白芍总苷治疗类风湿关节炎的多中心临床研究

目的进一步评价白芍总苷（TGP）作为治疗类风湿关节炎（RA）病情改变药物的作用。方法370例RA患者随机开放进入甲氨蝶呤（MTX）组、TGP＋MTX组、MTX＋柳氮磺吡啶（SSZ）组、TGP＋SSZ组以及TGP组．共5组．疗程24～48周。观察指标有关节疼痛数、关节压痛数目和压痛指数、关节肿胀数目和肿胀指数、晨僵时间、握力、关节功能、血沉（ESR）、C反应蛋白（CRP）及类风湿因子（RF）。结果治疗24周时，各组临床指标改善的疗效相当。但TGP＋MTX组对关节肿胀指数的改善不如其他组，MTX组对晨僵的改善更优于其他组：治疗36周时．各组疗效继续相当，但MTX组有4项、TGP＋SSZ组有3项、MTX＋SSZ组和TGP组分别有2项比其他组的疗效更好，而TGP＋MTX组有3项的疗效低于其他组；治疗48周时，MTX组有5项、TGP组有3项、MTX＋SSZ组和TGP＋SSZ组均有2项更优于其他组，而TGP＋MTX组有3项、TGP＋SSZ组与TGP组分别有1项指标疗效低于其他各组。治疗24周及48周时，各组ESR均明显下降，除MTX＋TGP组外，其余各组CRP水平也明显下降。治疗24周时，除TGP组外，其余各组RF滴度亦降低；48周时MTX组和TGP＋MTX组RF降低的水平优于TGP＋SSZ组和MTX＋SSZ组。TGP对关节功能的改善较好．但总的起效时间较MTX晚。TGP的主要不良反应为稀便，腹泻，其与其他药物联合后仍以稀便为主，随着治疗时间延长，副作用未见增加。各组均无严重不良反应。结论单独TGP或TGP与MTX及与SSZ的联合对RA的疗效与已知的MTX和MTX＋SSZ疗效相当。除稀便，腹泻外TGP无严重不良反应，提示该品为一有效、安全并具有改变RA病情的植物药。

A clinical study of total glucosides palony in the treatment of rheumatoid arthritis: a multi-center trial

Objective To further evaluate the efficacy and safety of total glucosides palony (TGP) as a DMARD in the treatment of rheumatoid arthritis (RA). Methods Three hundred and seventy cases of RA were randomly divided into five groups: MTX, MTX plus TGP, MTX plus SSZ, TGP plus SSZ, and TGP group in a randomized, 24~48 week open trial. The registered indexes included joint pain, number and index of joint tenderness and joint swelling, duration of morning stiffness, grip strength, joint function status, ESR, CRP and RF. Results After 24 weeks of treatment, the clinical items improvement was similar among five groups except the index of joint swelling in TGP plus MTX group and morning stiffness in MTX group was better than that of the other groups. After 36 weeks the efficacy was better than other groups in 4 items for MTX group, 3 items for TGP+SSZ and 2 items for MTX plus SSZ and TGP groups. Efficacy was worse than other groups in 3 items for TGP plus MTX group. After 48 weeks, the efficacy was better than other groups in 5 items for MTX group, 3 items for TGP group, 2 items for MTX plus SSZ and TGP plus SSZ group. Meanwhile the efficacy was not as good as other groups in 3 items in TGP plus MTX group and one parameter in TGP plus SSZ and TGP group. ESR declined significantly after 24 and 48 weeks, CRP was decreased with similar pattern except for MTX plus TGP group. RF was invariable in TGP group after treatment for 24 and 48 weeks. MTX and TGP plus MTX group were more effective in RF reduction than TGP plus SSZ group and MTX plus SSZ group. TGP had an advantage in the improvement of joint function and later onset of effect than MTX. The primary side-effect for TGP was diarrhea/constipation with no severe adverse events happened in all groups. No other side-effect was observed in 48 weeks. Conclusion TGP, TGP combined with MTX or with SSZ may have an equivalent effect to MTX and MTX plus SSZ. It suggests that TGP may be an effective drug for RA with less side-effects and good safety.