体外培育牛黄治疗慢性乙型肝炎湿热蕴结证临床观察

目的：观察体外培育牛黄治疗慢性乙型肝炎（ CHB）湿热蕴结证患者的临床疗效及安全性。方法：本研究为开放研究，采用前瞻性随机平行对照临床实验方法，来自于湖北省中医院肝病科的66例CHB湿热蕴结证患者随机分为治疗组33例（脱落1例），对照组33例。对照组患者予以西医常规治疗（包括抗HBV治疗），治疗组患者在对照组治疗基础上，加用体外培育牛黄0.15～0.3g口服，1次/d。两组均以4周为1个疗程。观察两组患者治疗前后中医证候疗效、肝功能的改善情况、安全性指标及不良反应，并进行比较。结果：治疗组患者中医证候疗效明显优于对照组（100％vs 81.8％， P＜0.05），尤其对主要症候如倦怠乏力、胁肋刺痛、身目尿黄等的改善明显优于对照组（P＜0.05）；对于ALT、 GGT及TBil的改善明显优于对照组（P＜0.05）；无不良反应。结论：体外培育牛黄治疗CHB湿热蕴结证，具有显著的护肝、降酶和退黄作用，尤其対中医证候的改善有显著效果，安全性良好。

Clinical observation of bezoar cultivated in vitro for treating chronic hepatitis B with syndrome of damp and heat retention

Objective： To observe the clinical efficacy and safety of the calculus bovis cultured in vitro for the treatment of chronic hepatitis B （ damp heat retention ） .Methods： The study was open research, in the prospective clinical randomized controlled experiments, 66 patients of chronic hepatitis B from Hubei Provincial Traditional Chinese Medicine （ TCM） Hospital were randomly divided into treatment group 33 cases （ one case fall off） and control group 33 cases.The control group received routine treatment （including anti HBV treatment）, the treatment group received the calculus bovis cultivated in vitro 0.15g or 0.3g oral, once a day , based on the treatment of control group.The two groups were 4 weeks for one course.Two groups were observed before and after treatment in patients with TCM syndrome curative effect and liver function improve, meanwhile safety and adverse reaction were compared.Results： The curative effect of TCM syndrome in the treatment group was better than the control group （100%vs 81.8%, P〈0.05）, especially on the improvement of main symptoms such as fatigue, stabbing pains over hypochondrium, yellow appearance of the skin, and urine, were significantly better than the control group （ P〈0.05 ） .ALT, GGT and TBil of the treatment group were improved significantly superior to the control group （ P〈0.05） no adverse reac-tion.Conclusion： The calculus bovis cultivated in vitro has significant curative effect in reducing enzyme, protecting liver, falling back yellow during the treatment of chronic hepatitis B （ damp heat retention） , especially has a significant effect on the improve-ment of TCM syndrome with the good safety.