香桂胶囊治疗寒凝血瘀型原发性痛经的临床观察

Clinical Observation on Treatment of Syndrome of Blood Stasis Due to Cold Accumulation of Primary Dysmenorrhea with Xianggui Capsule

目的:观察香桂胶囊治疗寒凝血瘀型原发性痛经的临床疗效及对经血中前列腺素含量的影响。方法:将180例原发性痛经患者分为香桂胶囊组、少腹逐瘀颗粒组和西药组,每组各60例。连续治疗3个月经周期。治疗前后采用数字评分法(numerical rating scale,NRS)对患者的疼痛程度进行定量评价,并观察经血中前列腺素F2α、前列腺素E2含量的变化,并比较3组患者子宫血流指标变化。结果:临床疗效香桂胶囊组临床痊愈24例(40.00%),显效16例(26.67%),有效18例(30.00%),无效2例(3.33%),总有效率96.67%;少腹逐瘀颗粒组临床痊愈12例(20.00%),显效18例(30.00%),有效26例(43.33%),无效4例(6.67%),总有效率93.33%;西药组临床痊愈4例(6.67%),显效24例(40.00%),有效20例(33.33%),无效12例(20.00%),总有效率80.00%;香桂胶囊组临床疗效与西药组比较有统计学意义(P<0.05)。治疗后3组疼痛分值均下降(P<0.01),香桂胶囊组疼痛分值为(0.63±0.67)分,低于少腹逐瘀颗粒组(2.56±0.68)分和西药组(2.79±0.85)分(P<0.01)。治疗后3组经血中前列腺素F2α水平显著降低,而前列腺素E2水平明显升高(P<0.01),香桂胶囊组与少腹逐瘀颗粒组和西药组比较均有统计学意义(P<0.01)。但少腹逐瘀颗粒组疼痛分值、经血PGF2α和PGE2水平与西药组比较无统计学意义(P>0.05)。结论:香桂胶囊治疗寒凝血瘀型原发性痛经的临床疗效均优于少腹逐瘀颗粒组和西药组,其作用机制可能与降低患者经血中前列腺素F2α含量,升高前列腺素E2水平有关。

Objective ：To observe the clinical therapeutic effect of a Xianggui Capsule for Syndrome of blood stasis due to cold accumulation of primary dysmenorrhea and its influence on prostaglandin level in menstrual fluid. Methods ： 180 patients with Syndrome of blood stasis due to cold accumulation of primary dysmenorrhea were assigned equally to the Xianggni Capsule group, the Shaofu Zhuyu Keli group and the control group （oral administrated with compoud aminopyine phenacetin tablets）. The treatment course was 3 menstrual cycles. The effect in relieving menalgia was evaluated using numerical rating settle （NRS） before and after treatment and change of PGF2,, and PGE2 content in menstrual fluid and uterln artery hemodynamics was tested as well. Results ： After treatment,in the Xianggui Capsule group 24 patients （40. 00% ） were clinically cured,treatment was markedly effective in 16 patients（26.67% ） ,effective in 18 （30. 00% ） and ineffective in 2（3. 33% ） ,and in the Shaofu Zhuyu Keli group were 12 （20. 00% ）, 18 （ 30. 00% ）, 26 （ 43.33 % ） and 4 （ 6. 67% ）, while the control group were 4 （ 6.67% ）, 24 （ 40. 00% ）, 20 （33.33%） and 12（20. 00% ）respectively ,the clinical effect in Xianggui Capsule group was superior to that in the control group （P 〈0.05）o The NRS score was （0. 63 ± 0. 67 ） in the Xianggui Capsule group, Significantly lower than that in the Shaofu Zhuyu Keli group and in the control group, which was （ 2.56 ± 0.68） and （ 2.79±0. 85 ） respectively （ P 〈 0. 01 ）. The PGF2, level after treatmentwas significantly lower and the PGE2 level after treatment was significantly higher in the Xianggui Capsule group than that in the Shaofu Zhuyu Keli group and in the control group ,respectively （P 〈0. 01 ）. There showed no difference in the three aspects between the Shaofu Zhuyu Keli group and the control group （ P 〉 0. 05 ）. Conclusion ： Xianggui Capsule has a reliable therapeutic effect on Syndrome of blood stasis due to cold accumulation of primary dysmenorrhea,which is superior to that of Somiton tablet, and its mechanism might be exerted by regulating PGF2,,and PGE2 level in menstrual fluid.