OBJECTIVE:To explore the idea and method of post-marketing safety reevaluation of TCM injection in our hospi-tal. METHODS:In case-control study,salvianolate for injection was chosen for practice. 1 000 patients with stable angina receiv-ing Salvianolate for injection in our hospital during May 2012-Oct. 2013 were selected as subjects. The occurrence of ADR/ADE were observed and Logistic regression analysis was conducted by using SPSS 20.0 software. RESULTS:The incidence of ADR/ADE was 0.6%,and rare(0.1%-1%). The ADR/ADE were general and mainly manifested as erythra(66.67%). Skin and its ap-pendants were main organs involved in ADR(66.67%). Logistic regression analysis showed that gender,drug combination and age are risk factors of ADR/ADE. CONCLUSIONS:The post-marketing safety reevaluation of TCM injection not only make up for the deficiency of pre-marketing safety evaluation of TCM injection and find out potential delayed and severe ADR/ADE and drug inter-action,but also provide reference for rational drug use in the clinic and guarantee the safe and rational drug use.

Objective:To investigate the relationship between the gene polymorphism cluster of differentiation 14 (CD14)-159C/T (rs2569190),and interleukin-8 (IL-8)-251A/ T (rs4073)and the susceptibility of necrotizing enterocolitis (NEC),to clarify the influencing factors of susceptibility of NEC and to provide genetics theory basis for the research on the pathogenesis of NEC. Methods:Total 28 newborns with NEC and 41 newborns without NEC were selected.The amplification of peripheral blood DNA was conducted by PCR.The genotypic and allelic frequencies of CD14-159C/T and IL-8-251A/T of the patients were detected by Sanger DNA sequencing method. The relationship between them and the susceptibility of NEC was studied.Results:The distribution of genotypic frequencies of CD14-159C/T and IL-8-251A/T was consistent with Hardy-Weinberg equilibrium (P >0.05).There were no significant differences of the allelic and genotypic frequencies of CD14-159C/T,or genotypic frequencies of IL-8-251A/T between two groups (P >0.05).While in NEC group,the T allelic frequency of IL-8-251A/T site was higher than that in control group (χ2 = 4.184, P = 0.041, OR = 2.14, 95% CI: 1.03 - 4.46 ). Conclusion:The polymorphism of CD14-159C/T is irrelevant to the pathogeny of NEC,but T allelic frequency of IL-8-251A/T site might be related to the susceptibility of NEC.So T allele in IL-8-251A/T may be one of the danger factors of NEC.

Objective To discuss how to use the core elements of international classification of functioning,disability and health(ICF) as a guide in stroke operation treatment to develop targeted,effective therapy plan and rehabilitation goals,establish individualized treatment of rehabilitation,and to observe the effect of limb movement function in stroke patients. Methods Sixty cases patients with stroke and aged from 40 to 65 years old were selected. The body function and structure of all stroke patients were marked by comprehensive evaluation scores of The National Institutes of Health Stroke Scale ( NIHSS ) and Fugl?Meyer assessment. And then they were randomly divided into two groups,30 cases in each group. The observation group used the Chinese version of brief ICF Core Sets for evaluation, and set individualized treatment according to the results of the assessment;The control group, according to the conventional rehabilitation process, involved in training routine physical therapy. Again 8 weeks after treatment for patients with evaluation,the assessment results was compared with the results of the first assessment. Results Before treatment, the NIHSS, Fugl?Meyer assessment and Chinese version of brief ICF core elements scale scores for the observation group were 7. 95±2. 37,34. 5±4. 0 and 82. 15±17. 96,for the control group were 7. 58±2. 25,34. 8±4. 0 and 81. 55±18. 78. After treatment,the above three rating scale scores, for the observation group were improved to 4. 78 ± 1. 63, 56. 3 ± 4. 2, 60. 45 ±11. 04,for the control group were improved to 5. 13±1. 75,48. 1±3. 8,73. 56±16. 89. The two groups were significantly improved ( observation group:t=4. 94, 15. 51, 18. 59, P<0. 05;control group:t=3. 17, 14. 66, 12. 33,P<0. 05). After treatment,compared with the control group of three rating scale scores(5. 13±1. 75,48. 1
±3. 8 and 73. 56±16. 89),the observation group(4. 78±1. 63,56. 3±4. 2 and 60. 45±11. 04) improved more apparently(t=3. 15,14. 54,15. 45,P<0. 05) . Conclusion Guided by the idea of ICF and scale,with the demand of the patients as the center,to develop personalized physical therapy,can achieve more productive and more targeted rehabilitation goals.

