Clinical research of different pulmonary surfactant administration techniques on premature infants with respiratory distress syndrome

doi:10.3877/cma.j.issn.1673-5250.2020.03.007

Objective

To investigate the efficacy, safety and prognosis of less invasive pulmonary surfactant administration (LISA) and intubation-surfactant-extubation (INSURE) techniques in the treatment of respiratory distress syndrome (RDS) in premature infants.

Methods

Twenty-six premature infants with RDS who underwent LISA technique at the Affiliated Hospital of Yangzhou University from January 1, 2018 to April 30, 2019 were included in LISA group, and 36 premature infants with RDS who underwent INSURE technique at same hospital from July 1, 2016 to December 31, 2017 were included into INSURE group. The gestational age, birth weight, and postnatal Apgar score of 2 groups were statistically compared by using independent-samples t test. The age at admission, nasal continuous positive airway pressure (NCPAP) duration, mechanical ventilation (MV) duration, total oxygen consumption time, hospital stay, hospitalization costs and fraction of inspiration oxygen (FiO₂) at different time points between 2 groups were statistically compared by Mann-Whitney U test. The pH value, partial pressure of oxygen in artery (PaO₂), and partial pressure of carbon dioxide (PaCO₂) between 2 groups were compared by the variance analysis of repeated measurement data; furthermore, overall comparison within groups were compared by one-way ANOVA, and least significant difference (LSD) method was used for further pairwise comparison within groups. The Friedman rank sum test was used for within-group comparisons of FiO₂ at different time points. The gender composition ratio, cesarean section rate, transfe rate from other hospitals, maternal prenatal hormone use rate and incidence of related adverse reactions between 2 groups were compared by chi-square test, continuity correction of chi-square test or Fisher′s exact test. The procedures followed in this study was in accordance with the ethical standards established by the Human Beings Test Committee of Affiliated Hospital of Yangzhou University, and was approved by the committee (Approval No. 2020-YKL05-003). Informed consent was obtained from each participate′s parents.

Results

①There were no statistically significant differences in the gender composition ratio, gestational age, birth weight, modes of delivery, pregnancy rate of twins, age at admission, Apgar score after birth, transfer rate from other hospitals and maternal prenatal hormone use rate between 2 groups (P>0.05). ②No death occurred in 2 groups of RDS preterm infants. The median duration of MV (0) and total oxygen consumption time [84 h (45-180 h)] were significantly shorter than those of INSURE group [0 h (0-80 h), 137 h (107-235 h)], there were significantly statistical differences (Z=2.877, 1.991; P=0.004, 0.047). There were no differences between 2 groups in the aspects of NCPAP duration, MV rate within 72 h after birth, hospital stay, costs and incidence of different complications (P>0.05). ③The comparison results of pH value, PaO₂ and PaCO₂ levels before and after the treatment between 2 groups showed that there were no interactions between treatment measures and determination time factors (F_{treatment × time} = 1.751, P=0.152, F_{treatment × time} =0.338, P=0.852, F_{treatment × time}=0.396, P=0.810). The pH value, PaO₂ and PaCO₂ levels of children in LISA group before and at 1, 8, 24, 48 h after treatment were compared with each other in the group as a whole, and the differences were statistically significant (pH value: F=47.318, P<0.001, PaO₂: F=30.37, P<0.001, PaCO₂: F=27.140, P<0.001). The pH value, PaO₂ and PaCO₂ levels of children in INSURE group before and at 1, 8, 24, 48 h after treatment were compared with each other in the group as a whole, and the differences were statistically significant (pH value: F=20.773, P<0.001, PaO₂: F=16.976, P<0.001, PaCO₂: F=23.016, P<0.001). The pH value, PaO₂ and PaCO₂ levels of 2 groups were compared before PS treatment and at 1, 8, 24, 48 h after PS treatment respectively, and there were no statistically significant differences (P>0.05). ④ There were significant differences in FiO₂ at 0.5, 1, 6, 12, 24, and 48 h after PS treatment in 2 groups (LISA group: χ² = 131.108, P<0.001; INSURE group: χ²=81.589, P<0.001). The FiO₂ at 1, 6, 12, 24, and 48 h after treatment were significantly different from those before treatment (P<0.05). Compared with pre-treatment, there were significant differences in FiO₂ at 1, 6, 12, 24 and 48 h after treatment in 2 groups, respectively (P<0.05). There were no significant differences between 2 groups of FiO₂ before PS treatment and 0.5, 1 and 6 h after PS treatment (P>0.05). The FiO₂ of LISA group was lower than that in INSURE group at 12, 24 and 48 h after PS treatment, and the difference were statistically significant (Z=3.315, 4.312, 4.280, P=0.001, <0.001, <0.001). ⑤ There were 18 cases (69.2%) without adverse reactions after treatment in LISA group, and 27 cases (75.0%) in INSURE group. There was no statistically significant difference between 2 groups (χ²=0.252, P=0.615). In addition, there was no significant difference in the incidence of adverse reactions such as transcutaneous oxygen saturation(TcSO₂)<85% and bradycardia between 2 groups during PS administration (P>0.05).

