【摘要】 目的 评价舒林酸治疗结直肠息肉的有效性和安全性。 方法 计算机检索PubMed、Cochrane Iibrary、Embase、SCI、CNKI、万方、维普、CBM数据库。按Cochrane系统评价的方法评价纳入研究质量，并进行Meta分析。 结果 共纳入7个随机对照试验（RCT），共235例患者。Meta分析结果显示舒林酸治疗腺瘤性息肉病（FAP）在有效率、息肉消失率方面与安慰剂比较，差异无统计学意义（Pgt;0.05）；治疗散发性结肠腺瘤性息肉病（SCAP）在有效率、息肉消失率、腺瘤直径变化方面与安慰剂比较，差异有统计学意义（Plt;0.05）；舒林酸的不良反应多为消化道症状，与安慰剂比较差异有统计学意义（Plt;0.05）。 结论 系统评价结果显示舒林酸对于家族性FAP的疗效尚不确切，而对SCAP有一定的疗效。【关键词】结直肠息肉；舒林酸；有效性；不良反应；系统评价【Abstract】 Objective To assess the efficacy and safety of sulindac on colorectal polyps. Methods The literatures were searched from several databases including PubMed,Cochrane Iibrary,SCI,CNKI,Wanfang,VIP,and CBM. The quality of the researches was evaluated according to Cochrane systematic reviews, and the Meta analysis was performed. Results Seven RCT were enrolled with a total of 235 patients. Meta analysis showed that there was no significant difference in the effective rate and polyps disappearance rate of FAP between the two groups (Pgt;0.05). There were significant differences in the effective rate, polyps disappearance rate and size of adenomas between the two groups (Plt;0.05); the most common adverse event was the symptoms of digestive tract which differed much from that in the placebo group (Plt;0.05). Conclusion The therapeutic effect of sulindac on FAP is not sure, but it is effective on SCAP.
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 assess the efficacy and safety of mesalazine versus sulfasalazine in the treatment of ulcerative colitis.Methods The literatures were searched from PubMed (1966 to January 2010), the Cochrane Library (1966 to January 2010), EMbase (1974 to January 2010), CNKI (1994 to January 2010), VIP (1989 to January 2010), and CBM (1978 to January 2010). The data were extracted, the quality of studies was evaluated according to The Cochrane Handbook, and meta-analyses were performed using RevMan 5.0 software. Results Sixteen RCTs involving 1 333 patients were included in this study. The results of meta-analyses showed that the total effective rate of the mesalazine group was significantly higher than that of the sulfasalazine group (RR=1.10, 95%CI 1.04 to 1.17, Plt;0.05), and significant differences were noted in the total remission rate (RR=1.82, 95%CI 1.14 to 2.91, Plt;0.05), while there was no significant difference in the relapse rate between the two groups (RR=0.86, 95%CI 0.57 to 1.29, Pgt;0.05). Twelve RCTs reported adverse effects and meta-analyses showed that the incidence of adverse effects was significantly lower in the mesalazine group than in the sulfasalazine group (RR=0.56, 95%CI 0.42 to 0.73, Plt;0.05). Conclusion Analyses show that mesalazine is much more effective and safe in the management of ulcerative colitis than sulfasalazine. However, there is a moderate risk of bias due to methodological quality problems in all 16 included RCTs, so more strictly-designed multi-centered randomized controlled trials with high quality in large-scale are needed to confirm this result.
Objective To review the efficacy and safety of Kushenin combined with Adefovir Dipivoxil for Chronic Hepatitis B (CHB). Method Randomized controlled trails of Kushenin combined with Adefovir Dipivoxil for CHB were gathered from PubMed, CBMdisc (1978 to 2009), and CSJD (1989 to 2009), while other relative researches were searched manually; every research was evaluated, and then analyzed with RevMan 5.0.0 software. Result Ten randomized controlled trials were included; among total 855 patients, 436 were in trial group and the other 419 were in control group. As the Meta-analysis showed, the therapeutic effect of kushenin combined with Adefovir Dipivoxil was better than that of Adefovir Dipivoxil in aspects of improving the negative rate of serum ALT (RR=1.28, 95%CI 1.17 to 1.40), the negative rate of serum HBV-DNA (RR=1.27, 95%CI 1.13 to 1.42), the negative rate of serum HBeAg (RR=1.80, 95%CI 1.32 to 2.44), and the conversion rate of HBeAg and anti-HBe (RR2.06, 95%CI 1.43 to 2.95). Conclusion Kushenin combined with Adefovir Dipivoxil in treating CHB can improve the conversion rate of HBeAg and anti-HBe and further take better therapeutic effect.
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.
