Objective To evaluate the efficacy and safety of labor induction by the double balloon device in women with preeclampsia and eclampsia.Methods Labor induction was carried out in 37 women with preeclampsia and eclampsia from July 2011 to November 2012.All the labor inductions were performed using the double balloon device.Results The cervical Bishop scores of 37 cases of patients with preeclampsia and eclampsia were significantly lower before using double balloon device [(3.38 ± 0.50) scores] compared with after using double balloon device [(6.44 ± 0.63) scores] with a statistically significant difference (t =23.54,P ＜0.01).Blood pressure had no obvious change before and after using double balloon device [SBP(158.38 ± 13.89)mmHg vs (162.48 ± 12.56)mmHg,P ＞ 0.05,and SDP(112.71± 15.53) mmHg vs (108.19 ± 8.37) mmHg,P ＞ 0.05].The rate of vaginal delivery was 89.2％ (33/37),and the total hours of labor were (5.8 ± 0.63) h.Compared with selective cesarean section,vaginal delivery after double balloon to promote cervical mature had less blood loss (t =9.19,P ＜0.01),quicker postpartum recovery,shorter hospitalization time (t =11.18,P ＜ 0.01),lower birth body mass (t =2.96,P ＜0.01) and higher scores of 1 minutes Apgar score (t =2.34,P ＜0.05).Conclusions The double balloon device appeared to be a safe and effective method to induce labor in women with preeclampsia and eclampsia.Wide scale studies and further use of the device for labor induction in women with preeclampsia and eclampsia were warranted.

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
Device Approval ; China ; Equipment and Supplies

Objective To investigate the risk factors affecting the malignancy of amorphous calcifications in the breast and to establish a predictive nomogram.Methods Patients with amorphous calcifications detected by mammography were retrospectively collected,clinical data were obtained from electronic medical record(EMR),and the mammographic features of the patients were assessed by diagnostic physicians.The risk factors affecting the malignancy of amorphous calcifications were analyzed to develop a predictive model and to assess the performance of the model.Results A total of 153 amorphous calcifications in 144 patients were included in the study,and the overall malignancy rate of calcifications was 20.92％.Patient's age ≥45 years,linear distribution of calcifications,unilateral single or unilateral multiple calcifications,and a larger maximum ratio of calcification extent all predicted a higher probability of malignancy,establishing a nomogram based on these 4 risk factors,with a 3.65％predicted probability of malig-nancy as the cut-off,33.99％(52/153)of patients were allowed to be spared biopsy.Conclusion Patient's age and the distribution,number,and maximum ratio of calcifications may be the risk predictors of malignancy for amorphous calcifications,with nomogram con-struction for distinguishing benignity from malignancy of amorphous calcifications via combining with mammographic features and clinical data.

Macrophages play an important role in the development of inflammation,the core mechanism of athero-sclerosis.In recent years,nanotechnology has provided a new perspective for the diagnosis and treatment of atherosclerosis with its unique characteristics of biological compatibility and precise targeting.In this paper,the patholog-ical mechanism of atherosclerosis,the realization of atherosclerosis imaging by targeting macrophages with nanomaterials and the application of macrophage cell membrane biomimetic nanoparticles in anti-atherosclerosis were reviewed.