ObjectiveTo systematically evaluate the efficacy and safety of radiofrequency ablation versus amiodarone in the treatment of atrial fibrillation, so as to provide reference for the chosen of clinical treatment options. MethodsWe searched PubMed, The Cochrane Library (Issue 10, 2014), CNKI, VIP and WanFang data from inception to October 2014 to collect randomized controlled trials (RCTs) comparing radiofrequency ablation versus amiodarone for atrial fibrillation. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 4 RCTs involving 511 atrial fibrillation patients were included. The results of meta-analysis showed that:compared with amiodarone, radiofrequency ablation could reduce the risk of atrial fibrillation recurrence (RR=0.35, 95%CI 0.22 to 0.55, P<0.000 01). There was no significant difference in all-cause mortality (RR=0.97, 95%CI 0.17 to 5.61, P=0.97) between both groups. The incidence of adverse events in the radiofrequency ablation group was 7.7%, and was lower than 12.7% of the amiodarone group, but there was no significant difference between the two groups. ConclusionCurrent evidence shows that, compared with amiodarona, radiofrequency ablation is related to lower recurrence rate and higher efficacy, but there is no difference in the safety between the two interventions. However, due to the limited quality and quantity of included studies, higher quality studies are needed to verify the above conclusion.
ObjectiveBased on the off-label drug use (OLDU) record application of Alprostadil injection (LipoPGE1) which was the only one rejected in the Guangdong General Hospital in 2013, the interventional measures were carried out to reduce unreasonable off-label drug use of Lipo-PGE1. MethodsMedical orders about OLDU in dosage of Lipo-PGE1 were intervened in through education, communication and monitoring. The situation of drug use was summarized in all departments after intervention through exporting all the medical orders about inpatients' use of LipoPGE1 during hospitalization in August, 2013 to July, 2014 and OLDU incidence in dosage, prescribed daily dose (PDD) and drug use density (DUD) in each department were calculated. The interventional effect was analyzed by comparing with the baseline data. Resultsa) A total of 78 044 medical orders involving 6 426 case-times were analyzed. According to the data of cases, medical orders and drug use amount, the OLDU incidences were 8.68%, 5.87% and 10.53%, respectively, compared with 34.43%, 25.16% and 41.37% before intervention had declined significantly (P < 0.05). OLDU occurred in 69.44% departments (25/36) before intervention and declined to 55.56% (20/36) after intervention. b) OLDU incidences of 22 departments were declined after intervention. There were 2 departments with the OLDU incidence in dose > 20%: ICU (39.68%) and cardiac surgery (32.78%). c) After the intervention, the PDD of the whole hospital fell to 10.52μg from 12.77μg and DUD fell to 8.87 from 15.12. There were 20 departments whose PDDs were off-label and 3 departments whose PDDs were above the average level of the whole hospital after the intervention. The three departments were ICU (13.61μg), cardiac surgery (12.68μg) and rheumatology (11.26μg). ConclusionExtensive publicity and education, targeted communication and regular monitoring and feedback are effective measures to intervene in unreasonable OLDU. After intervention, the phenomenon of off-label drug use of Lipo-PGE1 is improved significantly. This study provides a workable avenue to manage off-label drug use in hospital.
ObjectiveBased on the off-label drug use (OLDU) record application of alprostadil injection (Lipo-PGE1) which was the only one rejected in the Guangdong General Hospital in 2013, we retrospectively investigated all the background information of inpatients' OLDU of Lipo-PGE1 in 2012, so as to provide references for intervention of OLDU and effect evaluation. MethodsAccording to OLDU in dose record application of clinical departments, we summarized medical orders about inpatients' use of Lipo-PGE1 during hospitalization in 2012 and analyzed OLDU situation according to drug labels. Then, we summarized situation of drug use in all departments, analyzed OLDU incidence in dose, calculated prescribed daily dose (PDD) and drug use density (DUD) in each department to evaluate the degree of OLDU in dose. Resultsa) A total of 106 576 medical orders involving 8 620 case-times were analyzed. According to the data of cases, medical orders and drug use amount, the OLDU incidences were 34.43%, 25.16% and 41.37%, respectively. Lipo-PGE1 was used in every clinical department in this hospital and OLDU occurred in 69.44% departments (25/36). b) According to the number of medical orders, there were 6 departments with the OLDU incidence in dose > 50% and 5 departments with the OLDU incidence in dose during 50% to 20%. c) The average of PDD of the whole hospital was 12.77 μg. A total of 25 departments' PDDs were off-label, and 10 departments' PDDs were above the average level of the whole hospital. The ICU's PDD was the highest, with 2.35 times more than label dose. d) The PDD in each department was not directly proportional to DUD, which indicated the degree of OLDU in dose was not directly proportional to use intensity. This may be caused by different disease burdens in departments. ConclusionLipo-PGE1 is widely used in the Guangdong General Hospital where OLDU in dose occurs commonly. Since PDD and DUD reflect different contents, the two indicators should be combined to monitor OLDU.
