【摘要】：目的以保肝西藥為對照,觀察中藥復方清肝解毒湯對肝功能、肝纖維化、HCV RNA及癥狀體征的影響,客觀評價該方劑治療難治性慢性丙型肝炎的臨床療效。方法采用開放性對照試驗的臨床研究方法,入選難治性丙型肝炎患者60例,其中試驗組30例,對照組30例。試驗組給予中藥復方清肝解毒湯(治療過程中針對兼證加減用藥)治療,對照組給予保肝西藥(還原性谷胱甘肽片、水飛薊賓膠囊)治療,療程為48周。分別觀察治療前后的證候療效,對癥狀體征進行記錄評分,并檢測客觀療效指標:肝功能(ALT、AST、TBil、DBil、GGT、ALB、GLOB)、HCV RNA定量、肝纖維化指標及腹部B超評分,同時監(jiān)測血、尿、便常規(guī),心電圖、腎功能等安全性指標,觀察評價其療效及安全性。結果共有58例病人完成48周療程,試驗組、對照組各29例。兩組各有1例脫落病例。兩組治療后癥狀、體征較治療前有所改善,且在改善肝脾腫大、脅痛、脘悶腹脹、口干而苦、乏力、身目發(fā)黃、蛛痣肝掌、噯氣、大便稀溏方面試驗組優(yōu)于對照組(P0.05)�？共《警熜Х矫�,試驗組與對照組HCV RNA陰轉率均為0,但試驗組病毒定量均數(shù)小于對照組病毒定量均數(shù),且P0.05,有統(tǒng)計學差異,試驗組抑制丙肝病毒復制的療效優(yōu)于對照組。臨床綜合療效方面,試驗組顯效率、有效率、總有效率分別為51.72%、41.37%、93.10%,均優(yōu)于對照組(分別為27.59%、48.27%、75.86%),差異有統(tǒng)計學意義(P0.05)。抗肝纖維化方面,兩組治療后血清肝纖維化各項指標均較治療前改善,且試驗組HA、LN、CⅣ各項指標的改善優(yōu)于對照組。腹部B超評分提示兩組無統(tǒng)計學差異(P0.05)。整個研究過程未出現(xiàn)不良反應。結論清肝解毒湯在改善難治性丙型肝炎患者的臨床癥狀和體征方面有明顯優(yōu)勢,且有一定的保肝降酶功效、抗肝纖維化作用;還有一定程度的抑制丙肝病毒復制作用。但腹部B超改善不明顯,考慮與療程尚短有關。
[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，

本文編號：2458366