| Objective:Through a randomized controlled double-blind study, make the objective evaluation about the Effect of dry eyes dry mouth and security of the "Sheng Jin Run Zao Yang Xue" ways for the treatment of the type of YinXuJinKui of primary Sjogren's syndrome.Method:Patients with the primary sjogren's syndrome and YinXuJinKui were brought into with the principle of blindness, randomness, and controll, These patients were divided into two groups, They have differently been treated by ShengJinRunZaoyangXue grain and placebo. The period of treatment were both six weeks. when 6 weeks Symptoms of dry mouth and dry eyes points to reduced rate≥30% and objective indicators (salivary flow rate, filter paper test, sugar test) improvement for the effective, comprehensive evaluation of the two groups of improvement curative effect of dry eyes and dry mouth and simultaneously to observe the incidence of adverse drug reactions.Result:1.56 cases were enrolled in this study. case source:rheumatology clinics of Jiangsu Province Hospital of Traditional Chinese Medicine and Jiangsu Province Hospital, male to female ratio: 1:13, mean age (years) 46.5 (9.1) course of the study, a total of 16 patients withdrew from the study, of which 7 cases treated group, control group 8 patients. Exit reason unwilling to continue treatment 4 patients (treatment group 1 patients because of urinary tract infection,1 case of upper respiratory tract infection, poor symptom improvement in 1 case,1 case control group because urinary tract infections),11 patients (Control group 7 examples, treatment group 4 examples) lost due to unknown reasons.2.40 cases in full compliance with the program (treatment group 21 patients, control group 19 patients) showed statistical improvement of dry mouth and dry eyes curative effect of the end of 6 weeks of treatment in the treatment group was 66.7%,28.6% in the control group, the X2 test, P<0.05, difference statistically significant. Dry mouth and dry eyes to improve the efficacy of test odds ratio (OR) 4.3 (1.15-16.32),risk difference of 38.1%. the two groups the difference between dry mouth and dry eyes improved 1.03 points, the treatment group before and after comparison P<0.01, statistically significant differences, but between the two groups after treatment, P> 0.05, suggest no significant difference. Filter paper test left and right eye (mm/5 min) the difference between the two groups (95% CI) were 2.07 (1.86-2.28),3.32 (3.28-3.36), before and after treatment comparison P> 0.05, the difference was not statistically significant comparison between the two groups of left and right eye P values were> 0.05, respectively, 0.052,0.060, the difference was not statistically significant. Salivary flow rate and sugar tests are negative difference, treatment front and back and the two groups contrast P value all>0.05.The difference was not statistically significant.3. The difference (95% CI) of TCM syndrome score to improve is 0.76 (0.09-1.43), treatment front and back and the two groups contrast P value all>0.05,respectively,0.360,0.620, the difference was not statistically significant.4. The test laboratory parameters (ESR, C-reactive protein, rheumatoid factor, immune globulin) treatment front and back and the two groups contrast P value all>0.05, the difference was not statistically significant.5. Treatment and control groups the proportion of adverse events was 21%(6/28) and 4% (1/28), and Adverse reactions to the treatment group compared to 14%(4/28), all were diarrhea, most patients can tolerate, no cases thus fall off, two groups of 40 patients before and after treatment safety index (routine blood test,liver and kidney function) were normal, and P> 0.05, the difference was not statistically significant.Conclusion:1. " ShengJinRunzaoyangXue " treatment of SS patients may improve the symptoms of dry mouth and dry eyes and objective indicators (salivary flow rate, Schirmer's filter paper test, sugar test).2. ShengJinRunZaoyangXue grain can cause diarrhea, but most patients can tolerate, no other adverse reactions, it is high security. |
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