OBJECTIVE: To provide references for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.METHODS: FDA's CGMP Warning Letters on medical products issued by the USA during 2002～2006 were analyzed statistically,and FDA's emphasis and intent on quality management system of medical products was discussed.RESULTS & CONCLUSIONS: The contents stated in FDA Warning Letters are of great importance for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.Chinese enterprises can probe into the problems and solutions of quality management of medical products by analyzing FDA's emphasis and intent on quality management system of medical products as well as field investigation.

Objective To evaluate the treatment effects on schistosomiasis hepatic fibrosis with Dangguibuxue decoction.Methods Thirty-four rabbits weighing 2.0-2.5 kg were selected.The procedure for the model of schistosomiasis liver fibrosis was as follow.Thirty-four snails infected by schistosoma japonicum were placed in triangle flask to escape cercariain.Abdominal skin of each rabbit wag infected by 100 schistosoma japonicum cercariaes.All rabbits were housed in conventional cages at room temperature.After 13 weeks schistosoma japonicum infected,the rabbits'livers were examined by B-ultrasound examination every week.After 18 weeks of infection,B-ultrasound showed images of schistosomiasis liver fibrosis,the rabbits were thus identified as schistosomiasis liver fibrosis.Praziquantel Was as insecticide to treat rabbits.All rabbits were divided into treatment and control groups according to body weigh.The high and low dosage group were treated with Dangguibuxue decoction at 50 g/kg and 5 g/kg(n=11),respectively,and the control group with no treatment(n=12).Two groups were treated with Dangguibuxue decoction every day for 10 weeks.After 10 weeks of treatment,the rabbits were killed and the livers were obtained to go HE staining and histopathological examination under microscope.Results After 18 weeks of infection,B-ultrasound showed that the liver parenchyma Was coarse and net-shaped.having hyperechoie spots with lightbrand and facula.The liver's shape Was abnormal,portal and splenic vein diameter was widened.Histopathological examination showed that the high dosage group presented fibrosis,which was formed by collagen fiber extending to peripherM regions,low dosage group showed mild fibrosis,mild collagen fiber present with extension without compartment formation, while the control group presented severe fibrosis and severe collagen fiber present with a thickening of the partial compartments and the distribution of eggs nodules. The liver histopathological ranking results from different groups showed that the difference was significant (χ2= 13.585,P < 0.01), the difference between the treatment groups of high and low dosage and control group was significant,respectively(all P < 0.01 ). Conclusions The histopathology results showed that both high and low dosage Dangguibuxue decoction can reverse or eliminate schistosomiasis liver fibrosis in rabbits.

Denonvilliers fascia locating between the front of the rectum and urogenital organs is an important barrier separating the urogenital organs and the rectum.It has great significance in the clinical treatment of rectal tumors and genitourinary system tumors.However,controversial on the embryological origins and anatomic characteristics of the Denonvilliers fascias still exist.In this article,the embryonic origin,anatomical structure,adjacent structures and clinical applications of the Denonvilliers fascias were introduced.

Recent studies have showed that nanotechnology pro-vides a new revolution for the treatment of complex,refractory autoimmune or inflammatory diseases.Nanoparticles combined with specific autoantigens can restore the peripheral tolerance and reduce immunopathological damage in a variety of autoimmune disease models.In this paper,we review the progress and trends of nanomedcine for treatment of autoimmune or inflammatory dis-eases as immunomodulatory therapy from the physical and chemi-cal characteristics of nanoparticles,the route of administration, and the role and mechanism of induction or reconstitution of im-mune tolerance,which provides a theoretical basis for seeking new treatments to treat inflammatory diseases.

Donguibogam was introduced from traditional Chinese medicine (TCM) instead of the local representa-tive work of the Democratic People's Republic of Korea (DPRK). It is also the concrete manifestation of theories of different schools of doctors according to Dr. Xu Jun's medical thoughts. In this paper, from Dr. Xu's advocacy to Taoism and the concept of aftercare spirit, the exploration was made on health cultivation for different body constitu-tions. According to the health cultivation effects of the medicinals and edible food, the focus was made on the sys-tematic collation and induction of more than 1 400 kinds of herbs contained in the soup liquid from papers in three volumes. The medicinals were divided into eight categories, which were benefiting qi, nourishing yin, tonifying yang, clearing heat and promoting dieresis, drying dampness and resolving phlegm, promoting blood circulation for remov-ing blood stasis, dispersing stagnated liver qi, nourishing blood for hemostasis. Donguibogam specified the health cultivation concept from the correspondence between the body constitution and the medicinal performance. It has a certain guiding significance to the current health cultivation.

