内异膏治疗肾虚血瘀证子宫内膜异位症痛经的临床疗效研究

Clinical Effect of Neiyi Soft Extract in Treating Dysmenorrhea Induced by Endometriosis and Differentiated as Syndrome of Kidney Deficiency and Blood Stasis

【目的】探讨内异膏治疗肾虚血瘀证子宫内膜异位症(EM)痛经的临床疗效。【方法】将70例肾虚血瘀证EM痛经患者随机分为内异膏方组和内异方汤剂组,每组各35例。内异膏方组给予内异膏治疗,内异方汤剂组给予内异方汤剂治疗,均在非经期服用,经期停服,疗程为3个月。观察2组患者治疗前后痛经视觉模拟量表(VAS)评分、痛经程度评分及血清糖类抗原125(CA125)水平的变化情况,评价2组患者的痛经疗效和安全性。【结果】(1)本研究共完成病例观察66例,其中内异膏方组和内异方汤剂组各33例。(2)治疗3个月后,内异膏方组的总有效率为100.0%(33/33),内异方汤剂组为84.8%(28/33);组间比较(Mann-Whitney U检验),内异膏方组的痛经疗效明显优于内异方汤剂组,差异有统计学意义(P<0.05)。(3)治疗3个月后,2组患者的痛经VAS评分和痛经程度评分均较治疗前明显降低(P<0.05),且内异膏方组的降低作用均明显优于内异方汤剂组,组间治疗后及治疗前后差值比较,差异均有统计学意义(P<0.05)。(4)治疗3个月后,内异膏方组患者的血清CA125水平较治疗前有所降低(P<0.05),而内异方汤剂组患者的血清CA125水平较治疗前有所升高(P<0.05),内异膏方组对血清CA125水平的降低作用明显优于内异方汤剂组,组间治疗后及治疗前后差值比较,差异均有统计学意义(P<0.05)。(5)2组患者治疗前后血常规和谷丙转氨酶、肌酐等肝肾功能指标均无明显异常。【结论】内异膏方组治疗肾虚血瘀证EM痛经的疗效明显优于内异方汤剂组,且服用方便,治疗过程安全、无副作用。

Objective To observe the clinical efficacy of Neiyi Soft Extract for the treatment of dysmenorrhea induced by endometriosis(EM)and differentiated as the syndrome of kidney deficiency and blood stasis.Methods Seventy cases of EM-induced dysmenorrhea patients with the syndrome of kidney deficiency and blood stasis were randomly divided into Neiyi Soft Extract group and Neiyi Decoction group,35 cases in each group.The patients of the two groups were given oral use of Neiyi Soft Extract or Neiyi Decoction according to the trial design in the nonmenstrual period,and the medication was suspended during the menstrual period.The course of treatment lasted for 3 consecutive months.Before and after treatment,the visual analogue scale(VAS)scores for dysmenorrhea,scores for dysmenorrhea grading,and serum carbohydrate antigen 125(CA125)in the two groups were observed,and then the clinical efficacy and safety for dysmenorrhea were evaluated.Results(1)A total of 66 cases completed the trial,33 cases from Neiyi Soft Extract group and 33 cased from Neiyi Decoction group.(2)After 3 months of treatment,the total effective rate in Neiyi Soft Extract group was 100.0%(33/33)and that in Neiyi Decoction group was 84.8%(28/33).The intergroup comparison by Mann-Whitney U test showed that the clinical efficacy of Neiyi Soft Extract group was stronger than that of Neiyi Decoction group,and the difference was statistically significant(P<0.05).(3)After 3 months of treatment,VAS scores for dysmenorrhea and scores for dysmenorrhea grading in the two groups were obviously decreased in comparison with those before treatment(P<0.05),and the decrease of the scores in Neiyi Soft Extract group was superior to that in Neiyi Decoction group,the differences of the scores after treatment and the difference value of pre-and post-treatment scores between the two groups being statistically significant(P<0.05).(4)After 3 months of treatment,the serum CA125 level in Neiyi Soft Extract group was decreased(P<0.05),while the CA125 level in Neiyi Decoction group was increased(P<0.05)in comparison with that before treatment.The effect of Neiyi Soft Extract group on decreasing CA125 level was superior to that of Neiyi Decoction group,and the differences of the CA125 level after treatment and the difference value of pre-and post-treatment CA125 level between the two groups was statistically significant(P<0.05).(5)No abnormality was found in the routine test for blood,or in the indexes of liver and kidney function such as alanine transaminase and creatinine in the two groups before and after treatment.Conclusion Neiyi Soft Extract group is more effective and safer than Neiyi Decoction group for the treatment of EM-induced dysmenorrhea patients with the syndrome of kidney deficiency and blood stasis,and the medication of the soft extract is more convenient than the decoction.