ObjectiveTo observe the safety and efficacy of Keluoxin capsules in the treatment of moderate to severe non-proliferative diabetic retinopathy (NPDR). MethodsAn open-label, multi-center, single-arm, phase Ⅱa clinical trial. From May 2014 to December 2016, the patients diagnosed with moderate to severe NPDR who received Keroxin treatment in General Hospital of Central Theater Command, Affiliated Eye Hospital to Nanchang University, Xiyuan Hospital of China Academy of Chinese Medical Sciences, and Eye Hospital China Academy of Chinese Medical Sciences were divided into moderate NPDR group and severe NPDR group. The baseline data of the patients were obtained, best-corrected visual acuity (BCVA), optical coherence tomography, fundus fluorescein angiography and fundus photography were performed. On the basis of maintaining the original diabetes treatment, all patients took Keluoxin capsules orally for 24 weeks; 24 weeks after treatment was used as the time point for evaluating the efficacy. BCVA letters, central macular thickness (CMT) and 6 mm diameter total macular volume (TMV), retinal vascular leakage area, and retinal non-perfusion (RNP) area within an average diameter of 6 mm were compared between the two groups at baseline and 24 weeks after treatment. Independent sample Mann-Whitney U test was used to compare continuous variables between groups. Categorical data were compared by χ2 test. ResultsA total of 60 NPDR patients and 60 eyes were included, 9 cases were lost to follow-up, and 51 cases and 51 eyes were finally included, including 37 eyes in the moderate NPDR group and 14 eyes in the severe NPDR group, respectively. At baseline, BCVA in moderate NPDR group and severe NPDR group were (80.1±6.8), (81.4±6.3) letters, respectively. CMT were (249.5±32.1), (258.9±22.2) μm, respectively. TMV were (8.79±1.09), (8.95±1.31) mm3, respectively. Retinal vascular leakage areas were (7.69±10.63), (10.45±7.65) mm2, respectively. RNP area were (2.48±5.74), (10.63±20.06) mm2, respectively. There were 11 (29.7%, 11/37) and 4 (28.6%, 4/14) eyes with diabetic macular edema (DME), respectively; 24 weeks after treatment, BCVA in moderate NPDR group and severe NPDR group increased by (1.3±5.2), (3.2±3.0) letters, respectively. Compared with baseline, there was a statistically significant difference in the severe NPDR group (t=－3.986, P=0.033). CMT were (252.1±45.6), (269.8±57.2) μm, respectively. There were no significant differences compared with baseline (t=－0.567, －0.925; P＞0.05). TMV were (9.96±1.16), (10.09±1.32) mm3, respectively. There were no significant differences compared with baseline (t=－0.996, －1.304; P＞0.05). Retinal vascular leakage area decreased (0.19±6.90), (1.98±7.52) mm2, respectively. There were no significant differences compared with baseline (t=0.168, 0.983; P＞0.05). RNP area were (3.01±6.47), (10.36±19.57) mm2, respectively. Compared with baseline, the differences were statistically significant (t=－1.267, 0.553; P＞0.05). There were 8 (21.6%, 8/37) and 3 (21.4%, 3/14) eyes with DME, respectively. Compared with baseline, the difference was statistically significant (χ2=11.919, 4.571; P=0.001, 0.033). ConclusionKeluoxin capsules can stabilize or improve BCVA, CMT, TMV and RNP area in patients with moderate and severe NPDR, and reduce the area of retinal vascular leakage.
