compared with prophylactic antibiotics, although these differences were not statistically significant.

Limitations of the study included retrospective design. In addition, adverse effects, complications, and parent satisfaction with treatment were not documented, they noted.

“Our findings might encourage practitioners to treat patients earlier with Deflux as opposed to continuing to watch children on prophylactic antibiotics,” Dr. Hyun told Medscape.

However, she pointed out that some patients should continue to take prophylactic antibiotics. “Deflux is not suitable for patients with high-grade reflux, but for low-grade reflux, this approach seems superior,” Dr. Hyun said.

She also emphasized that general practitioners should keep in mind that highly effective treatments for children with VUR are now available and such patients should be referred to a pediatric urologist for earlier intervention. “Encouraging antibiotic compliance is also important,” she added.

Douglas A. Canning, MD, chief of the Division of Urology at the University of Pennsylvania School of Medicine, who moderated the session on VUR, noted that the paradigm of VUR treatment is currently shifting. “We are not even sure whether every child with VUR requires antibiotic prophylaxis, and this study evaluating up-front treatment of VUR compared antibiotic prophylaxis adds some insight into this issue,” he told Medscape.

“Historically, we have always presumed that the least invasive approach to treatment is antibiotic prophylaxis, but it appears that endoscopic injection with Deflux may be more effective than either of the other two approaches (ie, prophylaxis and surgery) in some patients,” Dr. Canning said.

The study was funded by Q-Med, the maker of Deflux.

AAP 2006 Annual Meeting: Abstract 455. Presented October 8, 2006.

    
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