OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

OBJECTIVES: To investigate the incidence of extrauterine growth retardation (EUGR) and its risk factors in very preterm infants (VPIs) during hospitalization in China. METHODS: A prospective multicenter study was performed on the medical data of 2 514 VPIs who were hospitalized in the department of neonatology in 28 hospitals from 7 areas of China between September 2019 and December 2020. According to the presence or absence of EUGR based on the evaluation of body weight at the corrected gestational age of 36 weeks or at discharge, the VPIs were classified to two groups: EUGR group (n=1 189) and non-EUGR (n=1 325). The clinical features were compared between the two groups, and the incidence of EUGR and risk factors for EUGR were examined. RESULTS: The incidence of EUGR was 47.30% (1 189/2 514) evaluated by weight. The multivariate logistic regression analysis showed that higher weight growth velocity after regaining birth weight and higher cumulative calorie intake during the first week of hospitalization were protective factors against EUGR (P<0.05), while small-for-gestational-age birth, prolonged time to the initiation of total enteral feeding, prolonged cumulative fasting time, lower breast milk intake before starting human milk fortifiers, prolonged time to the initiation of full fortified feeding, and moderate-to-severe bronchopulmonary dysplasia were risk factors for EUGR (P<0.05). CONCLUSIONS It is crucial to reduce the incidence of EUGR by achieving total enteral feeding as early as possible, strengthening breastfeeding, increasing calorie intake in the first week after birth, improving the velocity of weight gain, and preventing moderate-severe bronchopulmonary dysplasia in VPIs.
Female ; Fetal Growth Retardation ; Gestational Age ; Hospitalization ; Humans ; Incidence ; Infant ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight ; Prospective Studies ; Risk Factors

Child ; Consensus ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Respiratory System

ObjectiveTo investigate the effect and mechanism of SDF-1/CXCR4 in radicular pain induced by autograft of nucleus pulposus. MethodsThree parts were included. ① 26 rats were randomly divided into sham group and model group. Autograft of nucleus pulposus was done in model group. Paw withdrawal threshold （PWT） was tested by von Fray filaments. The expression of SDF-1， CXCR4， pERK and pAKT of spinal cord was tested by western blot. Immunofluorescence staining was used to locate the expression of SDF-1 and CXCR4. ② 54 rats were randomly and equally divided into sham group， model group， vehicle group， SDF-1 neutralizing antibody group， AMD3100 group， and isotype IgG group. Drug was administered intrathecally. PWT and the expression of pERK and pAKT of spinal cord were tested. ③ 18 rats were randomly and equally divided into model group， U0126 group and LY294002 group. Drug was administered intrathecally. PWT was tested. Results① Autologous nucleus pulposus transplantation in rats reduced PWT （P＜0.001） and increased the expressions of SDF-1， CXCR4， pERK and pAKT in spinal cord of rats （P＜0.05）. SDF-1 was mainly co-expressed with neuron， while CXCR4 was co-expressed with neuron and astrocyte. ② SDF-1 neutralizing antibody and CXCR4 inhibitor AMD3100 reduced PWT （P＜0.05）. The expression of pERK and pAKT in spinal cord of SDF-1 neutralizing antibody group and AMD3100 group was reduced （P＜0.05）. ③ Intrathecally administration of MEK inhibitor U0126 or PI3K inhibitor LY294002 reduced PWT （P＜0.05）. ConclusionSDF-1/CXCR4 activates ERK and PI3K/AKT signaling， which contributes to the pathogenesis of radicular pain induced by autograft of nucleus pulposus.

Objective: To assess the safety and feasibility for treating the patients with severe external carotid artery (ECA) stenosis and ipsilateral internalcarotid artery (ICA)occlusion by external carotid artery steting (ECAS). Methods: A total of 17 consecutive patients with severe ECA stenosis and ipsilateral ICA occlusion treated in our hospital by ECAS from 2008-01 to 2013-06 were retrospectively studied. Post-operative improvements of cerebral ischemia and neurocognitive function [Mini-mental state examination (MMSE) and Montreal cognitive assessment (MOCA)] were evaluated, complications at peri-operative and 12 months follow-up period were recorded. Results: The patients' mean age was (65.4±8.0) years including 13(76.5％) male. The success rate of ECAS was 100％;2 patients had hemodynamic depression at peri-operative period and were completely recovered by 2 days treatment.1 patient suffered from contralateral minor stroke at 12 months follow-up time, the other 16 patients were without cerebral ischemia symptoms. No complication occurred at peri-operative and 12 months follow-up period. Compared with pre-operative condition, MMSE score [(25.1±1.4) vs (23.3±1.8), P<0.01] and MOCA score [(23.9±1.2) vs (22.2±1.6), P<0.01] were increased at 3 months after ECAS; both scores were continuously increasing during 12 months follow-up period. Conclusion: ECAS may improve cerebral ischemia and cognitive function in patients with severe ECA stenosis and ipsilateral ICA occlusion.

