OBJECTIVE:To improve the efficiency and quality of adverse drug reaction(ADR)monitoring in China.METHODS:The current situation,existing difficulties,as well as problems yet to be solved in the construction of informa-tionalized reporting system of ADR in our country were discussed.RESULTS&CONCLUSION:The management software at national,provincial and individual levels should be developed.Also,The data collection should be improved for variety,quickness,and timeliness as well as modularization and expansion.

Abstract: Our previous work revealed berberine can significantly enhance the susceptibility of fluconazole against fluconazole-resistant Candida albicans, which suggested that berberine has synergistic antifungal activity with fluconazole. Preliminary SAR of berberine needs to be studied for the possibility of investigating its target and SAR, improving its drug-likeness, and exploring new scaffold. In this work, 13-substitutited benzyl berberine derivatives and N-benzyl isoquinoline analogues were synthesized and characterized by 1H NMR and MS. Their synergetic activity with fluconazole against fluconazole-resistant Candida albicans was evaluated in vitro. The 13-substitutited benzyl berberine derivatives 1a-1e exhibited comparable activity to berberine, which suggested that the introduction of functional groups to C-13 can maintain its activity. The N-benzyl isoquinolines, which were designed as analogues of berberine with its D ring opened, exhibited lower activity than berberine. However, compound 2b, 2c, and 4b showed moderate activity, which indicated that berberine may be deconstructed to new scaffold with synergistic antifungal activity with fluconazole. The results of our research may be helpful to the SAR studies on its other biological activities.

Objective: To understand the changes of smoking behavior among primary and middle school students in Beijing during 2005-2015. Methods: The primary and middle schools in Beijing were classified and then taken as a sampling frame. Twophase stratified random cluster sampling was conducted with school as primary sampling unit (PSU) and class as the minimum sampling unit, respectively. Beijing Schoolbased Smoking Monitoring Questionnaire was surveyed in 2005 and 2005, 2010, 2011, 2013 and 2015 anonymously. Results: In 2015, the smoking rate among primary and middle school students in Beijing was 9.41%. Among them, for primary, junior, high school and vocational high school students, the rates were 7.05%, 7.06%, 12.41% and 34.11%, respectively. The smoking rates were now 3.26%, with 1.99%, 1.80%, 3.48% and 20.22%, respectively, among primary, middle and high school and vocational high school students. male, vocational school students were more likely to report smoking across six waves of surveillance. Results from the surveillance in 2015 showed a decreasing trend in ever smoking rate and current smoking rate compared with previous survey. About half of the current student smokers were reported to take 1 cigarette/day, and about 10% smokers were reported to take 10 cigarettes/day. Students were most likely to smoke at home(24.02%), followed by smoking at schools(12.74%). The percentage of buying cigarettes by themselves was increased from 17.10% in 2008 to 66.09% in 2015. Conclusion From 2005 to 2015, both ever smoking and current smoking rate among middle school students in Beijing decreased in general, however smoking among vocational high school students warrants further attention.

In this retrospective study, 56 cases of adverse reactions caused by Niuhuang Jiedu tablet (pill) were statistically analyzed in respects of genders, ages, routes of administration, clinical manifestations, etc. We pinpointed that the main factors related to safety problems of Niuhuang Jiedu tablet (pill) are irrational drug use and drug quality, and put forward suggestions for strengthening the surveillance and administration of Niuhuang Jiedu tablet (pill) and improving clinical rational use.
Adolescent ; Adult ; Age Factors ; Child ; Child, Preschool ; Drug Therapy ; standards ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Infant ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors ; Sex Factors ; Tablets ; Young Adult

