| Objective:To evaluate efficacy and safety of tripterygium glycosides in the treatment of hyperglobulinemia of the patients with primary Sjogren syndrome (pSS), We have designed a trial to understand the effect of tripterygium glycosides in the reducing the level of serum globulin, IgA, IgG, IgM, erythrocyte sedimentation rate, and C-reactive protein, as well as in alleviating the extent of dry eye and mouth.Methods:66cases were randomly divided into trial group A (n=22), trial group B (n=22) and control group (n=22), treatment for12weeks, The watchpoints is0weeks (before treatment), after4,8and12weeks of treatment. The trial group A takes oral Tripterygium glycosides tablet,20mg, tid; and the trial group B takes oral Tripterygium glycosides tablet,20mg, bid, while the control group was treated with hydroxychloroquine tablets,0.2g, bid,0-4weeks,0.2, qd,5-12weeks, and the three groups may only be used artificial saliva and artificial tears when severe dry mouth and eyes, and make a corresponding record.Results:(1)The changes of the serum globulin level of three groups of patients:After8and12weeks of treatment, the serum globulin level of the trial group A is less than the serum globulin level of the trial group B and the control group, and there is statistical significance in the serum globulin level variance (P<0.05). After12weeks of treatment, the serum globulin level of the control group is less than the serum globulin level of trial group B, and there is statistical significance in the serum globulin level difference (P<0.05). The serum globulin level of the trial group A after8and12weeks of treatment is less than the serum globulin level of this group before treatment, and there is statistical significance in the serum globulin level variance (P<0.05). and there is statistically significance in the variance of the serum globulin level of the trial group B of patients at each watchpoints (P<0.05), but the variance has no realistic significance (P>0.05). The difference of the serum globulin level of the control group of patients between after12weeks of treatment and before treatment has statistically significance (P<0.05), and the serum globulin level of after12weeks of treatment is less than the serum globulin level of before treatment.(2)The changes of the serum IgA level of three groups of patients:After12weeks of treatment, the serum IgA level of the trial group A is less than the serum IgA level of the trial group B and the control group, and there is statistically significance in the variance of the serum IgA level (P<0.05). The serum IgA level of the trial group A of patients after8weeks and after12weeks of treatment is less than the serum IgA level of this group of patients before treatment, and there is statistically significance in the difference of the serum IgA level (P<0.05). The serum IgA level of the trial group B of patients after12weeks of treatment is less than the serum IgA level of this group of patients before treatment, and there is statistically significance in the variance of the serum IgA level(P<0.05). The serum IgA level of the control group of patients after8and12weeks of treatment is less than the serum IgA level of this group of patients before treatment, and the difference has statistically significance (P<0.05).(3)The changes of the serum IgG level of three groups of patients:Multiple comparisons of the serum IgG levels of the three groups of patients before treatment can be carried out, and the differences of the serum IgG levels among the three groups are not statistically significant (P>0.05).(4)The changes of the serum IgM level of three groups of patients:After8weeks of treatment, the serum IgM level of the trial groups of patients are less than the serum IgM level of the control group of patients, the serum IgM level of the trial A group of patients is less than the serum IgM level of the trial B group of patients, and the variance is statistically significance (P<0.05). The serum IgM level of the trial group A and the control of patients is less than the serum IgM level of the trial group B of patients, and there is statistically significance in the difference of the serum IgM levels (P<0.05). After12weeks of treatment, the serum IgM levels of the trial groups A of patients and the control group are less than the serum IgM level of the trial group B of patients, and the variance is statistically significance(P<0.05). The serum IgM levels of the trial group A of patients after8and12weeks of treatment are less than the serum IgM level of this group of patients before treatment The variances in the serum IgM levels of the trial group B of patients at each watchpoints are not statistically significance (P>0.05). The serum IgM level of the control group of patients after12weeks of the treatment is less than the serum IgM levels of this group of patients before treatment, and there is statistically significance in the differences of the serum IgM levels (P<0.05).(5)The changes of the serum ESR level of three groups of patients:The serum ESR levels of the three groups of patients after treatment are significantly less than the serum ESR levels of those groups of patients, and the variances are statistically significance(P<0.05). The ESR levels of the three groups after treatment was no statistically significance(P>0.05).(6)The changes of the serum CRP level and of dry mouth and eyes of three groups of patients:The serum CRP level of the trial group A of patients is less than the serum CRP levels of the other groups of patients after treatment and of the this group before treatment, and the difference is statistically significance(P<0.05). There is no statistically significance in the variance of between the serum CRP levels of the trial group B of patients and the control group of patients after treatment. The difference of the serum CRP levels of the trail B group of patients and the control group of patients after treatment is no statistically significance(P>0.05). The extent of variances in the dry mouth and eyes of the three groups of patients after treatment are statistically significance(P<0.05) and the differences of those three groups of patients after treatment are not statistically significant(P>0.05). Conclusion:In reducing the serum globulin, the onset time of the trial A group of the patients is earlier than the onset time of the control group of the patients, and the curative effect of the trial A group is better than the curative effect of the control group of the patients. In reducing the IgA, the trial A group and the control of patients is earlier than the trial B group of patients in the onset time, and the curative effect of the trial A group of patients is better than the curative effect of the trial B group of patients and of the control group of patients, the equilibrium of curative effect is between the trial B group and the control group of patients. In reducing the IgG, the onset time of the trial A group is earlier than the onset time the trial B group of patients, the curative effect is quite between the trial A group and the trial B group, and is better than the curative effect of the control group of patients. In reducing IgM, the trial A group of patients is earlier than the control group of patients in the onset time, the curative effect is quite between the trial A group of patients and the control group of patients, and the curative effect of the trial A group of patietnts and of the control group of patients is better than the curative of trial B group of patients. In reducing CRP, the curative effect of the trial A group is better than the curative effect of the other groups, and the equilibrium of curative effect is between the trial B group and the control group. In the remission of dry eye and mouth, the curative effect of the three groups is quite. |
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