Objective To evaluate the efficacy and safety of Chinese medicine for the treatment of angina pectoris. Methods PubMed, EMbase, The Cochrane Library (Issue 11, 2015), VIP, WanFang Data and CNKI databases were used to evaluate the curative effect and safety of proprietary Chinese medicine in the treatment of angina pectoris. The retrieval time was up to November 2015. Two reviewers screened literatures, extracted data and assessed the methodological quality of included studies, and then the GRADE evaluation system was used to assess the quality of evidence. Results A total of 42 systematic reviews/Meta-analysises were included in the study. There were 15 kinds of proprietary Chinese medicines, and the drugs published most were compound composite salvia. AMSTAR evaluation results showed that the quality of all studies were low. The main problems were: ① no consideration was given to the publication of the inclusion criteria (eg, gray literature); ② only the list of articles included in the study literature was not available; ③ all articles did not describe the relevant conflicts of interest. The results of GRADE systems showed that: ① as to the total effective rate: musk pills (RR=3.44, 95%CI 2.99 to 3.96,P=0.08) and suxiaojiuxin Pills (RR=4.25, 95% CI 3.31 to 5.47,P<0.01) were superior to Western medicine, and the level of evidence was very low. ② As to the ECG changes efficiency rate: Puerarin (RR=3.61, 95% CI 2.95 to 4.42,P=0.05), Musk pill (RR=2.48, 95%CI 2.12 to 2.91,P<0.01) and Shuxuening (RR=1.62, 95% CI 1.33 to1.97,P<0.01) were superior to Western medicine, and the evidence level was low. The level of evidence was low for the remaining effective rate of proprietary Chinese medicine; ③ as to the adverse reactions: the musk Baoxin pill (RR=0.05, 95% CI 0.01 to 0.37,P=0.04) was less than Western medicine, and the evidence level was low. Conclusion Although the number of systematic reviews of published proprietary Chinese medicines for angina pectoris is high, but the methodological quality and evidence level are low. There are serious defects in the low quality of the original research literature and the systematic evaluation method. We suggest future studies to improve for two aspects: ① reasonable design to reduce the selective bias, to carry out the required clinical trials to reduce the implementation bias, the implementation of multi-center, the sample size of sufficient randomized controlled clinical trials to reduce the number of patients into the group less resulting in the loss of bias, strict implementation of the standard data collection methods to reduce the occurrence of measurement bias; ② in accordance with the requirements of clinical trials to report to improve the report quality of the literature.
ObjectivesTo provide a useful framework for improved understanding of international value drivers in the decision-making process of medical insurance access, and to explore the value assessment criteria of orphan drugs from stakeholders’ perspective.MethodsPubMed, EMbase, CINAHL Plus, ProQuest, Web of Science, CNKI and WanFang Data databases were electronically searched to collect studies from January 1st, 1983 to December 31st, 2018. Research questions were constructed based on SPIDER model. We established the inclusion and exclusion criteria to filter studies. Study quality was evaluated using the Critical Appraisal Skills Programme (CASP) checklist. A thematic synthesis was undertaken to develop descriptive themes, analytical constructs and third-level themes of value drivers by NVivo 11 software, and confidence in the findings was assessed using the CERQual method.ResultsA total of 10 studies including 20 research countries were included. Fifty descriptive themes were interpreted and embedded within 14 analytical constructs and 3 third-level themes after induction. Specifically, 3 broad themes were disease-related influence factors, which included severity, unmet requirements, disease burden, affected individuals, and moral and ethical considerations; drug-related influence factors, which included safety, efficacy, economics, innovation, quality of evidence; and some external and non-pharmaceutical intrinsic properties factors, which included reimbursement status in other countries or regions, government goals and priorities, confirmed drug supply and impact on environment.ConclusionsIn addition to conventional considerations such as efficacy and pharmacoeconomics, stakeholders are willing to take a broader perspective when in the case of the value assessment of orphan drugs. Comprehensive understanding of these value drivers is important to shape policy and enhance decision-making.
