目的 探讨初治肺结核患者早期应用胸腺肽α1辅助治疗的临床治疗效果.方法 收集2009年6月至2014年12月陕西省安康市中心医院感染性疾病科收治的初治肺结核患者,根据随机数字表法进行随机分组:106例进入胸腺肽α1组(化疗加胸腺肽α1,简称“α1组”),109例进入对照组(单纯化疗).观察治疗前及治疗后第1个月末、3个月末和6个月末的临床疗效、免疫功能变化及复发情况.结果 两组患者均进行临床治疗,其中治疗6个月时,两组患者均有2例失访.治疗前α1组和对照组CD4+T淋巴细胞计数[分别为450(318～535)个/“l、420(326～508)个/μl]差异无统计学意义(U=5599.00,P=0.696),化疗1个月后两组CD4+T淋巴细胞计数均上升,α1组上升的幅度[262(163～376)个/μ1]高于对照组[189(100～282)个/μl],差异有统计学意义(U=4019.50,P＜0.01).治疗第3、6个月末时,α1组患者的痰菌阴转率分别为69.8％(74/106)、99.0％(103/104),均高于对照组同期的痰菌阴转率[分别为55.0％(60/109)、91.6％(98/107)],差异均有统计学意义(x2=4.99,P=0.025;x2=6.48,P=0.011).治疗第3、6个月末时,α1组胸部影像学表现有效率分别为77.4％(82/106)、87.5％(91/104),明显高于对照组[分别为65.1％(71/109)、73.8％(79/107)],差异均有统计学意义(x2=3.91,P=0.048;x2=5.18,P=0.023);α1组空洞缩小率分别为76.1％(35/46)、89.1％(41/46),均优于对照组同期的空洞缩小率[分别为53.5％(23/43)、69.8％(30/43)],差异均有统计学意义(x2=5.00,P=0.025;x2=5.17,P=0.023);6个月疗程结束时,α1组患者的空洞闭合率(69.6％,32/46)明显高于对照组(48.8％,21/43),差异有统计学意义(x2=3.96,P=0.046).6个月疗程结束时,α1组治疗成功率为97.1％(101/104),失败率为2.9％(3/104);对照组治疗成功率为89.7％(96/107),失败率为10.3％(11/107),两组患者的治疗转归情况差异无统计学意义(U=5272.00,P=0.435).结论 初治肺结核患者早期抗结核治疗的同时辅助应用胸腺肽α1有助于痰菌阴转、肺内病变的吸收好转和免疫功能的改善.“,”Objective To evaluate clinical efficacy of thymosin alpha 1 in the early treatment of primary pulmonary tuberculosis.Methods Two hundred and fifteen cases with primary pulmonary tuberculosis were enrolled in the Department of Infectious Disease of Ankang City Central Hospital during Jun.2009 to Dec.2014.According to random number table method,all cases were randomly divided into two groups.That was 106 cases in thymosin alpha 1 group (chemotherapy combined with thymosin alpha 1,alpha 1 group),and 109 cases in the control group (chemotherapy).Clinical effect,immune function and recurrence were observed before treatment and in 1,3 and 6 months after treatment.Results Clinical efficacy was demonstrated in the two groups.There were each 2 lost cases in alpha 1 group and control group in the 6 months after treatment.The CD4+ T lymphocyte count in the α1 group (450(318-535)/μl) and control group (420(326-508)/μl) before treatment were no difference statistically (U=5599.00,P=0.696).The CD4+ T lymphocyte counts were increased in two group in the 1 month after treat ment.The increase of CD4+ T lymphocyte count in the α1 group (262 (163-376)/μl) was higher than that (189 (100-282)/μl) in the control group with significant difference statistically (U=4019.50,P＜0.01).The rates of sputum negative conversion in the 3 and 6 months after treatment in the α1 group (69.8％ (74/106) vs.99.0％ (103/104)) were higher than those (55.0％(60/109) vs.91.6％(98/107)) in the control group with significant difference statistically (x2 =4.99,P=0.025;x2 =6.48,P=0.011).The rates of chest imaging effect in the 3 and 6 months after treatment in the α1 group (77.4％(82/106) vs.87.5％(91/104)) were higher than those (65.1％ (71/109) vs.73.8％(79/107)) in the control group with significant difference statistically (x2 =3.91,P=0.048;x2 =5.18,P=0.023).The cavity reducing rates in the 3 and 6 months after treatment in the α1 group (76.1％ (35/46) vs.89.1％(41/46)) were better than those (53.5％(23/43) vs.69.8％(30/43)) in the control group with significant difference statistically (x2 =5.00,P =0.025;x2 =5.17,P =0.023).The cavity closure rates in the 6 months after treatment in the α1 group (69.6 ％ (32/46) were higher than that (48.8 ％ (21/43)) in the control group with significant difference statistically (x2=3.96,P=0.046).After 6 months of treatment,the rates of success and failure were 97.1％ (101/104) vs.2.9％ (3/104) in the α1 group,89.7％ (96/107) vs.10.3％ (11/107) in the control group without significant difference statistically (U=5272.00,P=0.435).Conclusion Chemotherapy combined with adjunctive therapy with thymosin alpha 1 earlier is helpful to sputum negative conversion,lung lesion absorption and immune function improvement in primary pulmonary tuberculosis.