Objective To observe the cage subsidence after oblique lateral interbody fusion(OLIF)for lumbar spondylo-sis,summarize the characteristics of the cage subsidence,analyze causes,and propose preventive measures.Methods The data of 144 patients of lumbar spine lesions admitted to our hospital from October 2015 to December 2018 were retrospectively ana-lyzed.There were 43 males and 101 females,and the age ranged from 20 to 81 years old,with an average of(60.90±10.06)years old.Disease types:17 patients of lumbar intervertebral disc degenerative disease,12 patients of giant lumbar disc hernia-tion,5 patients of discogenic low back pain,33 patients of lumbar spinal stenosis,26 patients of lumbar degenerative spondy-lolisthesis,28 patients of lumbar spondylolisthesis with spondylolisthesis,11 patients of adjacent vertebral disease after lumbar internal fixation,7 patients of primary spondylitis in the inflammatory outcome stage,and 5 patients of lumbar degenerative scoliosis.Preoperative dual-energy X-ray bone mineral density examination showed 57 patients of osteopenia or osteoporosis,and 87 patients of normal bone density.The number of fusion segments:124 patients of single-segment,11 patients of two-seg-ment,8 patients of three-segment,four-segment 1 patient.There were 40 patients treated by stand-alone OLIF,and 104 patients by OLIF combined with posterior pedicle screw.Observed the occurrence of fusion cage settlement after operation,conducted monofactor analysis on possible risk factors,and observed the influence of fusion cage settlement on clinical results.Results All operations were successfully completed,the median operation time was 99 min,and the median intraoperative blood loss was 106 ml.Intraoperative endplate injury occurred in 30 patients and vertebral fracture occurred in 5 patients.The mean follow-up was(14.57±7.14)months from 6 to 30 months.During the follow-up,except for the patients of primary lumbar interstitial in-flammation and some patients of lumbar spondylolisthesis with spondylolisthesis,the others all had different degrees of cage subsidence.Cage subsidence classification:119 patients were normal subsidence,and 25 patients were abnormal subsidence(23 patients were grade Ⅰ,and 2 patients were grade Ⅱ).There was no loosening or rupture of the pedicle screw system.The height of the intervertebral space recovered from the preoperative average(9.48±1.84)mm to the postoperative average(12.65±2.03)mm,and the average(10.51±1.81)mm at the last follow-up.There were statistical differences between postop-erative and preoperative,and between the last follow-up and postoperative.The interbody fusion rate was 94.4％.The low back pain VAS decreased from the preoperative average(6.55±2.2 9)to the last follow-up(1.40±0.82),and there was statistically significant different.The leg pain VAS decreased from the preoperative average(4.72±1.49)to the final follow-up(0.60± 0.03),and the difference was statistically significant(t=9.13,P＜0.000 1).The ODI index recovered from the preoperative av-erage(38.50±6.98)％to the latest follow-up(11.30±3.27)％,and there was statistically significant different.The complication rate was 31.3％(45/144),and the reoperation rate was 9.72％(14/144).Among them,8 patients were reoperated due to fusion cage subsidence or displacement,accounting for 57.14％(8/14)of reoperation.The fusion cage subsidence in this group had obvious characteristics.The monofactor analysis showed that the number of abnormal subsidence patients in the osteopenia or osteoporosis group,Stand-alone OLIF group,2 or more segments fusion group,and endplate injury group was higher than that in the normal bone mass group,OLIF combined with pedicle screw fixation group,single segment fusion group,and no endplate injury group,and the comparison had statistical differences.Conclusion Cage subsidence is a common phenomenon after 0-LIF surgery.Preoperative osteopenia or osteoporosis,Stand-alone OLIF,2 or more segments of fusion and intraoperative end-plate injury may be important factors for postoperative fusion cage subsidence.Although there is no significant correlation be-tween the degree of cage subsidence and clinical symptoms,there is a risk of cage migration,and prevention needs to be strengthened to reduce serious complications caused by fusion of cage subsidence,including reoperation.

