Objective To evaluate the effectiveness and safety of different doses of interferon alfa (INF-α) in the treatment of chronic hepatitis C (CHC). Methods Such databases as MEDLINE, EMbase, CENTRAL, CBM, CNKI, VIP and WanFang Data were searched to collect the randomized controlled trials (RCTs) on different doses of INF-α in the treatment of CHC published before August, 2012. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and evaluated the quality of the included studies, and then meta-analysis was performed using RevMan 5.0 software. Results A total of 13 RCTs involving 1 442 patients were included. The results of meta-analysis on different doses of INF-α showed that, a) There was no significant difference in the complete response rate between the 3 MU dose group and the 1 MU dose group (RR=0.83, 95%CI 0.52 to 1.32, P=0.43), but there was significant difference in the sustained response rate between those 2 groups (RR=1.89, 95%CI 1.00 to 3.59, P=0.05); and b) No significant differences were found in the complete response rate among the 3 MU dose group, the 6 MU dose group, and the 1 MU dose group. Conclusion INF-α in dose of 3 MU, 3 times daily, is effective in treating CHC, but it would not rule out that higher dose takes more effective action. When INF-α is used to treat CHC, an individualized medication should be applied according to patients’ tolerance and economic status.
Objective To evaluate the efficacy and safety of saxagliptin in type 2 diabetes patients. Methods The following databases as The Cochrane Library (Issue 2, 2011), PubMed (1978 to May 2011), EMbase (1974 to May 2011), CNKI (1978 to May 2011), VIP (1989 to May 2011) and CBM (1978 to May 2011) were searched. The quality of included randomized controlled trials (RCTs) was assessed according to the Cochrane Collaboration system review, and then meta-analysis was performed using RevMan 5.0. Results A total of 7 RCTs were included. The results of meta-analyses showed that HbA1c was significantly reduced in the saxagliptin group than that in placebo group (MD= –0.69, 95%CI –0.78 to –0.60, Plt;0.000 01). There was no significant difference in the incident rate of adverse reaction between two groups (RR=1.02, 95%CI 0.98 to 1.06, P=0.26). Conclusion Saxagliptin is effective and safe for type 2 diabetes. But its long-term efficacy and safety still need to be confirmed by performing more high quality, large sample RCTs with long-term follow-up.
Objective To evaluate the effectiveness and safety of ramelteon for chronic insomnia in adults. Methods The following databases as CENTRAL, PubMed, EMbase, ISI, CNKI, CBMdisc, VIP and WanFang Data were searched from the date of their establishment to November 2010. The randomized controlled trials (RCTs) meeting the inclusion criteria were included. The data extraction and quality assessment were conducted according to the methods of Cochrane Reviewers’ Handbook recommend by The Cochrane Collaboration, and meta-analysis was performed with RevMan5.0 software. Results A total of 5 RCTs involving 1 772 patients were included. The results of meta-analyses showed that: a) Effectiveness: In the effectiveness, ramelteon was superior to placebo in latency to persistent sleep (MD=18.36, 95%CI 11.55 to 25.18, Plt;0.000 01), total sleep time (MD= –15.47, 95%CI –22.50 to –8.43, Plt;0.000 1), sleep efficiency (MD= –3.39, 95%CI –5.32 to –1.46, P=0.000 6), sleep quality (MD=0.14, 95%CI 0.03 to 0.25, P=0.01) after one week treatment and latency to persistent sleep (MD=13.02, 95%CI 6.01 to 20.03, P=0.000 3) except for wake after sleep onset (MD= –8.79, 95%CI –17.24 to –0.35, P=0.04) after one month treatment. b) Safety: significant differences were only found in the female prolactin (MD=5.50, 95%CI 2.02 to 8.98, P=0.002) and male free testosterone (MD=15.30, 95%CI 0.62 to 29.98, P=0.04) between the two groups, rather than in all the other hormones concentration, rebound insomnia, withdrawal syndrome, next-day residual effects and incidence rate of adverse reactions. Conclusion Ramelteon has marked effects on adults’ chronic insomnia after 1-week treatment, but its effect is not obvious after 1-month treatment. The adverse reactions are mostly the somnolence, rising of male free testosterone and female prolactin concentration.
