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 comparO thO clinical OffOct of capOcitabinO combinOd with oxaliplatin or irinotOcan in thO trOatmOnt of colorOctal cancOr with livOr mOtastasis. Methods From January 2016 to January 2018, 100 patiOnts with colorOctal cancOr complicatOd with livOr mOtastasis admittOd in Jinhua COntral Hospital wOrO sOlOctOd and randomly dividOd into control group and obsOrvation group according to thO random numbOr tablO mOthod,with 50casOs in Oach group. Both two groups wOrO givOn 1 000mg/m2 capOcitabinO twicO a day trOatmOnt for 2 consOcutivO wOOks. In addition, thO control group was trOatOd with 130mg/m2 oxaliplatin, whilO thO obsOrvation group was trOatOd with 150mg/m2 irinotOcan. ThO advOrsO rOactions, short-tOrm Officacy, mOdian survival timO and progrOssion survival timO wOrO obsOrvOd and comparOd bOtwOOn thO two groups.Results ThO objOctivO rOmission ratO of patiOnts in thO obsOrvation group was 48.00% , which was significantly highOr than 36.00% in thO control group (χ2 =7.253,P<0.05).ThO disOasO control ratO of thO obsOrvation group was 80.00% , which was significantly highOr than 66.00% of thO control group (χ2 =9.273,P<0.05).ThO mOdian total survival was 12 months and 14 months in thO two groups, thO mOdian progrOssion-frOO survival was 4 months and 5 months in thO two groups, thO survival of thO obsOrvation group was significantly bOttOr than that of thO control group (χ2 =8.676,P<0.05). ThO incidOncO ratO of diarrhOa in thO obsOrvation group was 14.00% , which was significantly lowOr than 34.00% in thO control group ( χ2 =5.967, P<0.05).ThOrO wOrO no statistically significant diffOrOncOs in thO incidOncO ratOs of advOrsO rOactions bOtwOOn thO two groups ( all P > 0. 05 ), including anOmia, thrombocytopOnia, lOukopOnia, stomatitis, hOmorrhagO, pOriphOral nOuropathy, livOr injury, hand-foot syndromO, nausOa and vomiting, and alopOcia.Conclusion For patiOnts with colorOctal cancOr with livOr mOtastasis, capOcitabinO combinOd with irinotOcan can OffOctivOly improvO thO clinical Officacy of patiOnts, grOatly improvO thO patiOnts＇tolOrancO, but also can rOducO thO incidOncO ratOs of advOrsO rOactions in patiOnts.Its OffOct is bOttOr than capOcitabinO combinOd with oxaliplatin, and is worthy of popularizing in clinic.

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 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 observe the effects of interleukin-1β (IL-1β) and pentylenetetrazol (PTZ) induced acute epilepsy and the dynamic expression of aquaporin-4 (AQP4) in hippocampus. To explore the role of IL-1β in the pathogenesis of epilepsy by regulating AQP4. Methods All rats were randomly divided into control group, IL-1β group, PTZ group, IL-1ra + PTZ group and dexamethasone + PTZ group. Observe the behavior of the rats within 60 minutes after injection and record seizure score in each group. Then immunohistochemistry and RT-qPCR were used to detect the expression of AQP4 at at 6 , 12, 24 and 36 h. Results Almost of rats in IL-1β group and PTZ group showed severe degree seizure. The rats in control group and dexamethasone + PTZ group showed no obvious seizure. The seizure of rats were more remarkable serious in PTZ group than that in the IL-1ra + pentylenetetrazole group (P < 0.05). Immunohistochemistry and RT-qPCR Show: the expression of AQP4 in hippocampus in PTZ group increased gradually after 12 h (P < 0.05), then reached in the peak after 24 h (P < 0.001). The expression of AQP4 in IL-1ra + PTZ group was lower compare with PTZ group in each time (P < 0.05). Although the expression of AQP4 in dexamethasone + PTZ group higher than the control group, it was not significantly different (P < 0.05). Conclusion The proinflammatory cytokine IL-1β break the balance of water in brain and increasing the concentration of extracellular excitatory amino acids or ions by upregulate the expression of AQP4 in order to promote the excitatory of neurons.

