1.Clinical verification of vancomycin population pharmacokinetics in patients with augmented renal clearance
Haodi LU ; Lian TANG ; Shengmin XUE ; Zhiwei ZHUANG ; Jie FANG ; Fuli ZHAO ; Erning SHANG
Chinese Critical Care Medicine 2018;30(5):444-448
Objective To evaluate the predictive value and to verify the clinical effect of JPKD-vancomycin for the trough concentration of vancomycin in patients with augmented renal clearance (ARC), and to provide a reference for clinical individualized drug therapy. Methods A retrospective analysis was conducted. The clinical data of 48 adult patients with ARC using vancomycin and monitoring steady-state trough concentration of vancomycin admitted to Suzhou Hospital Affiliated to Nanjing Medical University from July 2013 to July 2017 were collected. A combination of classical Vancomycin Calculator software and JPKD-vancomycin software was used. Based on the individual conditions of patients [gender, age, height, weight, serum creatinine (SCr), disease status], Vancomycin Calculator software was used to obtain the recommended regimen and its steady-state trough concentration, and then JPKD-vancomycin software was used to predict the steady-state trough concentration of initial regimen. If the regimen was adjusted during the treatment, JPKD-vancomycin software was used to predict the steady-state trough concentration of the adjusted regimen. The measured values of steady-state trough concentration were recorded. The weight deviation between predicted concentration and measured concentration (WRES) was calculated. WRES < 30% was considered as good prediction, and the predictive value of JPKD-vancomycin software was evaluated for vancomycin trough concentration. Results Forty-eight patients with ARC were enrolled, of whom 24 patients had adjusted the dosing regimen during the treatment. The initial concentration of blood samples was 48, after adjusting the dosage regimen, 24 blood samples were collected. The initial and adjusted daily dose of vancomycin was (2 000±500) mg/d and (2 500±600) mg/d, respectively, and the initial trough concentrations and adjusted trough concentrations was (8.4±7.3) mg/L and (9.1±4.3) mg/L, respectively. Only 14.6% and 25.0% of initial and adjusted trough concentrations reached the target range (10-20 mg/L) without significant difference (P > 0.05). The WRES value of adjusted trough concentrations predicted by JPKD-vancomycin software was significantly lower than that of initial regimen [10.6% (3.0%, 16.4%) vs. 14.3% (10.5%, 38.2%), P < 0.05], and the percentage of WRES < 30% also tended to increase [95.8% (23/24) vs. 70.8% (34/48), P < 0.05]. The well predictive rate of JPKD-vancomycin software for vancomycin trough concentration was 79.2% (57/72), but there were 15 patients with WRES > 30%. Conclusions JPKD-vancomycin software has good predictive value for the vancomycin trough concentration of ARC patients, especially for the trough concentration after adjusting the treatment regimen. JPKD-vancomycin can provide a reference for the design of clinical individualized application of vancomycin.
2.Pharmaceutical Care on Anti-infection Therapy of Patients with Augmented Renal Clearance
Lian TANG ; Qi DING ; Fuli ZHAO ; Gang WU ; Guangxiang CHEN ; Erning SHANG
Herald of Medicine 2017;36(4):439-441
Objective To investigate the role of clinical pharmacist in anti-infection therapy for patients with augmented renal clearance (ARC).Methods A case with multi-site severe infection after traffic accident was treated with anti-infection therapy.According to the characteristics of infection and pharmacokinetics,clinical pharmacist discussed the intervention by clinical pharmacist in terms of formulating anti-infection program and adjustment of individual dose.Results After consultation and evaluation by clinical pharmacist,the patient was diagnosed as ARC.According to pharmacokinetics characteristics reported by literature,vancomycin was adjusted to 1 g (once per 8 h).Based on detection result of pathogenic bacteria,meropenem was replaced by cefoperazone/sulbactam,and the dose was increased to 3 g (once per 6 h).And then,vancomycin concentration was detected again,and it reached > 10 μg· mL-1;pathogenic bacteria culture result was negative.This patient obtained good therapeutic effect.Conclusion Clinical pharmacist could assist physician on anti-infection treatment and dose adjustment of ARC patient,and improve ARC patient's therapeutic effect.
