Objective To analyse the correlative factors of secondary vertebral fracture after percutaneous kyphoplasty (PKP) in treatment of osteoporotic vertebral compression fracture (OVCF) at different levels (adjacent and/or nonadjacent levels). Methods Between December 2002 and May 2008, 84 patients with OVCF were treated with PKP, and the cl inical data were analysed retrospectively. There were 11 males and 73 females with an average age of 70.1 years (range, 55-90 years). All patients were followed up 24-96 months (mean, 38 months). Secondary vertebral fracture occurred in 12 cases at 3-52 months after PKP (secondary fracture group), no secondary fracture in 72 cases (control group) at over 24months. The preoperative bone mineral density, postoperative vertebral height compression rate, postoperative Cobb angle, amount of injected bone cement per vertebra, puncture pathway (uni- or bilateral puncture), age, gender, number of fracture segment, and cement intradiscal leakage were compared between 2 groups to find correlative factors of secondary vertebral fractures. Results There was no significant difference in preoperative bone mineral density, postoperative vertebral height compression rate, postoperative Cobb angle, amount of injected bone cement per vertebra, puncture pathway, age, gender, and number of fracture segment between 2 groups (P gt; 0.05). But the incidence of cement intradiscal leakage was much higher in secondary fracture group than in control group (χ2=5.294, P=0.032). Conclusion Cement intradiscal leakage may be the correlative factor of secondary vertebral fracture after PKP in OVCF.
High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
Evidence-based Chinese medicine is a relatively new discipline which applies the concepts and methods of evidence-based medicine (EBM) to the clinical research and practice of Chinese medicine. It is not only a branch of EBM but also a natural product of the development of Chinese medicine. This paper introduces the theoretical concepts of evidence-based Chinese medicine and reviews the process of its development. It then elucidates the main characteristics of evidence-based Chinese medicine, emphasizes its holistic approach, prescription-syndrome relationship, and its human-centered approach. Research contents and status quo are also summarized to point out the challenges of the production and application of evidence. Finally, we innovatively indicate further research directions on combining individual-based research with population-based research and developing narrative EBM.