| ObjectiveThis study uses Danshen injection as a starting point to treat primary dysmenorrhea of qi stagnation and blood stasis type through randomized controlled clinical trials.Efficacy and safety assessment provide scientific basis for acupuncture differentiation and treatment of primary dysmenorrhea,and provide scientific evidence for the optimization of acupuncture treatment of primary dysmenorrhea.MethodsAll subjects participating in the study were from patients with primary dysmenorrhea of qi stagnation and blood stasis type recruited from either network or department of acupuncture,Guangdong Provincial Hospital of Traditional Chinese Medicine.Time of case collection time is from March 2019 to October 2019,a total of 70 volunteers with primary dysmenorrhea of qi stagnation and blood stasis who met the inclusion criteria were collected.Grouping method:envelope method was used to randomly divide all patients into treatment group and control group.Intervention:The treatment group was Danshen injection acupoint injection method,Zigong,Xuehai,Sanyinjiao acupoints were selected,each point was injected with 0.5ml Danshen injection;the control group was Danshen injection non-acupoint injection method.The non-acupoint injection point is 2cm away from Zigong,Xuehai,Sanyinjiao.The rest of the operation methods are the same as those in the treatment group.Sessions:once every 2 days from 7 to 10 days before menstruation,3 times a month menstrual cycle is 1 course,a total of 3 courses 9 times,and follow-up for 1 month,Efficacy evaluation was performed before treatment,at the end of each course of treatment,and at five points during the follow-up period.Efficacy evaluation indicators included VAS score,TCM syndrome score,and CMSS dysmenorrhea scale.All data were managed and analyzed by SPSS19.0 statistical analysis software.Measurement data were expressed as mean ±standard deviation.Repeated measurement data were analyzed by repeated measurement data variance analysis.Ranked data were used by rank sum test.The significance level was P=0.05.Results8 cases fell off during the study process,3 cases fell off in the treatment group,5 cases fell off in the control group,and finally 32 cases of Danshen injection acupoint injection group and 30 cases of Danshen injection non-acupoint injection group.1.Baseline comparison:There was no significant difference between the two groups in terms of age,menarche age,menstrual period,menstrual cycle,course of disease,VAS,TCM syndrome evaluation,dysmenorrhea symptom score(symptom severity,total symptom frequency)(P>0.05)comparable.2.Impact on VAS scores:Compared with before treatment,the VAS scores of the treatment group and the control group were significantly lower after the first,second,and third treatment courses and during the follow-up period,and the differences were statistically significant(P<0.05).With the increase of the course of treatment,the VAS score decreased more significantly,and the difference between the courses was statistically significant(P<0.05);the score during the follow-up period was slightly higher than after the third course,but there was no statistical difference between the two was not statistically significant(P>0.05).Comparisons between groups showed statistically significant differences in VAS scores at each time point(P<0.05).Compared with the control group,the treatment group made the VAS decline trend more obvious.3.Impact on TCM syndrome scores:Compared with before treatment,the TCM syndrome scores in the treatment group and the control group were significantly lower after the first,second and third treatment courses and during the follow-up period.The differences were statistically significant(P<0.05);with the increase of the course of treatment,the TCM syndrome score decreased more significantly,and the differences between the nodes were statistically significant(P<0.05).The score during the follow-up period was slightly higher than after the third course of treatment.Comparison between groups,except for the second course of treatment,the differences of TCM syndrome scores at each time point were statistically significant(P＜0.05).Compared with the control group,the treatment group made the trend of TCM syndrome scores more obvious.4.Impact on CMSS dysmenorrhea symptoms score:Compared with before treatment,the CMSS dysmenorrhea symptoms score(severity,total frequency)in the treatment group and the control group were both after the first,second and third treatment courses and during the follow-up period.Significantly lower than before treatment,the differences were statistically significant(P<0.05);with the increase of the course of treatment,the CMSS dysmenorrhea symptom score decreased more significantly,the differences between the nodes were statistically significant(P＜0.05),and the follow-up score was slightly higher After the third course.Comparison between groups,except for the first course,the CMSS dysmenorrhea symptom scores at different time points were statistically significant(P＜0.05).Compared with the control group,the treatment group made the CMSS dysmenorrhea symptom scores decline more significantly.5.Comparison of curative effect between groups:The clinical curative effect was evaluated by changing the VAS score.After the third course of treatment,the total effective rate of the treatment group was 93.75%,and the total effective rate of the control group was 86.67%.The comparison between groups was P＜0.05,and the difference was statistically significant.The clinical effect was evaluated by the change of TCM syndrome score.After the third course of treatment,the total effective rate of the treatment group was 90.60%,and the total effective rate of the control group was 83.30%.The comparison between the groups was(P＜0.05),and the difference was statistically significant.Conclusions(1)The treatment group and the control group are effective in treating primary dysmenorrhea of qi stagnation and blood stasis type,which can reduce the painful degree of dysmenorrhea,improve the symptoms of traditional Chinese medicine,reduce the frequency of dysmenorrhea and improve clinical symptoms.(2)Within a certain course of treatment,the longer the course of treatment in the treatment group and the control group,the better the clinical effect.(3)The curative effect of the treatment group is better than that of the control group,suggesting that the selection of acupoints and Danshen injection for the specificity of dysmenorrhea of qi stagnation and blood stasis type,and the acupoints may have a synergistic effect on the injected drugs. |
PDF Full Text Request