Department of Oncology, Shijiazhuang First Hospital and Hebei Provincial Hospital of Myasthenia Gravis, 36 Fanxi Road, Shijiazhuang, Hebei 050011, China.
Evid Based Complement Alternat Med. 2013;2013:816829. doi: 10.1155/2013/816829. Epub 2013 Nov 20.
Purpose. To evaluate the treatment effect and side effect of Shenqi Fuzheng Injection (SFI) on alleviating transient worsening of myasthenia gravis (MG) symptoms caused by high-dose steroids pulse therapy. Methods. Sixty-six consecutive patients with MG were randomly divided into two groups: the treatment group treated with SFI and methylprednisolone pulse therapy (MPT) and the control group treated with MPT alone. The severity of MG before, during, and after MPT and the duration of transient worsening (TW) were evaluated and compared with the clinical absolute scoring (AS) and relative scoring (RS) system. Results. Twenty-nine patients experienced TW in each group. At TW, the AS was significantly increased (P < 0.000) in both groups compared with baseline data, with the AS increase in the treatment group (16.8 ± 2) significantly smaller (P < 0.05) than in the control group (24.9 ± 2.5). At the end of the treatment course, the AS for the treatment group was significantly decreased (7.5 ± 0.9) compared with at TW, although no significant difference compared with the control (9.7 ± 1.1). The TW lasted 1-6 days (mean 3.7) for the treatment group, significantly shorter (P < 0.05) than 2-12 days (mean 7.8) for the control. The RS for the treatment group at the end of treatment was 43.8%-100% (mean 76.8% ± 2.6%), significantly better than the control group: 33.3%-100% (mean 67.2 ± 3.6%). Slight side effects (18.75%) included maldigestion and rash in the treatment group. Conclusion. SFI has a better treatment effect and few side effects and can alleviate the severity and shorten the duration of the transient worsening of MG during steroids pulse therapy.
目的。评估参芪扶正注射液(SFI)在缓解大剂量类固醇脉冲治疗引起的重症肌无力(MG)症状短暂恶化方面的治疗效果和副作用。
方法。将 66 例连续 MG 患者随机分为两组:治疗组用 SFI 和甲基强的松龙脉冲治疗(MPT),对照组单用 MPT。用临床绝对评分(AS)和相对评分(RS)系统评估和比较 MPT 前后、TW 期间 MG 的严重程度和 TW 持续时间。
结果。两组各有 29 例患者出现 TW。在 TW 时,两组的 AS 均明显升高(P < 0.000),与基线数据相比,治疗组的 AS 升高(16.8 ± 2)明显小于(P < 0.05)对照组(24.9 ± 2.5)。治疗结束时,与 TW 时相比,治疗组的 AS 显著降低(7.5 ± 0.9),但与对照组(9.7 ± 1.1)相比无显著差异。TW 持续 1-6 天(平均 3.7 天),治疗组明显短于对照组(2-12 天,平均 7.8 天)(P < 0.05)。治疗结束时,治疗组的 RS 为 43.8%-100%(平均 76.8% ± 2.6%),明显优于对照组:33.3%-100%(平均 67.2% ± 3.6%)。治疗组出现轻微副作用(18.75%)包括消化不良和皮疹。
结论。SFI 具有较好的治疗效果,副作用少,能减轻 MG 在类固醇脉冲治疗期间的严重程度和缩短 TW 持续时间。