The EU is an international bridge of traditional Chinese medicine (TCM), and TCM in EU is of strategic importance. In this paper the progress on policies and regulations and approved products of herbal medical products in EU in 10 years were briefly reviewed, registration regulations were systematically, studied and some typical cases were analyzed. To provide reference for successful registration of TCM in EU and implementation of international strategy of TCM, five key elements (i. e. registration classification, approval procedure, approval authority, application product and application enterprise) to break through the registration barriers on TCM in EU were putted forwards correspondingly.
Drug Approval ; European Union ; Medicine, Chinese Traditional ; Policy ; Publications ; Social Control, Formal

Objective To explore the clinical efficacy and safety of progesterone combined with Tiaojinghuoxue tablets in treating amenorrhea induced by antipsychotic drugs. Methods Total 100 patients were randomly divided into treatment group treated by progesterone combined with Tiaojinghuoxue tablets and progesterone group. The index including prolactin (PRL), luteinizing hormone (LH), estradiol (E2), endometrial thickness were measured before and after treatment in both groups . Also the clinical efficacy of the twogroups were compared. Results PRL, LH, E2, endometrial thickness and the recovery of menstrual flow rates in combination group were all better than the progesterone group, (P<0.05 or P<0.01). Cure rate in the combined group was 54.00%and the control group was 74.00%(P<0.05). Total effective rate of combined group was 90.00%and the control group was 80.00%(P>0.05). The rate of adverse reactions in combined group was 40.00%, less than 22.00%in progesterone group, (P<0.05). Conclusion The efficacy of progesterone combined withTiaojinghuoxue tablets is better than single progesterone treatment and have fewer adverse reactions in therpy antipsychotics drug induced amenorrhea.

BACKGROUND:Regional myocardial diastolic dysfunction has been recognized as a sensitive and characteristic sign of myocardial ischemia and infarction,train rate imaging(SRI)is a novel ultrasonic technique with good spatial and high temporal resolution,nd it can be used to quantitatively analyze regional myocardial function.OBJECTIVE:To investigate the characteristics of the longitudinal diastolic strain rate(SR)in ischemic and infarct myocardium by SRI,n order to explore the clinical value of SRI in evaluating regional left ventricular diastolic dysfunction in patients with coronary artery disease.DESIGN:A case-control study.SETTING:Department of Cardiology.Second Affiliated Hospital of Sun Yat-Sen University.PARTICIPANTS:All the participants were selected from outpatients and/or inpatients of the Second Affiliated Hospital of Sun Yat-sen University between October 2005 and April 2006.Twenty-one patients with myocardial infarction(MI group)and 11 patients with angina pectoris(AP group)were enrolled in the study.Twenty age-matched healthy subjects served as controls.METHODS:After performing conventional echocardiographic examination,olor tissue Doppler images from apical four-,three- and two-chamber views (posterior septum and lateral wall,nterior septum and posterior wall,nterior and inferior wall)were recorded on magneto-optical disk.Then SR curves were derived from the stored images off-line using QLAB 4.2software.MAIN OUTCOME MEASURES:Ischemic segments in the AP group,nfarct segments in the MI group and normal segments in the control group were analyzed.The parameters measured included peak early diastolic SR (SRe)and peak late diastolic SR(SRa).RESULTS:Compared with the normal myocardium,oth SRe and SRa decreased significantly in the infarct and ischemic myocardium(all P＜0.05).No significant differences were observed with respect to SRe and SRa between the infarct and ischemic myocardium(both P＞0.05).CONCLUSION:SRI can be used to quantitatively analyze regional myocardial diastolic dysfunction in patients with coronary artery disease,ut its value is limited in differentiating infarct from ischemic myocardium.

