Interpretation for Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China / 中国药房

Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment ， Development，and Evaluation （GRADE）approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ，this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ，involving evaluation prior to administration （liver and renal function ，pleural effusion and ascites ， comedication，genetic testing ），pre-treatment and routine dosing regimen （pretreatment of hydration and alkalization ，urine alkalization，routine dosing regimen ），therapeutic drug monitoring （necessity，method，timing，target concentration ），leucovorin rescue（rescue timing ，rescue regimen ，rescue dose optimization ），and management of toxicities （liver and kidney function monitoring，supportive treatment ，blood purification treatment ）. This article aims to summarize and interpret the recommendations of this guideline ，so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.

Analysis of Influential Factors for Acute Kidney Injury after Lung Transplantation / 中国药房

OBJECTIVE：To analyze the occurrence of acute kidney injury （AKI）after lung transplantation and its possible influential factors . METHODS ：Medical records of 64 patients who received lung transplantation in our hospital from April 2017 to June 2018 were included in this retrospective study. Patients were divided into AKI group （44 cases）and non-AKI group （20 cases），according to whether AKI occurred after operation. According to diagnostic criteria for lung transplantation in our hospital ， all patients were given Methylprednisolone sodium succinate for injection or Methylprednisolone sodium succinate for injection combined with Basiliximab for injection ，and triple immunosuppressive therapy of Tacrolimus capsules+Mycophenolate mofetil dispersible tablets or Mycophenolate mofetil capsules or Mycophenolate sodium enteric-coated tablets+Methylprednisolone tablets or Prednisone acetate tablets were given after operation. The occurrence of AKI in AKI group within a week after operation were recorded. Intraoperative influential factors （operation type ， operation duration ， ECMO support ， immune inhibitor use ， intraoperative blood loss ），postoperative influential factors [days of ICU ，mechanical ventilation and ECMO support ，median value of Scr within one week after operation ，median tacrolimus concentration and the use of potential nephrotoxic drugs （≥4 kinds）， hospitalization days] and survival rate one year after operation were observed in 2 groups. RESULTS ：Within one week after lung transplantation，44 patients（68.8％）had experienced at least one episode of AKI ，among which 19 cases（29.7％）were stage 1， 17 cases（26.5％）were stage 2 and 8 cases（12.5％）were stage 3. The incidence of AKI was the highest on post-operative day 4 （57.4％）. The incidence of AKI at stage 3 exhibited growth trend within the first week after operation ，and reached the highest on median post-operative day 5（8.7％）. Operation duration ，median value of Scr within one week after operation ，median tacrolimus concentration in non-AKI group were significantly shorter or lower than AKI group ；there was no significant difference in operation type， ECMO support ， use of immunosuppressive agents ， intraoperative blood loss ，ICU days ，mechanical ventilation days，ECMO support days ，the utilization rate of potential nephrotoxic drugs （ ≥4 kinds） and hospitalization days between 2 groups （P＞0.05）. There was no statistical significance in the survival rate at stage 1 and 2 one year after operation between AKI group and non-AKI group （P＞0.05）. One year after operation ，survival rate of AKI group at stage 3 was significantly lower than that of non-AKI group （P＜0.05）. CONCLUSIONS：The incidence of AKI is high after lung transplantation. Operation duration ，median value of Scr within one week after operation ，median tacrolimus concentration were possible factors for the occurrence of AKI after operation.

