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<p><b>BACKGROUND</b>Traditional Chinese medical treatment of primary Sjögren's syndrome has advantages over Western medicine in terms of fewer side effects and improved patient conditions. This study was a multicenter, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of ShengJinRunZaoYangXue granules for the treatment of primary Sjögren's syndrome, including the symptoms of dry mouth and dry eye.</p><p><b>METHODS</b>We undertook a 6-week, double-blind, randomized trial involving 240 patients with primary Sjögren's syndrome at five centers in East China. A computer-generated randomization schedule assigned patients at a 2:1 ratio to receive either ShengJinRunZaoYangXue granules or placebo once daily. Patients and investigators were blinded to treatment allocation. The primary endpoints were the salivary flow rate, Schirmer test results, and sugar test results. Intention-to-treat and per-protocol analyses were performed.</p><p><b>RESULTS</b>All 240 patients were randomly allocated to either the treatment group (n = 160, ShengJinRunZaoYangXue granules) or placebo group (n = 80) and were included in the intention-to-treat analysis. After program violation and loss to follow-up, a total of 199 patients were included in the per-protocol analysis. At six week, intention-to-treat and per-protocol analyses of the left-eye Schirmer I test results showed an improved difference of 1.36 mm/5 min (95% CI: 0.03 to 2.69 mm/5 min) and 1.35 mm/5 min (95% CI: 0.04 to 2.73 mm/5 min), respectively, and those of the right-eye Schirmer I test results showed an improved difference of 1.12 mm/5 min (95% CI: 0.02 to 2.22 mm/5 min) and 1.12 mm/5 min (95% CI: -0.02 to 2.27 mm/5 min), respectively. There was no significant difference between the two groups before treatment. After treatment, the between-group and within-group before-and-after paired comparison results were statistically significant (P < 0.05). Intention-to-treat and per-protocol analyses showed an improved salivary flow rate by 0.04 ml/15 min (95% CI: -0.49 to 0.58 ml/15 min) and 0.04 ml/15 min (95% CI: -0.52 to 0.60 ml/15 min), respectively, but the differences were not significant. Intention-to-treat and per-protocol analyses showed that the sugar test results were improved by 1.77 minutes (95% CI: 0.11 to 3.44 minutes) and 1.84 minutes (95% CI: 0.12 to 3.55 minutes), respectively, but the differences were not significant. For the secondary endpoint, intention-to-treat and per-protocol analyses showed significant improvement in the integrated evaluation of treated patients with dry eye and dry mouth after six weeks of treatment. The incidence of adverse events was 15.6% in the treatment group and 10.0% in the placebo group. Most (94%) adverse events were mild to moderate in the two groups, and only two cases of serious adverse events occurred in the treatment group; both were caused by autoimmune liver disease.</p><p><b>CONCLUSIONS</b>Six-week treatment with ShengJinRun ZaoYangXue granules for primary Sjögren's syndrome in this large-scale study improved the symptoms of dry mouth, dry eyes, and low tear flow rate with minimal adverse events.</p>
Subject(s)
Female , Humans , Male , Middle Aged , China , Double-Blind Method , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Models, Theoretical , Sjogren's Syndrome , Drug TherapyABSTRACT
Objective To investigate the expression of Aurora-A in gliomas and its relationship with clinical significance of gliomas.Methods Forty glioma specimens kept with paraffin,including 8 with WHO grade Ⅰ,8 with WHO grade Ⅱ,10 with grade Ⅲ and 14 with grade Ⅳ,collected in our hospital from June 2010 to August 2012 during the surgery,were chosen in our study.The expression of Aurora-A was detected by immunohistochemistry in these 40 glioma specimens.The relationships between Aurora-A expression and clinical factors were analyzed.Results The Aurora-A protein expression mainly located in the cytoplasm and (or) nucleus; positive expression rate of Aurora-A was 72.5％ (29/40); the Aurora-A protein expression was significantly different in the glioma specimens of different pathological grades and different survival times of the patients:Aurora-A protein expression was positively related with pathological grades,and the Aurora-A protein expression in patients having survival time shorter than or equal to 3 years was significantly higher than that in patients having survival time longer than 3 years (P＜0.05).Conclusion Over-expression of Aurora-A in gliomas is correlated with prognosis of patients; Aurora-A maybe a potential marker for gliomas and a new therapy target.
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Objective To investigate the Effects of conventional open craniotomy and key-hole approach on neurosurgical management of hypertensive intracerebral hemorrhage (HICH) and on cellular immunal function of these patients.Methods Eighty-three patients with HICH,admitted to and performed operation in our hospital from September 2008 to May 2011 (53 underwent conventional open craniotomy and 30 underwent surgery via key hole approach) were chosen in our study.Their CD3,CD4 and CD8 positive cell percentage and ratio of CD4/CD8 in serum before operation and 1 and 7 d after operation were detected.The infectious complications were analyzed and prognoses were evaluated by activities of daily living (ADL) grading.Results The CD3 and CD8 positive cell percentage,and ratio of CD4/CD8 in serum 1 and 7 d after the operation were significantly decreased as compared with those before operation (P＜0.05),and those 7 d after operation were significantly increased as compared with those 1 d after operation (P＜0.05).One and 7 d after operation,the CD3 and CD8 positive cell percentage,and ratio of CD4/CD8 in the key hole approach group were significantly higher than those in the conventional open craniotomy group (P＜0.05).The postoperative pulmonary infection rate in the conventional open craniotomy group was significantly higher than that in the key hole approach group (P＜0.05).Conclusion As compared with conventional open craniotomy,surgery via key-hole approach has the same prognosis in treatment of HICH which has not yet occurred herniation,while the influence of cellular immunal function and the incidence of lung infection is relatively lower.
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[Objective]To investigate the therapeutic influencing factors for surgical treatment of deep comatose patients after spontaneous cerebellar hemorrhage.[Methods]The clinical data of 23 patients in deep coma due to spontaneous cerebellar hemorrhage,admitted to our hospital fiom March 2003 to January 2012,were studied retrospectively.Eighteen patients received surgical treatment were divided into 2 groups depending on their different prognoses;the therapeutical effect and their prognostic factors were analyzed.[Results] The interval between onset of symptom and operation in patients having favorable outcome was significantly shorter than that in patients with unfavorable outcome (P=0.023).No significant differences on age,hospitalization time,hematoma size,presence of obstructive bydrocephalus,obliteration of perimesencephalic cistern and presence of cycle respiration were noted between the 2 groups.[Conclusion] Deep coma is not a contraindication for surgery in very recent onset patients after spontaneous cerebellar hemorrhage and immediate surgical relief of brain stem compression is the most important factor for reduction mortality in patients with spontaneous cerebellar hemorrhage.