克痹通络汤合独活寄生汤加减治疗强直性脊柱炎肝肾阴虚证患者54例临床观察

Combination with Modification of Kebi Tongluo Tang(克痹通络汤) and Duhuo Jisheng Tang(独活寄生汤)for Ankylosing Spondylitis with Liver and Kidney Yin Deficiency Pattern:A Clinical Observation on 54 cases

目的探讨克痹通络汤合独活寄生汤加减治疗强直性脊柱炎(AS)肝肾阴虚证患者的临床疗效及可能作用机制。方法 108例AS肝肾阴虚证患者随机分为对照组与治疗组各54例。对照组予饭后口服吲哚美辛肠溶片50 mg/次,3次/天,治疗组给予克痹通络汤合独活寄生汤加减治疗,每日1剂,分早晚两次口服,两组均治疗6个月。观察两组治疗前后体征指标和骨代谢指标变化,并评价临床疗效及安全性。结果治疗组临床疗效总有效率为90.57%,对照组为78.85%,两组比较差异无统计学意义(P>0.05);两组患者治疗后枕墙距、指地距、颌柄距、胸廓活动度、腰椎活动度、脊柱活动度、"4"字试验均较治疗前显著改善(P<0.01),且治疗组各指标改善程度均优于对照组(P<0.01)。与治疗前比较,两组患者骨钙素(BGP)均显著升高,甲状旁腺激素(PTH)均显著降低(P<0.05);治疗后治疗组BGP显著高于对照组(P<0.05)。治疗组不良事件发生率(7.55%)与对照组(3.85%)比较,差异无统计学意义(P>0.05)。结论克痹通络汤合独活寄生汤加减治疗AS肝肾阴虚证疗效确切,其作用机制可能与调节骨代谢相关激素有关。

Objective To analyse the effect and its possible mechanism of modification of Kebi Tongluo Tang and Duhuo Jisheng Tang on treating ankylosing spondylitis（ AS） patients with liver and kidney Yin Deficiency pattern.Methods One hundred and eight AS patients were randomly divided into a control group and a treatment group,with54 cases in each group. The control group was treated with oral administration of indomethacin entric-coated tablets after a meal,50 mg per time,trice per day for 6 months,and the treatment group was given modification of Kebi Tongluo Tang and Duhuo Jisheng Tang,one dose daily,half in the morning and half in the evening for 6 months.The changes of physical signs and bone metabolism were observed before and after treatments,and the efficacy and security were also evaluated. Results The total effective rate in the treatment group was 90. 57%,showed no obviously difference compared with 78. 85% in the control group（ P 0. 05）. Compared with pre-treatment,the physical signs indexes including the pillow-wall distance,finger-floor distance,jaw-handle distance,the mobility of the thoracic,lumbar vertebra and spine,and the Gaenslen test were significantly improved in both groups（ P 0. 01）,and the treatment group showed more improved than the control group（ P 0. 01）. Meanwhile,the bone gla protein（ BGP） of patients were much increased and the parathyroid hormone（ PTH） were markedly descend in both groups（ P 0. 05）,especially BGP in the treatment group（ P 0. 05）. There is no significant difference in the adverse event rate between the treatment group（7. 55%） and the control group（3. 85%）（ P 0. 05）. Conclusion The modification of Kebi Tongluo Tang and Duhuo Jisheng Tang had good efficiency in treating AS,and its mechanism might be related with regulating the hormones associated with the bone metabolism.