Objective To develop an intelligent assist order system for parenteral nutrition and embed it into hospital information system,so as to facilitate rational prescription of parenteral nutrition.Methods Comprehensive database,knowledge base and control system of parenteral nutrition orders were set up based on production rule.An intelligent assist order system for parenteral nutrition was designed and developed.Individual energy demand of patients were calculated automatically and compared with doctors' orders of parenteral nutrition.Cation concentration was calculated automatically and controlled for the stability of all-in-one parenteral nutrition admixture.Results This system achieved successful and fast calculation of individual energy demand,over-standard warning of total energy,the ratios of carbohydrates to lipids and non-protein calories to nitrogen,ion concentration,and liquid volume.It also controlled the cation concentration,thus avoiding demulsification.Conclusions The intelligent assist order system for parenteral nutrition can solve the problems of energy calculation and ensure the stability of all-in-one parenteral nutrition admixture.As a result,it can improve the utilization of parenteral nutrition in hospital.

Objective: To evaluate the self-developed intelligent assist order system for parenteral nutrition on the control of concentration exceeding standard of positive ions.Methods: The special comments, pharmacist audit and information control were used to intervene the concentration exceeding standard of positive ions in parenteral nutrition orders and the effect of the three intervention methods were evaluated.Results: For the intervention of concentration exceeding standard of positive ions in parenteral nutrition orders, the information control was better than the special comments and pharmacists audit.Conclusion: The intelligent assist order system for parenteral nutrition can solve the problem of concentration exceeding standard and promote the rational application of parenteral nutrition in hospitals.

Objective: To construct the management model for intravenous drug use based on index system in a hospital.Methods: A three-level organizational framework was established, the KPI assessment method was used to set control index and observational index respectively for outpatients and inpatients.The completion of the clinical department indicators were monitored and analyzed with the help of the hospital information systems, and regulated by pharmacy and management tools.Results: After the application of the hospital intravenous drug use management model, the qualification rate of intravenous medication orders was improved in December 2015 (89%) when compared with that in December 2014 (68%), and the difference was statistically significant(P＜0.05).The indices of intravenous drug use of inpatients and outpatients in 2015 were significantly improved when compared with those in 2014.Conclusion: The hospital intravenous drug use management model based on index system construction can effectively reduce unnecessary intravenous medication and promote the rationality of intravenous medication.

Objective To investigate the distribution of pelvic recurrence in rectal cancer after radical resection and analyze the outcome and prognostic factors of pelvic recurrent rectal cancer treated with radiotherapy. Methods Ninety-three patients with pelvic recurrent rectal cancer who received radiotherapy from August 2000 to August 2006 were retrospectively analyzed. Of them, 21 patients received pelvic radiation alone;56 received pelvic radiation plus chemotherapy and 16 received pelvic radiation plus surgery and/or chemotherapy. Radiotherapy was delivered with 60Coγor 6/15 MV X ray to a median dose of 59. 4Gy (range,20-74 Gy). Conventional fractionation was used in 90 patients. Chemotherapy was given to 68patients with a median number of 3 cycles ( range, 1 - 8 cycles). Concurrent chemo-radiation with 5-FU based regimen was given to 42 patients. After radiotherapy, 16 patients underwent surgical resection, with 7R0 resection and 9 palliative resection. Results The entire cohort included 132 recurrent sites. The most common recurrent sites were peri-rectal region ( 31.8% ), pre-sacral region ( 30. 3% ) and internal iliac nodal region (20. 2% ). The follow-up rate was 92% for the entire cohort, 39 and 4 patients had minimum follow-up time of 2 and 5 years respectively. Overall clinical response ( complete and partial symptomatic relief) was achieved in 83% of the patients after radiation therapy. The 2-and 5-year local progression-free survival rates were 49% and 22% respectively, and the 2-and 5-year overall survival rates were 46% and 14% respectively. Multivariate analysis showed that treatment modality was the independent prognostic factor for local progression-free survival. Patients treated with radiation plus surgery and/or chemotherapy had better local progression-free survival than those treated with radiation plus chemotherapy or radiation alone.Recurrent tumors larger than 5 cm in diameter, disease-free interval less than 2 years and distant metastasis after radiotherapy were independent unfavorable prognostic factors for overall survival. Conclusions Perirectal region, pre-sacral region and internal iliac nodal region were the most common pelvic recurrent sites in rectal cancer. Radiotherapy is an effective palliative approach for patients with pelvic recurrent rectal cancer.Radiotherapy plus surgery and/or chemotherapy was associated with better local progression-free survival,and recurrent tumors lager than 5 cm in diameter, disease-free interval less than 2 years and distant metastasis after radiotherapy were unfavorable prognostic factors for overall survival of pelvic recurrent rectal caner.

