ObjectivesTo systematically review the efficacy and safety of autologous bone marrow cells therapy for patients with diabetic foot. GRADE system was used to evaluate the evidence quality of outcomes.MethodsWe searched databases including PubMed, EMbase, The Cochrane Library, CBM, WanFang Data and CNKI for randomized controlled trials (RCTs) about bone marrow cell transplantation in patients with diabetic foot from inception to February 28th 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed using RevMan 5.3 software. The evidence quality was evaluated by using GRADE profiler 3.6 software.ResultsFour RCTs were included. Meta-analysis showed that the bone marrow cell transplantation could decrease the rate of amputation (RR=0.08, 95%CI 0.00 to 1.32, P=0.08) and rest pain score (MD=–1.89, 95%CI –2.24 to –1.55, P<0.000 01), increase the rate of ameliorate ulcer healing (RR=2.01, 95%CI 1.45 to 2.79,P<0.000 1) and the quantity of new collateral vessels (MD=1.33, 95%CI 0.60 to 2.05,P<0.000 3). Besides, bone marrow cell transplantation could improve ankle-brachial index (MD=0.16, 95%CI 0.10 to 0.22,P<0.000 01) and transcutaneous arterial oxygen tension (MD=18.81, 95%CI 16.06 to 21.57,P<0.000 01). No adverse event was reported for all included studies. The qualities of evidence for all outcomes were rated as "low" to "very low".ConclusionBased on the current evidence, autologous bone marrow cells transplantation therapy has a certain effect and it is safe for patients with diabetic foot. However, due to the limited quantity and quality of included studies, the above conclusions are still needed more multicenter clinical trials with large sample size to confirm.
Objective To systematically review the effect of different nutrient interventions on the physical function of elderly people with frailty through network meta-analysis. Methods The PubMed, Cochrane Library, EMbase and Web of Science were electronically searched to collect randomized controlled trials of different nutrient interventions on physical function of the elderly with frailty, from database inception to June 30, 2022. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Network meta-analysis was then performed using ADDIS 1.16.8, GeMTC 14.3, and Stata 15.0 software. Results A total of 13 studies involving 1 144 patients were included. There was no statistically significant difference in handgrip strength, time up to go test, gait speed, and short physical performance battery (SPPB) among different nutrient interventions. Significant differences were not found in vitamin D+ whey protein (VDWP) vs. placebo and Leu vs. placebo in handgrip strength, or VDWP vs. placebo in SPPB. The probability ranking diagram showed that the most effective of handgrip strength, time up to go test, gait speed, and SPPB were milk protein concentrate (MPC80), L-carnitime (L-Car), leucine (Leu), and MPC80, respectively. Conclusion The current evidence suggests that nutritional intervention did not significantly improve physical function in the frail elderly. MPC80, Leu, L-Car, and VDVEWP may play a role in improving the physical function of frail elderly people. Nutritional support programs that increase the above nutrients, combined with exercise training may become a better way to improve the physical function of frail elderly.
ObjectiveTo systematically review the efficacy and safety of roflumilast for patients with chronic obstructive pulmonary disease (COPD). MethodsWe searched PubMed, Web of Science, SpringerLink, Ovid, ClinicalTrials.gov, CBM, WanFang Data and CJFD to collect randomized control trials (RCTs) of roflumilast for COPD patients from inception to December 2014. Two reviewers independently screened literatures according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed by using RevMan 5.3 software. ResultsA total of 10 RCTs were included. The results of meta-analysis showed that. Roflumilast could significantly improve trough FEV1 (WMD=54.82, 95%CI 46.36 to 63.28, P<0.000 01), and other spirometric parameters; Roflumilast could reduce the exacerbation rate (RR=0.84, 95%CI 0.75 to 0.94, P<0.000 01), and improve TDI score (WMD=0.23, 95%CI 0.04 to 0.42, P=0.002), but did not improve SGRQ score (WMD=-0.48, 95%CI -2.39 to 1.43, P=0.63); Roflumilast could increase some adverse events including diarrhea, headache, nausea, and weight loss. ConclusionCurrent evidence shows roflumilast could significantly improve pulmonary function, reduce the mean exacerbation rate in COPD patients, and has good safety.
