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9 result(s) for "Shen, Zhibi"
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Study on the efficacy and safety of the combination of Shi’s manual therapy and percutaneous endoscopic lumbar diskectomy for lumbar disc herniation with radiculopathy: study protocol for a multicenter randomized controlled trial
Background Lumbar disc herniation (LDH) is a common chronic musculoskeletal disorder that seriously affects quality of life. The percutaneous endoscopic lumbar diskectomy (PELD) technique was developed to address spinal nerve root compression through direct visualization of pathological findings while minimizing tissue destruction upon exposure. It is an effective and safe treatment for LDH. However, recurrent LDH is a major concern after lumbar discectomy for primary LDH. A considerable number of clinical studies have reported that patients with LDH with radiculopathy could benefit from manual therapy. Shi’s manual therapy (SMT) was established based on traditional Chinese medicine (TCM) theory and has been shown to have a superior effect in alleviating muscle tension and loosening joints to improve lumbar and leg pain, radiculopathy, stiffness, activity discomfort, and related disorders. However, there is a lack of high-quality clinical evidence to support this conclusion. The purpose of this study is to evaluate the efficacy and safety of the combination of Shi’s manual therapy (SMT) and PELD for LDH with radiculopathy. Methods/design A multicenter randomized controlled trial (RCT) with a 1-year follow-up period will be performed. A total of 510 participants with LDH with radiculopathy will be recruited from four clinical centers. The sample size was estimated, and statistical analysis will be performed and supervised by biostatisticians from an independent third-party research institution. Two hundred fifty-five subjects will be randomly allocated to each group. The subjects in the control group will undergo PELD. Participants in the intervention group will be treated with a combination of SMT and PELD. Recurrence rate is the primary endpoint and the survival analysis of recurrence rate is the secondary endpoint, and the primary analysis of recurrence rate is the chi-square test and the secondary analysis of recurrence rate is survival analysis. The primary outcome measure is the recurrence rate of LDH with radiculopathy at the 1-year follow-up after treatment. The secondary outcome measures will be the ODI score, the VAS score for pain for the lumbar spine and lower limbs, the straight leg raise angle, the stability of the operated lumbar segment, and the SF-36 scores. Assessments will occur at baseline, postoperation, and 1 week, 4 weeks, 13 weeks, 26 weeks, and 1 year postoperation. In addition, adverse events related to clinical symptoms and signs and the results of laboratory tests will be documented during the clinical trials. Discussion This study will provide reliable evidence of the effectiveness and safety of the combination of SMT and PELD for LDH with radiculopathy. If the results are favorable, it is expected that patients with LDH with radiculopathy will benefit from this study, and many patients could gain a good alternative treatment for LDH with radiculopathy. Trial registration China Registered Clinical Trial Registration Center ChiCTR2000036515 . Registered on 13 November 2020.
The correlation between coagulation biomarkers, bone turnover markers, and bone mineral density in Chinese adults aged ≥ 50 years
Osteoporosis patients undergoing surgery often have significant bleeding, which is closely related to coagulation function. This study aimed to assess the correlation between bone turnover markers (BTMs), bone mineral density (BMD), and coagulation biomarkers. Cases meeting the inclusion criteria were included from our center from January 2020 to December 2021. The relationships between coagulation biomarkers, BTMs, and BMD were investigated by Spearman correlation analysis and canonical correlation analysis (CCA). Consequently, age, bone mass stage, 25-hydroxyvitamin D (25-(OH)D), and BMD were included as independent variables in the logistic regression model. Furthermore, the international normalized ratio (INR), fibrinogen, platelets, and D-dimer levels were set as dependent variables in the regression analysis. Finally, multivariable regressions were conducted to adjust for differences in demographics and comorbidities among groups. A total of 306 patients were included in the study. Significant differences were observed in prothrombin time, fibrinogen, INR, D-dimer, and platelets ( < 0.05). D-dimer exhibited the most significant positive association with age and the most pronounced negative correlation with the BMD of Ward's triangle ( = 0.322, < 0.001; = -0.298, < 0.001; respectively). 25-(OH)D and calcium were related to coagulation biomarkers. Multivariate analysis demonstrated that age was positively associated with D-dimer levels (odd ratio [OR] = 1.046, = 0.007), while the BMD of Ward's triangle was negatively related to D-dimer levels (OR = 0.004, = 0.0017). For the Chinese population aged 50 and above, attention should be paid to alterations in coagulation biomarkers.
Efficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial
The clinical diagnosis of atlantoaxial joint subluxation (AJS) in traditional Chinese medicine (TCM) is characterized by an unequal distance between the lateral mass of the atlas and the odontoid process on imaging, resulting in neck pain accompanied by symptoms such as dizziness, headache, and limited cervical mobility. In Shanghai, Shi cervical rotational manipulation (SCRM) is a commonly employed TCM manual therapy for treating this condition. Nevertheless, there is a lack of evidence-based medical information regarding the clinical efficacy and safety of this technique. The principal aim of this study is to evaluate the efficacy and safety of SCRM in patients diagnosed with AJS. This study is a prospective randomized controlled clinical trial that will be conducted at a single center and that has a follow-up period of 24 weeks. A total of 96 patients diagnosed with AJS will be recruited from outpatient and inpatient clinics at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. These patients will be randomly assigned to either the experimental group (SCRM) or the comparison group (basic cervical manipulation [BCM]). Treatment sessions consisting of SCRM or BCM will be administered twice a week for a duration of 4 weeks. Clinical monitoring indicators include the presence or absence of clinical symptoms as recorded on a symptom recording form, cervical imaging examination findings using cervical computed tomography, degree of neck pain measured by a visual analog scale (VAS), cervical range of motion assessed through cervical mobility measurement, degree of vertigo evaluated using the Vertigo Symptoms Scale-Chinese Version (VSS-C), and adverse events that may occur during the follow-up period. The time points for data collection and follow-up are baseline and postintervention (weeks 4, 8, 12, 16, 20, and 24). This paper presents an overview of the reasoning and structure of a prospective randomized controlled trial with the objective of investigating the clinical efficacy and safety of SCRM in patients with AJS by assessing improvements in clinical symptoms, neck pain severity, and vertigo severity and evaluating changes in cervical imaging findings. Recruitment was started in March 2023. By the end of May 2024, 76 patients were included in this project. The last follow-up data are predicted to be collected by the end of February 2025. This investigation will yield dependable evidence regarding the efficacy and safety of SCRM in patients with AJS. Chinese Clinical Trial Registry ChiCTR2300068510; https://www.chictr.org.cn/showprojEN.html?proj=186883. DERR1-10.2196/57865.
Morphology and transverse alignment of the patella have no effect on knee gait characteristics in healthy Chinese adults over the age of 40 years
Background: The influence of patella morphology and horizontal alignment on knee joint kinematics and kinetics remains uncertain. This study aimed to assess patella morphology and transverse alignment in relation to knee kinetics and kinematics in individuals without knee conditions. A secondary objective was to investigate the impact of femur and tibia alignment and shape on knee gait within this population. Patients and methods: We conducted a prospective collection of data, including full-leg anteroposterior and skyline X-ray views and three-dimensional gait data, from a cohort comprising 54 healthy individuals aged 40 years and older. Our study involved correlation and logistic regression analyses to examine the influence of patella, femur, and tibia morphology and alignment on knee gait. Results: The patellar tilt angle or the patella index did not show any significant relationships with different aspects of gait in the knee joint, such as velocity, angle, or moment ( p > 0.05, respectively). Using multivariate logistic regression analysis, we found that the tibiofemoral angle and the Q angle both had a significant effect on the adduction angle (OR = 1.330, 95%CI 1.033–1.711, p = 0.027; OR = 0.475, 95% CI 0.285–0.792, p = 0.04; respectively). The primary variable influencing the knee adduction moment was the tibiofemoral angle (OR = 1.526, 95% CI 1.125–2.069, p = 0.007). Conclusion: In healthy Chinese individuals aged over 40, patella morphology and transverse alignment do not impact knee gait. However, the femoral-tibial angle has a big impact on the knee adduction moment.
The Molecular Mechanism Investigation of HBP‐A Slows Down Meniscus Hypertrophy and Mineralisation by the Damage Mechanical Model
HBP‐A is the main active component of a traditional Chinese medicine Huaizhen Yanggan Capsule, for the remarkable treatment of knee osteoarthritis (KOA). This study aimed to elucidate the ameliorative effect of HBP‐A on meniscus hypertrophy and mineralisation in KOA and the molecular mechanism of its action. An Hartley guinea pig model of KOA that underwent anterior cruciate ligament transection (ACLT) and a model of rat primary meniscus fibrochondrocytes (PMFs) were used to investigate the ameliorative effect of HBP‐A on meniscal hypertrophy and calcification and its signal transduction mechanism of action. The results show that Guinea pig's meniscus width, as well as the area of meniscus calcification and meniscus and articular cartilage injury score, were significantly reduced in the HBP‐A intervention group compared to the ACLT group. The expression levels of mtrix metalloproteinase 13 (MMP13), runt‐related transcription factor 2 (Runx2), Indian hedgehog (Ihh), alkaline phosphatase (ALP), and ankylosis homologue (ANKH) at the protein and gene level significantly decreased in the HBP‐A intervention group compared to the ACLT group. In vitro study, apoptosis, hypertrophy, and calcification of rat PMFs after 10% stretch force were significantly improved with HBP‐A intervention. Western blot and RT‐qPCR showed that hypertrophy, calcification, and p38 MAPK signalling pathway‐related markers of PMFs were incredibly depressed in the HBP‐A intervention group compared to the 10% stretch force group. In conclusion, HBP‐A can slow down meniscus hypertrophy and mineralisation induced by abnormal mechanical loading, and its mechanism of action may be through the p38‐MAPK signalling pathway.
