乳糖酶添加剂对早产儿乳糖不耐受有效性及安全性：一项前瞻性、多中心、随机对照研究

doi:10.12372/jcp.2023.22e1095

Abstract

Abstract: Objective To explore the efficacy and safety of lactase additive in improving lactose intolerance in premature infants. Methods Preterm infants with lactose intolerance admitted to Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai First Maternal and Infant Health Hospital, Children's Hospital Affiliated to Zhejiang University School of Medicine and Children's Hospital Affiliated to Soochow University from January 2018 to December 2019, who met the inclusion criteria were included in the study. They were divided into lactase treatment group and control group randomly, with 80 cases in each group. For the patients in the lactase treatment group, 4 drops (180 mg) of lactase were added to each feeding of breast milk or formula milk for premature infants, and Bifidobacterium triple viable powder was orally administered and abdominal massage was used as adjuvant therapy. For patients in the control group, 4 drops (180 mg) of placebo were added to each feeding, and the same probiotics and abdominal massage as the treatment group were given, After 1 and 2 weeks treatment, symptoms of lactose intolerance, weight, fecal pH, fecal reducing sugar and other indicators were compared between the two groups. Results seventy-eight patients in the lactase treatment group and 77 patients in the control group, respectively, completed the whole study. After the first week intervention, the positive rate of reducing sugar in the lactase treatment group was lower than that in the control group (P<0.05). At the end of the second week treatment, the proportion of abdominal distension in the lactase treatment group were lower than those in the control group (P<0.05), and the positive rate of reducing sugar was lower than that in the control group (P<0.05). The increase of feeding amount was also higher than that of the control group (P<0.05). During the course of the study, no adverse reactions to lactase additives or probiotics were found in both groups. Conclusions Lactase supplementation can effectively and safely improve the clinical symptoms caused by lactose intolerance in premature infants.

Key words: lactose intolerance, lactase supplement, safety, efficacy, premature infant

ZHA Xinyi, WANG Yiwen, MAO Pengliang, CHEN Mingyan, JIANG Wei, WANG Huawei, HU Xuefeng, SHI Liping, ZHU Xueping, QIAN Jihong. Efficacy and safety of lactase additive in preterm infants with lactose intolerance: a prospective, multi-center, randomized controlled trial[J].Journal of Clinical Pediatrics, 2023, 41(1): 34-41.

Figures/Tables 6

References 25

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医院	组别	例数	胎龄 [x±s/M(P₂₅~P₇₅)]/周	性别（男） [n(%)]	入组日龄 [M(P₂₅~P₇₅)]/d	入组体重 [x±s/M(P₂₅~P₇₅)]/g
上海新华医院	对照组	20	31.42±2.15	10(50.0)	9.00(2.25~16.00)	1641.80±389.22
	乳糖酶治疗组	29	30.78±2.30	13(44.8)	8.00（3.00~15.50）	1536.66±407.88
	统计量		t=0.98	χ²=0.13	Z=0.05	t=0.903
	P		0.33	0.72	0.96	0.37
上海市第一妇婴保健院	对照组	26	29.71(28.40~31.54)	13(50.0)	17.00(12.50~22.25)	1521.54±393.28
	乳糖酶治疗组	14	30.86(29.25~34.14)	10(71.40)	21.00(11.25~24.00)	1498.93±346.97
	统计量		Z=1.32	χ²=1.71	Z=0.55	t=0.18
	P		0.19	0.19	0.58	0.86
浙江大学医学院附属儿童医院	对照组	11	29.21±1.11	6(54.5)	34.00(23.00~43.00)	1 822.73±354.04
	乳糖酶治疗组	14	29.47±1.49	9(64.3)	32.00(21.75~39.00)	1 939.29±346.71
	统计量		t=0.49	?-	Z=0.44	t=0.83
	P		0.63	0.70¹⁾	0.66	0.42
苏州大学附属儿童医院	对照组	20	32.43(31.25~33.86)	11(55.00)	12.00(5.75~17.75)	1 755.00 (1 645.00~2 392.50)
	乳糖酶治疗组	21	33.57（31.79~35.43）	10(47.60)	10.00(5.00~18.00)	2 020.00 (1 560.00~2 400.00)
	统计量		Z=1.31	χ²=0.22	Z=0.34	Z=0.55
	P		0.19	0.64	0.73	0.58

