Objective
To investigate the method and effect of continuous improvement of adverse drug reaction (ADR) monitoring in a major public hospital’s cooperating branch hospital.
Methods
PDCA cycle management was used to continuously improve the quality of ADR monitoring. ADR report network platform was established in the fourth quarter of 2014; ADR report specification training for the medical personnel was held in the first quarter of 2015; a examine mechanism was built in the second quarter of 2015. The quality and quantity of ADR monitoring before and after the PDCA cycle management were analyzed.
Results
ADR report timeliness conform to the requirements increased from 45.5% (from the first to third quarter of 2014) to 98.1% (from the fourth quarter of 2014 to the second quarter of 2015); accurate ADR types checking, normal name writting, and complete process description increased from 68.6%, 65.7%, 8.6% (from January 2014 to Frequency 2015) to 92.9%, 96.4%, 85.7% (from March to June 2015); the quantity of ADR report was obviously improved.
Conclusion
Learning from public hospital’s experience and considering its own condition in ADR monitoring, cooperating branch hospital utilizes PDCA cycle management which could continuously improve the ADR monitoring.
Objective To assess the effectiveness of exemestane in the treatment of postmenopausal women with breast cancer. Methods We searched The Cochrane Library, PubMed, CBMdisc, and CNKI to identify randomized controlled trials (RCTs) that met the inclusion and exclusion criteria. Two reviewers extracted the data and evaluated the quality of included trials, respectively. Meta-analysis was performed using RevMan 5.0 software. Results A total of 12 RCTs involving 6 166 participants were included, and the results of meta-analyses showed that: (1) When used in neoadjuvant endocrine therapy after operation, exemestane was more effective in progression-free survival than tamoxifen; (2) When used in rescue therapy, exemestane was more effective in objective response than tamoxifen, but not more effective than letrozole or anastrozole; (3) When used in new neoadjuvant endocrine therapy before operation, exemestane was not more effective than letrozole, and there was too little research about it. Conclusions The current evidence shows that exemestane has certain short-term therapeutic effect, but its long-term therapeutic effect is unknown. More high-quality clinical trials are expected for further study.
Objective To systematically review the effectiveness and safety of erlotinib for the elderly with Non-small-cell lung cancer (NSCLC). Methods Databases including The Cochrane Library, PubMed, EMbase, CBM, VIP, CNKI and WanFang Data were electronically searched for relevant randomized controlled trails (RCTs). Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.0 software. Results Totally 5 studies were included. The results of meta-analysis showed that, the objective response rate and stable disease rate was similar between the erlotinib group and the control group with no significant difference (RR=0.99, 95%CI 0.34 to 2.93, P=0.99; RR=1.17, 95%CI 0.95 to 1.43, P=0.14). The incidences of Grade Ⅲ-Ⅳ neutropenia and thrombocytopenia were lower in the erlotinib group than those in the control group (OR=0.12, 95%CI 0.03 to 0.52, P=0.005; OR=0.19, 95%CI 0.04 to 0.91, P=0.04); and the incidences of nausea and vomiting as wel as liver impairments were alike between the two groups (OR=0.93, 95%CI 0.12 to 7.08, P=0.95; OR=0.80, 95%CI 0.24 to 2.68, P=0.71); the incidences of diarrhea and skin rashes in the erlotinib group were higher (OR=5.96, 95%CI 1.28 to 27.88, P=0.02; OR=6.77, 95%CI 1.52 to 30.10, P=0.01). Conclusion Current evidence shows that, erlotinib is effective and safe in treating the elderly with NSCLC with better effects and no serious adverse reaction. However, due to the limited quantity and quality of the included studies, more high quality studies with large sample size and long-term follow-up are still needed to verify the above conclusion.
Objective To review the efficacy and safety of Kushenin combined with Adefovir Dipivoxil for Chronic Hepatitis B (CHB). Method Randomized controlled trails of Kushenin combined with Adefovir Dipivoxil for CHB were gathered from PubMed, CBMdisc (1978 to 2009), and CSJD (1989 to 2009), while other relative researches were searched manually; every research was evaluated, and then analyzed with RevMan 5.0.0 software. Result Ten randomized controlled trials were included; among total 855 patients, 436 were in trial group and the other 419 were in control group. As the Meta-analysis showed, the therapeutic effect of kushenin combined with Adefovir Dipivoxil was better than that of Adefovir Dipivoxil in aspects of improving the negative rate of serum ALT (RR=1.28, 95%CI 1.17 to 1.40), the negative rate of serum HBV-DNA (RR=1.27, 95%CI 1.13 to 1.42), the negative rate of serum HBeAg (RR=1.80, 95%CI 1.32 to 2.44), and the conversion rate of HBeAg and anti-HBe (RR2.06, 95%CI 1.43 to 2.95). Conclusion Kushenin combined with Adefovir Dipivoxil in treating CHB can improve the conversion rate of HBeAg and anti-HBe and further take better therapeutic effect.
