Cerebral Cortex ; physiology ; Electroencephalography ; Humans ; Magnetic Resonance Imaging ; Positron-Emission Tomography ; Taste Perception ; physiology

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

Dental Porcelain ; Dental Prosthesis, Implant-Supported ; Humans

Infection and inflammatory response can induce the brain damage in neonate,but the mechanism involved in it has not been elucidated completely.Proposed mechanisms include inflammatory response,cytokine and free radical-mediated injury,and excitatory amino acids-induced injury.The activation of microglia and selective vulnerability of immature oligodendrocyte play an important role in the whole process.Recent researches show that the fetal inflammatory response and complex gene regulation are also involved in the infection-induced brain damage.

OBJECTIVETo explore the distribution characteristics of basic syndromes and its related factors in patients with chronic functional constipation (CFC).

METHODSThe complete data of 538 patients with CFC were collected and initial database was established with Epidata 3. 0. TCM syndrome typing was performed. The distribution characteristics of basic syndromes were analyzed using SPSS 17. 0 Software. The univariate and multivariate Logistic regression analyses were performed with SPSS 17. 0 Software to determine basic syndrome related factors such as age, engaged professionals, sleep quality, depression, mental stress, interpersonal relations, work fatigue, stimulating beverage, exercise conditions, Western medicine type of constipation, and so on.

RESULTSThe TCM syndrome frequency of CFC patients was sequenced from high to low as qi deficiency syndrome (380 cases, 70.6%), qi stagnation syndrome (337 cases, 62.6%), blood deficiency syndrome (234 cases, 43.5%), yin deficiency syndrome (220 cases, 40.9%), yang deficiency syndrome (197 cases, 36.6%), and others(58 cases, 10. 8%) . Most patients were complicated with complex syndromes, and the most common complex syndromes were qi deficiency complicated qi stagnation syndrome (275 cases, 51.1%) and qi deficiency complicated blood deficiency syndrome (222 cases, 41.3%). Aging, work fatigue, and exercise conditions were main related factors for qi deficiency syndrome (P <0. 01, P <0. 05). Poor emotional (depression and anxiety tendencies), mental stress, interpersonal relations, defecation barriers constipation were main related factors for qi stagnation syndrome (P <0.01). Sleep quality and poor emotional (depression and anxiety tendencies) were main related factors for blood deficiency syndrome (P <0. 01, P < 0.05). Stimulating beverages were main related factor for yin deficiency syndrome (P <0.05). Engaged in mental work and slow transit constipation were main related factors for yang deficiency syndrome (P < 0. 01, P <0. 05).

CONCLUSIONSCFC is featured as complex syndromes. The most common complex syndromes were qi deficiency complicated qi stagnation syndrome and qi deficiency complicated blood deficiency syndrome. Basic syndrome related factors such as age, engaged professionals, sleep quality, poor emotional (depression and anxiety tendencies), mental stress, interpersonal relations, work fatigue, stimulating beverage, exercise conditions, Western medicine type of constipation were associated with the distribution of CFC syndromes.

Anxiety ; complications ; Constipation ; complications ; diagnosis ; psychology ; therapy ; Depression ; complications ; Diagnosis, Differential ; Factor Analysis, Statistical ; Fatigue ; Humans ; Medicine, Chinese Traditional ; Qi ; Stress, Psychological ; complications ; Syndrome ; Yang Deficiency ; diagnosis ; Yin Deficiency ; diagnosis

A male patient,39 years old,presented with symptoms of cataract,dwarf,progeria,polydactyly and genu valgum,after the extracapusular cataract extraction and intraocular lens implantation on both eyes,the visual acuity was improved and his fundus examination was normal.As the syndrome is different from any eye syndrome we have ever known,so it maybe a new one.

The symbiotic bacterium exists in the intestines of entomopathogenic nematodes and is a potential biological agent.Systematic classification of these bacteria is scarce in China.In this paper,seven strains of symbiotic bacteria from local entomopathogenic nematodes were identified by both observation of mor-phology,physiological,biochemical characteristics and sequence analysis of 16S rDNA fragments.