Determination of 9 Amino Acid Endogenous Substances in Morning Urine of Depression Patients by LC-MS/MS / 中国药房

ABSTRACT OBJECTIVE：To establish a method for the determination of 5-hydroxyindole acetic acid（5-HIAA），glutamine， hippurate，pimelate，proline，tryptophan，tyramine，tyrosine and valine in human urine. METHODS：Morning urine samples were collected from depression patients. The sample was extracted with acetonitrile after addition of internal standard cortisone. LC-MS/ MS method was adopted. The determination was performed on XTerra RP18 column with mobile phase consisted of 0.1％ acetic acid-water as mobile phase A and 0.1％ acetic acid-acetonitrile as mobile phase B（gradient elution）. The column temperature was set at 40 ℃，and flow rate was 0.45 mL/min. Electrospray ion source（ESI）was used for quantitative analysis by multiple reaction monitoring （MRM）. The precursor/product ion transitions （m/z） were monitored at m/z 192.2→146.1，m/z 147.2→130.0，m/z 180.1→105.1，m/z 161.1→125.2，m/z 116.1→70.2，m/z 205.2→188.2，m/z 138.2→121.1，m/z 182.0→123.0，m/z 118.2→72.1 and m/z 361.2→163.0（+ion-mode）for 5-HIAA，glutamine，hippurate，pimelate，proline，tryptophan，tyramine，tyrosine，valine and cortisone，respectively. RESULTS：The linear range of 5-HIAA，glutamine，pimelate，proline，tyramine and valine were 10.00-3 200 ng/mL（r＝0.993 8-0.998 9，n＝6）. The lower limit of quantification was 10 ng/mL；the linear range of hippurate，tryptophan and tyrosine were 1 600-51 200 ng/mL（r＝0.999 2-0.999 7，n＝6）. The lower limit of quantitation was 1 600 ng/mL. The results of accuracy tests were 86.29％-98.65％（n＝6）. RSDs of intra-day and inter-day precision tests were no more than 14.65％（n＝6）CV of matrix effect were 6.18％-14.37％（n＝6）. Extraction recovery rates were 86.21％-98.14％（n＝6）. RE of stability tests were no more than 14.71％（n＝3-6）. CONCLUSIONS：The method is sensitive，accurate and suitable for the determination of 9 substances in human.

Comparative Study on Regulatory Measures of Biosimilars in China ，the United States ，Japan and Europe / 中国药房

OBJECTIVE：To provi de reference for drug admini stration supervision of biosimilars in China. METHODS ： Referring to the authoritative documents of the official websites of National Medical Products Administration of China ，FDA of the United States ，European Drug A dministration and Japan ’s D rug and M edical Devices Agency ，and comparing their regulatory measures on the definition ，effectiveness，safety and clinical application of biosimilars，the suggestions were put forward for the improvement of regulatory measures of biosimilars in China. RESULTS & CONCLUSIONS ：Although the definitions biosimilars in different countries/regions were different ，they all required that biosimilars should have the same drug quality ，safety and effectiveness as their corresponding reference drugs. The United States ，the European Union and Japan required enterprises to provide studies on the similarity of early pharmacy ，non-clinical studies such as pharmacology and toxicology ，and clinical studies on immunogenicity ，pharmacokinetics and pharmacodynamics of biosimilars and reference drugs. However ，the similarity between biosimilars and reference drugs had not been required in China. All countries/regions supported the extrapolation of indications of biosimilars. Among which the United States and the European Union required manufacturers to provide detailed data ；Japan only mentioned the relevant concepts of indications extrapolation of biosimilars，but did not mention the specific data requirements. The relevant description of the conditions for the extrapolation of biosimilars in China was not clear enough ，and its application in China was still facing great challenges. In terms of drug interchangeability ，although the United States allowed the use of interchangeable biosimilars to replace reference drugs under the conditions permitted by state laws ，no relevant biosimilars had been approved；European countries had different regulations on the interchangeability of biosimilars；but there was no document explicitly mentioned in China and Japan on the interchangeability of biosimilars. It is suggested that the principle of comparison should be further improved and strict requirements should be appropriately enforced in ensuring the effectiveness and safety of biosimilars；in the field of indication extrapolation ，more detailed data requirements should be put forward ，and the possible risks after extrapolation should be evaluated scientifically ；in terms of the interchangeability of biosimilars ，it is suggested to try to implement the principle of conversion of biosimilars ，but it should be used after consultation among doctors ，pharmacists and patients，and drug use safety should be monitored timely. Meanwhile ，a sound traceability system should be established to ensure drug safety of patients.

