维生素D3纳米喷剂在维生素D不足儿童中吸收性和安全性评估：一项前瞻性随机非劣效性对照试验

doi:10.12372/jcp.2025.25e0226

临床儿科杂志 ›› 2025, Vol. 43 ›› Issue (10): 755-761.doi: 10.12372/jcp.2025.25e0226

维生素D₃纳米喷剂在维生素D不足儿童中吸收性和安全性评估：一项前瞻性随机非劣效性对照试验

李静¹, 乔荆², 罗瑛仁³, 单红梅⁴, 洪莉¹(), 张程辰³()

1.临床营养科上海交通大学医学院附属上海儿童医学中心（上海 200127）
2.健康管理中心上海交通大学医学院附属上海儿童医学中心（上海 200127）
3.临床研究管理中心上海交通大学医学院附属上海儿童医学中心（上海 200127）
4.国际门诊部上海交通大学医学院附属上海儿童医学中心（上海 200127）

收稿日期:2025-03-13 录用日期:2025-08-13 出版日期:2025-10-15 发布日期:2025-09-29
通讯作者: 洪莉,张程辰 E-mail:hongli@scmc.com.cn;zhangc_scmc@126.com
基金资助:
浦东新区科技发展基金事业单位民生科研专项项目(PKJ2023-Y47);上海申康医院发展中心医企融合创新支撑技能培训专项(SHDC2023CRS028)

Evaluation of the absorbency and safety of vitamin D₃ nano-spray in children with vitamin D insufficiency: a prospective randomized non-inferiority controlled trial

LI Jing¹, QIAO Jing², LUO Yingren³, SHAN Hongmei⁴, HONG Li¹(), ZHANG Chengchen³()

1. Department of Clinic Nutrition, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
2. Department of Health Management, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
3. Center of Clinical Research, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
4. International Clinical Division, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China

Received:2025-03-13 Accepted:2025-08-13 Published:2025-10-15 Online:2025-09-29
Contact: HONG Li, ZHANG Chengchen E-mail:hongli@scmc.com.cn;zhangc_scmc@126.com

摘要/Abstract

摘要：

目的评估维生素D₃纳米喷剂在维生素D不足儿童中的吸收性和安全性。方法纳入2023年10月至2024年9月就诊于上海儿童医学中心的维生素D不足的3~18周岁患儿47例，采用前瞻性随机非劣效性对照设计，将受试者随机分配至试验组（n=19）和对照组（n=28）。试验组接受维生素D₃纳米喷剂，对照组接受维生素D₃滴剂（胶囊型），于基线及用药第56天测量受试者的血清维生素D水平，以评估维生素D₃补充效果；检测受试者基线以及用药第56天血液肝肾功能和甲状旁腺激素水平以评估药物安全性。结果试验组和对照组分别予维生素D₃纳米喷剂或维生素D₃滴剂56天后，两组血清维生素D水平均较基线明显改善，但两组间维生素D上升幅度差异无统计学意义（P>0.025）。用药第56天试验组的血清25-羟维生素D₃水平显著高于对照组，差异有统计学意义（P<0.025）。受试者用药56天后肝肾功能和甲状旁腺激素水平均未出现异常。结论维生素D₃纳米喷剂对维生素D不足儿童的补充效果与维生素D₃滴剂相比无显著性差异，研究期间未报告不良反应。

关键词: 维生素D₃纳米喷剂, 维生素D不足, 25-羟维生素D, 儿童

Abstract:

