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目的:观察温阳化浊通络方治疗系统性硬化病(systemic sclerosis,SSc)的临床疗效及其可能作用机制。方法:82例SSc患者随机分为两组,对照组(41例)予甲氨蝶呤、泼尼松口服治疗,治疗组(41例)予温阳化浊通络方联合甲氨蝶呤、泼尼松口服治疗,均连续6个月。分别采取酶联免疫吸附法和免疫散射比浊法检测血清B细胞激活因子(B-cell activating factor,BAFF),Ⅲ型前胶原氨基端原肽(aminoterminal propeptide of typeⅢprocollagen,PⅢNP),Ig G和Ig M水平,同时观察皮肤积分和疾病活动指数等。结果:治疗组疗效优于对照组,差异具有统计学意义(P<0.05)。两组治疗后BAFF,Ig G,Ig M和PⅢNP水平均较治疗前明显降低(P<0.05,P<0.01),但治疗组对上述指标的改善优于对照组(P<0.05)。同时两组治疗后SSc患者皮肤积分、疾病活动指数亦较治疗前降低(P<0.05,P<0.01),且治疗组改善更明显(P<0.05)。SSc患者治疗前、后BAFF水平与皮肤积分,疾病活动指数,PⅢNP水平呈正相关性(P<0.01)。结论:温阳化浊通络方可以降低皮肤积分、疾病活动指数,改善临床症状,其机制可能与降低SSc患者血清BAFF水平,抑制免疫反应,减少PⅢNP含量有关。
Objective: To observe the clinical efficacy of Wenyang Huazhuo Tongluo Recipe in treating systemic sclerosis (SSc) and its possible mechanism. Methods: Eighty-two patients with SSc were randomly divided into two groups. The control group (41 cases) received methotrexate and prednisone. The treatment group (41 cases) received Wenyang Huazhuo Tongluo Decoction combined with methotrexate, Prednisone oral treatment, were continuous for 6 months. Serum levels of B-cell activating factor (BAFF), aminoterminal propeptide of type Ⅲprocollagen (PⅢNP), Ig G and Ig were measured by enzyme-linked immunosorbent assay (ELISA) M level, while observing the skin score and disease activity index. Results: The curative effect of the treatment group was better than that of the control group, the difference was statistically significant (P <0.05). After treatment, the levels of BAFF, Ig G, Ig M and PⅢNP in both groups were significantly lower than those before treatment (P <0.05, P <0.01). However, the improvement of these indexes in the treatment group was better than that in the control group (P <0.05). At the same time, the skin scores and disease activity index of SSc patients in both groups were also lower than those before treatment (P <0.05, P <0.01), and the improvement in the treatment group was more obvious (P <0.05). The level of BAFF in patients with SSc before and after treatment was positively correlated with the skin score, disease activity index and PⅢNP level (P <0.01). Conclusion: Wenyang Huazhuo Tongluo Recipe can reduce skin integral, disease activity index and improve clinical symptoms. The mechanism may be related to reducing serum BAFF level, inhibiting immune reaction and decreasing PⅢNP level in SSc patients.