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目的观察中药降脂复方与阿托伐他汀(ATV)联用治疗中医诊断为痰浊阻遏证型的原发性高脂血症患者的疗效和安全性,并分析药物交互作用。方法采用2×2析因设计、单盲、分层随机对照试验设计,将符合纳入标准的原发性高脂血症(痰浊阻遏证)患者根据入组血脂水平及危险因素分为ATV 10 mg组(A组)、ATV 20 mg组(B组)、ATV 10 mg+降脂复方治疗组(C组)、ATV 20 mg+降脂复方治疗组(D组)和降脂复方治疗组(E组)共5组。观察一个疗程(2周)后的降脂疗效及安全性。结果共纳入92例患者,其中A组20例、B组25例、C组21例、D组17例、E组9例。结果显示:1 C组与B组相比,在降低血清总胆固醇(TC)和低密度脂蛋白胆固醇(LDL-C)水平方面,差异无统计学意义(PTC=0.226,PLDL-C=0.818)。2 2×2析因交互作用分析结果显示,中药因素与西药因素在降低TC和LDL-C疗效上无明显交互作用(PTC=0.605,PLDL-C=0.843)。3各组安全性指标在治疗前后差异无统计学意义(P>0.05)。结论 ATV 10 mg+降脂复方治疗与ATV 20 mg治疗在降低TC和LDL-C水平方面的疗效相当。降脂复方治疗与ATV联用无显著交互作用,两者短期疗程联用的安全性较高。
Objective To observe the curative effect and safety of combination of lipid-lowering compound of traditional Chinese medicine and atorvastatin (ATV) on patients with primary hyperlipidemia diagnosed as TCM syndrome of phlegm-dampness syndrome and to analyze the drug interaction. Methods The 2 × 2 factorial design, single-blind, stratified randomized controlled trial design, the inclusion of patients with primary hyperlipidemia (phlegm blocking syndrome) according to the level of serum lipids and risk factors into ATV 10 (group A), ATV 20 mg group (group B), ATV 10 mg + lipid-lowering compound treatment group (group C), ATV 20 mg + lipid-lowering compound treatment group (group D) and lipid lowering compound treatment group A total of 5 groups. Observe the course of one course of treatment (2 weeks) after lipid-lowering efficacy and safety. Results A total of 92 patients were enrolled, including 20 in group A, 25 in group B, 21 in group C, 17 in group D and 9 in group E. The results showed that there was no significant difference (P> 0.05) between group C and group B in decreasing serum total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) . The results of 2 2 × 2 factorial interaction analysis showed that there was no significant interaction between traditional Chinese medicine and western medicine in reducing the effect of TC and LDL-C (PTC = 0.605, PLDL-C = 0.843). There was no significant difference in the safety indexes between the three groups before and after treatment (P> 0.05). Conclusion ATV 10 mg + lipid-lowering compound treatment and ATV 20 mg treatment in the reduction of TC and LDL-C levels have similar efficacy. There was no significant interaction between lipid-lowering compound therapy and ATV, and the safety of short-term combination therapy was high.