荷芪散联合二甲双胍治疗肥胖型多囊卵巢综合征临床研究

Heqi San combined with metformin for obese polycystic ovary syndrome

目的 评价荷芪散联合二甲双胍治疗肥胖型多囊卵巢综合征（polycystic ovary syndrome,PCOS）的疗效.方法 将符合入选标准的60例肥胖型PCOS患者按随机表法分为2组,每组30例.对照组口服二甲双胍,治疗组在对照组基础上加用荷芪散.2组均治疗3个月,随访3个月.采用葡萄糖氧化酶法测定FPG,采用放射免疫法测定空腹胰岛素（fasting insulin,FINS）、TC、TG、LDL-C、HDL-C水平,采用稳态模型评估法（homeostasis model assessment,HOMA）计算胰岛素抵抗指数（HOMA insulin resistance,HOMA-IR）,采用全自动电化学发光仪检测促黄体生成素（luteotropic hormone,LH）、促卵泡激素（follicle stimulating hormone,FSH）、睾酮,并根据LH及FSH结果计算LH/FSH比值,观察治疗前后卵巢体积变化及BMI变化,评价临床疗效.结果 治疗后,治疗组BMI[（20.09±3.12）kg/cm2比（23.39±1.43）kg/cm2,t=6.889]、FPG[（4.44±0.17）mmol/L比（4.74±0.16）mmol/L,t=6.945]、FINS[（10.69±2.4）IU/L比（16.29±5.95）IU/L,t=4.778]、TC[（3.91±0.50）mmol/L比（4.20±0.39）mmol/L,t=2.505]、LDL-C[（2.64±0.63）mmol/L比（3.18±0.62）mmol/L,t=3.346]、LH[（8.70±2.44）U/L比（10.27±2.69）U/L,t=2.934]、LH/FSH比值[（1.33±0.58）比（2.18±0.56）,t=5.775]、睾酮[（1.73±0.74）nmol/L比（2.95±1.10）nmol/L,t=5.040]和卵巢体积[（12.61±2.29）mm3比（14.26±2.52）mm3,t=6.982]低于对照组（P〈0.01或P〈0.05）,FSH[（7.33±2.28）U/L比（5.95±1.20）U/L,t=2.934]水平高于对照组（P〈0.05）.治疗组总有效率83.3%（25/30）、对照组为63.3%（19/30）,2组比较差异有统计学意义（χ2=3.068,P=0.050）.结论 荷芪散联合二甲双胍可有效改善PCOS患者BMI,糖代谢、脂代谢指标及性激素水平,缩小卵巢体积,疗效优于口服二甲双胍治疗.

Objective Objective To evaluate the efficacy of Heqi San combined with metformin in the treatment of obese polycystic ovary syndrome （PCOS）. Methods A total of 60 patients with obese polycystic ovary syndrome who met the inclusion criteria were randomly divided into 2 groups, 30 patients in each group. The control group was treated with metformin, and the treatment group was treated with Heqi San on the basis of the control group. Both groups were treated for 3 months. The FPG was determined by glucose oxidase method, and fasting insulin （FINS）, TC, TG, LDL-C, HDL-C level were measured by radio immunoassay, and the insulin resistance index （IR） was measured by the method of HOMA-IR. The luteotropic hormone （LH）, pro follicle stimulating hormone （FSH） and testosterone （T） were detected by the automatic electrochemical light detector, and the ratio of LH/FSH was calculated. The ovarian volume and body mass index changes and clinical effect were evaluated. Results After treatment, the BMI （20.09 ± 3.12 kg/cm2 vs. 23.39 ± 1.43 kg/cm2, t=6.889）, FPG （4.44 ± 0.17 mmol/L vs. 4.74 ± 0.16 mmol/L, t=6.945）, FINS （10.69 ± 2.41 IU/L vs. 16.29 ± 5.95 IU/L, t=4.778）, TC （3.91 ± 0.50 mmol/L vs. 4.20 ± 0.39 mmol/L, t=2.505）, LDL-C （2.64 ± 0.63 mmol/L vs. 3.18 ± 0.62 mmol/L, t=3.346）, LH （8.70 ± 2.44 U/L vs. 10.27 ± 2.69 U/L, t=2.934）, the ratio of LH/FSH （1.33 ± 0.58 vs. 2.18 ± 0.56, t=5.775）, T （1.73 ± 0.74 nmol/L vs. 2.95 ± 1.10 nmol/L, t=5.040） and ovarian volume （12.61 ± 2.29 mm3 vs. 14.26 ± 2.52 mm3, t=6.982） in the treatment group were significantly lower than those in the control group （P〈0.01 or P〈0.05）. The FSH （7.33 ± 2.28 U/L vs. 5.95 ± 1.20 U/L, t=2.934） in the treatment group were significantly higher than those in the control group （P〈0.05）. The total effective rate in the treatment group was 83.3% （25/30） and 63.3% （19/30） in the control group. The difference between the 2 groups was statistically significant （χ2=3.068, P=0.050）. Conclusions The Heqi San combined with metformin can effectively improve the body mass index, glucose metabolism, lipid metabolism index and sex hormone level, and reduce the volume of ovary in patients with PCOS, and the curative effect is better than that of oral metformin alone.