3.Nutritional risk screening and nutritional support survey of patients with severe stroke
Chun LIU ; Xiaochen YANG ; Bowen CHEN ; Erning SHANG
Journal of Pharmaceutical Practice 2016;34(5):408-411
Objective To discuss the signficance using nutrtional risk screening (NRS) to evaluate nutritional status in patients with severe stroke .In the meantime compare the clinical application value between enteral and parenteral nutritional support therapies .Methods A retrospective survey was adopted to analyze the nutritional status in 267 patients with severe stroke .Their nutritional statuses were evaluated by NRS 2002 nutrtional risk screening . Patients were divided into three groups ,including enteral nutrition (EN) group ,parenteral nutrition (PN) group and EN+ PN group based on the type of their nutritional support .By comparing changes of indicators before and after of adiministration of nutritional support ,the clinical efficacy and adverse reactions for each group were evaluated .Results In EN group and EN+ PN group total protein and albu-min level were significantly increased after 10 days nutritional support (P<0 .05) .Small changes in patients'liver and kidney function indices in EN group .The incidence of co-infection was 16 .67% in EN group ,which was lowest among three groups . Conclusion Enteral nutrition support could not only improve the nutritional status of patients with severe stroke ,but also could reduce the incidence of infections and gastrointestinal complications .It significantly improves the prognosis of patients .
4.Clinical efficacy and safety of vancomycin compared with linezolid for the treatment of neonatal gram-positive bacterial sepsis
Lian TANG ; Jie FANG ; Sannan WANG ; Xiaohong WENG ; Jingjing LI ; Erning SHANG
Chinese Journal of Pediatrics 2016;54(9):686-691
Objective To evaluate the clinical efficacy and safety of vancomycin and linezolid for the treatment of gram-positive neonatal bacterial sepsis.Method The data of neonates diagnosed as grampositive bacterial sepsis in neonatology department of Suzhou Municipal Hospital from June 2009 to December 2015 were retrospectively collected.These neonates were divided into vancomycin group and linezolid group.Propensity score matching (PSM) on baseline variables was used to balance the two groups by identifying a comparable group of neonates who received vancomycin and linezolid therapy.Clinical and microbiologic success rates were compared by chi-square test,and changes of laboratory parameters before and after treatment at the end of treatment were then directly compared by rank-sum test between the matched groups.In vancomycin group,correlation between trough concentration of vancomycin and clinical efficacy were evaluated.Result Totally 108 and 209 cases were respectively selected in vancomycin and linezolid groups;108 cases with well-matched baseline characteristics were included in matched linezolid group.The clinical success rates of vancomycin vs.linezolid therapy were 86.1% (93/108) and 88.9% (96/108) (P =0.681),and the microbiologic success rates were 91.7% (99/108) and 93.5% (101/108) (P =0.795).The average trough concentration of vancomycin was (12 ± 8) mg/L.The rate of reaching the high trough concentration standard was only 33.3% (36/108).In 50 (46.3%) cases the dose was adjusted according to the initial concentration data.Compared to less than 10 mg/L,the clinical efficacy of trough concentration in 10-20 mg/L was much higher(93.9% (46/49) vs.78.6% (33/42),P =0.031).Total bilirubin and platelet count had significant difference between the two-matched groups (34.1 (14.9,91.0)μmol/L vs.53.0(27.0,121.6) μmol/L,P =0.034;301.0 (198.8,416.0) × 109/L vs.195.5 (94.0,283.2) × 109/L,P =0.000).The incidence of linezolid related thrombocytopenia was 13.4% (28 cases).Conclusion The clinical effect of vancomycin and linezolid on gram-positive bacterial sepsis in neonates is comparable.The rate of trough concentration of vancomycin reaching the high trough concentration standard is low,and the clinical efficacy is related to trough concentration.Linezolid have an effect on bilirubin and platelet count,the risk of thrombocytopenia should be monitored closely during linezolid treatment.
