Objective:To discuss the regulation requirements of software based on the analysis of software-related recalls of medical devices. Methods:The data of software-related recalls of medical devices in America were collected and processed, and the type, situation, cause and trend of software-related recalls were analyzed, then the suggestions on the regulation requirements of software were proposed. Results:During the four periods from 1983 to 2011, the percentage of software-related recalls vs medical device recalls in America increased from 6%to 19%, and the year-on-year growth rate of software-related recalls rose by 47%to 164%, significantly higher than medical device recalls in the same period (from 13%to 54%). Especially, the problem of software-related recalls in radiology medical devices was the most serious. Conclusion: The regulatory situation of software is more complicated and severe, so the regulation requirements of software, including software validation, adverse event monitoring and usability design, need to be further strengthened according to the particularity of software.

OBJECTIVE:To improve the determination method for the contents of main components and related substances in Loxoprofen sodium tablets. METHODS:RP-HPLC method was adopted. The determination was performed on Inspire C18 column with mobile phase consisted of acetonitile-0.01 mol/L potassium dihydrogen phosphate(containing 0.2% triethylamine,phosphoric acid adjusted to 3.0±0.1,62 : 38,V/V)at the flow rate of 1.0 mL/min. The column temperature was 40 ℃,and the detection wave-length was set at 221 nm. The sample size was 20 μL. RESULTS:The peak of loxoprofen sodium was well separated with the peak of its related substances(R>1.5). The linear range of loxoprofen sodium ranged 30.0-90.0 μg/mL(r=0.9998). The detection lim-it of loxoprofen was 0.3 μ g/mL. RSDs of precision,stability and repeatability tests were <1.0% . The average recovery rates ranged 99.00%-99.87%(RSD=0.33%,n=9). CONCLUSIONS:This method is accurate,simple,rapid and suitable for the quali-ty control of Loxoprofen sodium tablets.

Objective To evaluate the damage to the brochial plexus produced by pulsed radiofrequency (PRF)and radiofrequency thermocoagulation(RFTC).Methods Fifty-five male Wistar rats weighing 250-300 g were randomly divided into 3 groups:groupⅠPRF(n=25):groupⅡRFTC(n=25)and groupⅢnormal control(n=5).The animals were anesthetized with intraperitoneal chloral hydrate.The left brochial plexus was exposed and PRF or RFTC was applied to the left brochial plexus.The voltage and current of the minimal stimulation which elecited muscle twitching and the impedance before and after operation were recorded in group PRF and RFTC.The nerve function was scored according to Tarloo(0=flaccid paresis,5=normal gait)before and at 3d after operation.The animals were killed and the left brachial plexus was removed immediately and at 1, 7,14,30 d after operation(n=5 at each time point)for determination of histopathological changes using microscope.Results The impedance and Tarlov score were significantly decreased after operation as compared to the baseline values before operation in group RFTC and were also significantly lower than in group PRF. Microscopic examination showed that the myelinated nerve fibers exhibited Wallerian degeneration and axon regeneration and the cytochondria in cylindraxile were severely injured or disappeared in group RFTC.The myelinated nerve fibers and the cytochondria in cylindraxile were significantly less injured after operation in group PRF than in group RFTC and returned to normal at 7 d and 30 d respectively.Conclusion The injury to brachial plexus produced by PRF is slighter than that produced by RFTC.

Objective To analyze and compare the therapeutic drug monitoring (TDM) and regularity of tacrolimus in deceased donor liver transplantation (DDLT) and living-donor partial liver transplantation (LDLT) the therapeutic drug monitoring (TDM) and regularity of tacrolimus.Method The clinical data of 68 patients undergoing liver transplantation from January 2010 to October 2011 were analyzed retrospectively.Thirty cases underwent LDLT as group A,and the remaining 37 underwent DDLT as group B.Result The time to reach therapeutic window was shorter in group A(3.9 ± 0.7 days) than in group B (6.5 ± 1.0 days,P＜0.01).The tacrolimus dosage in group A was significantly less than that in group B during the first 28 days post-transplantation.However,the tacrolimus dosage approached gradually and tended to be consistent after 28 days.On the postoperative day 7,14,21 and 28,the Tacrolimus dosage in group A was 72.37％,79.31％,90.11％ and 95.45％ of that in group B respectively.Concentration-dose ratio in group B was in a steady state (80-90 g/L).Concentration-dose ratio in group A was decreased with time,culminating at 28th day and close to that in group B.Correlation analysis revealed that graft recipient weight ratio(GRWR) had a significantly positive correlation with the tacrolimus dosage on the first 7 days (r =0.557) and a significantly negative correlation with the tacrolimus concentration/dose ratio (r =-0.578).Conclusion The early tacrolimus dosages in patients subject to LDLT were correlated significantly with the GRWR.The early tacrolimus dosages in patients undergoing LDLT were about 70％ of those in patients undergoing LDLT.However,with the regeneration of the liver,they tended to be consistent after 28 days.

