ObjectiveTo systematically review the efficacy and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. MethodsWe searched PubMed, EMbase, MEDLINE, The Cochrane Library (Issue 7, 2014), CBM, CNKI, VIP and WanFang Data from their inception to August 2014, to collect randomized controlled trials (RCTs) on the effectiveness and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. And then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 4 RCTs involving 3 881 patients were included. The results of meta-analysis showed that:compared with the placebo group, the flibanserin group was superior in increasing the number of satisfying sexual events (SSE) (MD=0.72, 95%CI 0.51 to 0.92, P<0.000 01), improving the eDiary desire score (MD=2.21, 95%CI 1.45 to 2.97, P<0.000 01), FSFI domain score (MD=0.29, 95%CI 0.24 to 0.35, P<0.01) and FSFI total score (MD=1.82, 95%CI 1.47 to 2.17, P<0.000 01), and decreasing the FSDS-R item 13 score (MD=-0.24, 95%CI -0.31 to -0.17, P<0.000 01) and FSDS-R total score (MD=-2.70, 95%CI -3.43 to -1.96, P<0.000 01). However, the incidence of adverse events in the flibanserin group was higher than that of the placebo group (OR=1.31, 95%CI 1.11 to 1.54, P=0.001). ConclusionThe current evidence suggests that, in premenopausal women with HSDD, flibanserin treatment is effective but may increase the incidence of adverse events.
The treatment of ocular fundus diseases is of significant issue in the clinic, but there exists large controversy on how to standardize the clinical treatment and how to evaluate the effectiveness of treatment on ocular fundus diseases. Emerging application of evidencebased medicine (EBM) provides us a rigorous and feasible pathway for the clinical treatment of ocular fundus diseases. We can improve the quality of clinical treatment research by exploring high quality randomized control trial (RCT) on the basis of patients with ocular fundus diseases in China; and by making full use of the best clinical evidences at home and abroad according to the EBM methods, which may further improve diagnosis and treatment of common ocular fundus diseases in China.
Objective We searched and reviewed medical evidence to find the guide of treatment for local advanced nasopharyngeal carcinoma. Methods Firstly, we put forward clinical questions. Secondly, we searched medical evidence from Medline (1985-2002), Embase (1984-2000), Cochrane library (2002.1) and ACP. And then we reviewed the results. The key words we used were "nasopharyngeal carcinoma, chemotherapy and radiotherapy randomized" and "meta analysis or randomized control trial". Results Through searching, we got 17 papers including 1 systematic review and 16 randomized control trials, in which there were 8 prospective randomized phase Ⅲ trials. Most of these trials concluded that combination chemo-radiotherapy were better than radiotherapy alone. We think these results were suitable for our patient’treatment decision. Conclusion To treat our patients,we choosed the method of the mutimodality of squeitial neoadjuvant chemotherapy, concurrent chemo-radiotherapy and adjuvant chemotherapy with the drug doses down-adjusted.
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 investigate the effectiveness of pretreatment with mixture of lidocaine and flurbiprofen axetil in reducing injection pain of propofol. Methods One hundred and sixty ASI I–II patients undergoing general anaesthesia were randomly allocated into four groups (40 cases in each group): the control group, the lidocaine (Lc) group, the flurbiprofen axetil (FA) group and the mixture of lidocaine and flurbiprofen axetil (hereafter termed as “mixture”) group. After the occlusion of venous drainage, patients were pretreated with 7 mL of 0.9% saline in the control group, 5 mL (50 mg) of flurbiprofen axetil and 2 mL of 0.9% saline in the FA group, 2 mL (40 mg) of 2% lidocaine and 5 mL of 0.9% saline in the Lc group, and 5 mL (50 mg) of flurbiprofen axetil and 2 mL (40 mg) of 2% lidocaine in the mixture group, respectively. The occlusion was released 2 min later and then 0.5 mg/kg propofol was injected into the vein within 5 s. During injecting propofol, the patients were asked by another anesthetist to assess and record their pain through using VSR. Results No significant differences in the demographic characteristics were found among the four groups. In comparison with the control group, the incidence rates of propofol injection pain were obviously lower in the mixture group, the FA group and the Lc group (Plt;0.05); there was a significant reduction in the incidence rate of pain in the mixture group compared with the other three groups. The median pain score was significantly lower in the mixture group and the Lc group than that in the control group. During the 24 hour follow-up after operation, neither the adverse events such as red-swelling in injection site, phlebitis or drug eruption, nor the gastrointestinal stimulating signs were found. Conclusion The mixture of flurbiprofen axetil and lidocaine is found to be more effective in reducing injection pain of propofol.