ObjectiveTo discuss the safety and effectiveness of the improved technique by comparing the effects of low temperature bone cement infusion before and after the improvement in the percutaneous vertebroplasty (PVP).MethodsThe clinical data of 170 patients (184 vertebrae) with osteoporotic vertebral compression fracture who met the selection criteria between January 2016 and January 2018 were retrospectively analyzed. All patients were treated with PVP by low-temperature bone cement perfusion technology. According to the technical improvement or not, the patients were divided into two groups: the group before the technical improvement (group A, 95 cases) and the group after the technical improvement (group B, 75 cases). In group A, the patients were treated by keeping the temperature of bone cement at 0℃ and parallel puncture; in group B, the patients were treated by increasing the temperature of bone cement or reducing the time of bone cement in ice salt water and cross puncture. There was no significant difference in gender, age, disease duration, T value of bone mineral density, operative segment, and preoperative vertebral compression rate, visual analogue scale (VAS) score between the two groups (P>0.05). CT examination was performed immediately after operation, and the leakage rate of bone cement was calculated. The amount of bone cement perfusion and the proportion of bone cement in contact with the upper and lower endplates at the same time were compared between the two groups. The vertebral compression rate was calculated and the VAS score was used to evaluate the pain before operation, at immediate after operation, and last follow-up.ResultsThere was no complication such as incision infection, spinal nerve injury, or pulmonary embolism in both groups. There was no significant difference in the amount of bone cement perfusion between groups A and B (t=0.175, P=0.861). There were 38 vertebral bodies (36.89%) in group A and 49 vertebral bodies (60.49%) in group B exposed to bone cement contacting with the upper and lower endplates at the same time, showing significant difference (χ2=10.132, P=0.001). Bone cement leakage occurred in 19 vertebral bodies (18.45%) in group A and 6 vertebral bodies (7.41%) in group B, also showing significant difference (χ2=4.706, P=0.030). The patients in group A and group B were followed up (13.3±1.2) months and (11.5±1.1) months, respectively. The vertebral compression rates of the two groups at immediate after operation were significantly lower than those before operation (P<0.05), but the vertebral compression rate of group A at last follow-up was significantly higher than that at immediate after operation (P<0.05), and there was no significant difference in group B between at immediate after operation and at last follow-up (P>0.05). The VAS scores of the two groups at immediate after operation were significantly lower than those before operation (P<0.05); but the VAS scores of group A at last follow-up were significantly higher than those at immediate after operation (P<0.05) and there was no siginificant difference in group B (P>0.05). There was no significant difference in VAS scores between the two groups at immediate after operation (t=0.380, P=0.705); but at last follow-up, VAS score in group B was significantly lower than that in group A (t=3.627, P=0.000).ConclusionThe improved advanced low-temperature bone cement perfusion technology during PVP by increasing the viscosity of bone cement combined with cross-puncture technology, can reduce bone cement leakage, improve the distribution of bone cement in the vertebral body, and reduce the risk of vertebral collapse, and achieve better effectiveness.
ObjectiveTo investigate the effect of pulsed colloid infusion combined with continuous blood purification (CBP) for treatment of severe capillary leak syndrome (CLS). MethodsAccording to random principle,61 patients were divided into a control group(n=21),a CBP1 group(n=18) and a CBP2 group(n=22). All patients of three groups received routine treatment according to international guidelines 2008 for management of severe sepsis. The patients in the control group also received pulsed infusion colloid combined lasix. The patients in the CBP1 and CBP2 groups also received continuous veno-venous hemofiltration(CVVH) for 72 hours. The patients in the CBP1 group received concentrated colloid infusion combined lasix,and the patients in the CBP2 group received concentrated colloid infusion combined removing fluid. Blood gas analysis and Impedance Cardiography was performed before and 24,48 and 72 hours after therapy. The angiopoietin-2(Ang-2) was measured. Also the length of ICU stay,duration of mechanical ventilation,and death rate of patients in 28 days were observed. ResultsCompared with the control group and the CBP1 group,the length of ICU stay(days) and duration of mechanical ventilation (days) in the CBP2 group were significantly shorter(P<0.05),and the death rate in 28 days was lower(P<0.05). The patients in the CBP2 group showed more reduction in the APACHEⅡ score compared with the CBP1 group after therapy(P<0.05). The oxygenation index in the CBP2 group respectively increased at 24,48 and 72 hours after therapy(P<0.05). Compared with the control group and the CBP1 group,the oxygenation index in the CBP2 group respectively increased at the same time(P<0.05). The thoracic fluid content (TFC) in the CBP2 group respectively decreased at 24,48 and 72 hours(P<0.05) after therapy,and decreased compared with the control group and the CBP1 group at the same time(P<0.05). The serum levels of Ang-2 in the CBP2 group respectively decreased at 24,48 and 72 hours after therapy(P<0.05),and decreased compared with the control group and the CBP1 group at the same time(P<0.05). ConclusionPulsed colloid infusion combined with continuous blood purification can reduce the severity of capillary leak and improves the outcome of patients with severe sepsis.
ObjectiveTo explore the mechanism of liver capillary permeability in rats with severe acute pancreatitis (SAP). MethodsTotally 40 healthy Sprague-Dawley (SD) rats were randomly divided into two groups: sham operation (SO) group and SAP group, SAP group were divided into four subgroups according to sampling time (3 h， 6 h, 12 h， and 24 h). The model was established by injecting 5% sodium taurocholate retrogradely into pancreaticobiliary ducts. The changes of tumor necrosis factor-α (TNF-α), pathohistology, and tissue moisture content were compared among different groups. Liver occludin protein expression was analyzed by immunohistochemistry method, and occludin mRNA was measured by RT-PCR. ResultsThere was no significant pathological changes of liver tissue in the SO group. Typical pathological changes of SAP， such as interstitial edema, vasodilatation, infiltration of inflammatory cells, were found in the SAP group. TNF-α level and tissue moisture content of each phase increased gradually, and the highest level appeared at 24 h within the observing period. The two above indicators at different time point in subgroups were significantly different from each other and higher than those in the SO group (Plt;0.05)． In the SAP group, the expression of occludin and it’s mRNA began to decrease at 3 h to the bottom at 6 h and rebounced significantly at 12 h, 24 h compared with those at 6 h (Plt;0.05), but still lower than those in the SO group (Plt;0.05). ConclusionUpregulation in TNF-α and subsequent downregulation in occludin protein and mRNA maybe bly related to the severe liver capillary permeability in rats with SAP.
