FDA核准:奥林匹克降温套、Spanner支架与CellSearch系统


January 3, 2007 — 美国食品药物管理局(FDA)已经核准一种作为婴儿预防中度至重度缺氧性脑病变脑部伤害的降温套;一种使用于接受微创手术的良性摄护腺肥大病患,维持尿流量、与自发性排尿的暂时人工支架;以及一种自动化内皮细胞分析系统的新适应症,应用于转移性乳癌的监测。
  
  选择性降温装置(奥林匹克降温套)预防或是避免婴儿脑部伤害
  12月20日,FDA核准一种婴儿降温套(奥林匹克降温套,由奥林匹克医疗器材公司(已由Natus医疗器材公司于2006年12月收购)),使用于中度至重度缺氧性脑病变(HIE)的足月婴儿,作为该公司奥林匹克CFM大脑功能监视器(CFM 6000)辅助诊断用。
  
  根据FDA新闻稿,每年约有5000至9000个婴儿发生中度至重度HIE,过去并没有有效的治疗,支持性/症状性疗法的死亡率约20%,且有25%发生神经功能缺损造成永久失能的机会。
  
  该新的治疗系统包括一个降温系统、控制单位、温度探针、以及一个装水的包覆套,透过稳定流动控温的水来维持头部低温,同时以一个辐射型回温器来维持核心体温(根据肛温温度),将温度维持在低于正常的限制(34.5℃ ± 0.5℃);可以手动操作,以及根据监视器上的温度调整;包覆套的温度可于1℃的范围之间调整。
  
  该核准案是根据一项国际性、多中心、前瞻性随机试验,收纳234位婴儿,结果显示,相较于目前的标准疗法,使用降温包覆套可以降低综合性死亡率试验终点,以及18个月时的严重神经发育失能的比例(胜算比为0.53;95%信赖区间为0.29至0.98;P=0.042)。
  
  不同组之间发生不良反应的频率并无统计上显著差异,18位婴儿中16位发生可预期的不良反应;降温婴儿发生心律不整的比例较高(9%相较于1%;P=0.004),这样的不良反应并非出乎意料,因为低体温已知可能造成窦性心搏过速。
  
  使用降温包覆套与增加颅骨水肿有关(21%相较于1%;P<0.0001),其严重度为轻度至中度(23位婴儿中有20位(87%)),只有少数病例是严重的(23位婴儿中有3位(13%));所有颅骨水肿都在降温治疗之前或完成之后缓解,且无须任何动作、按摩、改变姿势、或是调整降温套。
  
  根据FDA核准的状况,制造商将会设立一个病患注册资料库,以收集使用该装置病患的信息以及追踪治疗结果;并且限制该装置使用于符合原试验收纳条件的婴儿,条件如下:
  
  首先,该降温套适用于36周以上婴儿,且必须符合以下任何一项条件:出生10分钟以内Apgar分数低于5分、出生后10分钟内持续需要进行复苏、出生60分钟内发生酸中毒;或是出生60分钟以内碱缺乏16 mmol/L以上。
  
  符合以上任一条件的婴儿必须也有中度至重度脑病变,包括意识状况改变(嗜睡、恍惚、或是昏迷),以及至少有以下一项条件,肌张力低下;反射异常(包括眼部运动或是瞳孔缩放异常);缺乏或吸吮力低下;以及临床上癫痫发作病征。对于瘫痪的婴儿而言,这些条件中必须有异常的项目,且之后须进行以下的评估。
  
  最后,婴儿必须接受一项至少20分钟的整合振幅的脑电图/大脑功能监测(aEEG/CFM)纪录,且结果须显示出中度/严重的异常aEEG背景值(分数2或3)或是癫痫发作;aEEG/CFM应该在出生1小时后进行,且应该在静脉注射抗癫痫药物30分钟内进行,因为该药物会抑制EEG活性。
  
