OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.

Objective To determine the minimum alveolar concentration for endotracheal intu-bation (MACEI )of sevoflurane for curbing the responses to endotracheal intubation in 50% premature infants less than 37 weeks of corrected age.Methods Twenty-seven ASA Ⅰ or Ⅱ premature infants less than 37 weeks of corrected age were enrolled in this study.At first,the anesthesia induction was started by inhaling 6% sevoflurane.After the patient lost consciousness,the end tidal sevoflurane concentration (CET Sev)was adjusted to the target concentration and maintained stable for 1 5 min.En-dotracheal tube was then intubated.The up-and-down sequential method was used to calculate the MAC.The initial CET Sev was 3.0% and it was increased or decreased by 0.2% in the next patient ac-cording to the endotracheal intubation response.If the intubation response was positive,the CET Sev was increased;if the intubation response was negative,the CET Sev was decreased.The midpoint from negative response to positive response was set as a balance point and the mean value of the concentra-tions of sevoflurane at all the balance points were calculated as MACEI .Results The end tidal sevoflurane concentration for blunting the responses to endotracheal intubation in 50% premature in-fants was 2.55%±0.20%,and the MAC9 5 was 2.81% (95% confidence interval 2.67%-3.58%). Conclusion The MACEI of sevoflurane for curbing the responses to endotracheal intubation in 50%premature infants less than 37 weeks of corrected age is 2.55%,which is lower than that in the full-term children.

Standardized rotary residency training is an important part of clinical medical education. Traditional clinical teaching can't meet the rapid development of oncology medicine. In the rotary residency training in oncology department, we put forward the problems encountered in clinical practice, stimulate the interest and initiative of residence, the PBL teaching model is combined with the evidence-based medicine in the teaching process through the relevant training, literature review and discussion. By standardizing the treatment concept the residence's understanding of the basic theory and frontier knowledge of oncology was improved, the thinking innovation and clinical practice ability of the residency doctors were enhanced.

AIM: To study compatibility rationality of combination of Paeonia lacliflora and Glycyrrhiza uralensis. METHODS: The effective combination of paeoniflorin(44% purity),glycyrrhizic acid(50% purity) and liquorice flavones(52% purity),glycyrrhizic acid(50% purity) and liquorice flavones(52% purity) were respectively administered to rats.Pharmacokinetic change of these constituents in rat blood was studied. RESULTS: The pharmacokinetic parameters of these constituents in rat blood showed that the increases in AUC and C_(max) of effective combination group were more than that of glycyrrhizic acid group or that of liquorice flavones group.T_(max) of the former was extended with respect to the latters.Clearance of effective combination markedly slowed down. CONCLUSION: The effective combination of paeonia lacliflora and Glycyrrhiza uralensis have the advantage of either Paeonia lacliflora or Glycyrrhiza uralensis.

Objective To show the international protocols for blood pressure monitoring based on a real example. Methods The assessment process of international protocol that can be released by Working Group on Blood Pressure Monitoring of European Society of Hypertension was evaluated. Results 33 participants were selected, which all indexes in evaluation stage one and stage two of the indicators were detected through. The 95% consistency interval in difference between tested device and reference monitor was 10.65～-12.67 mmHg for systolic BP and 13.68～-14.03 mmHg for diastolic BP, and there were 7.1% (7/99) and 6.1% (6/99) of valid points out of the 95% consistency interval. Conclusion The measured automatic blood pressure in the normal environment, measuring accuracy and the standard with the control of mercury -type sphygmomanometer is coincident, so it can be recommended for home application.

Objective To compare blood pressures results measured by automated sphygmomanometer and standard mercury sphygmomanometer,and to investigate the application of measurements consistency evaluation method in accurate measurement of automated sphygmomanometer.Methods Intraclass correlation coefficient was used to estimate the reliability of repeated measurements,and Bland -Altman method was adopted to evaluate the consistency between automated sphygmomanometer and standard mercury sphygmomanometer.Meanwhile,the results were compared with protocol of European Society of Hypertension.Results The tested automated sphygmomanometer did not adapt to the criteria of European Society of Hypertension.The intraclass correlation coefficient of mercury sphygmomanometer was 0.937 for systolic blood pressure,0.849 for diastolic blood pressure.The intraclass correlation coefficient of tested sphygmomanometer was 0.944 for systolic blood pressure,0.929 for diastolic blood pressure.The 95% consistency interval was(-10.20 to 16.94)mmHg for systolic blood pressure and(-6.25 to 11.69)mmHg for diastolic blood pressure.Conclusion Normally,Bland-Altman method has the same judgment result with protocol of European Society of Hypertension.

Objective To identify the role of survivin and VEGF in angiogenesis of colorectal tumor by investigating tissue expression of survivin, VEGF and CD34 in human colorectal tumors. Methods Immunohistochemical staining for the paraffin sections by using the polyclonal antibodies of survivin, monoclonal antibodies of VEGF and CD34, was performed by the standard avidin-biotin-peroxidase technique. The percentage of positive cell and quantitative analysis were made by image analysis system, which also helped to calculate the amount of MVD. Results The immunoreactivity of survivin significantly increased in the transition from adenoma with low dysplasia to adenoma with high dysplasia (P <0.01). Similar changes in protein expression were observed for VEGF and MVD. The expression of survivin was closely related with that of VEGF. Both were positively correlated with MVD. Conclusion Survivin promotes angiogenesis of colorectal tumor together with VEGF. VEGF may be the potential causes of reexpression of survivin during colorectal tumorigenesis.

