内异丸合内异灌肠液联合治疗子宫内膜异位症的临床观察

Clinical Observation on Neiyi Pill Combined with Neiyi Enema for Endometriosis

【目的】观察内异丸(丹参、血竭、三棱、莪术、桃仁、三七、当归、桂枝、香附、牛膝等)合内异灌肠液(丹参、血竭、桃仁、莪术、赤芍、虎杖等)联合治疗子宫内膜异位症的疗效。【方法】对58例经腹腔镜诊断为子宫内膜异位症的患者,采用随机单盲的研究方法分成3组,A组(内异丸组)16例,B组(内异丸合内异灌肠液组)24例,C组(丹那唑组)18例。3组均连续治疗3个月经周期,于治疗前及治疗1、2、3个月经周期(MC)后按《中药新药临床研究指导原则》进行痛经评分,观察治疗后痛经、腰骶部不适、直肠刺激症状、后穹隆触痛结节、附件包块等症状和体征,以及血瘀证候的变化及不良反应。【结果】3组治疗后对痛经评分的疗效内异丸合灌肠液组明显优于丹那唑组(P<0.01),也优于内异丸组(P<0.05),而内异丸组与丹那唑组比较无显著性差异(P>0.05)。3组治疗后对腰骶部不适和血瘀证候的疗效内异丸组和内异丸合灌肠液组均优于丹那唑组(P<0.05),但内异丸合灌肠液组与内异丸组比较无显著性差异(P>0.05)。3组治疗后对直肠刺激症状、后穹隆触痛结节和附件包块的疗效内异丸合灌肠液组优于丹那唑组(P<0.05),但内异丸合灌肠液组与内异丸组、内异丸组与丹那唑组比较均无显著性差异(P>0.05)。【结论】内异丸合内异灌肠液联合治疗子宫内膜异位症疗效优于单纯内异丸和西药丹那唑,且无明显不良反应。

[ Objective] To observe the therapeutic effect of oral use of Neiyi Pill （composed of Radix Salviae Mihiorrhizae, Sanguis Draxonis, Rhizoma Sparganii, Rhizoma Curcumae, Semen Persicae, Radix Notoginseng, Radix Angelicae Sinensis, Ramulus Cinnamomi, Rhizoma Cyperi, Radix Achyranthis Bidentatae, etc. ） combined with enteroclysis of Neiyi Enema （composed of Radix Salviae Mihiorrhizae, Sanguis Draxonis, Semen Persicae, Rhizoma Curcumae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati, etc. ） for dysmenorrhea induced by endometriosis （EMS）. [Methods] Fifty-eight patients diagnosed as endometriosis by laparoscopy were divided into 3 groups randomized single-blind method. Group A （ n = 16） was treated with Neiyi Pill orally, Group B （ n = 24） with Neiyi Pill orally combined with enteroclysis of Neiyi Enema and Group C （ n = 18） with danazol orally. The 3 groups respectively received the corresponding treatment for 3 successive menstrual cycles （MC）. Dysmenorrhea scoring was carried out according to the Guide for Clinical Research of New Chinese Herbal Medicine before treatment and after 1, 2 and 3 menstrual cycles. The effects on symptoms of dysmenorrhea, lumbosacral discomfort and irritative symptom of rectum, signs of tenderness and nodule in posterior fornix of vagina and adnexal masses, and syndrome of blood stasis were observed. Meanwhile, the adverse reactions were also monitored. [Results] After treatment, effect on relieving dysmenorrhea in group B was superior to that in group C （ P 〈 0.01 ） and group A （ P 〈 0.05）, and the difference between group A and group C was insignificant （ P 〉 0.05 ）. Effect on lumbosacral discomfort and syndrome of blood stasis in groups A and B was superior to that in group C （ P 〈 0.05）, and the difference between group A and group B was insignificant （ P 〉 0.05 ）. Effect on irritative symptom of rectum, tenderness and nodule in posterior fornix of vagina and adnexal masses in group B was superior to that in group C （ P 〈 0.05）, and the difference between group A and group B, as well as that between group A and group C was insignificant （ P 〉 0.05 ）. [ Conclusion ] Oral use of Neiyi Pill combined with enteroclysis of Neiyi Enema has a better effect for endometriosis than only oral use of Neiyi Pill only or danazol, and has no obvious adverse reactions.