西维美林改善原发性舍格伦综合征患者临床症状的疗效评价

doi:10.12016/j.issn.2096-1456.2021.01.006

摘要/Abstract

摘要：

目的探讨西维美林应用于原发性舍格伦综合征（primary Sj?gren syndrome,pSS）患者的临床疗效,为pSS的治疗提供新的思路。方法纳入2018年1月至2019年9月在徐州医科大学附属淮安医院被诊断为pSS的患者63例,随机分入治疗组和对照组,治疗组给予西维美林,对照组给予安慰剂,服用3周后,在第2周,第3、6个月复诊,复诊时测定患者唾液、泪液分泌量以及主观症状改善情况。结果共有58患者完成试验并纳入统计,患者在第2周和第3个月复诊时,治疗组唾液、泪液分泌量高于对照组,且差异有统计学意义（P < 0.05）。主观症状方面,第3个月复诊时,口腔、眼部与唾液腺症状均有所改善（P < 0.05）,而第6个月复诊时,与对照组相比,治疗组仅唾液腺症状评分具有统计学意义（P < 0.05）。结论西维美林具有良好的特异性和安全性,能够在短期内增加唾液、泪液分泌,对改善pSS临床症状具有良好的疗效。

关键词: 西维美林, 舍格伦综合征, 自身免疫病, 腺体分泌, 症状改善, 唾液分泌, 泪液分泌, 视觉模拟评分

Abstract:

Objective To investigate the clinical efficacy of cevimeline as a pharmacotherapeutic approach to stimulating gland activity in improving the symptoms and signs of primary Sj?gren syndrome (pSS). Methods Sixty-three patients diagnosed with pSS who attended the Affiliated Huai'an Hospital of Xuzhou Medical University from January 2018 to September 2019 were included in this trial. They were randomly assigned to the therapeutic group and control group. All patients were recalled at baseline and after 2 weeks, 3 months and 6 months. Measurement of salivary and lacrimal flow as well as evaluation of subjective symptoms was performed at the follow-up. Results Fifty-eight patients completed the trial and were included in the statistical analysis. There was a significant difference between the two groups in the measurement of salivary and lacrimal flow at the second week and third month (P < 0.05). Improvement in subjective symptoms of oral, ocular and gland was detected at the third month (P < 0.05). At the sixth month, compared with the control group, only the salivary gland symptom score of the treatment group was statistically significant (P < 0.05). Conclusion Cevimeline has good specificity and safety and can increase salivary and lacrimal flow and improve subjective symptoms of pSS in a short time.

Key words: cevimeline, Sj?gren′s syndrome, autoimmune disease, gland secretion, improving symptoms, salivary secretion, lacrimal secretion, visual analog scale

中图分类号:

R78
R593

汪声明,李芳芳,吴尧,史新连,柳欣. 西维美林改善原发性舍格伦综合征患者临床症状的疗效评价[J]. 口腔疾病防治, 2021, 29(1): 40-44.

WANG Shengming,LI Fangfang,WU Yao,SHI Xinlian,LIU Xin. Evaluation of the efficacy of cevimeline in improving the clinical symptoms of patients with primary Sjögren′s syndrome[J]. Journal of Prevention and Treatment for Stomatological Diseases, 2021, 29(1): 40-44.

图/表 5

参考文献 21

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	Therapeutic Group	Control Group	t/χ²	P
Sex（n）
Male	6	5	0.34	0.73
Female	21	26	0.34	0.73
Age（year）	61.8±10.9	64.9±8.6	10.9	0.60
Saliva Flow	29.0±4.0	28.1±4.3	0.84	0.40
Lacrimal Flow	1.8±0.5	2.1±0.2	-0.45	0.35
LFS（score）	5.3±1.7	5.5±1.9	-0.44	0.66

	Therapeutic Group	Control Group	t/χ²	P
Sex（n）
Male	6	5	0.34	0.73
Female	21	26	0.34	0.73
Age（year）	61.8±10.9	64.9±8.6	10.9	0.60
Saliva Flow	29.0±4.0	28.1±4.3	0.84	0.40
Lacrimal Flow	1.8±0.5	2.1±0.2	-0.45	0.35
LFS（score）	5.3±1.7	5.5±1.9	-0.44	0.66

Subjective symptoms	3^rd month			6^thmonth
Subjective symptoms	Oral	Ocular	Gland	Oral	Ocular	Gland
Therapeutic group	5.6±1.6	2.8±0.9	1.9±0.5	5.4±2.1	3.8±0.5	1.8±0.7
Control group	6.8±2.3	3.9±0.8	2.6±1.8	6.3±0.5	4.1±0.6	2.8±1.9
t	2.9	2.6	1.6	0.9	1.1	2.5
P	0.02	0.03	0.03	0.21	0.16	0.04

Subjective symptoms	3^rd month			6^thmonth
Subjective symptoms	Oral	Ocular	Gland	Oral	Ocular	Gland
Therapeutic group	5.6±1.6	2.8±0.9	1.9±0.5	5.4±2.1	3.8±0.5	1.8±0.7
Control group	6.8±2.3	3.9±0.8	2.6±1.8	6.3±0.5	4.1±0.6	2.8±1.9
t	2.9	2.6	1.6	0.9	1.1	2.5
P	0.02	0.03	0.03	0.21	0.16	0.04