  降温装置不能使用于肛门闭锁、头部外伤、或是因颅骨骨折造成的颅内出血、以及体重低于1800公克的婴儿;该装置尚未被其它国家核准使用。
  
  暂时性的摄护腺支架(Spanner)用于BPH治疗后维持尿流量
  12月14日,FDA核准一种暂时性摄护腺支架(Spanner,由AbbeyMoor医疗器材公司制造)使用于接受良性摄护腺肥大(BPH)微创手术、以及术后植入导管时,以维持尿流量与自发性排尿;该装置可以使用长达30天。
  
  该核准案是根据一项多中心、前瞻性、控制组控制随机分派试验结果,收纳了100位45岁以上接受经尿道微波温疗法(TUMT)治疗BPH的病患;结果显示,使用该装置相较于标准照护(未置放支架)可以降低排尿后残余尿量、且以国际摄护腺症状分数(IPSS)自试验前平均评估1至2周表现的下泌尿道症状改善(平均改变分数,7.28分相对于4.42分;P=0.019)。
  
  FDA表示,虽然该试验是以接受TUMT病患组成,其它治疗BPH的微创手术,因为其主要作用机转,也有相似治疗后组织坏死的病程;该试验结果因此可以应用于其它手术,包括经尿道针刺烧灼(TUNA)以及组织间隙雷射凝固法(ILC)。
  
  使用摄护腺支架的禁忌症包括尿道细菌培养阳性、或是尿道感染、有症状的泌尿道疾病病史(例如尿道狭窄、膀胱结石、或是其它显著异常),这些情况可能影响支架功能,其它包括尿道解剖构造异常、或是手术改变泌尿生殖构造、摄护腺尿道长度短于4公分或长度超过9公分。
  
  该装置过去于2003年7月由欧盟核准上市。
  
  细胞分析系统(CellSearch)用于监测乳癌治疗疗效
  FDA于12月核准一项自动内皮细胞分析系统(CellSearch,由Veridex LLC与Johnson & Johnson公司制造)的新适应症,应用于辅助监测转移性乳癌。
  
  该系统用于确认以及定量病患血液中循环的肿瘤细胞;根据该公司新闻稿,一连串的测试可以与其它临床检验并用于监测乳癌,在治疗的第一个循环与之后任何时间点决定目前治疗的疗效。
  
  该系统过去于2004年1月由FDA核准作为预测转移性乳癌病患未恶化以及整体存活率的诊断工具。

FDA Approvals: Olympic Cool-Ca

By Yael Waknine
Medscape Medical News

January 3, 2007 ??The US Food and Drug Administration (FDA) has approved an infant cooling cap to prevent or reduce brain damage in infants with moderate to severe hypoxic-ischemic encephalopathy; a temporary prostatic stent to maintain urine flow and allow voluntary urination in patients recovering from minimally invasive procedures for benign prostatic hyperplasia; and an expanded indication for an automated epithelial cell analyzer system, allowing its use as an aid for monitoring metastatic breast cancer.


Selective Cooling Device (Olympic Cool-Cap) Prevents or Reduces Infant Brain Damage

On December 20, the FDA approved an infant cooling cap (Olympic Cool-Cap, made by Olympic Medical [acquired by Natus Medical Inc in October 2006]) for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE), as diagnosed in conjunction with results from the company's Olympic CFM Cerebral Function Monitor (CFM 6000).

According to an FDA news release, the annual incidence of moderate to severe HIE is approximately 5000 to 9000 infants. No effective treatment was previously available, and support/symptomatic treatment is associated with a 20% mortality rate and a 25% rate of neurologic deficits leading to permanent disability.

The new therapeutic system consists of a cooling unit, a control unit, temperature probes, and a water-filled cap that is placed on the infant's head. The cap is designed to prevent or reduce brain damage by keeping the head cool via a steady flow of temperature-regulated water, while working with a radiant warmer to maintain core temperature (based on rectal temperature values) at slightly below-normal levels (34.5繙 C 篑 0.5繙 C). Operation is manual and based on temperature values displayed on the monitor; cap temperature can be adjusted within 篑 1繙 C.

Its approval was based on data from an international, multicenter, prospective, randomized study of 234 infants showing that use of the cooling cap yielded significant decreases in a composite end point of mortality rate and the rate of severe neurodevelopmental disability at 18 months compared with the current standard of care (odds ratio, 0.53; 95% confidence interval, 0.29 - 0.98; P = .042).