Objective To assess the effectiveness and safety of irbesartan for hypertensive patients with hyperuricaemia. Methods The databases such as The Cochrane Library (Issue 2, 2010), MEDLINE (by the end of April 2010), SCI (by the end of April 2010), CBM (by the end of April 2010) and CNKI (by the end of April 2010) were searched to collected randomized controlled trails (RCTs) on irbesartan for hypertensive combined with hyperuricaemia. Studies were screened according to the inclusion and exclusion criteria; data were extracted; the methodological quality was evaluated; and meta-analyses were conducted by using RevMan 5.0.0 software. Results Nine studies involving 977 patients were included. The results of meta-analyses showed that compared with the control group, irbesartan was superior in decreasing serum uric acid (SUA) (MD=57.12, 95%CI 16.08 to 98.15, P=0.006); it was similar in controlling blood pressure (Systolic pressure: MD= –0.24, 95%CI –2.19 to 1.71, P=0.81; Diastolic pressure: MD=0.46, 95%CI –1.58 to 2.50, P=0.66), and lower in the incidence rate of adverse reaction (RR=0.07, 95%CI 0.02 to 0.24, P=0.000 1). Conclusion The study suggests that irbesartan is effective and safe to control blood pressure and decrease serum uric acid for hypertensive patients with hyperuricaemia. But because all nine included studies are graded C in quality, the conclusion still needs to be further verified by long-term, large scale and high quality studies.
Objective To evaluate the efficacy and safety of vildagliptin vs. placebo for patients with type 2 diabetes.Methods The following databases as The Cochrane Library (Issue 2, 2010), PubMed (1978 to September, 2010), EMbase (1974 to September, 2010), CNKI (1978 to September, 2010), VIP (1989 to September, 2010) and CBM (1978 to September, 2010) were searched to collect the randomized controlled trials (RCTs) of vildagliptin vs. placebo in treating type 2 diabetes. Two reviewers screened the trials according to the inclusion and exclusion criteria, extracted the data, assessed the quality in accordance with the Cochrane Collaboration, and conducted meta-analyses with RevMan 5.0 software. Results A total of 13 studies were included. The results of meta-analyses showed that the vildagliptin given as monotherapy led to greater reduction in HbA1c compared with the placebo (MD= –0.76, 95%CI –0.94 to –0.58, Plt;0.000 01), but it was inferior to the placebo in losing weight (MD=0.68, 95%CI 0.29 to 1.07, P=0.000 6). When the vildagliptin was given as monotherapy, there was no statistical difference in the incidence of overall adverse events (AEs) (OR=1.00, 95%CI 0.83 to 1.21, P=0.98) and hypoglycaemia (OR=1.03, 95%CI 0.65 to 1.65, P=0.89). When the vildagliptin was combined with other oral antihyperglycemic drugs or insulin, it produced greater reduction in level of HbA1c (MD= –0.76, 95%CI –0.94 to –0.58, Plt;0.000 01), and there was no statistically significant difference between vildagliptin and placebo in weight loss (MD=0.40, 95%CI –0.25 to 1.05, P=0.23), AEs (OR=0.95, 95%CI 0.76 to 1.18, P=0.62) and hypoglycaemia (OR=1.11, 95%CI 0.49 to 2.53, P=0.80). Conclusion The vildagliptin treatment for type 2 diabetes is effective and safe. A long-term study in large scale with high quality is required to confirm its long-term outcomes.
目的 总结鲑鱼降钙素致不良反应的一般规律和特点。 方法 检索中国期刊全文数据库（CNKI）、万方数据库（WanFang）1994年1月－2012年3月鲑鱼降钙素所致不良反应的个案报道，按患者年龄、性别、给药途径、用药剂量、不良反应发生时间、临床表现症状、有无过敏史、治疗与转归等进行分类统计分析。 结果 15例不良反应包括皮肤系统、心血管系统、消化系统、神经系统和超敏反应，高年龄段和女性发生率较高。 结论 临床上应重视鲑鱼降钙素可致不良反应，坚持合理用药。
【摘要】 目的 探讨抗菌药物诱导尖端扭转型室速（torsade de pointes，TDP）的规律及特点，为临床合理用药提供参考。 方法 检索中国期刊全文数据库、维普、万方、中国生物医学文献数据库建库至2011年7月有关抗菌药物致TDP的病例报道，共16例，并进行分析。 结果 16例患者中男3例，女13例；年龄17～88岁，平均54岁。6例患者存在心脏疾病；诱导TDP的抗菌药物包括常用的莫西沙星、司帕沙星、头孢拉定、头孢哌酮、磷霉素、克林霉素、两性霉素B、氟康唑、伊曲康唑以及不常用的红霉素、酮康唑；TDP发生时间为用药后（5.1±6.6） d，多数患者先出现心悸、心电图提示QTc间期延长，进而出现TDP。 结论 临床医师、药师应重视抗菌药物诱导TDP的不良反应。【Abstract】 Objective To investigate the regularity and characteristics of antimicrobial agents-induced torsade de pointes(TDP),and to provide reference for rational use of drugs. Methods A total of 16 reported cases of antimicrobial agents-induced TDP were analyzed. Results The 16 cases including 3 males and 13 females at the age of 17-88 years with the mean age of 54. Six patients suffered from heart disease. The antimicrobial agents included moxifloxacin, sparfloxacin, cefradine, cefoperazone, fosfomycin, clindamycin, amphoterincin B, fluconazole, and itraconazole; which were used frequently, as well as some less frequently-used ones liked erythromycin, ketoconazole. The mean time from medication to onset of TDP was (5.1±6.6) days. Patients usually presented with palpitations at first following by prolonged QTc intervals, and then TDP appeared. Conclusion Clinical physicians and pharmacists should pay attention to antimicrobial agents-induced TDP.
