During the seven-year transitional period of European Union Directive 2004/24/EC, only a few of traditional Chinese medicines had been approved for registration. In other words, the EU directive has become an unavoidable registration barrier to hinder Chinese enterprises from entering EU market. By analyzing difficulties of enterprises in registration in EU and studying the only successful case in China--Di Ao Group, this article proposes countermeasures in the hope of providing effective reference for Chinese enterprises in expanding EU market, and promoting the internationalization progress of traditional Chinese medicine.
European Union ; Humans ; Medicine, Chinese Traditional

Objective To investigate the efficacy and side effects of the molecular targeted drug sunitinib in the treatment of metastatic renal cell carcinoma(mRCC). Methods Fifteen patients with histopathological confirmed mRCC,including 10 males and 5 females,were enrolled in the study.The median age was 56(range from 37 to 73 years).Fourteen cases of clear-cell RCC and 1 papillary RCC were diagnosed.Thirteen patients had prior nephrectomy,and 6 patients were treated with cytokines previously.All of the patients were given sunitinib at a dosage of either 50 mg daily(4 weeks on/2 weeks off)or 37.5 mg daily continuously.Objective response rate(ORR),progressive-free survival(PFS)and overall survival(OS)were evaluated,and adverse events were also observed. Results The median follow-up was 13 months(2-24 months).According to RECIST,partial response could be evaluated in 8 patients and stable was found in another 5 patients.Only 2 patients were confirmed disease progression.The ORR was 53% with the disease control rate of 87%,However,the median PFS and OS were not yet available due to the short-term follow-up.During the treatment,the most common adverse events experienced by patients were hand-foot syndrome 11/15(73%),changes in hair color 10/15(67%),mucositis 9/15(60%),alopecie 9/15(60%),diarrhea 8/15(53%)and neutropenia 8/15 (53%). All of adverse events were manageable and reversible. Conclusions Sunitinib as a single agent in the treatment for Chinese mRCC patient is efficient and the side effects are reversible. Further long-term follow-up and expanded samples should be expected to confirm the efficacy and safety of sunitinib.

Objective To observe the blood biochemical and histological changes before and after pancreas freezing, to provide evidence for cryosurgery for pancreatic cancer. Methods Fifteen healthy pigs were divided into deep frozen group (n = 5), shallow frozen group (n = 5), non-frozen group (n = 3) and normal group (n = 2). After anesthesia and Iaparotomy, a probe of the Argon-Helium Surgical System was inserted into the pancreas, 100% and 10% argon output power were used in deep and shallow frozen group, respectively;and the temperature were - 130 ～ - 140℃ and - 110 ～ - 120℃, respectively;which results in an ice-ball with 15 ～ 20 mm in diameter. Then helium gas was inputted to increase the temperature to 10 ～ 20℃ for three minutes;then the whole process was repeated. A probe was inserted into the pancreas in the non-frozen group only and only laparotomy was performed in non-grozen group normal group and normal group. Serum amylase, IL-6, CRP levels before and after the experiment was determined;the pigs were sacrificed at day 7 and the pancreas was harvested for light microscope and electron microscope examination. Results The frozen pancreatic tissue became pitchy necrosis zone, and it could be distinguished from non-frozen tissue;there were obvious tissue necrosis in the center and para-center of frozen area, and the ultra-structure were destroyed and disappeared, mitochondria degranulation and rough endoplasmic reticulum degrannlation were observed. Serum amylase was elevated in 13 (86.7%) pigs and most returned to normal at 6th day. Serum IL-6 was slightly elevated in 5 (33.3%) pigs. There was no significant difference among all the groups in term of serum CRP. All the pigs were alive until the time of sacrifice. Conclusions Cryosurgery has affirmative fatal ablative effects on pancreatic tissue, and it is safe with no serious complications.

OBJECTIVETo study the analgesic, antipyretic and anti-inflammatory effect of Bailian Caogen granule.

METHODThe antipyretic effects of Bailian Caogen granule was evaluated in rabbit fever model induced by peptone. The analgesic effect of the drug was studied with pain model of mice induced by acetic acid and hot plate, The severity of oedema in inflamed animal was observed to study the anti-inflammatory effects of Bailian Caogen granule.

RESULTBailian Caogen granule could obviously inhibit the fever of rabbits. The number of writhing induced by acetic acid was reduced and the pain threshold of mice was increased by Bailian Caogen granule. Bailian Caogen granule also had anti-inflammatory activity against xylene-induced mouse ear swelling and carrageenin-induced rat paw edema.

CONCLUSIONBailian Caogen granule has significant analgesic, antipyretic and anti-inflammatory activities.

