盐酸川芎嗪注射液联合重组人干扰素γ治疗慢性肝炎肝纤维化的临床研究  

Clinical trial of ligustrazine injection combined with recombinant human interferon γ in the treatment of chronic hepatitis

作　　者：曹海军[1] 王牡丹[1] 李善高[1] 朱灵[1] 郑健豪 

机构地区：[1]浙江省中医院消化内科,杭州310018

出　　处：《中国临床药理学杂志》2016年第15期1367-1369,1377,共4页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省自然科学基金资助项目(LY14H030007)

摘　　要：目的观察盐酸川芎嗪注射液联合重组人干扰素γ治疗慢性肝炎肝纤维化的临床疗效及安全性。方法将62例慢性肝炎肝纤维化患者随机分为对照组31例和试验组31例。对照组予以肌内注射重组人干扰素γ50万单位,qd,连续用药3~4 d后,增加剂量至100万单位,qd,第2个月起改为隔日用药注射100~200万单位,连续用药2个月;试验组在对照组治疗的基础上,予以静脉滴注盐酸川芎嗪注射液40~80 mg,qd,每个月连续注射10 d,治疗3个月。比较2组患者的临床疗效、肝纤维化四项指标、血清金属蛋白酶组织抑制因子^(-1)(TIMP^(-1))和瘦素水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.55%(29/31例)和74.19%(23/31例),差异有统计学意义(P<0.05)。治疗后,试验组与对照组的血清中Ⅲ型前胶原分别为(103.55±83.09),(205.52±94.18)μg·L^(-1);Ⅳ型胶原分别为(94.46±45.22),(110.56±80.67)μg·L^(-1);层粘连蛋白分别为(110.64±49.73),(156.56±52.86)μg·L^(-1);透明质酸酶分别为(137.56±54.22),(189.57±65.85)μg·L^(-1);TIMP^(-1)分别为(136.41±35.7),(183.46±40.37)ng·m L^(-1);瘦素分别为(0.78±0.05),(1.09±0.24)μg·L^(-1),差异有统计学意义(P<0.05)。试验组发生的药物不良反应主要为胃肠道反应、嗜睡和低血压;对照组发生的药物不良反应主要为胸闷、胃肠道反应和嗜睡。试验组和对照组的药物不良反应发生率分别为9.68%和22.58%,差异有统计学意义(P<0.05)。结论盐酸川芎嗪注射液联合重组人干扰素γ治疗慢性肝炎肝纤维化的临床疗效显著,且安全性较高。Objective To observe the clinical efficacy and safety of ligustrazine injection combined with recombinant human interferon γ in the treatment of chronic hepatitis. Methods Sixty - two patients with chronic hepatitis liver fibrosis were randomly divided into control group （n =31 ） and treatment group（ n = 31 ）. Control group was treated with recombinant human interferon γ 0. 5 million U, continuous treatment for 3 - 4 days, after increased to 1 million U, then increased to 1 - 2 million U qd for injection at the second month, continuous treatment for 2 months. Treatment group was given ligustrazine injection 40- 80 mg intravenous drip, qod, continuous injection of 10 days each month for 3 months, on the basis of control group. The clinical efficacy, four indicators of liver fibrosis, levels of serum tissue inhibitor of metalloproteinase - 1 （ TIMP - 1 ） and leptin, incidence of adverse drug reactions were compared between two groups. Results After treatment, the total effective rate of treatment group was 93.55% （29/31 ）, while the control group was 74. 19% （23/31 ）, and the difference was significant （P 〈 0. 05 ）. After treatment, the main observation indexes in treatment and control groups： the level of serum type Ⅲ procollagen were （103.55±83.09）, （205.52 ±94.18） μg·L^-1; the level of type 1V collagen were （94.46 ±45.22）, （ 110.56 ± 80. 67 ）μg·L^-1; the level of laminin were （ 110. 64 ± 49.73 ）, （ 156. 56 ± 52. 86 ）μg·L^-1; the level of hyaluronidase were （ 137.56 ±254.22）, （ 189.57 ±65.85） μg·L^-1; the level of TIMP - 1 were （ 136.41 ± 35.7）, （ 183.46 ± 40. 37 ） ng·mL^-1 and the level of leptin were （ 0. 78 ± 0.05 ）, （ 1.09 ± 0. 24 ） μg·L^-1, and the differences were with great significance （P 〈 0.05 ）. The adverse drug reactions were based on gastrointestinal reactions, drowsiness and hypotension in treatment group and chest tightness, gastrointestinal reactions, drowsiness in control group. The incide

关 键 词：盐酸川芎嗪注射液 重组人干扰素Γ 慢性肝炎肝纤维化 临床疗效 安全性 

分 类 号：R975.5[医药卫生—药品]