OBJECTIVE:To strengthen the implementation of Drug Recall Administration(DRA).METHODS:Based on the study of "DRA" and the analysis of the current drug recall status both in China and abroad,effective measures for the enforcement of the regulation was presented.RESULTS & CONCLUSIONS:In the initial enforcement stage of "DRA",some relative effective measures should be taken from the aspects of drug manufacturing enterprises,consumers and the related supporting regulations to ensure the effective enforcement of the regulation.

Objective To study the effect and safety of recombinant human brain natriuretic peptide (rhBNP)on hemodynamics in patients with refractory heart failure(RHF).Methods A total of 16 patients with RHF were enrolled in the study.We defined RHF as the symptoms and signs had not been improved with conventional intensive treatment.The patients started to receive the infusion of rhBNP with 1.5 μg/kg bolus intravenous injection followed by 0.007 5 μ4/(kg · min)for 24 hours.During 24 hours,the hemodynamic parameters,systolic blood pressure,heart rate and electrolyte were monitored.After rhBNP infused,echocardiography was used to measure the cardiac index(CI),left ventricular end diastolic diameter(LEVDD)and ejection fraction(EF)in the third day.Results After rhBNP infused,pulmonary capillary wedge pressure (PCWP),mean pulmonary artery pressure(MPAP)were significantly reduced at 15 minutes(PCWP[22.7 ±4.0]mm Hg vs[25.3 ±3.9]mm Hg;MPAP[31.9 ±3.6]mm Hg vs[34.6 ±7.8]mm Hg,P ＜0.05),the systolic blood pressure decreased remarkably at one hour([105.2 ± 11.5]mm Hg vs[119.0 ± 17.2]mm Hg,P ＜ 0.01),and the effect disappeared gradually,heart rate decreased remarkably([109.0 + 10.8]beat/min vs [82.2 ± 8.6]beat/min).blood K +,Na + and renal function remained unchanged(P ＞ 0.05).CI([3.7 ± 0.6]L/m2 vs[1.8 ±0.4]L/m2),LEVDD([63.6 ±5.7]mm vs[67.3 ±6.2]mm)and EF([43.1 ±8.3]％ vs [31.2 ± 6.4]％)were significantly improved(P ＜ 0.01).There was no symptomatic hypotension or other adverse events.Conclusion Injection of rhBNP is safe,feasible,and effective in patients with refractory heat failure for improving hemodynamics.

Objective:To explore therapeutic effect of behavioral nursing on patients with atherosclerotic stenosis after percutaneous coronary intervention (PCI).Methods: A total of 112 patients with atherosclerotic stenosis treated in our hospital were selected.According to ramdom number table and parallel control analysis method, they were randomly and equally divided into routine nursing group and behavioral nursing group (received more active behavioral nursing based on routine nursing group), both groups were treated and observed for six months.The self-care ability scale score before and after nursing, incidence of complications and quality of life (QOL) score after six months were compared between two groups.Results: Compared with before nursing care, after six-month nursing, self-care ability scores significantly rose in both groups, P<0.01 both;compared with routine nursing group after six months, there were significant rise in self-care ability score [(110.34±12.84) scores vs.(128.49±11.39) scores](P=0.001) and each dimension score of QOL(P=0.001 all), and significant reduction in incidence rate of complications (21.4% vs.7.1%,P=0.031) in behavioral nursing group.Conclusion: Behavioral nursing can improve self-care ability, quality of life, promote rehabilitation, effectively reduce occurrence of postoperative complications in patients with atherosclerotic stenosis after percutaneous coronary intervention.