Correlation of Tacrolimus Concentrations among Transplant Patients ’Whole Blood ，Plasma and Blood Cells / 中国药房

OBJECTIVE： To study the correlation of tacrolimus concentrations among transplant patients’ whole blood， plasma and blood cells， analyze the effects of transplant types and ages on the their correlation， and to provide reference for rational drug use in clinic. METHODS： Totally 20 patients receiving tacrolimus anti-rejection therapy after transplantation and undergoing therapeutic drug monitoring （TDM） were randomly selected. According to the type of transplantation， they were divided into renal transplantation group and lung transplantation group （10 cases for each group）.  According to age， they were divided into three groups： 20-40 years old group， 41-60 years old group and 61-80 years old group （4， 9， 7 cases for each group）. Their residual blood after TDM was collected. Chemiluminescence microparticle immuno assay  （CMIA） was used to detect the concentration of tacrolimus in whole blood. UPLC-MS/MS was used to measure the concentrations of tacrolimus in plasma and blood cells. Pairs plots and Spearman rank correlation analysis were used to analyze the correlation of tacrolimus between whole blood and plasma， between whole blood and blood cells， between plasma and blood cells as well as the effects of transplant types and ages on tacrolimus concentrations among tansplant patient’s whole blood， plasma and blood cells. RESULTS： The correlation of tacrolimus concentrations in whole blood and plasma （r＝0.623，P＜0.01） was slightly stronger than that of whole blood and blood cells （r＝0.591， P＜0.01）； while  the correlation of tacrolimus concentration in plasma and blood cells was relatively weak （r＝0.497，P＜0.05）. Transplant type and age had an effect on the correlation of tacrolimus concentrations among patients’ whole blood， plasma， blood cells. The correlation of tacrolimus concen- tration in whole blood， blood cells and plasma in renal transplantation group was also weak （all r＜0.5）， and was weaker than that in lung transplantation group. The correlation of tacrolimus concentration among whole blood， plasma and blood cells was weak in patients of aged 20-40 years old group （all r＜0.3）， and was weaker than that of patients of aged 41-60 years old group and 61-80 years old group. CONCLUSION： Post-transplantation patients’ tacrolimus concentrations in whole blood， plasma and blood cell have a weak correlation. Rejections and adverse effects should be monitored in these patients， especially those renal transplantation patients or those patients aged 20 to 40.

Analysis of the Quality of Pharmaceutical Care for Cancer Pain Therapy in 64 Hospitals from Beijing / 中国药房

OBJECTIVE： To investigate pharmaceutical care of cancer pain therapy in medical institutions from Beijing area， and to provide reference for improving the quality of pharmaceutical care for cancer pain in medical institutions and formulating cancer pain therapy decision by public health administration departments at different levels. METHODS： Inspection results of standardized diagnosis and treatment for cancer pain were analyzed retrospectively in Beijing Pain Therapy Quality Control and Improvement Center during Feb.-Mar. 2018. Scoring results of pharmaceutical care （20 points） and its 5 sub-items （personnel participation， drug supply， drug management， outpatient prescription comment and inpatient prescription comment， 4 points each item） were analyzed statistically and classified according to hospital level and pharmaceutical care inspection results. RESULTS： A total of 64 hospitals in Beijing participated in the inspection， including 27 tertiary A hospitals （42.19％）， 21 tertiary B hospitals （32.81％）， 16 secondary hospitals or first-level hospitals （25.00％）. Pharmaceutical care in all hospitals met the inspection requirements with qualified rate of 100％. 52 hospitals performed excellently （81.25％）， and 12 hospitals were qualified for pharmaceutical care （18.75％）. Among 5 sub-items of personnel participation， drug supply， drug management， outpatient prescription comment and inpatient prescription comment， the average score of drug supply item was the highest （3.83±0.05）； the lowest was the personnel participation item （2.93±0.13）. The results of pharmaceutical care inspection in tertiary A hospitals （17.80±0.28） and tertiary B hospitals （17.78±0.30） were significantly better than those in secondary hospitals or first-level hospitals（16.16±0.50）（P＜0.01 or P＜0.05）； there was statistical significance only in the score of outpatient prescription comment among 5 sub-items（P＝0.026）. Total scores of the hospitals with excellent pharmaceutical care were significantly higher than those of the hospitals with qualified pharmaceutical care in terms of personnel participation， outpatient prescription comment and inpatient prescription comment （P＜0.01 or P＜0.05）. There was significant difference in the inspection results of pharmaceutical care among the excellent group， the qualified group and the unqualified group classified by the results of personnel participation item （P＜0.01 or P＜0.05）. CONCLUSIONS： The quality of pharmaceutical care for cancer pain therapy in medical institutions from Beijing area has reached the qualified level， but the participation of clinical pharmacists in cancer pain therapy and outpatient prescription comment still need improvement in further. The training of clinical pharmacists and information construction of narcotic drug management should be strengthened so as to improve the overall quality of pharmaceutical care for cancer pain.