Acetic Acid ; Analgesics, Non-Narcotic ; pharmacology ; Animals ; Body Temperature ; drug effects ; Coptis ; chemistry ; Drug Combinations ; Drugs, Chinese Herbal ; pharmacology ; Edema ; pathology ; prevention & control ; Female ; Fever ; physiopathology ; prevention & control ; Glycyrrhiza uralensis ; chemistry ; Hot Temperature ; Hyperalgesia ; etiology ; physiopathology ; prevention & control ; Male ; Mice ; Pain ; chemically induced ; physiopathology ; prevention & control ; Pain Threshold ; drug effects ; Phellodendron ; chemistry ; Plants, Medicinal ; chemistry ; Pueraria ; chemistry ; Rabbits ; Random Allocation ; Rats ; Rats, Sprague-Dawley

Objectives:To analyze the statistics of nursing errors of nursing staff in the top three hospital during last year,and the relationship between nursing staff's job satisfaction and job. Methods:From February 2017 to Au-gust 2017,a cluster randomized sampling method was used to select 320 cases of standard nursing staff in the top three hospitals. The questionnaires for general information, questionnaires for nursing job errors, job satisfaction questionnaire,and job burnout survey questionnaire for nursing staff were used to investigate and analyze,and to ex-plore the relevance of nursing work errors, job satisfaction and job burnout. Results:The incidence of nursing error rate was 65.61%. Statistical analysis shows that the occurrence of nursing work errors was related to job satisfaction and job burnout. Among them, nursing staff's personal sense of achievement, personality and overload work, work not recognized, lack of management, unclear responsibility, and low welfare benefits easily led to nursing errors. Conclusions:Based on the impact of job satisfaction and job burnout on the work of nursing staff,improving the nurs-ing staff satisfaction,alleviating the job burnout would reduce the occurrence of nursing errors through the optimiza-tion of scheduling,welfare,management communication and other development opportunities.

Objective To investigate the clinical outcomes and complications of augmented antibiotic-loaded cement spacer in two-stage infected total hip arthroplasty with acetabular bone defect.Methods The periprosthetic infection (PJI) patients with acetabular bone defect were retrospectively reviewed from January 2007 to June 2016 in our hospital.A total of 26 patients (11 males and 15 females) were eligibly included in the present study.The mean age was 46.7 years old.The two-stage revision arthroplasty included implants removel,meticulous debridement,implantation of antibiotic-loaded cement spacer in firststage.After systemic therapy of antibiotics,the prosthesis was implanted in the second-stage.The supra-acetabular antibiotic cement shelf with screws was used to improve hip stability with acetabular wall defect.The handmade acetabular spacer was able to prevent femoral spacer ifto pelvis in patients with acetabular internal wall defect.The clinical outcomes and complications (spacer dislocation,spacer fracture and acetabular wear) were measured.Results The positive rate of bacteria culture was 80.8％ (21/26)and 57.7％ (15/26) patients were cultured with staphylococcus.The others were 2 fungus,2 Gram-positive rod,1 brucella,1 pseudomonas aeruginosa,1 escherichia coli,1 enterococcus faecalis,1 defective probiotics,1 serratiamarcescens and 1 Kocuriaroseus.Moreover,19.2％ (5/26) patients were mixed infection.There was one patient with spacer dislocation and two with spacer fracture.No patients were recurrent infection.Infection was controlled,and two-stage revision was successfully performed in 24 patients.Twenty-two patients were followed averaging 4.1 years (1-8) and the Harris Hip Score was significantly improved from 40.9± 14.0to 81.2± 11.2 at the final follow-up (P＜0.05).Conclusion The application of augmented antibiotic-loaded cement spacer has satisfactory clinical outcomes in PJI patients with acetabular bone defect.It can provide joint mobility and increase additional joint stability with decreased iatrogenic bone defect caused by acetabular wear.

Scm in volume(42/60),multiple site involvement(44/60),blood type"O"(31/41),in comparison with those of survival group,and the difference was statistically significant.C-erbB-2,p16,p53,P-gp,CD_(44) and CD_(25)expression were not significantly different in these two groups. Conclusion The clinical stage, lymph node metastasis,lymphatic tumor emboli and/or neural involvement,infiltration depth,histological dif- ferentiation,tumor volume,involvement extension are important prognostic factors in patients with gastric can- cer,while the significance of cancer-related gene expression in gastric carcinomas needs to be studied further.

OBJECTIVETo assess the diagnostic value of multiplex ligation-dependent probe amplification (MLPA) for detection of common chromosome aneuploidy in amniotic fluid (AF) cells in order to obtain an accurate, rapid, cost-effective and high-throughput method in routine prenatal clinical practice.

METHODSThe MLPA test was performed on 500 AF samples by using kit P095 and the results were obtained by using analysis software RH-MLPA-v511. The results were compared with that from fluorescence in situ hybridization (FISH) and traditional karyotyping (TK). The technical critical issues were analyzed in routine diagnostic application.

RESULTSThe absolute specificity and sensitivity of the MLPA test to detect the aneuploidy were 100%. For the 500 AF samples, the success rate of the MLPA tests was 97%. Among them 92% were finished within three working days and 5% required more days for repeating. The test failure rate was 3%. The results confirmed that for the 38 detectable aneuploid samples, the probe reliability weighted mean ratio values were more than 4SD compared to normal diploids and the 2 suspected trisomy samples were more than 2SD. In this study, authors analyzed hybridization efficiencies of 8 probes for chromosome 21, and the presence of a trisomy was considered if at least 4 of the 8 probes gave probe ratio of >1.3.