ObjectiveTo evaluate the effectiveness of orthopedic robot with modified tracer fixation (short for modified orthopedic robot) assisted percutaneous kyphoplasty (PKP) in treatment of single-segment osteoporotic vertebral compression fracture (OVCF). Methods The clinical data of 155 patients with single-segment OVCF who were admitted between December 2017 and January 2021 and met the selection criteria was retrospectively analyzed. According to the operation methods, the patients were divided into robot group (87 cases, PKP assisted by modified orthopedic robot) and C-arm group (68 cases, PKP assisted by C-arm X-ray fluoroscopy). There was no significant difference in gender, age, body mass index, T value of bone mineral density, therapeutic segment, grade of vertebral compression fracture, and preoperative visual analogue scale (VAS) score, midline vertebral height, and Cobb angle between the two groups (P>0.05). The effectiveness evaluation indexes of the two groups were collected and compared. The clinical evaluation indexes included the establishment time of working channel, dose of intraoperative fluoroscopy, the amount of injected cement, VAS score before and after operation, and the occurrence of complications. The imaging evaluation indexes included the degree of puncture deviation, the degree of bone cement diffusion, the leakage of bone cement, the midline vertebral height and the Cobb angle before and after operation. Results The establishment time of working channel in robot group was significantly shorter than that in C-arm group, and the dose of intraoperative fluoroscopy was significantly larger than that in C-arm group (P<0.001). There was no significant difference in the amount of injected cement between the two groups (t=1.149, P=0.252). The patients in two groups were followed up 10-14 months (mean, 12 months). Except that the intraoperative VAS score of the robot group was significantly better than that of the C-arm group (P<0.05), there was no significant difference between the two groups at other time points (P>0.05). No severe complication such as infection, spinal cord or nerve injury, and pulmonary embolism occurred in the two groups. Five cases (5.7%) in robot group and 7 cases (10.2%) in C-arm group had adjacent segment fracture, and the difference in incidence of adjacent segment fracture between the two groups was not significant (χ2=1.105, P=0.293). Compared with C-arm group, the deviation of puncture and the diffusion of bone cement at 1 day after operation, the midline vertebral height and Cobb angle at 1 month after operation and last follow-up were significantly better in robot group (P<0.05). Eight cases (9.1%) in the robot group and 16 cases (23.5%) in the C-arm group had cement leakage, and the incidence of cement leakage in the robot group was significantly lower than that in the C-arm group (χ2=5.993, P=0.014). There was no intraspinal leakage in the two groups. ConclusionCompared with traditional PKP assisted by C-arm X-ray fluoroscopy, modified orthopedic robot-assisted PKP in the treatment of single-segment OVCF can significantly reduce intraoperative pain, shorten the establishment time of working channel, and improve the satisfaction of patients with operation. It has great advantages in reducing the deviation of puncture and improving the diffusion of bone cement.
Objective To evaluate the feasibility and safety of percutaneous endoscopic technique in the treatment of intraspinal cement leakage after percutaneous vertebroplasty (PVP). Methods Between May 2014 and March 2016, 5 patients with lower limb pain and spinal cord injury caused by intraspinal cement leakage after PVP, were treated with percutaneous endoscopic spinal decompression. Of 5 cases, 3 were male and 2 were female, aged from 65 to 83 years (mean, 74.4 years). The course of disease was 10-30 days (mean, 16.2 days). Imageological examinations confirmed the levels of cement leakage at T 12, L 1 in 3 cases, and at L 1, 2 in 2 cases; bilateral sides were involved in 1 case and unilateral side in 4 cases. Two patients had lower limb pain, whose visual analogue scale (VAS) were 8 and 7; 3 patients had lower extremities weakness, whose Japanese Orthopedic Association (JOA) 29 scores were 18, 20, and 19. According to American Spinal Injury Association (ASIA) impairment scale, neural function was rated as grade E in 2 cases and grade D in 3 cases. Results The operation time was 55-119 minutes (mean, 85.6 minutes), and the blood loss was 30-80 mL (mean, 48 mL). CT scan and three-dimensional (3D) reconstruction at 1 day after operation showed that cement leakage was removed in all patients. Five cases were followed up 6-21 months (mean, 12 months). In 2 patients with lower limb pain, and VAS score was significantly decreased to 2 at last follow-up. In 3 patients with lower extremities weakness, the muscle strength was improved progressively, and the JOA29 scores at last follow-up were 21, 23, and 22. Conclusion Percutaneous endoscopic technique for intraspinal cement leakage after PVP is safe, effective, and feasible.