Objective To evaluate the efficacy and safety of low-dose versus standard-dose cyclosporine immunosuppressive therapy in kidney transplant recipients. Methods We searched MEDLINE, EMbase, SCI, CBM and The Cochrane Library from the establishment to December 2009 to screen randomized controlled trials (RCTs) of low-dose versus standard-dose cyclosporine immunosuppressive therapy in kidney transplant recipients. Quality assessment and meta-analyses were performed for the included studies. Results A total of 6 RCTs involving 1551 patients were identified, among which 4 RCTs were graded A and two were graded B. The meta-analyses indicated that there were no significant differences between the two groups at the end of 6-month and 12-month follow-up in the acute rejection rate at a RR 1.07, 95%CI 0.69 to 1.65 and a RR 1.06, 95%CI 0.71 to 1.57, respectively. There were no significant differences between the two groups at the end of 6-month and 12-month follow-up in the patients’ death rate at a RR 0.64, 95%CI 0.20 to 2.03 and a RR 0.61, 95%CI 0.30 to 1.24, respectively. There were no significant differences between the two groups in renal function and safety. Conclusion Based on the current evidence, compared with standard-dose CsA, low-dose CsA has the same effect and safety for the short-term results, but the long-term results need to be further studied.
Objective To assess the effectiveness of exemestane in the treatment of postmenopausal women with breast cancer. Methods We searched The Cochrane Library, PubMed, CBMdisc, and CNKI to identify randomized controlled trials (RCTs) that met the inclusion and exclusion criteria. Two reviewers extracted the data and evaluated the quality of included trials, respectively. Meta-analysis was performed using RevMan 5.0 software. Results A total of 12 RCTs involving 6 166 participants were included, and the results of meta-analyses showed that: (1) When used in neoadjuvant endocrine therapy after operation, exemestane was more effective in progression-free survival than tamoxifen; (2) When used in rescue therapy, exemestane was more effective in objective response than tamoxifen, but not more effective than letrozole or anastrozole; (3) When used in new neoadjuvant endocrine therapy before operation, exemestane was not more effective than letrozole, and there was too little research about it. Conclusions The current evidence shows that exemestane has certain short-term therapeutic effect, but its long-term therapeutic effect is unknown. More high-quality clinical trials are expected for further study.
Objective To assess the efficacy and safety of glimepiride for type 2 diabetes mellitus (T2DM). Methods We searched the literature from PubMed, Ovid (All EBM Reviews), CNKI, Wanfang, VIP, CBM and other databases. Evaluating the quality of the study according to Cochrane systematic reviews, Meta-analysis was performed for the results of homogeneous studies by The Cochrane Collaboration’s software RevMan 5.0, and the heterogeneous data conducted a descriptive qualitative analysis. Results Six RCTs included in the analysis and Meta-analysis was not performed due to the insufficient data (for the median or standard deviation). Six RCTs are multi-center, randomized, double-blind, placebo-controlled trials. The results showed that glimepiride groups to reduce glycosylated hemoglobin, lower fasting and postprandial blood glucose, postprandial plasma insulin enhance the efficacy were statistically significant differences (Plt;0.05) compared to placebo groups. Four studies informed the impact of fasting plasma insulin (FI) and 3 studies showed that the glimepiride groups improving the fasting plasma insulin (FI) were statistically significant differences (Plt;0.05), but 1 study showed the two groups had no significant difference (Pgt;0.05). All studies showed minor adverse reactions of glimepiride. Conclusion Glimepiride can reduce the glycosylated hemoglobin, lower the fasting and postprandial blood glucose, improve fasting and postprandial plasma insulin for type 2 diabetes patients, and have minor adverse reactions. In a word, glimepiride is an effective and security sulfonylureas drug.
Objective To assess the effectiveness and safety of Tongxinluo Capsule in the treatment of vertebrobasilar artery insufficiency. Methods The Cochrane Library, MEDLINE, VIP and CNKI were searched. Two authors independently collected data, including randomized controlled trials that met the inclusion criteria. They evaluated the quality of these trials and performed meta-analysis using The Cochrane Collaboration’s RevMan 5.0. Results Eleven studies involving 1157 participants were included. All the included studies were inadequate at reporting randomization, concealment of allocation and blinding. Meta-analysis based on the included studies showed that Tongxinluo Capsule with Danshen was better than Danshen alone in vertebrobasilar artery insufficiency (RR= 1.35, 95%CI 1.24 to 1.48) and blood flow velocity of vertebrobasilar artery (WMD=3.60, 95%CI 2.44 to 4.77 and WMD=3.46, 95%CI 1.89 to 5.04). Tongxinluo Capsule with simple basic therapy was better than simple basic therapy alone in vertebrobasilar artery insufficiency (RR=1.21, 95%CI 1.11 to 1.31) and blood flow velocity of vertebrobasilar artery (WMD=3.85, 95%CI 2.19 to 5.51). Conclusion Tongxinluo Capsule is an effective and safe drug for vertebrobasilar artery insufficiency. However, due to the limited quantity and quality of the included studies, we can not draw a firm conclusion about the effectiveness of Tongxinluo Capsule compared to the simple basic therapy or Danshen. The results suggest that further and larger-scale trials using Tongxinluo Capsule for vertebrobasilar artery insufficiency are needed.