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find Keyword "Randomized controlled trial" 877 results
  • Effectiveness and Safety of TACE Combined with AHCS for Primary Hepatic Carcinomas: A Systematic Review

    Objective To evaluate the clinical effectiveness and safety of transcatheter arterial chemoembolization (TACE) combined with argon-helium cryotherapy system (AHCS) for primary hepatic carcinomas (PHC), and to provide references for clinical practice and research. Methods Such databases as The Cochrane Library, PubMed, EMbase, Web of Science, CBM, CNKI, VIP and WanFang Data were searched, and other sources like the relavant references were also retrieved to collect the randomized controlled trials (RCTs) about TACE combiend with AHCS for PHC published by May 1st, 2012. After literature screening, data extraction and quality evaluation performed by two reviewers independently according to the inclusion criteria, the meta-analysis was conducted using RevMan 5.1 software. Results A total of 16 RCTs involving 1 467 patients were included. The results of meta-analysis showed: a) The TACE+AHCS group was superior to the TACE alone group in total effective rate, complete necrosis rate, 0.5-, 1-, 1.5-, 2- and 2.5-year survival rates, AFP, CD4 and Th/Ts cells, and there were significant differences (Plt;0.05); and b) The TACE+AHCS group was superior to the AHCS alone group in 0.5-, 1.5-, 2- and 2.5-year survival rates, AFP and Th/Ts cells, and there were significant differences (Plt;0.05). Conclusion Compared with the TACE or AHCS alone, TACE combined with AHCS can improve long-term survival rate and short-term curative effect, and improve PHC patients’ immunity. However, its long-term curative effect and safety still needs to be further verified by more large sample and high quality RCTs.

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  • Effects of Vitamin D Supplement on Blood Pressure: A Systematic Review

    Objective To systematically review the impact of vitamin D supplement on blood pressure, so as to provide a basis for clinical treatment. Methods Such databases as The Cochrane Library (Issue 8, 2011), MEDLINE (1996 to August 2011), EMbase (1974 to August 2011), CBM (1989 to 2011), CNKI (1997 to August 2011) and VIP (1989 to 2011) were searched to collect the randomized controlled trials (RCTs) about the impact of vitamin D supplement on blood pressure. Two reviewers independently screened the literature according to the inclusion criteria, extracted the data and assessed the quality. Then the meta-analysis was performed using RevMan 5.0 software. Results A total of 8 studies involving 907 participants were included. The methodological quality based on the improved Jadad scales displayed that, 7 studies scored 4 to 7 and only 1 study scored less than 4. The results of meta-analysis showed that compared with the placebo groups, vitamin D supplement had no significant difference in both systolic and diastolic blood pressure. Conclusion Based on current research evidences, compared with placebo, vitamin D supplement has no marked impact on either systolic or diastolic blood pressure. Due to the lack of studies, this conclusion still needs to be proved by conducting more well designed, large sample, and multicenter RCTs.

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  • Effectiveness and Safety of Dexmedetomidine for Postoperative Sedation in Cardiac Patients: A Meta-Analysis

    Objective To evaluate the effectiveness and safety of dexmedetomidine for postoperative sedation in cardiac patients. Methods Such databases as PubMed, EBSCO, Springer, Ovid, The Cochrane Library, CBM, CNKI, VIP and WanFang Data were searched electronically from the date of their establishment to May 2012, and other relevant journals and references of the included literature were also searched manually. Two reviewers independently screened the studies in accordance with the inclusion and exclusion criteria, extracted data and assessed methodology quality. Then the meta-analysis was performed using RevMan 5.1software. Results A total of 8 randomized controlled trials (RCTs) involving 1 157 patients were included. The Jadad scores of 7 RCTs were more than 3, and only 1 RCT scored 2. The results of meta-analysis showed that compared with the control group, dexmedetomidine significantly raised peripheral oxygen saturation (RR=0.90, 95%CI 0.31 to 0.49, P=0.003), decreased the incidence of average heart rate (RR=–5.86, 95%CI –7.31 to −4.40, Plt;0.000 01), ventricular tachycardia (RR=0.27, 95%CI 0.08 to 0.88, P=0.03), delirium (RR=0.28, 95%CI 0.16 to 0.48, Plt;0.000 01) and postoperative hyperglycemia (RR=0.57, 95%CI 0.38 to 0.85, P=0.006), and reduced the number of patients who needed vasoactive agents such as epinephrine (RR=0.53, 95%CI 0.29 to 0.96, P=0.04) and β-blocker (RR=0.60, 95%CI 0.38 to 0.94, P=0.03). However, it failed to shorten the time of both ICU stay (RR=−1.24, 95%CI −4.35 to 1.87, P=0.43) and mechanical ventilation (RR=−2.28, 95%CI −5.13 to 0.57, P=0.12), increase mean artery pressure (RR=−2.78, 95%CI −6.89 to 1.34, P=0.19), and well control postoperative nausea, vomiting and atrial-fibrillation. There were no significant differences between the two groups in myocardial infarction, acute cardiac failure, acute kidney failure, and mortality rate. Conclusion For postoperative sedation in cardiac patients, dexmedetomidine can effectively stabilize hemodynamic indexes, and reduce tachycardia, delirium, postoperative hyperglycemia and vasoactive agents. However, it has no marked influence on the prognosis. For the quantity and quality limitation of included studies, this conclusion needs to be proved by performing more high quality and large sample RCTs.