Objective To investigate the clinical efficacy of laparoscopic radical gastrectomy in elderly patients with advanced gastric cancer.Methods The clinical data of 85 elderly patients with advanced gastric cancer who were admitted to the Ningbo First Hospital from January 2012 to June 2014 were retrospectively analyzed.Laparoscopic radical gastrectomy was performed on 46 patients (LRG group) and open radical gastrectomy on 39 patients (ORG group).All the patients underwent primary tumor resection for gastric cancer + D2 lymph node dissection,and the postoperative recovery plans were done according to enhanced recovery program.The volume of blood loss,number of lymph node dissected,operation time,intraoperative arterial partial pressure of carbon dioxid (PaCO2),time to anal exsufflation,indwelling time of gastric tube,time for out-off-bed activity,time for fluid diet intake,postoperative hemoglobin,duration of hospital stay and occurrence of complications in the 2 groups were analyzed.The follow-up by outpatient examination and telephone interview was carried out on patients up to August 2014.The count data were analyzed by the chi-square test and Fisher exact probability.The measurement data with normal distribution were presented as x ± s and analyzed using the t test.The t' test was used if the data were deficient.Results Surgical procedures in the 2 groups were successfully carried out and no perioperative death occurred.There was no conversion to open surgery in the LRG group.The resection margins in all the patients were negative.The operation time and number of lymph node dissection in the LRG group were (239 ±68)minutes and 27 ± 10,compared with (227 ±50)minutes and 26 ± 10 in the ORG group,with significant differences (t =0.919,0.179,P ＞ O.05).PaCO2 in the LRG group was (41 ± 5) mmHg (1 mmHg =0.133 kPa),which was significantly higher than(36 ± 5) mmHg in the ORG group (t =4.745,P ＜ 0.05).The volume of blood loss was (102 ± 44)mL in the LRG group,which was significantly less than (200 ± 120) mL in the OPG group (t' =-4.807,P ＜ 0.05).The postoperative level of hemoglobin in the LRG was (110 ± 15) g/L,which was significantly higher than (98 ± 27)g/L in the ORG group (t' =2.471,P ＜ 0.05).The time to anal exsufflation,indwelling time of gastric tube,time for out-off-bed activity,time for fluid diet intake,duration of hospital stay in the LRG group were (2.6 ± 0.7) days,(2.1 ± 0.7) days,(1.1 ± 0.3) days,(4.1 ± 0.7) days and (11 ± 4) days,which were significantly different from (4.8 ± 1.5) days,(4.0 ± 1.8) days,(4.5 ± 0.6) days,(5.9 ± 1.8) days and (18 ± 3) days in the OR G group (t' =-8.415,-6.206,-33.831,-5.879,t =9.632,P＜0.05).Eight patients in the LRG group and 15 patients in the ORG group had complications,with the incidence of complications of 17.4％ (8/46) and 38.5％ (15/39),respectively,showing a significant difference (x2 =4.748,P ＜ 0.05).Forty-four patients in the LRG group and 36 patients in the ORG gorup were followed up for 2-25 months,1 patient in the LRG group and 2 patients in the ORG group died and others had full recovery.Conclusions Laparoscopic radical gastrectomy could provide a safe and complete tumor resection for elderly patients with advanced gastric cancer compared with open radical gastrectomy,meanwhile,it can improve postoperative recovery and reduce postoperative complications in elderly patients with advanced gastric cancer.

Objective The purpose of the study was to develop an instrument to measure nursing professional values held by Chinese nurses.Methods 381 nurses were enrolled for the survey on their professional values by the draft of nursing professional values assessment tool(NPVAT).With the item analysis,such as dispersion degree,correlation efficient,discriminability,alpha coefficients index and exploratory factor analysis,the items were selected.Results As a result of the item analysis,the final version of NPVAT was composed of 20 items selected from a total of 32 items.Exploratory factor analysis resulted in a four-factor solution explaining 51.99％ of the common variance.Conculsions The NPVAT developed in this research can be used for measuring the nursing professional values among nurses.