Objective To explore the current status of H.pylori infection in the natural population of Sanya City,analyze its influencing factors,and provide a reference basis for the prevention and control of H.pylori infection.Methods A total of 677 residents from four districts of Sanya City were selected by overall stratified random sampling method,and were subjected to urea 14C breath test and questionnaire survey to calculate the positive rate of H.pylori in the natural population and analyze the influencing factors of H.pylori infection.Results A total of 606 residents were included,and the number of H.pylori positive detections was 261,with a positive detection rate of 38.5％.Among them,different ethnicity,marital status,smoking,eating vegetables and fruits,and literacy level were associated with H.pylori infection(P＜0.05);gender,age,BMI,alcohol consumption,drinking water source,betel quid chewing,and the number of cohabitants were not significantly associated with H.pylori infection(P＞0.05).Family infection was an independent risk factor for H.pylori infection in the natural population of Sanya City,and Li ethnicity,frequent consumption of fruits and vegetables,and college and higher education level were independent protective factors for H.pylori infection in the natural population of Sanya City.Conclusion The rate of H.pylori infection in the natural population of Sanya City is lower than the national average.Consuming more fruits and vegetables and improving the awareness of hygiene protection are conducive to the prevention of H.pylori infection;and the promotion of the family and related members with the same examination and treatment is important to avoid aggregation of infection within the family.

Humans ; Carcinoma, Mucoepidermoid/pathology* ; Breast/pathology*

OBJECTIVE: To explore the feasibility and clinical effect of Stand-alone oblique lateral interbody fusion (OLIF) in the treatment of lumbar intervertebral disc degeneration with Modic changes and endplate sclerosis. METHODS: A retrospective analysis was performed on 16 cases with lumbar intervertebral disc degeneration with Modic changes and endplate sclerosis admitted to three medical centers from January 2015 to December 2018. There were 6 males and 10 females, the age ranged from 45 to 67 years old with an average of (55.48±8.07) years old, the medical history ranged from 36 to 240 months with an average of (82.40±47.68) months. The lesion sites included L_2,3 in 2 cases, L_3,4 in 5 cases, and L_4,5 in 9 cases. All patients presented with chronic low back pain with lower limb neurological symptoms in 3 cases. All patients were treated by Stand-alone oblique lateral lumbar interbody fusion. Clinical and radiological findings and complications were observed. RESULTS: There was no vascular injury, endplate injury and vertebral fracture during the operation. The mean incision length, operation time, and intraoperative blood loss were(4.06±0.42) cm, (45.12±5.43) min, (33.40±7.29) ml, respectively. The mean visual analogue scale (VAS) of the incision pain was (1.14±0.47) at 72 hours after operation. There was no incision skin necrosis, poor incision healing or infection in patients. Sympathetic chain injury occurred in 1 case, anterolateral pain and numbness of the left thigh in 2 cases, and weakness of the left iliopsoas muscle in 1 case, all of which were transient injuries with a complication rate of 25%(4/16). All 16 patients were followed up from 12 to 36 months with an average of (20.80±5.46) months. The intervertebral space height was significantly recovered after operation, with slight lost during the follow-up. Coronal and sagittal balance of the lumbar spine showed good improvement at the final follow-up. There was no obvious subsidence or displacement of the cage, and the interbody fusion was obtained. At the final follow-up, Japanese Orthopaedic Association(JOA) score and Oswestry disability index(ODI) were significantly improved. CONCLUSION As long as the selection of case is strict enough and the preoperative examination is sufficients, the use of Stand-alone OLIF in the treatment of lumbar intervertebral disc degeneration with Modic changes and endplate sclerosis has a good results, with obvious clinical advantages and is a better surgical choice.
Male ; Female ; Humans ; Child, Preschool ; Intervertebral Disc Degeneration/surgery* ; Retrospective Studies ; Sclerosis ; Treatment Outcome ; Lumbar Vertebrae/surgery* ; Spinal Fusion/methods*

Humans ; Consensus ; Hypersensitivity ; Desensitization, Immunologic/adverse effects* ; Immunotherapy/adverse effects* ; Injections, Subcutaneous ; Allergens

