直接证据来自直接比较我们关注的干预措施用于我们关注的患者人群，并测量患者重要结局的研究。间接证据可由以下4种方式之一产生。第一，患者可能与我们关注的患者不同（适用性一词常用于这类间接性）。第二，所检验的干预措施可能与我们关注的干预措施不同。有关患者和干预措施间接性的决策取决于对生物或社会因素差异是否大到可能使效应尺度出现预期的较大差异的考虑。第三，结果可能有别于最初设定的结局指标——如替代结果本身不重要，但测量之是基于替代结果的变化反映患者重要结局变化这一假设。第四类间接性在概念上与前三类不同，发生于临床医生必须在未经直接比较的两种干预措施间做出选择时。这种情况下比较治疗方案需要特定的统计方法，并根据患者人群、联合干预措施、结局测量指标及备选干预措施试验方法的差异程度，将证据级别降低1或2级。
Objective To evaluate the effectiveness and safety of traditional Chinese medicine therapies (TCMT) for prostatitis. Methods We searched Cochrane Controlled Trials Register (CCTR), China EBM/Cochrane center database (CEBM/CCD), PubMed, Chinese Biomedical Literature Database (CBM), Papers on Academic Conference of China (PACC), Chinese Dissertation Database Full-Text (CDDBFT), and Evidence-based Traditional Chinese Medicine Database (EBTCMD). All searches were updated on January 15, 2007. We also performed a manual search of the RCTs of TCMT for prostatitis among periodicals related to TCM, researched the related studies by correlative websites, such as “Baidu” and “Google”, gray literatures, and studies included in the references of eligible studies. At least two reviewers independently screened the studies for eligibility, evaluated the quality, and extracted the data from the eligible literatures, with a cross-check to confirm accuracy. Different views were settled by a third party. We evaluated the quality of eligible studies with the revised Jadad’s scale, and extracted valid data using data tables. Meta-analyses were performed for homogeneous studies using RevMan 4.3 software. If heterogeneity existed among the studies, descriptive analysis was conducted. The potential publication-bias was analyzed by funnel plot analysis. Results A total of 52 randomized clinical trials of TCMT for prostatitis (n=5 209) among 1 282 original studies were identified. The methodological quality ranked high in 9 RCTs (the revised scale were ≥ 4 scores), and 22 RCTS reported the methods of random sequence production. The analysis indicated some TCMT were more effective than the treatments in the controls in relieving the proatatitis patients’ pain or discomfort, paruria, impact of symptoms and NIH-chronic prostatitis symptom index (NIH-CPSI), improving the EPS-WBC and urine flow rate etc. Of the trials, 29 randomized clinical trials of TCMT for prostatitis that studied safety (n=2 502) were identified. The methodological quality ranked high in 8 RCTs (the revised scale were ≥ 4 scores), and 18 RCTs reported the method of random sequence production. Analysis indicated some TCMT may cause lower digestive tract symptoms when compared to the control therapies and some Chinese herbs formulas- may cause sexual disfunction. Conclusion Some TCMT may be more effective than the controls in relieving the patients’ pain or discomfort, paruria, impact of symptoms and NIH-CPSI, improving the prostatic tenderness with DRE, improving the EPS-WBC, lecithin lipophore, and urine flow rate etc. However, some TCMT of the trials included may cause lower digestive tract symptoms when compared to the controls, and some Chinese herbs formulas cause sexual disfunction. Because of the generally low methodological quality and the variations of the herbs used, the overall effects cannot be pooled for analysis. More evidence is needed to support this finding.
Objective To evaluate the effectiveness of GnRH antagonist on vitro fertilization-embryo transfer (IVF-ET). Methods We searched CBMdisc (1979 to 2010), Wanfang (1994 to 2010), CNKI (1994 to 2010), VIP (1989 to 2010), PubMed (1997 to 2010), PML (1997 to 2010), FMJS (2000-2010), and 9 related journals to identify randomized controlled trials (RCTs) on the comparison between GnRH antagonist (GnRHA) and GnRH agonist (GnRHa). The quality of included trials was critically appraised. RevMan 4.2.7 software was used for statistical analysis. Results Six published RCTs involving 1 208 participants were included. Compared with the GnRHa group, stimulation duration in the GnRHA group was lower (WMD= –1.07, 95%CI –1.38 to –0.76), dose of gonadotrophins (Gns) in the GnRHA group was slightly lower (WMD= –0.49, 95%CI –1.63 to 0.66), endometrial thickness at the time of HCG administration was no significant difference in the two groups (WMD= –0.09, 95%CI –0.42 to 0.24), number of oocytes retrieved in the GnRHA group was lower (WMD= –1.80, 95%CI –2.48 to –1.12), OHSS rate in the GnRHA group was slightly lower (Peto OR= 0.77, 95%CI 0.35 to 1.72), pregnancy rate in the GnRHA group was slightly lower (Peto OR= 0.83, 95%CI 0.65 to 1.05), miscarraige rate as no significant difference in the two groups (Peto OR= 1.49, 95%CI 0.79 to 2.82). Conclusions Compared with GnRHa, GnRHA requires shorter stimulation duration and less Gn, less affected the pregnancy rate, and reduces the incidence of OHSS. The use of GnRHA in clinical practice is relatively flexible with good acceptability. GnRHA for the superovulation IVF-ET offers an alternative treatment. The above conclusion still needs more well-designed, multi-center, and large-scale RCTs to confirm and update.
