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

Hand Disinfection ; Health Personnel ; Humans ; Infant, Newborn ; Intensive Care Units, Neonatal

Objective To study the serum level of brain natriuretic peptide (BNP) and atrial natriuretic peptide (ANP) in patients with congestive heart failure (CHF) and assess the value of BNP. Methods The serum levels of BNP and ANP were determined by enzyme- linked immnoabsorbent assay.Cardial mdex(CI)and left ventricular election fraction(LVEF)in heart failure stage and period recouery of children with heart failare were determined by Doppler ultrasonography cardiogram. Results The BNP serum levels began to increase before heart failure (P

Objective:To compare the clinical characteristics in primary hyper(-) parathyroid hormone (PHPT) of the different patholog-ic types. Methods:Clinical data of 140 patients with PHPT proved by operation and pathology during January 2010 to June 2016 were retrospectively analyzed. Results:A total of 140 PHPT patients, including 13 (9.29%) cases of parathyroid carcinoma (PC), 27 (19.29%) cases of parathyroid hyperplasia (PH), and 100 (71.43%) cases of parathyroid adenoma (PA). The duration of the PC group was longer than the PH group and the duration of the parathyroid adenoma (PH) group was longer than the PA group (P<0.05). The percentage of young patients with PC was higher than in the other two groups (P=0.003). The diameters of the PC group were larger than those of the other two groups, and those of the PA group were larger than those of the PH groups (P<0.05). Blood calcium, parathyroid hor-mone (PTH), AKP, fasting blood glucose (FBG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamete transpepti-dase (GGT), blood urine nitrogen (BUN), creatine (CRE), urinary calcium, and phosphorus of the PC group were higher than in the oth-er two groups (P<0.05). The blood calcium, PTH, alkaline phosphatase (AKP), urinary calcium of the PH group were lower than those in PA group (P<0.05). The proportion of ostalgia was 46.15%(6/13), 44.44%(12/27), and 49.00%(49/100). No statistical difference was observed (P>0.05). The postoperative calcium level of PC group was lowest (P<0.001), and the highest was of PTH (P<0.001). The pro-portions of clinical manifestation of the urinary system, digestive system, and nervous system in the PC group were 76.92%(10/13), 76.92%(10/13), and 15.38%(2/13), respectively, and these values were the highest in the three groups (P<0.05). The proportion of the clinical manifestation of the urinary system of the PH group was higher than that of the PA group. The fracture rate (30.77%, 4/13) and constipation rate (38.46%, 5/13) of the PC group were the highest among the three groups (P<0.05). Conclusion:The duration of patients with PC was the longest among the three groups. The percentage of young patients with PC was the highest. The abnormal parathyroid glands in the PC group were the heaviest. The PC group exhibited the lowest postoperative calcium level and the highest PTH level. The biochemistry and clinical manifestations of PC were obvious.

Objective To evaluate the neuroprotective effect and safety of neonatal hypoxic-ischemic encephalopathy(HIE)treated with recombinant human erythropoietin(rhEPO).Methods Fifty-three neonates with HIE were randomly divided into rhEPO treated group(n=29) with the dosage of 300 U/(kg?time),three times a week for 2 weeks and control group(n=24)without rhEPO.All supportive measures were same between 2 groups.Neurological scoring was evaluated at d3,d5 and d7 Neonatal behavioral neurological assessment(NBNA) was evaluated at d7,d14 and d28.The neurodevelopment quote was evaluated at age of 3 and 6 months.Blood pressure,liver and renal function,blood electrolytes and blood hemoglobin,platelet and reticular red blood cell count were monitored before and after treatment in all infants.Results The neurological scoring between two groups had no difference at d3.The significant difference was found at d7(P0.05).Conclusions Teraphy with rhEPO on neonatal HIE infants can promote neurological recovery,and there is no serious side effect with rhEPO treatment.

