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©The Author(s) 2011.
世界华人消化杂志. 2011-09-18; 19(26): 2777-2785
在线出版 2011-09-18. doi: 10.11569/wcjd.v19.i26.2777
在线出版 2011-09-18. doi: 10.11569/wcjd.v19.i26.2777
表1 纳入试验基本情况
研究者 | n(试验组/对照组) | 年龄(岁) | 性别(男/女) | 随访时间(wk) | |||||||||
试验组 | 对照组 | 试验组 | 对照组 | 干预措施 | 备注 | ||||||||
HBeAg 阳性 | HBeAg 阴性 | HBeAg阳性 | HBeAg阴性 | HBeAg阳性 | HBeAg阴性 | HBeAg阳性 | HBeAg阴性 | HBeAg阳性 | HBeAg阴性 | ||||
Liaw等[5] | 458/463 | 222/224 | 32 | 43 | 33 | 43 | 333/125 | 174/48 | 331/112 | 177/47 | (1) | 104 | 临床Ⅲ期试验 |
Lai等[6] | 458/463 | 222/224 | 32 | 43 | 33 | 43 | 333/125 | 174/48 | 351/112 | 177/47 | (1) | 52 | 临床Ⅲ期试验 |
Lai等[7] | 44/19 | - | 22 | - | 34 | - | 35/9 | - | 15/4 | - | (2) | 52 | 临床Ⅱ期试验 |
Hou等[8] | 147/143 | 20/22 | 28 | 38 | 29 | 36 | 118/29 | 17/3 | 107/36 | 19/3 | (1) | 52 | |
Safadi等[9] | 81/81 | 41/43 | 36 | 37 | 87/35 | 95/29 | (1) | 24 | 临床Ⅲb期试验 | ||||
Chan等[10] | 24W:45/8952W:43/42 | - | A:34, B:30, C:33 | - | A: 35/10, B: 40/4, C: 27/19 | - | (3)(4) | 24/52 | |||||
钟旬华等[11] | 60/60 | 60/60 | 29±8.2 | 41±10.1 | 30±8.5 | 42±9.5 | 42/19(6) | 38/22 | 40/20 | 34/26 | (1) | 52 | |
汤东澄等[12] | 56/52 | 29/27 | - | - | - | - | - | - | - | - | (1) | 48 | |
潘建华等[13] | 40/40 | - | 31±12 | - | 33±13 | - | 36/4 | - | 34/6 | - | (3) | 4/8/12/24/48 | |
邱绍勤等[14] | 21/9 | 20/10 | 41.45±10.98 | 48/12 | (5) | 52 |
表2 纳入研究方法学质量
表3 LDT组与LAM组对比其HBV DNA检测不到率结果
HBeAg | 疗程(wk) | 纳入研究数 | LDT组/LAM组(n) | P值, I2值 | DNA转阴率(LDT组/LAM组) | RR值(95%CI) |
阳性 | 48 | 1个[12] | 56/52 | - | 60.71%/40.38% | 1.50(1.02, 2.22) |
52 | 4个[6-8,11] | 709/685 | 0.45, 0% | 62.34%/40.58% | 1.54(1.38, 1.72) | |
104 | 1个[5] | 458/463 | - | 55.60%/55.60% | 1.45(1.26, 1.67) | |
总疗程 | 6个 | 1 223/1 200 | 0.70, 0% | 59.77%/39.75% | 1.50(1.38, 1.64) | |
敏感性分析 | 3个[5,6,8] | 1 063/1 069 | 0.36, 1% | 59.08%/39.20% | 1.51(1.38, 1.65) | |
阴性 | 48 | 1个[12] | 29/27 | - | 差异无统计学意义 | 0.99(0.66, 1.48) |
52 | 3个[6,8,11] | 302/306 | 0.59, 0% | 86.09%/69.28% | 1.24(1.14, 1.36) | |
104 | 1个[5] | 222/224 | - | 82.00%/56.70% | 1.45(1.27, 1.65) | |
总疗程 | 5个 | 553/557 | 0.15, 41% | 83.18%/63.91% | 1.30(1.21, 1.40) | |