Effects of Resveratrol on Cognitive Function and SIRT 1/NF-κB Signaling Pathway in Neonatal Rats with Hypoxic-ischemic Brain Injury / 中国药房

OBJECTIVE： To study the effects of resveratrol （Res） on cognitive function and SIRT1/NF-κB signaling pathway in neonatal rats with hypoxic-ischemic brain injury. METHODS： SD neonatal rats were randomly divided into sham operation group （normal saline）， model group （normal saline）， Res low-dose and high-dose groups （30， 60 mg/kg）， with 12 rats in each group. Except that sham operation group received sham operation， hypoxic-ischemic brain injury model was established by Rice method in other groups. After modeling， the rats were given relevant medicine intraperitoneally each day， for consecutive 6 weeks. Water maze test was used to analyze spatial learning and memory function of rats in each group. The escape latency after 1， 3 and 6 weeks of administration and the times of crossing platform after 6 weeks of administration were recorded. TTC staining was used to detect cerebral infraction area of rats after 6 weeks of medication. Western blot was used to detect the expression of Bcl-2， Bax， Caspase-3， SIRT1， SIRT1/NF-κB pathway related protein SIRT1 and p-NF-κB in hippocampal CA1 region. RESULTS： Compared with sham operation group， escape latency of rats was prolonged significantly in model group after 1， 3， 6 weeks of medication （P＜0.05）， the times of crossing platform was decreased significantly after 6 weeks of medication （P＜0.05）； the area of cerebral infarction was increased significantly （P＜0.05）； the protein expression of Bax， Caspase-3 and p-NF-κB in hippocampus CA1 region were increased significantly， while the protein expression of Bcl-2 and SIRT1 were decreased significantly （P＜0.05）. Compared with model group， the escape latency of Res low-dose and high-dose groups were shortened significantly after 1， 3， 6 weeks of medication （P＜0.05）， while the times of crossing platform was increased significantly after 6 weeks of medication （P＜0.05）； the area of cerebral infarction was decreased significantly （P＜0.05）， and the protein expression of Bax， Caspase-3 and p-NF-κB protein in hippocampal CA1 area were decreased significantly， while the protein expression of Bcl-2 and SIRT1 were increased significantly （P＜0.05）. The improvement of above indexes in high-dose group were significantly better than low-dose group （P＜0.05）. CONCLUSIONS： Res can improve cognitive dysfunction in neonatal rats with hypoxic-ischemic brain injury， which is related with SIRT1/NF-κB signaling pathway.

