OBJECTIVE To construct the drug utilization evaluation criteria for Dezocine injection,so as to provide reference for the rational drug use in medical institutions.METHODS On the basis of evidence methodology,relevant guidelines/expert consensus,systematic reviews/meta-analysis were consulted;the evaluation criteria framework for Dezocine injection was established after screening evidence.Delphi method was employed,whereby 28 clinicians and clinical pharmacists from secondary and above-level medical institutions across eight provinces,including Tianjin,Beijing and Shandong,were selected to participate in two rounds of questionnaire surveys.The final indicators were determined based on the experts'enthusiasm coefficient,authority coefficient,and degree of coordination.RESULTS The effective recovery rate of questionnaire was 100%in the first round and 92.86%in the second round;expert authority coefficient was 0.82 in the first round and 0.81 in the second round;the coordination degree of experts in the first round was 0.29,and in the second round was 0.31(P＜0.001).Drug utilization evaluation standard system for Dezocine injection was formed finally,including three dimensions of medication indications,medication process and medication results,with a total of 11 first-level indicators(such as indications,usage and dosage)and 33 second-level indicators(such as labor analgesia and the management of severe pain following major or moderate surgeries combined with other analgesic drugs).The average importance scores for each indicator ranged from 4.08 to 5.00 points,with an overall average score of 4.61 points and coefficient of variation ranging from 0 to 0.19.CONCLUSIONS The drug utilization evaluation criteria for Dezocine injection established based on evidence-based methodology and Delphi method is authoritative and scientific,which provides a reference for subsequent evaluation of the rationality of clinical medication.

Objective:To evaluate the efficacy, safety, and economics of ertapenem in the treatment of infectious diseases by means of rapid health technology assessment.Methods:The relevant databases and health technology assessment websites (up to July 31, 2023) were searched to collect the meta-analyses and economic literature on the efficacy, safety, and economics of ertapenem and other antibacterial drugs in the treatment of infectious diseases. The quality of meta-analyses and economic researches were evaluated by a measurement tool to assess systematic reviews and consolidated health economic evaluation reporting standards, respectively. The patients were divided into ertapenem group and control group (using other antibacterial drugs). The outcome indicators of meta-analysis (clinical cure rate, bacterial clearance rate) and the incidence of adverse reactions were compared between the 2 groups. The economic research were cost-effectiveness analysis and cost-consequence analysis. The relevant results were described qualitatively.Results:A total of 13 literature were enrolled, including 7 systematic reviews/meta-analyses (4 of high-quality, 3 of medium quality) and 6 pharmacoeconomics literature (4 of high quality, 2 of medium quality). There were no significant differences on the clinical cure rate and bacterial clearance rate for complex abdominal infection, community-acquired pneumonia, complex skin and appendage infection between the ertapenem group and the control group (all P>0.05). The clinical cure rate of severe diabetic foot infection in the ertapenem group was lower than that in the piperacillin sodium and tazobactam sodium group [91.5% (119/130) vs. 97.2% (139/143), P=0.04]. The bacterial clearance rate of complicated urinary tract infection in the ertapenem group was higher than that in the ceftriaxone group [98.71% (305/309) vs. 95.45% (273/286), P=0.03]. The incidence of adverse reactions (elevated transaminase and alkaline phosphatase or elevated platelet count) in patients with complex abdominal infection in the ertapenem group was higher than that in the control group [8.96% (68/759) vs. 6.49 %(50/771), P<0.05]. The incidence of adverse reactions after ertapenem treatment for complex infections (community-acquired pneumonia, complicated urinary tract infection and complex abdominal infection) was higher than that in ceftriaxone treatment with or without metronidazole group [10.62% (163/1 535) vs. 7.89% (91/1 153), P=0.02]. The incidence of diarrhea in patients with diabetic foot infection in the ertapenem group was lower than that in the piperacillin sodium and tazobactam sodium group [8.14% (24/295) vs. 14.09% (41/291), P=0.02]. It was more cost-effective using ertapenem than using piperacillin sodium and tazobactam sodium, ceftriaxone in treatment of complex abdominal infection, diabetic foot infection, complicated urinary tract infection, community-acquired pneumonia, etc. Conclusions:The efficacy of ertapenem in treatment for complex abdominal infection, community-acquired pneumonia and complex skin and appendage infection are similar to that of commonly used antibiotics in clinic, and the bacterial clearance rate in treatment for complicated urinary tract infection was higher than that of ceftriaxone. There are differences in the incidence of adverse reactions in complex abdominal infection, community-acquired pneumonia, complicated urinary tract infection, and diabetic foot infection between the 2 groups. The use of ertapenem can reduce the cost of drug treatment and has economic advantages.