Objective To determine the fecal elastase-1 (FE-1) in critically ill children in order to investigate the relationships between FE-1 and trypsin,sepsis as well as the severity of the disease.Methods Totally 402 critically ill children admitted in pediatric intensive care unit (PICU) of Hunan Children' s Hospital from July 2013 to March 2014 were studied.The formed stool of patients was collected during the first 24 h after admission.Subjects were divided to 3 groups according to FE-1 concentration:＞ 200 μg/g for normal pancreatic exocrine function (group A,n =300),100-200 μg/g for mild to moderate exocrine pancreatic insufficiency (group B,n =52),＜ 100 μg/g for severe pancreatic exocrine insufficiency (group C,n =50).The analyses of the relationships between FE-1 and pancreatic enzymes,sepsis severity,shock,the number of organ dysfunction,PCIS (pediatric critically ill score),SOFA score,and APACHE Ⅱ score were carried out.Chi-squared test was used for data statistics.The median and four percentile interval were used for the measurement data of abnormal distribution or non-neat variance,the rank sum test of each two of multiple samples compared each other was used for non-parametric test,only when it was statistically significant,and the Spearman method of correlation analysis was used for correlation analysis.Results (1) There was significant difference in serum lipase between group A and group B (P ＜ 0.01).(2) There was statistical difference in FE-1 level between sepsis group and non-sepsis group (P ＜ 0.05).Children with sepsis were divided into three groups according to the severity of sepsis:mild sepsis group,severe sepsis group and septic shock group.There were significant difference in FE-1 level among different severities of sepsis groups and as well as non-sepsis group (P ＜ 0.01).(3) The proportions of FE-1 in septic children of A,B and C groups in comparison with those in non-septic children of three groups were 65.79％ vs.78.13％,15.79％ vs.11.80％,18.42％ vs.10.07％,respectively.The proportions of FE-1 in septic children of B and C groups escalated were higher than those in children without sepsis.(4) The general trend in FE-1 concentrations varied along with the severity of sepsis.There were no significant differences in FE-1 concentration between non-sepsis group and mild sepsis group,and between severe sepsis group and septic shock group,but other paired comparisons between the four groups had statistical significant (P ＜0.01).(5) Along with FE-1 level decreased,the number of organ dysfunction,SOFA score,APS score (This is a part of APACHE Ⅱ score and other part,CPS,is excluded) increased and PCIS score decreased (rs1 =-0.194,P =0.000; rs2 =-0.348,P =0.000; rs3 =-0.176,P =0.000; rs4 =0.185,P =0.000).Conclusions Pancreatic exocrine function damage is associated with sepsis,the pancreatic dysfunction in patients with mild sepsis may not be significant,but its incidence increases gradually with the development of sepsis or with the deterioration of the disease.

AIM:To detect and compare the longitudinal mitral annulus diastolic velocity and time interval changes by pulsed Doppler tissue imaging(DTI)in patients with angina pectoris(AP)and myocardial infarction(MI),and to explore the value of mitral annulus diastolic velocities and time intervals for evaluation of global left ventricular diastolic dysfunction.METHODS:Fifty patients with established coronary artery disease were divided into AP group(16 cases)and MI group(34 cases).Sixteen age-matched healthy individuals served as the control group.The septum,lateral,anterior and inferior walls of the mitral annulus were displayed,and selected for DTI spectrum sampling.Peak early and late diastolic velocities and their ratio,time to the onset and peak of the early diastolic wave,and regional isovolumic relaxation time were measured,and the average values of the four mitral annular sites were calculated and presented as Em,Am,Em/Am,QEm,TEm and IVRTm,respectively.RESULTS:Compared with the control group,Em and Em/Am were significantly lower in both the AP and the MI groups(P＜0.01).Em was even lower in the MI group than that in the AP group(P＜0.01).QEm,TEm and IVRTm were significantly longer in the AP and the MI groups than those in control group(P＜0.01 or P＜0.05).IVRTm was even longer in the MI group than that in AP group(P＜0.01).IVRTm had significantly negative correlation with Em(r=-0.64,P＜0.01).CONCLUSION:Em,Em/Am,QEm,TEm and IVRTm as measured by pulsed DTI may be promising indexes for quantitative assessment of global left ventricular diastolic dysfunction in patients with coronary artery disease.Em and IVRTm may indicate the severity of ischemic myocardial damage.