ObjectiveTo compare the cost-effectiveness of warfarin and enoxaparin overlapping treatment for the prevention of venous thromboembolism (VTE) or pulmonary embolism (PE) in patients with nephrotic syndrome (NS). MethodsA decision tree model was constructed. The efficacy data applied in our decision tree were from clinical data, and the cost data was based on the hospitalization cost of 103 patients with nephrotic syndrome in Guangdong Provincial People's Hospital from 2013 to 2014, State Development and Reform Commission pricing and literature report. The one-way sensitivity analyses was conducted to analyze the stability of test. ResultsIn base case, the cost and cost-effective ratio of warfarin and enoxaparin overlapped treatment for 3 days were 10305.49 yuan and 31607.15, respectively. While those overlapped treatment for 4 days were 8849.36 yuan and 20896.46, overlapped treatment for 5 days and above were 9494.29 yuan and 21659.95, respectively. The incremental cost-effectiveness ratio of 4 days versus 5 days and above was 5600.96. The cost-effective ratio of 4 days was lower but the incremental cost-effectiveness ratio of it was higher. The sensitivity analysis showed the test result was stable. ConclusionCost-effectiveness analysis shows that warfarin and enoxaparin overlapping treatment for 4 days in patients with nephrotic syndrome has cost-effective advantage. Due to the limited sample size of our study, the above conclusion should be proved by more large-scale high-quality clinical studies.
ObjectiveTo investigate the situation of off-label drug use in dose (OLDUD) of ambroxol hydrochloride injection (AHI) in perioperative period among patients for stanford type A aortic dissection in Guangdong General Hospital, so as to provide references for the rational application of AHI in clinical practice. MethodsAll medical orders of AHI for patients had aortic arch replacement for Stanford type A aortic dissection in Guangdong General Hospital between January 2005 and December 2014 were included. The patients were divided into a mild OLDUD ( < 450 mg) group, a moderate OLDUD (450 mg≤OLDUD < 900 mg) group, and a high OLDUD (≥900 mg)group. The preoperative and postoperative features, incidence of PPCs, mortality, incidence of reintubation, time of mechanical ventilation, time stay in ICU, time stay in hospital and the overall costs among three groups were compared by SPSS 22.0 software. Resultsa) A total of 549 patients were included. The incidence of OLDUD was 99.82%. The most common PMDDs were 450 mg (n=358) and 900 mg (n=88). b) The three groups were well matched for perioperative and operative variables. c) The incidence of preoperative drug use was 8.6%. The incidences (5.5% vs. 7.7% vs. 15.7%, P=0.022) and maximum doses (180 mg vs. 300 mg vs. 450 mg, P=0.014) of preoperative drug use were statistically different in mild OLDUD, moderate OLDUD and high OLDUD groups. The days of preoperative drug use were not different (3 d vs. 2.5 d vs. 2 d, P=0.307). The days of postoperative drug use (9.5 d vs. 13 d vs. 19 d, P < 0.001) and postoperative drug use in maximum doses (7 d vs. 8 d vs. 7 d, P=0.005) were different. d) The incidence of PPCs was 100%, and the mortality (8.2% vs. 6.6% vs. 9.0%, P=0.696) was not statistically different among mild OLDUD, moderate OLDUD and high OLDUD groups. However the incidence of reintubation (14.3% vs. 13.8% vs. 27%, P=0.009), time of mechanical ventilation (37 h vs. 50 h vs. 114 h, P < 0.001), time stay in ICU (138 h vs. 178.5 h vs. 316 h, P < 0.001), time stay in hospital (25 d vs. 27 d vs. 34 d, P=0.001) and the overall costs (¥ 0.17 million vs. ¥ 0.19 million vs. ¥ 0.25 million, P < 0.001) were different among three groups. Moreover, they were all increasing along with the dose of AHI. ConclusionAHI cannot improve the prognosis of patients having aortic arch replacement for Stanford Type A Aortic Dissection in a dose-dependent manner. Further well-designed prospective studies should be conducted to verification or falsification.
ObjectiveTo retrospectively analyze off-label drug use (OLDU) situation of ambroxol hydrochloride injection (AHI) among inpatients in the Guangdong General Hospital in 2012, so as to provide references for AHI OLDU. MethodsAll medical orders of AHI for inpatients in the Guangdong General Hospital in 2012 were included, and OLDU was judged according to drug labels. We summarized situation of drug use in all departments, analyzed OLDU incidence in administration path and in dose, calculated prescribed daily dose (PDD) and utilization index (DUI) in each department to evaluate the degree of OLDU in dose. Resultsa) A total of inpatients 138 227 patient-days who used AHI were included. OLDU occurred in all departments in this hospital and the total OLDU incidence was 67.06%. b) OLDU in dose occurred in 71.43% of the departments (25/35) with an incidence of 29.53%; the top 4 departments were cardiac surgery intensive care unit department (CICU) (97.74%), cardiac surgery department (97.51%), pediatric cardiac surgery department (72.30%) and pediatric intensive care unit department (PICU) (70.28%) in order. c) The PDDs in CICU department, cardiac surgery department, PICU departments, pediatric cardiac surgery department, oncological surgery ward, neurosurgery ward and intensive care unit (ICU) were higher than the defined daily dose (DDD), of which, the DUI/cDUI in CICU, cardiac surgery department, PICU and pediatric cardiac surgery department were 1 to 3 times higher than normal level. d) No relevant adverse drug reaction/adverse event (ADR/AE) reports were received in this hospital in 2012. ConclusionAHI is widely used in the Guangdong General Hospital, and AHI OLDU is commonly-seen. Further studies should be conducted to analyze the influence factors of AHI OLDU in dose and to evaluate the rationality of its application.
A study on clinical management methods and process of off-label drug use (OLDU) is carried out at managerial level in the Guangdong General Hospital to develop management regulations, processes and strategies of OLDU, so as to regulate OLDU behaviour in clinic. The hospital officially initiated the application-recording-approval process of OLDU in February, 2013, receiving 22 OLDU applications from 5 clinical departments in the first batch. The pharmacy management and pharmacotherapeutics committee approved eight applications and rejected one application according to regulation procedures. In this way, the Guangdong General Hospital well regulate the OLDU behaviour of physicians, which is significant to the further studies in OLDU in this hospital.