OBJECTIVE: To summarize and compare the endplate injury occurrence characteristics and clinical results of transforaminal intervertebral fusion combined with pedicle screw fixation through intermuscular approach and oblique lateral intervertebral fusion combined with pedicle screw fixation in the treatment of lumbar disease. METHODS: A retrospective analysis of 213 cases of lumbar disease admitted from January 2016 to June 2019, including 73 males and 140 females. The age ranged from 24 to 81 years old, with an average of(54.9±10.5) years old. The courses of disease ranged from 6 to 180 months, with an average of (40.30±28.71) months. There were 35 cases of degenerative lumbar intervertebral disc disease, 22 cases of giant lumbar disc herniation, 15 cases of discogenic low back pain, 9 cases of primary lumbar intervertebral inflammation at the turn of inflammation, 52 cases of lumbar spinal stenosis, 47 cases of lumbar degenerative spondylolisthesis, 33 cases of lumbar spondylolysis with or without spondylolisthesis. There were 191 cases of single-segment lesions, including 5 cases on L2, 3, 24 cases on L3, 4, 162 cases on L4, 5. And there were 22 cases of two-segment lesions, including 3 cases on L2, 3 and L3, 4, and 19 cases on L3, 4 and L4, 5. One hundred and ten cases were taken by bilateral pedicle screw fixation and interbody fusion under the posterior muscle space approach (abbreviated as posterior fusion group), and 103 cases were taken by oblique lateral interbody fusion combined with bilateral pedicle screw fixation under the posterior muscle space approach (oblique lateral fusion group). Observed the characteristics of endplate injury in the two groups, and compared the clinical and imaging results and complications of the two groups. RESULTS: There were 8 cases of endplate injury occurred in 9 segments in the posterior fusion group. According to the number of cases, the incidence rate was 7.27%(8/110), 1 case was male, 7 cases were female, with an average age of (63.22±3.51) years old. Among the 8 cases, there were 7 cases of bone loss or osteoporosis before the operation, 5 cases using banana fusion cages, 3 cases using anatomical fusion cages. Three cases occurred in the upper endplate of the vertebral body and 6 cases in the inferior endplate of the vertebral body. In the oblique lateral fusion group, there were 21 cases of endplate injury in 24 segments, and the incidence rate was 20.39%(21/103). There were 4 males and 17 females, with an average age of (62.50±5.02) years old. Among the 21 cases, 16 cases were bone loss or osteoporosis before operation. There were 5 cases used large fusion cages, 4 cases had abnormal endplate anatomy, and 3 cases had iliac crest hypertrophy. It occurred in 20 segments of the upper endplate of the vertebral body, and 4 segments of the lower endplate of the vertebral body. Two of the 21 cases of endplate injury combined with vertebral body fractures. The incidence of endplate injury of the posterior fusion group was significantly lower than that of the oblique lateral fusion group. No incision infection occurred in the two groups, the follow-up time was ranged from 12 to 48 months, and the median follow-up period was 12 months. In the follow-up, 22 cases occurred fusion cage subsidence in the posterior fusion group, 43 cases in the oblique lateral fusion group, and 1 case in each group occurred fusion cage displacement. There was no loosening, displacement or breakage of the internal fixation. The incidence of complications in the oblique lateral fusion group 33.98%(35/103) was significantly higher than that in the posterior fusion group 23.64%(26/110), P=0.039. The height of the intervertebral space in both groups recovered well after the operation, but it was lost to varying degrees during follow-up. The fusion rate of the posterior fusion group was 94.5%(104/110), and 96.1%(99/103) in the oblique lateral fusion group(P=0.083). At the latest follow-up, the clinical symptoms of the two groups of patients were significantly improved. CONCLUSION Two methods in treating single or two-segment lumbar spine lesions obtained good clinical effects. The characteristics of endplate injury in the two fusion methods are not completely the same. Although the endplate injury did not affect the final clinical results of the two fixed fusion methods, it still needs to be paid attention to and emphasize the prevention and effective treatment of endplate injury, especially for oblique lateral intervertebral fusion.
Humans ; Male ; Female ; Middle Aged ; Aged ; Young Adult ; Adult ; Aged, 80 and over ; Spondylolisthesis/surgery* ; Spinal Fusion/methods* ; Case-Control Studies ; Retrospective Studies ; Lumbar Vertebrae/surgery* ; Spinal Fractures ; Treatment Outcome ; Osteoporosis ; Inflammation