Objective: To explore the advantage of RR-Lorenz plot (RR-LP) in analyzing the patients of sinus rhythm with long RR interval.
Methods: A total of 308 RR-LP patients with long RR interval were retrospectively studied. The patients were divided into 7 groups according to the type of long RR intervals. ① Sinus bradycardia with arrhythmia group, n=63,②Repeated transient sinus arrest group, n=16, ③Ⅱ° sino-atrial block group, n=14, ④Ⅱ° atrial ventricular block (Ⅱ° AVB) group, n=47, ⑤ Un-passed atrial premature beats (APB) group, n=28, ⑥ Atrial premature beats group, n=72 and ⑦ Premature ventricular beats group, n=68. We analyzed the patients of RR interval greater than 1500 ms with ambulatory electrocardiogram record.
Results: ①RR-LP of sinus bradycardia with arrhythmia group showed a single distributing area with 1500 ms for the origin of transverse and longitudinal axis with B line slope at 1, tilt angle of 45°.②RR-LP of repeated transient sinus arrest,Ⅱ° sino-atrial block,Ⅱ° AVB and APB groups showed special four distributing areas with B line slope at (0.51 ± 0.01), tilt angle of (23.04 ± 0.50) °, B line slope at 0.6, tilt angle of (27°), B line slope at (0.57 ± 0.21), tilt angle of (25.69 ± 9.59)° and B line slope at (0.50 ± 0.01), tilt angle of (22.59 ± 0.54) ° respectively.③RR-LP of premature beats groups showed special four regional distributing areas, B line slope for atrial premature beats was at (0.38 ± 0.12), tilt angle of (17.06 ± 5.22) ° and B line slope for ventricular premature beats was at (0.07 ± 0.05), tilt angle of (3.02 ± 2.39) °.
Conclusion: RR-LP in patients of sinus rhythm with long RR interval had speciifc morphology and distribution features, the local abnormality could be found in a plane via all RR intervals which provided a differential diagnosis for repeated occurrence of short RR interval.

OBJECTIVE:To provide reference for rational use of antibiotics in the clinic. METHODS:From 2012 to 2014,5 medical records were selected randomly from 17 clinical departments each month,1 005 cases in 2012,1 020 cases each year in 2013 and 2014,a total of 3 045 cases. Rationality of antibiotics use was analyzed to summarize and analyze irrational drug use. RE-SULTS:The rate of antibiotics use from 2012 to 2014 were 39.90%,36.27% and 32.84%;the rational rate of antibiotics medical orders were 40.90%,68.11% and 82.67%. Irrational drug use manifested as irrational medication time,unreasonable drug selec-tion,inappropriate indications,inappropriate drug selection,inappropriate usage and dosage,inappropriate drug combination, off-label use etc. CONCLUSIONS:By clinical pharmacistsadvance interventionandadministrative intervention,the use of an-tibiotics in wards of our hospital tend to be more reasonable. But it still necds to strengthen awareness arnd management to effective-ly protect the rational drug use.

Objective To explore the impact of berberine on serum levels of insulin resistance and cytokines in schizophrenia patients treated with risperidone. Methods Sixty-four schizophrenia patients treated with risperidone were randomized to berberine group (n=31) and control group (n=33). The fasting plasma blood glucose (FBG) and fasting insulin (Fins) were detected before and after treatment in two groups. The homeostasis model assessment for insulin resistance (HOMA-IR) was calculated. The serum levels of interleukin (IL)-1β, IL-6, tumor necrosis factor-alpha (TNF-α) were evaluated by enzyme linked immunosorbent assay before and after the treatment. Results Compared with control group and pre-treatment group, the levels of FBG, Fins, HOMA-IR, IL-1β, IL-6 and TNF-α were significantly decreased after treatment in berberine group (P<0.05). The FBG level was significantly higher, the levels of IL-1β, IL-6 and TNF-αwere significantly lower, after treatment in control group (P < 0.01). There were no significant changes in Fins and HOMA-IR after treatment (P > 0.05). There was positive correlation between HOMA-IR and IL-1β, IL-6 and TNF-α in berberine group (r=0.316, 0.351 and 0.401, P<0.01). Conclusion Berberine can significantly decrease FBG, Fins, HOMA-IR, IL-
1β, IL-6 and TNF-α levels in schizophrenia patients treated with risperidone. The HOMA-IR level is closely correlated with IL-1β, IL-6 and TNF-αlevels.