Practical stability of whole-genome bisulfite sequencing using plasma cell-free DNA / 生物工程学报

With the development of liquid biopsy technology, plasma cell-free DNA (cfDNA) becomes one of the research hotspots. Whole-genome bisulfite sequencing of plasma cell-free DNA has shown great potential medical applications such as cancer detection. However, the practical stability evaluation is still lacking. In this study, plasma cell-free DNA samples from two volunteers at different time were collected and prepared for sequencing in multiple laboratories. The library preparation strategies include pre-bisulfite, post-bisulfite and regular whole-genome sequencing. We established a set of quality control references for plasma cell-free DNA sequencing data and evaluated practical stability of blood collection, DNA extraction, and library preparation and sequencing depth. This work provided a technical practice guide for the application of plasma cfDNA methylation sequencing for clinical applications.

Diagnostic value of DCE-MRI and BI-RADS-MR in differentiation of breast lesions / 实用医学杂志

Objective To evaluate the diagnostic value of DCE-MRI and breast MR reporting and data system(BI-RADS-MR)in differentiation of breast lesions. Methods Seventy-five patients with 75 pathological-confirmed breast lesions underwent DCE-MRI before treatment and DCE-MRI quantitative analysis. Two senior doc-tors assessed the imaging features blindly by BI-RADS-MR. The pathology results were set as a gold standard. The receiver operating characteristic curve(ROC)interpretation of two physician′s curve analysis was used to evaluate the sensitivity,specificity of BI-RADS classification. Results According to the BI-RADS MR score,38 breast cancer patients were rated as 1 case in grade Ⅰ,0 case in grade Ⅱ,4 cases in gradeⅢ,13 cases in gradeⅣ,20 cases in grade V;37 breast benign tumors were rated as 17 cases in grade Ⅰ,5 cases in grade Ⅱ,12 cases in gradeⅢ,3 cases in gradeⅣandⅤ0 cases. The statistical difference of Tpeak,S max,K1 between benign and malig-nant breast tumors were significant(P<0.05). On ROC,the area under the curve was 0.940,95%confidence in-terval was from 0.887 to 0.994. The sensitivity of BI-RADS in the diagnosis of breast cancer was 94.59%and speci-ficity was 92.11%. Conclusion DCE-MRI combined with BI-RADS-MR classification in diagnosis of benign and malignant breast tumors has an important value and can improve diagnosis and differential diagnosis level.

Analysis of genetic mutation of UGT1A1 * 28 and UGT1A1 * 6 in renal transplant patients with unconjugated hyperbilirubinemia / 中华器官移植杂志

Objective To explore the clinical significance and gene mutation profiles of renal transplant patients with unconjugated hyperbilirubinemia (Gilbert's syndrome).Methods Genomic DNA was extracted from peripheral blood samples of 8 renal transplant patients with Gilbert'S syndrome.UGT1A1 * 6 and UGT1A1 * 28 genotypes were identified through digital fluorescence molecular hybridization and DNA sequencing.Results There are 2 cases of UGT1A1 * 28 heterozygous mutant,3 cases of UGT1A1 * 6 homozygous mutant,2 case of UGT1A1 * 6 heterozygous mutant,1 case of UGT1A1 * 28 heterozygous mutant combined with UGT1A1 * 6 heterozygous mutant.Conclusion There is a higher heterozygous or homozygous gene mutation rate of UGT1A1 * 6 and UGT1A1 * 28 in renal transplant patients with Gilbert's syndrome.Genetic mutation of UGT1A1 * 6 and UGT1A1 * 28 may be the reason of Gilbert's syndrome after renal transplant.

Innovation and development of gel dressings in bone exposed wound repair / 中国组织工程研究