Objective:To evaluate the efficacy, safety, and economics of ertapenem in the treatment of infectious diseases by means of rapid health technology assessment.Methods:The relevant databases and health technology assessment websites (up to July 31, 2023) were searched to collect the meta-analyses and economic literature on the efficacy, safety, and economics of ertapenem and other antibacterial drugs in the treatment of infectious diseases. The quality of meta-analyses and economic researches were evaluated by a measurement tool to assess systematic reviews and consolidated health economic evaluation reporting standards, respectively. The patients were divided into ertapenem group and control group (using other antibacterial drugs). The outcome indicators of meta-analysis (clinical cure rate, bacterial clearance rate) and the incidence of adverse reactions were compared between the 2 groups. The economic research were cost-effectiveness analysis and cost-consequence analysis. The relevant results were described qualitatively.Results:A total of 13 literature were enrolled, including 7 systematic reviews/meta-analyses (4 of high-quality, 3 of medium quality) and 6 pharmacoeconomics literature (4 of high quality, 2 of medium quality). There were no significant differences on the clinical cure rate and bacterial clearance rate for complex abdominal infection, community-acquired pneumonia, complex skin and appendage infection between the ertapenem group and the control group (all P>0.05). The clinical cure rate of severe diabetic foot infection in the ertapenem group was lower than that in the piperacillin sodium and tazobactam sodium group [91.5% (119/130) vs. 97.2% (139/143), P=0.04]. The bacterial clearance rate of complicated urinary tract infection in the ertapenem group was higher than that in the ceftriaxone group [98.71% (305/309) vs. 95.45% (273/286), P=0.03]. The incidence of adverse reactions (elevated transaminase and alkaline phosphatase or elevated platelet count) in patients with complex abdominal infection in the ertapenem group was higher than that in the control group [8.96% (68/759) vs. 6.49 %(50/771), P<0.05]. The incidence of adverse reactions after ertapenem treatment for complex infections (community-acquired pneumonia, complicated urinary tract infection and complex abdominal infection) was higher than that in ceftriaxone treatment with or without metronidazole group [10.62% (163/1 535) vs. 7.89% (91/1 153), P=0.02]. The incidence of diarrhea in patients with diabetic foot infection in the ertapenem group was lower than that in the piperacillin sodium and tazobactam sodium group [8.14% (24/295) vs. 14.09% (41/291), P=0.02]. It was more cost-effective using ertapenem than using piperacillin sodium and tazobactam sodium, ceftriaxone in treatment of complex abdominal infection, diabetic foot infection, complicated urinary tract infection, community-acquired pneumonia, etc. Conclusions:The efficacy of ertapenem in treatment for complex abdominal infection, community-acquired pneumonia and complex skin and appendage infection are similar to that of commonly used antibiotics in clinic, and the bacterial clearance rate in treatment for complicated urinary tract infection was higher than that of ceftriaxone. There are differences in the incidence of adverse reactions in complex abdominal infection, community-acquired pneumonia, complicated urinary tract infection, and diabetic foot infection between the 2 groups. The use of ertapenem can reduce the cost of drug treatment and has economic advantages.

