加减益肾蠲痹汤治疗早期活动性强直性脊柱炎肾虚督寒证的临床疗效观察

Clinical Observation on the Therapeutic Effect of Modified Yishen Juanbi Decoction in the Treatment of Early Active Ankylosing Spondylitis with Kidney Deficiency and Governor Vessel Cold Syndrome

目的:观察加减益肾蠲痹汤对于早期活动性强直性脊柱炎(AS)肾虚督寒证的临床疗效。方法:选取符合纳入标准的肾虚督寒证AS患者52例,使用区组随机分组法将其随机分为对照组及观察组,每组各26例。对照组口服双氯芬酸钠缓释片,1次/d,75 mg/次;柳氮磺吡啶肠溶片,3次/d,75 mg/次,同时口服安慰汤剂。观察组在对照组治疗方案基础上服用加减益肾蠲痹汤治疗;两组均治疗4周。比较两组治疗前后MASEI评分、骶髂关节血流分级、RI指数、BASDAI评分及中医证候积分变化情况,监测不良反应发生情况并比较两组临床疗效。结果:观察组总有效率96.2%(25/26)优于对照组总有效率73.1%(19/26),差异具有统计学意义(P<0.05);与治疗前比较,两组患者治疗后MASEI评分、骶髂关节血流分级及RI指数、BASDAI评分、中医证候积分均改善,差异具有统计学意义(P<0.05),且观察组上述指标优于对照组(P<0.05);对照组不良反应发生率23.1%(6/26),观察组不良反应发生率15.4%(4/26),两组比较差异无统计学意义(P>0.05)。结论:加减益肾蠲痹汤可有效缓解早期活动性AS肾虚督寒证患者的附着点炎,改善骶髂关节炎症,降低疾病活动度,且安全性较高。

Objective:To observe the clinical efficacy of modified Yishen Juanbi Decoction in treating early active ankylosing spondylitis(AS)with kidney deficiency and governor vessel cold syndrome.Methods:Fifty-two AS patients with kidney deficiency and governor vessel cold syndrome who met the inclusion criteria were selected and randomly divided into a control group and an observation group using block randomization method,with 26 cases in each group.The control group received oral sustained-release diclofenac sodium tablets,once a day,75 mg/time;sulfasalazine enteric coated tablets,three times a day,75 mg/time;and oral placebo decoction.The observation group was treated the same in addition to modified Yishen Juanbi Decoction instead of placebo decoction.Both groups have a 4-week course of treatment.The changes in MASEI score,sacroiliac joint blood flow grading and RI index,BASDAI score,and traditional Chinese medicine syndrome score between two groups before and after treatment were compared,the occurrence of adverse reactions was monitored,and the clinical efficacy of the two groups was compared.Results:The total effective rate of 96.2%(25/26)in the observation group was better than that of 73.1%(19/26)in the control group,and the difference was statistically significant(P<0.05).After treatment,the MASEI score,sacroiliac joint blood flow grading and RI index,BASDAI score,and traditional Chinese medicine syndrome score of the two groups of patients improved significantly(P<0.05),and they improved more in the observation group than in the control group(P<0.05).The incidence of adverse reactions in the control group was 23.1%(6/26),while the incidence of adverse reactions in the observation group was 15.4%(4/26),with no statistically significant difference(P>0.05).Conclusion:Modified Yishen Juanbi Decoction can effectively alleviate attachment point inflammation in early active AS patients with kidney deficiency and governor vessel cold syndrome,improve sacroiliac joint inflammation,reduce disease activity,and has high safety.