5.Clinical efficacy of linezolid in treatment of neonatal septicemia and its influence on platelets
Lian TANG ; Sannan WANG ; Xiaohong WENG ; Erning SHANG
Adverse Drug Reactions Journal 2016;18(2):99-104
Objective To analYze the clinical efficacY of linezolid,the influence of linezolid on PLT and risK factors for treatment of neonatal septicemia. Methods The medical record data of neonates,who received the treatment with linezolid,diagnosed as late onset gram positive bacterial sepsis,and hospitalized in Department of neonatologY,suzhou Municipal Hospital from June 2009 to MaY 2015,were collected. The infants'sex,age in daYs when medication was applied,bodY weight when theY were born,gestational weeKs at birth, diagnosis and complications, course of treatment, combined antimicrobial agents, results of pathogenic bacterial culture and laboratorY examination before and after treatment,and the prognosis were recorded. Linezolidˊs clinical efficacY,bacteriological efficacY,and the influence on PLT in infants were analYzed. The risK factors of linezolid related thrombocYtopenia were analYzed bY single and multi factor Logistics regression analYsis. Results A total of 195 infants were enrolled in the studY. Of them,109 were boYs and 86 were girls with age in daYs when medication from 8 to 28 daYs and an average age in daYs was(16 ± 8)daYs,gestational weeKs at birth from 27 to 42 weeKs and average gestational weeKs was(33 ± 3)weeKs,time of medication from 7 to 23 daYs and an average time was(12 ± 4)daYs. Of the 195 infants, 133(68. 21%)were premature babies and 96(49. 23%)were used of other antimicrobial agents at the same time. The results of evaluation of clinical efficacY showed the recoverY were 117 cases(60. 00%), excellence were 58 cases(29. 74%). The total effective rate was 89. 74%. There were 208 bacterial strain of gram-positive bacteria and 18 of gram-negative bacteria in 195 infants. The results of bacteriological efficacY showed the bacteria eradication were 178 cases(91. 28%),partial removal of bacteria were 11 cases (5. 64%),bacteria not cleared were 3(1. 54%)cases,and bacterial substitution were 3(1. 54%)cases. The bacterial eradication rate was 96. 92%. There were 27 cases appeared PLT decreasing on 5 to 15 daYs of medication[an average daYs of(9 ± 5)d]in 195 infants. Of them,22 cases(81. 48%)were premature, 19 infants with normal PLT baseline developed thrombocYtopenia inⅠ,Ⅱ,Ⅲ andⅣdegree were 8,7,4 and 0 cases,respectivelY. six cases appeared the decreasing of hemoglobin( ﹥50% of baseline). Eight infants with thrombocYtopeniaⅠdegree baseline developed to Ⅱ,Ⅲ and Ⅳdegree were 5,1,and 2 cases, respectivelY. Two cases appeared the decreasing of hemoglobin( ﹥ 50% of baseline ). Linezolid was withdrawn immediatelY in 27 infants who developed thrombocYtopenia. Of them,19 cases’ PLT returned to normal bY themselves on 3 to 13 daY[an average time was(5 ± 4)daYs]of drug withdrawal ,and two cases discharged according to their parents,PLT in 6 cases returned to normal after receiving the sYmptomatic treatment. The results of Logistics regression analYsis showed that bodY weight when theY were born, gestational weeKs at birth, baseline levels of PLT, albumin and total bilirubin were related to thrombocYtopenia due to linezolid,gestational weeKs at birth,baseline levels of PLT,albumin and total bilirubin were independent risK factors of thrombocYtopenia due to linezolid. Conclusions Linezolid has a good efficacY in treatment of neonatal gram-positive bacterial sepsis. The risK of thrombocYtopenia due to linezolid maY be increased when the infants receiving linezolid who with premature birth,or lower PLT baseline,or hYpoproteinemia or hYperbilirubinemia.
