阿达木单抗联合三痹汤治疗寒湿型强直性脊柱炎的疗效观察

Clinical observation on treating ankylosing spondylitis of cold dampness type with adalimumab plus the Sanbi decoction

目的:阿达木单抗联合三痹汤治疗寒湿型强直性脊柱炎临床观察。方法:选取东莞东华医院、东莞台心医院2017年6月-2020年10月收治的寒湿型强直性脊柱炎84例为研究对象,采用随机数字表法将其分为对照组与观察组各42例。对照组予阿达木单抗治疗,观察组予三痹汤联合阿达木单抗治疗。对两组患者实施为期12周的治疗,治疗后,比较两组患者治疗前后雌激素受体(Estrogen Receptor,ESR)、C反应蛋白(C-reactive Protein,CRP)、白细胞介素-6(Interleukin-6,IL-6)、肿瘤坏死因子-α(Tumor Necrosis Factor-α,TNF-α)变化、症状指标[疼痛视觉模拟评分法(Visual Analogue Scale,VAS)评分、晨僵时间、Bath强直性脊柱炎疾病活动指数(Bath Ankylosing Spondylitis Disease Active Index,BASDAI)、AS疾病活动度(ASDAS)]、疗效及不良反应(上呼吸道感染、肝功能异常、腹痛、腹泻等)发生率。结果:对照组患者的治疗总有效率为76.19%(32/42),观察组治疗总有效率为92.86%(39/42),组间差异有统计学意义(P<0.05)。两组治疗12周后CRP、ESR、IL-6、INF-α水平明显下降(P<0.05);VAS评分、晨僵时间、BASDAI、ASDAS同样明显下降(P<0.05);且治疗后观察组各实验室指标下降优于对照组(P<0.05)。治疗12周后观察组临床总显效率显著高于对照组,差异有统计学意义(P<0.05)。观察组上呼吸道感染、肝功能异常、腹痛、腹泻等不良反应发生率稍高于对照组,但组间差异无统计学意义(P>0.05)。结论:阿达木单抗联合三痹汤治疗寒湿型强直性脊柱炎能提高临床疗效,且不增加不良反应,可显著改善ESR、CRP、IL-6、INF-α,降低疼痛程度,使晨僵时间、BASDAI、ASDAS显著改善,可考虑推广。

Objective:To observe clinically adalimumab plus the Sanbi decoction(三痹汤)in the treatment of ankylosing spondylitis of cold dampness type.Methods:From June 2017 to October 2020,84 cases of ankylosing spondylitis of cold dampness type admitted to Dongguan Donghua Hospital and Dongguan Taixin Hospital were selected as the research subjects and divided into the control group and the observation group by random number table method,with 42 cases in each group.The control group was treated with adalimumab,and the observation group was treated with the Sanbi decoction plus adalimumab.The two groups were treated for 12 weeks.The changes of ESR,CRP,IL-6,INF-α,symptom indicators(VAS score,morning stiffness time,BASDAI,ASDAS),efficacy and incidence of adverse reactions(upper respiratory tract infection,abnormal liver function,abdominal pain,diarrhea,etc.)before and after treatment were compared between the two groups.Results:The total effective rate in the control group was 76.19%(32/42),and the total effective rate in the observation group was 92.86%(39/42),there was a difference between the two groups(P<0.05).After 12 weeks of treatment,the levels of CRP,ESR,IL-6 and INF-αin the two groups were significantly decreased(P<0.05).VAS score,morning stiffness time,BASDAI and ASDAS were also significantly decreased(P<0.05).After treatment,the decrease of laboratory indexes in the observation group was better than that in the control group(P<0.05).After 12 weeks of treatment,the total clinical efficiency in the observation group was significantly higher than the control group,and the difference was statistically significant(P<0.05).The incidence of adverse reactions such as upper respiratory tract infection,abnormal liver function,abdominal pain and diarrhea in the observation group was slightly higher than that in the control group,but there was no significant difference between the two groups(P>0.05).Conclusion:Adumumab plus the Sanbi decoction can improve the clinical efficacy without increasing adverse reactions,significantly promote the changes of ESR,CRP,IL-6 and INF-α,reduce the degree of pain,and significantly ameliorate the morning stiffness time,BASDAI and ASDAS in the treatment of ankylosing spondylitis of cold dampness type,which can be considered for promotion.