Objective To evaluate the effect of physician-nurse-pharmacist collaboration on cardiovascular disease risk factors in diabetes patients. Methods Randomized controlled trails (RCTs) on collaboration among physicians, nurses and pharmacists for reducing cardiovascular disease risk factors in diabetes patients were collected from Cochrane Central Register of Controlled Trials, Medline (Ovid SP), Embase, China Knowledge Resource Integrated Database, VIP and WanFang. We screened the retrieved studies according to the inclusion and exclusion criteria, evaluated the quality of included studies, and then performed meta-analysis with the Cochrane Collaboration’s Revman 5.3.0 software. Results Seven RCTs were included. The results of meta-analysis showed that the change in glycosylated hemoglobin A1c, systolic blood pressure, diastolic blood pressure and low density lipoprotein-cholesterol were significantly reduced in the collaboration group than in usual care group [SMD=–0.39, 95%CI (–0.56, –0.21),P<0.000 1;SMD=–0.30, 95%CI (–0.43, –0.18),P<0.000 01;SMD=–0.37, 95%CI (–0.64, –0.11),P=0.006;SMD=–0.11, 95%CI (–0.16, –0.06),P<0.000 1]. Conclusions Collaboration among physicians, nurses and pharmacists is effective for reducing cardiovascular disease risk factors in diabetes patients. But its long-term efficacy still needs to be confirmed by performing higher quality, large sample RCTs with long-term follow-up.
Objective To assess the efficacy of telbivudine in the treatment of chronic hepatitis B (CHB). Methods Randomized controlled trials (RCTs) of telbivudine therapy vs. lamivudine therapy in both Chinese and English were retrieved from seven electronic databases with a cut-off date in February 2010, including PubMed, EMbase, VIP, CBM, CNKI, and The Cochrane library. The meta-analyses and evaluation on methodology quality were performed for the included studies. Results Two RCTs as Grade-A study were included. The meta-analyses showed that telbivudine was superior to lamivudine in aspects of therapeutic response (RR=1.28, 95%CI 1.10 to 1.48, P=0.001), ALT normalization (RR=1.12, 95%CI 1.01 to 1.23, P=0.02), and PCR-negative HBV DNA or below the lower limit (RR=1.44, 95%CI 1.36 to 1.53, Plt;0.000 01), primary treatment failure (OR=0.28, 95%CI 0.18, to 0.43, Plt;0.000 01), viral breakthrough (OR=0.38, 95%CI 0.32 to 0.47, Plt;0.000 01) and viral resistance (OR=0.44, 95%CI 0.36 to 0.55, Plt;0.000 01). Conclusion Based on the current clinical evidence, telbivudine demonstrates superiority in comparison with lamivudine on all direct measures of antiviral efficacy for CHB. Because of the short follow-up duration and the small sample size of the included studies, it is expected to further discuss the long-term efficacy.
Objective To evaluate the effectiveness and safety of calcineurin inhibitor (CNI) withdrawal from target-of-rapamycin-inhibitor(TOR-I)-based immunosuppression in kidney transplant recipients. Methods We searched MEDLINE, EMbase, SCI, CBM and The Cochrane Library to screen randomized controlled trials (RCT) of calcineurin inhibitor (CNI) withdrawal from target-of-rapamycin-inhibitor-(TOR-I)-based immunosuppression in kidney transplant recipients. The search was updated in Semptember 2009. The quality of the included trials was assessed. RevMan 5.0 software was used for meta-analyses. Results A total of 14 reports from 10 RCTs were identified. Five RCTs were graded A and five graded B. The meta-analyses indicated: RR (95%CI) values of the 1, 2, 4-year acute rejection rates were 1.64 (1.19, 2.27), 1.53 (1.06, 2.22) and 1.21 (0.73, 1.98), respectively; RD (95%CI) values of 1, 2, 4-year patient survival rates were – 0.01 (– 0.02, 0.01), – 0.00 (– 0.03, 0.02) and 0.03 (– 0.01, 0.08), respectively; RD (95%CI) values of 1, 2, 4-year graft survival rates were 0.00 (– 0.02, 0.02), 0.00 (– 0.03, 0.04) and 0.07 (0.01, 0.12), respectively; and glomerular filtration rate WMD was 9.50 and 95%CI 2.96 to 16.03. Conclusion Based on the current evidence, compared to CNI, CNI withdrawal from sirolimus-based immunosuppression in kidney transplantation could be advantageous for renal function. One-year acute rejection rate and 4-year graft survival rate increase. One-year patient/graft survival and fouryear acute rejection rate remain virtually unvariable. The long-term results need further confirmation.