6.Clinical efficacy of linezolid in treatment of neonatal septicemia and its influence on platelets
Lian TANG ; Sannan WANG ; Xiaohong WENG ; Erning SHANG
Adverse Drug Reactions Journal 2016;18(2):99-104
Objective To analYze the clinical efficacY of linezolid,the influence of linezolid on PLT and risK factors for treatment of neonatal septicemia. Methods The medical record data of neonates,who received the treatment with linezolid,diagnosed as late onset gram positive bacterial sepsis,and hospitalized in Department of neonatologY,suzhou Municipal Hospital from June 2009 to MaY 2015,were collected. The infants'sex,age in daYs when medication was applied,bodY weight when theY were born,gestational weeKs at birth, diagnosis and complications, course of treatment, combined antimicrobial agents, results of pathogenic bacterial culture and laboratorY examination before and after treatment,and the prognosis were recorded. Linezolidˊs clinical efficacY,bacteriological efficacY,and the influence on PLT in infants were analYzed. The risK factors of linezolid related thrombocYtopenia were analYzed bY single and multi factor Logistics regression analYsis. Results A total of 195 infants were enrolled in the studY. Of them,109 were boYs and 86 were girls with age in daYs when medication from 8 to 28 daYs and an average age in daYs was(16 ± 8)daYs,gestational weeKs at birth from 27 to 42 weeKs and average gestational weeKs was(33 ± 3)weeKs,time of medication from 7 to 23 daYs and an average time was(12 ± 4)daYs. Of the 195 infants, 133(68. 21%)were premature babies and 96(49. 23%)were used of other antimicrobial agents at the same time. The results of evaluation of clinical efficacY showed the recoverY were 117 cases(60. 00%), excellence were 58 cases(29. 74%). The total effective rate was 89. 74%. There were 208 bacterial strain of gram-positive bacteria and 18 of gram-negative bacteria in 195 infants. The results of bacteriological efficacY showed the bacteria eradication were 178 cases(91. 28%),partial removal of bacteria were 11 cases (5. 64%),bacteria not cleared were 3(1. 54%)cases,and bacterial substitution were 3(1. 54%)cases. The bacterial eradication rate was 96. 92%. There were 27 cases appeared PLT decreasing on 5 to 15 daYs of medication[an average daYs of(9 ± 5)d]in 195 infants. Of them,22 cases(81. 48%)were premature, 19 infants with normal PLT baseline developed thrombocYtopenia inⅠ,Ⅱ,Ⅲ andⅣdegree were 8,7,4 and 0 cases,respectivelY. six cases appeared the decreasing of hemoglobin( ﹥50% of baseline). Eight infants with thrombocYtopeniaⅠdegree baseline developed to Ⅱ,Ⅲ and Ⅳdegree were 5,1,and 2 cases, respectivelY. Two cases appeared the decreasing of hemoglobin( ﹥ 50% of baseline ). Linezolid was withdrawn immediatelY in 27 infants who developed thrombocYtopenia. Of them,19 cases’ PLT returned to normal bY themselves on 3 to 13 daY[an average time was(5 ± 4)daYs]of drug withdrawal ,and two cases discharged according to their parents,PLT in 6 cases returned to normal after receiving the sYmptomatic treatment. The results of Logistics regression analYsis showed that bodY weight when theY were born, gestational weeKs at birth, baseline levels of PLT, albumin and total bilirubin were related to thrombocYtopenia due to linezolid,gestational weeKs at birth,baseline levels of PLT,albumin and total bilirubin were independent risK factors of thrombocYtopenia due to linezolid. Conclusions Linezolid has a good efficacY in treatment of neonatal gram-positive bacterial sepsis. The risK of thrombocYtopenia due to linezolid maY be increased when the infants receiving linezolid who with premature birth,or lower PLT baseline,or hYpoproteinemia or hYperbilirubinemia.
7.Analysis of the Application Effects of PDCA Cycle Theory in ADR Monitoring and Management
Lian TANG ; Yanxia YU ; Qin ZHOU ; Chun LIU ; Erning SHANG
China Pharmacy 2015;(28):4027-4029
OBJECTIVE:To explore the effects of PDCA(plan,do,check,action)cycle theory in the ADR monitoring of our hospital. METHODS:The problems of ADR monitoring in our hospital in 2012 were analyzed and intervened by PDCA cycle. The effects of PDCA cycle were evaluated 1 year later. RESULTS:After implementation of PDCA cycle,we had improved the manage-ment system,brought ADR monitoring into the appraisal of clinical pharmacists,established the networking platform of ADR report-ing,strengthened the training of physicians and nurses,the publicty of ADR information and ADR monitoring of important medi-cine. The number of ADR reports increased by 18.37% in 2013,the proportion of new and serious ADR reports obviously in-creased(increasing from 22.28% to 38.42%);in terms of ADR reporting source,the ADR reporting in wards obviously increased (increasing from 8.16% to 43.84%). The proportion of ADR induced by antibiotics or TCM preparation decreased significantly(re-spetively decreasing from 54.52% to 43.84% and 23.03% to 13.30%);in term of ADR clinical manifestations,the proportion of skin and its appendants involved decreased significantly (decreasing from 53.64% to 39.41%). CONCLUSIONS:The application of PDCA cycle obviously improves the management of ADR monitoring in our hospital.
