温通散神阙穴敷贴治疗寒凝血瘀型原发性痛经的疗效及作用机制研究

Efficacy and mechanisms of Wentong Powder with Shenque acpoint application in the treatment of primary dysmenorrhea with syndrome of blood stasis due to coagulated cold

目的观察温通散神阙穴敷贴治疗寒凝血瘀型原发性痛经的临床疗效,并探讨其可能的起效机制。方法将72例寒凝血瘀型原发性痛经患者随机分为治疗组与对照组,每组36例。对照组予布洛芬缓释胶囊,治疗组予温通散神阙穴敷贴。两组疗程均为2个月经周期,观察比较中医证候积分,以及血清相关指标环氧化酶-2(COX-2)、前列腺素PGF_(2α)及PGE_2、白介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、雌二醇(E2)、孕酮(P)的变化情况。结果 (1)治疗前后组内比较,两组中医证候积分差异均有统计学意义(P<0.05);组间治疗前后差值比较,治疗组中医证候积分改善明显优于对照组(P<0.05)。(2)治疗前后组内比较,两组COX-2、PGF_(2α)、PGF_(2α)/PGE_2水平均明显下降(P<0.01);治疗组PGE_2水平明显升高(P<0.01),对照组PGE_2水平明显降低(P<0.01)。组间治疗后比较,两组COX-2、PGF_(2α)、PGE_2水平差异显著(P<0.01),而PGF_(2α)/PGE_2差异尚无统计学意义(P>0.05)。(3)治疗前后组内比较,两组IL-6、TNF-α水平均明显下降(P<0.01);组间治疗后比较,IL-6及TNF-α水平差异有统计学意义,治疗组明显低于对照组(P<0.05)。治疗前后组内比较,治疗组E_2水平明显升高(P<0.01),对照组E_2水平无明显变化(P>0.05),两组P水平均无明显变化(P>0.05);组间治疗后比较,治疗组E_2水平明显高于对照组(P<0.01)。(4)试验期间,两组均未见不良反应;治疗前后,两组患者血常规、二便常规、肝肾功能均未检出异常。结论温通散神阙穴敷贴治疗寒凝血瘀型原发性痛经,可显著改善患者痛经情况,其机制可能是通过升高E_2,降低COX-2、IL-6、TNF-α,调节前列腺素(降低PGF_(2α),升高PGE_2)水平等多靶点或通路而实现。

Objective To observe the clinical efficacy of Wentong Powder with Shenque acpoint application in the treatment of primary dysmenorrhea with syndrome of blood stasis due to coagulated cold,and discuss its possible mechanisms. Methods 72 patients of primary dysmenorrhea with syndrome of blood stasis due to coagulated cold were randomly divided into the treatment group and control group,36 cases in each group. The control group was treated with ibuprofen sustained release capsules and the treatment group was treated with acpoint application of Wentong Powder at Shenque point（ CV8）,with a course of 2 menstrual cycles. The Chinese medical syndrome score was compared,and the changes on the serum levels of cyclooxygenase-2（ COX-2）,prostaglandin F2α（ PGF2α）,prostaglandin E2（ PGE2）,interleukin-6（ IL-6）,tumor necrosis factor-α（ TNF-α）,estradiol（ E2） and progesterone（ P） were observed and compared. Results（1）In both groups,there was statistically significant difference on Chinese medical syndrome score between treatment before and after（ P〈0.05）. After treatment,the improvement on Chinese syndrome score in the treatment group was obviously better than that in the control group（ P〈0.05）.（2）Compared with treatment before,the levels of COX-2,PGF2α and PGF2α/PGE2 were significantly decreased in both groups after treatment（ P〈0.01）,the level of PGE2 was significantly increased in the treatment group（ P〈0.01） but obviously decreased in the control group（ P〈0.01）. After treatment,there were statistically significant differences on the levels of COX-2,PGF2α and PGE2 between the two groups（ P〈0.01）,while there was no statistically significant difference on the level of PGF2α/PGE2 between the two groups（ P〉0.05）.（3）Compared with treatment before,the levels of IL-6 and TNF-α were significantly decreased in both groups after treatment（ P〈0.01）.After treatment,there were statistically significant differences on the levels of IL-6 and TNF-α between the two groups,and the levels in the treatment group were obviously lower than those in the control group（ P〈0.05）. Compared with treatment before,the E2 level was significantly increased in the treatment group（ P〈0.01） but no obvious change was found in the control group（ P〉0.05）after treatment. There was no obvious change on the P level in both groups（ P〉0.05）. After treatment, the E2 level in the treatment group was significantly higher than that in the control group（ P〈0.01）.（4） During the trial,no adverse reactions were observed in both groups,and no abnormality in routine examinations of blood,urine,stool and liver and kidney function was detected in both groups before and after treatment. Conclusion Wentong Powder with Shenque acpoint application in the treatment of primary dysmenorrhea with syndrome of blood stasis due to coagulated cold can significantly improve the dysmenorrhea in patients. Its mechanisms may be related to increasing E2,decreasing COX-2,IL-6 and TNF-α and regulating PGs（ decreasing PGF2αand increasing PGE2）.