Objective To evaluate the absorption and safety of vitamin D₃ nano-spray in children with vitamin D insufficiency. Methods A total of 47 children aged 3 to 18 years with vitamin D insufficiency who visited Shanghai Children's Medical Center from October 2023 to September 2024 were included and a prospective randomized non-inferiority controlled design was adopted, and the subjects were randomly assigned to the experimental group (n=19) and the control group (n=28). The experimental group received vitamin D₃ nano-spray, while the control group received vitamin D₃ drops (capsule form). The serum vitamin D levels of the subjects were measured at baseline and on the 56^th day of medication to evaluate the supplementation effect of vitamin D₃. The blood liver and kidney functions and parathyroid hormone levels of the subjects at baseline and on the 56^th day of medication were detected to evaluate the drug safety. Results After a 56-day intervention period, serum vitamin D levels in both experimental and control groups demonstrated a statistically significant improvement compared to baseline. Despite the overall improvement, the change of serum vitamin D levels was not significantly different between the two groups (P>0.05). Notably, the experimental group had significantly higher serum vitamin D₃ levels than the control group after 56 days (P<0.05). Throughout the study, no abnormalities in liver function, kidney function, and parathyroid hormone levels were observed. Conclusions The supplementation effect of vitamin D₃ nano-spray on children with insufficient vitamin D was not significantly different from that of vitamin D₃ drops. No adverse reactions were reported during the study period.

Key words: vitamin D₃ nano-spray, vitamin D insufficiency, 25(OH)D, child

中图分类号:

李静, 乔荆, 罗瑛仁, 单红梅, 洪莉, 张程辰. 维生素D₃纳米喷剂在维生素D不足儿童中吸收性和安全性评估：一项前瞻性随机非劣效性对照试验[J]. 临床儿科杂志, 2025, 43(10): 755-761.

LI Jing, QIAO Jing, LUO Yingren, SHAN Hongmei, HONG Li, ZHANG Chengchen. Evaluation of the absorbency and safety of vitamin D₃ nano-spray in children with vitamin D insufficiency: a prospective randomized non-inferiority controlled trial[J]. Journal of Clinical Pediatrics, 2025, 43(10): 755-761.

图/表 4

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项目	试验组(n=19)	对照组(n=28)	统计量	P
年龄($\bar{x}±s$)/岁	9.94±1.89	11.34±2.89	t=1.84	0.072
男性[n(%)]	11(57.89)	15(53.57)	χ²=0.09	0.770
25-羟维生素D[M(P₂₅~P₇₅)]/ng·mL^-1	15.54(14.07~17.24)	14.38(12.78~18.15)	Z=1.02	0.317
25-羟维生素D₂[M(P₂₅~P₇₅)]/ng·mL^-1	0.30(0.01~1.54)	0.37(0.01~0.80)	Z=0.68	0.501
25-羟维生素D₃[M(P₂₅~P₇₅)]/ng·mL^-1	14.38(12.83~16.35)	13.80(12.58~16.13)	Z=0.09	0.940
肝功能
ALT[M(P₂₅~P₇₅)]/U·L^-1	11.00(10.00~13.00)	14.00(13.00~19.00)	Z=2.24	0.025
DB($\bar{x}±s$)/μmol·L^-1	2.96±0.78	3.55±0.84	t=1.68	0.110
AST[M(P₂₅~P₇₅)]/U·L^-1	23.00(19.50~23.50)	24.00(20.00~27.00)	Z=0.64	0.520
ALP[M(P₂₅~P₇₅)]/U·L^-1	265.00(220.50~316.50)	219.00(207.00~292.00)	Z=0.84	0.401
TB($\bar{x}±s$)/μmol·L^-1	7.30±3.22	8.13±2.10	t=0.73	0.477
肾功能
UREA($\bar{x}±s$)/mmol·L^-1	4.58±1.18	4.50±1.44	t=0.57	0.576
CREA[M(P₂₅~P₇₅)]/μmol·L^-1	39.00(34.13~45.82)	41.00(38.96~45.05)	Z=0.52	0.602
PTH($\bar{x}±s$)/pg·mL^-1	32.94±11.28	29.00±8.07	t=0.83	0.418