OBJECTIVE: To observe the clinical efficacy of joint application of electroacupuncture (EA), acupointinjection and fire-needle in the treatment of menopausal syndrome (MS) women. METHODS: One hundred MS patients were randomized into control group and combined treatment group (n=50 patients in each). The combined treatment group was treated by joint application of EA, acupoint-injection and fire-needle stimulation, and the control group treated by EA stimulation alone. EA was applied to Shenshu (BL 23), Xinshu (BL15), Taixi (KI 3), Sanyinjiao (SP 6), Laogong (PC 8), Pishu (BL 20), etc., for 30 min, once daily for 10 days. Point-injection of red ginseng-ophiopogon root injection (0.5 mL) or red-hot needle stimulation was applied to bilateral BL15, BL 20, SP 6 and BL 23 once daily for 10 days and once every other day for 5 times, respectively. The modified Kupperman index scale was used to evaluate symptoms (hot flashes and night sweats: 4 points; paresthesia, insomnia, dyspareunia, irritability and problems of urinary system: 2 point each; depression, dizziness, fatigue, joint pain or muscular pain, headache, palpitation, skin formication: 1 point each) of the perimenopausal syndrome, and 3 months' follow-up survey was conducted after the treatment. Each symptom score was calculated as the product of the symptom severity score (0, no; 1, mild; 2, moderate; 3, severe) multiplied by the points of symptom index. The total Kupperman score was the sum of the scores of all the items. The therapeutic effect was also evaluated according to the "Guiding Principles for Clinical Trials of New Drugs of Chinese Materia Medica" (2002). RESULTS: The Kupperman scores were significantly decreased following the 10 days' treatment and 3 months thereafter in both control and combined treatment groups in comparison with their individual pretreatment (P<0.05), and were obviously lower in the combined treatment group than in the control group after treatment (P<0.05). Of the both 50 patients in the control and combined treatment groups, 22(44%) and 35 (70%) experienced a remarkably improvement, 18(36%) and 12(24%) were effective, and 10(20%) and 3 (6%) ineffective, with the total effective rates being 80% and 94%, respectively. The therapeutic effect of the combined treatment group was notably superior to that of the control group (P<0.05). CONCLUSION: The joint application of electroacupuncture (EA), acupoint-injection and fire needle is significantly superior to that of simple EA in improving the symptoms of patients with menopausal syndrome.

Objective To evaluate the diagnostic value of magnetic resonance tomographic angiography(MRTA) with 3.0T scanner for neurovascular compression in patients with trigeminal neuralgia and hemifacial spasm.Methods MRTA using three-dimensional time-of-flight(TOF) sequence was performed in 52 cases with trigeminal neuralgia and 9 cases with hemifacial spasm.MR oblique sagittal and coronal images were created to display the relationship between trigeminal and facial nerves and surrounding vessels,and compared with that of operation MRA showed that.Results In 52 cases with trigeminal neuralgia,the trigeminal nerves were compressed by vessels or contacted with vessels in 46 cases at MRTA,and in 9 cases with hemifacial spasm,all trigeminal nerves showed having vascular compression or in contact with vessels.The accuracy,sensitivity and specificity of MRA in diagnosing trigeminal neuralgia and hemifacial spasm caused by vascular compression were 90.2%,96.4% and 80%,respectively,which compared with that of operation.Conclusion MRTA is sensitive to neurovascular compression,which plays an important role in diagnosing trigeminal neuralgia and hemifacial spasm.

