| Objective: To develop a safe,effective and easy-to-operate heat-sensitive moxibustion instrument and observe its clinical efficacy and safety.method:This research is mainly divided into two parts:1.Development and testing of heat-sensitive supervisory moxibustion instrument:The heat-sensitive supervisor-moxibustion instrument was developed through the quantitative transformation of data from the clinical application of heat-sensitive supervisor-moxibustion in the early stage.Randomly select 30 heat-sensitive supervisor-moxibustion instruments,and observe the temperature changes of various parts of the moxibustion instruments during the moxibustion process of the heat-sensitive supervisor-moxibustion instruments under standardized operation to detect their safety;Its sensitivity;the temperature change of the bottom partition contacting the skin surface to detect whether it meets the needs of clinical supervisor moxibustion,and provide a reference for the next clinical use.2.Clinical detection and curative effect observation of heat-sensitive supervisor moxibustion instrument:A total of 60 patients with lumbar intervertebral disc herniation of cold-damp obstruction type were selected and randomly divided into a treatment group(heat-sensitive governor moxibustion instrument group)and a control group(general governor moxibustion group),30 cases in each group,and the treatment group was given a heat-sensitive governor moxibustion instrument,Moxibustion was applied for 1h,and the control group was treated with ordinary governor moxibustion for 1h.Both groups were treated once every other day,10 times as a course of treatment,a total of 1 course of treatment.After the course of treatment,the VAS visual analog scale and the Japanese Orthopaedic Association JOA lumbar spine function score were used to evaluate the efficacy indicators,and the efficacy was observed.Its clinical safety and efficacy.result:1.Based on the success of thermosensitive supervisor moxibustion in the early stage,a thermosensitive supervisor moxibustion instrument with easy operation and efficient temperature control was developed.2.The detection results of the maximum temperature of each part of the heat-sensitive supervisor moxibustion instrument in different states: in the state of large holes: the center of the top of the moxibustion is about46.8 °C,the center of the outer wall is about 45.3 °C,the middle of the edge of the bottom of the moxibustion is about 44.6 °C,The center of the gingerbread is about 45.2°C,the middle of the edge of the gingerbread is about 45.4°C,and in the mesoporous state,it is: about45.3°C in the center of the top of the moxibustion,about 44.6°C in the center of the outer wall,about 43.4°C in the middle of the edge of the bottom of the moxibustion,The center of the gingerbread is about 44.2°C,the middle of the edge of the gingerbread is about 43.5°C,and in the state of the small holes,respectively: the center of the top of the moxibustion is about 41.3°C,the center of the outer wall is about 40.1°C,the center of the edge of the bottom of the moxibustion is about 39.2°C,The center of the gingerbread is about 39.7°C,and the center of the edge of the gingerbread is about 39.4°C.The thermosensitive moxibustion instrument can maintain constant temperature for about 60 minutes in the state of large holes,about 80 minutes under the state of medium holes,and about 100 minutes under the state of small holes.The values ??are all greater than 0.05,which is in line with the normal distribution.3.The detection results of the temperature change under different hole positions of the heat-sensitive supervisor-moxibustion instrument: the thermo-sensitive supervisor-moxibustion instrument has a large hole constant temperature of about 45°C,and the time it takes to reach the middle hole constant temperature of 42°C after being adjusted to the middle hole is about 1 minute.And the constant temperature can be maintained for 60 min.After adjusting to the small hole,the time to reach the constant temperature of the small hole at 39℃ is about 1 minute,and the constant temperature can be maintained for 80 min.After the normality test of each group of data,the P value is greater than 0.05,indicating that The data were not statistically significant and conformed to a normal distribution.4.A total of 57 cases were completed in the clinical trial.One person in the treatment group fell off due to personal reasons,one person in the control group fell off after receiving other treatments,and the other was excluded due to back burns.There were no significant differences in the course of disease,gender,age,and VAS score and JOA score before treatment between the groups(P>0.05).5.The comparison results of the stimulation rate of moxibustion and the duration of moxibustion: the stimulation rate of moxibustion in the treatment group was 79.31%,and the stimulation rate of moxibustion in the control group was 42.86%.After chi-square test,P<0.05,the difference was statistically significant.The average duration of moxibustion sensation in the heat-sensitive supervisor moxibustion instrument group was about 40 minutes,while the average moxibustion sensation duration in the ordinary supervisor moxibustion group was about20 minutes.6.Analysis of the temperature change results of clinical use of heat-sensitive supervisor-moxibustion instrument: The temperature change of the clinical thermo-sensitive supervisor-moxibustion instrument during the moxibustion process was about 42.7°C,42.7°C and42.7°C at 10 min,20min,30 min,40min,50 min,and 60 min,respectively.℃,42.8℃,42.8℃,42.8℃,42.6℃,after the normality test of the data in each group,the P values ??were all greater than 0.05,indicating that the data were not statistically significant and conformed to the normal distribution.7.Comparison of VAS score and JOA score: the VAS scores of the control group and the treatment group were both decreased(the VAS difference in the treatment group was 4.62,and the VAS difference in the control group was 3.54).The VAS was 2.1,and the VAS of the control group after treatment was 3.39),and the difference was statistically significant(P<0.05).The JOA lumbar spine function scores in the control group and the treatment group were both decreased to a certain extent(the difference in JOA in the treatment group was 9.38,and the difference in JOA in the control group was 7.75).The improvement was more obvious(the JOA in the treatment group was 21.51 after treatment,and the JOA in the control group was 18.5after treatment).8.Results of safety evaluation: Among the 60 patients included,one person suffered a scald of the back due to the failure to handle it in time during the treatment process.None of the patients had serious adverse medical events such as moxibustion burns,scalds,allergies,halo moxibustion,and aggravation.8.Comparison results of clinical efficacy: the total effective rate was96.55% in the treatment group and 82.14% in the control group.The markedly effective rate was 51.72% in the treatment group and 25.00% in the control group.After the rank sum test,P<0.05,the difference was statistically significant.in conclusion:(1)The heat-sensitive supervisor moxibustion instrument can greatly improve the stimulation rate of moxibustion sensation and the duration of moxibustion sensation.It has a good clinical effect on lumbar disc herniation and is worthy of clinical promotion.(2)The heat-sensitive supervisor moxibustion instrument developed this time has good safety performance and temperature control effect,and can meet clinical needs. |
PDF Full Text Request