多奈哌齐联合骨化三醇治疗轻度认知功能障碍的效果观察

沈佳英; 范佳佳; 张晨; 王晓艳; 朱梦娜; 任菁菁

doi:10.16766/j.cnki.issn.1674-4152.003837

多奈哌齐联合骨化三醇治疗轻度认知功能障碍的效果观察

doi: 10.16766/j.cnki.issn.1674-4152.003837

沈佳英^{1, 2, 3},
范佳佳^{1, 2, 3},
张晨⁴,
王晓艳⁴,
朱梦娜⁴,
任菁菁^5, ,

1.
湖州市中心医院全科医学科，浙江湖州 313000
2.
浙江中医药大学第五临床医学院，浙江杭州 310000
3.
湖州师范学院附属中心医院，浙江湖州 313000
4.
湖州市吴兴区仁皇山滨湖街道社区卫生服务中心，浙江湖州 313000
5.
浙江大学医学院附属第一医院全科医学科，浙江杭州 310000

基金项目:

浙江省医药卫生科技计划项目 2022KY370

浙江省医药卫生科技计划项目 2023KY1186

浙江省医药卫生科技计划项目 2024KY1662

详细信息

通讯作者:
任菁菁，E-mail：3204092@zju.edu.cn

中图分类号: R741.05
计量
- 文章访问数: 34
- HTML全文浏览量: 13
- PDF下载量: 1
- 被引次数: 0
出版历程
- 收稿日期: 2024-01-28
- 网络出版日期: 2025-02-13

Curative effect observation of donepezil combined with calcitriol in the treatment of mild cognitive impairment

SHEN Jiaying^{1, 2, 3},
FAN Jiajia^{1, 2, 3},
ZHANG Chen⁴,
WANG Xiaoyan⁴,
ZHU Mengna⁴,
REN Jingjing^{5
, ,}

1.
Department of General Practice, Huzhou Central Hospital, Huzhou, Zhenjiang 313000, China

摘要

摘要: 目的本研究旨在通过对比分析单用多奈哌齐与多奈哌齐联合骨化三醇口服治疗对轻度认知功能障碍(MCI)的临床效果，以期为MCI患者的治疗方案提供科学依据和指导。方法选择2020年2月—2022年7月在湖州市中心医院就诊的MCI患者172例，采用随机数字表将患者分为对照组(74例)和观察组(98例)。对照组在非药物治疗基础上口服多奈哌齐5 mg/d+安慰剂(生理盐水胶丸)1丸/d，观察组口服多奈哌齐5 mg/d+骨化三醇0.25 μg/d，分别在治疗6个月和12个月时比较2组简易智能精神状态检查量表(MMSE)、蒙特利尔认知评估量表(MoCA)和社会功能活动问卷(FAQ)评分。结果 2组MMSE、MoCA、FAQ评分在治疗6、12个月较基线时均改善(P＜0.05)；以治疗12个月为终点，观察组的MMSE优于对照组(P＜0.05)，2组MoCA、FAQ差异均无统计学意义(P>0.05)；对照组和观察组的药物不良反应发生率分别为1.35%(1/74)和1.02%(1/98)，服药依从差的比例分别为12.16%(9/74)和11.22%(11/98)，组间比较差异均无统计学意义(P=0.999、0.849)。结论非药物干预基础上口服多奈哌齐或联合口服多奈哌齐+骨化三醇对MCI有治疗效果，但联合用药未体现出明显的优越性。
- 轻度认知功能障碍 /
- 维生素D /
- 多奈哌齐 /
- 骨化三醇
Abstract: Objective The present study aims to compare and analyze the clinical efficacy of donepezil monotherapy versus the combination therapy of donepezil and calcitriol in treating mild cognitive impairment (MCI), with the intention of providing a scientific basis and guidance for therapeutic regimens for MCI patients. Methods A total of 172 MCI patients were selected from Huzhou Central Hospital from February 2020 to July 2022 and divided into a control group (74 cases) and an observation group (98 cases) by random number table method. The control group was given donepezil (5 mg/d) and placebo (saline capsule, 1 pill/d) on the basis of non-drug treatment. The observation group was given donepezil (5 mg/d) and calcitriol (0.25 μg/d). Mini-mental state examination (MMSE) scale, Montreal cognitive assessment (MoCA) scale, and functional activity questionnaire (FAQ) were compared between the two groups at the 6th month and 12th month. Results There were statistically significant improvements in MMSE, MoCA, and FAQ in both groups at the 6th month and 12th month compared to baseline (P < 0.05). With the 12th month as the main endpoint, the MMSE of the observation group was better than that of the control group (P < 0.05), and there were no significant differences in MoCA and FAQ between the two groups (P>0.05); The incidence of adverse drug reactions in the control group and observation group was 1.35% (1/74) and 1.02% (1/98), respectively, and the proportion of poor medication adherence was 12.16% (9/74) and 11.22% (11/98), respectively. There were no statistically significant between the two groups (P=0.999, 0.849). Conclusion Donepezil or combined administration of donepezil + calcitriol based on non-drug intervention has a favorable impact on MCI patients, but the drug combination scheme does not exhibit evident advantages.
- Mild cognitive impairment /
- Vitamin D /
- Donepezil /
- Calcitriol

