重组人干扰素α-1b不同给药途径治疗婴幼儿毛细支气管炎的临床研究

发布时间：2018-07-14 19:48

【摘要】：目的:评价重组人干扰素α-1b(Recombinan human Interf--eronα-1b,rh IFN-α1b)不同给药途径治疗婴幼儿毛细支气管炎的有效性及安全性,为临床用药推荐合理的用药途径及用量。方法:选择320例确诊为毛细支气管炎的患儿作为研究对象,其中对照组(A):雾化1组(B):雾化2组(C):肌注组(D)=1:1:1:1,每组80例。A组:对症支持治疗:根据病情给予解热镇痛药、吸氧、雾化布地奈德(普米克令舒)+β2-受体激动剂/或M受体抑制剂。雾化组:对症支持治疗+rh IFN-α1b雾化吸入,将rh IFN-α1b溶入3ml生理盐水,加入压缩空气式雾化器进行治疗,10-15分钟/次,rh IFN-α1b用法为:B组:1μg/kg/次,2次/日,C组:2μg/kg/次,2次/日,每次用量不超过40μg。D组:对症支持治疗+1μg/kg/次rh IFN-α1b肌注,1次/日。比较临床疗效、临床症状消失时间和疗效指标评分、住院时间、肺功能。同时观察记录不良反应。结果:1、咳嗽症状缓解:1、咳嗽症状缓解:(1)d1:B组、C组、D组与A组比较,患儿咳嗽评分无统计学意义(F=1.283,P=0.280);(2)在d2、d3、d4、d5、d6、d7,B组、C组、D组与A组比较,咳嗽评分较低,其差异具有统计学意义(P0.05);(3)在d2、d3、d4、d5,B组、D组咳嗽评分较C组高,其差异具有统计学意义(P0.05);(4)在d2、d3、d4、d5、d6、d7,B组与D组咳嗽评分差异无统计学意义(P0.05)。在咳嗽缓解程度上,雾化组及肌注组明显优于对照组,而雾化2组效果更好。2、肺部哮鸣音缓解:(1)d1:B组、C组、D组与A组比较,患儿哮鸣音评分的差异无统计学意义(F=0.959,P=0.413);(2)d2、d3、d4、d5、d6、d7,A组哮鸣音评分较C组、D组高,差异具有统计学意义(P0.05);(3)d5、d6、d7,A组哮鸣音评分高于B组,其差异具有统计学意义(P0.05);(4)d2、d3、d4,C组哮鸣音评分高于D组其差异具有统计学意义(P0.05)。在哮鸣音缓解方面,雾化组、肌注组明显优于对照组,雾化2组、肌注组优于雾化1组,而在治疗前4天,雾化2组又优于肌注组。3、三凹征缓解:(1)d1:A组、B组、C组、D组患儿三凹症评分的差异无统计学意义(F=1.920,P=0.126);(2)d2、d3、d4、d5、d6、d7,A组三凹征评分较B组、C组、D组高,其差异具有统计学意义(P0.05);(3)d2、d3、d4、d5,B组、D组三凹征评分较C组高,其差异具有统计学意义(P0.05);(4)d2、d3、d4、d5、d6、d7,B组与D组三凹征评分差异无统计学意义(P0.05)。提示:雾化组、肌注组在缓解缺氧上优于对照组,而在治疗前5天,雾化2组优于雾化1组及肌注组。4、退热时间:(1)d1、d4、d5、d6、d7各组体温的差异均无统计学意义(P0.05);(2)d2、d3:A组体温较B组、C组、D组高,差异具有统计学意义(F=3.782,P=0.011);(3)d1、d2、d3、d4、d5、d6、d7,B组、C组、D组间体温差异无统计学意义(P0.05)。干扰素雾化组、肌注组在退热时间上短于对照组。5、肺功能改善:达峰时间比(Time to PTEF/expiratory time,TPEF/TE):(1)d1:各组TPEF/TE比值的差异无统计学意义(F=0.243,P=0.867);(2)d7:A组TPEF/TE比值较B组、C组、D组低,差异具有统计学意义(F=225.825,P0.001)。干扰素雾化组、肌注组在改善TPEF/TE上优于对照组。达峰容积比(Expiratory volume at PTEF/expiratory volume,VPEF/VE):(1)d1:各组VPEF/VE比值的差异无统计学意义(F=2.040,P=0.108);(2)d7:A组VPEF/VE比值较B组、C组、D组低,差异具有统计学意义(F=271.321,P0.001)。干扰素雾化组、肌注组在改善VPEF/VE上优于对照组。6、有效率及住院时间:(1)总有效率:A组有效率较B组、C组、D组低,差异具有统计学意义(F=12.015,P=0.007);(2)对RSV有效率:A组有效率较B组、C组、D组低,差异具有统计学意义(F=12.825,P0.001);(3)总住院天数:A组住院天数较B组、C组、D组长,差异具有统计学意义(F=57.657,P0.001),其中D组较B组、C组住院时间短。干扰素雾化组、肌注组在总有效率、对RSV有效率、住院天数上优于对照组,且雾化2组在住院天数上优于雾化1组及肌注组。7、肝功能:四组在治疗前后肝功能均在正常范围内,未造成明显肝功能损害。提示:干扰素治疗对肝功能无明显影响。结论:重组人干扰素α-1b对婴幼儿毛细支气管炎有明显疗效,且雾化吸入的效果优于肌肉注射,可明显促进毛细支气管炎患儿的临床症状和生命体征恢复,缩短病程,临床疗效显著、安全,值得在临床上进一步推广使用。
[Abstract]:Objective: To evaluate the efficacy and safety of recombinant human interferon alpha -1b (Recombinan human Interf--eron alpha -1b, Rh IFN- a 1b) in the treatment of infantile bronchiolitis, and to recommend rational drug use and dosage for clinical use. Methods: 320 cases of children with bronchiolitis were selected as the research object, and the control was used as the control. Group (A): atomization of 1 groups (B): atomization group (C): intramuscular group (D) =1:1:1:1, 80 cases in each group.A group: symptomatic support therapy: antipyretic analgesics, oxygen inhalation, atomization of budesonide (Pulmicort) + beta 2- receptor agonist / or M receptor inhibitor. Treatment with compressed air nebulizer, 10-15 minutes / time, Rh IFN- alpha 1b: B group: 1 mu g/kg/ times, 2 times / day, C group: 2 mu g/kg/, 2 times per day, each dosage is not more than 40 mu g.D group: symptomatic support treatment +1 mu g/kg/ sub RH IFN- alpha muscle injection, 1 times / day. Comparison of clinical efficacy, clinical symptoms vanishing time score score, stay time, hospitalization time, Lung function and observed adverse reaction. Results: 1, cough symptom relief: 1, cough symptom relief: (1) d1:B group, C group, group D and A group, the cough score is not statistically significant (F=1.283, P=0.280); (2) in D2, D3, D4, D5, D6, D7, group, and the difference has statistical significance; (3) The cough score of D4, D5, B and D was higher than that of the C group, and the difference was statistically significant (P0.05). (4) there was no significant difference in the cough score in D2, D3, D4, D5, D6, D7, and groups. The atomization group and the inject group were obviously better than the control group, but the effect of atomization group and the injection group was better than that of the control