Objective:To evaluate the management effect of clinical pharmacist on antibiotics use during perioperative period of great saphenous varicose veins surgery. Methods:The medical records of all the patients undergoing simple great saphenous vein strip-ping, great saphenous vein high ligation plus simple stripping and saphenous vein ligation plus endovenous laser treatment between June and September in 2010 ( before the intervention) , 2011 ( after the intervention) and 2014 ( consolidation period) were selected, and the rationality of prophylactic use of antibiotics during perioperative period was evaluated. Results: After the management of clinical pharmacists, the preventive application of antibiotics during perioperative period was markedly improved in the indication, medicine va-riety choice,application and dosage, administration route, solvent and solvent dose, administration time, course of treatment and drug combination when compared with that before the intervention. Antibiotics use ratio, average hospitalization days, antibiotics ratio, drug ratio and infusion ratio were reduced obviously, which could be consolidated. Conclusion: The intervention of clinical pharmacists in antibiotics use during perioperative period of great saphenous varicose veins surgery improves the reasonable use ratio of antibiotics, and makes certain significance in the cost reduction for patients and the specification for hospital management.

OBJECTIVE:To establish microbial limit test for Compound clindamycin hydrochloride gel and to carry out the validation of three methods.METHODS:According to the appendices volumeⅡof Chinese Pharmacopeia(edition 2005),microbial limit test which contained routine test,medium dilution method and membrane-filter method was adopted to validate Compound clindamycin hydrochloride gel.Recoveries of three methods were compared to make sure the suitable validation method.RESULTS:In routine test,recovery of trial bacteria was lower than 70%and controlled bacteria couldn't be found out.In medium di-lution method,recovery of trial bacteria was higher than 70%and still lower than the recovery of diluents.In membrane-filter method,recovery of trial bacteria was higher than 90%,and controlled bacteria grew well.Membrane-filter method could eliminate inhibition effect of Compound clindamycin hydrochloride gel on bacteria.CONCLUSION:Membrane-filter method is effective and practical for microbial limit test of Compound clindamycin hydrochloride gel.

Objective: To observe the effect of moxibustion on behaviors and related products of tryptophan (Trp) metabolism in the colon of mice with irritable bowel syndrome (IBS), and to explore the mechanism of moxibustion in the IBS treatment.Methods: Twenty-four mice were randomly divided into a normal group, a model group, a moxibustion group, and a probiotic group, with 6 mice in each group. The visceral pain model of IBS was established by enema with 2,4,6-trinitrobenzene sulfonic acid (TNBS) solution. Mice in the moxibustion group were treated with mild moxibustion at bilateral Zusanli (ST36), and those in the probiotic group were treated with probiotics such as Bifidobacterium by gavage. Abdominal withdrawal reflex (AWR) test, elevated plus-maze (EPM) test, and forced swimming test (FST) were performed after treatment. The expression levels of 5-hydroxytryptamine (5-HT) and tryptophan hydroxylase 1 (TPH1) in the colon were detected by immunofluorescence, and the expression levels of Trp, kynurenine (Kyn), and indole-2,3-oxygenase (IDO) in the colon were detected by enzyme-linked immunosorbent assay. Results: Compared with the normal group, the AWR scores were increased significantly in the model group under different pressure values (P<0.01), the open-arm staying time and open-arm entries in the EPM test were decreased significantly (P<0.01, P<0.05), the motionless time in the FST was increased significantly (P<0.01), and the expression levels of colonic Trp, TPH1, IDO, 5-HT, and Kyn were increased significantly (P<0.01) in the models. Compared with the model group, the AWR scores were differently decreased (P<0.05 or P<0.01), the open-arm entries in the EPM test were increased (P<0.05), the motionless times in the FST were decreased (P<0.05), and the colonic expression levels of Trp, TPH1, IDO, and 5-HT were decreased (P<0.01 or P<0.05) in the moxibustion and probiotic groups; the open-arm staying time was significantly increased in the moxibustion group (P<0.01), and the colonic expression level of Kyn was significantly decreased in the probiotic group (P<0.01). Conclusion: Moxibustion at Zusanli (ST36) improves visceral pain and pain mood and down-regulates the expression levels of colonic TPH1, IDO, Trp, 5-HT, and Kyn in IBS mice.