A PILOT STUDY TO INVESTIGATE THE MECHANISMS UNDERLYING STEROID REDUCTION IN SEV
一项试点研究,调查 SEV 中类固醇减少的机制
基本信息
- 批准号:6114162
- 负责人:
- 金额:$ 2.8万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:
- 资助国家:美国
- 起止时间:至
- 项目状态:未结题
- 来源:
- 关键词:
项目摘要
This is an open-label pilot study which is evaluating the effectiveness of
IVIG as measured by in vitro steroid responsiveness, improved pulmonary
function, and oral steroid reduction in severe steroid dependent
asthmatics. We have enrolled 12 patients with steroid dependent asthma
thus far. Of the 12 enrolled, 11 patients have successfully completed the
study, 1 patient completed the study but her data will not be analyzed due
to the diagnosis of a neutrophil defect being made after she was enrolled
into the study. This neutrophil defect resulted in her developing
recurrent pneumonias with pseudomonas and staph species. The recurrent
lung infections made it difficult to determine the effect of IVIG on her
lung function. All patients enrolled been were adolescents or young adults
with an age range of 14 to 21 years (15.5+/-0.8 yrs). There were 5 males
and 6 females. Four patients were African American, 1 patient Hispanic,
and 6 were Caucasian. Six months of IVIG therapy resulted in >70%
reduction in oral GC dose (34+/-8 pre- vs. 9+/-3 mg/d post-IVIG; p=0.01),
decreased the number of prednisone bursts (2.6+/-0.5 vs. 1.1+/-0.4;
p=0.04) and hospitalizations (3.0+/-.3 vs. 0.6+/-0.3; p=0.001) compared to
6 the months prior to entry. PEFR and FEV1values remained unchanged
during the study despite the reductions in oral GC. IVIG resulted in
improved GCR binding affinity (baseline Kd 38+/-5, 3 mo Kd 22+/-3, 6 mo
Kd 21+/-3 nM). IVIG also caused a dose dependent suppression of
lymphocyte stimulation with the combination of IVIG and GC resulting in
greater suppression than either alone. We had two serious adverse events
associated with IVIG which resulted in hospitalization- severe headache
and anaphylaxis. Subject (WR) was enrolled in October 1996, and per
protocol, received intravenous gamma globulin (IVIG) at a dose of 2
grams/kg of body weight. He tolerated the infusion without incident, but
developed severe headache, nausea and lethargy 2 days post infusion. He
was admitted to the Pediatric Special Care (PSC) Unit for observation and
by the second day, his symptoms had resolved. The association to the
study drug (IVIG) was considered likely. Due to the above reaction, WR
received pre-treatment with hydrocortisone and diphenhydramine and his
infusions were divided over two days. With the above changes, WR
tolerated subsequent infusions without problems. Subject (JV) was
enrolled in June 1997, and per protocol, received intravenous gamma
globulin (IVIG) at a dose of 2 grams/kg of body weight. JV had tolerated
the infusions without difficulty until October 13, 1997 (infusion #5) when
he developed anaphylaxis. He had received approximately 70 gm out of a
total of 90 gm of Gamimune-N when he developed facial "tingling", total
body flushing, and generalized urticaria. He also felt "light headed" and
nauseated. The infusion was immediately discontinued, his blood pressure
was measured and noted to have fallen from 135/72 pre-infusion to 91/44.
He was given 50 mg of Benadryl, and 100 mg of hydrocortisone
intravenously. Upon my arrival, JV appeared "flushed" with urticaria
over his upper body and face. He also had eyelid edema but was in no
distress. No stridor or wheezing heard and he had good air entry. Oxygen
was administered at 3 LPM and he was transferred to the Pediatric Special
Care Unit where he received 0.3 cc epinephrine subcutaneously, and normal
saline at 200 cc/hr intravenously. Over the next couple hours, JV's blood
pressure improved, the urticaria resolved, and he was discharged to the
outpatient department. The following day, he received his second infusion
of IVIG (90 gm) over 6 hours without incident. The association to the
study drug (IVIG) was considered likely. Due to the above reaction, JV
received pre-treatment with hydrocortisone and diphenhydramine and the
rate of his infusions were slowed. With the above changes, JV tolerated
his subsequent infusions without incident.