Backgroud Chronic hepatitis is the major infectious disease of liver. There is no effective drug for it up to now. Clinical trials have showed that glycyrrhizin have potentional effective for chronic hepatitis. Objective To evaluate the effectiveness, safety and economics of glycyrrhizin for chronic hepatitis B and C. Search strategy The search terms include glycyrrhizin and its products’ name, chronic hepatitis and chronic carrier status. The thais registers of the Cochrane Hepato-Biliary Group, the Cochrane Complementary Medicine Field, and the central database of The Cochrane Library as well as MEDLINE, EMBASE and Chinese Biomedical CD Database were searched from their date of inception onward. And the free Internet search was operated to find ongoing and unpublished researches. Twenty Chinese medical journals and relevant academic conference proceedings have been searched by manual method. The reference lists of identified documents were checked as the complementary search. Inclusion criteria All randomized trials that tested glycryyhizin for chronic hepatitis B virus or hepatitis C virus infection were included in this review. Method of the review According to the principle of Cochrane systematic review, selection of thai for inclusion, assessment of methodological quality, data extraction and data syntheses were conducted by two reviewers.
Background Hepatitis B is one of the major infectious diseases of mankind, and up to now, there is no effective way to handle it. Recent clinical trials have shown the potential advantages of Kurorinone an extract of Chinese herb, in treament of chronic HBV infection. Objectives Systermically review the safety and efficacy of Kurorinone in treatment of chronic HBV infection. Search strategy With the searching terms including Kurorinone, its products’ name, hepatitis B and chronic carrier status, the trials registers of the Cochrane Hepato- Biliary Group, the Cochrane Complementary Medicine Field, and the central database of the Cochrane Library as well as MEDILINE, EMBASE and Chinese Biomedical CD Database were searched from their date of inception onward. 20 Chinese medical journals and relevant academic conference proceedings have been searched by hand. The reference lists of identified documents were checked as the complementary search. Inclusion Criteria All RCTs that tested Kurorinone for chronic HBV infection were included in this review. Method of the review According the demand of Cochrane systematic review, selection of trial for inclusion, assessment of methodological quality, data extraction and data syntheses would be conducted for each included trial.
Objective To evaluate the effectiveness of TCu380AIUD comparing with other common IUDs. Methods CBMDISC (1979 to 2005), Wanfang (1994 to 2005), CNKI (1974 to 2005), CMCC (1979 to 2005), CMAC (1994 to 2005), EMbase (1974 to 2004), MEDLINE (1974 to 2005), WHO/RHL (2004 to 2005), The Cochrane Library (Issue 4, 2004), SCI (1985 to 2005), POPLINE (1966 to 2003) and 9 relevant journals were searched for randomized controlled trials (RCTs) comparing TCu380AIUD with other common IUDs. The quality of included trials was critically appraised. RevMan4.2.7 software was used for statistical analysis. Results Fifteen published studies involving 20 417 participants were included. The results of meta-analyses were expressed with OR (cumulative expulsion rate, cumulative pregnancy rate, cumulative rate of removing for medical reasons) and 95% CI. Compared with TCu380A, TCu220C resulted in lower cumulative expulsion rate at 0.5 and 1 year of follow-up [OR 0.36 (0.18 to 0.70); 0.44 (0.31 to 0.62), respectively], higher cumulative pregnancy rate at ten years of follow-up [1.22 (1.04 to 1.43)], lower cumulative rate of removing for medical reasons at 0.5 year of follow-up [0.59 (0.36 to 0.97)]; MLCu375 resulted in higher cumulative expulsion rate at 1 year of follow-up [2.17 (1.29 to 3.67)], higher cumulative pregnancy rate at 1 and 2 years of follow-up [1.72 (1.18 to 2.50); 1.28 (1.02 to 1.60)]; UCD300 resulted in lower cumulative expulsion rate at five years of follow-up [0.38 (0.27 to 0.56)]; Medicated Gamma 380IUD resulted in lower cumulative rate of removing for medical reasons at 1 year of follow-up [0.31 (0.14 to 0.70)]. Conclusions Compared with TCu380A which is considered as a standard of IUDs, the performance of TCu220C is inferior in contraception, but TCu220C is also a good IUD in performance; The overall clinical performance of MLCu375IUD was as good as that of TCu380A; UCD300 is of the characteristic of lower cumulative expulsion rate; Medicated Gamma 380IUD can decrease side effects effectively. However, larger multi-center randomized comparative trials with longer follow-up periods are needed to confirm the conclusion
