白芍总苷治疗非系统受累干燥综合征的临床观察

Clinical Observation on Effect of Total Glucosides of Paeony in Treating Patients with Non-systemic Involved Sjgren Syndrome

目的观察白芍总苷(TGP)治疗非系统受累干燥综合征(NSI-SS)的疗效及不良反应情况。方法回顾性总结口服TGP治疗2年以上的患者(TGP组,27例),选择阳性药硫酸羟基氯喹(HCQs)口服治疗2年以上的患者(对照组,20例)。观察两组患者治疗前后不同时间(1、3、6、12及24个月)唾液流量、Schirmer试验、血清γ-球蛋白及两药的不良反应情况。结果唾液流量:两组从治疗6个月时开始明显增加(P<0.01),但组间比较差异无显著性。Schirmer试验:对照组从治疗6个月开始后,TGP组从治疗12个月开始后均明显改善(P<0.01),6个月时两组比较差异有显著性(P<0.01)。γ-球蛋白:对照组从治疗3个月开始后,TGP组从治疗6个月开始后均明显下降(P<0.01),3个月时两组比较差异有显著性(P<0.01),其他时间点两组比较差异无显著性。TGP组有1例因严重腹泻撤出治疗。对照组1例因谷丙转氨酶升高(治疗6个月时)、1例因视力下降(9个月时)撤出治疗。结论TGP治疗NSI-SS疗效与HCQs相当,起效时间在治疗6～12个月,且安全性好于HCQs。

Objective To investigate the efficacy and adverse reaction of total glucosides of paeony （TGP） in treating patients with non-systemic involved Sjoegren syndrom （NSI-SS）. Methods Retrospective study was conducted on 27 patients with NSI-SS who received TGP treatment for over two years as the TGP group, and 20 patients received hydroxychloroquine sulfate （HCQs） for over two years in the HCQs group for positive control. Salivary flow, Schirmer＇ s test and serum γ-globulin at different time points, i.e. before treatment, and at the end of 1st, 3rd, 6th, 12th and 24th month respectively, were compared between groups, and adverse reactions associated with TGP and HCQ were also observed. Results In the TGP group, saliva secretion was significantly increased and serum γ-globulin decreased significantly from the 6th month （P 〈 0.01 ）, Schirmer＇ s test improved significantly after 12 months （P〈0.01） . While in the HCQs group serum γ-globulin was significantly decreased from the 3rd month （P 〈 0.01 ）, saliva secretion and Schirmer＇ s test improved significantly after six months （P 〈 0.01）. However, the 3 indexes determined at the end of the 3rd month were insignificantly different from those before treatment. Mild diarrhea occurred in 4 cases in the TGP group, they were improved two weeks later, but one case with severe diarrhea was dropped. While in the HCQs group, 2 patients were dropped, one for the raising of alanine aminotransferase at the 6th month and the other for decreased vision at the 9th month. Conclusion Efficacy of TGP is equivalent to that of HCQs in treating NSI-SS, but with higher safety and the effect initiating time being about 6 - 12months.