Clinical observation of Bushenqiangji decoction combined with adalimumab in patients with ankylosing spondylitis

doi:10.11958/20241020

Abstract

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

CLC Number:

R593.23

Figures/Tables 7

References 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^＊＊