Objective To observe the baseline characteristics and visual outcomes after two years follow-up of exudative age-related macular degeneration (AMD) patients treated with ranibizumb. Methods Forty-four eyes of 44 patients with exudative AMD were enrolled into this retrospective study, 19 were men and 25 were women. The mean age was 78 years (range 64 – 92 years). All patients were underwent best corrected visual acuity (BCVA, Early Treatment of Diabetic Retinopathy Study), fundus color photography, fundus fluorescein angiography (FFA), indocyanine green angiography (ICGA) and optical coherence tomography (OCT). The mean BCVA was (50.36±14.43) letters, the mean central foveal thickness (CFT) was (291.95±82.19) μm, and the fluorescence leakage area of choroidal neovascularization (CNV) was (7.61±5.84) mm2. All patients received three initial intravitreous injection of ranibizumb (IVR) and were retreated with monthly IVR when needed. The mean follow up time was 25.6 months (range 24 – 29 months). On 1, 2, 3, 6, 12, 18 and 24 months after treatment, BCVA and OCT were repeated. On 3, 6, 12, 18 and 24 months after treatment, FFA and ICGA were repeated. The change of BCVA, CFT and fluorescence leakage area of CNV were observed. The association of baseline characteristics and two year visual outcomes were analyzed. Results On 1, 2, 3, 6, 12, 18 and 24 months after treatment, the BCVA were improved significantly (t= −1.89, −3.51, −4.61, −4.04, −5.77, −4.69;P＜0.05), the CFT were decreased significantly (t=1.51, 2.30, 3.40, 3.28, 3.54, 3.88, 3.73;P＜0.05). On 3, 6, 12, 18 and 24 months after treatment, the fluorescence leakage area of CNV were reduced significantly (t=2.12, 2.90, 3.51, 4.12, 4.06;P＜0.05). The lower baseline BCVA, the more improved after treatment. The BCVA improvement degree has a negative relationship with baseline BCVA and fluorescence leakage area of CNV (r=0.505, −0.550;P＜0.05), but no correlation with baseline CFT (r=0.210,P＞0.05). Conclusion Two year visual outcomes of exudative AMD patients treated with ranibizumb is negative correlated with baseline BCVA and fluorescence leakage area of CNV, but not correlated with baseline CFT.
Objective To observe the ultrasonographic features of idiopathic uveal effusion syndrome (IUES). MethodsA retrospective controlled study. From January 2012 to December 2023, 13 patients with IUES (26 eyes) diagnosed by ophthalmology examination in Department of Ophthalmonogy of Beijing Tongren Hospital (IUES group) and 22 healthy people with 30 eyes (control group) were included in the study. Both eyes of all participants were examined by color Doppler ultrasound (CDU) and ultrasonic biomicroscopy (UBM). The thickness of the ocular wall at 300 μm on the temporal side of the optic disc was measured by CDU. UBM was used to measure the thickness of the nasal and temporal scleral processes. Corneal thickness (CT), anterior chamber depth (AD), lens thickness (LT) and axial length (AL) were measured by A-mode ultrasound. There were no significant differences in age (t=0.842), sex component ratio (χ2=0.540), eye difference (χ2=0.108) and AL (t=0.831) between IUES group and control group (P＞0.05). The CDU and UBM imaging features and biometrics of IUES affected eyes were observed. Independent sample t test was used for comparison between groups. ResultsCDU examination results showed that in 26 eyes of IUES group, choroidal detachment occurred in 20 eyes (76.9%, 20/26), which showed arc-shaped band echo connected with peripheral and equatorial eye wall echo, with uniform low echo area below, and blood flow signal could be seen on the band echo. The echo thickened and decreased in 4 eyes (15.3%, 4/26). Nine eyes (33.3%, 9/26) were accompanied by retinal detachment, which showed that the posterior pole vitreous echo was connected to the optic disc echo, and the blood flow signal was seen on the ribbon echo. UBM results showed ciliary detachment in 22 eyes (84.7%, 22/26), showing a spongy thickening of the ciliary body with interlamellar echo separation and an echoless area between the sclera. Ciliary body echo thickened and decreased in 2 eyes (7.7%, 2/26). Shallow space between ciliary body and sclera was observed in 2 eyes (7.7%, 2/26). Compared with the control group, CT (Z=2.054), LT (Z=1.867), scleral thickness (Z=2.536) and ocular wall thickness (Z=2.094) were thickened in IUES group, and AD (Z=1.888) were decreased, with statistical significance (P＜0.05). ConclusionsThe CDU of IUES is characterized by a thickened echo of the ocular wall and a uniform low echo area under the detached choroid. UBM is characterized by a spongy thickening of the ciliary body echo with interlaminar echo separation.