BACKGROUND: Bone exposed wounds are frequently required to deal with in orthopaedic surgeries, involving the treatment of open fractures, bone tumors, osteomyelitis, and many other diseases, in which the defect of soft tissue caused by open fractures is the most difficult to deal with. Conventional debridement or negative pressure closed drainage technology is difficult to make bone exposed wounds heal, and the process is extremely cumbersome, during which,patients suffer a lot of pain.OBJECTIVE: To evaluate the advantages and disadvantages of the various types of dressings, and review the application of new hydrogel dressing in bone exposed wounds based on its advantages, such as keeping wound environment moisture, restoring skin physical barrier, contributing to routine dressing change.METHODS: A computer-based online retrieval of PubMed and CNKI databases was performed to search papers published between 2000 and 2016 using the key words hydrogel dressing, bone exposed wound, traditional wound dressing, antibiotic in English and Chinese, respectively. A total of 55 papers suitable for final analysis from the application of traditional and new dressings in bone tissue engineering were reviewed.RESULTS AND CONCLUSION: The treatment of bone exposed wounds involves the treatment of many diseases, such as open fractures, bone tumors, osteomyelitis, which is still an orthopedic problem to solve. The novel hydrogel dressings with unique advantages are able to provide better plans for bone exposed wounds, and the use of these dressings solves the regeneration and repair of exposed bone, and improves the infection of antibiosis. In addition, the gel dressings currently have become a hot spot of research because of the characteristics of sustained-release.

Diagnosis of Multi-slice Spiral CT Enhanced Scanning in Borderline and Invasive Ovarian Tumor / 中国医学影像学杂志

Purpose To investigate the diagnostic value of multi-slice spiral CT (MSCT) enhanced scanning in borderline and invasive ovarian tumor,and to provide valuable image evidence for clinical treatment.Materials and Methods One hundred and one patients with pathological-confirmed borderline and invasive ovarian tumor in the First Affiliated Hospital of Jinzhou Medical University from October 2012 to October 2016 were selected,and the preoperative abdominal MSCT enhanced imaging,clinical and pathological data were retrospectively analyzed.The MSCT imaging was observed,and the prediction model of MSCT differentiating borderline and invasive ovarian tumor was established.Results The differences of onset age,menopausal status,tumor solid components,maximum diameter,septa and margin were all statistically significant between borderline and invasive ovarian tumor groups (P＜0.05).The prediction model of MSCT differentiating borderline and invasive ovarian tumor was established using multivariate Logistic regression,on the basis of following variables (OR＞l,P＜0.05):tumor size,solid components and septa.The sensitivity and specificity of the prediction model were respectively 81.3％ (95％ CI:0.622-1.000) and 85.7％ (95％ CI:0.741-0.973) in predicting borderline ovarian tumor for patients before menopause,and respectively 92.1％ (95％ CI:0.835-1.000) and 91.7％ (95％ CI:0.761-1.000) for those after menopause.Conclusion MSCT enhanced scanning is helpful to differential diagnose of borderline and invasive ovarian tumor,and it has important significance for clinical treatment and prognosis evaluation.

Cross-sectional Survey on Therapeutic Drug Monitoring of Vancomycin in Our Hospital / 中国药房

OBJECTIVE:To explore the necessity of developing therapeutic drug monitoring of vancomycin in our hospital and its existing problems,and provide a reasonable basis for the clinical rational use of vancomycin. METHODS:The cross-sectional survey was designed to collect the clinical data of 92 patients with therapeutic drug monitoring of vancomycin and statistically ana-lyze 192 cases of plasma concentration monitoring data. RESULTS:The average plasma trough concentration was (15.96 ± 8.06) mg/L;with the increase of age,the plasma trough concentration was increasing,there was no significant difference in the plasma trough concentration among different age groups (P=0.000);there were only 13 cases (6.77%) that obtained the plasma trough concentration within 30 min before the fourth dose;after using wancomycin,clearance rates of Cr and the endogenous creatinine were slightly higher than before,but there was no significant difference(P=0.722);36 cases(39.13%)showed vancomycin sus-ceptible gram positive cocci;after using wancomycin,the body temperature,white blood cell count and neutrophil percentage were lower than before,the differences were statistically significant (P=0.006,P=0.000,P=0.000);48 cases (52.17%) in treatment received initial loading dose,and only 15 cases (16.30%) did not use in combination with other anti infective drugs. CONCLU-SIONS:The results showed there are still a lot of problems in the treatment of vancomycin in our hospital,for example,the stan-dard rate of the plasma trough concentration is about 50%;most of the time of blood sampling is not reasonable;the detection rate of the pathogen is low;only about half of the cases are given the loading dose,etc. Therefore clinical pharmacists’intervention for blood sampling is an important part to promote rational drug therapy monitoring. Meanwhile,data interpretation of the monitoring results of serum drug concentration of vancomycin is a basic method for clinical pharmacists in clinical monitoring to correct the un-reasonable operations,and also the necessary measures for preventing the drug renal toxicity,it is a very important significance for the medication safety and effectiveness especially in severe infection patients,the elderly,the children and the people with renal function insufficiency.

