ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
ObjectiveTo summarize the treatment measures and experience for one patient with acute pulmonary thromboembolism after modified radical mastectomy for breast cancer. MethodsThe discussion on MDT (multi-disciplinary team) of a breast cancer patient admitted to The First Hospital of Lanzhou University in March 2018 and the results of the discussion on acute pulmonary thromboembolism after operation were summarized. ResultsThis patient had many high risk factors for deep venous thrombosis of the lower extremities, such as obesity, advanced age, hypertension, malignant tumor, and surgical stress. The operative time was about 90 min and the blood loss was 30 mL, without nerve and vascular injuries. Acute pulmonary thromboembolism occurred suddenly on 10 days after operation, which led to heart failure. Eventually, the patient died of the peripheral circulatory insufficiency caused by respiratory failure and heart failure. ConclusionSurgeons should pay great attention to the perioperative management of the patients with many high-risk factors, who may occur acute pulmonary thromboembolism caused by deep venous thrombosis of lower limbs after radical mastectomy.
Objective To compare the effectiveness of modified distal tibial tubercle-high tibial osteotomy (DTT-HTO) and open-wedge HTO (OWHTO) in the treatment of medial compartment osteoarthritis. Methods A clinical data of 80 patients with medial compartment osteoarthritis treated with HTO between January 2016 and January 2019 was retrospectively analyzed, including 40 patients treated with DTT-HTO (DTT-HTO group) and 40 patients treated with OWHTO (OWHTO group). There was no significant difference in gender, age, body mass index, affected side, disease duration, Kellgren-Lawrence grading of osteoarthritis, and preoperative knee society score (KSS), Hospital for Special Surgery (HSS) score, knee joint visual analogue scale (VAS) score, hip-knee-ankle angle (HKA), posterior tibial slope (PTS), weight-bearing line ratio (WBL), Blackburne-Peel index (BPI), Caton-Deschamps index (CDI), and Insall-Salvati index (ISI) between the two groups (P>0.05). The operation time, incision length, bleeding volume, hospital stay, and complications in both groups were recorded. The KSS, HSS, and VAS scores were used to evaluated the effectiveness. A self-made questionnaire was used to evaluate the recovery of low-impact sports ability of the knee. X-ray films were used to observe the osteotomy healing and measure the HKA, PTS, WBL, and the patellar height indexes (BPI, CDI, ISI). Results All operations successfully completed in both groups. The OWHTO group operated longer than the DTT-HTO group (P<0.05). There was no significant difference in the incision length, bleeding volume, and hospital stay between the two groups (P>0.05). All incisions healed by first intention in both groups. There were 2 cases of lateral hinge fractures in the OWHTO group, and 1 case of lateral hinge fracture and 2 cases of tibial plateau fractures in the DTT-HTO group. No other complications occurred. The patients in both groups were followed up 2-4 years with an average of 2.8 years. The HSS, KSS, and VAS scores in both groups significantly improved after operation when compared with preoperative scores (P<0.05). All scores gradually improved with the time and there were significant differences between different time points (P<0.05). The HSS, KSS, and VAS scores were significantly better in the DTT-HTO group than in the OWHTO group at 3 months after operation (P<0.05). There was no significant difference between the two groups at 6 months, 1 year, and 2 years (P>0.05). At 1 year, the low-impact sports ability of the OWHTO group was rated as excellent in 8 cases, general in 25 cases, and poor in 7 cases, and as excellent in 7 cases, general in 26 cases, and poor in 7 cases of the DTT-HTO group. There was no significant difference between the two groups (Z=−0.715, P=0.475). X-ray film reexamination showed that the osteotomies healed in both groups. The healing time was (4.52±1.23) months in the OWHTO group, and (4.23±1.56) months in the DTT-HTO group, showing no significant difference (t=0.923, P=0.359). At immediate after operation, the HKA and WBL of the two groups significantly improved when compared with the preoperative values (P<0.05). However, the pre- and post-operational difference was not significant between the two groups (P>0.05). The PTS of the OWHTO group was significantly higher than preoperative value (P<0.05), while the PTS of the DTT-HTO group was lower than preoperative value (P>0.05). The pre- and post-operational difference between the two groups was significant (P<0.05). BPI and CDI in the OWHTO group were significantly lower than preoperative values (P<0.05), but there was no significant difference in ISI when compared with preoperative value (P>0.05). There was no significant difference in the BPI, CDI, and ISI of the DTT-HTO group between pre- and post-operation (P>0.05). The pre- and post-operational differences of BPI and CDI between the two groups were significant (P<0.05), and there was no significant difference in the pre- and post-operational difference of ISI (P>0.05). ConclusionThe two osteotomies in the treatment of medial compartment osteoarthritis can significantly change the varus deformity and achieve satisfactory effectiveness. The early functional recovery of DTT-HTO is faster, which can avoid the increased PTS and patellar baja of traditional OWHTO. However, neither of the two surgical procedures can restore the patient’s ideal low-impact sports ability of the knee.