CONCLUSIONThedata suggested that MLPA is a rapid, simple and reliable method for large scale testing for aneuploidy of chromosomes 13, 18, 21, X, or Y in AF. The MLPA technology is complementary to AF culture and valuable for prenatal diagnosis.

Amniotic Fluid ; cytology ; Aneuploidy ; Chromosomes, Human, Pair 21 ; Female ; Humans ; Nucleic Acid Amplification Techniques ; methods ; Pregnancy ; Prenatal Diagnosis ; methods ; Sensitivity and Specificity ; Trisomy ; diagnosis ; genetics

OBJECTIVETo explore the optimal treatment selection for treating varicocele (VC) male infertility patients accompanied with oligozoospermia or azoospermia of different Chinese medical syndrome types by comparing the efficacies of integrative medicine.

METHODSOne hundred and twenty male infertility patients with VC accompanied with oligozoospermia or azoospermia were assigned to Chinese medical treatment group (A) and the surgical group (B), each consisting of three Chinese medical syndrome types, i.e., damp-heat stagnation syndrome (DHSS), Shen-deficiency blood stasis syndrome (SDBSS), and blood stasis stagnation syndrome (BSSS), 20 in each group. Corresponding Chinese medical treatment was administered to those in Group A, C, and E, while microscopic ligation of internal vena spermatic was administered to those in Group B, D, and F. The routine analysis of semen, biochemical analysis of seminal plasma, and serum sex hormones (prolactin, testosterone, follicle stimulating hormone, luteinizing hormone, and estradiol) were performed before treatment and by the end of the 24th week after treatment.

RESULTSTotally 18 patients' spouses were pregnant. Of them, 1 in Group A of DHSS (abbreviated as Group A), 3 in Group B of DHSS (abbreviated as Group B), 4 in Group A of SDB-SS (abbreviated as Group C), 5 in Group A of SDBSS (abbreviated as Group D), 1 in Group A of BSSS (abbreviated as Group E), and 4 in Group B of BSSS (abbreviated as Group F). After 24-week treatment, the sperm concentration, class a sperm percentage, class a + b sperm percentage, the motility rate, the seminal plasma of fructose density, and the seminal plasma neutral alpha-glucosidase were more significantly improved in Group B, C, D and F, when compared with the same group before treatment (P <0. 01, P <0. 05). There was no statistical difference in the aforesaid indices between before and after treatment in Group A and Group E (P >0.05). As for the improvement percentage of seminal routine indices, the difference of the seminal plasma of fructose density, and the difference of seminal plasma neutral alpha-glucosidase between before and after treatment in the same Chinese medical syndrome types, better effects were obtained in Group B than in Group A (P <0.01), and better effects were obtained in Group F than in Group E (P <0.01). There was no statistical difference between Group C and D (P >0.05). There was no statistical difference in the 5 items of sex hormones in each group between before and after treatment (P >0.05).

CONCLUSIONSSurgical treatment could effectively improve the semen quality for male infertility VC patients accompanied with oligozoospermia or azoospermia. Of them, Chinese medical treatment could be recommended to those of SDBSS who would not receive surgical treatment.

Adult ; Humans ; Infertility, Male ; diagnosis ; etiology ; therapy ; Integrative Medicine ; Male ; Medicine, Chinese Traditional ; Phytotherapy ; Varicocele ; complications ; diagnosis ; therapy

OBJECTIVETo identify polymorphisms of the serotonin transporter(5-HTT) gene and to find out whether there was relationship between any such polymorphisms and sleep apnea syndrome (SAS).

METHODSFor two polymorphisms of 5-HTT target DNA gene was amplified using polymerase chain reaction (PCR) and 6% non-denaturing polyacrylamide gels electrophoresis. The frequencies of the different forms of the genotypes and alleles of 5-HTT gene were analyzed in 104 patients with SAS and 150 healthy controls.

RESULTSThe frequencies of the S or L alleles and the S/S, S/L or L/L genotypes in promoter region of 5-HTT gene in SAS group were not significantly different to those in healthy controls (P > 0.05). However, the frequencies of 10/10, 12/10 genotypes of 5-HTT-VNTR in SAS patients were significantly higher than those in healthy control subjects (P < 0.05). Moreover, the frequency of the allele 10 of 5-HTT-VNTR in SAS patients was significantly higher than that in healthy controls (P<0.01).

CONCLUSIONThe allele 10 of 5-HTT-VNTR might be a susceptible factor in the pathogenesis of SAS.

Adult ; Aged ; Alleles ; Female ; Gene Frequency ; Genetic Predisposition to Disease ; genetics ; Genotype ; Humans ; Male ; Middle Aged ; Minisatellite Repeats ; genetics ; Polymerase Chain Reaction ; Polymorphism, Genetic ; Promoter Regions, Genetic ; genetics ; Serotonin Plasma Membrane Transport Proteins ; genetics ; Sleep Apnea Syndromes ; genetics ; Young Adult