CAJ | 학술논문

目的：采用随机对照试验（RCT）方法，对比观察“补肾生髓成肝”法联合聚乙二醇干扰素α-2a治疗HBeAg阳性慢性乙型肝炎（ CHB）的临床疗效。方法：将80例HBeAg阳性CHB患者，随机分为治疗组和对照组，每组各40例。治疗组患者采用“补肾生髓成肝”法联合派罗欣治疗，对照组患者只采用派罗欣。治疗后第1、4、8、12、24、48、72周时检测患者外周血白细胞计数、丙氨酸氨基转移酶（ ALT）、血清总胆红素（ TBil）、 HBV DNA、HBsAg、 HBeAg、 HBeAb等指标。结果：治疗组患者外周血白细胞计数在治疗后第8周为（3.74±0.49）×109/L、12周为（4.06±0.17）×109/L、24周为（4.20±0.63）×109/L，分别显著高于同期对照组的（3.49±0.58）×109/L、（3.02±0.49）×109/L、（2.29±0.28）×109/L；治疗组患者ALT水平在第8周为（259.70±9.49） U/L、第12周为（125.0±9.10） U/L、第24周为（92.0±10.60） U/L，分别显著低于同期对照组的（312.40±10.58） U/L、（335.0±8.50） U/L、（232.0±9.00） U/L；治疗组患者TBil在第12周为（14.0±4.00）μmol/L、第24周为（9.20±3.60）μmol/L，分别显著低于对照组的（28.2±9.60）μmol/L、（32.0±9.50）μmol/L；治疗组患者第72周HBV DNA阴转率为75％、 HBeAg/HBeAb转换率为50％，显著高于对照组的51.3％、38.5％；治疗第48周后， HBsAg＜1000 IU/ml的患者，治疗组有26例，对照组为15例。以上结果经统计学处理，差异有显著性意义（ P＜0.05）。结论：采用体现“补肾生髓成肝”治疗法则的“补肾健脾”方联合Peg-IFNα-2a治疗CHB，可以获得“减毒”（减少骨髓抑制，降低肝损伤）“增效”（提高病毒学应答）的生物学效应，增加患者的受益。
목적：채용수궤대조시험（RCT）방법，대비관찰“보신생수성간”법연합취을이순간우소α-2a치료HBeAg양성만성을형간염（ CHB）적림상료효。방법：장80례HBeAg양성CHB환자，수궤분위치료조화대조조，매조각40례。치료조환자채용“보신생수성간”법연합파라흔치료，대조조환자지채용파라흔。치료후제1、4、8、12、24、48、72주시검측환자외주혈백세포계수、병안산안기전이매（ ALT）、혈청총담홍소（ TBil）、 HBV DNA、HBsAg、 HBeAg、 HBeAb등지표。결과：치료조환자외주혈백세포계수재치료후제8주위（3.74±0.49）×109/L、12주위（4.06±0.17）×109/L、24주위（4.20±0.63）×109/L，분별현저고우동기대조조적（3.49±0.58）×109/L、（3.02±0.49）×109/L、（2.29±0.28）×109/L；치료조환자ALT수평재제8주위（259.70±9.49） U/L、제12주위（125.0±9.10） U/L、제24주위（92.0±10.60） U/L，분별현저저우동기대조조적（312.40±10.58） U/L、（335.0±8.50） U/L、（232.0±9.00） U/L；치료조환자TBil재제12주위（14.0±4.00）μmol/L、제24주위（9.20±3.60）μmol/L，분별현저저우대조조적（28.2±9.60）μmol/L、（32.0±9.50）μmol/L；치료조환자제72주HBV DNA음전솔위75％、 HBeAg/HBeAb전환솔위50％，현저고우대조조적51.3％、38.5％；치료제48주후， HBsAg＜1000 IU/ml적환자，치료조유26례，대조조위15례。이상결과경통계학처리，차이유현저성의의（ P＜0.05）。결론：채용체현“보신생수성간”치요법칙적“보신건비”방연합Peg-IFNα-2a치료CHB，가이획득“감독”（감소골수억제，강저간손상）“증효”（제고병독학응답）적생물학효응，증가환자적수익。
Objective: To observe the clinical efficacy of tonifying kidney to promote liver regeneration ( TKPLR) combined with peginterferon alfa-2a (pegasys) for chronic hepatitis B with HBeAg-positive.Methods: Eighty patients suffering from chron-ic hepatitis B with HBeAg-positive were enrolled in this study.Participants were randomly assigned to two groups in a 1∶1 ratio.The treatment group treated by TKPLR combined with pegasys.The control group treated by pegasys.Leukocyte counts , ALT, TBil, HBV DNA, HBsAg and HBeAg were detected on weeks of 1st, 4th, 8th, 12th, 24th, 48th and 72th after treatment.Results: After the treatment of treated by TKPLR combined with pegasys for chronic hepatitis B , the leukocyte counts in treat-ment group were significantly higher than control group at 8th week (3.74 ±0.49 vs 3.49 ±0.58, P<0.05), 12th (4.06 ± 0.17 vs 3.02 ±0.49, P<0.05) and 24th week (4.20 ±0.63 vs 2.29 ±0.28, P<0.05); the level of ALT in treatment group were significantly lower than control group on weeks of 8th, 12th and 24th respectively (259.70 ±9.49 vs 312.40 ±10.58,125.0 ±9.10 vs 335.0 ±8.50 and 92.0 ±10.60 vs 232.0 ±9.00, all P<0.05);the level of TBil in treatment group were sig-nificantly lower than control group on weeks of 12th and 24th, respectively (14.0 ±4.00 vs 28.2 ±9.60 and 9.20 ±3.60 vs 32.0 ±9.50, all P<0.05);the negative rate of HBV DNA and seroconversion rate of HBeAg /HBeAb in treatment group were significantly higher than control group on weeks of 72th (75%vs 51.3%and 50%vs 38.5%, all P<0.05);after 48 weeks of treatment , the result of HBsAg was less than 1000 IU /ml in patients of the treatment group with 26 cases, and 15 cases in the control group (P<0.05) .Conclusion: There are the biological effects of “Jiandu” (reduce bone marrow depression and liver damage ) as well as “Zengxiao” ( improved virologic response ) to increase the benefit of patients in the course of treating chronic hepatitis B with the chinese herbs Bushen Jianpi prescription embodying therapeutic principle of TKPLR combined with pegasys .