ObjectivesTo systematically review the efficacy and safety of ivabradine (IVA) for patients with chronic heart failure (CHF).MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of IVA for patients with CHF from inception to April, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed using Stata 12.0 software.ResultsA total of 22 RCTs involving 2 010 patients were included. The results of meta-analysis showed that, compared with control group, IVA group could decrease heart rate (HR) (WMD=−10.58, 95%CI −12.47 to −8.69, P=0.000) and N-terminal probrain natriuretic peptide (NT-proBNP) (WMD=−457.87, 95%CI −842.63 to −73.11, P=0.020). IVA group was superior in 6 minutes’ walk distance (6MWD) (WMD=40.49, 95%CI 27.83 to 53.15, P=0.000), left ventricular ejection fraction (LVEF) (WMD=5.11, 95%CI 3.74 to 6.48, P=0.000), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left ventricular end-diastolic dimension (LVEDd), left ventricular end-systolic dimension (LVESd) and incidence of endpoint events with significant difference. However, the total effective rate, the incidence of adverse reactions and blood pressures were similar between two groups.ConclusionCurrent evidence shows that IVA could significantly reduce HR, improve cardiac function and exercise tolerance in CHF patients with no significant increase of adverse events. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
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.
ObjectiveTo systematically review the efficacy and safety of Heluo Shugan capsule in the treatment of hepatitis B fibrosis. MethodWe searched PubMed, The Cochrane Library (Issue 8, 2015), CBM, CNKI, VIP and WanFang Data from their inception to August 2015, to collect randomized controlled trials (RCTs) on Heluo Shugan capsule for hepatitis B fibrosis. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. ResultsA total of 15 RCTs involving 1 840 patients were included. The results of meta-analysis showed that: (1) As for reduced level of serum hyaluronic acid (HA), Heluo Shugan capsule was superior to placebo (MD=82.31, 95%CI 37.44 to 127.19, P=0.000 3), but worse than Fuzheng Huayu capsule (MD=-137.45, 95% CI-196.29 to-78.62, P < 0.000 01), Fufang Biejia Ruangan tablet (MD=-51.19, 95% CI-67.58 to-34.81, P < 0.000 01) and Anti-fibrosis decoction (MD=-82.13, 95% CI-102.37 to-61.88, P < 0.000 01). (2) As for reduced level of serum laminin (LN), Heluo Shugan capsule was superior to placebo (MD=36.83, 95% CI 11.84 to 61.82, P=0.004), but worse than Fufang Biejia Ruangan tablet (MD=-36.00, 95% CI-64.29 to-7.71, P=0.01), Ganfujian capsule (MD=-22.14, 95% CI-37.28 to-7.00, P=0.004) and Anti-fibrosis decoction (MD=-38.64, 95% CI-75.00 to-2.29, P=0.04). (3) As for reduced level of serum procollagen type III peptide (PCIII), Heluo Shugan capsule was superior to placebo (MD=47.17, 95% CI 32.68 to 61.66, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-4.80, 95% CI-9.08 to-0.51, P=0.03), Dahuang Zhechong pills (MD=-53.77, 95% CI-105.01 to-2.53, P=0.04), Ganfujian capsule (MD=-46.82, 95% CI-66.30 to-27.34, P < 0.000 01) and Anti-fibrosis decoction (MD=-28.68, 95% CI-55.59 to-1.77, P=0.04). (4) As for reduced level of serum type-IV-collagen (IV-C), Heluo Shugan capsule was superior to placebo (MD=72.77, 95% CI 47.65 to 97.89, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-34.69, 95% CI-56.65 to-12.73, P=0.002), Dahuang Zhechong pills (MD=-21.26, 95%CI-38.79 to-3.73, P=0.02), Fufang Biejia Ruangan tablet (MD=-69.04, 95%CI-124.38 to-13.69, P=0.01), Ganfujian capsule (MD=-19.84, 95% CI-37.41 to-2.27, P=0.03) and Anti-fibrosis decoction (MD=-37.98, 95% CI-72.99 to-2.96, P=0.03). ConclusionCurrent evidence shows that, Heluo Shugan capsule was superior to placebo, but worse than Fufang Biejia Ruangan tablet, Fuzheng Huayu capsule, Dahuang Zhechong pills, Ganfujian capsule and Anti-fibrosis decoction in reducing the level of serum hepatic fibrosis. Due to the limited quantity and quality of included studies, more high-quality, large-scale RCTs are need to verify the above conclusion.
