OBJECTIVE:To control the drug quality risk in drug withdrawal links of hospital pharmacy,and provide reference for the application of quality risk management(QRM)in hospital pharmacy. METHODS:Drug QRM was developed in drug with-drawal links through risk identification,risk assessment,risk control,risk assessment and other steps. Using the incidence of risk factors and reusable rate of withdrawal drug as indexes,related data of before(Jul.-Dec. 2015)and after(Jan.-Jun. 2016)devel-oping QRM in our hospital were compared to evaluate the effect of drug QRM. RESULTS:Determining whether specific storage drugs kept the required storage conditions,whether the numbers of withdrawal drugs counted to minimal packaging and other 5 fac-tors were high-risk factors(the risk score of each factor>4 points);control measures were taken separately for high risk factors, then high-risk factors were reduced to acceptable levels(risk score<4 points). After developing QRM,the incidence of risk factors were reduced than before(reduce 1.35%-6.19%),reusable rate of withdrawal drug was increased(98.64% vs. 86.32%)(all P<0.05). CONCLUSIONS:Developing QRM in drug withdrawal links of hospital pharmacy can reduce the drug quality risk.

AIM: To determine the aqueous, vitreous, serum levels of pigment epithelium-derived factor (PEDF)and vascular endothelial growth factor(VEGF)in patients with proliferative diabetic retinopathy(PDR), and to speculate on the source of the change in concentration and to discuss its clinical significance.METHODS:Forty-one eyes withproliferative diabetic retinopathy were included in the study, 16 of which were complicated by neovascularization of iris (NVI).Twenty-one eyes with idiopathic macular hole (MH)were as controls. The aqueous, vitreous, serum levels of PEDF and VEGF of all the groups were determined with ELISA. PEDF, VEGF and the levels in the three groups were compared with analysis of variance (ANOVA). The PEDF, VEGF concentrations in aqueous,vitreous and serum were analyzed with Pearson correlation test,and the correlation of PEDF and VEGF levels was also analyzed with Pearson correlation test.RESULTS:The aqueous levels of PEDF decreased significantly in sequence in groups of control, PDR without NVI, PDR with NVI. VEGF levels increased coordinately. The similar findings existed in vitreous samples. The PEDF,VEGF levels in aqueous were not correlated significantly with those in serum,but correlated positively with those in vitreous. The intraocular levels of PEDF had a negative correlation to those of VEGF.CONCLUSION:The reduction of intraocular PEDF level and elevation of intraocular VEGF level may play an important role in the occurrence and progression of PDR. In the development of PDR, the PEDF,VEGF levels in aqueous may be mainly effected by local pathological changes, as anti-angiogenic and pro-angiogenic factors, their unbalanced intraocular distribution may promote the angiogenesis of the iris and retina.

Objective To evaluate the clinical application value of amniotic membrane transplantation in the treatment of intrauterine adhesions.Methods Totally 48 intrauterine adhesions patients of infertility were treated with amniotic membrane transplantation from January to December 2013 in our hospital.They were divided into mild adhesion in 11 cases (group A),moderate adhesion in 17 cases (group B),and severe adhesive group in 20cases (group C) by American Fertility Association.They were treated with amniotic membrane transplantation and estrogen/progesterone sequential treatment after operation.Clinical effect and feasibility of each group were analyzed.Results There was statistical significance in the endometrium thickness after 3 months (P ＜ 0.05).The menstruation of all patients with mild and moderate intrauterine adhesion (IUA) was improved,and the menstrual improvement rate in patients with severe intrauterine adhesions was 90％.IUA cure rate of groups A,B,and C were different after 3 months of surgery,[groupA100％ (11/11),group B 94.1％ (16/17),group C70％ (14/20),x2 =6.73,P ＜0.01],The cure rate of group A was significantly higher than that of group C (x2 =4.00,P ＜ 0.05),although the cure rate of group B was higher than that of group A,but the difference was not statistically significant (P ＞ 0.05).Conclusions The cure rate of amniotic membrane transplantation combined with estrogen in the treatment of intrauterine adhesions was high.It could promote the recovery of the endometrium and improve the recovery of menstruation.There was no transplantation rejection and safety.It also had the advantages of easy drawing materials,simple operation,and can be applied to clinical application and promotion.