Important Roles of Pharmaceutical Excipients Standards and Guidelines System Construction in Excipients Regulatory Reform in China / 中国药师

Pharmaceutical excipients are implementing registration and approval management in our country. As the disadvantages of the registration system appearing continuously, the demand for reform is getting higher and higher. The cry for drug master files ( DMF) model instead of registration and approval management is becoming more prominent. Based on the understanding of DMF sys-tem, the article discussed the positive roles of the excipients standards and guidelines construction in DMF implementation using phar-maceutical excipients supervision experience in the United States as the reference and starting from the standards and guidelines system of excipients, which aimed to provide suggestions for the supervision and management of pharmaceutical excipients, and improve the quality and safety of pharmaceutical excipients and drugs.

Analysis of the Utilization of Tripterygium Glycosides Tablet in Outpatient Department of Our Hospital / 中国药房

OBJECTIVE:To provide for rational use of Tripterygium glycosides tablet clinically. METHODS:The utilization of Tripterygium glycosides tablet were collected from hospital information system(HIS)in our hospital during Jun. 2012-Jun. 2014. Then the data about the basic information,patients’age,departments and diagnosis,were analyzed by the Excel. RESULTS:The application of Tripterygium glycosides tablet remained stable since Jun. 2012. There were 4 600 prescriptions in average every year, and the age of patients was distributed from 11 to 90. Tripterygium glycosides tablet was mainly used in rheumatology department (52.11%),followed by TCM rheumatology department(20.62%),skin disease and venereal disease department(18.15%),ne-phrology department(3.52%)and integrated traditional and western medicine cardiology department(1.77%). It was mainly used to treat rheumatoid arthritis,Sjogren's syndrome,polymyalgia rheumatica,osteoporosis and nephrotic syndrome. CONCLUSIONS:The application of Tripterygium glycosides tablet as immunosuppressant is widely used,but the age of patient is with wide distribu-tion;the narrow gap exists between minimum effective dose and minimum lethal dose;so ADR should be concerned closely.

Study on the Correlation of Cyclosporine Exposure Monitoring in Healthy Volunteers with Sampling Time Points of Blood / 中国药房

OBJECTIVE:To study pharmacokinetics of cyclosporine in healthy volunteers, and to investigate the relationship of drug exposure with blood sampling time after treatment. METHODS: The data of trial at the first 12 blood sampling time points after medication were collected from bioequivalence test in 24 healthy volunteers (trial preparation vs. reference preparation). Multiple linear regression analysis was used to study the blood concentrations of cyclosporine at different sampling time points and the area under the blood concentration-time curve (AUC). RESULTS: The concentrations at two points were adopted to estimate AUC. The correlation coefficient of different cyclosporines could reach 0.9 with estimation deviations less than 15%. The AUC of cyclosporine of trial preparation could be estimated by C8 and C12, and that of reference preparation by C2.5 and C12. CONCLUSION: The AUC estimated by concentrations at two points can meet clinical demand. There is great difference in estimate point among different preparations.

