中药复方扶正强筋片治疗重症肌无力的前瞻性研究

A Prospective Study of Tablet Fuzhengqiangjin Therapy in Patients with Myasthenia Gravis

目的探讨复方中药制剂扶正强筋片治疗重症肌无力(MG)的有效性、安全性及使用时机。方法收集2004-02—2004-04确诊的164例MG患者,随机分为A组(泼尼松+溴吡斯的明)、B组(泼尼松+溴吡斯的明+扶正强筋片)和C组(扶正强筋片),评估扶正强筋片的起效时间、疗效、使用时机及其不良反应。结果单用扶正强筋片组于治疗后1个月左右起效,至观察终点有效率为46.9%;扶正强筋片在泼尼松减量或停药时能明显减少患者复发率,B组(10.5%)和C组(6.67%)复发率明显低于A组(31.3%)(P<0.01),并能减少上呼吸道感染的发生率,且无明显不良反应。OssermanI型患者疗效与性别、年龄及伴发病无明显相关性。结论单用扶正强筋片治疗MG疗效不肯定,但与泼尼松联用能减少不良反应发生,在泼尼松减量或者停药时可有效预防症状反跳。

Objective The prospective study was designed to evaluate the efficacy, safety and suitable using method of a Chinese herb mixture tablet Fuzhengqiangjin in treating out-patients with myasthenia gravis （MG）. Methods From February 2004 to April 2004, 164 ocular and mild generalized myasthenic patients were randomly classified into three groups and followed up. Patients in group A were treated with prednisone and pyridostigmine, and the patients in group C with concoction of Chinese herbs tablet Fuzhengqiangjin, and the ones in group B with therapies both in group A and group C. The recruited patients were followed up until March, 2006, to assess the efficacy, side-effects and suitable using method. The influences of sex, age at onset, the accompanying disorders and the development of ocular MG had been analyzed. At the same time, the evolving pattern of ocular MG in the generalized type of MG and the influence of the prednisone therapy on the evolution of MG types were observed. Results During a mean follow-up of nearly 2 years, the total effectiveness rate of tablet Fuzhengqiangjin was only 46.9 ~, but the tablets significantly reduced relapse rate when the daily dose of prednisone tapered and significantly lowered incidence of side-effects of prednisone therapy including Cushing phenomenon and respiratory tract infection. Fifteen ocular myasthenic patients in the study eventually converted into generalized type of MG in 2 years. The study showed that the long-term prednisone therapy reduced the conversion. Both the efficacy of tablet Fuzhengqiangjin and the conversion showed no relations with sex, age at onset, the accompanying disorders and the level of AchRAb. Conclusions The concoction of Chinese herbs tablet Fuzhengqiangjin might be helpful in controlling relapse when prednisone was tapered or withdrawn. In the 2-year treatment with the concoction, the incidence of side-effects of prednisone and the rate of respiratory tract infection were significantly reduced. However, when administered alone, the efficacy of the concoction was not satisfactory. The conversion of ocular type into generalized type can be significantly reduced by prednisone therapy.