Conclusions

LISA technique can shorten MV duration and total oxygen consumption time in premature infants with RDS, and does not increase the adverse prognosis.

Key words: Respiratory distress syndrome, newborn, Pulmonary surfactant, Less invasive surfactant administration, Blood gas analysis, Continuous positive airway pressure, Infant, premature

表1 2组RDS早产儿一般临床资料比较

组别	例数	性别[例数(%)]		分娩胎龄(周，±s)	出生体重(g，±s)	剖宫产术分娩[例数(%)]	双胎[例数(%)]	入院时年龄[生后时间(h)，M(P₂₅～P₇₅)]
组别	例数	男	女	分娩胎龄(周，±s)	出生体重(g，±s)	剖宫产术分娩[例数(%)]	双胎[例数(%)]	入院时年龄[生后时间(h)，M(P₂₅～P₇₅)]
LISA组	26	16(61.5)	10(38.5)	31.6±2.7	1 876±646	16(61.5)	5(19.2)	1.5(0.9～2.5)
INSURE组	36	26(72.2)	10(27.8)	31.8±2.3	1 956±623	20(55.5)	7(19.4)	1.6(0.5～2.7)
检验值		χ²＝0.789		t＝0.326	t＝0.488	χ²＝0.222	χ²＝0.000	Z＝0.179
P值		0.375		0.746	0.628	0.638	0.983	0.858
组别	例数	生后Apgar评分(分，±s)		外院转入[例数(%)]	母亲产前使用激素[例数(%)]	开始NCPAP年龄[生后时间(h)，M(P₂₅～P₇₅)]	首剂PS应用时间[生后时间(h)，M(P₂₅～P₇₅)]
组别	例数	1 min	5 min	外院转入[例数(%)]	母亲产前使用激素[例数(%)]	开始NCPAP年龄[生后时间(h)，M(P₂₅～P₇₅)]	首剂PS应用时间[生后时间(h)，M(P₂₅～P₇₅)]
LISA组	26	8.3±1.4	8.8±1.7	10(38.4)	12(46.2)	1.5(0.5～2.1)	3.0(2.0～4.3)
INSURE组	36	7.8±1.7	8.3±1.7	13(36.1)	11(30.5)	2.0(0.5～2.9)	4.0(2.3～6.0)
检验值		t＝1.229	t＝1.403	χ²＝0.036	χ²＝1.574	Z＝0.524	Z＝1.662
P值		0.638	0.210	0.224	0.983	0.600	0.096

