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OBJECTIVE:To explore the incidence,clinical manifestations and influential factors of ADR induced by Xuebi-jing injection,and to provide reference for safe and rational use of it. METHODS:The inpatients who used Xuebijing injection in our hospital during Jan. 2012 to Dec. 2016 was registered and monitored centrally,and analyzed statistically in respects of clinical characteristics,occurrence time of ADR,clinical manifestation,outcome,etc.RESULTS:A total of 3 300 patients records were in-cluded,involving 81 ADR cases with incidence of 2.45%. There was no correlation between ADR and gender. The incidence of ADR was in high level in the patients with age over 60 years(6.53%),history of allergy(72.84%),original diseases as respirato-ry disease(3.33%),blood system disease(3.11%)and central nervous system disease(3.03%),and receiving combination of TCM injection(34.57%),antibiotics(25.93%)and immune enhancer(14.81%). Single-day culmulative amount with no more than 50 mL had relatively higher proportion(36.67%),and there was no statistical significance in the ADR with different sin-gle-day culmulative amounts(P>0.05). 38.27% of ADR occurred within 30 min after first medication. Organs/systems involved in ADR were mainly skin and its appendants(37.04%),cardiovascular system(19.75%)and gastrointestinal system(14.81%). To-tally 15 cases had severe ADR,which were mainly anaphylactic shock(33.33%,5/15)and systemic rash(20.00%,3/15). All ADR were recovered after drug withdrawal or symptomatic treatment. CONCLUSIONS:ADR induced by Xuebijing injection are mainly anaphylactic type. The incidence of ADR is higher in patients with primary respiratory disease,blood system disease,drug combination,allergic history and advanced age. The part of them are not mentioned in drug package inserts.Manufacturers are sug-gested to collect ADR information and improve drug package insets in time.
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OBJECTIVE:To explore the incidence,clinical manifestations and influential factors of ADR induced by Xuebi-jing injection,and to provide reference for safe and rational use of it. METHODS:The inpatients who used Xuebijing injection in our hospital during Jan. 2012 to Dec. 2016 was registered and monitored centrally,and analyzed statistically in respects of clinical characteristics,occurrence time of ADR,clinical manifestation,outcome,etc.RESULTS:A total of 3 300 patients records were in-cluded,involving 81 ADR cases with incidence of 2.45%. There was no correlation between ADR and gender. The incidence of ADR was in high level in the patients with age over 60 years(6.53%),history of allergy(72.84%),original diseases as respirato-ry disease(3.33%),blood system disease(3.11%)and central nervous system disease(3.03%),and receiving combination of TCM injection(34.57%),antibiotics(25.93%)and immune enhancer(14.81%). Single-day culmulative amount with no more than 50 mL had relatively higher proportion(36.67%),and there was no statistical significance in the ADR with different sin-gle-day culmulative amounts(P>0.05). 38.27% of ADR occurred within 30 min after first medication. Organs/systems involved in ADR were mainly skin and its appendants(37.04%),cardiovascular system(19.75%)and gastrointestinal system(14.81%). To-tally 15 cases had severe ADR,which were mainly anaphylactic shock(33.33%,5/15)and systemic rash(20.00%,3/15). All ADR were recovered after drug withdrawal or symptomatic treatment. CONCLUSIONS:ADR induced by Xuebijing injection are mainly anaphylactic type. The incidence of ADR is higher in patients with primary respiratory disease,blood system disease,drug combination,allergic history and advanced age. The part of them are not mentioned in drug package inserts.Manufacturers are sug-gested to collect ADR information and improve drug package insets in time.
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OBJECTIVE:To systematically review the clinical efficacy and safety of macrolide antimicrobial drugs in the adju-vant treatment of lung infection of Pseudomonas aeruginosa (PA) and provide evidence-based reference for the clinical treatment. METHODS:Retrieved from PubMed,Ovid,CJFD,VIP,CBM and Wangfang database,randomized controlled trials(RCT)about sensitive antimicrobial drugs of PA combined with macrolide antimicrobial drugs (test group) vs. sensitive antimicrobial drugs of PA alone(control group)in the treatment of lung infection of PA were included and comprehensively evaluated using Jadad scale. The homogeneity results were analyzed by Rev Man 5.2 software. RESULTS:13 RCTs were included,involving 872 patients. Me-ta-analysis showed that the effective rate [OR=6.42,95%CI(4.23,9.74),P<0.001] and PA clearance rate[OR=6.10,95%CI(4.10, 9.09),P<0.001] in test group were significantly higher than control group;the time of body temperature returned to normal[MD=-1.14,95%CI(-1.35,-0.94),P<0.001],time of cough sputum disappearance [MD=-1.70,95%CI (-1.97,-1.44),P<0.001] and time of the blood returned to normal[MD=-1.24,95%CI(-2.04,-0.43),P<0.001] were significantly shorter than control group,there were significant difference between 2 groups. There was no significant difference in the incidence of adverse re-action [OR=1.30,95%CI(0.73,2.31),P=0.37]. CONCLUSIONS:Macrolide antimicrobial drugs have good efficacy and safety in the adjuvant treatment of PA infection. Duo to the limit of research methodology quality,it remains to be further verified by large-sample and high-quality RCT.
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OBJECTIVE:To establish a method to determine the content of chlorogenic acid in Yinhuang qinghuo capsule. METHODS:HPLC was performed on the column of Acclaim120? C18 with mobile phase of acetonitrile-0.4% phosphoric acid(12:88,V/V)at flow rate of 1 ml/min,the detection wavelength was 327 nm,column temperature was 25 ℃,and volume injection was 10 μl. RESULTS:The linear range of chlorogenic acid was 56-224 μg;RSDs of precision,stability and reproduciblity tests were lower than 3.0%,recovery was 96.91%-104.76%(RSD=1.46%,n=9). CONCLUSIONS:The method is simple and reproducible, and can be used for the quality control of Yinhuang qinghuo capsule.
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Objective To systemically review the efficacy and safety of low dose spironolatone combined with angiotensin convertig enzyme inhibitors (ACEI) or angiotensin Ⅱ receptor blockers (ARB) on diabetic nephropathy.Methods PubMed,the Cochrane library (Issue 4,2014),CBM,CNKI,VIP and WanFang Data were searched from inception to July 2014 for randomized controlled trials (RCTs) concerning ACEI or ARB combined with low-dose spironolatone in the treatment of diabetic nephropathy.Two reviewers screened literature according to the inclusion and exclusion criteria,extracted data,and assessed the methodological quality of included studies.Then Meta analysis was performed using RevMan 5.2 software.Results A total of 19 RCTs involving 1313 patients were included in this study.The results of Meta-analysis showed that compared with ACEI or ARB treatment alone,ACEI or ARB combined with low-dose spironolatone had lower urinary albumin excretion rate (UAER) [mean difference (MD) =21.03,95％ CI:18.51-23.56,P＜ 0.01] and proteinuria (MD=171.29,95％ CI:81.96-260.62,P＜0.01),and had no influence on plasma albumin (Alb) (MD=-0.25,95％ CI:-0.66-0.17,P＞0.05),meanwhile had lower serum creatinine (Scr) (MD=2.63,95％CI:0.92-4.34,P＜0.05),but had higher concentration of blood potassium (MD=-0.26,95％ CI:-0.37-0.14,P＜0.01).Conclusions ACEI or ARB combined with low-dose spironolactone can significantly reduce the urinary albumin level and delay the deterioration of renal function.Blood potassium concentrations in most patients are within the normal range,although it is increased after the treatment of ACEI or ARB combined with low-dose spironolactone.