络活胶囊降压作用及对血浆肾上腺髓质素和组织因子途径抑制物的影响

Hypotensive Action of Luohuo Capsule and Its Effect on Plasma Adrenal Medullin and Tissue Factor Pathway Inhibitor

目的 :观察络活胶囊降压的临床疗效。方法 :按照随机、分层、单盲、阳性药物对照进行临床试验。90例高血压病患者随机分为治疗组 6 0例 ,对照组 30例。治疗组服用络活胶囊 ;对照组服用北京降压 0号 ,疗程 4周。观察指标 :安全性观测、临床症状、血压、血液流变学检查、血脂、肾上腺髓质素 (AdM )、血浆组织因子途径抑制物 (TFPI)。结果 :络活胶囊降压总有效率 85 0 0 % ,对照组总有效率 86 6 7% ,两组降压疗效比较差异无显著性 (P =0 915 ) ;络活胶囊组部分临床症状改善优于对照组 (P <0 0 5或P <0 0 1) ;络活胶囊组可改善高血压病患者的血液流变学状态 (P <0 0 1)、减轻高血压病患者血脂紊乱的状态 (P <0 0 5 )、调节血浆肾上腺髓质素 (P <0 0 5 )及血浆组织因子途径抑制物水平 (P <0 0 5 )。结论 :络活胶囊治疗Ⅰ、Ⅱ级高血压是安全的 ,无毒副反应出现。

Objective: To study the therapeutic effect of Luohuo Capsule (LHC) clinically. Methods: Clinical trial on 90 patients were carried out adopting randomized, stratified, single-blinded and positive drug controlled method, by divided patients into the treated group (n=60) and the control group (n=30). The treated group was treated with LHC, which was mainly consisted of Leech, Radish seed, Water-plantain Tuber, Chuanxiong, etc. The control group was treated with Beijing Hypotensive. No. 0. The therapeutic course was 4 weeks. The diagnosis and efficacy evaluation were in accord with corresponding national standards, using the indexes including safety, clinical symptoms, blood pressure, hemorrheologic parameters, blood lipid, adrenal medullin (AdM) and plasma tissue factor pathway inhibitor (TFPI). Results: The total effective rate of LHC in lowering blood pressure in the treated group and the control group was 85.00% and 86.67% respectively, comparison of them showed no significant difference (P=0 915). Most of the improvement of clinical symptoms in the treated group were better than those in the control group (P<0 05 or P<0 01). LHC could also improve the hemorrheologic status (P<0 01), alleviate the blood lipids disorder (P<0 05), and adjust AdM and TFPI (P<0 05). Conclusion: LHC is safe in treating hypertension grade Ⅰ and Ⅱ with no adverse reaction.