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 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 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 .

Objective To investigate the effects of total nutrient admixture (TNA) on the recovery of patients with gastric cancer after radical gastrectomy.Methods The clinical data of 50 patients with gastric cancer who were admitted to the Affiliated Hospital of Luzhou Medical College between March 2013 and March 2014 were retrospectively analyzed.Among 50 patients receiving radical gastrectomy,26 patients receiving TNA were allocated to the experimental group and 24 patients receiving conventional fluid infusion were allocated to the control group.Patients in the experimental group received the nutritional support therapy using TNA at preoperative day 5 and at postoperative days 1-5,and patients in the control group received the postoperative intravenous rehydration including water,glucose,electrolyte,vitamins and micro elements.The nutritional indexes [albumin (Alb),prealbumin,transferrin and hemoglobin (Hb)],time to anal exsufflation,incidence of complications (wound infection,anastomotic leakage,blooding and intestinal obstruction) and duration of hospital stay were observed before nutritional support therapy and at postoperative day 8.The count data were analyzed using the chi-square test.The chi-square value of correction for continuity was used when 1 ≤ minimum theoretical frequency ≤ 5.The measurement data with normal distribution were presented as (x) ±s and analyzed using the t test or repeated measures ANOVA.The ordinal data were analyzed by the analysis of variance.Results The Alb,prealbumin,transferrin and Hb in the experimental group were (38.6 ± 2.0) g/L,(281 ± 33) mg/L,(2.5 ± 0.9) g/L and (111 ± 20) g/L before nutritional support therapy and (38.2 ± 1.9) g/L,(277 ± 16) mg/L,(2.3 ± 1.1) g/L and (112 ± 37) g/L at postoperative day 8,respectivley.The Alb,prealbumin,transferrin and Hb in the control group were (38.3 ±2.4) g/L,(287 ± 34) mg/L,(2.4 ± 1.1) g/L and (107 ± 21) g/L before nutritional support therapy and (30.3 ±2.3) g/L,(190 ± 41) mg/L,(1.6 ± 0.3) g/L and (93 ± 22) g/L at postoperative day 8,respectivley.There were significant differences in the nutritional indexes at postoperative day 8 between the 2 groups (F =174.042,95.637,9.529,4.919,P ＜ 0.05).The time to anal exsufflation in the experimental group were (52 ± 11) hours,which was significantly different from (70 ± 12) hours in the control group (t =-5.176,P ＜ 0.05).The incidence of complications was 15.4％ (4/26) in the experimental group,which was significantly different from 58.3％ (14/24) in the control group (x2=6.460,P ＜0.05).Patients with complications in the 2 groups were cured by anti-infective or symptomatic treatment.The duration of hospital stay was (9 ± 3) days in the experimental group and (12 ± 4) days in the control group,with a significant difference between the 2 groups (t =-2.912,P ＜ 0.05).Conclusion TNA can improve the nutritional status of patients after radical gastrectomy in a short time.It could help patients to get through the perioperative period smoothly,and enhance the postoperative recovery.

Objective To investigate the effects of transcutaneous electrical acupoint stimulation (TEAS) on early postoperative lung function in patients undergoing video-assisted thoracoscopic pneumonectomy.Methods Sixty ASA physical status Ⅰ or Ⅱ patients whose preoperative forced expiratory volume in 1 second (FEV1) ＞ 1.5 L,scheduled for elective video-assisted thoracoscopic pneumonectomy under general anesthesia,were randomly divided into 3 groups (n =20 each) using a random number table:control group (group C),Lieque (LU7)-Quchi (LI11)-Neiguan (PC6)-Hegu (LI4) group (group S1),and Xinshu (BL1S)-Feishu (BL13)-PC6-LI4 group (group S2).TEAS was applied to the corresponding acupoints on the operated side for 30 min once a day starting from 30 min before induction of anesthesia until the end of surgery,and on 1 st and 2nd days after surgery in S1 and S2 groups.The frequency was 2/100 Hz,the intensity was the maximum current that could be tolerated,and the intensity was about 6-18 mA for LU7,LI11,PC6 and LI4,or about 20-35 mA for BL15 and BLI3.Patient-controlled intravenous analgesia was performed to maintain the score for the intensity of pain ＜ 4.Before and after surgery,forced vital capacity (FVC) and FEV1 were measured after the chest tube was withdrawn and the changing rate was calculated.Results FEV1 and FVC were significantly lower after surgery than before surgery in all the groups (P ＜ 0.05).There was no significant difference in FEV1 and FVC before and after surgery and the changing rate between the three groups (P ＞ 0.05).Conelusion TEAS (applied during surgery and within 2 days after surgery,30 min/d,2/100 Hz) provides no obvious improvement in early postoperative lung function for the patients undergoing video-assisted thoracoscopic pneumonectomy.

Objective To compare the intraoperative opioids-sparing effects of transcutaneous electrical acupoint stimulation (TEAS) of Lieque (LU7)-Quchi (LI11)-Neiguan (PC6)-Hegu (LI4) versus Xinshu (BL15)-Feishu (BL13)-PC6-LI4 in patients undergoing video-assisted thoracoscopic lobectomy.Methods Sixty ASA physical status Ⅰ or Ⅱ patients,aged 34-83 yr,weighing 50-93 kg,scheduled for elective video-assisted thoracoscopic lobectomy,were randomly divided into 3 groups (n =20 each):control group (group C),LU7-LI11-PC6-LI4 group (group S1),and BL15-BL13-PC6-LI4 group (group S2).TEAS was applied to the corresponding acupoints on the operated side starting from 30 min before induction of anesthesia until the end of operation in S1 and S2 groups.The wave length was 0.6 ms when the frequency was 2 Hz,and the wave length was 0.2 ms when the frequency was 100 Hz.The intensity was the maximum current that could be tolerated,and the intensity was 6-18 mA for LU7,LI11,PC6 and LI4,or 20-35 mA for BL15 and BL13.Anesthesia was induced with iv injection of midazolam,propofol,sufentanil and cisatracurium and maintained with target-controlled infusion of remifentanil and propofol,iv infusion of cisatracurium,and iv boluses of sufentanil when necessary.The plasma concentration of propofol was adjusted to maintain BIS value at 40-60 during operation.The initial effect-site concentration of remifentanil was set at 1 ng/ml and then adjusted to 4 ng/ml at skin incision,and the concentration of remifentanil and consumption of sufentanil was adjusted to maintain Analgesia Nociception Index (ANI) value at 50-70.If the concentration of remifentanil was increased to 4 ng/ml,ANI value was still less than 50,and then sufentanil 0.1 μg/kg was injected intravenously.The time of operation and intraoperative consumption ofremifentanil and propofol were recorded.Results Compared with group C,the intraoperative consumption of remifentanil was significantly decreased in S1 and S2 groups (P ＜ 0.05).There was no significant difference in the intraoperative consumption of remifentanil between group S1 and group S2 (P ＞ 0.05).There was no significant difference in the time of operation and intraoperative consumption of propofol between the three groups (P ＞0.05).Conclusion TEAS of LU7-LI1 1-PC6-LI4 provides similar opioids-sparing effects during operation as TEAS of BL15-BL13-PC6-LI4 in patients undergoing video-assisted thoracoscopic lobectomy.

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.

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.

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.