Objective To study the relationship between Lidocaine blood drug level and the cause of death from Lidocaine anaphylactic shock. Method Comparing and analyzing the blood drug levels by HPLC between two groups of people whose various indexes are normal before the surgery. Group 1 included 8 cases who accepted Lidocaine as anesthetic and died from Lidocaine anaphylactic shock. Group 2 included 11 cases who also took Lidocaine as anesthetic and passed the surgery smoothly. Results Lidocaine blood level of Group 1 (1.61?0. 45mg/L) is lower than that of Group 2 (2. 44 ?0. 47mg/L). Conclusion Lidocaine blood drug level has nothing to do with the cause of Lidocaine anaphylactic shock.

Objective:This study has two objectives. One is to detect the methylation status of reversion-inducing cysteine-rich protein with Kazal motifs (RECK, a new tumor suppressor gene) gene promoter in primary laryngeal squamous cell carcinoma and nor-mal laryngeal mucosa. The other is to analyze the correlation between RECK gene methylation status and radiosensitivity in laryngeal squamous cell carcinoma. Methods:Methylation-specific polymerase chain reaction was used to detect the RECK gene methylation of 70 specimens of laryngeal squamous cell carcinoma and 15 normal tissues of laryngeal mucosa. The patients underwent six cycles of ra-diotherapy and were followed-up for 5 years. The correlation between RECK gene methylation status and radiosensitivity in laryngeal squamous cell carcinoma was analyzed. Results: After six cycles of radiotherapy, 47 patients (67.14%) showed sensitivity and 23 (32.86%) showed tolerance to radiotherapy. The methylation level of the RECK gene was lower in the radiation-sensitive group than in the nonradiation-sensitive group (P<0.05). The methylation level of the RECK gene was lower in the remission group than in the non-remission group. RECK gene methylation could increase the risk of cancer by approximately 5.010 times (OR=5.010, 95%CI:1.616-15.533). Conclusion:RECK gene promoter methylation in human laryngeal squamous cell carcinoma is an early event that is correlated with the patient's sensitivity to radiotherapy. Thus, the patient's sensitivity to radiation can be predicted by detecting the meth-ylation status of the RECK gene promoter.

Objective To observe the effects of recombinant staphylokinase (r-SAK) on platelet activation parameters in patients with acute myocardial infarction(AMI) by intravenous thrombolysis in order to investigate the clinical thrombolytic efficacy of r-SAK therapy in AMI comparing with recombinant tissue-type plasminogen activator(rt-PA) therapy.Methods Thirty-three patients with AMI within 12 h after the onset were selected and divided randomly into the r-SAK therapy group(n=17) and rt-PA therapy group(n=16).Coronary artery angiography(CAG) was performed 90 min after thrombolytic therapy in patients.Thrombin-antithrombin complex(TAT) and alpha granule membrane protein(GMP-140) were measured by similar commercial enzyme-linked immunosorbent assay(ELISA).Results In r-SAK group and rt-PA group,the plasma contents of GMP-140 2 h after thrombolytic therapy were significantly higher than before therapy(P0.05).In rt-PA group,the plasma content of TAT 2 h after thrombolytic therapy increased significantly(P0.05).) Conclusion r-SAK has similar effect with rt-PA and it will become available for highly fibrin-selective thrombolytic therapy of AMI.Thrombolytic treatment with r-SAK can improve the injury of myocardial microperfusion.

