Establishment of safety evidence for Xingxue Shuxuening injection

OBJECTIVE： To systematically investigate the safety of Xingxue Shuxuening injection（SXN） in preand post-marketing, and to ensure clinical drug safety.METHODS： Strict quality control in raw herb selection and production processes was adopted and pharmacology research on SXN was performed by the drug manufacturing company, Heilongjiang ZBD Pharmaceutical Co., Ltd. We systematically reviewed the safety literature of Xingxue SXN. Adverse drug reaction（ADR） data of the drug, extracted from Spontaneous Reporting System（SRS）, and clinical characters based on 20 hospital information systems（HIS） in China, were analyzed. Large-scale prospective safety monitoring and Risk Minimization Action Plans（Risk MAPs） of XingxueSXN were carried out.RESULTS： The quality of SXN was stable and controllable when it was produced. Drug toxicology studies found no effect on rabbits with hemolytic or condensed, local stimulation and muscle stimulation, and no allergic reactions in guinea pigs. The ADRs of Xingxue SXN were dizziness, phlebitis,and vomiting based on SRS data. The injection did not conform to instructions in clinical practice when we analyzed HIS database, and patient＇s abnormal blood urea nitrogen levels may be related to the drug, when analyzed using the propensity score method. A nested case-control study was designed and performed to analyze the influencing factors of suspected allergic reactions to SXN. The study showed that patients with an allergy history were more prone to allergic reactions（P〈0.001）,and some medicine combinations could cause allergic reactions.CONCLUSION： These studies have established a body of evidence on Xingxue SXN safety, and provide a good model for Chinese medicine injection for clinical safety. The Xingxue SXN production process and toxicology research indicate the safety of the injection. However, the use of the injection is not consistent with instructed clinical practice.Xingxue SXN causes ADRs perhaps from inappropriate usage or its     

Effect of estrogen on regression of vascular calcification in rats

Objective To investigate the effect of estrogen on regression of vascular calcification in rats induced by vitamin D3 plus nicotine. Methods Ninety?six female SD rats were divided randomly into control group (n=24) and calcification group (n=72). Vascular calcification of 72 rats was induced by vitamin D3 and nicotine (VDN). On the day 1, the VDN group rats were injected with vitamin D3(300 000 U/kg, i.m), and were intragastric administrated with nicotine (25 mg/kg), after 9 hours, another dosage of nicotine was given again. After 4 weeks, the VDN group rats were subdivided randomly into 4 groups: VDN group(n=16), Sham operation group (n=16), ovariotomy group (n=16), estrogen group(after ovariotomy, 17β ?estrogen was subcutaneously injected, 50 μg•kg-1•d-1, n=16). Results After 4 weeks，the VDN group showed obvious vascular calcification, and calcium content of the vessel wall was significantly higher than that of control group (P<0.01). Extensive calcification was witnessed on the aortic tunica media of the VDN group. After 12 and 8 weeks, the calcium content of the vessel wall in each subdivided groups was significantly lower than that at 4 weeks point(P<0.01), and the lowest calcinm content was in estrogen group, meanwhile the reduction of previously accumulated arterial calcium precipitate in each group was different. Conclusions It is a reversible process that vascular calcification induced by vitamin D plus nicotine in rats. Estrogen can promote the regression of vascular calcification.     

替普瑞酮对阿司匹林致胃黏膜损伤的保护作用

目的 研究替普瑞酮对阿司匹林所致胃黏膜损伤的保护作用.方法 2008年至2010年在浙江省中医院心血管科住院的首次服用常规剂量阿司匹林的患者296例,随机分为两组.阿司匹林组166例,每日服用阿司匹林肠溶片100 mg；阿司匹林+替普瑞酮组130例,在等同于阿司匹林组服用阿司匹林剂量的基础上,口服替普瑞酮舒50 mg/次,3次/d.分别观察两组患者3个月、6个月及1年后消化道症状和胃黏膜的损害情况.结果 阿司匹林组入组143例,阿司匹林+替普瑞酮组入组118例.服药3个月后阿司匹林组消化道症状的发生率为1.40％,与阿司匹林+替普瑞酮组比较差异有统计学意义(0,x2=1.663,P=0.197).服药6个月后随访,阿司匹林组消化道症状的发生率为4.96％,与阿司匹林+替普瑞酮组比较差异有统计学意义(0,x2=6.021,P＝0.014).服药1年后随访,阿司匹林组消化道症状的发生率为20.15％,与阿司匹林+替普瑞酮组比较差异有统计学意义(1.69％,x2=20.984,P=0.001).阿司匹林+替普瑞酮组随访6个月及1年后症状和胃镜积分与阿司匹林组相比明显降低(P值分别＜0.05和0.01).阿司匹林组1年后症状和胃镜积分与6个月时相比明显增高(P值分别＜0.05和0.01).结论 替普瑞酮对阿司匹林所致胃黏膜损伤有一定的保护作用.长期服用常规剂量的阿司匹林会引起胃黏膜不同程度的损害,胃黏膜损害的发生会随着服药时间增加而增加.     

