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培哚普利治疗老年早期糖尿病肾病的疗效观察
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作者 陈化 《中国动脉硬化杂志》 CAS CSCD 2003年第3期269-270,共2页
为探讨培哚普利对血压正常的老年早期糖尿病肾病患者 2 4h微量白蛋白尿的影响 ,选择住院老年糖尿病患者中 ,血压为 10 0~ 14 0 6 0~ 90mmHg ,2 4h尿白蛋白排泄率为 2 0~ 2 0 0 μg mim的早期糖尿病肾病患者 5 0例 ,随机分为实验组 3... 为探讨培哚普利对血压正常的老年早期糖尿病肾病患者 2 4h微量白蛋白尿的影响 ,选择住院老年糖尿病患者中 ,血压为 10 0~ 14 0 6 0~ 90mmHg ,2 4h尿白蛋白排泄率为 2 0~ 2 0 0 μg mim的早期糖尿病肾病患者 5 0例 ,随机分为实验组 30例和对照组 2 0例。两组血糖均控制在空腹≤ 7.0mmol L、餐后 2h≤ 10 .0mmol L后 ,检测血压、微量白蛋白尿、肾功能和血清钾离子水平 ,给予实验组培哚普利 2~ 4mg 天 ,对照组给予安慰剂 ;治疗后第 12周和 2 4周分别复检上述指标。结果发现 ,较治疗前比较 ,治疗后第 12周和 2 4周微量白蛋白尿实验组分别下降 4 9.6 % (P<0 .0 5 )和 4 1.4 % (P <0 .0 5 ) ,对照组分别增加 7.8%和 2 .5 % ,两组间同期比较差异有显著性 (P <0 .0 5 ) ;治疗后两组患者的血压、肾功能和血清钾离子水平均无显著变化 ;实验组因咳嗽停药者占 6 .7% (2 30 )。结果提示 。 展开更多
关键词 培哚普利 糖尿病肾病 疗效 药物对照试验 微量白蛋白 老年人 药物治疗
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2008年4月份美国FDACDER会议安排
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作者 李晓明(摘) 《国外药讯》 2008年第4期7-7,共1页
抗感染药顾问委员会 4月1~2日,委员会将讨论用于轻至中度和中到重度社区获得性肺炎的产品开发及临床试验设计。主要是讨论有关确定活性药物对照试验中适合的非劣性限度。
关键词 FDACDER会议 社区获得性肺炎 顾问委员会 美国 临床试验设计 药物对照试验 抗感染药 产品开发
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Effects of telbivudine and entecavir for HBeAg-positive chronic hepatitis B: A meta-analysis 被引量:6
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作者 Qi-Min Su Xiao-Guang Ye 《World Journal of Gastroenterology》 SCIE CAS CSCD 2012年第43期6290-6301,共12页
AIM:To compare the effects of telbivudine (LDT) and entecavir (ETV) in treatment of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B by meta-analysis. METHODS:We conducted a literature search using PubMed, M... AIM:To compare the effects of telbivudine (LDT) and entecavir (ETV) in treatment of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B by meta-analysis. METHODS:We conducted a literature search using PubMed, MEDLINE, EMBASE, the China National Knowledge Infrastructure, the VIP database, the Wanfang database and the Cochrane Controlled Trial Register for all relevant articles published before April 1, 2012. Randomized controlled trials (RCTs) comparing LDT with ETV for treatment of HBeAg-positive chronic hepatitis B were included. The data was analyzed with Review Manager Software 5.0. We used relative risk (RR) as an effect measure, and reported its 95% CI. Meta-analysis was performed using either a fixedeffect or random-effect model, based on the absence or presence of significant heterogeneity. Two reviewers assessed the risk of bias and extracted data indepen- dently and in duplicate. The analysis was executed using the main outcome parameters including hepatitis B virus (HBV) DNA undetectability, alanine aminotransferase (ALT) normalization, HBeAg loss, HBeAg seroconversion, drug-resistance, and adverse reactions. Meta-analysis of the included trials and subgroup analyses were conducted to examine the association between pre-specified characteristics with the therapeutic effects of the two agents. RESULTS:Thirteen eligible trials (3925 patients in total) were included and evaluated for methodological quality and heterogeneity. In various treatment durations of 4 wk, 8 wk, 12 wk, 24 wk, 36 wk, 48 wk, 52 wk, 60 wk and 72 wk, the rates of HBV DNA undetectability and ALT normalization in the two groups were similar, without statistical significance. At 4 wk and 8 wk of the treatment, no statistical differences were found in the rate of HBeAg loss between the two groups, while the rate in the LDT group was higher than in the ETV group at 12 wk, 24 wk, 48 wk and 52 wk, respectively (RR 2.28, 95% CI 1.16, 7.03, P = 0.02; RR 1.45, 95% CI 1.16, 1.82, P = 0.001; RR 1.45, 95% CI 1.11, 1.89, P = 0.006; and RR 1.86, 95% CI 1.04, 3.32, P = 0.04). At 4 wk, 8 wk, 60 wk and 72 wk of the treatment, there were no significant differences in the rate of HBeAg seroconversion between the two groups, while at 12 wk, 24 wk, 48 wk and 52 wk, the rate in the LDT group was higher than in the ETV group (RR 2.10, 95% CI 1.36, 3.24, P = 0.0008; RR 1.71, 95% CI 1.29, 2.28, P = 0.0002; RR 1.86, 95% CI 1.36, 2.54, P < 0.0001; and RR 1.87, 95% CI 1.21, 2.90, P = 0.005). The rate of drug-resistance was higher in the LDT group than in the ETV group (RR 3.76, 95% CI 1.28, 11.01, P = 0.02). In addition, no severe adverse drug reactions were observed in the two groups. And the rate of increased creatine kinase in the LDT group was higher than in the ETV group (RR 5.58, 95% CI 2.22, 13.98, P = 0.0002). CONCLUSION:LDT and ETV have similar virological and biomedical responses, and both are safe and well tolerated. However, LDT has better serological response and higher drug-resistance. 展开更多