ObjectiveTo systematically evaluate the efficacy and safety of early initiation of antiretroviral therapy (ART) in asymptomatic HIV-infected, treatment-naive adults and adolescents. To assess the evidence for the optimal time to initiate ART. MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 4, 2016), CBM, CNKI, VIP and WanFang Data were searched to collect randomized controlled trials (RCTs) about early initiation and optimal time to initiate ART in asymptomatic, treatment-naive HIV-infected patients from January 1996 to April 2016. Two review authors independently assessed study eligibility, extracted data and graded methodological quality. Data extraction and methodological quality were checked by a third author who resolved differences when these arose. We meta-analysed dichotomous outcomes using the risk ratio (RR) and report the 95% confidence intervals (95% CIs) by using RevMan 5.3 software. ResultsA total of 4 RCTs involving 8 751 patients were included. The results of meta-analysis showed that initiating ART at CD4+ T-cell counts (CD4 counts) ≥350 cells/μL or 500 cells/μL, comparing to deferring initiation of ART to CD4 counts <350 cells/μL, would benefit patients more: (1) Risk of AIDS-defining illnesses which representing disease progression, reduced significantly when starting ART at higher CD4 counts (no less than 350 cells/μL) (RR=0.49, 95%CI 0.38 to 0.64, P<0.001). The reduction of risk was even more significant when initiating ART at CD4 counts of not less than 500 cells/μL (RR=0.38, 95%CI 0.24 to 0.59, P<0.001). (2) When initiating ART at CD4 counts of not less than 350 cells/μL, the risk of serious non-AIDS related events was significantly reduced by 42% (RR=0.58, 95%CI 0.40 to 0.83, P=0.003). When initiating ART at CD4 counts of not less than 500 cells/μL, according to START 2015, the risk of serious non-AIDS related events could be reduced by 39% (RR=0.61, P=0.04). (3) However, when initiating ART at CD4 counts of not less than 350 cells/μL or 500 cells/μL, comparing to deferring initiation, there were no statistically significant differences in death (RR=0.70, 95%CI 0.48 to 1.02, P=0.06) and serious adverse events (RR=0.67, 95%CI 0.38 to 1.20, P=0.18). ConclusionOur findings contribute to the evidence base for recommending initiating ART at CD4 counts of 350-500 cells/μL compared to initiating it later when CD4 counts fall below 350 cells/μL. As for patients with CD4 counts of not less than 500 cells/μL, initiation of ART is also recommended.
Objective To systematically review the efficacy and safety of CDK4/6 inhibitors in combination with endocrine therapy for HR+/HER2‒ breast cancer. Methods The PubMed, Cochrane Library, Web of Science, WanFang Data, CNKI, American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO) and San Antonio Breast Cancer Symposium (SABCS) databases were electronically searched to collect randomized controlled trials on CDK4/6 inhibitors in combination with endocrine therapy for HR+/HER2‒ breast cancer from inception to July 5, 2023. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4 software and Stata 14.0 software. Results A total of 8 studies involving 4 580 patients were included. The results of meta-analysis showed that overall survival and progression-free survival were significantly longer in the combination therapy group than those in the endocrine therapy alone group (HR=0.80, 95%CI 0.73 to 0.89, P<0.05; HR=0.54, 95%CI 0.50 to 0.59, P<0.05). The results also showed that patients in the combination therapy group also had significantly higher rates of objective remission and clinical benefit than those in the endocrine therapy group alone (RR=1.47, 95%CI 1.34 to 1.62, P<0.05; RR=1.20, 95%CI 1.11 to 1.30, P<0.05). In addition, the combination treatment group also increased the incidence of haematological toxicity such as neutropenia and leucopenia, but the differences in the incidence of nausea, diarrhoea and headache were not statistically significant between the two groups. Conclusion The combination of CDK4/6 inhibitors with endocrine therapy for HR+/HER2‒ breast cancer patients improve overall survival, progression-free survival, clinical benefit rate and objective remission rate, with significant long-term and near-term efficacy; however, this regimen increased the incidence of several adverse effects, and clinical use should be considered when considering the occurrence of serious adverse effects.