敏感性分析 | 3个[5,6,8] | 464/470 | 0.08, 61% | 85.13%/64.68%1 | 1.29(1.12, 1.48)1 |
表4 LDT组与LAM组对比其ALT复常率结果
HBeAg | 疗程(wk) | 纳入研究数 | LDT组/LAM组(n) | P值, I2值 | DNA转阴率(LDT组/LAM组) | RR值(95%CI) |
阳性 | 48 | 1个[12] | 56/52 | - | 87.50%/71.15% | 1.23, (1.01, 1.50) |
52 | 4个[6-8,11] | 709/685 | 0.14, 44% | 80.67%/74.60% | 1.08, (1.02, 1.14) | |
104 | 1个[5] | 458/463 | - | 69.50%/61.70% | 1.12, (1.02, 1.23) | |
总疗程 | 6个 | 1 223/1 200 | 0.22, 30% | 76.42%/69.60% | 1.10, (1.05, 1.16) | |
阴性 | 48 | 1个[12] | 29/27 | - | 差异无统计学意义 | 1.03, (0.74, 1.43) |
52 | 3个[6,8,11] | 302/306 | 0.01, 77% | 差异无统计学意义 | 1.09, (0.90, 1.33)1 | |
104 | 1个[5] | 222/224 | - | 差异无统计学意义 | 1.11, (1.00, 1.24) | |
总疗程 | 5个 | 553/557 | 0.04, 60% | 差异无统计学意义 | 1.08, (0.96, 1.21)1 |
表5 LDT组与ADV组治疗效果比较
指标 | 时间(wk) | 结果 | RR值 | 95%CI | 纳入研究 |
HBV DNA检测不到率(PCR法) | 4 | = | 2.00 | 0.19, 21.18 | 潘建华等[13] |
8 | = | 1.50 | 0.26, 8.50 | 潘建华等 | |
12 | = | 2.00 | 0.65, 6.11 | 潘建华等 | |
24 | > | 2.45 | 1.56, 3.85 | 潘建华等/ Henry等[10] | |
P = 0.36, I2 = 0% | |||||
48 | > | 1.59 | 1.04, 2.42 | 潘建华等 | |
52 | = | 1.49 | 0.96, 2.32 | Henry等 | |
ALT复常率 | 4 | = | 1.63 | 0.76, 3.49 | 潘建华等 |
8 | = | 1.38 | 0.79, 2.43 | 潘建华等 | |
12 | = | 1.35 | 0.86, 2.12 | 潘建华等 | |
24 | = | 1.04 | 0.43, 1.29 | 潘建华等/ Henry等 | |
P = 0.37, I2 = 0% | |||||
48 | = | 1.14 | 0.89, 1.48 | 潘建华等 | |
52 | = | 0.92 | 0.76, 1.12 | Henry等 | |
HBeAg转阴率 | 4 | = | 3.00 | 0.13, 71.51 | 潘建华等 |
8 | = | 1.67 | 0.43, 6.51 | 潘建华等 | |
12 | = | 2.00 | 0.65, 6.11 | 潘建华等 | |
24 | = | 1.55 | 0.85, 2.84 | 潘建华等/ Henry等 | |
P = 0.73, I2 = 0% | |||||
48 | = | 1.89 | 0.96, 3.72 | 潘建华等 | |
52 | = | 1.41 | 1.68, 2.94 | Henry等 | |
HBeAg血清转换率 | 24 | = | 0.76 | 0.31, 1.85 | Henry等 |
52 | = | 1.47 | 0.67, 3.22 | Henry等 |
表6 LDT组与常规内科治疗组治疗效果比较
指标 | 时间(wk) | 结果 | RR值 | 95%CI |
血清HBV DNA检测不到率(PCR法) | 2 | > | 19.00 | 1.16, 312.42 |
4 | > | 24.00 | 3.47, 166.23 | |
12 | > | 8.33 | 2.81, 24.67 | |
HBeAg血清转换率 | 4 | = | 1.36 | 0.06, 30.64 |
12 | = | 0.43 | 0.03, 312.42 |
引文著录: 杨声坪, 李婧媛, 张鹏, 袁金秋, 刘雅莉. 替比夫定治疗慢性乙型肝炎疗效的系统评价. 世界华人消化杂志 2011; 19(26): 2777-2785