清肝解毒汤治疗难治性慢性丙型肝炎临床观察

发布时间：2019-04-15 18:15

【摘要】：目的以保肝西药为对照,观察中药复方清肝解毒汤对肝功能、肝纤维化、HCV RNA及症状体征的影响,客观评价该方剂治疗难治性慢性丙型肝炎的临床疗效。方法采用开放性对照试验的临床研究方法,入选难治性丙型肝炎患者60例,其中试验组30例,对照组30例。试验组给予中药复方清肝解毒汤(治疗过程中针对兼证加减用药)治疗,对照组给予保肝西药(还原性谷胱甘肽片、水飞蓟宾胶囊)治疗,疗程为48周。分别观察治疗前后的证候疗效,对症状体征进行记录评分,并检测客观疗效指标:肝功能(ALT、AST、TBil、DBil、GGT、ALB、GLOB)、HCV RNA定量、肝纤维化指标及腹部B超评分,同时监测血、尿、便常规,心电图、肾功能等安全性指标,观察评价其疗效及安全性。结果共有58例病人完成48周疗程,试验组、对照组各29例。两组各有1例脱落病例。两组治疗后症状、体征较治疗前有所改善,且在改善肝脾肿大、胁痛、脘闷腹胀、口干而苦、乏力、身目发黄、蛛痣肝掌、嗳气、大便稀溏方面试验组优于对照组(P0.05)。抗病毒疗效方面,试验组与对照组HCV RNA阴转率均为0,但试验组病毒定量均数小于对照组病毒定量均数,且P0.05,有统计学差异,试验组抑制丙肝病毒复制的疗效优于对照组。临床综合疗效方面,试验组显效率、有效率、总有效率分别为51.72%、41.37%、93.10%,均优于对照组(分别为27.59%、48.27%、75.86%),差异有统计学意义(P0.05)。抗肝纤维化方面,两组治疗后血清肝纤维化各项指标均较治疗前改善,且试验组HA、LN、CⅣ各项指标的改善优于对照组。腹部B超评分提示两组无统计学差异(P0.05)。整个研究过程未出现不良反应。结论清肝解毒汤在改善难治性丙型肝炎患者的临床症状和体征方面有明显优势,且有一定的保肝降酶功效、抗肝纤维化作用;还有一定程度的抑制丙肝病毒复制作用。但腹部B超改善不明显,考虑与疗程尚短有关。
[Abstract]:Aim to observe the effects of Qinggan jiedu decoction (QJD) on liver function, hepatic fibrosis, HCV RNA, symptoms and signs, and to evaluate objectively the clinical efficacy of Qinggan jiedu decoction (QJD) in the treatment of refractory chronic hepatitis C. Methods A total of 60 patients with refractory hepatitis C were enrolled in the open controlled trial, including 30 patients in the trial group and 30 patients in the control group. The experimental group was treated with Qinggan jiedu decoction, and the control group was treated with western medicine (reducing glutathione tablet, silybin capsule) for 48 weeks. The treatment group was treated with Qinggan jiedu decoction (in the course of treatment), and the control group was treated with western medicine (reducing glutathione tablet, silybin capsule) for 48 weeks. The symptoms and signs were recorded and scored before and after treatment, and objective therapeutic indexes were detected: liver function (ALT,AST,TBil,DBil,GGT,ALB,GLOB), HCV RNA quantitative), hepatic fibrosis index and abdominal B-ultrasound score. At the same time, blood, urine, stool routine, electrocardiogram, renal function and other safety indexes were observed and evaluated. Results A total of 58 patients completed 48-week course of treatment, 29 patients in the test group and 29 patients in the control group. There were 1 case of shedding in each group. The symptoms and signs of the two groups were improved after treatment, and the experimental group was better than the control group in improving the swelling of liver and spleen, hypochondriac pain, abdominal distension, dry and bitter mouth, fatigue, yellowing, spider's nevus, liver palms, belching and loose stool (P0.05). In terms of antiviral efficacy, the negative conversion rate of HCV RNA between the experimental group and the control group was 0, but the virus quantitative mean of the experimental group was lower than that of the control group, and there was a statistical difference between the experimental group and the control group (P 0.05). The therapeutic effect of the experimental group was better than that of the control group in inhibiting hepatitis C virus replication. In terms of clinical comprehensive curative effect, the effective rate of the experimental group was 51.72%, 41.37%, 93.10% respectively, which was better than that of the control group (27.59%, 48.27%, 75.86% respectively), and the total effective rate of the experimental group was 51.72%, 41.37% and 93.10%, respectively. The difference was statistically significant (P0.05). In the aspect of anti-hepatic fibrosis, the indexes of serum hepatic fibrosis in the two groups were improved after treatment, and the improvement of the indexes of HA,LN,C 鈪，

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