表1 2组RDS早产儿一般临床资料比较

组别	例数	性别[例数(%)]		分娩胎龄(周，±s)	出生体重(g，±s)	剖宫产术分娩[例数(%)]	双胎[例数(%)]	入院时年龄[生后时间(h)，M(P₂₅～P₇₅)]
组别	例数	男	女	分娩胎龄(周，±s)	出生体重(g，±s)	剖宫产术分娩[例数(%)]	双胎[例数(%)]	入院时年龄[生后时间(h)，M(P₂₅～P₇₅)]
LISA组	26	16(61.5)	10(38.5)	31.6±2.7	1 876±646	16(61.5)	5(19.2)	1.5(0.9～2.5)
INSURE组	36	26(72.2)	10(27.8)	31.8±2.3	1 956±623	20(55.5)	7(19.4)	1.6(0.5～2.7)
检验值		χ²＝0.789		t＝0.326	t＝0.488	χ²＝0.222	χ²＝0.000	Z＝0.179
P值		0.375		0.746	0.628	0.638	0.983	0.858
组别	例数	生后Apgar评分(分，±s)		外院转入[例数(%)]	母亲产前使用激素[例数(%)]	开始NCPAP年龄[生后时间(h)，M(P₂₅～P₇₅)]	首剂PS应用时间[生后时间(h)，M(P₂₅～P₇₅)]
组别	例数	1 min	5 min	外院转入[例数(%)]	母亲产前使用激素[例数(%)]	开始NCPAP年龄[生后时间(h)，M(P₂₅～P₇₅)]	首剂PS应用时间[生后时间(h)，M(P₂₅～P₇₅)]
LISA组	26	8.3±1.4	8.8±1.7	10(38.4)	12(46.2)	1.5(0.5～2.1)	3.0(2.0～4.3)
INSURE组	36	7.8±1.7	8.3±1.7	13(36.1)	11(30.5)	2.0(0.5～2.9)	4.0(2.3～6.0)
检验值		t＝1.229	t＝1.403	χ²＝0.036	χ²＝1.574	Z＝0.524	Z＝1.662
P值		0.638	0.210	0.224	0.983	0.600	0.096

表2 2组RDS早产儿治疗时间、并发症发生情况及出院转归等比较

组别	例数	生后72 h内接受MV治疗[例数(%)]	NCPAP时间[h，M(P₂₅～P₇₅)]	MV治疗时间[h，M(P₂₅～P₇₅)]	总用氧时间[h，M(P₂₅～P₇₅)]	住院时间[d，M(P₂₅～P₇₅)]	住院费用[万元，M(P₂₅～P₇₅)]
LISA组	26	1(3.8)	72(48～115)	0(0～0)	84(45～180)	20.0(12.8～30.5)	2.79(1.84～5.00)
INSURE组	36	9(25.0)	63(36～110)	0(0～80)	137(107～235)	23.5(15.3～37.8)	3.75(2.25～5.24)
检验值		χ²＝3.553^a	Z＝1.224	Z＝2.877	Z＝1.991	Z＝1.242	Z＝0.913
P值		0.059	0.214	0.004	0.047	0.214	0.361
组别	例数	并发症[例数(%)]			治愈[例数(%)]	转院[例数(%)]	需使用第2剂PS[例数(%)]
组别	例数	气胸	BPD	Ⅲ～Ⅳ级颅内出血	治愈[例数(%)]	转院[例数(%)]	需使用第2剂PS[例数(%)]
LISA组	26	1(3.8)	1(3.8)	4(15.4)	25(96.2)	1(3.8)	1(3.8)
INSURE组	36	1(2.8)	1(2.8)	10(27.8)	35(97.2)	1(2.8)	7(19.4)
检验值		—	—	χ²＝1.326	—	—	χ²＝2.028^a
P值		1.000	1.000	0.249	1.000	1.000	0.154