项目	退出组(n=23)	完成组(n=47)	统计量	P
年龄($\bar{x}±s$)/岁	10.42±1.89	11.10±2.89	t=1.05	0.296
男性[n(%)]	7(30.43)	26(55.32)	χ²=0.09	0.770
25-羟维生素D[M(P₂₅~P₇₅)]/ng·mL^-1	14.39(13.23~17.95)	13.83(12.66~16.23)	Z=1.38	0.169
25-羟维生素D₂[M(P₂₅~P₇₅)]/ng·mL^-1	0.01(0.01~0.67)	0.30(0.01~0.89)	Z=1.35	0.180
25-羟维生素D₃[M(P₂₅~P₇₅)]/ng·mL^-1	14.72(13.24~18.40)	15.08(13.23~17.86)	Z=0.43	0.675

项目	试验组(n=19)	对照组(n=28)	统计量	P
25-羟维生素D
用药前后变化	9.75±4.42	7.46±4.09	t=1.83	0.037
用药第56天	25.56±3.99	22.80±3.40	t=2.54	0.007
25-羟维生素D₃
用药前后变化	10.68±5.00	8.05±4.04	t=1.99	0.026
用药第56天	25.20±4.27	22.69±3.30	t=2.28	0.014

项目	试验组(n=19)	对照组(n=28)	统计量	P
用药第56天
肝功能
ALT[M(P₂₅~P₇₅)]/U·L^-1	12.00(10.00~15.50)	12.00(11.00~13.00)	Z=0.85	0.404
DB[M(P₂₅~P₇₅)]/μmol·L^-1	2.90(2.50~3.20)	3.50(2.85~4.70)	Z=2.25	0.026
AST[M(P₂₅~P₇₅)]/U·L^-1	22.00(20.00~23.00)	21.00(19.00~25.00)	Z=0.75	0.460
ALP($\bar{x}±s$)/U·L^-1	266.92±72.88	253.74±86.71	t=0.52	0.608
TB[M(P₂₅~P₇₅)]/μmol·L^-1	6.00(4.70~8.20)	7.10(6.10~11.50)	Z=2.46	0.014
肾功能
UREA($\bar{x}±s$)/mmol·L^-1	4.64±1.04	4.80±1.56	t=0.37	0.716
CREA[M(P₂₅~P₇₅)]/μmol·L^-1	43.13(38.62~46.48)	41.00(37.38~53.18)	Z=0.22	0.838
PTH[M(P₂₅~P₇₅)]/pg·mL^-1	26.35(19.16~29.83)	26.61(21.51~31.56)	Z=0.64	0.538
用药前后变化
肝功能
ALT[M(P₂₅~P₇₅)]/U·L^-1	－1.00(－2.00~2.00)	3.00(－1.00~6.00)	Z=1.21	0.226
DB[M(P₂₅~P₇₅)]/μmol·L^-1	－0.05(－0.30~0.20)	－0.60(－1.30~0.25)	Z=0.87	0.385
AST[M(P₂₅~P₇₅)]/U·L^-1	0.00(－1.00~1.00)	3.00(0.00~6.00)	Z=1.75	0.081
ALP[M(P₂₅~P₇₅)]/U·L^-1	2.00(－16.00~13.00)	6.00(－9.00~46.00)	Z=0.83	0.404
TB[M(P₂₅~P₇₅)]/μmol·L^-1	0.30(－0.30~1.70)	－1.40(－3.93~0.33)	Z=1.60	0.110
肾功能
UREA[M(P₂₅~P₇₅)]/mmol·L^-1	－0.35(－0.85~0.00)	－0.30(－0.60~0.50)	Z=0.77	0.442
CREA[M(P₂₅~P₇₅)]/μmol·L^-1	－3.12(－5.48~1.00)	－2.03(－4.00~0.68)	Z=0.37	0.713
PTH[M(P₂₅~P₇₅)]/pg·mL^-1	6.76(2.81~11.87)	3.47(0.29~6.56)	Z=1.15	0.248

维生素D₃纳米喷剂在维生素D不足儿童中吸收性和安全性评估：一项前瞻性随机非劣效性对照试验

Evaluation of the absorbency and safety of vitamin D₃ nano-spray in children with vitamin D insufficiency: a prospective randomized non-inferiority controlled trial

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