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.
ObjectiveTo evaluate the nursing health education for elderly patients with restoration of complete denture by meta-analysis.MethodsWe searched the Joanna Briggs Institute Library, The Cochrane Library, PubMed, CBM, CNKI and WanFang Data from inception to March 2016 to collect RCTs about nursing health education for elderly patients with restoration of complete denture. Two researchers independently screened literatures, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed by RevMan 5.2 software.ResultsThirteen RCTs including 1 086 elderly patients who underwent restoration of complete denture were included, involving 575 cases in nursing health education group and 511 in normal nursing group. The results of meta-analysis showed that: the total effective rate (RR=1.26, 95%CI 1.12 to 1.41, P<0.000 1), the degree of mastering related knowledge (RR=1.30, 95%CI 1.16 to 1.45, P<0.000 01) and satisfaction of complete denture (voice: MD=0.21, 95%CI 0.09 to 0.32, P=0.000 4; retention: MD=0.18, 95%CI 0.06 to 0.30, P=0.003; comfort: MD=0.43, 95%CI 0.22 to 0.63, P<0.000 1) in health education group were superior to the control group.ConclusionNursing health education is effective for elderly patients with restoration of complete denture. Due to the limited quantity and quality of include studies, the above conclusions are still needed to be verified by more studies.
Objective To compare the effects of operative versus nonoperative treatment for displaced intra-articular calcaneal fractures. Methods All randomized controlled trials (RCTs) of operative versus nonoperative treatment for displaced intra-articular calcaneal fractures were identified. Quality assessment and data extraction were performed by two reviewers independently. Results Four published trials involving 530 patients were included. All studies compared operative with nonoperative treatment. It was clear that operative treatment was superior to nonoperative treatment in terms of helping patients back to work, reducing problems wearing shoes, expanding the range of motion of subtalar joint, and improving the recovery of Bohler’s angle. As for foot pain, there was no difference between the two methods. Because the outcome measures varied across the trials, a meta-analysis could not be performed. Conclusions Both operative and nonoperative treatments produce comparable long-term outcomes in the treatment of displaced intra-articular calcaneal fractures. Because of the poor reporting of outcomes, it is not possible to determine if there is any significant difference in outcome measures apart from those listed above. More trials with high methodological quality are needed.
Objective To evaluate the effectiveness and safety of total enteral nutrition (TEN) versus total parenteral nutrition (TPN) in patients with severe acute pancreatitis (SAP). Methods The databases such as Pubmed (1996 to June 2011), EMbase (1984 to June 2011), Cochrane Central Register of Controlled Trials of The Cochrane Library (Issue 6, 2011) and CBM (1978 to June 2011) were electronically searched, and the relevant references of the included papers were also manually searched. Two reviewers independently screened the trials according to inclusion and exclusion criteria, extracted the data, and assessed the methodology quality. Meta-analyses were performed using the Cochrane Collaboration’s RevMan 5.1 software. Results Seven randomized controlled trials (RCTs) involving 379 patients with SAP were included. The results of meta-analyses showed that compared with TPN, TEN could significantly reduce the risk of mortality (RR=0.33, 95%CI 0.20 to 0.55, Plt;0.000 1), pancreatitis-related infections (RR=0.35, 95%CI 0.25 to 0.50, Plt;0.000 01), required rate of surgical intervention (RR=0.43, 95%CI 0.23 to 0.82, P=0.01), and incidence of multiple organ failure (MOF) (RR=0.28, 95%CI 0.17 to 0.46, Plt;0.000 01). There was no significant difference in the nutrition strategies associated complications between TPN and TEN (RR=1.16, 95%CI 0.42 to 3.22, P=0.78). Conclusion Meta-analyses show that compared with TPN, TEN can reduce the risk of mortality, pancreatitis-related infections, required rate of surgical intervention, and incidence of MOF; and it will not increase the nutrition strategies associated complications. Consequently, TEN should be considered a better choice for SAP patients as early as possible.