EFFECTS OF TONSIL-ADENOID SURGERY ON THROAT INFECTION
EFFECTS OF TONSIL-ADENOID SURGERY ON THROAT INFECTION
批准号:
3310663
负责人:
JACK L PARADISE
金额:
$28.68万
依托单位国家:
美国
项目类别:
财政年份:
1973
资助国家:
美国
项目状态:
已结题
起止时间:
1973-06-29 至 1989-08-31
关键词:
adenoidectomy diagnosis quality /standard disease /disorder proneness /risk health surveys human subject human therapy evaluation longitudinal human study oral pharyngeal disorder diagnosis pediatrics pharyngitis postoperative state preoperative state respiratory disorder respiratory disorder epidemiology respiratory infections
中文摘要
本研究旨在测试扁桃体切除术的疗效,
扁桃体切除术和腺样体切除术(T&A),在减少
既往有咽喉感染的儿童咽喉感染发作
符合目前建议和援引的标准的经验,
扁桃体切除术 具有特定最小和最大历史的儿童
从儿童医院中招募复发性咽喉感染者
门诊病人和社区医生转介的病人或
直接由父母。 经过评估,被认定符合条件的儿童
研究被随机分配到三个治疗组之一:
扁桃体切除术、T&A或非手术控制。 所有科目均于
六周间隔,也用于干预呼吸或相关
病 每两周打一次电话,询问指定的
一组症状和事件。 主要终点是频率
以及咽喉感染的严重程度,但其他措施,
还将分析发病率。
迄今为止,已对1367名儿童进行了评估,
随机分配到三个治疗组之一。 初步数据
扁桃体切除术和T&A之间的结果没有差异,但显示
结果的统计学显著差异有利于手术
治疗(扁桃体切除术或T&A)在非手术治疗期间
第一个随访年,第二年倾向于手术
后续年。 然而,外科手术之间的差异程度
而对照组受试者出现的次数少于我们早期的试验,
严重影响儿童。 特别是,控制对象已经开发出
少数事件被评定为中度或重度;几乎所有事件
都很温和 因此,这些受试者的手术获益可能会下降,
缺乏对风险和成本的合理解释。 如果这些结果继续下去,
在更长的时间内有更多的受试者,
结论(1)腺样体切除术不应作为扁桃体切除术的补充,
常规问题,以及(2)目前普遍接受的标准
关于扁桃体切除术的适应症的基础上复发性喉
感染不是足够严格,且应当被修改或
最不尖锐的资格。
受试者入组至1986年8月,随访至8月,
1989年似乎有必要取得足够的结论性结果,
对临床医生有说服力,并影响公认的标准,
实践
英文摘要
This study is designed to test the efficacy of tonsillectomy, and of
tonsillectomy with adenoidectomy (T&A), in reducing the occurrence of
episodes of throat infection in children with previous throat-infection
experiences that conform to currently recommended and invoked criteria for
tonsillectomy. Children with specified minimum and maximum histories of
recurrent throat infection are recruited from among Children's Hospital
outpatients and patients referred by community physicians or brought
directly by parents. After evaluation, children found to be eligible for
the study are offered random assignment to one of three treatment groups:
tonsillectomy, T&A, or nonsurgical control. All subjects are examined at
six-week intervals, and also for intervening respiratory or related
illness. Telephone calls are made bi-weekly to inquire about a specified
group of symptoms and events. The principal end-points are the frequency
and severity of episodes of throat infection, but other measures of
morbidity also will be analyzed.
To date 1367 children have been evaluated, and 141 children have been
randomly assigned to one of the three treatment groups. Preliminary data
show no differences in outcome between tonsillectomy and T&A, but show
statistically significant differences in outcome favoring surgical
treatment (tonsillectomy or T&A) over nonsurgical treatment during the
first follow-up year, and trends favoring surgery during the second
follow-up year. However, the magnitude of the differences between surgical
and control subjects appears less than in our earlier trial involving more
severely affected children. In particular, control subjects have developed
few episodes rated as moderate or severe; virtually all of their episodes
have been mild. Thus the benefit of surgery in these subjects may fall
short of justifying the risks and costs. If these results continue with
larger numbers of subjects over longer periods, it may be possible to
conclude (1) that adenoidectomy should not be added to tonsillectomy as a
matter of routine, and (2) that current, generally accepted standards
regarding indications for tonsillectomy on the basis of recurrent throat
infection are not sufficiently stringent, and should be modified or at
least sharply qualified.
Enrollment of subjects through August 1986 and follow-up through August,
1989 appears necessary to achieve results sufficiently conclusive to be
persuasive to clinicians and to influence well-established standards of
practice.
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