| Objective:With Chronic Pelvic Inflammatory Disease(CPID,cold-dampness stagnation type)patients as the research object,and the clinical efficacy of the heat-sensitive moxibustion combined with TCM enema on this disease was observed and evaluated,at the same time,it is also compared with TCM enema therapy,so as to provide a scientific basis for the effectiveness of heat-sensitive moxibustion.Methods:A total of sixty-eight patients who met the inclusion criteria of this study which collected in the clinical were randomly divided into heat-sensitive moxibustion combined with TCM enema therapy(treatment group)and TCM enema therapy by Shaofu Zhuyu Decoction(control group).There were 34 cases in each group.The two groups were once a day for treatment,10 times as a course,and a total treatment for 3 courses.TCM symptom score,the integral of clinical signs,WHOQOL-BREF,Visual Analogue Score/Scale(VAS),Hemorheology indexes and the Ultrasonography result as the observation indexes.The changes of various observation indexes were recorded,including before and after treatment,and the patients were followed up for 3 months after treatment to observe its long-term efficacy and recurrence rate.The clinical efficacy was evaluated according to the symptoms and signs of chronic pelvic inflammatory disease(CPID)that established in 《 Guidelines for clinical research of Traditional Chinese drug research 》,and also evaluated according to the diagnostic criteria of CPID that formulated by CDC.In the meantime,all adversereactions that occurred during the entire treatment were recorded by practician,including the time of occurrence,specific symptoms,treatment and results.the efficacy was calculated by the Nimodipine method.IBM SPSS 21.0 statistical software was used for data statistical processing.Results:1.The statistics analysis of Age,course of disease,degree of illness,TCM symptoms score,the clinical signs,WHOQOL-BREF scores,VAS score,Hemorheology indexes of two groups,the results were no statistically significant(P >0.05),which shows that the baseline data of the two groups are comparable.2.After therapy,the paired sample t test was used to analysis within the two groups,and the differences was statistically significant(P<0.01),means that the scores of both group were decreased obviously.The TCM symptom scores were significantly reduced in the two groups after treatment,and according to t-test(P>0.05),indicating that the two groups of treatments can improve clinical symptoms well.According to the independent sample t-test,the differences of the local physical sign scores and comprehensive scores that in the two groups were statistically significant(P < 0.05),pointing that the treatment group had better clinical effect than the control group;Comparison of the effective rate of TCM symptoms after treatment between the two groups by rank sum test(P<0.05),and compared to the control group(70.59%),the effectiveness of the treatment group(94.11%)was obviously higher;Comparison of the effective of clinical signs between two groups,the differences were statistically significant(P<0.05),the treatment group’s effectiveness(94.10%)was apparently higher than the control group(79.40%),indicating that compared with the control group,the treatment group was better at improving clinical signs;The synthesized effecacy of the two groups was compared using the rank sum test(P<0.05),the effectiveness of the treatment group(91.17%)was superior to the control group(76.47%).3.WHOQOL-BREF:the scores of the two groups were analyzed using the independent sample t-test.Before treatment,there was no significant differencebetween two groups(P>0.05),and the patients had the lowest scores in the psychological field and their own health status.After therapy,the paired sample t-test was used to analysis within the two groups,and the differences was statistically significant(P<0.01),the scores of each fields of the two groups were increased significantly.The evaluation in the physical field,psychological field,and self-health status after treatment between the two groups according to the independent sample t-test(P<0.05),which indicated that the treatment group was better than the control group.while,there was no significant difference(P > 0.05)in the comparison between social and environmental field of the two groups.4.VAS score: the VAS score of the two groups ware analyzed by the independent sample t-test.There was no statistical significance(P > 0.05)before treatment,means the two groups were comparable;The difference between the two groups was analyzed after treatment(P<0.05),it shows that the treatment group was better than the control group in relieving pain.5.Hemorheology index:the Hemorheological indexes that before and after treatment of the two groups were analyzed by the independent sample t-test.Before treatment,the differences of the indexes in the two groups were no significant(P > 0.05),which means the indexes of the two groups was comparable.The indexes that before and after therapy of the treatment group and control group were analyzed by the paired sample t-test analysis separately(P< 0.01),there is indication that the treatments of two groups are effective;After treatment,the comparison of the index between the treatment group and the control group have a significant statistical difference(P<0.05),it shows that the treatment group improved the indicators of Hemorheology,obviously better than the control group.6.Ultrasonography result:the differences of the Ultrasonography result between the the two groups after therapy were analyse by Chi-square test(P<0.05).The treatment group’s effective rate(83.33%)was higher than the control group(65.20%),shows that the treatment group has better effectivenesson improving or eliminating pelvic effusion and inflammatory mass than the control group.7.Recurrence rate:according to Kaplan meier analysis,the recurrence rate of the two group in 3 month was statistically significant(P<0.05),it shows that the treatment group’s recurrence rate was lower than the control group,and in terms of long-term efficacy,the treatment group was higher than the control group.Conclusion:Heat-sensitive moxibustion combined with traditional Chinese medicine enema therapy can obviously improve the clinical symptoms and related signs of patients with chronic pelvic inflammatory disease(cold and dampness stagnation type),it has a significant effect to reduce or even eliminate the patient suffering,enhance the quality of patient’s life.In addition,heat-sensitive moxibustion therapy is safe and effective,operated easily,non-toxic and side effect,also economical.Therefore,it worth to popularize and application in the treatment of CPID. |
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