This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference.
Materials Management, Hospital ; organization & administration

This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.
Materials Management, Hospital ; Quality Assurance, Health Care

Objective To investigate the cytokine genotypes of the renal transplantation recipients with or without acute rejections.Methods The cytokine genotypes of peripheral blood TNF ?, TGF ? IL 6 and IFN ? in 89 kidney to allograft receipients were detected by using PCR method. According to the test, the occurrence of acute rejection was compared among the groups. Results TNF ? and IFN ? high producer genotype (-308 GA and AA) showed a correlation with the high incidence of acute rejection to the HLA DR mismatching recipients. Conclusion To detect the cytokines gene polymorphisms before operations can find the high risk kidney receipients who may suffer from the acute rejection. It's very helpful in guiding the individual use of immunosuppressants following the renal transplantation.

OBJECTIVE:To evaluate the clinical efficacy and safety of letrozole combined with traditional Chinese medicine for ovulation dysfunction induced by polycystic ovarian syndrome(PCOS). METHODS: 300 PCOS outpatients were randomized to 3 groups of 100 each: clomiphene citrate (CC) group (188 cycles);urinary gonadotropin (HMG) group (104 cycles) and letrozole (LE) group (155 cycles). The occurrence rate of mature follicle,ovulation rate,pregnancy rate,abortion rate,superfoetation-terata rate,cancellation rate,incidence of no dominant follicle forming and OHSS etc were compared between the two groups after treatment. RESULTS: 30 babies were born in CC group,34 in HMG group and 43 in LE group were born. The occurrence rate of mature follicles,ovulation rate and pregnancy rate in the LE group were higher than in either CC group or HMG group(P0.05);the superfoetation rate in HMG group was higher than in CC group or LE group(P

Objective To investigate the effect of perforin and granzyme B in peripheral blood lymphocytes during acute rejection in renal transplantation.Methods Sixty-seven recipients of renal allograft were involved in the study.The recipients were divided into four groups: group 1 with 7 cases of acute rejection,group 2 with 8 cases of delayed graft function,group 3 with 27 cases of stable function and group 4 wih 25 cases of long-term survival.The expressions of perforin and granzyme B of peripheral blood lymphocytes were studied by quantitative reverse transcription polymerase chain reaction(RT-PCR).Results The expressions of perforin and granzyme B in acute rejection group were significantly higher than those of the other three groups(P

BACKGROUND: Using color Doppler ultrasonography, renal graft size, appearance, structure, and blood flow distribution can be observed. Through the use of blood flow display technique, blood flow perfusion of renal graft can be accurately observed to assist diagnosis and differential diagnosis of complications following renal transplantation. OBJECTIVE: To observe the hemodynamic characteristics during different periods of acute renal transplant rejection, summarize its specific manifestations through analyzing different reaction of two dimensional and color Doppler flow imaging (CDFI) during renal transplantation in order to get valuable index on acute rejection of renal transplantation.DESIGN, TIME AND SETTING: Comparative observation was performed at the Jinan University and First Hospital of Shenzhen University between January 2003 and January 2007.PARTICIPANTS: A total of 299 patients undergoing renal transplantation were divided into normal allograft group (n=236) and acute rejection group (n=63) according to renal allograft function.METHODS: The systolic peak flow rate, end-diastolic flow rate, mean flow rate, pulsatility index and resistance index of main renal artery and arcuate artery in patients of two groups were compared. MAIN OUTCOME MEASURES: Renal allograft arterial inner diameter and hemodynamics of two groups.RESULTS: Compared with normal allograft group, the blood flow perfusion was reduced at acute rejection, which could not reach cortex margin, blood velocity was decreased at the diastolic phase, pulsatility index and resistance index were increased (P < 0.05). CONCLUSION: Color Doppler ultrasound, as a convenient, economical and noninvasive technique, provides the reliable evidences for the renal artery pulsatility index and resistance index in clinic, and also is valuable for the acute rejection early diagnosis of renal allograft.

The paper introduces supervision situation of enterprises of medical devices from the aspects of supervision team of medical devices, construction of credit system and implementation of regulation of quality management of medical devices, and raises supervision difficulties and puts forwards corresponding proposals.
China ; Equipment and Supplies ; standards ; Quality Control