group, and the effect of atomization was better than that of the control group. (1) Group comparison, the difference of wheeze score of children was not statistically significant (F=0.959, P=0.413); (2) D2, D3, D4, D5, D6, D7, and A group was higher than C group and D group, and the difference was statistically significant (P0.05); (4) the difference had statistical significance. (4) the score of wheezing sounds was higher than that of the group. There was statistical significance (P0.05). In the alleviation of wheezing sound, the atomization group and the injection group were obviously superior to the control group. The atomization group was 2 groups and the inject group was superior to the nebulization group 1 groups, while at 4 days before the treatment, the atomization 2 groups were better than the intramuscular group.3 and three concave sign: (1) there was no statistical difference (F=1.920, P=0.126) in group d1:A, group B, C and D children (F=1.920, P=0.126); (2) D2, D3, D4, D5, D6, D7, A group three concave sign score was higher than B group, C group and D group, and the difference was statistically significant (P0.05); (3) D2, D3, D4, and three concave signs were higher than those of the group. (4) there was no significant difference between the three concave sign scores. 5 days before the treatment, the atomization 2 groups were better than the nebulization 1 groups and the inject group.4, and the fever time: (1) D1, D4, D5, D6, D7, the temperature difference was not statistically significant (P0.05); (2) D2, the body temperature of d3:A group was higher than that of B group, C group and D group. There was no statistical significance (P0.05). The IFN atomization group, the injection group was shorter than the control group.5, and the lung function was improved: the peak time ratio (Time to PTEF/expiratory time, TPEF/TE): (1) the TPEF/TE ratio of each group was not statistically significant (F=0.243, P=0.867), and (2) the ratio of d7:A group was lower than that of the group, and the difference was statistically significant. F=225.825 (P0.001). The IFN atomization group was better than the control group on the improvement of TPEF/TE. The peak volume ratio (Expiratory volume at PTEF/expiratory volume, VPEF/VE): (1) d1: VPEF/VE ratio was not statistically significant (F=2.040, 2), and the difference was statistically significant. 71.321, P0.001). The IFN atomization group was better than the control group.6, and the efficiency and time of hospitalization were better than the control group. (1) the total effective rate: the effective rate of group A was lower than that of B group, C group and D group (F=12.015, P=0.007), and (2) the efficiency of A group was lower than that in B group, group and group, and the difference was statistically significant. (3) total hospital days: the number of days in group A was more than that of group B, C group and D group, the difference was statistically significant (F=57.657, P0.001), among which group D was shorter than that of B group and C group. The efficiency of interferon atomization group and intramuscular injection was better than that of the control group, and the number of nebulization groups was superior to the nebulization group 1 groups and the.7, liver function in the hospital days. Four groups in the normal range of liver function before and after treatment, not causing obvious liver function damage. Hint: interferon therapy has no obvious effect on liver function. Conclusion: recombinant human interferon alpha -1b has obvious effect on infant bronchiolitis, and the effect of atomization inhalation is better than that of intramuscular injection, and it can obviously promote the children with bronchiolitis The clinical symptoms and vital signs recovered, the course of disease was shortened, the clinical effect was significant, safe, and worthy of further promotion in clinical practice.
【学位授予单位】：西南医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R725.6

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