No statistically significant differences were observed between groups with respect to the frequency of serious adverse events or for 16 of 18 anticipated adverse events. Minor cardiac arrhythmias occurred more often in the cooled infants (9% vs 1%; P = .004). This effect was not unexpected because mild sinus bradycardia is known to be associated with hypothermia; all episodes resolved with appropriate therapy.

Use of the cooling cap was also linked to an increased incidence of scalp edema (21% vs 1%; P < .0001), the majority of which were mild to moderate in severity (20 [87%] of 23 infants); only a few cases were severe (3 [13%] of 23 infants). All cases of scalp edema resolved prior to or after completion of cooling treatment with either no action, massage, changing position, or cap adjustment.

According to the conditions of the FDA approval, the manufacturer will set up a patient registry to collect information on device use and track treatment outcomes; organize a training and certification process for all device operators; and restrict use of the device to infants who meet the eligibility criteria as defined in the original study, as follows:

First, the cooling cap is indicated for use in infants at 36 weeks' gestational age or older with one of the following: Apgar score of 5 or lower at 10 minutes after birth; continued need for resuscitation at 10 minutes after birth; acidosis within 60 minutes of birth; or a base deficit of 16 mmol/L or greater within 60 minutes of birth.

Infants in one of the aforementioned categories must also have moderate to severe encephalopathy consisting of altered state of consciousness (lethargy, stupor, or coma) and at least one of the following: hypotonia; abnormal reflexes (including oculomotor or papillary abnormalities); absent/weak suck; and clinical seizures. For paralyzed infants, an abnormal evaluation for these criteria must be assumed and the evaluation should proceed to the following step.

Finally, the infant must have an amplitude-integrated electroencephalogram/cerebral function monitor (aEEG/CFM) recording of at least 20 minutes that shows either moderately/severely abnormal aEEG background (score of 2 or 3) or seizures. The aEEG/CFM should be performed after 1 hour of age and should not be performed within 30 minutes after intravenous anticonvulsant therapy due to potential suppression of EEG activity.

Use of the cooling device is contraindicated in infants with an imperforate anus, evidence of head trauma or skull fracture causing major intracranial hemorrhage, and those weighing less than 1800g at birth. It has not been approved for use in any other country.


Temporary Prostatic Stent (Spanner) Maintains Urine Flow after BPH Treatment

On December 14, the FDA approved a temporary prostatic stent (Spanner, made by AbbeyMoor Medical, Inc) to maintain urine flow and allow voluntary urination in patients after minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial posttreatment catheterization. The device may be used for up to 30 days.

The approval was based on data from a multicenter, prospective, controlled, randomized clinical trial of 100 patients older than 45 years who had undergone transurethral microwave thermotherapy (TUMT) for BPH. Results showed that use of the device decreased postvoid residuals and improved lower urinary tract symptoms compared with the standard of care (no stent), as evaluated by improvements in International Prostate Symptoms Scores (IPSS) from baseline at a mean of 1 to 2 weeks (mean ?, 7.28 vs 4.42 points; P = .019).

The FDA notes that although the study was made up of TUMT patients, other minimally invasive treatments for BPH produce the same posttreatment necrotic process as their primary mechanism of action. The study results are therefore deemed applicable to these other methods, including transurethral needle ablation (TUNA) and interstitial laser coagulation (ILC).

Contraindications to use of the prostatic stent include positive urine culture or active urinary tract infection, history of symptomatic urinary tract disease (eg, urethral stricture, bladder stones, or other significant conditions) that could affect stent function, abnormal urethral anatomy or surgically altered urogenital anatomy, or prostatic urethral length less than 4 cm or longer than 9 cm.

The device was previously approved by the European Commission in July 2003.


Cell Analyzer System (CellSearch) for Monitoring Efficacy of Breast Cancer Therapy

The FDA approved in December an expanded indication for an automated epithelial cell analyzer system (CellSearch, made by Veridex LLC, a Johnson & Johnson company), allowing its use as an aid for monitoring metastatic breast cancer.

    
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