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表 1 2组MCI患者一般资料比较

Table 1. Comparison of general information between two groups of MCI patients

组别	例数	性别(例)		婚烟状态(例)		基础疾病(例)								年龄 [M(P₂₅, P₇₅)，岁]		受教育年限 [M(P₂₅, P₇₅)，年]
组别	例数	男性	女性	单身	已婚	DM	HBP	CAD	COPD	CVD	CKD	吸烟	饮酒	年龄 [M(P₂₅, P₇₅)，岁]		受教育年限 [M(P₂₅, P₇₅)，年]
对照组	74	47	27	21	53	27	39	9	12	15	5	29	18	78.00(72.75, 87.00)		2.00(0.00, 8.00)
观察组	98	61	37	25	73	33	51	11	13	9	8	39	22	78.50(74.00, 87.00)		1.50(0.00, 8.00)
统计量		0.029^a		0.177^a		0.147^a	0.007^a	0.036^a	0.296^a	0.020^a	0.119^a	0.006^a	0.083^a	-0.429^b		-0.200^b
P值		0.865		0.674		0.702	0.931	0.849	0.587	0.886	0.730	0.936	0.773	0.668		0.841

组别	例数	25羟基维生素D [M(P₂₅, P₇₅)，ng/mL]		总胆固醇 (x±s，mmol/L)		高密度脂蛋白 (x±s，mg/dL)		低密度脂蛋白 [M(P₂₅, P₇₅)，mg/dL]			甘油三酯 [M(P₂₅, P₇₅)，mmol/L]			尿素氮 [M(P₂₅, P₇₅)，mmol/L]	肌酐 [M(P₂₅, P₇₅)，μmol/L]	C反应蛋白 [M(P₂₅, P₇₅)，mg/L]
对照组	74	17.77(12.68, 21.12)		3.21±1.06		37.43±11.98		70.94(53.30, 86.75)			1.06(0.74, 1.53)			1.20(0.82, 1.70)	79.90(65.88, 96.43)	4.40(2.58, 8.85)
观察组	98	16.86(11.68, 21.01)		3.11±1.06		37.96±11.74		73.81(56.94, 93.28)			1.20(0.82, 1.70)			1.20(0.82, 1.70)	82.65(67.28, 104.23)	3.95(1.60, 9.20)
统计量		-0.614^b		0.589^c		-0.259^c		-0.677^b			-0.863^b			-0.070^b	-0.492^b	-0.780^b
P值		0.539		0.556		0.768		0.498			0.388			0.945	0.623	0.436
注：单身包括离婚或丧偶；DM为糖尿病(diabetes mellitus)，HBP为高血压(high blood pressure)，COPD为慢性阻塞性肺疾病(chronic obstructive pulmonary disease)，CAD为心血管疾病(cardiovascular disease)，CVD为脑血管疾病(cerebrovascular disease)，CKD=慢性肾脏病(chronic kidney disease)。^a为χ²值，^b为Z值，^c为t值。

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表 2 2组MCI患者各量表评分[M(P₂₅, P₇₅)，分]