Effect of Anti-tuberculosis Therapy on Plasma Concentration of Calcineurin Phosphatase Inhibitors in Renal Transplant Recipients / 中国药房

OBJECTIVE:To discuss the effect of anti-tuberculosis therapy on plasma concentration of calcineurin phosphatase inhibitors in renal transplant recipients.METHODS:The change in plasma concentration of calcineurin phosphatase inhibitors in 2 renal transplant recipients who were complicated with tuberculosis infection before or after renal transplantation was analyzed.The patients were routinely treated with cyclosporine(CsA)or tacrolimus(FK506)+ mycophenolate mofetil(MMF)+ prednisolone(Pred).Monoclone fluorescence polarization immunoassay(FPIA)was employed to determine the concentration of CsA or FK506 in different time point before and after administration of antituberculosis drugs.RESULTS:Plasma concentration of CsA was down-regulated significantly by Rifampicin,and the daily dose of CsA has to be increased to more than 3 times the previous concentration before meeting the target concentration.The concentration of FK506 was slightly down-regulated by rifapentine.CONCLUSION:The concentration of CsA or FK506 and the adverse effect of antituberculotic drugs should be closely monitored for renal transplant recipients complicated with tuberculosis infection.

Pharmacokinetics and Relative Bioavailability of Domestic Carveidilol in Healthy Volunteers / 中国药房

OBJECTIVE： To study the pharmacokinetics of domestic carvedilol and relative bioavailability of carvedilol capsule in Chinese volunteer.METHODS： Eight volunteers orally took a single dose of 30mg test preparation and 25mg control preparation in a random crossover and self-control method.Samples were determined by RP-HPLC fluorescent method.RESULTS： Profiles of carvedilol in vivo could be described as open two-compartment model.The main pharmacokinetics parameters of test and control preparations were as follows： Cmax（98.89± 27.60） ng/ml、 （70.06± 27.29） ng/ml， Tmax（0.4 849± 0.2 635） h、 （0.6 037± 0.1 707） h， CL（0.1 621± 0.08 057） （mg· h） /（ng· ml） 、 （0.1 796± 0.09 198） （mg· h） /（ng· ml） ， V/F(c)（0.2 127± 0.1 260） mg/(ng· ml)、 （0.2 777± 0.1 860） mg/（ng· ml） ， T1/2β （2.011± 1.709） h、 （1.959± 1.156） h， AUC（233.1± 97.12） ng/（ml· h） 、 （168.0± 70.61） ng/（ml· h） ； Mean relative bioavailability in man was (111.3± 15.18)％ .CONCLUSION： The results can be used for design of therapeutic scheme.

New Polymorphic Microsatellite Loci Identified Using Genomic Resource for Schistosoma japonicum / 中国寄生虫学与寄生虫病杂志

Objective To identify new microsatellite loci from genome sequence database for the study of poly-morphicsm of Schistosoma japonicum. Methods Schistosoma japonicum isolates were obtained from seven endemic sites in China: Tongling and Guichi counties of Anhui Province, Duchang county of Jiangxi Province, Changde and Yueyang Cities of Hunan Province, Shashi City of Hubei Province, Xichang City of Sichuan Province. In order to study the genetic variance, genomic DNAs of 96 individual adult worms were screened against 17 new Schistosoma japonicum microsatellites and the raw data were analyzed by GenMapper 4.0. Furthermore, the varieties of alleles were inverstigated using GenAlEx 6 and genetic distances within a subpopulation (GenClone) and among populations(UPGMA, MEGA 3.1) were analyzed. Results High levels of polymorphism were found between and within population samples, and significant genetic diversity was observed among the seven subpopulations.Within Jiangxi population, most genetic distances (17 loci) among samples range from 25 to 32, indicating a significant genetic diversity. There are three clusters among the seven populations: Jiangxi, Tonglin, Shashi and Changde population, with the genetics distances ranging from 0.017 8 to 0.036 3; Guichi and Yueyang population belong to another cluster, with the genetic distance of 0.024 7; However, Xichang population is an unique group. Its genetic distances to other populations are notable with a range from 0.019 2 to 0.069 3. Conclusion The 17 new polymorphic microsatellites identified may be used as suitable markers for the study on population genetics of Schistosoma japonicum and the genetic variance of the worms seems to be complicated.