中医病证结合方案联合西药治疗轻型系统性红斑狼疮的临床观察

Clinical Observation on Traditional Chinese Medicine Disease-Syndrome Differentiation and Treatment Protocols Combined with Western Medicine for the Treatment of Mild Systemic Lupus Erythematosus

【目的】探讨中医病证结合方案联合西药治疗轻型系统性红斑狼疮(SLE)的临床疗效及安全性。【方法】根据入组时患者的治疗意愿,将60例轻型SLE患者分为西医治疗组(对照组)27例和中西医结合治疗组(试验组)33例。对照组给予糖皮质激素和/或免疫抑制剂等治疗,试验组在对照组的基础上加用中医药辨证治疗(风湿热痹型采用白虎加桂枝汤加减,阴虚内热型采用青蒿鳖甲汤加减,气血亏虚型采用归脾汤加减),12周为1个疗程,共观察2个疗程(合计24周)。观察2组患者治疗前后狼疮疾病活动性指数(SLEDAI)评分、红斑狼疮病人生活质量量表(LupusQoL)评分、激素日用量和血清补体C3、补体C4、抗dsDNA抗体水平的变化情况,评价2组患者的中医证候疗效、疾病复发情况及安全性。【结果】(1)治疗24周后,试验组和对照组的总有效率分别为90.9%(30/33)、81.5%(22/27),组间比较,试验组的中医证候疗效明显优于对照组(P<0.01)。(2)治疗后,2组患者的SLEDAI评分、SLE病情活动度和LupusQoL评分均较治疗前明显改善(P<0.01),且试验组的改善程度均明显优于对照组(P<0.05或P<0.01)。(3)治疗后,2组的糖皮质激素用量及抗dsDNA水平均较治疗前明显下降(P<0.05或P<0.01),补体C3、C4水平均较治疗前明显上升(P<0.01),但组间比较,差异均无统计学意义(P>0.05)。(4)治疗期间,2组患者均未观察到疾病复发,治疗前后血常规、尿组合、肝肾功能检查均未见明显异常变化;对照组和试验组分别有2例、1例患者出现不良反应,2组不良反应发生率比较,差异无统计学意义(P>0.05)。【结论】中医病证结合方案联合西药治疗轻型SLE具有协同增效作用,能有效改善患者的生活质量及免疫功能,减少激素用量及疾病复发,且具有较高的安全性,值得重视和推广。

Objective To investigate the clinical efficacy and safety of the traditional Chinese medicine(TCM)disease-syndrome differentiation and treatment protocols combined with western medicines for the treatment of mild systemic lupus erythematosus(SLE).Methods According to patients’the treatment intention at the enrollment,60 patients with mild SLE were divided into the control group(27 cases)and the trial group(33 cases).The control group was given glucocorticoids and/or immunosuppressants,while the trial group was treated with the syndrome differentiation and treatment of Chinese medicine on the basis of treatment for the control group,i.e.,modified Baihu plus Guizhi Decoction was adopted for wind-damp and heat obstruction syndrome,modified Qinghao Biejia Decoction was adopted for internal heat due to yin deficiency syndrome,and modified Guipi Decoction was adopted for qi and blood deficiency syndrome.A total of 12 weeks constituted one course,and the treatment for both groups lasted for 2 courses(24 weeks in total).The changes in the systemic lupus erythematosus disease activity index(SLEDAI)scores,lupus quality of life(LupusQoL)score,daily hormone dosage,and serum levels of complement 3(C3),complement 4(C4),and anti-dsDNA antibodies were observed before and after treatment.After treatment,the TCM syndrome efficacy,disease recurrence and clinical safety in the two groups were evaluated.Results(1)After 24 weeks of treatment,the overall effective rates of the trial group and control group were 90.9%(30/33)and 81.5%(22/27),respectively,and the intergroup comparison showed that the TCM syndrome efficacy in the trial group was significantly superior to that in the control group(P<0.01).(2)After treatment,the SLEDAI scores,SLE disease activity,and LupusQoL scores in the two groups were significantly improved compared with those before treatment(P<0.01),and the degree of improvement in the trial group was significantly superior to that in the control group(P<0.05 or P<0.01).(3)After treatment,the glucocorticoid dosage and anti-dsDNA levels in both groups were significantly decreased(P<0.05 or P<0.01),and the C3 and C4 levels were significantly increased(P<0.01)compared with those before treatment,but the post-treatment intergroup comparison showed that the differences were not statistically significant(P>0.05).(4)During the treatment period,no recurrent case of the two groups was found,or there were no significant abnormal changes were observed in blood routine test,urine combination test,liver and kidney function test before and after treatment.There were 2 cases in the control group and one case in the trial group having adverse reactions,and the difference in the incidence of adverse reactions between the two groups was not statistically significant(P>0.05).Conclusion The TCM disease-syndrome differentiation and treatment protocols combined with western medicines has synergistic effect for the treatment of mild SLE,which can effectively improve patients’quality of life and immune function,and reduce hormone dosage and disease recurrence.Moreover,the therapy is safe.