世界中医药

目的：研究探讨龙牡壮骨颗粒对比碳酸钙D3颗粒用于防治婴儿早期维生素D缺乏性佝偻病的临床疗效及安全性。方法：选取2017年1月至2018年1月在黄石市妇幼保健院出生的健康新生儿84例作为研究对象，按照随机数字表法随机分为对照组和观察组，每组42例。对照组给予碳酸钙D3颗粒进行预防治疗，观察组给予龙牡壮骨颗粒预防治疗。连续服用12个月后，对2组婴儿维生素D缺乏性佝偻病的患病率、血液生化指标、骨密度、随访期间非特异性神经精神症状及体征变化情况、身高、体质量、安全性等进行统计对比。结果：观察组维生素D缺乏性佝偻病患病率为4.76%(2/42)，低于对照组为19.05%(8/42)，组间比较差异有统计学意义(P<0.05)。治疗前2组血清生化指标水平对比无统计学差异，治疗后观察组血清25-(OH)D3、钙磷乘积与对照组比较，差异无统计学意义(P>0.05)，观察组血清骨钙素(BGP)、骨碱性磷酸酶(BALP)水平均低于对照组，组间比较差异有统计学意义(P<0.05)。治疗12个月后观察组骨密度(BMD)水平略高于对照组，组间比较差异无统计学意义(P>0.05)。经3、6、9、12个月随访观察，观察组非特异性神经精神症状及体征变化发生率低于对照组，组间对比差异有统计学意义(P<0.05)。观察组身高、体质量均略高于对照组，但2组比较差异无统计学意义(P>0.05)。治疗期间观察组不良反应发生率为9.52%(4/42)，低于对照组为26.19%(11/42)，组间比较差异有统计学意义(P<0.05)。结论：相比于碳酸钙D3颗粒，龙牡壮骨颗粒用于婴儿早期维生素D缺乏性佝偻病的防治效果更好，在降低患病率、血清学指标、非特异性神经精神症状及体征变化等方面有显著的改善作用，且治疗安全性更好，值得临床推荐使用。

English Summary:

To study and explore clinical efficacy and safety of Longmu Zhuanggu Granules compared with Calcium Carbonate D3 Granules in prevention and treatment of early vitamin D deficiency rickets in infants.Methods:A total of 84 healthy newborns born in Huangshi Maternal and Child Health Hospital from January 2017 to January 2018 were selected as the study subjects.They were divided into observation group and control group according to random number table method, with 42 cases in each group.The control group was given Calcium Carbonate D3 Granules for prevention and treatment, while the observation group was given Longmu Zhuanggu Granules for prevention and treatment.After 12 months of continuous administration, incidence of vitamin D deficiency rickets, blood biochemical indexes, bone mineral density(BMD), changes of non-specific neuropsychiatric symptoms and signs during follow-up, height, weight and safety were compared between the 2 groups.Results:The incidence of vitamin D deficiency rickets in the observation group was 4.76%(2/42), which was lower than that in the control group(19.05%(8/42).There was a significant difference between the 2 groups(P<0.05).There was no statistical difference in serum biochemical indexes between the 2 groups before the treatment.There was no statistical difference in 25-(OH)D3 and calcium-phosphorus product between the observation group and the control group after the treatment(P>0.05).Levels of serum osteocalcin(BGP)and bone alkaline phosphatase(BALP)in the observation group were lower than those in the control group, and there was significant difference between the 2 groups(P<0.05).After 12 months of the treatment, the BMD level in the observation group was slightly higher than that in the control group, and there was no statistical difference between the 2 groups(P>0.05).After 3, 6, 9 and 12 months of follow-up observation, the incidence of changes in non-specific neuropsychiatric symptoms and signs in the observation group was lower than that in the control group, and the difference between the groups was statistically significant(P<0.05).The height and weight in the observation group were slightly higher than those in the control group, but there was no significant difference between the 2 groups(P>0.05).During the treatment, the incidence of adverse reactions in the observation group was 9.52%(4/42), which was lower than that in the control group 26.19%(11/42).There was significant difference between the 2 groups(P<0.05).Conclusion:Compared with Calcium Carbonate D3 Granules, Longmu Zhuanggu Granules is more effective in the prevention and treatment of early vitamin D deficiency rickets in infants.It can significantly improve the morbidity, serological indicators, and changes in non-specific neuropsychiatric symptoms and signs, and has a better therapeutic safety, which is worthy of clinical recommendation.

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