China ; History, 20th Century ; History, 21st Century ; Pathology ; Periodicals as Topic ; history

BACKGROUND:The bispectral (BIS) index is a processed electroencephalogram (EEG) parameter with extensive validation and demonstrated clinical utility. The study aimed to investigate the correlation between the BIS index and the prognosis of patients with coma in the ICU. METHODS:A total of 208 patients with coma in the ICU were enrolled in this study. According to the BIS value, the patients were divided into four groups:group I, BIS value 0 to 20; group Ⅱ, BIS value 21 to 40; group Ⅲ, BIS value 41 to 60; and group IV, BIS value greater than 60. The difference in BIS values with the differences in prognosis of patients with coma was compared between the four groups, and the prognosis of patients with coma was stratified into consciousness, coma, vegetative state, and brain death. Subsequently, the best cut-off score of BIS values calculated for determining the correlation between BIS value and mental state was proposed. RESULTS:There are no significant differences in the age and APACHE Ⅱ scores between the four groups (P>0.05). An inverse correlation was observed between BIS value and mental state (r=–0.749, P=0.00). According to the ROC curve, as BIS value was greater than 42.5, there were higher sensitivity and specificity in conscious-coma patients. CONCLUSION:BIS value is correlated with the prognosis of patients with coma in ICU, and BIS value can be a useful marker for estimating the prognosis of comatose patients.

Objective To perform a molecular epideminlogical investigation on the types of Leptospira interrogans isolates from leptospirosis patients and animal hosts in Jiangxi province,using a pulsed-field gel electrophoresis (PFGE).Methods The extracted chromosomal DNA from leptospiral isolates were digested with restriction endonuclease Not Ⅰ and the DNA segments were separated by using PFGE.By BiOnurerics V4.0 software and 75% similarity as the standard,the obtained PFGE images from leptospiral isolates were managed to establish a digitization database and then the PFGE maps of leptospiral isolates were compared with those of reference standard strains belonging to 15 serovars in 15 serogroups of L.interrogans,for cluster analysis.Results 139 strains of L.interrogans isolated from different areas of Jiangxi province were classified into 46 PFGE types.Among the PFGE types,LepNot Ⅰ.0071,LepNotⅠ.0072 and LepNot Ⅰ .0043 were the predominant types that accounting for 28.06%,15.11% and 7.19% of all the leptospiral isolates,respectively.The PFGE maps from 84.89% (118/139) of the 139 leptospiral isolates were found to basically match those of 6 reference standard strains belonging to 6 serovar in 6 serogroups of L.interrogans.In the 118 matched ieptospiral isolates,32.37% (45 strains),15.83% (22 strains) and 15.11% (21 strains)belonged to sero-groups Icterohaemorrhagiae serovar Lai,sero-groups Australis serovar Australis and sero-group Javanica serovar Javanica,respectively.Conclusion PFGE seemed a fast,accurate and effective method for typing of L.interrogans isolates.Serogroup Icterohaemorrhagiae serovar Lai and followed by serogroup Australis serovar Australis as well as serogroup Javanica serovar Javanica were the predominant L.interrogans species in humans and animal hosts in Jiangxi province.

We reports a nursing process for one uremic patient undergoing peritoneal dialysis during pregnancy.The key of this case is:through the closely follow-up by the specialist nurses in peritoneal dialysis center,the center could find problems and make treatments,and adjust the prescription timely;by effective observation and nursing care,the center reduced the incidence of peritoneal dialysis related infection and minimized the risk;the center provided strong supports for the patient including close examination of fetal,individual diet guidance and psychological support.With all the efforts,the center eventually ensured the safety and stability of the patient during pregnancy.

OBJECTIVETo observe the therapeutic effect of Shennong No. 33 (SN33) in treating multiple organ dysfunction syndrome (MODS) by APACHE II and APACHE II scoring.

METHODSOne hundred and twenty-nine patients of MODS were randomly divided into the treated group (n = 72) and the control group (n = 57), they were treated with comprehensive therapy and to the treated group, SN33 was given additionally. The changes of APACHE II and APACHE III scores and blood endotoxin level were observed at the time points of within 24 hrs after hospitalization, and the 3rd, 5th and 7th day.

RESULTSIn the treated group, 50 patients survived and 22 died, while in the control group, 25 survived and 32 died. The APACHE II and APACHE III scores of the survivors were higher than those of the decedent (P<0.05), which in the treated group was lower than those in the control group (P<0.05). The blood level of endotoxin in the treated group was also lower than that in the control group (P<0.05).

CONCLUSIONSN33 in treating MODS could improve patients' condition, lead to the lowering of APACHE scores. APACHE scoring system could be applied as the criteria for evaluating the condition and prognosis of critical patients, and the APACHE III scoring is more accurate.

APACHE ; Adolescent ; Adult ; Aged ; Anti-Bacterial Agents ; therapeutic use ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Endotoxins ; blood ; Female ; Humans ; Male ; Middle Aged ; Multiple Organ Failure ; drug therapy ; Phytotherapy