| BackgroundChronic bone disease is a type of chronic disease caused by various internal and external factors such as degeneration,external sensations,and strain,resulting in imbalance of internal and external balance of bones,joints,and muscles.It is caused by local or systemic pain,movement disorders,and sensory abnormalities due to long-term untreated or mistreated conditions.According to the "13th Five Year Plan" for higher education in the Chinese medicine industry nationwide,the textbook "Traditional Chinese Orthopedics and Traumatology Science"(the fourth edition of the new century),chronic bone diseases mainly include degenerative arthritis of bones and joints(knee osteoarthritis,cervical spondylosis,lumbar disc herniation),osteoporosis,and difficult to treat diseases such as femoral head necrosis.Blood stasis syndrome refers to a series of symptoms caused by poor blood circulation,or blood stasis,or blood overflowing outside the veins and stopping in the body.Clinical manifestations include pain,complexion,lips and tongue dullness,cyanosis,and pulse congestion.Through relevant literature research,it was found that regardless of the type of syndrome,treatment principles,and prescriptions,blood stasis is the core pathogenesis of chronic bone disease.Blood stasis can serve as both a pathological factor and a pathological product,and runs through the entire process of the occurrence and development of chronic bone disease.With the rapid development of society and economy,and the rise of the aging population,chronic diseases are gradually manifested as high incidence and disability rates.The reason for this is the low treatment and control rates of chronic diseases.As an important component of the chronic disease prevention and control system,chronic bone diseases not only affect the health and quality of life of the majority of middle-aged and elderly people,but also bring a heavy social burden.Chronic bone disease is the dominant disease in the treatment of traditional Chinese medicine,and promoting blood circulation and removing blood stasis is also the most commonly used treatment principle.However,there is no standardized clinical diagnostic criteria for blood stasis syndrome of chronic bone disease,which is difficult to meet the needs of clinical syndrome differentiation and treatment.To comprehensively improve the clinical diagnosis level of blood stasis syndrome of chronic bone disease,and form the diagnostic criteria of blood stasis syndrome of chronic bone disease.Purpose1.Delphi method was used to conduct a questionnaire survey on experts in the field of orthopedics,and to construct TCM syndrome differentiation criteria for blood stasis syndrome of chronic bone disease.2.Through clinical verification,the syndrome and symptom characteristics of chronic bone disease with blood stasis syndrome were analyzed,and the reliability and validity of the standard were tested,so as to provide theoretical support for the standard.Methods1 Construction of traditional Chinese medicine syndrome differentiation standard questionnaire for chronic bone disease with blood stasis syndrome based on Delphi method.By systematically searching the literature on blood stasis syndrome of chronic bone disease in CNKI,Wanfang and VIP databases from 1980 to 2022,combined with previous research results and expert consultation,a questionnaire was designed.The first round of expert questionnaire was conducted on 10 experts in the field of orthopedics.The collected questionnaires were counted and the basic information and positive coefficient of experts were analyzed,the average and coefficient of variation of each item were calculated,the deletion and addition of items proposed by experts were summarized and expert consultation was conducted.Finally,the TCM syndrome differentiation criteria of blood stasis syndrome of chronic bone disease were determined,and the questionnaire content was designed for clinical trials.2 Basic Information,Traditional Chinese Medicine Syndromes,and Symptom Investigation of Chronic Bone Disease with Blood Stasis Syndrome.Through the formulation of inclusion and exclusion criteria,a questionnaire was conducted on patients who had been diagnosed with chronic bone disease and blood stasis syndrome by doctors with associate senior titles or above in outpatient and ward of the hospital.The doctors who conducted the questionnaire survey were professionally trained,and the researchers could assist in filling out the questionnaire in a certain range.The content of the questionnaire should be filled out carefully and completely,and the data should not be modified randomly.The basic information,syndromes and symptoms of patients were input into EXCEL,and the data were analyzed by SPSS 25.0.The measurement data were expressed as(±s),and the count data were expressed as frequency and percentage[n(%)].The characteristics of weight,age,gender,height,body mass index and TCM syndromes were analyzed.3 Clinical Verification of Traditional Chinese Medicine Syndrome Differentiation Standards for Chronic Bone Disease with Blood Stasis Syndrome.Through the investigation of patients with blood stasis syndrome of chronic bone disease by clinical questionnaire,the real content of the questionnaire was evaluated by the feasibility.Pearson correlation coefficient and factor analysis were used to test the validity of TCM syndrome differentiation criteria.SPSS 25.0 software was used to test the internal consistency reliability of the questionnaire,Cronbach’s a coefficient,and the split-half coefficient method was used to test the reliability of the TCM syndrome differentiation standard questionnaire.Through the analysis of the test results,the syndrome/symptom items were combined,increased or decreased,and the TCM syndrome differentiation criteria of blood stasis syndrome of chronic bone disease were finally determined after optimization.Results1 Construction of traditional Chinese medicine syndrome differentiation standard questionnaire for chronic bone disease with blood stasis syndrome based on Delphi method.1.1 The first round of expert questionnaire entries determined by literature search and expert consultation.A total of 17598 literatures were retrieved,and 2477 literatures were finally obtained after two rounds of screening by 6 researchers.By extracting data such as syndromes and symptoms from the literatures,we initially obtained 26 TCM syndrome items,among which the top 10 in frequency were tongue ecchymosis or