Aim To observe the effect of epidurally application of osthole on the model of nucleus pulposusinduced inflammatory radicular pain and the expression of p38 MAPK signaling related pathway in the spinal dorsal horn of rats.Methods The model of radicular pain was generated by putting nucleus pulposus to the L5 dorsal root ganglion (DRG).50％ MWT was measured using Von Frey filaments to calculate mechanical pain threshold before and after operation.50 μL of 20 g · L-1 osthole was administered epidurally in group Ost and 50 μL of 100 mL · L-1 DMSO in group DMSO at postoperative day (POD).The expression of phosphorylated p38 (p-p38),IL-18 and IL-18R in the lumbar spinal dorsal horn was detected by Western blot.IL-18 mRNA was assessed by real-time PCR.Results The mechanical pain threshold significantly decreased after operation (P ＜ 0.05),while the expression of protein p-p38 MAPK,IL-18,IL-18R and IL-18 mRNA was significantly different.Compared with DMSO group,50％ MWT was significantly increased and accompanied with the decrease of protein p-p38,IL-18,IL-lgR and IL-18 mRNA in Ost group after drug administration (P ＜ 0.05).The correlation analysis between protein concentration of p38 MAPK and IL-18 mRNA showed that the Spearman correlation coefficient was 0.9 (P ＜ 0.05).Conclusion p-p38 and IL-18 of spinal dorsal horn participate in the rat model with inflammatory radicular pain induced by nucleus pulposus,and IL-18R plays a role in maintenance of the pain.Osthole administered epidurally in the early stage of pain could alleviate the pain for a long time,which may be related with inhibiting p38 MAPK signaling related pathways.

BACKGROUND: The short-term effects of dynamic internal fixation and whether dynamic internal fixation system can prevent or delay the process of adjacent level degeneration after lumbar surgery remain in controversy.OBJECTIVE: To investigate the short-term clinical effectiveness of single-level Isobar TTL dynamic internal fixation in the treatment of degenerative lumbar diseases. METHODS: Data of 20 patients who suffered from lumbar degenerative diseases and underwent posterior decompression combined with single-level Isobar TTL dynamic internal fixation, including 11 male patients and 9 female patients, were retrospectively analyzed; the average age of these patients was 47.4 (35-62) years old. Visual analog scale, Japanese Orthopaedic Association scores and Oswestry disability index were used to assess clinical outcomes. Disc height, range of motion, and University of California at Los Angeles Grading Scale were measured on X-ray films to evaluate the status of disc degeneration on both dynamic fixed segment (index segment) and superior adjacent segment. RESULTS AND CONCLUSION: All follow-up patients successfully completed the operation. The average follow-up time was 14.4 (12-27) months. No blood vessels, nerve injury, loose internal fixation or rupture occurred. At the last follow-up, Visual Analog Scale, Japanese Orthopaedic Association scores and Oswestry Disability Index were significantly improved (P < 0.05); range of motion of dynamic fixation segment reduced (P < 0.05) as compared with that before surgery. Intervertebral height of dynamic fixation segments and University of California at Los Angeles Grading Scale classification were not significantly different between follow-up and before surgery (P > 0.05). Intervertebral height of superior adjacent segment, intervertebral range of motion and University of California at Los Angeles Grading Scale classification were not significantly different (P > 0.05). These results indicate that single-level Isobar TTL dynamic internal fixation proved to have satisfactory clinical outcomes in the treatment of lumbar degenerative diseases. During follow-up, disc degeneration on either index segment or superior adjacent segment is not accelerated.