关键词 Telbivudine Entecavir Hepatitis B e antigen-positive chronic hepatitis B Randomized controlled trials Meta-analysis
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Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder:a randomized,double-blind,controlled trial 被引量:8
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作者 Ye Qing Zhou Jie +2 位作者 Yuan Xiaolei Yuan Canxing Yang Xuming 《Journal of Traditional Chinese Medicine》 SCIE CAS CSCD 2015年第4期381-388,共8页
OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100... OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder.Patients were randomly divided into the treatment group(n = 50) and the control group(n = 50) according to a random number table. The treatment group was given Zhenjingdingzhi decoction,while the control group was treated with Suanzaoren decoction. the pharmacological treatment lasted for 8weeks. The clinical efficacy was assessed by using Spiegel scale,Pittsburgh sleep quality index(PSQI)and Traditional Chinese Medicine(TCM) syndrome scores.RESULTS: Comparing Spiegel scores between the two groups at 4 and 8 weeks,the differences in curative effect between the two groups were both significant(both P < 0.05). The total effective rate was46% in the treatment group and 27.7% in the control group at 4 weeks,and 80% and 53.2% at 8weeks,respectively; After 8 weeks,PSQI scores showed that the total effective rates differed significantly between the two groups(P < 0.01): 84% in the treatment group and 59.6% in the control group; In improving sleep quality and sleep duration,the curative effect of the treatment group was better than that of the control group(P < 0.05).TCM syndrome,especially insomnia and palpitation,was improved better in the treatment group after 8 weeks as compared to that in the control group(P < 0.05). The total effective rate of the two groups was 84% and 66%,respectively.CONCLUSION: Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder,especially for improving sleep quality and sleep duration. 展开更多
关键词 Sleep initiation and maintenance disorders Shyness Heart Qi deficiency Zhenjingdingzhi decoction Randomized controlled trial Double-blind method
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Potassium dehydroandrographolide succinate injection for treatment of infantile pneumonia:a systematic review and Meta-analysis 被引量:17
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作者 Zhang Xiaomeng Wu Jiarui +1 位作者 Zhang Bing Dong Ling 《Journal of Traditional Chinese Medicine》 SCIE CAS CSCD 2015年第2期125-133,共9页
OBJECTIVE:To evaluate systematically the clinical efficacy and safety of potassium dehydroandrographolide succinate injection(PDS) in treatment of infantile pneumonia.METHODS:Randomized controlled trials(RCTs) of infa... OBJECTIVE:To evaluate systematically the clinical efficacy and safety of potassium dehydroandrographolide succinate injection(PDS) in treatment of infantile pneumonia.METHODS:Randomized controlled trials(RCTs) of infantile pneumonia treated by PDS were searched in China National Knowledge Infrastructure Database,China Science and Technology Journal Database,Wanfang Database,Chinese Biomedical Literature Database,PubMed,and Cochrane Library,from January 1979 to July 2013.Two reviewers independently retrieved the RCTs and extracted the information.The quality of included studies was assessed by the Cochrane risk of bias,and a Meta-analysis was conducted with Review Manager 5.2 software.RESULTS:A total of 9 studies with 1056 participants were included.The quality of the studies was generally no high,only one study mentioned the random method.The Meta-analysis indicated that PDS was significantly superior to the conventional therapy in the total effective rate[relative risk(RR)=1.21,95%CI(1.14,1.27),P<0.000 01],the time of temperature recovery[mean difference(MD)=-1.43,95%CI(-1.75,-1.11),P<0.000 01],rale disappeared and cough relieving[MD=-1.44,95%CI(-1.93,-0.90),P<0.000 01].Six adverse drug reactions from five studies mainly represented rash and diarrhea,and no serious ADRs were reported.CONCLUSION:Based on this systematic review,PDS was proved effective and relatively safe in treatment of infantile pneumonia.However the articles enrolled in the study were not high in quality,studies with higher quality should be conducted for assessment of efficacy and safety of PDS in treatment of infantile pneumonia. 展开更多
关键词 Pneumonia Meta-analysis Randomized controlled trials Potassium dehydroandrographolide succinate injection
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