这是一项开放标签试点研究,正在评估以下方法的有效性:
通过体外类固醇反应性测量 IVIG,改善肺功能
功能,以及严重类固醇依赖者口服类固醇的减少
哮喘患者。 我们招募了 12 名类固醇依赖性哮喘患者
到目前为止。 在 12 名入组患者中,11 名患者已成功完成
研究中,1 名患者完成了研究,但由于原因,她的数据不会被分析
在她入组后诊断出中性粒细胞缺陷
进入研究。 这种中性粒细胞缺陷导致她的发育
假单胞菌和葡萄球菌引起的复发性肺炎。 反复发作的
肺部感染使得很难确定 IVIG 对她的影响
肺功能。所有入组的患者都是青少年或年轻人
年龄范围为 14 至 21 岁(15.5+/-0.8 岁)。 有5名男性
和 6 名女性。 4 名患者为非裔美国人,1 名患者为西班牙裔,
其中 6 名是白人。 六个月的 IVIG 治疗结果 >70%
口服 GC 剂量减少(IVIG 前 34+/-8 毫克/天 vs. IVIG 后 9+/-3 mg/d;p=0.01),
减少泼尼松爆发次数(2.6+/-0.5 vs. 1.1+/-0.4;
p=0.04)和住院治疗(3.0+/-.3 vs. 0.6+/-0.3;p=0.001)
6 入境前几个月。 PEFR 和 FEV1 值保持不变
尽管口服 GC 有所减少,但在研究期间。 IVIG 结果
提高 GCR 结合亲和力(基线 Kd 38+/-5、3 个月 Kd 22+/-3、6 个月
Kd 21+/-3 nM)。 IVIG 还引起剂量依赖性抑制
IVIG 和 GC 联合刺激淋巴细胞
比单独使用任何一种都具有更大的抑制作用。 我们发生了两次严重的不良事件
与 IVIG 相关,导致住院 - 严重头痛
和过敏反应。 受试者 (WR) 于 1996 年 10 月注册,并且按照
方案,接受静脉注射丙种球蛋白 (IVIG),剂量为 2
克/公斤体重。 他顺利地忍受了输液,但是
输注后2天出现严重头痛、恶心和嗜睡。 他
被送入儿科特殊护理 (PSC) 病房观察并
到第二天,他的症状就消失了。 该协会对
研究药物(IVIG)被认为是可能的。 由于上述反应,WR
接受了氢化可的松和苯海拉明的预处理,他的
输液分两天进行。 经过上述改变,WR
可以毫无问题地耐受随后的输注。 主题(合资企业)是
于 1997 年 6 月入组,并按照方案接受静脉注射伽马射线
球蛋白 (IVIG),剂量为 2 克/公斤体重。 JV已经容忍了
输注没有困难,直到 1997 年 10 月 13 日(输注 #5)
他出现了过敏反应。 他收到了大约 70 克的
当他出现面部“刺痛”时,总共服用了 90 克 Gamimune-N,总计
身体潮红和全身性荨麻疹。 他还感到“头晕目眩”
恶心。 立即停止输液,血压下降
经测量并注意到已从输注前的 135/72 降至 91/44。
他服用了 50 毫克苯海拉明和 100 毫克氢化可的松
静脉注射。 我到达后,JV 出现荨麻疹“脸红”
在他的上半身和脸上。 他也有眼睑水肿,但没有
苦恼。 没有听到喘鸣或喘息声,空气入口良好。 氧
在 3 LPM 进行治疗,他被转移到儿科特殊科
监护室给他皮下注射 0.3 cc 肾上腺素,结果正常
生理盐水以 200 cc/hr 静脉注射。 在接下来的几个小时里,JV 的血液
压力好转,荨麻疹消退,他出院了
门诊部。 第二天,他接受了第二次输液
IVIG(90 克)超过 6 小时,没有发生任何事件。 该协会对
研究药物(IVIG)被认为是可能的。 由于上述反应,JV
接受氢化可的松和苯海拉明预处理,
他的输液速度减慢了。通过上述变化,JV 容忍了
他随后的输液没有发生任何事件。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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JOSEPH SPAHN其他文献
JOSEPH SPAHN的其他文献
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{{ truncateString('JOSEPH SPAHN', 18)}}的其他基金
NON ANTIMICROBIAL ACTIONS OF CLARITHYROMYCIN (BIAXIN) IN ADULTS WITH ASTHMA
克拉霉素(BIAXIN)对成人哮喘患者的非抗菌作用
- 批准号:
6114212 - 财政年份:1998
- 资助金额:
$ 2.8万 - 项目类别:
A PILOT STUDY TO INVESTIGATE THE MECHANISMS UNDERLYING STEROID REDUCTION IN SEV
一项试点研究,调查 SEV 中类固醇减少的机制
- 批准号:
6275397 - 财政年份:1997
- 资助金额:
$ 2.8万 - 项目类别:
NON ANTIMICROBIAL ACTIONS OF CLARITHYROMYCIN (BIAXIN) IN ADULTS WITH ASTHMA
克拉霉素(BIAXIN)对成人哮喘患者的非抗菌作用
- 批准号:
6275447 - 财政年份:1997
- 资助金额:
$ 2.8万 - 项目类别:
A PILOT STUDY TO INVESTIGATE THE MECHANISMS UNDERLYING STEROID REDUCTION IN SEV
一项试点研究,调查 SEV 中类固醇减少的机制
- 批准号:
6245302 - 财政年份:1997
- 资助金额:
$ 2.8万 - 项目类别:
NON ANTIMICROBIAL ACTIONS OF CLARITHYROMYCIN (BIAXIN) IN ADULTS WITH ASTHMA
克拉霉素(BIAXIN)对成人哮喘患者的非抗菌作用
- 批准号:
6304297 - 财政年份:
- 资助金额:
$ 2.8万 - 项目类别:
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