白芍总甙辅助治疗系统性红斑狼疮的临床观察

Clinical Study on Effect of Total Glucosides of Peony in Treating Systemic Lupus Erythematosus as Adjuvant Treatment

目的:探讨中药白芍提取物白芍总甙(total glucosides of peony,TGP)辅助西药治疗系统性红斑狼疮(SLE)的疗效和安全性。方法:采用随机双盲安慰剂对照的研究方法,将70例病情处于活动期的SLE患者随机分为两组(各35例),在原西药治疗的基础上,分别加用TGP(TGP组)和安慰剂(对照组)治疗,疗程3个月,比较两组本病的活动指数(DAI)、有效率、糖皮质激素用量及不良反应。结果:TGP组缓解率、部分缓解率和无效率分别为20.7％、51.7％和27.6％,对照组分别为6.5％、29.0％和64.5％,总有效率＊GP组显著高于对照组(P<0.01)。TGP组DAI、患者评估及医师评估均较对照组明显改善,且TGP组的激素用量较治疗前明显减少。TGP组的不良反应主要为轻度可耐受的胃肠道反应,与对照组比较差异无显著性。结论:TGP与糖皮质激素联合治疗SLE的疗效显著,且可减少激素用量,有轻度不良反应但可耐受。

Objective: To investigate the effectiveness and safety of total glucosides of peony (TGP) in treating systemic lupus erythematosus (SLE) as adjuvant treatment. Methods: Adopting randomized, double-blinded and placebo-controlled way, 70 patients with active SLE were equally divided into 2 groups. They were treated by western conventional treatment plus TGP or placebo capsule respectively for 3 months. The SLE disease activity index (DAI), therapeutic effective rate, dosage of concomitant glucocorticoid (GC) used and adverse reaction were comparatively observed. Results; After treatment, the remission rate, partial remission rate and ineffective rate in the TGP group were 20.69%, 51.72% and 27.59% respectively, in the control group were 6.45%, 29.03% and 64.52 % respectively, the therapeutic effect in the former was significantly superior to that in the latter. DAI, either assessed by physician or patient, was significantly improved in the TGP group, the dosage of GC used in the TGP group reduced significantly as compared with that used before treatment. The adverse reaction occurred in the TGP group was mainly mild tolerable digestive response, which was insignificantly different to that in the control group. Conclusion: TGP combining GC therapy is markedly effective for SLE. It could reduce the dosage of GC uesd, this effect would be more obvious in long-term application. The adverse reaction of the therapy is mild and tolerable.