Aim The relative bioavailability of domestic ibudilast sustained release capsules in healthy volunteers was observed.Methods A single oral dose of 20 mg of imported and domestic ibudilast sustained release capsules and 10 mg of ibudilast raw material was separately given to 12 healthy volunteers in a randomized crossover study. Ibudilast concentration in plasma was determined by HPLC method.Results The Cmax were (54.9?9.7),(60.7?9.1) and (62.2?11.5) ?g?L-1; the tmax were (3.8?0.8),(3.9?0.8) and (1.8?0.3) h;the t1/2(ke) were (1.5?1.4),(12.1?1.0) and (3.5?0.5) h,and the AUC(0～t) were (618.1?57.7),(588.1?66.6) and (233.0?46.4) ?g?h?L-1 in imported capsule group, domestic capsule group and raw material group respectively. The relative bioavailability of domestic sustained release capsules of ibudilast is (95.6?11.0)%. Conclusion The results of statistical analysis demonstrate that the imported and domestic sustained capsules have significant character of significantly sustained release and are bioequivalent.

BACKGROUNDA voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.

METHODSStructured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.

RESULTSThe response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22.8% of nurses, and 29.7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs, yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67.9%), unavailability of the ADR report form (60.4%), lack of knowledge of the existence of a national ADR reporting system (52.2%), and belief that the ADR in question was already well known (44.1%).

CONCLUSIONSHealthcare professionals in Wuhan, China have little basic knowledge of ADR and of the voluntary reporting system. The main reasons for underreporting were lack of basic knowledge about ADRs and the voluntary reporting procedure. Education and training of healthcare professionals is needed to improve the current ADR reporting system.

Adverse Drug Reaction Reporting Systems ; trends ; Attitude of Health Personnel ; China ; Health Knowledge, Attitudes, Practice ; Hospital Administrators ; Humans ; Interviews as Topic ; Nurses ; Physicians ; Surveys and Questionnaires

OBJECTIVETo investigate the knowledge and attitudes of healthcare professionals (doctors, nurses and administrators) to adverse drug reactions (ADR) in Wuhan city and to identify the reasons for under-reporting.

METHODSStructured interviews were carried out in Wuhan, Hubei province. Questionnaire survey to approximately 15% of the medical practitioners selected from 16 hospitals, was conducted during the period from February to March 2003.

RESULTSOnly 2.7% of the interviewees knew the definition of adverse drug reactions. 61.7% of the doctors, 62.7% of the nurses and 61.1% of the administrators had ever encountered an ADR during their practices, but did not report to the national monitoring center or other centers. The major reasons for not reporting included: ignorant about the requirement and the reporting process of ADR (71.4%); address of the reporting agency and Forms unavailable (67.9%, 60.4%); unaware of the existence of a national ADR reporting system (52.2%); needless to report as the ADR being too well known (44.1%). They mainly reported an ADR to the hospital pharmacy or other departments, or to the pharmaceutical administration. Education, training and developing new institutions were ways to improve the reporting system.

CONCLUSIONSOur results showed that healthcare professionals had little knowledge on the basic ADR knowledge. The main reasons for underreporting were related to factors on reporting process, address of related centers and unavailable of the Forms. Education and training to doctors and nurses to enhance the awareness of administrators were the ways to improve the reporting system.

Adverse Drug Reaction Reporting Systems ; Attitude of Health Personnel ; China ; Drug-Related Side Effects and Adverse Reactions ; Female ; Health Knowledge, Attitudes, Practice ; Humans ; Male ; Practice Patterns, Physicians' ; Surveys and Questionnaires

OBJECTIVETo assess the current status on re-evaluation of marketed drug in China since the promulgation of drug law in 1985.

METHODSReview of literature on Chinese pharmaceutical abstract and CBMdisc from 1985 to 2001 year was done.

RESULTS4029 papers and 855 marketed drugs from 1985 to 2001 were included. Drugs on anti-infection agent, cardiovascular system and digestive system were the main drugs being re-evaluated, with the proportions of 27.1%, 20.1% and 11.1% respectively. The amounts of both marketed drugs and literature were increasing year by year. The method used for re-evaluation were random and non-random clinical trial. 41.4% of all the samples had a sample size of 50 - 100 research subjects. There were 13 papers with more than 5000 samples. The level on evidence based literature was assessed. 44 papers were graded as first class, and 182 papers the second, 2466 papers the third and 1337 papers the fourth. The quality of literature was improved year by year.

CONCLUSIONThe amount, quality as well as the sample size of literature being re-evaluated on marketed drug were increased from 1985 to 2001. However, the design and evaluation of those trials were not standardized.

Anti-Infective Agents ; therapeutic use ; Biological Products ; therapeutic use ; Cardiovascular Agents ; therapeutic use ; China ; Clinical Trials as Topic ; Cost-Benefit Analysis ; Evidence-Based Medicine ; Humans ; Product Surveillance, Postmarketing