ObjectivesTo evaluate the current situation and rationality of electronic prescription in retail pharmacies in Chengdu, so as to provide references for further improving the sales of prescription drugs in retail drugstores and the level of rational drug use.MethodsA set of evaluation index system was constructed, and a prescription review group was set up. Eventually, 7 200 sample electronic prescriptions were collected for retrospective analysis and evaluation.ResultsPrescriptions from private medical institutions constituted the majority (3 543, 49.21%), and the majority of patients were junior and middle-aged, primarily respiratory diseases (38.24%) and circulatory diseases (17.11%), etc. The average quantity of drugs was 1.60 per prescription, percentage of antimicrobial use was 65.25%, percentage of essential medicines used was 34.92%, and reasonable rate of prescription was 95.21%.ConclusionsElectronic prescription services mode for retail pharmacy follows with the trend of “Internet + drug circulation” and complies with the rules of reasonable medical guidance and medication. However, optimizations are required, such as the lack of high-quality medical resources and the urgent need to optimize structure of prescription, and it is still essential to strengthen the management of antibacterial drugs and national essential medicines.
Objective To analyze chemical drugs included in the National Essential Medicines List (EML) of China, to provide reference on how to improve the selection criteria and strengthen management and supply of essential medicines. Methods Dosage form, specification and manufacturers of 201 kinds of chemical drugs included in the EML were retrieved through SFDA website, data collection and analysis were conducted using Excel software. Results Domestic chemical drugs in EML involved 24 kinds of dosage forms, 644 kinds of specifications, 37 854 kinds of drugs for sales, and 2 908 manufacturers. Imported chemical drugs in EML involved 12 kinds of dosage forms, 43 kinds of specifications, 113 kinds of drugs for sales, and 53 manufacturers. Included drugs were primarily normal dosage forms while chemical drugs had many different specifications. Medicines duplication in production was serious and the distribution in market was unbalanced. The sole and exclusive dosage form variety lacked of effective evidence. Selection mechanism and reevaluation needed to be developed. Conclusion It is suggested to include drug specification in EML, and refer to spectrum of diseases for detailed selection mechanism of essential drugs, reevaluation of the listed drugs and formulate strict drug bidding rules so as to optimize EML.
Objective To study the cl inical appl ication of Mobi-C prosthesis in treatment of anterior cervical discectomy and artificial disc replacement (ADR). Methods Between January 2009 and June 2009, 20 cases of degenerative cervical disease were treated with anterior discectomy and ADR by Mobi-C prosthesis, including 13 cases of cervical disc herniation and 7 cases of cervical spondylotic radiculopathy, and 25 Mobi-C prosthesis were implanted. There were 8 males and 12 females, aged 29-54 years (mean, 45.2 years). The disease duration was from 4 days to 5 years (mean, 1.2 years). Affected segments of process included C3, 4 in 1 case, C4, 5 in 2 cases, C5, 6 in 7 cases, C6, 7 in 5 cases, C4, 5 and C5, 6 in 2 cases, and C5, 6 and C6, 7 in 3 cases. Radiographs were taken regularly, and cervical range of motion (ROM) on segments of disc replacements were measured. The functions of cervical spinal cord were evaluated by “40 score” system (COA) preoperatively, immediately postoperatively, and at follow-up. The qual ity of l ife was evaluated by neck disabil ity index (NDI) and visual analogue scale (VAS) score. Results All incisions healed by first intention. No perioperative compl ication was found. All cases were followed up 16.5 months on average (range, 14-18 months). There was no significant difference in cervical ROM of operatied segment between preoperation and follow-up duration (t=0.808，P=0.440). No heterotopic ossification was found at follow-up. COA score at last follow-up (38.20 ± 1.14) was significantly higher than preoperative one (32.10 ± 2.96) , (t=9.278，P=0.000) , and the improvement rate at last follow-up was 77.2% ± 5.4%. VAS score at last follow-up (3.20 ± 1.23) had significant difference when compared with preoperative one (5.10 ± 1.29), (t=10.585，P=0.000). NDI score at last follow-up (29.40 ± 4.55) had significant difference when compared with preoperative one (39.20 ± 3.80), (t=16.039, P=0.000). Conclusion A satisfactory short-term curative effect can be obtained by using Mobi-C prosthesis in treatment of anterior cervical discectomy and ADR.
