ObjectiveTo systematically review the efficacy and safety of capecitabine combined with irinotecan (CAPIRI) versus capecitabine combined with oxaliplatin (CAPOX) for patients with advanced/metastatic colorectal cancer.MethodsPubMed, EMbase, The Cochrane Library, VIP, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) on CAPIRI versus CAPOX for patients with advanced/metastatic colorectal cancer from inception to August 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 12 RCTs involving 1 049 patients were included. The results of meta-analysis showed that: there were no significant differences in complete response (CR), partial response (PR), stable disease (SD), progression disease (PD), overall respond rate (ORR), median progression-free survival (mPFS), and median overall survival (mOS) between two groups (P>0.05). However, CARIRI group was lower on the disease control rate (RR=0.93, 95%CI 0.86 to 1.00, P=0.04) than CAPOX group. Incidence of diarrhea was higher in CAPIRI group (RR=1.83, 95%CI 1.37 to 2.45, P<0.000 1). However, the incidence rate of peripheral neurotoxicity in CAPOX group was higher (RR=0.13, 95%CI 0.05 to 0.35, P<0.000 1). There were no significant differences between two groups in the incidence rates of nausea and vomiting, hand-foot syndrome, anemia, thrombocytopenia, leukocytopenia and alopecia (P>0.05).ConclusionsCurrent evidence shows that two groups are equivalent in terms of curative effects. CAPIRI has a higher incidence rate of diarrhea, while CAPOX has a higher risk of peripheral neurotoxicity. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To explore the effectiveness and safety of ziprasidone in the treatment of female patients with schizophrenia. Methods A before-after study design with prospective consecutive data collection was adopted. From June 2006 to May 2007, 30 female patients with schizophrenia discharged from the Second Veterans Hospital of Shanxi Province were included. Ziprasidone 60-120 mg/d was orally administered for 6 weeks. Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were measured before the treatment and at the end of Week 2, 4 and 6 after the treatment, respectively.Results At Week 6, the significant improvement rate and the total improvement rate were 86.67% and 93.33%, respectively; the incidence of side effects was 86.67%. Conclusion Ziprasidone is safe and effective in the treatment of schizophrenia. Since it will not increase body weight or the level of prolactin, it can be especially applied to female schizophrenic patients.
ObjectiveTo investigate the variation regularity about volume of drainage after initial thyroidectomy, and to find out the time points of safety extubation and the time points of risk extubation. MethodsBetween September 2013 and April 2014, the clinical date of 71 cases of thyroid tumor who underwent thyroidectomy were prospectively analyzed and completely random designed. The patients were indwelling drain after thyroidectomy, the volume of drainage liquid were registered at each point of time in period of 48 hours after operation and analyzed its the variation regularity. ResultsThe volume of drainage fluid in 48 h after operation was gradually decreased in 71 patients. The reduce speed of volume of drainage fluid in the 12 h after operation was faster, then was significantly slower, and gradually stabilized. The amount of the drainage fluid reached the peak in 2 h after operation in 22 cases, and then gradually decreased and reached the stabilization. ConclusionsThe 2 hours after thyroidectomy is the risk drainage removing time when is relatively safe. The 12 hours after thyroidectomy is the safety drainage removing time, after that there is no longer any meaning to keep drainage tube.
ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.
ObjectivesThe present network meta-analysis was conducted to evaluate the potential efficacy and safety of various surgical approaches in the treatment of benign prostatic hyperplasia with enlarged prostate.MethodsPubMed, EMbase, The Cochrane Library, Clinicaltrials.gov and CNKI databases were electronically searched to identify eligible studies. Two reviewers independently screened literature, extracted data and evaluated risk of bias and the ADDIS 1.16.8 software was used to conduct meta-analysis.ResultsA total of 23 studies involving 2 849 patients with 5 approaches including open prostatectomy (OP), holmium laser enucleation of the prostate (HoLEP), plasmakinetic/bipolar plasmakinetic enucleation of the prostate (PK/BPEP), transurethral vaporization of the prostate (TUVP), and laparoscopic prostatectomy (LSP) were included. HoLEP, PK/BPEP and OP were superior to the other methods in improving the objective indicators and subjective feelings of patients during both short and medium-term follow-up. However, compared with OP, HoLEP and PK/BPEP were observed to result in a significantly lower hemoglobin level (MD=1.65, 95%CI 0.35 to 4.41; MD=2.62, 95%CI 0.64 to 2.90), longer postoperative irrigation time (MD=4.67, 95%CI 1.29 to 10.66; MD=2.67, 95%CI 1.32 to 6.63), as well as indwelling catheter after operation (MD=1.64, 95%CI 0.48 to 4.15; MD=2.52, 95%CI 0.60 to 3.78). In terms of short-term complications, PK/BPEP (RR=0.45, 95%CI 0.13 to 1.29) was found to be significantly lower than that of OP.ConclusionsHoLEP and PK/BPEP can be probably used as a superior treatment option for large volume benign prostatic hyperplasia because of its better curative effect, higher safety and quick postoperative recovery.
