保元强肾Ⅰ号胶囊治疗慢性肾功能衰竭临床研究

Clinical studies on treatment for chronic renal failure with Baoyuan Qiangshen No.1 Capsule

目的：探讨保元强肾Ⅰ号胶囊对慢性肾功能衰竭（ＣＲＦ中后期尿毒症期）的疗效。方法：４０例ＣＲＦ尿毒症期患者分为２组，均采用低蛋白饮食（ＬＰＤ）及一般综合治疗（维持水、电解质平衡，纠正心力衰竭和抗感染）。治疗组另加口服保元强肾Ⅰ号胶囊１５粒，每日２次，连用６０日。对照组加用必需氨基酸（ＥＡＡ）注射液２５０ｍｌ／ｄ静滴，连用６０日。观察用药后肾功能、尿前列腺素和营养状态的改善情况。结果：治疗组总有效率９０％，显著优于对照组３５％，Ｐ＜０．０１。治疗组治疗后血尿素氮〔ＢＵＮ，（１９．０８±３．８５）ｍｍｏｌ／Ｌ〕、血肌酐〔ＳＣｒ，（３８３．６７±１０１．１７）μｍｏｌ／Ｌ〕均显著低于治疗前〔分别为（３０．２０±８．９２）ｍｍｏｌ／Ｌ和（５８２．２０±９９．２７）μｍｏｌ／Ｌ〕和对照组治疗后〔分别为（２６．０４±７．７５）ｍｍｏｌ／Ｌ和（６０５．３４±１７０．５８）μｍｏｌ／Ｌ〕，Ｐ均＜０．０５；内生肌酐清除率〔ＣＣｒ，（２６．６±９．７）ｍｌ·ｓ－１·１．７３ｍ－２〕均显著高于治疗前〔（１８．８±４．７）ｍｌ·ｓ－１·１．７３ｍ－２〕和对照组治疗后〔（１３．１±６．８）ｍｌ·ｓ－１·１．７３ｍ－２〕，Ｐ均＜０．０５?

Objective:To investigate the curative efficacy of Baoyuan Qiangshen No.1 Capsule(BYQSC No.1) on moderated and advanced phases (uremia) of chronic renal failure (CRF).Methods:40 cases with CRF (uremia) were randomly divided into 2 groups.Low protein diet (LPD) and conventionally general therapy (keeping fluid and electrolyte balance,correcting heart failure,and antiinfections) were given to both two groups.The BYQSC No.1 15 pills twice a day for 60 days was added to treatment group ( n =20).Otherwise essential amino acids (EAA) injection 250 ml/d infused intravenously for 60 days was added to control group ( n =20).After using drugs the improvements of renal functions,urinary prostaglandins,and nutritional conditions were observed.Results:The total effective rate (90%) in treatment group was significantly superior to that (35%) in control group ( P <0 01).After therapy in treatment group the levels of blood urea nitrogen BUN,(19 08±3 85)mmol/L and serum creatinine SCr,(383 67±101 17)μmol/L were significantly lower than those (30 20±8 92)mmol/L and (582 20±99 27)μmol/L respectively before therapy and were also significantly lower than those (26 04±7 75)mmol/L and (605 34±170 58)μmol/L respectively after therapy in control group (all P <0 05).After therapy in treatment group the creatinine clearance rate CCr,(26 6±9 7)ml·s -1 ·1 73 m -2 was significantly higher than that (18 8±4 7)ml·s -1 ·1 73 m -2 before therapy and also higher than that (13 1±6 8) ml·s -1 ·1 73 m -2 after therapy in control group (all P <0 05).The 6ketoprostaglandin F 1α 6ketoPGF 1α ,(56 04±16 19)ng/L was significantly higher than that (31 53±19 66)ng/L before therapy and also higher than that (18 67±9 08)ng/L after therapy in control group (all P <0 05).The hemoglobin (78 1±13 3)g/L and red blood cell count (3 18±0 51)×10 12 /L were significantly higher than those (69 9±15 4)g/L and (2 26±0 74)×10 12 /L before therapy and also higher than those (58 6±11 8)g/L and (2 01±0 38)×10 12 /L significantly after therapy in control group (all P <0 05).Conclusions:BYQSC No.1 possesses better curative efficacy on moderate and advanced phases of CRF and is superior to treatment with EAA in depressing BUN,SCr,elevating CCr,6ketoPGF 1α ,and correcting anemia.