Objective To explore the correlative factors affecting the compl ications resulting from cement leakage after percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral body compression fractures (OVCF). Methods From February 2005 to October 2008, 71 patients with OVCF were treated by PKP and were retrospectively analyzed. There were 16 males and 55 females, and the average age was 71.5 years (range, 52-91 years). The average duration of disease was 5.7 months (range, 1-11 months). A total of 171 vertebra were involved in fracture including 19 cases of single vertebral fractures, 21 cases of double vertebral fractures, 20 cases of three vertebral fractures, and 11 cases of more than three vertebral fractures. All the treated vertebra were divided into acute (86 vertebra) or subacute (85 vertebra) state based on changes in MRI signal intensity. There was no radiculopathy or myelopathy. The average injected cement volumewas 4.6 mL (range, 1.5-6.5 mL). The treatment efficacy was assessed by observing the change in anterior and middle vertebral column height, Cobb angle, visual analogue scale (VAS) and Oswestry functional score at preoperation, 3 days after operation and last follow-up. The patients were divided into cement leakage group and no cement leakage group. All the compl ications were recorded, and then the correlative factors affecting the compl ications were analyzed. Results All the cases had rapid and significant improvement in back pain following PKP. All patients were followed up for 14 months (range, 7-18 months). There was no cement extravasation resulting in radiculopathy or myelopathy. Four patients (5.63%) had lung-related compl ications. During the follow-up, 9 recurrence vertebral fractures were observed in 6 patients (8.45%). The anterior and middle vertebral column height, Cobb angle, VAS and Oswestry score were significantly improved when compared with preoperation (P lt; 0.05). Cement leakage occurred in 17 (9.94%) vertebral bodies; of 17 cases, the cement leaked into the paravertebral space in 7 cases, intervertebral space in 6 cases, channel of needl ing insertion in 3 cases, and spinal canal in 1 case. Univariate analysis showed statistically significant differences (P lt; 0.05) in preoperative anterior and middle vertebral column height, injected cement volume and vertebral body wall incompetence between the cement leakage group and no cement leakage group. There were no significant differences (P gt; 0.05) in preoperative Cobb angle, freshness of vertebral fracture, location of operative vertebrae and operative approach between the two groups. Multiple logistic regression analysis showed that the injected cement volume [odds ratio (OR)=3.105, 95% confidence interval (CI)=1.674-5.759, P lt; 0.01] and vertebral body wall incompetence (OR=11.960, 95%CI=3.512-40.729, P lt; 0.01) were the predominant variable associated with the compl ications resulted fromcement leakage. Conclusion The injected cement volume and vertebral body wall incompetence were the factors affecting the compl ications. The improvement of surgical technique is the capital factor that may reduce the compl ications in the PKP.
ObjectiveTo evaluate the effect of intravenous immunoglobulin (IVIG) on prognosis of patients with idiopathic systemic capillary leakage syndrome (ISCLS). MethodsCase reports and case series related to IVIG on prognosis of ISCLS were electronically searched from the PubMed, CNKI and WanFang Data databases from inception to December 31, 2021. Two researchers screened literature and extracted the data independently, then, prognostic data were analyzed. ResultsA total of 143 case reports (175 patients) and 5 case series (169 patients) were included. About 75% of patients had monoclonal gamma globulin, most of those were IgG κ type. A total of 40 patients received prophylaxis with IVIG, most of whom received a high dose (2 g/kg) of IVIG per month. The 5-year and 10-year survival rates of ISCLS patients receiving IVIG secondary prevention treatment were 96% and 72%, respectively, significantly better than the rates of 66% and 43% in the group without IVIG. The median number of acute episodes per year was 0 (0-20) in the group receiving secondary prevention with IVIG and 2 (1-16) in the group not receiving IVIG. ConclusionHigh-dose (2g/kg) IVIG can improve the long-term survival of ISCLS patients, but efficacy of IVIG in acute episodes is unclear.