OBJECTIVETo compare therapeutic effects between unilateral decompression technique only and open decompression technique with fusion and internal fixation for the treatment of lumbar spinal stenosis.

METHODSFrom March 2008 to February 2011, 82 patients with lumbar spinal stenosis were treated with operations, and divided into two groups. There were 13 males and 19 females in group A, with a mean age of (56.31±4.31) years old. The patients in group A were treated with unilateral decompression via fenestration technique only, including 23 patients obtaining single level decompression and 9 patients obtaining two levels decompression. In group B, there were 18 males and 32 females, with a mean age of (57.53±4.28) years old. The patients in group B were treated with open decompressive technique with fusion and internal fixation, including 38 patients obtaining single level decompression and 12 patients obtaining two levels decompression. The VAS of back pain and leg pain, ODI were recorded before and after surgery to evaluate low back pain,leg pain and walking tolerance.

RESULTSAll the patients were followed up, and the duration ranged from 10.9 to 43.4 months,with a mean of 32.8 months. There were no differences in age, stenosis level, VAS of back and leg pain and ODI before surgery between two groups. Compared with the corresponding ones in group B, the operation time, blood loss, hospitalization time,recovery time of routine daily life and finacial expenditure of patients were all shorter or less in group A. There was no statistically difference in complications between two groups.

CONCLUSION"Unilateral decompression via fenestration technique" is a less invasive and more effective decompressive technique for degenerative spinal stenosis without posterior elements damage. It has advantages in operation time, blood loss, hospitalization time, recovery to daily life and financial expenditure. When controlling the operative indications strictly, the technique could be an important procedure for surgical treatment of degenerative spinal stenosis, especially in the elderly population.

Adult ; Aged ; Case-Control Studies ; Decompression, Surgical ; methods ; Female ; Humans ; Lumbar Vertebrae ; surgery ; Male ; Middle Aged ; Minimally Invasive Surgical Procedures ; methods ; Spinal Fusion ; methods ; Spinal Stenosis ; surgery

Antigens, CD20 ; metabolism ; Female ; Follow-Up Studies ; Humans ; Interferon Regulatory Factors ; metabolism ; Leg ; pathology ; Lymphoma, Large B-Cell, Diffuse ; complications ; metabolism ; pathology ; surgery ; Middle Aged ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; Skin Neoplasms ; complications ; metabolism ; pathology ; surgery ; Thrombocytopenia ; complications

OBJECTIVETo investigate the characteristics, diagnosis, and treatment of ovotesticular disorder of sex development (OT-DSD).

METHODSWe retrospectively analyzed 2 cases of OT-DSD treated in our hospital. The patients were 19 and 15 years old, respectively, and both received systematic physical examination and examinations of the karyotype, sex hormone, adrenocorticotropic hormone (ACTH), color Doppler ultrasonography, urethrocystoscopy, and human chorionic gonadotropin (HCG) test. Under the laparoscope, we performed surgical gonad exploration, gonadectomy, and vulvar orthopedics. Intraoperative exploration and pathology confirmed true hermaphroditism in both cases, with sex selection as female. One underwent laparoscopic resection of the ovotestis, and the other removal of the testis with the ovarian tissue reserved.

RESULTSThe patients were followed up for 12 months postoperatively, which found no abnormality in either the vulvas or the genital glands.

CONCLUSIONSurgical exploration of the gonad is the only method for the diagnosis of OT-DSD and sex selection is the key to treatment. Laparoscopic surgical exploration of the gonad and vulvar orthopedics are the first treatment options.

Adolescent ; Chorionic Gonadotropin ; Female ; Gonadal Steroid Hormones ; Humans ; Karyotype ; Laparoscopy ; Male ; Ovary ; Ovotesticular Disorders of Sex Development ; diagnosis ; surgery ; Retrospective Studies ; Testis ; surgery ; Young Adult