补肾强脊汤联合阿达木单抗对强直性脊柱炎患者的临床疗效观察

doi:10.11958/20241020

摘要/Abstract

摘要：

目的探讨补肾强脊汤联合阿达木单抗对强直性脊柱炎患者的临床疗效。方法纳入114例强直性脊柱炎患者并随机分为阿达木组和联合组，各57例。阿达木组给予阿达木单抗治疗，皮下注射，40 mg/次，隔周给药1次；联合组在上述基础上加用补肾强脊汤治疗，1剂/d，2组患者均连续治疗12周。评价2组疗效、中医证候积分、脊柱功能、临床指标、血清学指标及不良反应。结果联合组总有效率高于阿达木组（92.98% vs. 75.44%，P<0.05）。治疗后，联合组中医证候总积分、巴氏疾病活动度（BASDAI）评分、巴氏功能指数水平（BASFI）评分低于治疗前，且低于阿达木组（P<0.05）。治疗后，联合组指地距、枕墙距均减小，且小于阿达木组（P<0.05）；胸廓活动度增大，且大于阿达木组（P<0.05）。治疗后，联合组血清骨硬化蛋白、25-羟维生素D水平升高，且高于阿达木组（P<0.05）。联合组皮肤红疹、胃肠道反应等不良反应总发生率较阿达木组差异无统计学意义（10.53% vs. 14.04%，P>0.05）。结论补肾强脊汤联合阿达木单抗可发挥协同增效作用，明显改善强直性脊柱炎患者的疼痛、晨僵等症状，其作用机制可能与改善骨硬化蛋白表达，提升25-羟维生素D水平有关。

关键词: 脊柱炎, 强直性, 阿达木单抗, 补肾强脊汤, 指地距, 骨硬化蛋白

Abstract:

Objective To explore the clinical effect of Busshenqiangji decoction combined with adalimumab (Adam) in patients with ankylosing spondylitis. Methods A total of 114 patients with ankylosing spondylitis were included and randomly divided into the Adam group and the combined group, with 57 cases in each group. Patients in the Adam group were given adalimumab by subcutaneous injection, 40mg/ time, once every other week. Patients in the combined group were treated with Bushenqiangji decoction (1 dose/day) on the basis of the above, and both groups were treated continuously for 12 weeks. The efficacy, Traditional Chinese Medicine (TCM) syndrome score, spinal function, clinical index, serological index and adverse reactions were evaluated between the two groups. Results The total effective rate was 92.98% (53/57) in the combination group, which was higher than that of the Adam group ( 75.44%, 43/57, P<0.05). After treatment, the total score of TCM syndromes, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Andylosing Spondylitis Function Index (BASFI) scores were decreased in the combination group, and which were lower than those of the adalimumab group (P<0.05). After treatment, the finger-to-floor distance and occipital bone-to-wall distance were decreased in the combination group, and which were smaller than those in the Adam group (P<0.05). The chest range of motion increased, and which was greater than that in the Adam group (P<0.05). After treatment, serum levels of sclerostin and 25 hydroxyvitamin D were significantly increased in the combination group than those in the Adam group (P<0.05). There were no significant differences in the total incidence rates of adverse reactions, such as skin rash and gastrointestinal reactions between the two groups [10.53% (6/57) vs. 14.04% (8/57), P>0.05]. Conclusion Bushenqiangji decoction combined with adalimumab can play a synergistic role in the treatment of patients with ankylosing spondylitis, significantly improving the symptoms of pain and morning stiffness. The mechanism of action may be related to improving the expression of osteosclerosis protein and the increase of 25-hydroxyvitamin D.

Key words: spondylitis, ankylosing, adalimumab, Bushen Qiangji decoction, finger-to-floor distance, sclerostin

中图分类号:

R593.23

图/表 7

参考文献 22

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组别	性别		年龄/岁	病程/年
组别	男	女	年龄/岁	病程/年
阿达木组	34（59.65）	23（40.35）	39.63±7.46	4.12±1.12
联合组	32（56.14）	25（43.86）	40.19±7.82	4.05±1.27
χ²或t	0.144		0.392	0.312

组别	性别		年龄/岁	病程/年
组别	男	女	年龄/岁	病程/年
阿达木组	34（59.65）	23（40.35）	39.63±7.46	4.12±1.12
联合组	32（56.14）	25（43.86）	40.19±7.82	4.05±1.27
χ²或t	0.144		0.392	0.312

组别	显效	有效	无效	总有效
阿达木组	26（45.6）	17（29.8）	14（24.6）	43（75.4）
联合组	34（59.7）	19（33.3）	4（7.0）	53（93.0）
χ²				6.597^＊

组别	显效	有效	无效	总有效
阿达木组	26（45.6）	17（29.8）	14（24.6）	43（75.4）
联合组	34（59.7）	19（33.3）	4（7.0）	53（93.0）
χ²				6.597^＊

组别	腰骶脊背疼痛			晨僵			畏寒喜暖
组别	治疗前	治疗后	t	治疗前	治疗后	t	治疗前	治疗后	t
阿达木组	4.93±1.07	2.84±0.77	12.534^＊＊	4.79±1.01	2.70±0.80	12.827^＊＊	4.63±0.94	2.54±0.63	14.042^＊＊
联合组	4.84±1.03	2.00±0.53	17.158^＊＊	4.84±0.96	1.67±0.48	22.383^＊＊	4.72±0.92	1.61±0.49	22.769^＊＊
t	0.446	6.757^＊＊		0.285	8.389^＊＊		0.504	8.798^＊＊
组别	腰脊活动受限			腰膝酸软			精神不振
组别	治疗前	治疗后	t	治疗前	治疗后	t	治疗前	治疗后	t
阿达木组	4.63±0.99	2.49±0.78	14.571^＊＊	2.39±0.49	1.23±0.42	12.457^＊＊	2.47±0.54	1.35±0.48	12.407^＊＊
联合组	4.77±0.93	1.68±0.47	22.417^＊＊	2.44±0.50	0.88±0.33	20.772^＊＊	2.44±0.50	0.96±0.19	20.679^＊＊
t	0.780	6.682^＊＊		0.567	4.929^＊＊		0.360	5.647^＊＊
组别	乏力			眩晕耳鸣			总分
组别	治疗前	治疗后	t	治疗前	治疗后	t	治疗前	治疗后	t
阿达木组	2.44±0.50	1.33±0.48	13.509^＊＊	2.42±0.53	1.35±0.48	11.091^＊＊	28.70±2.19	15.84±1.56	38.140^＊＊
联合组	2.49±0.54	0.84±0.37	19.435^＊＊	2.49±0.50	0.93±0.26	20.772^＊＊	29.04±2.34	10.61±1.06	54.558^＊＊
t	0.540	6.168^＊＊		0.722	5.821^＊＊		0.786	20.934^＊＊