Objective:To explore the effect of MDR1(C3435T) gene polymorphism on tacrolimus metabolism early after pediatric liver transplantation.Methods:Preoperative blood samples of 90 donors and recipients of pediatric liver transplantation were collected and genotyped. According to the CYP3A5 genotype of donor/recipient, they were divided into four subgroups of recipient slow metabolism/donor slow metabolism (R/D-S), recipient fast metabolism/donor slow metabolism (R-F/D-S), recipient slow metabolism/donor fast metabolism (R-S/D-F) and recipient fast metabolism/donor fast metabolism (R/D-F). The values of concentration/daily dose (C 0/D) of tacrolimus in patients with different MDR1 genotypes were compared at the subgroup level. Results:The C 0/D value of MDR1 TT recipients was significantly higher than that of CC/ CT counterparts in the first week after liver transplantation ( P<0.01). The C 0/D value of CT recipients in R/D-S subgroup was significantly higher than that of CC counterparts in the 2nd week after operation ( P<0.05). The C 0/D value of CT recipients in R/D-F subgroup was significantly higher than that of CC counterparts in 2 weeks ( P<0.05) and 3 weeks ( P<0.01). Conclusions:MDR1(C3435T) gene polymorphism in recipients affects tacrolimus metabolism. Recipients with CC genotype metabolize faster than those with CT/TT genotypes. And the same daily dose and tacrolimus blood concentration are lower. Recipients with different MDR1 genotypes need to adjust the dosage of tacrolimus. This difference is more obvious in CYP3A5 fast metabolic subgroup, more attention should be paid to optimizing individualizing dosage regimens, reducing the incidence of adverse reactions and improving the efficacy.

Objective To explore the influencing factors of blood concentration of tacrolimus in pediatric living donor liver transplant recipients and provide rationales for individualized administration of tacrolimus .Methods Trough concentrations (C0 ) , doses of tacrolimus , recipient age , gender , body weight ,donor and recipient CYP3A5 genotypes ,hematocrit (HCT ) and liver/kidney function related indicators at 3 ,5 ,7 ,14 days ,1 month , 2 months and 3 months post living donor liver transplantation were collected from a total of 100 pediatric recipients .Taking ratio of concentration to dose (C0 /D) as a dependent variable ,the influencing factors of blood concentration of tacrolimus were analyzed by multivariate stepwise regression .Results The influencing factors of blood tacrolimus concentration at 3d post-transplantation were recipient CYP3A5 genotyp , donor CYP3A5 genotype and weight of recipients . The major influencing factors at 5d post-transplantation were recipient & donor CYP3A5 genotypes , recipient weight and HCT . The major relevant factors at 7d posttransplantation were CYP3A5 of recipients ,age and HCT .The influencing factors at 14 days were the same as those at 2 months ,i .e .CYP3A5 genotype and weight of recipients .At 1 month the major influencing factors were weight of recipients ,CYP3A5 of recipients and alkaline phosphatase (ALP) ; CYP3A5 genotype and weight of recipients at 3 months . Further study on CYP3A5 genotype of donors and recipients , the C0 /D ratio of CYP3A5 genotype non-expression group was significantly higher than that of expression group in recipients and C0 /D ratio of donor CYP3A5 genotype nonexpression group was significantly higher than that of expression group .Conclusions The influencing factors of concentration of tacrolimusvary at different timepoints after liver transplantation . Paying close attention to the changes of CYP3A5 genotype , weight of recipients and related biochemical indexes and considering various influencing factors facilitate individualized dosing for improving the prognosis of pediatric recipients .

Objective To investigate the diagnostic value of transgastric peritoneal endoscopy in diagnosis of ascites with unknown origin.Methods Endoscopy was introduced into peritoneal cavity through gastric wall in 23 patients with exudative ascites which was able to be diagnosed by routine methods and biopsy was made through endoscopy to get pathological diagnosis.Results Definite diagnosis was made in 22 patient (95.7%),of which 12 (54.6%) were malignant tumors,8 (36.4%) were tuberculosis peritonitis,1 (4.5%) was spontaneous peritonitis associated with liver cirrhosis and 1 (4.5%) was eosinophilic enteritis.Conclusion Natural orifice transluminal endoscopy combined with biopsy is an effective and accurate procedure for diagnosis of ascites of unknown canses.