Objective To assess the effectiveness and safety of tongxinluo capsule for coronary heart disease. Methods Both the randomized controlled trials (RCTs) and quasi-RCTs of tongxinluo capsule for coronary heart disease were collected through searching on computer from the following databases, The Cochrane Library (Issue 4, 2010), PubMed (2000 to April 2010), WanFang Data (1996 to April 2010), CNKI (1994 to April 2010) and VIP (1989 to April 2010). The trials selection based on inclusion and exclusion criteria, data extraction, cross check and quality assessment were conducted by two reviewers independently, and meta-analysis was performed with RevMan 5.0 software. Results A total of 13 studies involving 1 496 participants were included. The results of meta-analyses showed that: compared with the nitrate esters group, the tongxinluo capsule group had a better curative effect on the coronary heart disease than isosorbide dinitrate (RR=0.50, 95%CI 0.36 to 0.70) and isosorbide mononitrate (RR=0.19, 95%CI 0.12 to 0.30); there was significant difference in the total curative effect between the two groups (RR=0.34, 95%CI 0.26 to 0.44, Plt;0.000 01); the tongxinluo capsule was also better in improving the ECG than isosorbide dinitrate (RR=0.55, 95%CI 0.46 to 0.66) and isosorbide mononitrate (RR=0.58, 95%CI 0.48 to 0.70); there was significant difference in the total ECG improvement between the two groups (RR=0.56, 95%CI 0.49 to 0.64, Plt;0.000 01); the tongxinluo capsule group had a lower incidence rate of adverse reaction than the nitrate esters group with a significant difference (RR=0.33, 95%CI 0.20 to 0.53, Plt;0.000 01). Conclusion The present evidence indicates that tongxinluo capsule is not inferior to isosorbide dinitrate or isosorbide mononitrate in improving the curative effect and ECG, and it has fewer adverse reactions. More well-designed and large scale multi-centered RCTs are required with longer follow-up time to confirm this conclusion.
Objective To systematically evaluate the clinical effectiveness of platelet-rich plasma (PRP) combined with grafting material for the treatment of periodontal intrabony defects. Methods The following databases such as PubMed, The Cochrane Library, EMbase, CNKI, CBM and WanFang Data were searched on computer from inception to August, 2012 to collect the relevant randomized controlled trials (RCTs) on PRP combined with grafting material versus grafting material alone for periodontal intrabony defects. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality of the included studies. RevMan 5.2 software was applied for meta-analysis. Results A total of 11 RCTs involving 342 patients were included. The pooled analysis on 7 RCTs showed that there was a significant difference in lower increase of clinical attachment loss (WMD=0.70, 95%CI 0.51 to 0.90, Plt;0.000 01) between the PRP combined with grafting material group and the grafting material alone group. But there was no significant difference in the gingival recession (WMD= −0.01, 95%CI −0.15 to 0.13, P=0.86). The pooled analysis on 9 RCTs showed that there was no significant difference in the reduction of plaque index (WMD= −0.04, 95%CI −0.09 to 0.02, P=0.20) between the two groups. Conclusion PRP combined with grafting material is superior to grafting material alone in the clinical attachment loss. But, there are no significant differences in gingival recession and plaque index. However, given the limited sample size and incomplete measure indexes of included studies, this conclusion still needs to be further proved by conducting more high-quality and large-scale RCTs.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treatingchronic obstructive pulmonary disease (COPD) in a stable stage. Methods We searched MEDLINE (1950 to July 2008), PubMed (1996 to July 2008), VIP (1989 to July 2008), WanFang (1998 to July 2008), CNKI (1979 to July 2008), and CBM (1978 to July 2008)for randomized control trials about TCM to treat stable COPD. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conducted by using RevMan 4.2.7 software. Results A total of 30 randomized controlled trials (RCTs) in the Chinese language were identified. No pooled analysis was performed because of the significant heterogeneity among the included trials. (1) For TCM alone versus blank therapy or placebo: 3 RCTs reported the clinical effective rate and only 1 indicated TCM was more effective; 5 RCTs reported forced expiratory volume in one second (FEV1)% after treatment and 2 indicated TCM alone as more effective in improving lung function; 4 RCTs reported quality of life after therapy and 2 indicated TCM alone was more effective in improving quality of life after therapy. (2) For integrated tradtional and western medicine versus western medicine alone: 11 RCTs included the clinical effective rate, 3 RCTs showed that integrated traditional and western medicine was more effective. Of 8 RCTs reporting FEV1%, 2 RCTs suggested that integrated traditional and western medicine was more effective. There were 3 RCTs studying 6 minute walking distance and 4 RCTs about quality of life, which also showed that integrated traditional and western medicine was more effective. No obvious adverse reaction to TCM was reported.Conclusions The current evidence shows TCM tends to relieve the symptoms and improve quality of life for patients with stable COPD without obvious adverse reaction. Due to the low methodological quality of trials included, more RCTsof high quality and large scale are required.