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  • Effectiveness of Cognitive Behavioral Therapy Treating Insomnia in Patients with Breast Cancer: A Systematic Review

    Objectives To evaluate the effectiveness of cognitive behavioral therapy (CBT) treating insomnia in patients with breast cancer. Methods Such databases as CENTRAL (April 2011), The Cochrane Library (2005 to November 2011), MEDLINE (1948 to April 2011), EMbase (Junuary 1966 to April 2011), CINAHL (Cumulative Index to Nursing and Allied Health Literature, 1982 to April 2011), CBM (1978 to 2011) and CNKI (1979 to 2011) were searched to collect the randomized controlled trials (RCTs) about CBT treating insomnia in patients with breast cancer. Literature screening, data extraction and methodological quality assessment of the included studies were conducted according to the inclusion and exclusion criteria. Then RevMan 5.0 software was used for meta-analysis. Results A total of 5 RCTs were included. The results of meta-analysis showed that, compared with the control group, the CBT group was higher in the score of subjective sleep efficiency; however, it was lower in the subjective sleep onset latency. There were no significant differences between the two groups in the sleep efficiency, total sleep time, sleep onset latency and wake time after sleep onset measured by hypnocinematograph. Conclusion Cognitive behavioral therapy may improve the subjective sleep efficiency and sleep quality, and shorten the sleep onset latency in patients with breast cancer. However, its effect of improving objective sleep quality is still unverifiable at present. It suggests the following measures should be taken for providing better evidences: increasing sample size, adopting blind methods, confirming allocation concealment, and using unified hypnocinematograph.

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  • Effectiveness and Safety of Different Laparoscopic Surgeries for Ovarian Endometrioma: A Systematic Review

    Objective To systematically review the effectiveness and safety of different laparoscopic surgeries for ovarian endometrioma (OE). Methods Such databases as The Cochrane Library (Issue 3, 2011), MEDLINE (1966 to November 2011), EMbase (1980 to November 2011), CNKI (1980 to November 2011), CBM (1980 to November 2011) and WanFang Data (1978 to November 2011) were searched on computer, and the relevant references of the included literature were also retrieved manually to collect the randomized controlled trials (RCTs) about laparoscopic cystectomy vs. laparoscopic coagulation for OE. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and assessed quality. Then RevMan 5.1 software was used for meta-analysis. Results A total of 5 RCTs were included. The results of meta-analysis showed that, laparoscopic cystectomy for OE could reduce the reocurrence rates of dysmenorrhoea (RR=0.29, 95%CI 0.15 to 0.55, P=0.000 2), dyspareunia (RR=0.27, 95% CI 0.09 to 0.77, P=0.01) and non-menstrual pelvic pain (RR=0.19, 95% CI 0.05 to 0.76, P=0.02), decrease 1-year (RR=0.33, 95%CI 0.15 to 0.74, P=0.007) and 2-year (RR=0.49, 95%CI 0.26 to 0.95, P=0.03) postoperative reoccurence of OE, and lower the risk of short-term secondary operation (RR=0.25, 95%CI 0.07 to 0.85, P=0.03). However, it didn’t increase the 12-month (RR=2.82, 95%CI 1.44 to 5.50, P=0.002) and 24-month (RR=2.62, 95%CI 1.47 to 4.68, P=0.001) postoperative spontaneous pregnancy rates (SPR). In addition, although laparoscopic coagulation was superior to laparoscopic cystectomy in the 6-month postoperative ovarian reserve function (ORF), there was no significant difference in the 5-year postoperative ORF between the two groups (WMD=0.27, 95%CI −0.18 to 0.73, P=0.24). Conclusion Laparoscopic cystectomy for OE can reduce the reoccurence of dysmenorrhoea, dyspareunia, non-menstrual pelvic pain and endometriosis, decrease the risk of short-term secondary operation, and increase the postoperative SPR in women who had been diagnosed as infertility. Because of the quantity limitation of present clinical trials, this conclusion requires to be further proved by performing more high quality RCTs.