表2 2组RDS早产儿治疗时间、并发症发生情况及出院转归等比较

组别	例数	生后72 h内接受MV治疗[例数(%)]	NCPAP时间[h，M(P₂₅～P₇₅)]	MV治疗时间[h，M(P₂₅～P₇₅)]	总用氧时间[h，M(P₂₅～P₇₅)]	住院时间[d，M(P₂₅～P₇₅)]	住院费用[万元，M(P₂₅～P₇₅)]
LISA组	26	1(3.8)	72(48～115)	0(0～0)	84(45～180)	20.0(12.8～30.5)	2.79(1.84～5.00)
INSURE组	36	9(25.0)	63(36～110)	0(0～80)	137(107～235)	23.5(15.3～37.8)	3.75(2.25～5.24)
检验值		χ²＝3.553^a	Z＝1.224	Z＝2.877	Z＝1.991	Z＝1.242	Z＝0.913
P值		0.059	0.214	0.004	0.047	0.214	0.361
组别	例数	并发症[例数(%)]			治愈[例数(%)]	转院[例数(%)]	需使用第2剂PS[例数(%)]
组别	例数	气胸	BPD	Ⅲ～Ⅳ级颅内出血	治愈[例数(%)]	转院[例数(%)]	需使用第2剂PS[例数(%)]
LISA组	26	1(3.8)	1(3.8)	4(15.4)	25(96.2)	1(3.8)	1(3.8)
INSURE组	36	1(2.8)	1(2.8)	10(27.8)	35(97.2)	1(2.8)	7(19.4)
检验值		—	—	χ²＝1.326	—	—	χ²＝2.028^a
P值		1.000	1.000	0.249	1.000	1.000	0.154

表3 2组RDS早产儿PS治疗前、后不同时间点血气分析指标组间及组内比较(±s)

组别	例数	动脉血pH值					F值	P值
组别	例数	治疗前	治疗后1 h	治疗后8 h	治疗后24 h	治疗后48 h	F值	P值
LISA组	26	7.2±0.1	7.3±0.1	7.3±0.1	7.4±0.1	7.4±0.1	47.318	<0.001
INSURE组	36	7.2±0.1	7.3±0.1	7.3±0.1	7.3±0.1	7.3±0.1	20.773	<0.001
t值		0.008	0.015	0.010	0.017	0.029
P值		0.641	0.472	0.614	0.244	0.101
组别	例数	PaO₂ (mmHg)					F值	P值
组别	例数	治疗前	治疗后1 h	治疗后8 h	治疗后24 h	治疗后48 h	F值	P值
LISA组	26	46.1±12.9	76.0±13.2	73.1±13.6	74.5±14.4	70.3±12.1	30.370	<0.001
INSURE组	36	47.1±14.6	73.2±20.8	69.3±18.1	70.6±15.9	66.9±11.2	16.976	<0.001
t值		1.034	2.816	3.821	3.917	3.408
P值		0.773	0.547	0.369	0.324	0.256
组别	例数	PaCO₂(mmHg)					F值	P值
组别	例数	治疗前	治疗后1 h	治疗后8 h	治疗后24 h	治疗后48 h	F值	P值
LISA组	26	63.0±11.2	51.8±8.4	44.3±9.8	42.8±11.9	41.9±5.6	27.140	<0.001
INSURE组	36	63.6±12.6	52.0±16.4	45.5±12.4	44.3±7.6	45.8±7.8	23.016	<0.001
t值		0.600	0.154	1.209	1.459	0.487
P值		0.847	0.965	0.681	0.561	0.767

表3 2组RDS早产儿PS治疗前、后不同时间点血气分析指标组间及组内比较(±s)

