After taking a pause during national elections, the clinical effectiveness agency for England and Wales resumed its guidance issuance May 19. The agency handed down final decisions on two drugs for Crohn’s disease, new clinical guidelines for neonatal jaundice and for lower urinary tract symptoms in men, and new positive recommendations on four surgical procedures.

The National Institute for Health and Clinical Excellence’s guidance for people with severe active Crohn’s disease now favors the use of infliximab (Remicade, Schering-Plough) and adalimumab (Humira, Abbott), both of which work to inhibit tumor necrosis factor–a, a protein associated with inflammation of the intestine in people with Crohn’s disease.

The new guidance adheres closely to draft guidance issued in March. It recommends use of either drug for people unable to tolerate or not responding to conventional therapies such as corticosteroids, though practitioners are advised to start treatment with the less expensive drug (generally adalimumab).

The guidance also recommends infliximab for adults with active, fistulizing Crohn’s, and for children and young people aged 6-17 years with severe, active Crohn’s unable to tolerate, or not responding to, conventional therapies.

The National Health Service must provide funding and resources for the guidance within 3 months of it being published.

Also on May 19, NICE issued comprehensive clinical guidelines for the treatment of jaundice in newborns and for the treatment of lower urinary tract symptoms in men.

The jaundice guidelines outline risk-assessment, diagnostic, and treatment measures in accordance with a threshold chart dictating exactly which treatments (phototherapy, or in severe cases an exchange transfusion) must be given according to a baby’s age and precise serum bilirubin concentration.

Bilirubin must be measured by a blood test or transcutaneous bilirubinometer, and not by any other diagnostic test, according to the guidelines. The guidelines also contain extensive recommendations for delivering phototherapy and other treatments, and prohibit certain treatments such as albumin, glycerin, acupuncture, or homeopathy.

The guidelines are also presented in a separate format for parents and caregivers that explain how to identify jaundice, which babies are most vulnerable to developing jaundice, and what tests and treatments a health care provider is expected to perform.

NICE’s new extensive guidelines for lower urinary tract symptoms (LUTS) in men (storage, voiding, and postmicturition) are an attempt to address what the agency described as “uncertainty and variation in clinical practice” with clear recommendations on assessing and monitoring LUTS, which the agency estimates affects as many as 30% of men older than 65.

The LUTS guidelines present detailed recommendations on initial assessment of symptoms (including use of digital rectal examination; urinary frequency volume charts; and dipstick tests for urine blood, glucose, leukocytes, protein, and nitrites). They dictate when to use a serum creatine test and prostate-specific antigen testing, among other diagnostic tools. They also describe the conditions requiring specialist referral and offer recommendations for more involved forms of management, including catheterization, drug treatment and surgery.

Finally on May 19, NICE published new guidelines in favor of four surgical procedures:

–Laparoscopic radical hysterectomy– recommending that it be offered routinely for women with early stage cervical cancer.

–Limited macular translocation for wet age-related macular degeneration–recommending it as an alternative to drug treatment for patients willing to take the risks of ocular surgery.

–Prosthetic intervertebral disc replacement in the cervical spine– recommending that it be offered as an alternative to spinal fusion at surgical centers specializing in the neck and spine.

–Hemorrhoidal artery ligation– recommending that it be offered routinely as an alternative to surgical removal or stapling of hemorrhoids.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

英格兰和威尔士临床疗效评价机构于5月19日发布了此前因国家选举而搁置的指南。该机构宣布了对两种克罗恩病药物的最终决定，并发布了针对新生儿黄疸和男性下尿路症状的最新临床指南以及有关4种外科手术的最新积极建议。

 

目前，英国国家卫生与临床优化研究所(NICE)的指南主张使用英夫利昔单抗(Remicade，先灵葆雅) 和阿达木单抗(Humira，雅培)治疗重度活动期克罗恩病患者。这两种药物的作用机制在于抑制肿瘤坏死因子a，后者是一种见于克罗恩病患者的与肠道炎症相关的蛋白。

 

新指南与3月份发布的指南草案存在高度一致性。新指南推荐使用上述任何一种药物治疗不能耐受传统药物(如糖皮质激素)或经传统药物治疗无效的患者，不过建议医生使用较便宜的药物(一般为阿达木单抗)进行治疗。

 

该指南还推荐使用英夫利昔单抗治疗合并瘘的活动期克罗恩病成人患者和不能耐受传统药物或经传统药物治疗无效的重度活动期克罗恩病儿童和青少年患者(年龄为6~17岁)。

 

英国国民医疗保健系统(NHS)必须在指南发布3个月内为其提供资金和资源。

 

NICE还在5月19日发布了有关新生儿黄疸和男性下尿路症状的临床综合治疗指南。

 

黄疸指南描述了根据阈值图所制订的风险评价、诊断和治疗指标。该阈值图严格规定，根据婴儿的年龄和精确血清胆红素浓度，必须给予何种治疗(光疗或对严重病例给予换血治疗)。

 

指南规定，必须通过血检或经皮胆红素测量仪而不应通过任何其他诊断试验测量胆红素。指南还包含如何实施光疗和其他治疗的广泛建议，并禁止使用某些治疗，如白蛋白、甘油、针灸或顺势疗法。

 

另外，还专门为患者和照顾者提供了其他格式的指南，介绍如何识别黄疸、哪些婴儿最容易发生黄疸、以及医生可能进行的检查和治疗。

 

NICE最新关于男性下尿路症状(LUTS，涉及储尿、排尿和排尿后症状)的多项指南旨在通过明确的LUTS评价和监测建议来消除该机构所称的“临床实践中的不确定因素和差异”。NICE估计，65岁以上男性的LUTS发生率为30%。

 

LUTS指南提出了有关初步评价症状的详细建议(包括采用直肠指检；排尿频率/尿量图；以及采用试纸条检测尿液中的红细胞、葡萄糖、白细胞、蛋白质和亚硝酸盐)。指南规定了进行血清肌酐检查和前列腺特异性抗原检查等诊断性检查的时间。指南还描述了需要进行专科治疗的状况，并提供了更多相关形式的治疗建议，包括插管、药物治疗和手术。

 

NICE最终在5月19日发布了支持4种外科手术的最新指南：

 

–腹腔镜下根治性子宫切除术——建议常规对早期宫颈癌女性患者实施此术。

–湿性老年性黄斑变性局限性黄斑转位术——建议以此术代替药物疗法治疗意欲冒眼科手术风险的患者。

–人工颈椎间盘置换术——建议颈脊柱专科手术中心以此术代替脊柱融合术。

–痔动脉结扎术——建议作为痔切除术或吻合术的常规替代。

 

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