Objective:This retrospective study aims to determine the efficacy of chemotherapy and improve a salvage chemother-apy agent for metastatic colorectal cancer (MCRC) after failure of treatment with irinotecan and oxaliplatin. Methods:Between Janu-ary 2002 and March 2013, 37 patients with metastatic MCRC who had progressed after treatment with irinotecan and oxaliplatin were analyzed for their response rate (RR) and progression-free survival (PFS). Results:The overall RR of the 37 patients was 13.51%, with 5 cases of partial response (PR), 12 cases of disease stabilization (SD), and 20 cases of progression (PD). Compared with other chemo-therapy regimens, treatment with a pemetrexed-based chemotherapy agent had a higher RR (17.64%vs. 10.00%, P=0.64) without a lon-ger PFS (2.00 months vs. 1.63 months, HR=0.79, 95%, CI:0.35 to 1.78, P=0.58). Compared with other chemotherapy regimens, treat-ment with a raltirexed-based chemotherapy agent had a higher RR (16.67%vs. 12.00%, P=0.34) without a longer PFS (1.58 months vs. 1.90 months, HR=2.24, 95%, CI:0.98 to 5.12, P=0.06).Conclusion:In patients with MCRC after failure of treatment with irinotecan and oxaliplatin, a pemetrexed-based or raltirexed-based chemotherapy agent may beneficial during salvage treatment and is therefore worthy of further study.

Objective:This study aims to determine the efficacy of chemotherapy and to identify potential chemotherapy agents for advanced primary duodenal carcinoma (PDC). Methods:Fifty-six patients with advanced PDC, who did and did not receive chemo-therapy, were involved in this study. Response rates (RR), disease control rates (DCR), progression-free survival (PFS), and overall sur-vival (OS) were analyzed. Results:The overall RR and DCR of 43 patients were 19.04%and 71.42%, respectively. The patients who re-ceived chemotherapy agents fluorourzcil and oxaliplatin exhibited higher RR compared with patients who received other chemotherapy combinations (35.29%vs. 7.69%, P=0.010 9). Palliative chemotherapy improved the OS of patients with advanced PDC compared with patients who did not receive chemotherapy (13.35 months vs. 5.65 months, HR=0.203, 95%CI:0.083 to 0.497, P=0.000 5). Compared with the use of other chemotherapy regimens, treatment with a fluorourzcil-based chemotherapy agent resulted in a longer PFS (5.08 months vs. 1.08 months, HR=0.004, 95%CI:0.000 to 0.315, P=0.013 2). Multivariate analysis indicated mucinous histology and lymph mode metastasis as factors predictive of poor prognosis in patients with advanced PDC. Conclusion:Palliative chemotherapy may im-prove the OS of patients with advanced PDC.

To enhance the scientific and fair evaluation about proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs, and to ensure those medicines to be used safely by the public in their self-medication. Combined with current research status of toxic herbs, the experience and knowledge accumulated in the practical work of selection and switch of OTC Chinese medicines for years, thinking about the feasible standards about evaluation and management of proprietary Chinese medicines containing toxic herbs at this stage. Initially established ideas and methods about evaluation of proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs. Basically solved the main problem currently faced by toxic herbs during the OTC switch process of proprietary Chinese medicines, effectively promoted the work on OTC switch, and had the important significance in making consumers use non-prescription drugs conveniently and safely.
Humans ; Medicine, Chinese Traditional ; adverse effects ; methods ; Nonprescription Drugs ; adverse effects ; classification ; Plants, Toxic ; adverse effects ; classification ; Quality Control ; Research ; statistics & numerical data

Objective Based on the structure-activity relationships on the reported antifungal agents bearing quinoline or thiophene moieties ,novel compounds bearing both quinoline and thiophene were designed ,synthesized ,and evaluated for in vitro antifungal activity against Candida albicans .Methods With 5-cyanothiophene-2-carbaldehyde or 5-cyanothiophene-3-car-baldehyde as starting materials ,13 compounds were synthesized via reductive amination ,reduction of cyano group and amida-tion of quinoline-or isoquinoline-carboxylic acid .Their chemical structures were characterized by 1 H NMR and MS . In vitro antifungal screening against Candida albicans SC5314 was performed with the microbroth dilution method .Results All the compounds exhibited potent antifungal activities against Candida albicans .Among them ,compound 6k showed the highest an-tifungal activity with MIC80 value of 0 .5 μg/ml ,which is same potent as fluconazole .Conclusion The designed compounds bearing both quinoline and thiophene exhibited potent antifungal activities ,and deserve further research .

