CAJ | 학술논문

目的研究温肾方对替比夫定(LdT)治疗HBeAg阳性慢性乙型肝炎肾阳虚证患者的抗病毒疗效及肌酸激酶(CK)的影响. 方法将96例人组病例随机分到治疗组及对照组,各为48例.治疗组予温肾方联合LdT治疗；对照组予LdT单药治疗.疗程均为52周.观察两组患者的中医证候积分、生物化学应答、病毒学应答、HBeAg血清学应答、血清CK水平等.根据资料不同采用t检验、x2检验或Mann-Whitney检验,P＜0.05为差异有统计学意义.结果共有84例(治疗组43例)患者完成52周的研究.临床证候疗效方面治疗组总有效率优于对照组[88.37％ (38/43)对比63.41％(26/41),P＜0.01].治疗组在中医证候缓解、生物化学应答、病毒学应答、HBeAg血清学应答方面均优于对照组[(4.97±1.88)分对比(10.13±3.72)分、95.35％ (41/43)对比75.61％ (31/41)、81.40％ (35/43)对比56.10％ (23/41)、48.84％ (21/43)对比26.83％ (11/41),P＜0.05或P＜0.01).本研究中未发现原发无应答患者,共有7例出现病毒学突破,均发生在对照组,与治疗组比较,差异有统计学意义(P＜0.05).不良反应:两组均有CK升高,其中治疗组19例,占44.19％;对照组30例,占73.17％；两组间差异有统计学意义(P＜0.01).结论温肾方可提高LdT治疗肾阳虚型HBeAg阳性慢性乙型肝炎的抗病毒疗效,减少血清肌酸激酶的异常率.
목적 연구온신방대체비부정(LdT)치료HBeAg양성만성을형간염신양허증환자적항병독료효급기산격매(CK)적영향. 방법 장96례인조병례수궤분도치료조급대조조,각위48례.치료조여온신방연합LdT치료；대조조여LdT단약치료.료정균위52주.관찰량조환자적중의증후적분、생물화학응답、병독학응답、HBeAg혈청학응답、혈청CK수평등.근거자료불동채용t검험、x2검험혹Mann-Whitney검험,P＜0.05위차이유통계학의의.결과 공유84례(치료조43례)환자완성52주적연구.림상증후료효방면치료조총유효솔우우대조조[88.37％ (38/43)대비63.41％(26/41),P＜0.01].치료조재중의증후완해、생물화학응답、병독학응답、HBeAg혈청학응답방면균우우대조조[(4.97±1.88)분대비(10.13±3.72)분、95.35％ (41/43)대비75.61％ (31/41)、81.40％ (35/43)대비56.10％ (23/41)、48.84％ (21/43)대비26.83％ (11/41),P＜0.05혹P＜0.01).본연구중미발현원발무응답환자,공유7례출현병독학돌파,균발생재대조조,여치료조비교,차이유통계학의의(P＜0.05).불량반응:량조균유CK승고,기중치료조19례,점44.19％;대조조30례,점73.17％；량조간차이유통계학의의(P＜0.01).결론 온신방가제고LdT치료신양허형HBeAg양성만성을형간염적항병독료효,감소혈청기산격매적이상솔.
Objective To study the influences of warming kidney prescription on antiviral therapeutic efficacy and creatine kinase (CK) level in telbivudine-treated HBeAg-positive chronic hepatitis B patients with kidney yang deficiency syndrome.Methods Ninety-six cases were enrolled and randomly divided into two groups (n=48 each):warming kidney prescription treatment or control.Both groups were treated for 52 weeks with telbivudine monotherapy,but the treatment group received additional treatment with the warming kidney prescription.Traditional Chinese medicine (TCM) syndrome score,biochemical response,virological response,serological response,CK level,and adverse reactions were recorded for each group in order to perform comparative analysis of the warming kidney prescription's effects.Results A total of 84patients,including 43 cases in the treatment group,completed the study.The warming kidney prescription led to significantly improved total clinical syndrome efficacy,TCM syndrome score,biochemical response,virological response,and HBeAg serological responses,as evidenced by changes for each parameter observed in the treatment group versus the control group (respectively,88.37％ vs.63.41％,4.97 ± 1.88 vs.10.13 ±3.72,95.35％ vs.75.61％,81.40％ vs.56.10％,48.84％ vs.26.83％ (all,P ＜ 0.05)).No patient in either group experienced primary treatment failure.Seven cases,all from the control group,experienced virological breakthrough.Elevated CK was observed in both the treatment and control groups,but significantly more patients in the control group experienced this adverse reaction (respectively,73.17％ vs.44.19％; P ＜ 0.01).Conclusion The warming kidney prescription can increase telbivudine antiviral therapeutic efficacy and decrease the telbivudine-induced increase in creatine kinase in HbeAg-positive chronic hepatitis B patients with kidney yang deficiency syndrome.