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  • Laparoscopic Hysterectomy for Benign Gynecological Diseases: A Systematic Review

    Objective To assess the safety and effectiveness of laparoscopic hysterectomy (LH) for women with benign gynecological diseases. Methods Such databases as CENTRAL (The Cochrane Library, Issue 5, 2012), MEDLINE, EMbase, CNKI, WanFang Data, VIP and CBM were searched from the date of their establishment to May 2012, meanwhile the relevant gray literature was also retrieved to identify the randomized controlled trials (RCTs) about LH versus abdominal hysterectomy (AH) for benign gynecological diseases. The literature was screened according to the inclusion and exclusion criteria by two reviewers independently, and the methodology quality was evaluated after extracting the data, then RevMan 5.1 software was used for meta-analysis. Results A total of 22 RCTs involving 3 304 patients were included. The results of meta-analysis showed that, compared with AH, LH was shorter in the time of both hospital stay (MD=–2.31, 95%CI –3.03 to –1.60, Plt;0.000 01) and postoperative recovery (MD=−13.86, 95%CI −17.70 to −10.03, Plt;0.000 01), and lower in the incidences of both postoperative fever and other nonspecific infections (OR=0.72, 95%CI 0.54 to 0.95, P=0.02), but it was higher in the incidence rate of intraoperative urinary systematic injuries (OR=2.41, 95%CI 1.21 to 4.82, P=0.012), and longer in the operation time (MD=20.27, 95%CI 3.95 to 36.59, P=0.03). There were no significant differences between the two groups in the incidence of complications such as intraoperative intestinal injuries, vessel injuries, postoperative fistulizaion, postoperative urethral dysfunction, postoperative vaginal infection, etc. (Pgt;0.05). Conclusion This systematic review shows when treating benign gynecological diseases, LH is superior to AH in shortening the time of hospital stay and postoperative recovery, and in decreasing the incidence of operative fever and other nonspecific infections, but it results in a higher incidence of intraoperative urinary systematic injuries and longer operative time. Because there is no result regarding to the postoperative long-term life quality, so it expects to be further proved by more high quality RCTs.

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  • Effectiveness and Safety of Nedaplatin Combined with 5-Fluorouracil for Advanced Esophageal Cancer: A Meta-Analysis

    Objective To assess the effectiveness and safety of nedaplatin combined with 5-fluorouracil (5-Fu) for advanced esophageal cancer. Methods Such databases as PubMed, The Cochrane Library, EMbase, CBM, CNKI, VIP and WanFang Data were searched from the date of their establishment to May 4th, 2012 to collect the randomized controlled trials (RCTs) about nedaplatin combined with 5-Fu versus cisplatin combined with 5-Fu for advanced esophageal cancer. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and assessed the quality of the included studies. Then meta-analysis was conducted using RevMan 5.1 software. Results A total of 15 RCTs invloving 863 patients were included. The results of meta-analysis suggested that, compared with cisplatin combined with 5-Fu, nedaplatin combined with 5-Fu could improve short-term effects (RR=1.31, 95%CI 1.14 to 1.52, P=0.000 2) and reduce gastrointestinal reaction and renal function impairment, but it was associated with aggravated myelosuppression, increase of thrombocytopenia and leukopenia, and decrease of hemoglobin. There were no significant differences between the two groups in liver function impairment, diarrhea and peripheral neurovirulence. Conclusion Nedaplatin combined with 5-fluorouracil can increase short-term effects and reduce gastrointestinal reaction and renal function impairment. However, nedaplatin is associated with aggravated myelosuppression, so it should be applied in clinic with cautious. Nedaplatin combined with 5-fluorouracil can be used as a replacement chemotherapy regimen for advanced esophageal cancer, but the evidence about long-term effects and safety is still required. For the quality and quantity limitation of the included studies which decreases the level of evidence, so the conclusion of this systematic review only provides some references for clinical practice and research.

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  • Effectiveness and Safety of Nedaplatin Combined with Chemotherapy for Advanced Non-small Cell Lung Cancer: A Meta-Analysis

    Objective To evaluate the effectiveness and safety of nedaplatin combined with chemotherapy versus cisplatin combined with chemotherapy for advanced non-small cell lung cancer (NSCLC). Methods The randomized controlled trials (RCTs) on nedaplatin combined with chemotherapy versus cisplatin combined with chemotherapy for advanced NSCLC were searched in The Cochrane Library, PubMed, EMbase, CBM, VIP and WanFang Data from the date of their establishment to January 2012. According to the inclusion and exclusion criteria, two reviewers independently screened the studies, extracted the data and assessed the quality. Then RevMan 5.0 software was used for meta-analysis. Results A total of 15 RCTs involving 1 076 patients were included. The results of meta-analysis showed that, compared with the cisplatin combined with chemotherapy, nedaplatin combined with chemotherapy could reduce the risks of nausea and vomiting (RR=0.56, 95%CI 0.48 to 0.65, Plt;0.000 01), decrease the risk of renal function impairment (RR=0.47, 95%CI 0.30 to 0.74, P=0.001), but increase the risk of thrombocytopenia (RR=1.59, 95%CI 1.20 to 2.11, P=0.001). There were no significant differences between the two groups in objective response rate (ORR) (RR=1.09, 95%CI 0.92 to 1.29, P=0.03), leukopenia (RR=1.05, 95%CI 0.92 to 1.19, P=0.50), and hemoglobin reduction (RR=0.92, 95%CI 0.80 to 1.07, P=0.30). Conclusion Compared with cisplatin combined with chemotherapy for advanced NSCLC patients, nedaplatin in combination with chemotherapy can significantly reduce the risks of nausea, vomiting and renal function impairment. Although the ORRs are similar in the two groups, nedaplatin combined with chemotherapy can cause a higher risk of thrombocytopenia. For the quality restriction and possible publication bias of the included studies, more high quality RCTs are required to further verify this conclusion.

