Application Of Patient-reported Outcomes In Clinical Therapeutic Evaluation Of TCM In Treating Bone Metastases

Research ObjectivesIn this study,we collected the general information,survival data and efficacy evaluation data of patients with bone metastases in our hospital to summarize the clinical characteristics and common causes of death of patients with bone metastases,and apply different efficacy evaluation indexes to assess the clinical efficacy of Traditional Chinese medicine(TCM)for bone metastases,in order to explore the advantages and shortcomings of comprehensive treatment of TCM,and further evaluate the correlation between imaging evaluation and patients’ reported outcomes and TCM syndrome score,enrich the content of the TCM efficacy evaluation system for bone metastases,and provide a reference basis for clinical treatment.Research MethodsAll 105 patients with bone metastases were enrolled prospectively according to the inclusion criteria,and clinical data before and after 8 weeks of comprehensive TCM treatment to establish a database of bone metastases.The basic information,clinical data and efficacy evaluation data of these patients were summarized,follow up through WeChat and telephone until January 2022 to get the survival data of the patients,then apply imaging examination,EORTC QLQ-BM22 scores,laboratory tests and TCM syndrome score were applied to evaluate the clinical efficacy of comprehensive TCM interventions for bone metastases,and the correlation between QLQ-BM22 scores and imaging tests and TCM syndrome score was statistically analyzed.Research Result1.A total of 105 bone metastases patients were enrolled in this study,with a concentrated age distribution of 50-70 years old,of whom 45.7%had bone metastases at the time of malignancy diagnosis.Bone metastases from malignant tumors are often multi-site involved,accounting for 78.1%.In terms of involved sites,the proportion of spinal metastases is the highest,at 73.3%,followed by ribs(49.5%),pelvis(36.2%)and sternum(12.4%).2.Statistical analysis of 38 patients who died revealed that the average time from the diagnosis of bone metastasis to clinical death was 13.63 ± 15.41 months for patients with bone metastases,with a median time of 6 months,and the most important direct causes of death were pulmonary infection,disseminated intravascular coagulation and pulmonary embolism.3.By applying different efficacy evaluation indexes to assess the clinical efficacy of comprehensive TCM interventions for bone metastases,it was found that:(1)The application of imaging examinations to evaluate the repair of bone metastases revealed an efficiency rate of 8.8%and a benefit rate of 70.6%in patients.(2)The QLQ-BM22 scale was applied to assess patients’ quality of life before and after treatment in four domains,including painful site,painful characteristics,functional interference and psychosocial aspects,and it was found that patients’ scores in painful site and psychosocial aspects before and after treatment were statistically significant(P<0.05),without significant improvement in the area of painful characteristics and functional interference(P>0.05).(3)Applying the TCM syndrome score to evaluate the clinical efficacy of comprehensive TCM intervention,it was found that the TCM syndrome score was smaller after treatment than before,and the difference was statistically significant(P<0.05).(4)Applying the laboratory indexes CEA,ALP,NLR,LDH,and Ca to assess the clinical efficacy of patients before and after treatment,it was found that although comprehensive TCM treatment could reduce the levels of CEA,ALP,NLR,LDH,and Ca,the difference was not statistically significant(P>0.05).4.By analyzing the correlation between the before and after treatment differences of the domains of the QLQ-BM22 scale and the before and after treatment differences of the imaging evaluation and the TCM syndrome score,it was found that:(1)There was a significant positive correlation between the results of the imaging efficacy evaluation and the difference in the scores of the functional interference domain of the QLQ-BM22 scale before and after treatment(P<0.05).(2)There was a significant positive correlation between the difference in the TCM syndrome score and the difference in the painful site and pain characteristics before and after treatment(P<0.05),negatively but not significantly correlated with domains of functional interference(P>0.05).(3)The difference in the TCM syndrome score was negatively correlated with the imaging change results,but there was no significant correlation(P>0.05).Analysis Conclusion1.Bone metastases are often multiple and have a clear tendency to occur in the spine,ribs and pelvis,followed by the bones of the extremities,scapulae and skull.2.Pulmonary infection,disseminated intravascular coagulation,and pulmonary embolism are the top three direct causes of death in patients with bone metastases.A comprehensive assessment of the clinical efficacy of TCM interventions for bone metastases through multidimensional efficacy evaluation indexes revealed that integrated TCM can effectively control the progression of bone metastases,relieve the degree of pain,improve the clinical symptoms of patients,and improve their survival quality.However,there are still shortcomings in functional recovery and psychological guidance,and the interventions of rehabilitation and psychology departments are needed to promote the recovery of functional activities and relieve patients’ tension and anxiety.3.The improvement of pain and relief of clinical symptoms before and after TCM treatment does not mean the repair of bone metastases and improvement of functional movement.As the bone from the bone metastases is repaired,the patient’s functional impairment may improve.