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
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
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
基金Supported by Drug Research Fund of Hepatitis, Guangdong Pharmaceutical Association, No. 2012G01
文摘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.
基金Supported by Special Research Foundation of Selection and Cultivation for Outstanding Young Teacher of Shanghai University(Clinical Research on Zhenjingdingzhi Mixture for Insomnia,No.szy10046)the National Natural Science Foundation of China(Effect of Dopamine D1/D2 Receptor-MAPK/ERK Signal Transduction in PD Levodopa-induced Dyskinesias with Shudi Pingchan Tang,No.81302926)3-Year Action Plan for Shanghai Municipal Chinese Medicine Development Project(Clinical Succession Base of Ding's Medicine,No.ZYSNXD-CC-HPGC-JD-003)
文摘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.
基金Supported by National Natural Science Foundation of China(Study on the Key Factors of Allergic Reaction That Caused by Chinese Herbal Injection Based on the Three-dimensional Database and Multi-dimensional Data Mining,No.81473547)Scientific Research Innovation Team Project of Beijing University of Chinese Medicine(Research on the Disciplinary of Clinical Pharmacology of Traditional Chinese Medicine,No.2011-CXTD-14)Ministry of Education Research Fund for Doctor Program(No.20130013120001,20120013130002)
文摘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.