Objective To assess the efficacy of lamivudine in patients with HBeAg positive chronic hepatitis B.Methods MEDLINE, SCI, Current Content Connect, The Cochrane Library, and Chinese Biomedical Database were searched from the beginning to September 2005, and the references of eligible studies were manually screened. R.andomized controlled trials comparing lamivudine with non-antiviral interventions （ placebo, no treatment and standard care ） in patients with chronic hepatitis B were eligible for inclusion. Two investigators independently assessed the quality and extracted the data. Heterogeneity was examined by Chi-square test. Fixed and random effect meta-analysis were used to pool the data. Subgroup analyses were used in treatment course. Results Eleven R.CTs were included （ n = 1 237 ）. All reported the effect of lamivudine （100 mg/d） , and one of them included lamivudine （25 mg/d）. The treatment duration of 52 weeks and less than 26 weeks were reported in eight and three RCTs, respectively. Six RCTs adequately applied randomization, while other five RCTs were not reported in detail. Four RCTs adequately enforced allocation concealment, five RCTs enforced blinding bitterly. The others were not reported in detail. It was found by meta-analysis that, compared with the control, lamivudine （100 mg/d, 52 W） could significantly clear HBeAg [42.6% vs. 13% , RR 3.20, 95% CI （2.33, 4. 38）] and clearHBVDNA [71.78% vs. 20, 36%, RR3.42, 95%CI （2.80,4.19）], normalize ALT [65% vs. 34.9%, RR1.91, 95%CI （1.64,2.21）], achieve HBeAgseroconversion [16.1% vs. 7.29% , RR2.12, 95%CI （1.24,3.80） ] and histology response [57. 9% vs. 26.2%, RR 2. 17, 95% CI （ 1.67,2.81 ） ] ; Lanfivudine （100 mg/ d, 12 W） could effectively clear HBV DNA [ 50.7% vs 3.92% , RR 8.68, 95% CI （1.72,43.74 ） ] , but was not effective in loss of HBeAg, HBeAg seroconversion and normalization of ALT, Lamivudine （25 mg/d） could effectively clear HBV DNA [97.7% vs. 22.2% , RR 4.41, 95% CI （2.86,6.79） ] and improve histology response [59.3% vs. 30% , RR1.98, 95% CI （1.31,2.99 ） ], but was not effective in HBeAg seroconversion. Conclusions Lamivudine （100 mg/ d） is effective in clearing HBV DNA and HBeAg, normalizing ALT and achieving HBeAg seroconversion.
Objective To assess the effectiveness and safety of nine lipid-lowing agents in the national essential drug list (2000) and provide evidence for the adjustment and selection of essential drugs. Methods Based on principles of health technology assessment (HTA) and evidence-based medicine, we searched for all published clinical studies about these drugs from the following databases: MEDLINE (1966-2002.8), The Cochrane Library, EMBASE (1974-2002), CBMdisk (1979-2002.8) and VIP (1989-2002.8), the database of National Center for Adverse Drug Reaction(ADR) Monitoring of China and the database of WHO Uppsala drug monitoring center. Included studies were appraised, analyzed and compared for the reduction of triglyceride (TC) or low density lipoprotein (LDL-C), the prevention for the coronary events and the incidence of ADR. Results The results from comparative trials for lipid-lowing agents showed that the equivalent dose of statins for 25% reduction of LDL-C was atorvastatin 10 mg/d, simvastatin 20 mg/d, pravastatin 40mg/d, lovastatin 40 mg/d, cerivastatin 0.3 mg/d and fluvastatin 80 mg/d. It was difficult to compare fenofibrate with gemfibrozil, acipimox with statins or fibrates based on available data. The study on the primary and secondary prevention of cardiovascular events showed that pravastatin and lovastatin were effective in primary prevention, and long-term use could reduce the incidence of cardiovascular disease.Gemfibrozil could reduce the mortality from coronary heart disease (CHD) but the overall mortality was not changed. Pravastatin, simvastatin, atorvastatin, fluvastatin, gemfibrozil and fenofibrate had a confirmed effect in secondary prevention. Data from large-scale clinical trials and the reports from ADR monitoring center of England, America, Canada and Australia suggested that the statins which had rare ADR were safe and tolerated. Rhabdomyolysis was rare but had a serious adverse reaction associated with statins. The rate of fatal rhabdomyolysis related to cerivastatin was the highest among 6 statins. The safety of simvastatin, lovastatin and atorvastatin was lower than cerivastatin but higher than simvastatin and atorvastatin. The number of ADR reports of fenofibrate was fewer than that of gemfibrozil. Conclusions At present, the best evidence focused on pravastatin, simvastatin and lovastatin are widely used and have a confirmed safety and efficacy. Atorvastatin, fluvastatin and fenofibrate still need more data to confirm their effects on coronary heart disease prevention. The drugs which were shown to be inferior or insufficient evidence are cerivastatin, gemfibrozil and acipimox.
【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.