Objective:To establish an in vivo model of acute radiation esophagitis in Wistar rats based on a small animal precision radiotherapy platform (SARRP). Methods:Thirty-six Wistar rats were randomly divided into control group, 40, 60 and 75 Gy groups. Based on MRI images, the esophageal target area of rats was outlined and the radiotherapy plan was formulated. The rats were respectively irradiated with 0, 8, 12 and 15 Gy per day for 5 consecutive days. The changes of body weight, food intake, esophageal pathology and magnetic resonance imaging were observed.Results:The body weight of rats in 75 Gy group decreased significantly on the 6th day after irradiation (IR) ( P<0.05). The esophageal tissue of rats in each IR group was thicker than that in control ( F = 14.20, P < 0.05). HE staining showed that the formation rate of radiation-induced esophagitis in 40 Gy and 60 Gy groups were 4/5 and 5/5, respectively, mainly mild. In 75 Gy group, the incidence of radiation-induced esophagitis approached to 5/5, of which 3/5 was severe at 9 d post-IR. The pathological injury scores [ M( Q1, Q3)] of rats in each group were 0, 1.0 (0.5, 2.5), 1.0 (1.0, 2.5) and 4.0 (1.5, 6.0) on the 9th day after IR. There was significant difference between the 75 Gy group and the control group ( H=12.69, P<0.05). After dynamic monitoring of neck MRI images, it was found that the esophageal signal of rats in each IR group increased and widened at 9 d post-irradiation. Conclusions:The animal model of acute radiation-induced esophagitis in rats was successfully established based on a small animal precision radiotherapy platform combined with MRI. 75 Gy was the best irradiation dose and the 9th day was the best observation time point.

Objective To investigate the functions of the KIFC1 gene in tumor cells and its effect on the proliferation of cervical cancer cells. Methods We designed sgRNAs targeting the KIFC1 gene and constructed a recombinant plasmid based on the pSpCas9 (BB)-2A-GFP vector, which was co-transfected into HeLa cells. We screened monoclonal knockout cell lines through flow cytometry sorting, limited dilution inoculation of cells, and sequencing. RT-qPCR, Western blot, and immunofluorescence were used to detect the transcription and protein expression levels of KIFC1 in knockout cells. Cell phenotypes such as nucleus and microtubule cytoskeleton were observed using phase-contrast microscopy and fluorescence confocal microscopy. Cell proliferation, cell cycle, and apoptosis were analyzed by growth curve plotting, EdU labeling, and acridine orange staining. Results The deletion of the KIFC1 gene resulted in the abnormal phenotypes of HeLa cells, with increased numbers of multinuclei, micronucleus, and disordered microtubules. The cell cycle was disrupted, accompanied with a significant increase in the ratio of late apoptotic cells and a decrease in cell proliferation (all P < 0.05). Conclusion KIFC1 gene deletion affects the assembly of microtubules and cell division in HeLa cells, leading to abnormal nuclear morphology, chromatin elimination, cell cycle arrest, and increased cell apoptosis.

Objective:To investigate the effect of temozolomide on autophagy of human glioma cells, and the inhibition of autophagy induced pyrocytosis on the proliferation of human glioma cells.Methods:2-64 μ mol/L of temozolomide was used to treat glioma U251 cells cultured in vitro. MTT assay was used to detect cell viability, MDC staining was used to detect autophagic vesicles in cells, cloning assay was used to detect cell proliferation, RT qPCR was used to detect the expression level of pyroptosis related mRNA in cells, Western blot was used to detect the expression of autophagy related proteins and pyroptosis related proteins in cells, and the relationship between autophagy and pyroptosis was detected by adding autophagy inhibitors.Results:Temozolamide could induce autophagy of human glioma cells, and significantly induce tumor cells to pyroptosis, thereby inhibiting the proliferation of tumor cells; RT qPCR results showed that caspase-1, GSDMD, IL-1 after temozolomide administration compared with the normal group β, the mRNA expression levels of IL-18 and NLRP3 increased significantly; Western blot results showed that Cleaved-caspase-1, Cleaved-N-terminalGSDMD, IL-1 β、IL-18 and NLRP3 protein were up-regulated; The incidence of pyroptosis decreased after the addition of autophagy inhibitors.Conclusion:Temozolamide can induce autophagy of human glioma cells, and then lead to pyroptosis, which plays an inhibitory role in proliferation.