Objective To introduce the detailed surgical procedure of parachute-like-suture double-pouch pancreaticojejunostomy in laparoscopic pancreaticoduodenectomy (LPD),and to study its clinical results.Methods A retrospective study was conducted on 31 patients who underwent parachute-like-suture double-pouch pancreaticojejunostomy in laparoscopic pancreaticoduodenectomy between January 2016 and June 2018 in our department.Results Of 31 patients who underwent total laparoscopic pancreaticoduodenectomy,5 patients underwent two-dimensional (2D) LPD and 26 underwent three-dimensional (3D) LPD.Total mesopancreas excision (TMpE) was performed in 12 patients,including 2 patients combined with PV-SMV segmental resection and reconstruction.The mean operative duration,and mean estimated blood loss,post-operative hospital stay were 412.8 ± 102.4 min,462.8 ± 396.7 ml,14.7 ± 8.9 d,respectively.The operating time of parachute-like-suture double-pouch pancreaticojejunostomy was 29.7 ± 6.8 min (20 ～45 min).Post-operative complications occurred in 8 patients (25.8％),3 of whom suffered from more than two types of complications.There were 2 patients (6.5％) with postoperative B/C grade pancreatic fistula,4 patients with postoperative biliary leakage (12.9％),3 patients with delayed gastric emptying (9.7％),1 patient with portal vein thrombosis (3.2％) and 1 patient with peritoneal effusion (3.2％).One patient died during perioperative period due to gastrointestinal hemorrhage.Conclusions Parachute-like-suture double-pouch pancreaticojejunostomy in laparoscopic pancreaticoduodenectomy was a simple,convenient,reliable method.It is worthy of clinical promotion and further studied.

Objective:To investigate the application value of three dimensional (3D) imaging fusion navigation system (hereinafter referred as navigation system) in laparoscopic pan-creatic surgery.Methods:The retrospective and descriptive study was conducted. The clinical data of two volunteers, including volunteer 1 undergoing laparoscopic pancreaticoduodenectomy for cholangiocarcinoma and volunteer 2 undergoing laparoscopic pancreaticotomy + splenectomy for pancreatic cancer, who were admitted to the Second Hospital of Hebei Medical University from December 2020 to May 2021 were collected. The 2 volunteers were females, aged 68 years and 40 years, respectively. The self-developed navigation system was applied in laparoscopic simulator model test, including in rigid-body model and prosthesis model, and clinical test. Observation indicators: (1) results of model test; (2) results of clinical test. Measurement data with normal distribution were represented as Mean± SD. Results:(1) Results of model test. The rigid-body model or prosthesis model with occlusion can be seen in the laparoscopic visual field of the initial laparoscopic simulator. The rigid-body model or prosthesis model with occlusion and rigid-body model or prosthesis model without occlusion can be seen in the 3D visual reconstruction image of enhanced computer tomography (CT) examination. The rigid-body model or prosthesis model with occlusion can be seen in the laparoscopic visual field of the initial laparoscopic simulator after the 3D visual reconstruction image was superimposed and fused with the real-time laparoscopic image. Both of the rigid-body model and prosthesis model were in high consistency, with the distance error of marker points were (0.26±0.11)mm and (0.29±0.18)mm, respectively. (2) Results of clinical test. The abdominal organs and blood vessels with occlusion of the 2 volunteers can be seen in the initial laparoscopic visual field. The location of tumor, important organs and blood vessels can be seen in the navigation system using the 3D visual reconstruction image of enhanced CT examination. The location of tumor, important organs and important blood vessels can be seen in the laparoscopic visual field after the 3D visual reconstruction image was superimposed and fused with the real-time laparoscopic image. The distance error of marker points of the volunteer 1 was (1.36±0.57)mm and the distance error of marker points of the volunteer 2 was (1.24±0.33)mm.Conclusions:The self-developed navigation system can integrate the preoperative 3D visual reconstruction image of enhanced CT examination and the intraoperative real-time laparoscopic image with a good effect. The relationship between deep tissue and blood vessels which is not clarified in conventional laparoscopy can be shown in the navigation system assisted laparoscopic pancreatic surgery.