Pregnancy ; Humans ; Female ; Cesarean Section/adverse effects* ; Abdominal Cavity ; Neoplasms

Humans ; Sinus of Valsalva ; Death, Sudden, Cardiac/etiology* ; Coronary Stenosis/complications*

BACKGROUND: The introduction of cyclosporin A (CsA) has greatly enhanced the early survival rate of kidney graft, but the long-term graft survival rate is still limited. Whether tacrolimus prevents chronic allograft nephropathy (CAN) and prolongs survival time is now becoming a hot spot in field of renal transplantation.OBJECTIVE: To investigate the feasibility and safety of converting CsA to tacrolimus (FK506) in preventing progression of CAN. DESIGN: Observation and controlled trial.SETTING: Department of Urological Organ Transplantation, Center of Organ Transplantation, the Second Xiangya Hospital, Central South University.PARTICIPANTS: A total of 73 patients who had received kidney transplantation at the Department of Urological Organ Transplantation, Center of Organ Transplantation, the Second Xiangya Hospital of Central South University from April 2001 to October 2005, and had been diagnosed as CAN by graft biopsy (42 male patients and 31 female patients; age ranged 19-69 years), were enrolled in the study approved by the ethics committee of this hospital after their written informed consents. CsA soft capsules (Hangzhou Zhongmei Huadong Pharmaceutical Limited Company or Huabei Pharmaceutical Limited Company); mycophenolate mofetil capsules (Shanghai Roche Pharmaceutical Limited Company); prednisone acetate tablets (Second Xiangya Hospital of Central South University); tacrolimus capsules (Fujisawa Pharmaceutical Limited Company).METHODS: Seventy-three patients voluntarily participated in CsA group (n =30) or FK506 group (n =43). The two groups were homogenous regarding patients' sex, age and general data (P > 0.05). Patients in the CsA group were continued on their initial immunosuppression protocol, which consisted of CsA, mycophenolate mofetil and prednisone acetate. In the FK506 group, CsA was stopped, and FK506 was started at a dose of 0.08-0.1 mg/(kg·d) 24 hours later, twice daily, administered 2 hours after breakfast and supper. Three days later, the blood trough concentration of FK506 was tested and adjusted to a target range of 5-8μg/L. FK506 dosage adjustment was based on the blood trough concentration, serum creatinine (SCr) and its side effects. All 73 patients were treated for 12 months. MAIN OUTCOME MEASURES: SCr, glomerular filtration rate (GFR), 24-hour urine protein excretion, serum total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL) and the toxic side effects of calcineurin inhibitors (incidences of tremor, hyperglycemia and hypertension) were monitored during a follow-up of over 12 months. RESULTS: A total of 73 patients were involved in the result analysis.①12 months after conversion, the level of SCr was statistically reduced and GFR levels were markedly elevated in the FK506 group compared with the CsA group (P < 0.01). TC, TG and LDL levels in the FK506 group were significantly lower than those in the CsA group (P < 0.01).②Compared with the CsA group, the incidence of tremor was obviously increased [30% (9/30), 5% (2/43), P < 0.01] and the incidence of hypertension was obviously decreased [56% (24/43), 83% (25/30), P < 0.05] in the FK506 group.CONCLUSION: Conversion from CsA to FK506 can postpone renal dysfunction, reduce proteinuria and improve hyperlipidemia. FK506 treatment is an effective therapy in slowing the progression of CAN.

AIM: To investigate the mechanism of proliferation effect induced by (R,R)-XY-10 and (S,S)-XY-10 on retinal pigmented epithelial cells(ARPE-19).METHODS: Human retinal pigmented epithelial cells(ARPE-19) and human umbilical vein endothelial cells (HUVECs) were used to investigate the effect of (R,R)-XY-10 and (S,S)-XY-10 on cell growth,and their mechanisms of proliferative action by using ERK、 AKT、PI3K、Protein kinase C (PKC)and Nitric oxide synthase (NOS) inhibitors.RESULTS: (R,R)-XY-10 and (S,S)-XY-10 dose-dependently increased ARPE-19 cell proliferation,but not on HUVECs. When treated with proliferative inhibitors,H7(5μmol/L)、hypericin(20μmol/L)、PD98059(2μmol/L)、LY294002(50μmol/L)、SH-5 (10μmol/L) and L-NAME (100μmol/L),the proliferative effect was reduced by H7、hypericin、PD98059 and LY294002,but not by SH-5 and L-NAME.CONCLUSION: (R,R)-XY-10 and (S,S)-XY-10 can induce cell proliferation through MAPK and PI3K dependent pathway. KEYWORDS: age-related macular degeneration; (R,R)-XY-10; (S,S)-XY-10; ARPE-19 cells; human umbilical vein endothelial cells; proliferation