ObjectiveTo investigate effectiveness and safety of transcatheter aortic valve replacement in the treatment of aortic regurgitation. Methods PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, Wanfang Data and VIP were searched from inception to August 2021. According to the criteria of inclusion and exclusion, two reviewers independently screened the literature, extracted the data and evaluated the quality of the included studies. Then, Stata 16.0 software was used for meta-analysis. Subgroup meta-analysis of valve type used and study type was performed. ResultsTwenty-five studies (12 cohort studies and 13 single-arm studies) were included with 4 370 patients. Meta-analysis results showed that an incidence of device success was 87% (95%CI 0.81-0.92). The success rate of the new generation valve subgroup was 93% (95%CI 0.89-0.96), and the early generation valve subgroup was 66% (95%CI 0.56-0.75). In addition, the 30-day all-cause mortality was 7% (95%CI 0.05-0.10), the 30-day cardiac mortality was 4% (95%CI 0.01-0.07), the incidence of pacemaker implantation was 10% (95%CI 0.08-0.13), and the incidence of conversion to thoracotomy was 2% (95%CI 0.01-0.04). The incidence of moderate or higher paravalvular aortic regurgitation was 6% (95%CI 0.03-0.09). Conclusion Transcatheter aortic valve replacement for aortic regurgitation is safe and yields good results, but some limitations can not be overcome. Therefore, multicenter randomized controlled trials are needed to confirm our results.
ObjectiveTo investigate and analyze the knowledge, skills and attitudes of clinical medical students and nursing students to patient safety before internship so as to provide evidence for implementation of patient safety curriculum in medical and nursing students. MethodsFive-year clinical medical undergraduates and nursing students before internship in the Wannan Medical College were recruited. The questionnaire method was performed to investigate the knowledge, attitudes and skills of patient safety. The data were input using EpiData 3.0 software and were analyzed by SPSS 13.0. ResultsA total of 771 questionnaires were distributed, of which 320 clinical medical students and 435 nursing students completed the survey. The results showed that, the totals of both kinds of students were low concerning the knowledge, attitudes and skills of patient safety; scores were significantly higher in nursing students than in clinical medical students concerning the items of "Knowledge about medical errors" (P=0.012), "Feelings about making errors" (P=0.000), "Feelings about making errors" (P=0.001), and "Personal attitudes to patient safety" (P=0.001). Scores of "Feelings about making errors" were significantly higher in female students than in male students. ConclusionBoth nursing students and clinical medical students lack the knowledge of patient safety before internship, and the latter lack more. More attention should be paid to the knowledge of patient safety for both clinical medical and nursing students.
Objective To evaluate the safety and efficacy of steroid withdrawal in modern triple immunosuppressant (Cycloproine/Tacrolimus, Mycophenolate Mofetil and Steroid) on renal transplantation recipients. Methods We searched MEDLINE (1966-Sep. 2005), OVID (1966-2004), EMBASE (1984-2004), The Cochrane Library (Issue 4, 2005), CBMdisc (1994-2005), and handsearched 7 Chinese Journals. Randomized controlled trials (RCTs) adopting modern triple immunosuppressant, and comparing steroid withdrawal (SW), group and steroid continuing group (SC) were selected. The quality of included studies was evaluated and graded according to Cochrane Reviewer’s Handbook 4.2.5, and meta-analysis was performed by using RevMan 4.2.7 software. Results Nine RCTs including 1 681 patients (845 in SW and 836 in SC) were identified. The average follow-up time was 6-12 months. No significant difference was found in using CsA or Tac in modern triple immunosuppressant. The results of our meta-analysis showed: ① the risk of acute rejection was two times higher in SW than SC (RR 2.05, 95% CI 1.54 to 2.72, P lt;0.000 01), mainly Banff grade I (mild) (RR 1.92, 95% CI 1.16 to 3.17, P =0.01); but no significant differences were found on Banff grade II and III between the two groups. ② the rate of graft and patient survival and chronic rejection were the same between two groups. ③ Steroid withdrawal decreased the incidence of opportunistic infection (mainly caused by simplex herpes virus and Candida) and urinary tract infection. While the incidence of CMV and sepsis infection has no significant difference between two groups. Conclusion Steroid withdrawal within 3 months in modern immunosuppressive regimen ① increases the risk of Banff Grade I rejection reaction, but the moderate and severe rejection are similar between the two groups; ② doesn’t affect the rate of graft, patient survival, and chronic rejection; ③ decreases the incidence of opportunistic and urinary tract infection, but doesn’t improve the CMV infection and sepsis. To prophylaxis serious infection, steroid withdrawal is worth considering under sufficient immunosuppressive regimen. The key point is to balance the benefit and harm for individual recipients.
Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.