ObjectiveTo study the significance of lateral lymph nodes sweeping in lower rectal cancer. MethodsRoutine pathological methods were used to detect the regularity of lateral lymph nodes metastasis and the survival rate of the patient. All the data was analysed by χ2 test. Results①Lateral lymph nodes metastasis was observed in 12.5% rectal cancer below the peritoneum,and it was the main lymph metastatic way. ②Low differented adenocarcinoma and mucous adenocarcinoma had more lateral lymph nodes metastasis than other types. Lateral lymph nodes metastasis was also related with invaded degree of invasion. ③The survival rate of the case with lateral lymph node metastasis was 42.2%.ConclusionLateral lymph nodes should be swept in advanced rectal cancer to prevent remains of lymph nodes remained and increase the survival rate.
This paper explores the relationship between the cardiac volume and time, which is applied to control dynamic heart phantom. We selected 50 patients to collect their cardiac computed tomography angiography (CTA) images, which have 20 points in time series CTA images using retrospective electrocardiograph gating, and measure the volume of four chamber in 20-time points with cardiac function analysis software. Then we grouped patients by gender, age, weight, height, heartbeat, and utilize repeated measurement design to conduct statistical analyses. We proposed structured sparse learning to estimate the mathematic expression of cardiac volume variation. The research indicates that all patients’ groups are statistically significant in time factor (P = 0.000); there are interactive effects between time and gender groups in left ventricle (F = 8.597, P = 0.006) while no interactive effects in other chambers with the remaining groups; and the different weight groups’ volume is statistically significant in right ventricle (F = 9.004, P = 0.005) while no statistical significance in other chambers with remaining groups. The accuracy of cardiac volume and time relationship utilizing structured sparse learning is close to the least square method, but the former’s expression is more concise and more robust. The number of nonzero basic function of the structured sparse model is just 2.2 percent of that of least square model. Hence, the work provides more the accurate and concise expression of the cardiac for cardiac motion simulation.
ObjectiveTo investigate the effectiveness of anterolateral femoral flap in combination with fascia lata grafting in repair of large Achilles tendon and skin defects.MethodsThe clinical data of 18 patients with large Achilles tendon and skin defects repaired with anterolateral femoral flap in combination with fascia lata grafting between January 2018 and January 2019 were retrospectively reviewed. There were 14 males and 4 females; age ranged from 32 to 57 years (mean, 42.1 years). There were 9 cases of postoperative infection of Achilles tendon rupture, 1 case of traffic accident injury, and 8 cases of combined infection of skin and Achilles tendon defects after heel trauma. The length of Achilles tendon defect was 4-8 cm, with an average of 5.6 cm; the range of the skin defect was 14 cm×3 cm to 20 cm×5 cm. Flap survival was observed, and ankle function recovery was evaluated according to McComis functional assessment criteria, and dorsal extension and plantar flexion mobility of the affected limb were measured at last follow-up and compared with those of the healthy side.ResultsEighteen cases were followed up 8-24 months, with an average of 16.7 months. All the flaps survived after operation, the flaps were soft and elastic, and the incisions healed by first intention. At last follow-up, 15 cases were excellent, 2 cases were good, and 1 case was acceptable according to McComis functional evaluation criteria, with an excellent and good rate of 94.4%. The two-point discrimination of the heel posterior region of the affected foot was 4-7 mm, with an average of 5.32 mm. The heel-raise test was negative. The dorsiflexion range of the affected side was (21.55±1.26)°, which was significantly different from that of the healthy side (25.23±1.45)° (t=8.128, P=0.000); the plantar flexion of the affected side was (44.17±1.52)°, which was not significantly different from that of the healthy side (46.13±1.31)° (t=0.444, P=0.660).ConclusionThe application of anterolateral femoral flap in combination with fascia lata grafting for the repair of large Achilles tendon and skin defects can achieve good effectiveness.
The use of repeated measurement data from patients to improve the classification ability of prediction models is a key methodological issue in the current development of clinical prediction models. This study aims to investigate the statistical modeling approach of the two-stage model in developing prediction models for non-time-varying outcomes using repeated measurement data. Using the prediction of the risk of severe postpartum hemorrhage as a case study, this study presents the implementation process of the two-stage model from various perspectives, including data structure, basic principles, software utilization, and model evaluation, to provide methodological support for clinical investigators.