Post-marketing safety analysis of inactivated enterovirus A71 vaccines / 中华预防医学杂志

Objectives@#To evaluate the safety of inactivated enterovirus A71(EV-A71) vaccines after large-scale immunization in the community.@*Methods@#We selected EV-A71 susceptible people (healthy children) aged 6-59 months in vaccination clinics from 89 counties in Zhejiang Province between April 2016 and March 2018. All local and systematic adverse actions were collected by 30 min on-site inspection, within 3 days and 4-30 days follow-up. Chi-square test and Fisher′s exact test were used to compare the difference of AEs incidence in various characteristics among two groups.@*Results@#A total of 71 663 doses of vaccines were included for active safety analysis, which included 37 331 doses in boys and 34 332 doses in girls. Among all the doses, children aged 6 to 11 months, 12 to 23 months and 24 to 59 months were received 13 707, 32 639 and 25 317 doses respectively. The incidence of adverse reactions within 30 min, 3 days and 4-30 days were 0.33% (239 doses), 1.58% (1 133 doses) and 0.34% (244 doses) respectively. Adverse reactions within 3 days were 1 372 doses, with a incidence of 1.91%; among all the cases, 539 doses (0.75%) were grade 1, 677 doses (0.94%) were grade 2 and 156 doses (0.22%) were grade 3, no grade-4 adverse reaction was reported. The common local adverse reactions were redness, swelling and pruritus, with the incidence rates were 0.05% (39 doses), 0.02% (16 doses) and 0.02% (12 doses), respectively, while the most common systemic adverse reaction was pyrexia with an incidence of 1.19% (856 doses), followed by diarrhea and anorexia with the incidence rates were 0.15% (104 doses) and 0.13% (90 doses) respectively.@*Conclusion@#Most adverse actions of EV-A71 vaccines were mild and moderate and majority of them were common adverse actions. No new adverse reactions were found in the study.

Performance of prenatal screening by non-invasive cell-free fetal DNA testing for women with various indications / 中华医学遗传学杂志

OBJECTIVE To assess the performance of non-invasive prenatal testing (NIPT) based on massive parallel sequencing. METHODS A total of 10 275 maternal blood samples were collected. Fetal chromosomal aneuploides were subjected to low coverage whole genome sequencing. Patients with high risks received further prenatal diagnosis. The outcome of all patients were followed up. RESULTS High-throughput sequencing detected 72 pregnancies with fetal autosomal chromosomal aneuploidy, including 57 cases of trisomy 21, 14 cases of trisomy 18, and 1 case of trisomy 13. The positive predictive value for trisomies 21 and 18 were 98.25% and 91.67%, respectively. Comparing its performance in intermediate or high risk pregnancies, advanced maternal age pregnancies and volunteering to test pregnancies, the positive predictive value were 100%, 95%, 90% and 50%, respectively. The follow up result was only 1 case of 21 trisomy false negative with high risk. For the 56 cases of trisomy 21, the high risk group accounted for 55%, advanced maternal age accounted for 29%, the intermediate risk referred to 14%, the volunteering to test group accounted for 2%. CONCLUSION The performance of NIPT for trisomies 21, 18 and 13 was satisfactory. The method can be used for women with advanced gestational age. NIPT has offered an ideal secondary screening method for those with an intermediate or high risk, and can reduce the rate of birth defects.

Application of QCC optimized the traditional Chinese medicine nursing program to promote the recovery of gastrointestinal function after cesarean section / 中国实用护理杂志

Objective To discuss the effect of Quality Control Circle activity optimize Traditional Chinese Medicine (TCM) nursing program in improving the recovery of gastrointestinal function after cesarean section. Methods In the management of applying QCC method to optimize TCM nursing program to promote the recovery of gastrointestinal function after cesarean section. The study was conducted on patients with cesarean section of the department of obstetrics and gynecology of shenzhen hospital of Guangzhou university of traditional chinese medicine (Futian). 36 cases of the control group were patients before the optimization of TCM nursing program by QCC on February 13-26, 2017, and 36 cases of the intervention group were patients after that on July 2 to 15, 2017. Before and after the QCC program, the time of postoperative of cesarean section patients' first anus exhaust, anal exhaust rate in 18 hours and lactation time were compared. The postoperative of cesarean section patients′first anus exhaust time, 18 hours anal exhaust rate and lactation time were investigated , and essential factors and really causes of the anal exhaust rate in 18 hours were analyzed, and a corresponding countermeasures were made. Results After TCM nursing program, the postoperative of cesarean section patients′ first anus exhaust time and lactation time were significant reduced (P<0.05);anal exhaust ratein 18 hours wasrise from 22.2％(8/36) to 86.1％(31/36). The patients after cesarean sectionwhose anal exhaust rate in 18 hours was increased significantly. The target success rate was as high as 116％, and the recovery rate was as high as 287.8％. Conclusions QCC activity optimize TCM nursing program can improve the recovery of gastrointestinal function after cesarean section. It enriched the connotation of TCM nursing programs, promote the implementation and standardizes the operation process of it. It also improved the clinical efficacy of TCM nursing program, and indeed promoted the patients′ gastrointestinal function after cesarean section, so that it is worthy of clinical application.