ObjectiveTo study effects of oxymatrine on proliferation and apoptosis of gastric cancer cell line BGC-823 and explore role of endoplasmic reticulum stress in apoptosis of gastric cancer cells induced by oxymatrine and elucidate its mechanism.MethodsThe gastric cancer BGC-823 cells at the logarithmic phase were divided into a control group, oxymatrine alone group (oxymatrine at 10, 30, 60 and 90 μmol/L concentrations), and combination group (oxymatrine at various concentrations combined with 2 μmol/L endoplasmic reticulum stress inhibitor salubrinal). The MTT assay was used to observe the inhibitory effect of the oxymatrine on the growth of BGC-823 cells. The flow cytometry was used to analyze the apoptosis and cell cycle. The Western blot and RT-PCR methods were used to detect the expressions of GRP78/Bip and the caspase-12 protein and gene, respectively.Results① Compared with the control group, the oxymatrine could significantly inhibit the growth of gastric cancer BGC-823 cells in a concentration-time dependent manner (P<0.05) and its IC50 (48 h) value was (59.5±0.5) μmol/L. The inhibitory effect of the combination group of 30, 60, and 90 μmol/L oxymatrine was significantly weakened as compared with the the corresponding oxymatrine alone group (P<0.05). ② The oxymatrine could significantly induce the apoptosis and arrest the G2/M phase in the gastric cancer BGC-823 cells in a concentration-dependent manner (P<0.05). The combination group of 60 μmol/L oxymatrine could significantly decreased the apoptosis rate and the number of cells in the G2/M phase in the gastric cancer BGC-823 cells after treating 48 h (P<0.05). ③ The protein and gene levels of GRP78/Bip and caspase-12 showed significant increases with the increase of oxymatrine concentrations in the oxymatrine alone group (except the protein and gene levels of caspase-12 at 10 μmol/L oxymatrine) as compared with the control group (P<0.05), which in the combination group of 60 μmol/L and 90 μmol/L oxymatrines were significantly decreased as compared with the corresponding oxymatrine alone group (P<0.05).ConclusionOxymatrine can inhibit growth of human gastric cancer cell line BGC-823, which maybe related to caspase-12-dependent induction of apoptosis and up-regulation of GRP78/Bip expression, which needs further experimental verification.
Objective To summarize the research progress of controlled release of angiogenic factors and osteogenic factors in bone tissue engineering. Methods The domestic and abroad literature on the controlled release structure of growth factors during bone regeneration in recent years was extensively reviewed and summarized. Results The sustained-release structure includes direct binding, microsphere-three-dimensional scaffold structure, core-shell structure, layer self-assembly, hydrogel, and gene carrier. A sustained-release system composed of different sustained-release structures combined with different growth factors can promote bone regeneration and angiogenesis. Conclusion Due to its controllability and persistence, the growth factor sustained-release system has become a research hotspot in bone tissue engineering and has broad application prospects.
Research of generating real-world evidence using real world data has attracted considerable attention globally. Outcome research of treatment based on existing health and medical data or registries has become one of the most important topics. However, there exists certain confusions in this line of research on how to design and implement appropriate statistical analysis. Therefore, in the fourth chapter of the series technical guidance to develop real world evidence by China REal world data and studies Alliance (ChinaREAL), we aim to provide an guidance on statistical analysis in the study to assess therapeutic outcomes based on existing health and medical data or registries.In this chapter, we first emphasize the significance of pre-specified statistical analysis plan, recommending key components of the statistical analysis plan. We then summarize the issue of sample size calculation in this content and clarify the interpretation of statistical p-value. Secondly, we recommend procedures to be considered to tackle the issue related to the selection bias, information bias and most importantly, confounding bias. We discuss the multivariable regression analysis as well as the popular causal inference models. We also suggest that careful consideration should be made to deal with missing data in real-world databases. Finally, we list core content of the statistical report.
As an important source for real-world data, existing health and medical data have gained wide attentions recently. As the first part of the serial technical guidance for real-world data and studies, this report introduced the concepts, features and potential applications of existing medical and health data, proposed recommendations for planning and developing a research database using existing health and medical data, and developed essential indicators for assessing the quality of such research databases. The technical guidance may standardize and improve the development of research database using existing health and medical data in China.