BACKGROUND: Patients with anterior cervical discectomy and fusion have a high incidence of dysphagia, which may be associated with a variety of factors. The specific mechanism remains unclear. OBJECTIVE: To explore the related factors of dysphagia after single-level anterior cervical discectomy and fusion. METHODS: We retrospectively analyzed patients with cervical degenerative disc disease receiving single-level anterior cervical discectomy and fusion in First Affiliated Hospital of Soochow University from January 2011 to January 2015. During hospitalization, basic patient data and surgery-related data were recorded, including operation time, intraoperative blood loss, surgical segment, internal fixation device and the use of recombinant human bone morphogenetic protein-2. The cervical alignment and prevertebral soft tissue swelling were measured preoperatively and 3 days postoperatively. At 1, 3, 6, 12, and 24 months postoperatively, the Bazaz swallowing function scoring system was used to assess the swallowing of the patients. RESULTS AND CONCLUSION: A total of 262 patients undergoing single-level anterior cervical discectomy and fusion were involved. The incidence of dysphagia at 1, 3, 6, 12, and 24 months postoperatively was 35.9%, 22.9%, 15.6%, 11.5% and 9.2% respectively. Univariate analysis showed that gender, operation time and course length were associated with postoperative dysphagia. Logistic multivariate regression analysis showed that the duration of operation (≥ 3 hours), female and course length (≥ 8 months) were risk factors for dysphagia after anterior cervical descectomy and fusion. Operation time and female may be associated with early and middle dysphagia postoperatively, and the course length may be associated with chronic dysphagia. Prevertebral soft tissue swelling and other factors are not related to dysphagia after single-level anterior cervical discectomy and fusion. Risk factors for dysphagia after multi-level fusion should be further studied.

BACKGROUND: Micro-arc oxidation (MAO) treatment can improve the biological properties of titanium alloy implants. Previous studies mostly focused on the evaluation of titanium alloy plate, while the effects of the MAO-modified 3D titanium scaffold on the cell growth and differentiation were rarely reported. OBJECTIVE: To investigate the effect of MAO coating on the biological performance of cells seeded onto the 3D-printed porous titanium alloy scaffold. METHODS: Rat bone marrow mesenchymal stem cells were seeded onto the MAO-modified Ti6Al4V alloy scaffolds (experimental group) and unmodified scaffolds (control group). After 4 and 7 days of culture, cell/scaffold constructs were retrieved and processed for the assessment of cell morphology by using scanning electron microscopy, cytoskeletal staining analysis and cell viability assay were also evaluated. At 4, 7 and 11 days of culture, the levels of alkaline phosphatase and osteocalcin in the cell supernatant were detected. At 1, 4, 7 and 11 days of culture, the cell proliferation rate was measured using the MTT assay. RESULTS AND CONCLUSION: (1) At 4 and 7 days of culture, live/dead staining showed that the bone marrow mesenchymal stem cells grew well on the two kinds of scaffolds. The analysis of cytoskeleton staining showed that the cytoskeleton of the experimental group was stereo and polygonal, while the cells on the scaffold surface in the control group were flat and spindle-shaped, spreading along the macro structure of the scaffolds. Under the scanning electron microscopy, the cells in the experimental group arranged closely and spread in a good condition, with interconnected lamellipodia and filopodia that firmly adhered to the scaffold surface in an anchor-shaped structure; in the control group, less filopodia interconnected, less extracellular matrix, and flat and sheet-like cells were observed. (2) With the time increase, the levels of alkaline phosphatase and osteocalcin increased gradually in both groups. The alkaline phosphatase level in the experimental group was significantly higher than that in the control group at 7 and 11 days of culture (P < 0.05), while the osteocalcin level was higher in the experimental group than the control group at 11 days of culture (P < 0.05). (3) With the prolongation of culture time, the number of cells in the two groups increased gradually. The number of cells cultured in the experimental group was significantly higher than that in the control group at 7 and 11 days of culture (P < 0.05). To conclude, the MAO-modified titanium alloy scaffold is favorable for cell adhesion, proliferation and differentiation.

Objective To explore the impact of local lipiodol deposition in liver of miniature pigs on the shape and size of the necrotic area after microwave ablation (MWA).Methods Ten healthy miniature pigs were selected and equally divided into experimental group and control group (each n=5).In experimental group,transcatheter hepatic arterial embolization with lipiodol was done before microwave ablation,while only standard microwave ablation was performed in control group.Immediate post-ablation CT images were obtained.Long-axis diameter (LAD),short-axis diameter (SAD),sphericity index (SI=SAD/LAD) and volume of ablation zone were calculated.The size and shape of the ablated areas were compared between two groups.Results The mean LAD,SAD,SI and volume of ablation zone in experimental group ([4.21 ± 0.52]cm,[2.87±0.38]cm,0.69±0.10,[18.72±6.08]cm3) were larger than those in control group ([3.71±0.42]cm,[2.19±0.42]cm,0.60±0.09,[9.44±2.29] cm3;all P＜0.05).Conclusion Local deposition of lipiodol in liver parenchyma of miniature pigs can help to produce larger and rounder necrosis in the ablation zone.