Table 2. Comparison of MMSE scores between 2 groups of MCI patients[M(P₂₅, P₇₅), points]

组别	例数	MMSE
组别	例数	基线	6个月	12个月
对照组	74	19.00(17.00, 20.00)	19.00(17.00, 21.00)	20.00(17.00, 21.25)
观察组	98	19.00(17.00, 20.00)	19.00(17.00, 22.00)	20.00(17.00, 21.25)

组别	例数	MoCA
组别	例数	基线	6个月	12个月
对照组	74	18.00(13.00, 20.00)	18.00(14.00, 20.00)	19.00(14.75, 21.00)
观察组	98	18.00(13.00, 20.00)	18.00(14.00, 20.25)	19.00(14.00, 22.00)

组别	例数	FAQ
组别	例数	基线	6个月	12个月
对照组	74	8.00(7.00, 9.00)	7.00(6.75, 8.00)	7.00(6.00, 8.00)
观察组	98	8.00(6.75, 10.00)	7.00(6.00, 8.25)	7.00(6.00, 8.00)

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表 3 2组MCI患者MMSE评分比较

Table 3. Comparison of MMSE scores between 2 groups of MCI patients

组别	时间	B	SE	Waldχ²	P值	OR值	95% CI
观察组	6个月^a	0.602	0.080	56.620	＜0.001	1.826	1.561~2.136
	12个月^a	1.969	0.103	369.138	＜0.001	7.166	5.862~8.761
对照组	6个月^a	0.351	0.078	20.569	＜0.001	1.421	1.221~1.654
	12个月^a	0.892	0.112	63.007	＜0.001	2.440	1.957~3.041
组间	基线	0.104	0.408	0.065	0.799	1.110	0.499~2.469
	6个月	0.355	0.417	0.724	0.395	1.426	0.630~3.227
	12个月	1.181	0.468	6.362	0.012	3.259	1.301~8.162
注：^a以基线为对照。

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表 4 2组MCI患者MoCA评分比较

Table 4. Comparison of MoCA scores between two groups of MCI patients

组别	时间	B	SE	Waldχ²	P值	OR值	95% CI
观察组	6个月^a	0.480	0.075	40.562	＜0.001	1.615	1.394~1.872
	12个月^a	1.408	0.102	191.064	＜0.001	4.088	3.348~4.992
对照组	6个月^a	0.500	0.084	35.558	＜0.001	1.649	1.399~1.943
	12个月^a	1.095	0.090	147.977	＜0.001	2.988	2.505~3.564
组间	基线	0.121	0.592	0.042	0.838	1.129	0.354~3.605
	6个月	0.101	0.589	0.029	0.864	1.106	0.349~3.510
	12个月	0.435	0.629	0.478	0.490	1.545	0.450~5.304
注：^a以基线为对照。

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表 5 2组MCI患者FAQ评分比较

Table 5. Comparison of FAQ scores between two groups of MCI patients

组别	时间	β	SE	Waldχ²	P值	OR值	95% CI
观察组	6个月^a	-0.602	0.077	60.561	＜0.001	0.548	0.471~0.637
	12个月^a	-1.143	0.107	114.036	＜0.001	0.319	0.259~0.393
对照组	6个月^a	-0.689	0.090	59.314	＜0.001	0.502	0.421~0.598
	12个月^a	-1.162	0.072	263.634	＜0.001	0.313	0.272~0.360
组间	基线	0.028	0.236	0.014	0.907	1.028	0.647~1.634
	6个月	0.115	0.234	0.241	0.623	1.122	0.710~1.773
	12个月	0.047	0.232	0.041	0.840	1.048	0.665~1.650
注：^a以基线为对照。

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表 6 2组MCI患者的用药安全性和服药依从性比较[例(%)]

Table 6. Comparison of medication safety and adherence in patients with MCI[cases(%)]

组别	例数	药物不良反应	服药依从性
对照组	74	1(1.35)	9(12.16)
观察组	98	1(1.02)	11(11.22)
χ²值			0.036
P值		0.999^a	0.849
注：^a为采用Fisher精确检验。药物不良反应包括便秘、腹胀、纳差，药物服从性包括漏服、多服和错服。

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