Outcome predictors of cirrhotic patients with spontaneous bacterial empyema

Background: Spontaneous bacterial empyema (SBE) is a complication of cirrhotic patients in which a pre‐existing pleural effusion becomes infected. This retrospective study was designed to investigate the bacteriology and outcome predictors of SBE in cirrhotic patients. Methods: Medical records of cirrhotic patients treated in a tertiary care university hospital from December 2004 to December 2008 were retrospectively reviewed. Results: Of 3390 cirrhotic patients seen during the study period, 81 cases of SBE were diagnosed. The incidence of SBE was 2.4% (81/3390) in cirrhotic patients and 16% (81/508) in patients with cirrhosis with hydrothorax. There were 46 monomicrobial infections found in 46 SBE patients. Aerobic Gram‐negative organisms were the predominant pathogens (n=29, 63%), and Escherichia coli (n=9, 20%) was the most frequently isolated sole pathogen. The mortality rate of SBE was 38% (31/81). Univariate analysis showed that Child–Pugh score, model for end‐stage liver disease (MELD)–Na score, concomitant bacteraemia, concomitant spontaneous bacterial peritonitis, initial intensive care unit (ICU) admission and initial antibiotic treatment failure were predictors of poor outcomes. Multivariate regression analysis demonstrated that the independent factors related to a poor outcome were initial ICU admission [odds ratio (OR): 4.318; 95% confidence interval 1CI) 1.09–17.03; P=0.037], MELD–Na score (OR: 1.267; 95% CI 1.08–1.49; P=0.004) and initial antibiotic treatment failure (OR: 13.10; 95% CI 2.60–66.03). Conclusion: Spontaneous bacterial empyema in cirrhotic patients is a high mortality complication. The independent factors related to poor outcome are high MELD–Na score, initial ICU admission and initial antibiotic treatment failure. High MELD–Na score may be a useful mortality predictor of SBE in cirrhotic patients.     

Sublobectomy Versus Lobectomy for Stage I Non-Small-Cell Lung Cancer,A Meta-Analysis of Published Studies

Background  

The selection of surgeries for patients with stage I NSCLC remains controversial. We evaluated the effectiveness of different surgeries for stage I NSCLC through a meta-analysis of studies that compared sublobectomy with lobectomy.     

Evaluation of Non-alcoholic Fatty Liver Disease Using Acoustic Radiation Force Impulse Imaging Elastography in Rat Models

The aim of this study is to evaluate the utility of acoustic radiation force impulse (ARFI) elastography for assessing hepatic fibrosis stage and non-alcoholic fatty liver disease (NAFLD) severity, as well as the relationship among hepatic histologic changes using shear wave velocity (SWV). Animal models with various degrees of NAFLD were established in 110 rats. The right liver lobe was processed and embedded in a fabricated gelatin solution (porcine skin). Liver mechanics were measured using SWV induced by acoustic radiation force. Among the histologic findings, liver elasticity could be used to differentiate normal rats from rats with simple steatosis (SS) as well as distinguish SS from non-alcoholic steatohepatitis (NASH), with areas under the receiver operating characteristic curves (AUROC) of 0.963 (95% confidence interval = 0.871–0.973) and 0.882 (95% confidence interval = 0.807–0.956), respectively. For NAFLD rats, the diagnostic performance of ARFI elastography in predicting significant fibrosis (F ≥ 2) had an AUROC of 0.963. For evaluating steatosis severity, we found a progressive increase in ARFI velocity proportional to steatotic severity in NAFLD rat models, but we observed no significant differences for steatotic severity after excluding the rats with fibrosis. ARFI elastography may be used to differentiate among degrees of severity of NAFLD and hepatic fibrotic stages in NAFLD rat models.     

葡聚糖硫酸钠结肠炎模型影响因素的研究进展

自1985年首次报道采用葡聚糖硫酸钠(dextran sulphate sodium,DSS)制备出仓鼠溃疡性结肠炎模型以来,已有大量研究证明DSS结肠炎模型与人类溃疡性结肠炎相似.该模型的病因、临床症状、病理改变及治疗应答均与人类UC相类似;对于研究UC病因、发病机制及UC相关增生和肿瘤,确定治疗手段有重要意义.虽然DSS模型制作简单;但该过程受到多个因素的影响:DSS浓度、给药时间、DSS相对分子质量和动物种属等.如不能正确处理这些因素,很难制造出成功的DSS结肠炎模型.本文主要针对DSS造模影响因素及尚需我们进一步研究和探讨的问题作综述如下.