BACKGROUND: Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study. METHODS: A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger (n = 440; 18-59 years of age) and older (n = 440; ≥60 years of age) adult participants in this trial were sequentially recruited into two distinct groups: two-dose regimen group in which participants were randomized either to follow a 10 or 25 μg of V-01 or placebo given intramuscularly 21 days apart (allocation ratio, 3:3:1, n = 120, 120, 40 for each regimen, respectively), or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 μg of V-01 or placebo (allocation ratio, 3:1, n = 120, 40, respectively). The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2, and specific binding antibodies to the receptor binding domain (RBD). The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events (AEs) within 30 days after full immunization. RESULTS: V-01 provoked substantial immune responses in the two-dose group, achieving encouragingly high titers of neutralizing antibody and anti-RBD immunoglobulin, which peaked at day 35 (161.9 [95% confidence interval [CI]: 133.3-196.7] and 149.3 [95%CI: 123.9-179.9] in 10 and 25 μg V-01 group of younger adults, respectively; 111.6 [95%CI: 89.6-139.1] and 111.1 [95%CI: 89.2-138.4] in 10 and 25 μg V-01 group of older adults, respectively), and remained high at day 49 after a day-21 second dose; these levels significantly exceed those in convalescent serum from symptomatic COVID-19 patients (53.6, 95%CI: 31.3-91.7). Our preliminary data show that V-01 is safe and well tolerated, with reactogenicity predominantly being absent or mild in severity and only one vaccine-related grade 3 or worse AE being observed within 30 days. The older adult participants demonstrated a more favorable safety profile compared with those in the younger adult group: with AEs percentages of 19.2%, 25.8%, 17.5% in older adults vs. 34.2%, 23.3%, 26.7% in younger adults at the 10, 25 μg V-01 two-dose group, and 50 μg V-01 one-dose group, respectively. CONCLUSIONS: The vaccine candidate V-01 appears to be safe and immunogenic. The preliminary findings support the advancement of the two-dose, 10 μg V-01 regimen to a phase III trial for a large-scale population-based evaluation of safety and efficacy. TRIAL REGISTRATION http://www.chictr.org.cn/index.aspx (No. ChiCTR2100045107, http://www.chictr.org.cn/showproj.aspx?proj=124702).
Aged ; Antibodies, Viral ; COVID-19/therapy* ; COVID-19 Vaccines ; Double-Blind Method ; Humans ; Immunization, Passive ; Recombinant Fusion Proteins ; SARS-CoV-2

Through the investigation of a large number of both domestic and overseas literatures and related quality standards, chemical compositions, quality evaluation system and quality control methods of Succus Bambusae were systematic summarized in this study. There were abundant chemical constituents in Succus Bambusae, mainly including volatile ingredients, amino acids, flavonoids, trace elements and vitamins, with high medicinal and edible value. The quality control methods involved traditional morphological identification, spectroscopy, chromatography and other techniques. However, the current quality standards of Succus Bambusae are relatively low, lacking safety indicators, and cannot effectively ensure its quality, seriously affecting the safety and effectiveness of its clinical use. Therefore, it is particularly important to establish a set of highly sensitive and specific quality evaluation system for Succus Bambusae. In this paper, the current research status of the chemical compositions and quality standards of Succus Bambusae were reviewed, with the purpose of providing a basis for further improvement of its quality evaluation system.
Drugs, Chinese Herbal ; Flavonoids ; Quality Control

Objective To explore the method of distinguishing the degree of hypoxic-ischemic brain damage ( HIBD) in living mice in early stage, so as to lay a foundation for the follow-up study of the molecular mechanism of different degrees of HIBD. Methods The modified Rice-Vannucci method was used to duplicate the HIBD model of C57BL/6 J mice. On the 1 day and 3 days after the model, the scalp of mice were cut and the brain tissue were observed to distinguish between mild and severe lesions in living mice, and then 2,3, 5-triphenyltetrazolium chloride (TTC) staining, laser speckle cerebral blood flow imaging, HE staining, Fluoro-Jade B ( FJB ) staining and body weight difference before and after operation were used to verify the reliability of observation in living mice. Results Through the gross observation of brain tissue in living mice, HIBD could be divided into mild injury (HI-M) group and severe injury (HI-S) group. On day 1 and day 3 after HIBD, a significant decrease in cerebral blood flow, obvious gray infarction and a large number of necrotic neurons were observed in the HI-S group, and the body weight was significantly lower than that before operation. In the HI-M group, the cerebral blood flow of the injured side decreased only on the 3rd day after HIBD, and the loose arrangement of neurons in the cortex and hippocampus of the injured side was observed morphologically. The body weight was lower than that before operation. Conclusion Gross observation of brain tissue by cutting the scalp is a reliable method to distinguish mild and severe brain injury in the early stage of HIBD in living mice.