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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 hydrochloride injection combined with recombinant human interferon γ in the treatment of chronic hepatitis with liver fibrosis. Methods Sixty-two patients with chronic hepatitis with liver fibrosis were randomly divided into control group (31 cases) and experimental group (31 cases). The control group was intramuscularly injected with recombinant human interferon gamma50,000 units, qd, continuous medication 3 ~ 4 d, increasing the dose to 1 million units, qd, 2 months from the injection into the next day changed to 100 to 200 million units, continuous Medication for 2 months; the experimental group in the control group based on the treatment, to be intravenous infusion of ligustrazine hydrochloride 40 ~ 80 mg, qd, continuous injection of 10 d per month for 3 months. The clinical efficacy, four indexes of liver fibrosis, TIMP - 1 and TIMP - 1 were compared between two groups. The incidence of ADR was also compared. Results After treatment, the total effective rates of the experimental group and the control group were 93.55% (29/31 cases) and 74.19% (23/31 cases), respectively, with statistical significance (P <0.05). After treatment, the serum levels of type Ⅲ procollagen in the test group and the control group were (103.55 ± 83.09) and (205.52 ± 94.18) μg · L -1, respectively. The type Ⅳ collagen were (94.46 ± 45.22) and (110.56 ± 80.67) μg · L -1; laminin were (110.64 ± 49.73) and (156.56 ± 52.86) μg · L -1, hyaluronidase was (137.56 ± 54.22) and 189.57 ± 65.85) μg · L -1, TIMP -1 were (136.41 ± 35.7) and (183.46 ± 40.37) ng · m L -1, respectively. Leptin was (0.78 ± 0.05) ), (1.09 ± 0.24) μg · L -1, the difference was statistically significant (P <0.05). Adverse drug reactions occurred in the experimental group mainly gastrointestinal reactions, lethargy and hypotension; adverse drug reactions occurred in the control group mainly chest tightness, gastrointestinal reactions and lethargy. The incidences of adverse drug reactions in the experimental and control groups were 9.68% and 22.58%, respectively, with significant differences (P <0.05). Conclusion Ligustrazine hydrochloride injection combined with recombinant human interferon-γ in the treatment of chronic hepatitis liver fibrosis clinical efficacy was significant and safe.