荷芪散治疗代谢综合征痰瘀证量效分析

摘要

目的：临床观察荷芪散不同剂量治疗代谢综合征痰瘀证的疗效。方法入选120例代谢综合征患者，对照组采用西药治疗方案，治疗组患者随机分为低、中、高剂量3个组，给予口服相应剂量的中药荷芪散，观察治疗前后各组中医证候积分、人体参数及血脂代谢指标（TG、TC、LDL）的变化。结果荷芪散能有效改善中医证侯指标，尤其以中、高剂量组效果明显，且治疗30 d后显效更明显；治疗组控制体重指数（BMI）较对照组显著（P＜0.05），且中、高剂量组疗效更显著（P＜0.05）；治疗组在降低餐后2 h血糖（P2hBG）较对照组显著（P＜0.05），而降低空腹血糖（FPG）差异无统计学意义（P＞0.05）；治疗后，治疗组餐后2 h胰岛素（P2hINS）降低（P＜0.05），高剂量组降低更明显（P＜0.05），而对照组治疗前后餐后2 h胰岛素水平差异无统计学意义（P＞0.05）；治疗组 TG、TC、LDL 水平降低较对照组显著（P＜0.01），且中、高剂量组 TG、TC水平降低差异有统计学意义（P＜0.05），而不同剂量组间LDL水平降低量效关系差异无统计学意义（P＞0.05）；对照组和治疗组均不能改善 HDL 水平（P＞0.05）；治疗组降低瘦素（LEP）、肿瘤坏死因子（TNF）水平和升高脂联素（APN）水平较对照组显著（P＜0.05），且中剂量组差异更显著（ P＜0.05）。结论荷芪散能降低中医证候积分，有效缓解临床症状，能显著控制BMI ，调整糖、脂代谢紊乱，减轻胰岛素抵抗，降低LEP ，升高APN 水平，减少 TNF的分泌，荷芪散不会引起高胰岛素血症，在降低BP、改善 HDL水平等方面无明显优势。本研究结果亦提示，荷芪散在临床处方中无需过量使用，中剂量即可达到满意的疗效。%Objective To observe the curative effect of different doses of He Qi San in treating the metabolic syndrome with phlegm‐blood stasis syndrome.Methods We collected 120 cases of the metabolic syndrome with phlegm‐blood stasis syndrome. The treatment groups were randomly divided into low‐dose ,middle‐dose and high‐dose groups ,taking different doses of He Qi San respectively ,while without any traditional Chinese medicine for the patients in the control group. We assessed the TCM syndrome integral and measured the human parameters and metabolic indexs of all patients ,both before and after the treatment.Results The TCM curative effect of this stud‐y showed that He Qi San can effectively improve the TCM syndrome indicators ,especially in middle‐dose group and high‐dose group. The curative effect was especially obvious after 30 days.Compared with the control group ,the treatment groups controled body weight better(P<0.05) ,obviously in middle‐dose group and high‐dose group(P<0.05). However ,there was no difference between the control group and the treatment group in decreasing waists and blood pressure(P>0.05) ,and the dose‐effect relationships were not obvious in three treatment groups(P<0.05). The treatment group acted much better than the control group in lowering postprandial glucose(P<0.05) , particularly in middle‐dose group and high‐dose group(P< 0.05) ,but without obvious effect in reducing fasting glucose(P> 0.05).The treatment group reduced postprandial insulin significantly(P< 0.05) ,with more obvious effect in high‐dose group(P<0.05).Whereas ,there was no obvious change in the insulin level of the control group after the treatment(P>0.05). TG ,TC and LDL levels reduced obviously in the treatment groups(P<0.05 ,P<0.01). TG and TC levels reduced particularly obviously in middle‐dose group and high‐dose group(P<0.05).Both groups could not improve HDL levels(P>0.05). Treatment group could strikly lower levels of leptin and tumor necrosis factor(TNF)and elevate adiponectin level(P< 0.05 ,P< 0.01) ,especially in low‐dose group(P< 0.05) . The clinical curative effect of most indexs in this study showed that there was no significant difference between middle‐dose group and high‐dose group.Conclusion The results showed that He Qi San can reduce TCM syn‐drome integral and relieve clinical symptoms effectively.It can significantly control body weight ,adjust the meta‐bolic disorder and relieve insulin resistance.It can also reduce the secretion of leptin and TNF and increase the level of adiponectin.The curative effect of middle dose and high dose of He Qi San are more ideal and comparable.In ad‐dition ,the results show ed that He Qi San doesn't cause hyperinsulinemia. How ever ,there w as no obvious advantage of He Qi San in low ering blood pressure and improving HDL levels. In conclusion ,this study suggests that He Qi San with middle dose can achieve satisfactory curative effect in clinical prescription.