8.A comparative study on the influence of biapenem and meropenem on valproic acid blood concentration
Lian TANG ; Zhiwei ZHUANG ; Fuli ZHAO ; Chen YANG ; Erning SHANG
Adverse Drug Reactions Journal 2015;(2):126-129
Objective To compare the influence of carbapenems such as biapenem and meropenem on valproic acid( VPA)blood concentration. Methods The clinical data of patients with symptomatic epilepsy and infections who were hospitalized in Suzhou Municipal Hospital during January 2008 to December 2013,and received concomitant therapy with VPA and biapenem or meropenem were collected and analyzed retrospectively. These patients were divided into biapenem group and meropenem group. The information of general clinical data and medication were recorded. VPA blood concentration,seizures and clinical treatment before and after the combination with carbapenems were compared between the two groups. Results A total of 79 cases were enrolled in the analysis. Six patients were treated with meropenem and biapenem successively at more than one month intervals,clinical data during the period of different carbapenems use were included in different groups. There were 37 cases in the biapenem group and 48 cases in the meropenem group;clinical data had no statistical significance between the 2 groups. The VPA blood concentration of biapenem group and meropenem group were significantly decreased. The VPA blood concentrations in biapenem group were higher than that of meropenem group(13. 3 ± 6. 2)mg/L vs(10. 7 ± 7. 0)mg/L,P= 0. 046). The mean decrease of VPA blood concentrations in biapenem group was also less than that of meropenem group(70. 6 ± 9. 6% vs 78. 8 ± 8. 8%,P=0. 010). The VPA blood concentrations of six patients treated with meropenem and biapenem successively were significantly decreased. The blood concentrations were also higher when combined with biapenem compared to meropenem. The rate of seizures had no significant difference between the 2 groups( 29. 7% vs 35. 4%,P =0. 749 ). Conclusions Both biapenem and meropenem could decrease VPA blood concentrations significantly. Biapenem had less impact on VPA blood concentration compared to meropenem,but also increased the risk of seizures.
9.A comparative study on the influence of biapenem and meropenem on valproic acid blood concentration
Lian TANG ; Zhiwei ZHUANG ; Fuli ZHAO ; Chen YANG ; Erning SHANG
Adverse Drug Reactions Journal 2015;(2):126-129
Objective To compare the influence of carbapenems such as biapenem and meropenem on valproic acid( VPA)blood concentration. Methods The clinical data of patients with symptomatic epilepsy and infections who were hospitalized in Suzhou Municipal Hospital during January 2008 to December 2013,and received concomitant therapy with VPA and biapenem or meropenem were collected and analyzed retrospectively. These patients were divided into biapenem group and meropenem group. The information of general clinical data and medication were recorded. VPA blood concentration,seizures and clinical treatment before and after the combination with carbapenems were compared between the two groups. Results A total of 79 cases were enrolled in the analysis. Six patients were treated with meropenem and biapenem successively at more than one month intervals,clinical data during the period of different carbapenems use were included in different groups. There were 37 cases in the biapenem group and 48 cases in the meropenem group;clinical data had no statistical significance between the 2 groups. The VPA blood concentration of biapenem group and meropenem group were significantly decreased. The VPA blood concentrations in biapenem group were higher than that of meropenem group(13. 3 ± 6. 2)mg/L vs(10. 7 ± 7. 0)mg/L,P= 0. 046). The mean decrease of VPA blood concentrations in biapenem group was also less than that of meropenem group(70. 6 ± 9. 6% vs 78. 8 ± 8. 8%,P=0. 010). The VPA blood concentrations of six patients treated with meropenem and biapenem successively were significantly decreased. The blood concentrations were also higher when combined with biapenem compared to meropenem. The rate of seizures had no significant difference between the 2 groups( 29. 7% vs 35. 4%,P =0. 749 ). Conclusions Both biapenem and meropenem could decrease VPA blood concentrations significantly. Biapenem had less impact on VPA blood concentration compared to meropenem,but also increased the risk of seizures.
10.Exploration of hospital pharmaceutical services
Yanxia YU ; Erning SHANG ; Linshan JI ; Jianglin YIN
Chinese Journal of Hospital Administration 2013;(2):151-153
The paper introduced a few models characteristic of pharmaceutical service(PS)in the hospital,classifying the service applicable in the hospital into personalized PS based on time,social PS based on space,and connotative PS based on expertise.This way pharmacist,doctors and nurses can work as a close team,providing not only high quality PS to a greater population,but also personalized and integrated PS to patients of special needs.In the end,PS can help improve hospital quality of care in general.

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