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find Keyword "Randomized clinical trial" 4 results
  • Autologous Transplantation of Stem Cells for Diabetic Peripheral Neuropathy: A Systematic Review

    Objective To systematically review the effectiveness and safety of autologous implantation of stem cells for diabetic peripheral neuropathy (DPN). Methods Randomized controlled trials on relevant studies were retrieved in databases including CBM (1978-2011.6), CNKI (1979-2011.6), MEDLINE (1950-2011.6), PubMed (1950-2011.6), EMbase (1970-2011.6) and The Cochrane Library (Issue 3, 2011). References of the included studies were also retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assess the methodological quality of the included studies. Then, meta-analysis was performed using RevMan 5.0 software.Results Four RCTs involving 68 patients (136 limbs) were included, most of which were low in methodological quality. The results of meta-analysis indicated that, autologous stem cell therapy improved or even eliminated DPN symptoms including pain, numbness, and cold sensation in the limbs, intermittent limping, and rest pain. Compared with the routine therapy, autologous stem cell therapy improved tibial sensory nerve conduction velocity (MD=5.75, 95%CI 3.86 to 7.64, Plt;0.000 01), tibial motor nerve conduction velocity (MD=4.04, 95%CI 0.90 to 7.18, P=0.001), sural sensory nerve conduction velocity (MD=7.47, 95%CI 4.00 to 10.94, Plt;0.000 1), and sural motor nerve conduction velocity (MD=3.38, 95%CI 0.07 to 7.58, P=0.05), with no adverse reaction reported. Conclusion Current evidence shows that, autologous stem cell therapy is effective in treating DPN. Due to the lack of high quality studies, more high quality RCTs are needed to verify the above conclusion.

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  • Shen-Mai Injection as an Adjunct Therapy to Tumor Chemotherapy: A Systematic Review

    Objective To assess the methodological quality of clinical studies using Shen-Mai injection as an adjunct therapy to tumor chemotherapy and to evaluate its efficacy and safety. Methods A comprehensive search strategy was designed to identify all randomized controlled trials (RCT) comparing Shen-Mai injection plus routine chemotherapy versus routine chemotherapy alone by searching for the CBMdisc (issue 3) and TCMLRS database (1981-2001). The methodological quality of the trials was assessed by two reviewers independently for which a meta analysis was perfermed. Results Thirteen RCTs met the inclusion criteria. methodological quality was poor (all the trials included were level C). Compared with the control group, the combined outcome of Shen-Mai injection increased the effect of chemotherapy (OR 1.73 95%CI 1.27 to 2.34, P=0.000 4), reduced the side effect of bone marrow inhibition (OR 0.29, 95%CI 0.16 to 0.52, P=0.000 04) in WBC counting and (OR 0.11, 95%CI 0.02 to 0.49, P=0.004 in PLT count. And Shen-Mai injection relieved the symptoms of nausea and vomiting (OR 0.26, 95%CI 0.16 to 0.43, Plt;0.000 01). Conclusions The methodological quality of the trails using Shen-Mai injection should be improved. Based on the results of the review and the meta-analysis, Shen-Mai injection may have positive effects on chemotherapy in patients with malignant tumor, although the evidence is weak. No serious adverse events are reported. Further well-designed clinical trials should be performed.

    Release date:2016-08-25 03:34 Export PDF Favorites Scan
  • Relationship of FastTrack Perioperative Period Clinical Care Mode and Inflammatory Response in Colorectal Operation. A Randomized Clinical Trial

    Objective To evaluate the effect of perioperative period clinical care mode through fast-track (FT) under nonminimal invasive operation on the inflammatory response of colorectal cancer resection. Methods Fifty-five patients underwent elective colorectal cancer resection were randomized divided into two groups: FT group (n=29) in which patients were performed FT perioperative care and tradition group (n=26) in which patients were received traditional perioperative care. The nonminimal invasive operations were performed in this study. The venous blood samples were respectively collected at 24 h before operation, at 24 h, 72 h, and 7 d after operation, and were used to detect the concentrations of serum C-reactive protein (CRP) and serum amyloid A protein (SAA).Results There was no complication such as infection, fistula of stoma and inflammatory ileus that was potential to influence the study results in two groups, and no patient died. The trend of changes in the concentrations of CRP and SAA of patients was accordant in each group. The peak concentrations of CRP and SAA of patients in FT group were respectively observed at 24 h after operation 〔CRP: (72.36±60.94) mg/L; SAA: (328.97±267.20) mg/L〕, while which were respectively delayed to 72 h after operation in tradition group 〔CRP: (112.71±63.92) mg/L; SAA: (524.18±331.03) mg/L〕. At the same time, the concentrations of CRP and SAA in FT group began to descend 〔CRP: (57.21±30.42) mg/L; SAA: (237.43±215.66) mg/L〕. The peak concentrations of CRP and SAA in tradition group were significantly higher than that in FT group (Plt;0.001) and the concentrations of CRP and SAA in FT group were significantly lower than those in tradition group at 72 h after operation (Plt;0.001). On 7 d after operation, the concentrations of CRP and SAA further decreased, but the difference between two groups was not significant (Pgt;0.05). Likewise, the concentrations of CRP and SAA at 7 d after operation were significant higher than those 24 h and 72 h after operation (Plt;0.001), lower than that 24 h before operation (Plt;0.001), respectively. Conclusion This study demonstrates that perioperative period clinical care mode through FT under non-minimal invasive operation can reduce the inflammatory response of colorectal carcinoma resections and scientific clinical care is an important means to promote quick rehabilitation.

    Release date:2016-09-08 10:54 Export PDF Favorites Scan
  • Hydrotalcite in the treatment of reflux esophagitis: a meta-analysis

    ObjectivesTo systematically review the efficacy and safety of hydrotalcite in the treatment of reflux esophagitis (RE).MethodsCBM, CNKI, WanFang Data, VIP, PubMed, EMbase, The Cochrane Library, Web of Science and Scopus databases were searched online to collect randomized clinical trials (RCTs) of hydrotalcite or hydrotalcite plus PPI versus PPI alone in the treatment of RE from inception to June 30th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed by RevMan 5.3 software.ResultsA total of 15 RCTs involving 1 655 patients were included. The results of meta-analysis showed that: after 4-8 weeks of treatment, there was no significant difference between hydrotalcite vs. PPI regarding RE healing rates (RR=0.87, 95%CI 0.76 to 1.00, P=0.05). However, there were significant increases in RE healing rate (RR=1.22, 95%CI 1.14 to 1.31, P<0.001) and symptom relief rate (RR=1.36, 95%CI 1.12 to 1.66,P<0.01) between hydrotalcite plus PPIvs. PPI alone. Similar increases of RE healing rate (RR=1.16, 95%CI 1.08 to 1.25, P<0.001) and symptom relief rate (RR=1.12, 95%CI 1.04 to 1.20,P<0.01) were seen in patients with refractory RE. No increase of adverse effect rate was shown with hydrotalcite or hydrotalcite plus PPI compared to PPI alone.ConclusionsCompared with PPI alone, hydrotalcite plus PPI confers a statistically significant improvement of healing rate and symptom relief rate, while it does not increase adverse effect rate. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.

    Release date:2018-09-12 03:22 Export PDF Favorites Scan
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