Objective To investigate the changes of brain tissue in bilateral temporal lobes at different stages after nasopharyngeal carcinoma radiotherapy by diffusion tensor imaging(DTI)and 1H-MR spectroscopy(1H-MRS).Methods DTI and 1H-MRS were performed in 48 patients with nasopharyngeal carcinoma.in which conventional MRI revealed normal findings after radiotherapy.Twenty-four healthy controls were enrolled in this study and underwent the galne MR scanning.After the image processing and spectral analysis,apparent diffusion coefficient(ADC),fractional anisotropy(FA) and 3 eigenvalue λ1,λ2,λ3 of DTI and the NAA/Cho,NAA/Cr,Cho/Cr of 1H-MRS were measured in bilateral temporal lobes.Forty-eight NPC patients were divided into 3 groups [ less than 6 months(16 cases),6 to 12 months (6 cases)and more than 12 months(26 cases)after radiotherapy]according to different stages of radiationinduced injury of brain.each group's DTI and 1H-MRS data were measured respectively and one-way ANOVA was applied to analyze each parameter. Results The FA value of each test group(less than 6 months.6 to 12 months and more than 12 months)and the control group were 0.445±0.017,0.460±0.016,0.461±0.025,0.473±0.023 respectively.The ADC values of each group were(8.51±0.43)×10-4.(8.48±0.34)×10-4,(8.40±0.33)×10-4,(8.68±0.57)×10-4mm2/s respectively.And the maximum eigenvalue λ1 of each group were(1.251±0.065)× 10-3,(1.293±0.051)×10-3,(1.317±0.074)×10-3,(1.350±0.091)× 10-3mm2/s.The three indicators were significantly difrerent among groups(F=10.873,3.399,9.750 respectively,P<0.05).λ2,λ3 values showed no significant difference among the groups.The NAA/Cho of 1H-MRS of each groups were0.910±0.112,0.972±0.101,1.060±0.095,1.261±0.105 respectively,and the NAA/Cr were 1.212±0.236,1.208±0.183,1.228±0.236,1.435±0.225 respectively.Both of them had significant differences among groups(F=52.840,8.176 respectively,P<0.01).Cho/Cr showed no significant difference among the groups.Conclusions DTI combining with 1H-MRS play a certain guiding role on monitoring and evaluating of radiation injury of brain tissue in nasopharyngeal carcinoma after radiotherapy.It Can provide a scientific basis for the dynamic monitoring of radiation brain injury.

A retrospective study was conducted based on the clinical data of 15 choledocholith patients after Billroth-Ⅱgastroenterestomy who were treated with endoscopic retrograde cholangio-pancreatography (ERCP) through colonoscopy or duodenoscopy.It showed that choledocholith removed by colonoscopy for patients with Billroth-Ⅱ gastroenterestomy can achieve comparable therapeutic effect,but this method can reduce the operation difficulty,shorten the operation time and significantly increase the success rate.

In an attempt to overcome the limitations of titanium in dental and orthopaedic clinical applications, a new method has been developed to prepare calcium carbonate coatings on sandblasted and acid-etched (SA) titanium implants. The purpose of this study was to investigate the effect of calcium carbonate-SA (CC-SA) implants on osseointegration in vivo. The surfaces of SA and CC-SA implants were characterised for surface morphology and surface chemistry. Subsequently, these two kinds of implants were implanted in the femoral condyles of rabbits. The implants were retrieved and prepared for histological and histomorphometric evaluation 1, 2, 4, 8 and 12 weeks after implantation. Significantly higher values of bone-to-implant contact of the entire implant except the gap area (BIC_ALL) and the bone-to-implant contact of the gap area (BIC_GAP) were found in animals with the CC-SA implants than in those with the SA implants at 4 weeks. Higher values of total gap bone were found in those with the CC-SA implants than in those with the SA implants at 1, 2 and 4 weeks. In conclusion, the current findings demonstrate that the calcium carbonate coating can improve and accelerate the early ingrowth of bone and osseointegration at the early healing phase. This may reduce clinical healing times and thus improve implant success rates.

Isolated alkaloids from Coptis chinensis Franch. The compounds were identified as berberine, columbamine, groenlandicine, jatrorrhizine, magnoflorine, corydaldine and ferulic acid methylester. Then measured their bitter degree based on the electronic tongue and evaluated the antibacterial. The results based on the Electronic Tongue showed that berberine, columbamine, groenlandicine and jatrorrhizine have higher bitter degree than magnoflorine and corydaldine. And they also appeared better antibacterial activity on E. coli and S. aureus. The correlation coefficients between bitter degree and the two bacteria antibacterial activity were 0.983 and 0.911. So there was close relationship between the bitter degree and antibacterial activity of bitter components. Thus, it is confirmed further that bitter components are the material foundation of medicinal effectiveness of bitter herbs.
Aporphines ; analysis ; Berberine ; analogs & derivatives ; analysis ; Berberine Alkaloids ; analysis ; Biomedical Research ; instrumentation ; methods ; Coptis ; chemistry ; Drugs, Chinese Herbal ; analysis ; chemistry ; pharmacology ; Electronics ; instrumentation ; methods ; Escherichia coli ; drug effects ; growth & development ; Microbial Sensitivity Tests ; Reproducibility of Results ; Staphylococcus aureus ; drug effects ; growth & development ; Taste

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.