补肾化痰清解法对胰岛素抵抗型多囊卵巢综合征氧化应激影响的临床观察

Clinical observation on effects of therapy of tonifying kidney and resolving phlegm and clearing heat on oxidative stress in polycystic ovarian syndrome with insulin resistance

目的观察补肾化痰清解法(促排汤)治疗胰岛素抵抗型多囊卵巢综合征的临床疗效及可能机制。方法将100例患者分为治疗组与对照组,每组50例。治疗组采用补肾化痰清解法(促排汤)治疗,对照组采用二甲双胍+叶酸+Vit B12治疗。两组疗程均为5个月、随访5个月,观察临床疗效,比较氧化应激相关指标、性激素相关指标及胰岛素抵抗指数(HOMA-IR)的变化情况。结果 (1)最终完成试验者97例,治疗组49例,对照组48例。(2)治疗组、对照组临床总有效率分别为87.8%和25.0%;组间临床疗效比较,差异有统计学意义,治疗组显著优于对照组(P<0.05)。(3)组间治疗后比较,SOD、MDA水平差异无统计学意义(P>0.05),而GSH-Px水平差异有统计学意义,治疗组明显高于对照组(P<0.05)。停药随访5个月后,治疗组SOD、GSH-Px水平仍显著高于治疗前,而MDA水平仍显著低于治疗前(P<0.05);停药随访5个月后治疗组MDA水平明显低于对照组水平(P<0.05)。(4)治疗前后组内比较,治疗组T、LH/FSH及HOMA-IR水平明显降低(P<0.05),对照组仅HOMA-IR水平明显降低(P<0.05)。组间治疗后比较,治疗组T水平明显低于对照组(P<0.05)。停药随访5个月后与治疗前比较,治疗组T及LH/FSH水平仍明显降低(P<0.05);停药随访5个月后组间比较,治疗组T及LH/FSH水平明显低于对照组(P<0.05),而HOMA-IR水平差异无统计学意义(P>0.05)。(5)两组不良反应发生率比较(8/48 vs 0/49),差异有统计学意义,治疗组明显低于对照组(P<0.05)。结论补肾化痰清解法(促排汤)治疗胰岛素抵抗型多囊卵巢综合征的疗效满意,其干预机制可能为持续、有效地降低患者氧化应激水平。

Objective To observe the clinical efficacy and possible mechanism of therapy of tonifying kidney and resolving phlegm and clearing heat( Cupai Decoction) in the treatment of polycystic ovarian syndrome( PCOS) with insulin resistance( IR). Methods 100 patients were randomly divided into the treatment group and control group,50 cases in each group.The treatment group was treated with the therapy of tonifying kidney and resolving phlegm and clearing heat( Cupai Decoction),and the control group was treated with metformin,folic acid and Vit B12. The treatment course in both groups was 5 months with five-month follow-up.The clinical efficacy was observed,and the changes on the oxidative stress related indexes,sex hormone related indexes and index of homeostasis model assessment for insulin resistance( HOMA-IR) were compared. Results(1)Finally 97 patients completed the trial,among 49 cases in the treatment group and 48 cases in the control group(2)The clinical total effective rates were 89.8% in the treatment group and 25.0% in the control group. There was statistically significant difference on the clinical efficacy between the two groups,and the clinical efficacy of the treatment group was significantly better than that of the control group( P < 0.05).(3)After treatment,there were no statistically significant differences on the levels of superoxide dismutase( SOD) and malondialdehyde( MDA) between the two groups( P>0.05); but there was statistically significant difference on the glutathione peroxidase( GSH-Px) level between the two groups,and the GSH-Px level of the treatment group was obviously higher than that of the control group( P<0.05). After five-month follow-up,the levels of SOD and GSH-Px in the treatment group were significantly increased compared with treatment before,and the MDA level in the treatment group was significantly decreased compared with treatment before( P<0.05). After five-month follow-up,the MDA level of the treatment group was obviously lower than that of the control group( P< 0.05).(4)Compared with treatment before,the levels of testosterone( T),luteinizing hormone( LH)/follicle stimulating hormone( FSH) and HOMA-IR index were obviously decreased in the treatment group( P<0.05),and the HOMA-IR index was obviously decreased in the control group( P<0.05). After treatment,the T level of the treatment group was obviously lower than that of the control group( P < 0.05). After five-month follow-up,the levels of T and LH/FSH in the treatment group were obviously decreased compared with treatment before( P<0.05). After five-month follow-up,the levels of T and LH/FSH in the treatment group were obviously lower than those in the control group( P < 0.05),but there was no statistically significant difference on the HOMA-IR index between the two groups( P > 0.05).(5) There was statistically significant difference on the incidence rate of adverse reaction between the treatment group and control group,and the incidence rate of treatment group( 0/49) was obviously lower than that of the control group( 8/48)( P<0.05). Conclusion The therapy of tonifying kidney and resolving phlegm and clearing heat( Cupai Decoction) shows good efficacy in the treatment of polycystic ovarian syndrome with insulin resistance. Its mechanism may be associated with the sustained and effective reduction on the level of oxidative stress in patients.