Objective To correctly apply the Capability Maturity Model Integration(CMMI) model to the development process of medical device software,thus optimizing and improving the development process and enhancing the software process capability.Methods The matching between CMMI and IEC62304 was analyzed.The compatibility on application was investigated by taking risk management(the core process) as an example.Results The interface between CMMI and IEC62304 was discovered as well as their optimized process in risk management.Conclusion The process of medical device software development not only can be improved by CMMI model,but also should be.

Upon the previous studies on the effect of spinal cord repair kinetics, we report the effect of extending the irradiation schedules to 3 treatment day per week. The animals in the experimental group received a pair of 2Gy fraction every other day separated by intervals (day/overnight) of 6h/42h and 8h/40h, respectively. There was significant shift by increasing interfraction intervals from 6/18h and 8/16h to6h/42h and 8h/40h, respectively. It is suggested that the tolerance of spinal cord is reduced while the overnight intervals are shortened from 42h and 40h to 18h and 16h, respectively and the repair of sublethal damage of spinal cord following multifraction treatment per day used in the clinic is not completed. With biexponential model, the ?/? ratio derived from these pooled data was 2.2Gy. T 1/2 values from spinal cord were obtained as 1.3h and 5.5h. It showed that the repair kinetics parameters are in well agreement with the results from the previous work. The repair processes are not influenced by interruption during radiotherapy.

The biology rationale for radiotherapy in the treatment of malignant disease is based on repair, repopulation,reoxygenation and cell cycle redistribution. Various aspects of the roles of the 4R' are discussed, including in determining the sensitivity of tumors and normal tissue tolerances. An improvement in therapeutic ratio may derive from reducing the dose per fraction and minimizing the overall treatmemt duration. Some methods have developed to predict the response of normal and tumor tissues before radiotherapy. The parameters of cell survival at 2Gy(SF2) was correlated with clinical outcome. There is reasons to suppose that the pretreatment tumor LI and Tpot mat be good predictors for tumor repopulation kinetics. This review also discussed the rationale for the use of LQ model in fractionated radiotherapy.

ObjectiveTo discuss the feasibility and effect of clinical application of the single-bag and double-chamber anus tube.MethodsPatients who needed retention enema and non-retention enema(80 cases) were divided into 2 groups with 40 cases in each group.The test group was given enema by single-bag and double-chamber anus tube.The control group was given enema by traditional rubber anus tube.The reaction and clinical effect were compared between the two groups.ResultsIn the test group,pain and malaise lessened,intestinal cleaning was good,enema liquid reservation prolonged,the satisfaction degree of patients improved,compared with that of the control group (P<0.01).ConclusionsClinical application of self-made single-bag and double-chamber anus tube can give lesser pain and better effect of patients,and it improved satisfaction degree of patients and efficiency of nursing work greatly.

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Objective To investigate the relationship between serum Angiopoietin-1 ( Ang-1 ) level and the onset, the severity and the prognosis at 90 d of acute cerebral infarction.Methods The level of serum Ang-1 was measured in 132 acute cerebral infarction patients ( case group ) and 108 healthy controls ( control group ) .The relevant clinical data was also collected.NIHSS was assessed at admission.The severity of the condition was defined according to the NIHSS score.NIHSS score <5, 5 -15 and ≥16 were defined as minor, moderate and severe condition, respectively.mRS was assessed at 90 d after admission.mRS≤2 was defined as good outcome and otherwise defined as poor outcome.Results Compared with control group, proportion of patients who had a history of smoking, hypertension, diabetes mellitus and atrial fibrillation were significant higher, serum Ang-1 concentration was significant lower ( all P<0.05 ) .Logistic analysis showed that serum Ang-1 level and a history of diabetes mellitus were associated with the occurrence of acute cerebral infarction ( all P<0.01 ) .The serum Ang-1 level in minor, moderate and severe condition patients was (1.12 ±0.35) ng/ml, (0.96 ±0.39) ng/ml and (0.76 ±0.49) ng/ml.There were significant differences among them ( P=0.003) .There was a significant relationship between the severity and the serum Ang-1 level ( r=-0.267, P=0.002 ) .Compared with good outcome patients, the poor outcome patients had significant higher NIHSS score and higher proportion of a history of hypertension, diabetes mellitus, atrial fibrillation, and lower serum Ang-1 concentration ( all P<0.05 ) .NIHSS score and serum Ang-1 concentration at admission had a significant relationship with 90 d outcome of acute cerebral infarction patients ( all P<0.01) .Conclusion Serum Ang-1 level was lower in acute cerebral infarction patients and it had significant relationship with the onset, severity and 90 d outcome of acute cerebral infaration.