HBP‐A Attenuates Knee Osteoarthritis Progression via MLK3/P38/HDAC4 Axis‐Mediated Dual Protection of Articular Cartilage and Quadriceps
Knee osteoarthritis (KOA), a degenerative joint disease driven by biomechanical instability, involves cartilage degradation, muscle dysfunction, and MLK3/P38 MAPK pathway activation. Histone deacetylase 4 (HDAC4), a regulator of chondrocyte and muscle homeostasis, interacts with this pathway during disease progression. While Hyriopsis Bioactive Polysaccharide‐Anodonta (HBP‐A) exhibits P38 MAPK inhibitory properties in vitro, its in vivo therapeutic effects on musculoskeletal tissues remain uncharacterised. A destabilisation of the medial meniscus (DMM) mouse model was established to investigate HBP‐A's therapeutic potential. Animals were randomly divided into sham‐operated, DMM‐induced, and HBP‐A‐treated groups. Following surgical induction, HBP‐A (0.26 g/kg) was administered daily via oral gavage for 4 weeks. Comprehensive assessments included behavioural tests for pain sensitivity, micro‐CT scanning, histological evaluation, and transmission electron microscope. Molecular mechanisms were investigated via immunohistochemical or immunofluorescence staining of MLK3, P38 MAPK, Caspase‐3, and HDAC4, complemented by RT‐qPCR analysis of myokine expression. HBP‐A treatment significantly alleviated pain sensitivity compared to the DMM group. Structural evaluations revealed preserved subchondral bone integrity and attenuated cartilage degeneration, with histological scoring confirming reduced pathological changes. Quadriceps exhibited mitigated atrophy and restored ultrastructural organisation. Molecular profiling demonstrated suppressed MLK3/P38 MAPK pathway activation, diminished apoptotic activity, and elevated HDAC4 expression in both cartilage and quadriceps. HBP‐A additionally normalised dysregulated expression of muscle‐derived osteogenic factors linked to bone‐cartilage crosstalk. These findings establish HBP‐A as a dual‐target therapeutic agent for KOA, concurrently mitigating cartilage and muscle degeneration through MLK3/P38 MAPK/HDAC4 axis modulation.
Shi’s Daoyin Therapy for Neck Pain: A Randomized Controlled Trial
Objective. To compare the immediate and short term effectiveness of Shi’s Daoyin therapy (DT) rather than the Melbourne Protocol (MP) in terms of pain, mobility, and isometric strength of cervical muscles in nonacute nonspecific neck pain patients. Material and Methods. A total of 114 nonacute nonspecific neck pain patients aged 20~50 years were recruited and randomly assigned to be treated by either Shi’s DT or the MP. 56 cases and 54 cases received treatment for 3 weeks and were evaluated before and after intervention and at 3-week follow-up in Shi’s DT group and MP group, respectively. The outcome measures were Chinese version of the Neck Disability Index (NDI), cervical range of motion (ROM), maximal voluntary isometric force (MVIF), and pain intensity (Numeric Pain Rating Scale, NPRS). Results. All outcomes of both groups showed statistically significant improvements after the intervention and at 3-week follow-up (P < 0.05), while no statistically significant difference was found in NDI between groups. When followed up after 3 weeks, the ROM in axial rotation was significantly greater in the Shi’s DT group (P < 0.05), and the NPRS in the Shi’s DT group was significantly lower than the MP group (P < 0.05). At the end of the treatment period, the MVIF in lateral bending in the Shi’s DT group had a lower value (P = 0.044) than in the MP group, but there was no significant difference in flexion and extension between the two groups. Conclusions. Both Shi’s DT and MP groups demonstrated an obvious reduction in pain intensity and improvements in neck mobility after a short term follow-up period. The improvement of Shi’s DT in disability and pain during functional activities is generally similar to that of the MP for the treatment of nonacute nonspecific neck pain.
Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial
Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results. Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P<0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group (P<0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant (P<0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group (P<0.05). Safety Evaluation. A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion. These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.
热消融治疗原发性和转移性肺部肿瘤的专家共识(2014年版)
在世界范围内肺癌均居癌症发病率和死因之首,全球每年发病约2,500,000人,每年有超过1,600,000人死于肺癌。在我国肺癌的发病形势更加严峻,据《2012年中国肿瘤年报》