痛经宁方对气滞血瘀型子宫内膜异位症患者临床疗效研究

Clinical Effect of Tongjingning Formula in the Treatment of Endometriosis of Qi Stagnation and Blood Stasis Type

【目的】观察痛经宁方治疗气滞血瘀型子宫内膜异位症患者的临床疗效。【方法】将60例气滞血瘀型子宫内膜异位症患者随机分为中药组和西药组,每组各30例。中药组患者给予中药痛经宁方口服治疗,对照组患者给予醋酸亮丙瑞林肌肉注射治疗,疗程为3个月,疗程结束后随访3个月。观察2组患者治疗前后疼痛视觉模拟量表(VAS)评分、中医证候评分和血清癌抗原125(CA125)和细胞间黏附分子1(ICAM-1)、基质金属蛋白酶9(MMP-9)、血管内皮生长因子(VEGF)水平的变化情况,并评价2组的近期疗效和远期疗效。【结果】(1)近期疗效:治疗3个月后,中药组的总有效率为80.0%(24/30),西药组为100.0%(30/30),组间比较,西药组的近期疗效优于中药组(P<0.05)。(2)远期疗效:随访3个月后,中药组的总有效率为83.3%(25/30),西药组为30.0%(9/30),组间比较,中药组的远期疗效明显优于西药组(P<0.05)。(3)治疗3个月后和随访3个月后,中药组患者的中医证候评分均较治疗前明显降低(P<0.05),而西药组的中医证候评分均较治疗前明显升高(P<0.05);组间比较,中药组在治疗3个月后和随访3个月后对中医证候评分的降低作用均明显优于西药组(P<0.05)。(4)治疗3个月后,2组患者的VAS评分均较治疗前明显降低(P<0.05);随访3个月后,中药组的VAS评分又较治疗3个月后降低(P<0.05),而西药组的VAS评分较治疗3个月后明显升高(P<0.05),重新恢复至治疗前水平(P>0.05);组间比较,中药组在随访3个月后对VAS评分的降低作用明显优于西药组(P<0.05)。(5)治疗后,中药组患者血清CA125、MMP-9、ICAM-1和VEGF水平均较治疗前明显降低(P<0.05),西药组患者仅血清CA125、MMP-9水平较治疗前明显降低(P<0.05),而血清ICAM-1和VEGF水平治疗前后比较,差异无统计学意义(P>0.05)。组间比较,中药组对血清CA125、MMP-9、ICAM-1和VEGF水平的降低作用均明显优于西药组(P <0.05)。【结论】痛经宁方治疗气滞血瘀型子宫内膜异位症疗效确切,可有效减轻患者疼痛症状,改善患者中医证候,降低血清CA125、ICAM-1、MMP-9和VEGF含量。

Objective To observe the clinical effect of Tongjingning Formula in the treatment of endometriosis of qi stagnation and blood stasis type. Methods Sixty patients with endometriosis of qi stagnation and blood stasis type were randomly divided into Chinese medicine(CM)group and western medicine group,30 cases in each group.Patients in the CM group were given oral use of Tongjingning Formula,and the patients in the control group were given intramuscular injection of Leuprorelin Acetate. The treatment course lasted 3 menstrual cycles and the patients were followed up for 3 months after the completion of treatment course. The changes of visual analogue scale(VAS) pain scores, traditional Chinese medicine(TCM) syndrome scores, and serum levels of carbohydrate antigen 125(CA125),intercellular adhesion molecule 1(ICAM-1),matrix metalloproteinase 9(MMP-9)and vascular endothelial growth factor(VEGF)in the two groups were observed before and after treatment, and the short-term efficacy and long-term efficacy in the two groups were also evaluated. Results(1)Short-term efficacy:after 3 months of treatment,the total effective rate of the CM group was 80.0%(24/30),and that of the western medicine group was 100.0%(30/30). The intergroup comparison showed that the short-term efficacy of the western medicine group was superior to that of the CM group(P<0.05).(2)Long-term efficacy:after 3 months of follow-up,the total effective rate of the CM group was 83.3%(25/30),and that of the western medicine group was 30.0%(9/30). The intergroup comparison showed that the long-term efficacy of the CM group was significantly superior to that of the western medicine group(P<0.05).(3)After 3-month treatment and 3-month follow-up,the TCM syndrome scores in the CM group were significantly lower than those before treatment(P<0.05),while the TCM syndrome scores in the western medicine group were significantly higher than those before treatment(P<0.05). The intergroup comparison showed that the effect on lowering the TCM syndrome scores in CM group after 3-month treatment and 3-month follow-up was significantly superior to that in the western medicine group(P<0.05).(4) After 3 months of treatment, VAS pain scores in two groups were significantly lower than those before treatment(P<0.05). After 3 month of follow-up,the VAS pain scores in the CM group were decreased compared with those after 3 months of treatment(P<0.05),while the VAS pain scores in the western medicine group were significantly increased(P<0.05)and then recovered to the pre-treatment level(P>0.05). The intergroup comparison showed that the effect on lowering VAS pain scores in CM group was significantly superior to that of the western medicine group after 3 months of follow-up(P<0.05).(5)After treatment, the serum levels of CA125, MMP-9, ICAM-1 and VEGF in the CM group were significantly decreased compared with those before treatment(P<0.05),the serum levels of CA125 and MMP-9 in the western medicine group after treatment were significantly decreased(P<0.05), but the serum levels of ICAM-1 and VEGF after treatment did not differ from those before treatment,and the difference was not statistically significant(P>0.05). The intergroup comparison showed that the effect on lowering serum CA125,MMP-9,ICAM-1 and VEGF levels in the CM group was significantly superior to that in the western medicine group(P<0.05).Conclusion Tongjingning Formula has a certain effect in the treatment of endometriosis of qi stagnation and blood stasis type. It can relieve the pain symptoms, improve the TCM syndromes and decrease the serum CA125,ICAM-1,MMP-9 and VEGF levels of the patients.