组别	例数	动脉血pH值					F值	P值
组别	例数	治疗前	治疗后1 h	治疗后8 h	治疗后24 h	治疗后48 h	F值	P值
LISA组	26	7.2±0.1	7.3±0.1	7.3±0.1	7.4±0.1	7.4±0.1	47.318	<0.001
INSURE组	36	7.2±0.1	7.3±0.1	7.3±0.1	7.3±0.1	7.3±0.1	20.773	<0.001
t值		0.008	0.015	0.010	0.017	0.029
P值		0.641	0.472	0.614	0.244	0.101
组别	例数	PaO₂ (mmHg)					F值	P值
组别	例数	治疗前	治疗后1 h	治疗后8 h	治疗后24 h	治疗后48 h	F值	P值
LISA组	26	46.1±12.9	76.0±13.2	73.1±13.6	74.5±14.4	70.3±12.1	30.370	<0.001
INSURE组	36	47.1±14.6	73.2±20.8	69.3±18.1	70.6±15.9	66.9±11.2	16.976	<0.001
t值		1.034	2.816	3.821	3.917	3.408
P值		0.773	0.547	0.369	0.324	0.256
组别	例数	PaCO₂(mmHg)					F值	P值
组别	例数	治疗前	治疗后1 h	治疗后8 h	治疗后24 h	治疗后48 h	F值	P值
LISA组	26	63.0±11.2	51.8±8.4	44.3±9.8	42.8±11.9	41.9±5.6	27.140	<0.001
INSURE组	36	63.6±12.6	52.0±16.4	45.5±12.4	44.3±7.6	45.8±7.8	23.016	<0.001
t值		0.600	0.154	1.209	1.459	0.487
P值		0.847	0.965	0.681	0.561	0.767

表4 2组RDS早产儿PS治疗前、后不同时间点FiO₂组内及组间比较[M(P₂₅～P₇₅)]

组别	例数	治疗前	治疗后						χ ²值	P值
组别	例数	治疗前	0.5 h	1 h	6 h	12 h	24 h	48 h	χ ²值	P值
LISA组	26	0.40(0.35～0.40)	0.35(0.30～0.35)	0.30(0.30～0.30)	0.30(0.25～0.30)	0.25(0.21～0.30)	0.21(0.21～0.25)	0.21(0.21～0.25)	131.108	<0.001
INSURE组	36	0.35(0.35～0.40)	0.30(0.30～0.38)	0.30(0.28～0.35)	0.30(0.25～0.34)	0.30(0.25～0.32)	0.30(0.25～0.35)	0.25(0.25～0.35)	81.589	<0.001
Z值		1.318	0.769	0.456	1.401	3.315	4.312	4.280
P值		0.187	0.442	0.648	0.161	0.001	<0.001	<0.001

表4 2组RDS早产儿PS治疗前、后不同时间点FiO₂组内及组间比较[M(P₂₅～P₇₅)]

组别	例数	治疗前	治疗后						χ ²值	P值
组别	例数	治疗前	0.5 h	1 h	6 h	12 h	24 h	48 h	χ ²值	P值
LISA组	26	0.40(0.35～0.40)	0.35(0.30～0.35)	0.30(0.30～0.30)	0.30(0.25～0.30)	0.25(0.21～0.30)	0.21(0.21～0.25)	0.21(0.21～0.25)	131.108	<0.001
INSURE组	36	0.35(0.35～0.40)	0.30(0.30～0.38)	0.30(0.28～0.35)	0.30(0.25～0.34)	0.30(0.25～0.32)	0.30(0.25～0.35)	0.25(0.25～0.35)	81.589	<0.001
Z值		1.318	0.769	0.456	1.401	3.315	4.312	4.280
P值		0.187	0.442	0.648	0.161	0.001	<0.001	<0.001

表5 2组RDS早产儿接受PS治疗后不良反应发生率比较[例数(%)]

组别	例数	TcSO₂<85%	心动过缓	PS反流	气管插管所致损伤
LISA组	26	4(15.4)	2(7.7)	3(11.5)	0(0)
INSURE组	36	6(16.7)	3(8.3)	0(0)	3(8.3)
χ²值		0.000^a	0.000^a	2.219^a	0.827^a
P值		1.000	1.000	0.136	0.363

表5 2组RDS早产儿接受PS治疗后不良反应发生率比较[例数(%)]

组别	例数	TcSO₂<85%	心动过缓	PS反流	气管插管所致损伤
LISA组	26	4(15.4)	2(7.7)	3(11.5)	0(0)
INSURE组	36	6(16.7)	3(8.3)	0(0)	3(8.3)
χ²值		0.000^a	0.000^a	2.219^a	0.827^a
P值		1.000	1.000	0.136	0.363

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