项目	对照组(n=77)	乳糖酶治疗组(n=78)	统计量	P
母乳喂养[n(%)]	46(59.74)	41(52.56)	χ²=0.81	0.37
入组时喂养量[M(P₂₅~P₇₅)]/mL·kg^-1·d^-1	88.00（46.75~131.05）	75.10（38.78~102.55）	Z=1.46	0.14
第1周末
喂养量（x±s）/mL·kg^-1·d^-1	128.12±36.51	123.56±34.26	t=0.80	0.42
喂养量增加[M(P₂₅~P₇₅)]/mL·kg^-1·d^-1	38.54（3.00~69.14）	46.85（19.00~76.83）	Z=1.26	0.21
第2周末
喂养量（x±s）/mL·kg^-1·d^-1	145.83±29.23	154.70±29.90	t=1.85	0.06
喂养量增加[M(P₂₅~P₇₅)]/mL·kg^-1·d^-1	62.00（16.13~94.70）	74.50（41.75~126.35）	Z=2.25	0.02

项目	对照组(n=77)	乳糖酶治疗组(n=78)	统计量	P
入组时
吐奶[n(%)]	12(15.58)	22(28.21)	χ²=3.60	0.06
腹胀[n(%)]	48(62.34)	39(50.00)	χ²=3.43	0.06
每日排便次数[M(P₂₅~P₇₅)]/次	2.00（1.00~4.00）	2.50（1.00~4.00）	Z=0.72	0.47
第1周末
吐奶[n(%)]	2(2.60)^1）	2(2.56)^1）	-	1.00³⁾
腹胀[n(%)]	24(31.17)^2）	15(19.23)^2）	χ²=2.96	0.09
每日排便次数[M(P₂₅~P₇₅)]/次	2.00(1.00~3.00)	2.00(1.00~3.00)	Z=0.04	0.96
第2周末
吐奶[n(%)]	0(0.00)¹⁾	1(1.28)¹⁾	-	1.00³⁾
腹胀[n(%)]	18(23.38)²⁾	2(2.56)²⁾	χ²=15.74	<0.01
每日排便次数[M(P₂₅~P₇₅)]/次	2.00(1.00~3.00)	2.00(1.00~3.00)	Z=0.04	0.96

项目	对照组(n=77)	乳糖酶治疗组(n=78)	统计量	P
入组时
粪便pH值阳性[n(%)]	36（46.75）	42（53.84）	χ²=0.78	0.38
还原糖[M(P₂₅~P₇₅)]/%	0.50（0.50~1.00）	0.50（0.50~1.00）	Z=0.30	0.77
还原糖阳性[n(%)]	77（100）	78（100）	-	-
第1周末
粪便pH值阳性[n(%)]	31（40.26）	35（44.87）	χ²=0.34	0.56
还原糖[M(P₂₅~P₇₅)]/%	0.50（0.25~1.00）	0.25（0.00~0.50）	Z=4.09	<0.01
还原糖阳性[n(%)]	65(84.42)	49(62.82)	χ²=9.29	<0.01
第2周末
粪便pH值阳性[n(%)]	28(36.36)	34(43.59)	χ²=0.84	0.36
还原糖[M(P₂₅~P₇₅)]/%	0.25（0.00~0.50）	0.00（0.00~0.25）	Z=3.22	<0.01
还原糖阳性[n(%)]	45(58.44)	24(30.77)	χ²=12.15	<0.01

项目	对照组(n=77)	乳糖酶治疗组(n=78)	t值	P
入组时
体重(x±s)/g	1 699.69±414.21	1 778.69±494.76	1.08	0.28
第1周末
体重(x±s)/g	1 860.13±422.73	1 962.41±540.79	1.31	0.19
t值	12.14	10.73
P	<0.01	<0.01
第2周末
体重(x±s)/g	2 058.83±463.33	2 157.65±585.01	1.17	0.25
t值	17.87	17.08
P	<0.01	<0.01

Efficacy and safety of lactase additive in preterm infants with lactose intolerance: a prospective, multi-center, randomized controlled trial

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