Objective To introduce the development of an adjustable and bed- type table for pleural puncture and observe its clinical effect. Methods 100 patients who were to undergo pleural puncture were divided into the experimental group and the control group with 50 cases in each group.The experimen-tal group adopted the adjustable and bed-type table for pleural puncture, while the control group used the conventional method.The pulse,respiration and artery blood oxygen saturation degree were observed. The ef-feet of puncture was also compared. Results The pulse and respiration increased and the artery blood oxygen saturation degree decreased after puncture,which were significantly different between the two groups. One- time success rate of puncture,comfort degree and satisfaction degree of patients in the experimental group were better than those of the control group. Conclusions Adjustable and bed- type table for pleu-ral puncture can reduce the uncomfort of patients and increase the success rate of puncture and satisfaction degree of patients.

Background and purpose:Radical cystectomy is viewed as the standard treatment for bladder carcinoma,but organ preservation has been attempted for patients with muscle-invasive bladder carcinoma over the past decades as an alternative to radical cystectomy.The majority of studies included transurethral resection of bladder tumor(TURB),radiotherapy,and chemotherapy,as a feasible and safe organ-sparing approach with the similar outcome to radical cystectomy.The current study evaluated the outcomes and complications of the radiation therapy for the patients with bladder cancer,and prognosis factors had been analyzed.Methods:We retrospectively analyzed 21 patients with bladder cancer.The clinical stages of the patients were 15 with T_2;5 with T_3 and 2 with T_4.2 of them were lymph node-positive,16 of patients were pathologically proved as transitional cell carcinoma,4 as adenocarcinoma and 1 as transitional cell carcinoma plus squamous cell carcinoma.Conventional fractionation radiotherapy was given at a median dose of 54.5Gy(ranged 49.2-69.9 Gy) after surgery.Kaplan-Meier method and Logrank method were used for the statistical analysis.Results:Median follow-up was 32 months.The overall survivals at 1 year,3 years and 5 years were 90.5%,47.1%,and 36.7% respectively.The local disease free rates were 95.0%,62.4%,and 47.5% respectively.15 of 16 patients' deaths were related to the tumor.In univariate analysis,only small field irradiation was found as a prognosis factor in survival(?~(2)=5.36,P=0.02).Conclusions:Combined treatment appears to provide high response rates and can be offered as an alternative option to radical cystectomy for selected patients who refuse or are unsuitable for surgery.A large number of patients,multicenter,prospective randomized trial would be desirable to evaluate the role of radiotherapy in the multi-modality treatment of bladder cancer.

Objective To analyze the clinical characteristics, treatment and prognosis of primary parotid non-Hodgkin's lymphoma. Methods From March 1988 to February 2001, twenty-nine patients with primary parotid non-Hodgkin' s lymphoma treated in our hospital were retrospectively analyzed. The data were analyzed according to the following factors: sex, age, stage, pathologic classification, chemotherapy given or not, cycles of chemotherapy, radiotherapy given or not, and the dose at the parotid. Kaplan-Meier method and Log-rank method were used in the statistic analysis. Results The overall 5-year and 10-year survival rates were 73. 3% and 51.0% . Stage and pathologic classification were prognostic factors in our statistic analysis. The 5-year survival rates were 81.6% and 25.0% for early stage ( I E + IIE) and advanced stage ( III E + IVE) patients, with the difference significant ( P

Objective To analyze the clinical feature, diagnosis, treatment a nd prognostic factors of primary lymphoma of the small bowel. Methods From Apr il 1989 to May 2002, 33 patients with non-Hodgkin's lymphoma of the small bowel were analyzed retrospectively. The Ann Arbor stages were: ⅠE 12, ⅡE 15 and Ⅳ E 6. The histological subtypes were: T-cell lymphoma 1 and B-cell lymphomas 32. A ll the patients received surgical treatment including radical or palliative rese ction. Twenty-six patients received postoperative radiotherapy including strip -f ield technique in 12 and opposed anterior-posterior fields in 14, with a median dose of 2543.5?cGy. Postoperative chemotherapy were applied to all patients inclu ding CHOP regimen in 17, COMP regimen in 6, COP regimen in 3, MINE regimen in 2, COPP regimen in 3 and BACOP regimen in 2. The median number of cycle was 4. Results The overall 5-year survival rate and disease-free survival rate were 48% and 39%. The 5-year survival rates were: ⅠE stage 42%, ⅡE stage 67% and ⅣE s tage 17%, respectively. Conclusions Most of the primary non-Hodgkin's lymphoma of the small intestine are in stage ⅠE and ⅡE, and the intermediate-grade and h igh-grade pathological subtypes are predominant. Surgery based combined treatme n t is effective and is advised. Radiotherapy and chemotherapy may improve the sur vival.