Effect of clinical pharmacist intervention on clinical rational use of antineoplastic drugs / 中国基层医药

Objective To explore the effect of clinical pharmacist on clinical rational use of antineoplastic drugs after participating in treatment group.Methods Retrospective research was used.According to whether there was a clinical pharmacist directly or indirectly involved in,all medical teams of the oncology department were divided into intervention group,advisory group and control group in our hospital.Intervention group was the medical team that had a specialist clinical pharmacist who could intervene irrational use of antineoplastic drug in the treatment on the spot.Advisory group was in the same area with the intervention group,and didn't have a specialist clinical pharmacist, but used to communicate with clinical pharmacist and take his medication advice,where clinical pharmacist indirectly involved in treatment.The control group was the medical group in the other area without clinical pharmacists of oncology department.The control group one and two were with the most beds among the control group.Randomly selected lung cancer,breast cancer,esophageal cancer,gastric cancer,colorectal cancer,gynecological cancer,liver/gallbladder/pancreatic cancer and other tumors patients from intervention group,advisory group,control group one and control group two,from January 2015 to December 2015,10 copies of each case,80 copies of each group.And antineoplastic drugs were commented specially.The information such as sex,age,clinical diagnosis,irrational antineoplastic drug use,adverse reaction and unexpected events and hospitalization time were recorded.Results The rate of irrational antineoplastic drug use of the intervention group (41.25%)was lower than the advisory group(80%),and was significantly lower than two control groups(147.50%,161.25%),advisory group was also lower than two control groups,but no significant differences between the two control groups(χ2 =0.193,P>0.05).Irrational chemotherapy, inappropriate usage and dosage and inappropriate indications were prominent problems in intervention group and advisory group.In addition,there were more improper solvent and contraindicated or adverse interaction problems in two control groups.Adverse events and incidence of unexpected events in intervention group (46.25%,12.50%) were significantly lower than those in two control groups[(73.75%,22.50%),(23.75%,18.75%)].Furthermore, the length of stay of intervention group patients was shortest in four groups (F=8.766,P<0.05).Conclusion By participating in the treatment group,clinical pharmacists can discover the irrational drug use and security risks in treatment,can provide medication guidance,consultation,publicity and other pharmaceutical service for specialist medical staff and patients.They will be more and more prominent in the treatment of cancer.

Individualized quality of life measurement and its application in health service / 中国卫生政策研究

Individualized quality of life measurement intends to explore the individual perspectives and unique preference in health service. The individualized quality of life instruments have been widely used in other countries. However, little research has been done in China. The individualized quality of life measurement could provide unique evidence of how the target population feels and what they value individually, which help better understanding of their quality of life and health service provision.

Practice and Experience of the Application of Automatic Pharmacy System in Outpatient Pharmacy of Our Hospital / 中国药房

OBJECTIVE:To provide reference for the construction and development of hospital modernization pharmacy in Chi-na,and to promote the application of pharmacy automation system in hospital. METHODS:By introducing the change of pharma-cy management due to the debugging and application of outpatient pharmacy automation system(rapid dispensing machine,intelli-gent access machine)in our hospital,the problems of automation system and countermeasures were put forward,and the effects of automation system in our hospital were evaluated. RESULTS:With the application of automation system,the pharmacy layout was adjusted,the drugs in the machine was debugged and optimized,the procedure on adding drugs and stocktaking drugs were im-proved,the reasonable scheduling work in outpatient pharmacy was worked,the complete management plan on validity of drugs was established;referring to the problems of automation system,the procedures of adding drugs by rapid dispensing machine and intelligent access machine were formulated as well as related working guide. The adding and delivering drug failure emergency han-dling procedure of rapid dispensing machine,intelligent access machine failure emergency handling procedure were formulated ac-cording to the possible fault of automation system. Related index evaluation showed that automation system was applied and continu-ously improved,which reduced labor intensity(step count of pharmacists adding drug decreased from 5 634.6 steps/day to 4 087.8 steps/day);the work efficiency was improved greatly(the number of prescriptions increased from 226.55 sheets/h to 311.55 sheets/h during rush hours);the work error was reduced(the number of dispensing internal error decreased from 54.75 items/week to 21.50 items/week). CONCLUSIONS:After appling the automation system in outpatient pharmacy,the drug dispensing and staff manage-ment has been standardized,and it become the hospital pharmacy development inevitable trend. But it is suggested to adjust and op-timize the automation system continuously so as to exert its maximal efficacy.

Quality control study on Bidouyan mixture / 中国基层医药

Objective To explore the application of HPLC method in the determination of contents of ephedrine hydrochloride in Bidouyan mixture.Methods A HPLC method detected by one wavelength-210 nm for ephedrine hydrochloride had been developed.The chromatographic procedure for determination was carried out using DiamonsilTM C 18 (250mm x 4.6mm,5 μm) as an analytic column gradient eluted with a mixture consisting of acetonitrile and 0.05％ H3PO4.Results The ranges of calibration curve of ephedrine hydrochloride was 0.011 ～ 0.277mg/ml.The established HPLC method was applied to determine 15 samples of Bidouyan mixture.The results showed that the ranges of ephedrine hydrochloride was 0.10 ～ 0.23mg/ml.Conclusion A simple,effective and feasible HPLC method to determine the contents of ephedrine hydrochloride was established for the quality control of Bidouyan mixture.

Feasibility Study on Blood Concentration Determination of Peripiocoside in Bawei Jiangu Tablet by Chemiluminescence Enzyme Immunoassay / 中药新药与临床药理

Objective To establish the clinical pharmacokinetics research method for Bawei Jiangu Tablet.Methods Drug blood concentration was estimated through analyzing the ingredients and preclinical pharmaceutical research results of Bawei Jiangu Tablet.Results Corresponding cardiac glycoside value in serum of animals treated with oral use of Bawei Jiangu Tablets and cortex periplocae extracts can be detected by drug monitor system of digoxin immunoreaction, which was similar to that in animals treated with digoxin.Corresponding cardiac glycoside value had also been detetected in serum of subjects in phaseⅠclinical tolerance trial,which was related to the time and dosage of administration.Clini- cal negative control trial showed that the reaction was specific.Conclusion Pharmacokinetics study on target of toxic components with cross-reaction of periplocoside is feasible through drug monitor system of digoxin immunoreaction.