【摘要】 目的 探討非諾貝特致藥品不良反應（ADRs）的一般規律和特點。 方法 檢索PubMed（1978年-2009年8月）、中國期刊全文數據庫CNKI（1980年-2009年8月）、中國生物醫學文獻數據庫CBMDise（1980年-2009年8月）非諾貝特所致ADRs文獻，進行統計、分析。 結果 非諾貝特致ADRs多發生在gt;40歲年齡段，與性別無顯著關聯；64例ADRs主要涉及骨骼肌肉系統、消化系統、泌尿生殖系統、過敏反應，及時處理者預后良好。 結論 臨床上應重視非諾貝特所致ADRs，及時處理。【Abstract】 Objective To analyse the clinical features, correlation factors, preventions and cures of (adverse drug reactions, ADRs) caused by fenofibrate. Methods The cases of ADRs caused by fenofibrate were collected and analyzed from Pubmed (1978 - August 2009), CNKI (1980 - August 2009) and CBMDise (1980 - August 2009). Results Fenofibrate-induced ADRs were mostly seen in patients over 40 years old, but which was independent for sex. Totally, 64 ADRs were involved in the skeletal musculature system, digestive system, urinogenital system, and allergic response. The prognosis was favorable. Conclusion More attention should be given to patients with fenofibrate and ADRs should be treated as soon as possibile.
Objective To evaluate the efficacy and safety of saxagliptin in type 2 diabetes patients. Methods The following databases as The Cochrane Library (Issue 2, 2011), PubMed (1978 to May 2011), EMbase (1974 to May 2011), CNKI (1978 to May 2011), VIP (1989 to May 2011) and CBM (1978 to May 2011) were searched. The quality of included randomized controlled trials (RCTs) was assessed according to the Cochrane Collaboration system review, and then meta-analysis was performed using RevMan 5.0. Results A total of 7 RCTs were included. The results of meta-analyses showed that HbA1c was significantly reduced in the saxagliptin group than that in placebo group (MD= –0.69, 95%CI –0.78 to –0.60, Plt;0.000 01). There was no significant difference in the incident rate of adverse reaction between two groups (RR=1.02, 95%CI 0.98 to 1.06, P=0.26). Conclusion Saxagliptin is effective and safe for type 2 diabetes. But its long-term efficacy and safety still need to be confirmed by performing more high quality, large sample RCTs with long-term follow-up.
Objective To investigate the relationship between adipocyte fatty acid binding protein ( A-FABP) and obstructive sleep apnea hypopnea syndrome ( OSAHS) . Methods A total of 120 patients were recruited and underwent polysomnography. The groups were allocated according severity of OSAHS and obesity. Plasma A-FABP ( ng/mL) levels were measured by ELISA. The associations between A-FABP and AHI, BMI, LSaO2 , MSaO2 , neck collar, waist /hip ratio, insulin resistance index were analyzed. Results Plasma A-FAPB levels were significantly higher in the OSAHS group than in the non-OSAHS group of same weight, independent of age and gender. In the non-OSAHS group and the severe OSAHS group, plasma A-FABP levels of obesity persons were significantly higher than those without obesity, independent of age and gender. Plasma A-FAPB level was positively correlated with AHI, BMI, insulin resistance index, neck collar, SLT90% , and waist/hip ratio, but negatevely correlated with LSaO2 and MSaO2 in the OSAHS group. In the non-OSAHS group, plasma A-FAPB level was positively correlated with BMI and insulin resistance index. Conclusions Plasma A-FABP level is higher in patients with severe OSAHS. Plasma A-FABP level is positively correlated with BMI and insulin resistance index both in OSAHS and non-OSAHS patients.
Objective
To evaluate the effect of physician-nurse-pharmacist collaboration on cardiovascular disease risk factors in diabetes patients.
Methods
Randomized controlled trails (RCTs) on collaboration among physicians, nurses and pharmacists for reducing cardiovascular disease risk factors in diabetes patients were collected from Cochrane Central Register of Controlled Trials, Medline (Ovid SP), Embase, China Knowledge Resource Integrated Database, VIP and WanFang. We screened the retrieved studies according to the inclusion and exclusion criteria, evaluated the quality of included studies, and then performed meta-analysis with the Cochrane Collaboration’s Revman 5.3.0 software.
Results
Seven RCTs were included. The results of meta-analysis showed that the change in glycosylated hemoglobin A1c, systolic blood pressure, diastolic blood pressure and low density lipoprotein-cholesterol were significantly reduced in the collaboration group than in usual care group [SMD=–0.39, 95%CI (–0.56, –0.21),P<0.000 1;SMD=–0.30, 95%CI (–0.43, –0.18),P<0.000 01;SMD=–0.37, 95%CI (–0.64, –0.11),P=0.006;SMD=–0.11, 95%CI (–0.16, –0.06),P<0.000 1].
Conclusions
Collaboration among physicians, nurses and pharmacists is effective for reducing cardiovascular disease risk factors in diabetes patients. But its long-term efficacy still needs to be confirmed by performing higher quality, large sample RCTs with long-term follow-up.
