加味没竭片治疗气滞血瘀型原发性痛经的临床研究

Clinical research on Jiawei Mojie Tablets in treating primary dysmenorrhea of qi stagnation and blood stasis syndrome

目的观察加味没竭片治疗气滞血瘀型原发性痛经的临床疗效。方法将73例气滞血瘀型原发性痛经患者随机分为治疗组35例、对照组38例。对照组予布洛芬治疗,治疗组予加味没竭片治疗,两组疗程均为3个月经周期。观察临床疗效,比较疼痛视觉模拟评分(VAS)、中医症状积分,血清炎症因子、β-内啡肽水平,以及焦虑自评量表(SAS)、抑郁自评量表(SDS)评分的变化情况。结果①试验期间治疗组脱落3例、对照组脱落4例,最终完成试验者治疗组32例、对照组34例。②治疗组、对照组总有效率分别为78.12%、55.88%,治疗组临床疗效优于对照组(P<0.05)。③治疗前后组内比较,两组疼痛VAS评分减少(P<0.05);组间治疗后比较,治疗组疼痛VAS评分少于对照组(P<0.05)。④治疗前后组内比较,治疗组腹痛、经血血块、乳房胀痛、肛门坠胀积分及中医症状总积分减少(P<0.05),对照组腹痛积分及中医症状总积分减少(P<0.05);组间治疗后比较,治疗组腹痛、经血血块、乳房胀痛、肛门坠胀积分及中医症状总积分少于对照组(P<0.05)。⑤治疗前后组内比较,治疗组血清白介素-6水平降低(P<0.05),血清白介素-10、β-内啡肽水平升高(P<0.05);对照组血清β-内啡肽水平升高(P<0.05)。组间治疗后比较,血清白介素-6、白介素-10、β-内啡肽水平差异无统计学意义(P>0.05)。⑥治疗前后组内比较,治疗组SDS评分减少(P<0.05),对照组SAS、SDS评分无明显变化(P>0.05);组间治疗后比较,治疗组SDS评分低于对照组(P<0.05)。结论加味没竭片可有效缓解气滞血瘀型原发性痛经患者的临床症状,改善抑郁情绪状态;其机制可能与降低血清白介素-6水平、升高血清白介素-10水平,从而改善炎症状态,以及促进内源性阿片类镇痛物质β-内啡肽的分泌,进而降低痛阈有关。

Objective To investigate the clinical effect of Jiawei Mojie Tablets on primary dysmenorrhea of qi stagnation and blood stasis syndrome.Methods Seventy-three cases of primary dysmenorrhea of qi stagnation and blood stasis syndrome were randomly divided into a treatment group(n=35)and a control group(n=38).The control group was administered with ibuprofen,while the treatment group was administered with Jiawei Mojie Tablets.The duration of treatment for both groups was 3 menstrual cycles.We observed the clinical efficacy,and compared the changes of pain visual analogue scale(VAS)scores,traditional Chinese medicine(TCM)symptom scores,the serum levels of inflammatory factors andβ-endorphin,the Zung Self-Rating Anxiety Scale(SAS)scores and the Zung Self-Rating Depression Scale(SDS)scores before and after intervention.Results①During the trial,there were 3 drop-out cases in the treatment group and 4 drop-out cases in the control group,and 32 cases in the treatment group and 34 cases in the control group finally completed the trial.②The total effective rate was 78.12%in the treatment group and 55.88%in the control group.The clinical efficacy of the treatment group was better than that of the control group(P<0.05).③After treatment,the pain VAS scores decreased in both groups(P<0.05);The pain VAS scores in the treatment group were lower than those in the control group(P<0.05).④After treatment,the sub-dimension scores of abdominal pain,menstrual blood clots,breast distension and pain,anal pendant expansion and total TCM symptom scores decreased in the treatment group(P<0.05),and the sub-dimension scores of abdominal pain and total TCM symptom scores decreased in the control group(P<0.05);After treatment,the sub-dimension scores of abdominal pain,menstrual blood clots,breast distension and pain,anal pendant expansion and total TCM symptom scores in the treatment group were lower than those in the control group(P<0.05).⑤After treatment,the serum level of interleukin-6(IL-6)decreased(P<0.05)and the serum levels of interleukin-10(IL-10)andβ-endorphin increased(P<0.05)in the treatment group,the serum levels ofβ-endorphin increased(P<0.05)in the control group.After treatment,the differences in serum levels of IL-6,IL-10 andβ-endorphin between the two groups were not statistically significant(P>0.05).⑥After treatment,SDS scores decreased in the treatment group(P<0.05),but SAS and SDS scores did not change significantly in the control group(P>0.05).After treatment,SDS scores in the treatment group were lower than those in the control group(P<0.05).Conclusions Jiawei Mojie Tablets can effectively alleviate the clinical symptoms and improve the depressed emotional state of patients with primary dysmenorrhea of qi stagnation and blood stasis syndrome.The mechanisms involved may be that Jiawei Mojie Tablets can lower IL-6 level,raise IL-10 level,reduce inflammation,and promote the secretion of endogenous opioid analgesic substanceβ-endorphin,which in turn lowers pain threshold.