Objective To prove the clinical effect of portable auto-haemostat machine on body's limbs. Methods Portable auto-haemostat machine was applied to the indicated patients in their clinical aid treatments course, i.e. the rapid hemostasis on limbs. Results The hemostasis was rapid and accurate with hemostatic pressure in the range from 190 to 230 mmHg. The excellent effect guarantees the diagnosis, observation, bandaging and secure transmission of victims until they were sent to the operation room. Conclusion It is reliable to use portable auto-haemostat machine on body's limbs in clinic works.

Objective To evaluate the safety and efficacy of intravenous dalteparin compared with unfractionated heparin in patients underwent coronary angiogram with or without percutaneous coronary intervention(PCI).Methods A total of 87 patients who underwent one-stage elective PCI were randomized to intravenously unfractionated heparin(UFH,10 000 IU) group or dalteparin group.The dalteparin group was further divided into low dose dalteparin(5 000 IU) group or high dose dalteparin(10 000 IU) group according to whether the patients underwent PCI procedure.Blood samples for anti-Xa levels and ACTs were assayed at baseline and at 10 min,20 min,1 hour,2 hours and 4 hours after all dalteparin or UFH doses were administered.Results Baseline characteristics were similar across the three groups.In all groups,ACTs reached the maximum at 10 min after the total doses given,with the highest value in the UFH group and lowest in the low dose dalteparin group(524.68 ?278.32 s vs 191.26?39.35 s vs 304.20?42.71 s,P0.05).Conclusion Both 5 000 IU and 10 000 IU dalteparin injected through sheath before PCI or coronary angiography could reach an anti-Xa levels similar to that achieved by 10 000 IU UFH.

Objective To investigate the mastery of clinical students' doctor-patient communi-cation skills and to assess the teaching effectiveness about the doctor-patient communication, and then propose some improvement ideas. Methods We conducted a study in students of clinical medicine of Nanjing Medical University in Grade 2009, using Objective Structured Clinical Examination (OSCE) after internship, which included graduation assessment of doctor-patient communication skills. Then we analyzed the doctor-patient communication skills and related scores of students trained in different clinical medical programs. Results The average score of doctor-patient communication skills of 549 students was (82.72±4.23), of which, the average score of 329 five-year students of clinical medicine was (81.88±4.23) and the average score of seven-year students was (83.96±3.91) in. The average score of seven-year students of clinical medicine was significantly higher than five-year students (P=0.000). Moreover, there was a significant positive correlation between the total score of OSCE and the score of doctor-patient communication skills in both five-year and seven-year students of clinical medicine (five year program students' score correlation coefficient was 0.520, P=0.000;seven year pro-gram students' score correlation coefficient 0.416, P=0.000). Conclusion The teaching effectiveness of doctor-patient communication has proved to be quite effective, and it is definitely of great significance in improving clinical students' doctor-patient communication skills. The score of the assessment of the doctor-patient communication reflects not only the training effectiveness of the communication skills, but also the comprehensive capacity.

Objective To evaluate the diagnostic accuracy of GenoType? M TBDRsl for the resistance to fluoroquinolones anti‐tuberculosis drugs .Methods Systematic and comprehensive literature was searched in PubMed ,Embase ,Web of Science ,CBM , CNKI ,VIP and Wanfang database .The relative studies of GenoType? MTBDRsl to fluoroquinolones anti‐tuberculosis drugs were included .After quality assessment ,Meta‐Disc1 .4 software was used to analyze the data .Results A total of 16 trials ,involving 1 766 participants ,were included .The results of Meta‐analysis showed that the weighted sensitivity ,specificity ,positive likelihood ra‐tio ,negative likelihood ratio ,diagnostic odds ratio ,and the area under summary receiver operation curve were 0 .83 ,0 .96 ,17 .50 , 0 .20 ,108 .46 and 0 .934 9 ,respectively .Conclusion GenoType? M TBDRsl assay for the resistance to fluoroquinolones anti‐tuber‐culosis drugs might be with high sensitivity and specificity ,which could be recommended as efficacy diagnostic tool .