ObjectiveTo analyze the clinical application and safety of Shenmai injection.MethodsWe collected clinical data of 30 012 patients using Shenmai injection from 26 hospitals nationwide from September, 2009 to June, 2013. The SPSS 15.0 software was used to analyze demographic characteristics, diagnostic information, and clinical application of the injection.ResultsAmong all patients, 14 270 were females (47.55%), 8 218 were aged 45-60 (27.38%), and 10 452 were aged 61-75 (34.83%). The primary use of Shenmai injection was as an adjuvant treatment of chemotherapy for cancer patients, and the top 3 cancers were lung cancer (1 533, 5.11%), breast cancer (1 509, 5.03%) and gastric cancer (847, 2.82%). The second important use of Shenmai injection was the treatment of coronary heart disease (5 703, 19.00%), of which the most common single dose was 50 mL (14 406, 48.00%), followed by 100 mL (10 804, 36.00%) and 200 mL (600, 2.00%). The solvents were used in 18 902 patients (62.98%), and the 5% glucose injection was used most frequently (84.64%). The adverse effects (AEs) rate was 0.15%, and 57.78% AEs occurred within 24 hours of infusion. The most common AEs were damage of the cardiovascular system, followed by damaging of blood system and respiratory system.ConclusionsShenmai injection has a wide range of applications and can be used in treatment of numerous diseases in the real-world, and the AEs have been linked to off-label uses.
Objective To systematically review the efficacy and safety of denosumab in the treatment of rheumatoid arthritis. Methods The PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, WanFang Data, and VIP databases were searched to collect randomized controlled trials (RCTs) of denosumab in the treatment of rheumatoid arthritis. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4 software. Results A total of 7 RCTs including 2 346 patients were included. The results of meta-analysis showed that administering 60 mg densuzumab every 6 months (Q6M) was superior to placebo in increasing the bone mineral density (BMD) of the lumbar spine, the hip, the femoral neck, and improving the modified total Sharp score. Administering 60 mg denosumab every 3 months (Q3M) and 60 mg Q6M were both superior to the placebo group at improving erosion score; in addition, the 60 mg Q3M group was superior to the 60 mg Q6M group. There was no significant difference between denosumab and the placebo in improving joint space narrowing score, the American College of Rheumatology 20%, 50%, or 70% responses, health assessment questionnaire disability index, or disease activity score. In terms of safety, there was no significant difference between denosumab and the placebo group. Conclusion Densuzumab can delay the progression of rheumatoid arthritis bone erosion, and its safety is acceptable. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
ObjectivesTo evaluate the reporting quality of clinical practice guidelines published in Chinese journals in 2015.MethodsCBM, CNKI, VIP and WanFang Data databases were searched to collect clinical practice guidelines published in Chinese journals from January, 2015 to December, 2015. Two reviewers independently screened literature, extracted data, and the reporting quality of clinical practice guidelines were evaluated by the Reporting Items for Practice Guidelines in Healthcare (RIGHT). Excel software was used for data analysis.ResultsA total of 74 clinical practice guidelines were included. It was found that among the seven domains of RIGHT, the reporting quality of basic information and background domains were acceptable. There were fewer problems in the domain of evidence and recommendation. There were many deficiencies in three domains, such as review and quality assurance, funding and the declaration/management of interests and other information.ConclusionsThe reporting quality of clinical practice guidelines published in Chinese journals in 2015 is low, and the full reporting rate of clinical practice guidelines need to be improved. It is suggested that guideline developers construct strict guidelines for the development and report the guidelines with international standard, thus improving the quality of the clinical practice guidelines.
ObjectivesTo systematically review the necessary factors of questionnaires design on patients' values and preferences in order to provide information on the most appropriate questionnaires when developing clinical practice guidelines.MethodsA systematic literature search of PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data databases was performed to identify studies on questionnaires evaluating patient values and preferences. The authors included the articles that used fully structured questionnaires or scales with standardized questions and answer options. We assessed the questionnaires' construction with psychometric methodology and summarized the necessary factors on patients' preferences and values into the domains and items.ResultsTwenty articles were eventually included. Five out of 20 studies (25%, 5/20) described the process of item generation while merely one questionnaire (5%, 1/20) mentioned pilot testing. Regarding validity, there were 6 questionnaires (30%, 6/20) that assessed validity. For acceptability, the time taken to complete the questionnaires range from 10 to 30 minutes and only 6 studies reported response rates. The results showed that the factors affecting the design of questionnaires on patients' values and preference were related to the effectiveness, safety, prognostic factors and others. The main factors were the effects, side effects and risk of complications, risk of relapse and the cost of treatments.ConclusionsOnly a few studies have developed questionnaires with rigorous psychometric methods to measure patients' preference and values. There is still no valid or reliable questionnaires for patients' preference and values when developing clinical practice guidelines. Further study should be conducted to develop standardized instruments to measure patients' preference and values. It is suggested that the factors this study provides can be used in formulating questionnaires on patients' preference and values.