petechasis,tingling,light day and heavy night,and pain refusing to press.Items were added,deleted and revised,and the first round of TCM syndrome differentiation standard and TCM syndrome items expert questionnaire of chronic bone disease blood stasis syndrome was preliminarily formed.Cervical spondylosis accounted for 77.67%of the reference diagnostic criteria of TCM.Osteoporosis accounted for 43.55%of the reference diagnostic criteria of "Guiding Principles for Clinical Research of New Chinese Medicine".Questionnaire distribution and collection status,as well as information on participating experts.1.2 Distribution and collection of questionnaires and information of participating experts.In the first round,10 electronic questionnaires were distributed,and 10 valid questionnaires were recovered.In the second round,25 questionnaires were distributed,and 24 valid questionnaires were recovered.The active coefficients of experts were 100%and 92.31%respectively.The experts who participated in the two rounds of questionnaires were from more than 20 hospitals or scientific research institutes in 14 provinces and cities such as Beijing,Shanghai and Guangdong,respectively.None of the experts who participated in the first round participated in the questionnaire in the second round.More than 50%of the experts suggested that the representative diseases of chronic bone disease were knee osteoarthritis,osteoporosis,osteonecrosis of the femoral head,lumbar disc herniation,and cervical spondylosis.The core pathogenesis of blood stasis syndrome of chronic bone disease was blood stasis,and blood stasis syndrome of chronic bone disease ran through the whole process.1.3 Selection of Traditional Chinese Medicine Syndrome Differentiation Criteria for Chronic Bone Disease with Blood Stasis Syndrome by Experts.The first round of experts had a high degree of concentration and coordination on 13 indicators,including tingling,pain fixed,induration,dark complexion,blood from meridian,limited activity,dark tongue,dark purple tongue,dark purple and dark collaterality under tongue,petechial or petechial tongue,astringent pulse,heavy pulse and astringent pulse.The average score()>7,importance degree K>70%,inimportance degree(R)=0,and expert coordination degree(CV)<20%were satisfied.In the second round of experts,the concentration degree and coordination degree of 9 indicators of tingling,pain fixation,pain rejection,limited movement,dark tongue,dark sublingual collaterality,ecchymosis or petectomy of the tongue,astringence of pulse and astringence of pulse chord were high,all of which met the average score>6.5,the importance degree K>50%,the inimportance degree R<10%,and the expert coordination degree CV<30%.Finally,it was determined that the pain did not press,tingling,resting pain,pain fixation,light day and heavy night,pain aggravation after activity,muscle atrophy,activity limitation,limb/skin numbness,dark face,blood from meridians/skin ecchymosis,dark lips and claws,astringent/heavy astringent/stringy astringent/fine astringent,dark tongue,dark sublingual collaterals,dark tongue,and ecchymosis or petechiae on the tongue could be used as the TCM syndrome syndrome of blood stasis syndrome of chronic bone disease Items of the bed questionnaire.2 Basic Information,Traditional Chinese Medicine Syndromes,and Symptom Investigation of Chronic Bone Disease with Blood Stasis Syndrome.2.1 Basic information analysis of the population with blood stasis syndrome in chronic bone disease.There were 46 males(46%)and 54 females(54%).The average age was 57.68 years old,the standard deviation was 16.13 years old,the youngest age was 15 years old,the oldest age was 86 years old.The mean weight was 70.97KG(standard deviation 12.67KG).The average height was 1.65 meters,standard deviation was 0.08 meters;The average BMI was 25.85kg/m2,and the standard deviation was 3.87kg/m2.The young people aged 18-45 years accounted for 21%,the middle-aged people aged 46-59 years accounted for 28%,and the largest proportion was the elderly population.2.2 Traditional Chinese Medicine Syndrome and Symptom Frequency of Chronic Bone Disease with Blood Stasis Syndrome.The frequency and sensitivity of clinical symptoms/symptoms in patients with chronic bone disease with blood stasis syndrome exceed 40%.The top ranked ones include fixed pain,refusal to press pain,tingling,limited activity,dull tongue,astringent pulse/sinking/stringing/fine astringency,purple and dark sublingual collaterals,blood/skin ecchymosis after menstruation,ecchymosis or ecchymosis on the tongue,increased pain after activity,and dull and purple tongue,all exceeding 60%of the frequency and sensitivity.3 Clinical Verification of Traditional Chinese Medicine Syndrome Differentiation Standards for Chronic Bone Disease with Blood Stasis Syndrome.3.1 Feasibility of the survey questionnaire.112 survey questionnaires were distributed,108 were recovered,and 8 were found to be unqualified.A total of 100 qualified questionnaires were obtained.The recovery rate and effectiveness rate of the survey questionnaires were above 90%,and the completion time was within 5 minutes,indicating the feasibility and strong practicality of this questionnaire in clinical application.3.2 Reliability evaluation of screening questionnaires.After statistical analysis of the syndrome items in the survey questionnaire,it was found that the questionnaire items were included a The value is 0.734,and the coefficient of half reliability is 0.649,indicating that the questionnaire items composed of traditional Chinese medicine differentiation standards for chronic bone disease with blood stasis syndrome have good consistency and half reliability.3.3 Validity evaluation of screening questionnaires.The structural validity of this questionnaire was measured using factor analysis.The results showed that the Kaiser Mayer Olkin test value was 0.628,Bartlett’s sphericity test approximate chi square was 662.761,the degree of freedom was 136,and p<0.01,indicating that further factor analysis can be conducted on this questionnaire.Through principal component analysis,a total of 7 common factors were extracted,with a cumulative variance contribution rate of 72.833%.The extracted 7 factors included dimensions such as pain properties,lips and sublingual dullness and ecchymosis,and tongue veins.All entries have a high load value(>0.5)on all factors,so there is no need to modify the entries,indicating good structural validity. |
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