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  • Effectiveness and Safety of Compound Glycyrrhizin Combined with Acitretin for Psoriasis: A Systematic Review

    Objective To assess the clinical effectiveness and safety of compound glycyrrhizin combined with acitretin for psoriasis. Methods The databases such as PubMed, The Cochrane Library, SpringerLink, CNKI, VIP, WanFang Data and CBM were searched to collect the randomized controlled trials (RCTs) about compound glycyrrhizin combined with acitretin vs. acitretin alone for psoriasis. Meanwhile, The Chinese Journal of Dermatovenereology, China Journal of Leprosy and Skin Diseases and the grey literature were also searched. The retrieval time was from January 2000 to March 2012. According to the Cochrane Reviewer’s Handbook, two reviewers independently screened the literature, extracted the data and assessed the methodological quality of the included studies. Then the meta-analysis was performed using RevMan5.0 software. Results A total of 17 RCTs involving 1 365 patients were included. The results of meta-analysis showed that, the regimen of compound glycyrrhizin combined with acitretin was superior to acitretin alone; there were significant differences in the total effective rate (OR=3.39, 95%CI 2.55 to 4.52, Plt;0.000 01) and in the incidence of skin and mucous membrane dryness (OR=0.54, 95%CI 0.32 to 0.98, P=0.04), skin erythema (OR=0.43, 95% CI 0.24 to 0.76, P=0.004), elevated AST and ALT (OR=0.13, 95%CI 0.04 to 0.41, P=0.000 5) and elevated blood lipid (OR=0.48, 95%CI 0.30 to 0.77, P=0.002). But no significant difference was found in the incidence of dry and cracked lips (OR=0.50, 95%CI 0.10 to 2.50, P=0.40). There was publication bias shown by funnel plot analysis. Conclusion The compound glycyrrhizin combined with acitretin for psoriasis can obviously increase the cure rate and effective rate, and reduce the incidence of adverse reaction, such as dryness of skin and mucous membrane, skin erythema, elevated AST and ALT, and elevated blood lipid. For the limitation of quality and quantity of included studies, this conclusion still needs to be proved by conducting more high quality researches.

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  • Effectiveness and Safety of Trazodone versus Alprazolam for Adults’ Generalized Anxiety Disorder: A Meta-Analysis

    Objective To assess the effectiveness and safety of trazodone versus alprazolam on adults’ generalized anxiety disorder (GAD). Methods Such databases as PubMed (1980 to May 2012), CBM (1990 to May 2012), VIP (1989 to May 2012), CNKI (1990 to May 2012) and WanFang Data (1990 to May 2012) were searched to collect the randomized controlled trials (RCTs) about trazodone vs. alprazolam for adults’ GAD. According to the inclusion and exclusion criteria, two reivewers screened literature, extracted data and assessed the quality of the included studies, then meta-analysis was conducted using RevMan 5.0 software. Results A total of 5 RCTs involving 403 patients were included. The results of meta-analysis showed that: a) After four-week treatment, there were no significant differences between the two groups in the HAMA scores (RR=1.04, 95%CI 0.95 to 1.13, P=0.38) and cure rate (RR=1.05, 95%CI 0.75 to 1.48, P=0.76); and b) The somnolence rate of the trazodone group was lower than that of the alprazolam group (RR=0.42, 95%CI 0.25 to 0.72, P=0.001). But there were no significant differences between the two groups in dizziness (RR=0.52, 95%CI 0.27 to 1.01, P=0.05), fatigue (RR=0.10, 95%CI 0.01 to 1.41, P=0.09), and poor appetite (RR=2.82, 95%CI 0.28 to 28.23, P=0.38). Conclusion There is no significant difference between razodone and alprazolam in the effectiveness when treating GAD, but razodone has lower side effects while alprazolam tends easily to cause somnolence. For the quantity limitation and low methodological quality of the included studies, this conclusion still needs to be further proved by more high quality RCTs.

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