To observe the pharmacokinetic and tissue-distribution characters of 5-flourouracil magnetic albumin deuto-microsphere (5-Fu-MAD) in normal and tumor-bearing mice, HPLC method for the determination of 5-Fu in plasma and tissues was established and applied to determine 5-Fu in mouse plasma and tissue samples. A Flame atomic absorption spectrometer was used to detect the iron concentration in mouse tissue. Plasma concentration-time curves of free 5-Fu, 5-Fu-MAD and 5-Fu-MAD plus the magnetic frame (MF) conformed to two compartment model of first order absorption and they had C(max) of 34.9, 7.95 and 5.97 mg x L(-1); T1/2 (Ke) of 22.26, 76.0 and 124.6 min, V(d) of 3.28, 30.7 and 66.1 L x kg; AUC(0-t), of 233.9, 78.3 and 50.2 mg x min x L(-1); AUC(0-infinity) of 237.2, 89.3 and 68.1 mg x min x L(-1), respectively. The distribution of 5-Fu and iron was the highest in the plenty blood perfusion organs like the liver, tumor, spleen and lung, while lower in the kidney and heart and lowest in brain and muscle. The tissue distribution of muscle and tumor increased significantly when a magnetic frame was inserted there. The pharmacokinetics and tissue distribution of 5-Fu-MAD exhibited sustained-release and target characteristics.
Albumins ; chemistry ; Animals ; Antimetabolites, Antineoplastic ; administration & dosage ; pharmacokinetics ; Area Under Curve ; Cell Line, Tumor ; Delayed-Action Preparations ; Female ; Fluorouracil ; administration & dosage ; pharmacokinetics ; Liver ; metabolism ; pathology ; Liver Neoplasms, Experimental ; metabolism ; pathology ; prevention & control ; Magnetics ; Male ; Mice ; Microspheres ; Random Allocation ; Tissue Distribution

Objective To evaluate the relative bioavailability and bio-equivalence of azathiopfine tablets in healthy volunteers.Methods A single oral dose of 100 mg azathioprine test and reference tablets were given to 20 male healthy volunteers in a randomized crossover study.Plasma metabolite 6-mercaptopurine of azathioprine wag determined by RP-HPLC.The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.Results The concentration-time curves were fitted to a one-compartment open modeL The main pharmacokinetic parameters of azathioprine test and reference tablets were as follows:t_(1/2)were(1.30±0.25)and(1.30±0.34)h;t_(max) were(1.25±0.16)and(1.24±0.21)h;C_(max) were(48.44±17.09)and(52.32±24.37)μg·L~(-1);AUC_(0-1)were(89.49±19.25)and(91.90±25.31)μg·h·L~(-1);AUC_(0-∞)were(96.11±19.74)and(98.36±24.66)μg·h·L~(-1),re-spectively.The relative bioavailability of F_(0-t) and F_(0-∞) were(99.62±15.29)%and(99.39±13.59)%,respectively.Conclusion The two azathiprine preparations are bioequivalent.

Objective To study the epidemiological features of hantavirus in rodents in Wenzhou,Zhejiang province.Methods Rodents were captured in Wenzhou,where hemorrhagic fever with renal syndrome (HFRS) had been endemic. Hantavirus antigens in the rat lungs were detected by immunofluorescence assay (IFA).Partial S segment (nt 620-999) and partial M segment (nt 2001-2301)sequences were amplified by RT-PCR,and then sequenced.Neighbor-joining method was used to construct for phylogenetic analysis.Results A total of 96 rodents were trapped in the epidemic areas,and 6 hantavirus antigens were identified from these lung samples (6.3%).Partial S and partial M segment sequences were successfully recovered from 5 samples and determined. Phylogenetic analysis of these sequences indicated that all viruses belonged to Seoul virus (SEOV),regardless of the sources (Rattus norvegicus,Rattus tanezumi and Rattus rattoide) that they were derived. However,the clustering pattern in the partial S-tree was different from that in the partial M-tree,suggesting that the re-assortment between SEOVs had occurred.Conclusion All Rattus rats carried SEOV in Wenzhou and the genetic reassortment with SEOV had occurred naturally.

Objective:To evaluate the strategy and safety of the radiofrequency ablation (RFA) on ventricular arrhythmias (VAs) originating from the pulmonary sinus cusp (PSC) in pediatric patients.Methods:Retrospective study.Fifteen patients with VAs originating from the PSC who were intervened by RFA in the Department of Pediatric Cardiology, Guangdong Provincial People′s Hospital between March 2014 to July 2020 were enrolled.All the patients met the indication criteria for RFA in pediatric patients.The electrocardiogram, ablation method of ablation were analyzed.Different curved catheters were selected for RFA according to the age and weight of the patients.The catheter was then inserted in a " U" or inverted " P" shape to the PSC.The long-term effect of ablation were reviewed.Results:The mean age and body weight of 15 patients with VAs originating from the PSC were (11.6±2.6) (6-15) years and (39.9±12.2) (19-65) kg, respectively.The electrocardiogram recorded during VAs originating from the PSC showed left bundle branch block and inferior axis with monomorphic R pattern, as well as a QS-wave in aVR and aVL.The electrocardiogram characteristics varied in patients with VAs originating from the PSC.The ideal excitation point was not found in the right ventricular outflow tract or the ablation was unsuccessful in all patients, and the earliest target was mapped and RFA was successful.Among the 15 patients, the successful ablation site was in the lower regions of the PSC, involving the right cusp in 11 patients(73.3%), the anterior cusp in 3 patients(20.0%), and the left cusp in 1 patient(6.7%). The earliest potential recorded at the PSC ablation site preceded the QRS complex onset by (27.3±6.0) ms.During the follow-up period for (2.7±2.0) years, no recurrence of VAs or complications were recorded.Conclusions:Under the premise of gentle catheterization procedure and appropriate radiofrequency energy, ablation was effective, safe and with low recurrence rate to eradicate VAs originating from the PSC in children.