目的:观察二黄方对多发性硬化(multiple sclerosis,MS)急性期的临床疗效和作用机制。方法:将65例住院患者随机分为对照组(35例)和治疗组(30例),对照组给予甲基泼尼松龙、泼尼松为主的常规西医治疗,治疗组在此基础上给予二黄方(熟地黄、生地黄、制首乌等组成),每日1剂。连续3—4周。结果:Krtzke扩充后的多发性硬化伤残量表评分(嘲expanded disability score scale,EDSS)两组比较无统计学意义。对对照组(16例)和治疗组(14例)进行1年随访,两组治疗后年复发次数比较,治疗组有降低趋势(P〉0.05)。治疗组脑脊液中单核巨噬细胞因子蛋白1(monocytokine protein-1,MCP-1)值明显降低,组织生长因子β1(growth factor-β1,TCF-β1)上调,α干扰素(interfemn-α,IFN-α)和白细胞介素2(irdedddn-2,IL-2)没有显著变化;对照组上述4种细胞因子均无显著变化。结论:在急性期,EDSS评分不能反映中药二黄方治疗多发性硬化的真实的临床作用,如改善肢体的麻木和疼痛,需要制定相应的中医评分量表。1年后年复发次数比较显示,二黄方具有潜在的降低复发的作用。调节脑脊液中细胞因子MCP-1和TCF-βI含量可能是二黄方临床作用的部分机制所在。
Objective: To observe the clinical curative effects of Erhuang Formula on treatment of sclerosis (DS) in its acute stage, and explore its mechanism. Methods: 65 cases of hospitalized patients were randomly divided into control group (35 cases) and treatment group (30 cases); in control group, conventional treatment method, mainly methylprednisolone and prednisone, were administrated; on the base of control group, Erhuang Formula was added to treatment group, one does per day, successive for 3 weeks. Results: Diffexence of EDSS scores between the two groups had no statistical significance. 16 cases in control group and 14 cases in treatment group were followed for one year; P value of comparison of relapsing rate was 0.069. In treatment group, monocytokine protein- 1 (MCP-1) in spinal fluid was reduced and tissue growth factor-βα(TGF-β) was elevated after treatment, while both interferon-α(α-IFN) and interlukin-2 (IL-2) had no significant changes. Conclusion: In acute stage of DS, EDKS scores can not reflect true clinical effects of Erhuang Formula, such as relieving numbness and pain of limbs and body of patients, so score criteria corresponding to Traditional Chinese Medicine need to be set up. Comparison of relapsing rate showed that Erhuang Formula has the potential effect reducing recurrence. Regulation of cytokines (MCP-1 and TGFβ1) in spinal fluid may be partial reasons for its clinical effects of Erhuang Formula.