Objective To investigate the information of label use of high-alert drugs for children of high risk population, in the Military General Hospital of Beijing PLA. Methods We selected high-alert drugs used in this hospital as objectives. The package inserts of these drugs were investigated and medication parts for children were analyzed. Results 201 drugs regarded as high-alert drugs were included, of which only 78 drugs have accurate detailed description of medication for children, accounting for 38.8% of the total of investigated high-alert drugs. Conclusion Children, as high-risk population, needs more attention concerning the use of high-alert drugs. However, risks in the use of high-alert drugs increased due to the lack of the information of label use of high-alert drugs. To ensure the safety of drug use in children, the information of drug use for children in the package inserts should be urgently supplemented.
Objective To analyze drug use for 23 sick and wounded hospitalized in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital, during one month after Lushan earthquake, so as to provide references for the drug use for the sick and wounded women and children. Methods Medication information was retrospectively investigated in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital during one month after Lushan earthquake. We extracted data including hospitalization duration, medication prescriptions, types and costs of essential medicines, types and costs of antibiotic medicines using the HIS system. Discharge diagnosis was standardized and classified according to ICD-10. Indicators of rational drug use included defined daily dose (DDD), defined daily dose statistic (DDDs), drug utilization index (DUI), children defined daily dose (cDDD), children drug utilization index (cDUI), proportion of essential medicines, proportion of antibiotic medicines, mismatch of medicine and diagnosis, repeated drug use, improper combination of drug, incorrect usage and dosage, and frequently drug change. Medication information was evaluated and discussed by the prescription working group. Discrepency was resolved by consulting with the panel. Results A total of 23 sick and wounded women and children were assessed during one month after Lushan Earthquake. There were 13 sick and wounded children in the department of pediatrics (mainly manifested as bronchial pneumonia) and 10 sick and wounded women in the department of gynaecology and obstetrics (mainly involved in cesarean delivery). Proportions of essential medicines were 13/13 in the department of pediatrics and 9/10 in the department of gynaecology and obstetrics. Proportions of antibiotic medicines were 10/13 in the department of pediatrics and 8/10 in the department of gynaecology and obstetrics. Irrational drug use was mainly caused by improper use of antibiotics. Conclusion The drug use for 23 hospitalized sick and wounded is rational in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital during one month after Lushan earthquake. Evaluation methods of rational drug use in high-risk population are urgently needed. Using cDDD and cDUI is an active exploration for the evaluation of pediatric drug use, which needs more practice to test and improve.
Objective To evaluate the efficacy and safety of adalimumab for rheumatoid arthritis failing to respond to disease-modifying anti-rheumatic drugs (DMARDs). Methods The Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP and Wanfang (from the date of their establishments to June 2010) were searched, and journals of relevant fields were retrieved to identify randomized controlled trials (RCTs). The data were analyzed by using RevMan 5.0 software. Results Four RCTs were included, all of which were from abroad and with good methodological quality. The baseline data of each trial were comparable. Meta-analyses showed that there was a significant difference between the adalimumab and the placebo in terms of ACR20, ACR50, ACR70, tender joint count, swollen joint count, patient assessment of pain, patient global assessment of disease activity, doctor global assessment of disease activity, and disability index of the HAQ. There was no difference between the adalimumab and the placebo in terms of serious adverse events, intractable adverse events and serious infection. Conclusion Adalimumab can treat rheumatoid arthritis failing to respond to DMARDs, but clinically the doctor should balance the benefit and the risk of the adalimumab.
Objective To investigate the use of oral anti-diabetic drugs and sugar blood control situation in advanced aged patient with diabetic mellitus in a community health centre in order to provide references for rational drug use. Methods A cross-sectional survey about oral anti-diabetic drugs was carried out in senile diabetic patients who visited the community health centre and established complete health documents voluntarily from February 2012 to February 2013. Results There were 176 cases of advanced aged patients with type 2 diabetic mellitus, of which, 107 cases were female and 69 cases were male, whose age ranged from 80 to 94. Among 176 cases, there were 107 (60.80%) patients with type 2 diabetic mellitus combined with hypertension, chronic heart diseases, and stoke; 155 had oral anti-diabetic drugs (88.06%). 67.19% of patients who took one oral anti-diabetic drug chose α-glycosidase inhibitors, followed by sulfonylurea. 53.73% of patients who received combination therapy chose glycosidase inhibitors and sulfonylurea. For the treatment of anti-diabetic drugs, 73.68% of patients met the criteria (fasting blood sugar: no more than 8.0 mmol/L), with control rates of 73.56% for α-glycosidase inhibitors and 72.58% for sulfonylurea. More than half of the patients could not be evaluated for their glycosylated hemoglobin levels were not tested. Conclusion Doctors working in community health centres should choose oral anti-diabetic drugs according to patients’ own conditions when treating advanced aged patients with diabetic mellitus in order to avoid adverse reaction such as hypoglycemia. Glycosidase inhibitors are the mostly used drug in the community health centre because it is safe with less adverse reaction when used in senile people and it could ideally control their blood sugara.
What drug dosage range is appropriate for treatment? What drug dosage range can maximally reduce the incidence of adverse drug reaction (ADR)? The gold zone method as a new method of evidence-based medical research was proposed to study those two blind areas of drug dosage in this article. Studying the dose-effect relationship, taking gold zone as the middle range and dividing empirical range into 3 sections were the key to study design. The evidence-based survey with extremely large sample showed a U-shaped rule existing between the antibiotics’ dosage and the incidence of ADR; and the dosage in gold zone appeared at the bottom of U-shaped curve. The gold zone method for determining dosage is a special breakthrough currently for solving those two blind areas of drug dosage
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.
The re-evaluation of the effectiveness of new drugs is of great importance when they are in post-market for there exist some limitations in clinical trials before these drugs are put on the market. The large sample multi-centre randomized controlled trial is the best method of re-evaluation of the effectiveness of new drugs. It could appropriately evaluate not only the large-term efficacy and safety of drugs, but the treatment effect on the survival state and its complications as well. This method will also lead to a great social amp; economic benefit.
Medical ethics must be considered for protecting the fights and interests of patients in clinical trials. Now the fights of the subjects are more and more emphasised, but there are some problems. It is evidence-based medicine (EBM) and emphasis of evidence that need the high-quality clinical trials, yet it violates the principle of ethics in some degree. It will be helpful for the administrators to supervise the clinical trials on drugs well from the point of ethical views.
Food and Drug Administration (FDA) has suspended the use of both celecoxib (Celebrex, Pfizer) and naproxen (Aleve, Bayer) in prevention large clinical trials after discovering that celecoxib and naproxen appeared to increase the risk of cardiovascular events with patients on placebo. FDA also advises patients who are currently taking over the counter naproxen products to carefully follow the instructions on the label. Pfizer suggested that alternatives to celecoxib should be considered based on individual patient needs and risk. The cardiovascular community responds differently.