CAJ | 학술논문

目的：评价利胆退黄方治疗肝胆湿热型病毒性瘀胆型肝炎的临床疗效及安全性，便于临床推广运用。方法采用多中心、随机对照平行研究，55例患者分为对照组(护肝降酶+熊去氧胆酸口服250 mg，bid)27例，治疗组(对照组治疗方案+利胆退黄方)28例，疗程4周。观察两组患者的临床疾病疗效、中医证候疗效和肝功能指标的变化。结果治疗组在改善临床疾病疗效、中医证候疗效方面明显优于对照组，差异有统计学意义(P<0.05)；治疗组患者的总胆红素(TB)、直接胆红素(DB)、谷丙转氨酶(ALT)、Y-谷氨酰转酞酶(GGT)和碱性磷酸酶(ALP)分别为(37.91±21.30)μmol/L、(23.70±18.49)μmol/L、(40.50±13.90)μmol/L、(64.30±17.80)μmol/L、(125.60±21.30)μmol/L，明显低于对照组的(78.96±34.48)μmol/L、(66.40±30.28)μmol/L、(68.60±24.80)μmol/L、(90.10±27.80)μmol/L、(157.49±36.49)μmol/L，差异均有统计学意义(P<0.05)；治疗组患者的血、尿常规、肾功能以及心电图等安全性观测指标均无异常，无因不良事件退出临床研究。结论利胆退黄方治疗肝胆湿热型病毒性瘀胆型肝炎安全有效，值得临床推广应用。
목적：평개리담퇴황방치료간담습열형병독성어담형간염적림상료효급안전성，편우림상추엄운용。방법채용다중심、수궤대조평행연구，55례환자분위대조조(호간강매+웅거양담산구복250 mg，bid)27례，치료조(대조조치료방안+리담퇴황방)28례，료정4주。관찰량조환자적림상질병료효、중의증후료효화간공능지표적변화。결과치료조재개선림상질병료효、중의증후료효방면명현우우대조조，차이유통계학의의(P<0.05)；치료조환자적총담홍소(TB)、직접담홍소(DB)、곡병전안매(ALT)、Y-곡안선전태매(GGT)화감성린산매(ALP)분별위(37.91±21.30)μmol/L、(23.70±18.49)μmol/L、(40.50±13.90)μmol/L、(64.30±17.80)μmol/L、(125.60±21.30)μmol/L，명현저우대조조적(78.96±34.48)μmol/L、(66.40±30.28)μmol/L、(68.60±24.80)μmol/L、(90.10±27.80)μmol/L、(157.49±36.49)μmol/L，차이균유통계학의의(P<0.05)；치료조환자적혈、뇨상규、신공능이급심전도등안전성관측지표균무이상，무인불량사건퇴출림상연구。결론리담퇴황방치료간담습열형병독성어담형간염안전유효，치득림상추엄응용。
Objective To evaluate the clinical efficacy and safety of Lidantuihuang Prescription in the treat-ment of liver and gallbladder damp-heat syndrome of cholestatic viral hepatitisease. Methods A multicenter, random-ized, controlled parallel study was conducted with 55 patients involved, which were divided into two groups. The con-trol group (27 cases) was treated with Liver JiangMei+oral ursodeoxycholic acid 250 mg, bid, and the treatment group (28 cases) applied the same basic treatments and the Chinese decotion for 4 weeks. Changes in clinical comprehensive efficacy, TCM syndromes, and liver function [total bilirubin (TB), direct bilirubin (DB), alanine aminotransferase (ALT), γ-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) were observed. Results The treatment group was significantly better than the control group in clinical efficacy, TCM syndrome, P<0.05. The blood serum levels of TB, DB, ALT, AST, ALP in treatment group were (37.91±21.30)μmol/L, (23.70±18.49)μmol/L, (40.50±13.90)μmol/L, (64.30 ± 17.80) μmol/L, (125.60 ± 21.30) μmol/L, all significantly lower than those in the control group: (78.96 ± 34.48) μmol/L, (66.40 ± 30.28)μmol/L, (68.60 ± 24.80)μmol/L, (90.10 ± 27.80)μmol/L, (157.49 ± 36.49)μmol/L, P<0.05. Safety indexes such as blood test, urine test, renal function and electrocardiogram showed no adverse events. Conclusion Lidantuihuang Prescription is efficient and safe for jaundice and liver-gallbladder damp-heat syndrome in cholestatic hepatitis virus, which is worthy of clinical promotion.