Objective To evaluate the clinic efficacy of sufentanil and remifentanil by target- controlled infusion (TCI) combined with propofol in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).Methods Sixty patients,ASA Ⅰ ～ Ⅱ,undergoing elective EBUS-TBNA were randomly divided into group S ( sufentanil group),group R (remifentanil group) and group SR (sufentanil + remifentanil group),each group were twenty patients.The anesthesia of all groups is propofol intravenous anesthesia with 2％ lidocaine topical anesthesia,to controll BIS between 50 and 60 during surgery.Heart rate(HR),mean arterial pressure(MAP) pulse oxygen saturation( SpO2 ) and respiratory rate (RR) were recorded and compared 5mins after entering room(T0),30mins after the beginning of surgery(T1 ) and after surgery(T3).Arterial blood gas and the times of cough during surgery were also recorded and compared in all groups.The use of propofol and lidocaine,the wake-up time,satisfaction with anesthesia and adverse reactions in 6 hrs after surgery were also obtained.Results ( 1 ) RR decreased distinctly in group R and PaCO2 increased distinctly in group S and group R compared with that of group SR (P ＜0.05) during surgery.(2)The times of cough and the wake-up time lessened distinctly in group R and group SR compared with that of group S ( P ＜0.05 ).(3) The use of propofol and lidocaine,satisfaction with anesthesia and adverse reactions in 6 hrs after surgery were similar in all groups ( P ＞ 0.05 ).Conclusion Sufentanil compounded remifentanil by TCI combined with propofol is a safe and feasible anesthesia option for EBUS-TBNA,which provides better efficacy,high satisfaction and less side effects compared with using alone of sufentanil and remifentanil respectively.

Objective To evaluate the analgesic efficacy of thoracic paravertebral block (PVB) in patients after lobectomy performed via video-assisted thoracoscope (VAT) .Methods Fifty ASA Ⅰ or Ⅱ patients of both sexes aged 20-76 yr weighing 45-90 kg undergoing elective lobectomy via VAT were randomly divided into 2 groups (n = 25 each): patient-controlled intravenous analgesia (PCIA) group and thoracic PVB group. PVB was performed according to the method described by Jamieson et al and Richardson et al. Paravertebral catheter was placed at T7-8 after induction of anesthesia and tracheal intubation. A loading dose of 0.5% ropivacaine 20 ml was administered via PVB catheter at 30 min before the end of operation. PVB was then controlled by the patients with 0.2% ropivacaine (bolus dose 8.0 ml, lockout interval 30 min). In PCIA group a loading dose of sufentanil 0.1 μg/kg was given iv at 30 mln before the end of operation. Sufentanil 1.0 μg/ml was used. PCIA included a bolus of 2 ml with a 15 min lockout interval and background infusion 2 ml/h. Numeric rating scale (NRS) (0=no pain, 10 = most severe pain) was used to assess the intensity of pain. NRS score, MAP, HR and SpO2 were recorded before operation (T0 ,baseline), 30 min after withdrawal of chest tube (Ti) and at 24, 48 and 72 h after operation (T2, T3, T4). Forced vital capacity (FVC) and forced expiratory volume first second (FEV1.0) were measured and FVC/FEV1.0 ratio was calculated after chest tube was withdrawn. Blood cortisone and glucose concentrations were determined at To, T1 and T4. Requirement for rescue analgesics and side effects were recorded. Results There was no significant difference in MAP, HR, SpO2 and NRS at rest between the 2 groups.NRS at coughing and blood cortisone and glucose concentrations were significantly lower and the postoperative FEV1.0 was significantly higher in PVB group than in PCIA group. The requirement for rescue analgesics and side effects were comparable between the 2 groups. Conclusion Thoracic PVB can provide better postoperative analgesia with little side effects.

Objective To observe reverse effect of anisodamine to the adverse effect of remifentanil during enteroscopy without pain for patients with bradycardia .Methods Sixty‐five patients with bradycardia were selected and divided randomly into group C (n=21 ,control group)、group A1 (n=22 ,anisodamine by instillation) and group A2 (n=22 ,anisodamine by continous infusion) .In‐duction :Intravenous etomidate 0 .08 mg/kg ,propofol 1 .00 mg/kg and remifentanil 0 .10μg/kg in 3 groups .Ten mg anisodamine in‐fused by instillation before induction in group A1 ,5 mg anisodamine infused by instillation before induction and continous infused by 0 .25 mg/min in group A2 .Maintenance:All group received propofol 4 mg · kg‐1 · h‐1 ,remifentanil 0 .05 μg · kg‐1 · min‐1 after un‐dergoing enteroscopy .stopping pumping propofol when colonoscopy reached ileocecal junction ,and we took off remifentanil when colonoscopy withdraw to decending colon .Then we observed and recorded HR ,SpO2 ,MAP ,dosage ,fluid infusion ,induction time , check time ,analepsia time ,degree and of enterospasm and numbers of cases and side effect at T0 (before induction) ,T1 (beginning of operation) ,T2 (into the transverse colon) ,T3 (to the ileocecal junction) ,T4 (exit) .Results There were no significant difference a‐mong 3 groups of induction time .Compared with group A1 and group A2 about check time and analepsia time ,group C was much shorter .The HR of group A1 and A2 were more stable than group C at T2 、T3 .At T1 、T2 ,the fluctuation of HR of group A2 was less than that of group A1 .There was obviously different among 3 groups of propofol′s dosage ,operation time and enterospasm ,the effect of group A1 and group A2 were better .There was statistically significant in number of cases of body movement between group A1 (1/22)and group C(4/21) ,there was also statistical significance between group A1 ,group A2 and group C(P<0 .05) .Conclusion There are no difference between 2 methods about relieving enterospasm ,refraining intestinal angina ,shortening operation time , saving anesthetic dosage .Effect of continous pumping to undulation of HR may be more stable .