艾肺Ⅰ号治疗HIV/AIDS病人合并肺部感染痰热壅肺证临床研究

Clinical effect of Aifei NO.1 in treatment of HIV/AIDS complicated with pulmonary infection and phlegm heat obstructing lung syndrome

目的观察艾肺Ⅰ号治疗福建地区艾滋病病毒(HIV)感染者/艾滋病(AIDS)病人(简称HIV/AIDS病人)合并肺部感染痰热壅肺证的临床疗效。方法采用随机、平行对照试验方法,将入组患者随机分为治疗组与对照组,对照组给予常规抗感染治疗,治疗组在常规抗感染基础上加自拟方艾肺I号治疗,观察第0、7、14天时的中医证候积分、白细胞计数(WBC)、C反应蛋白(CRP)及肺部CT改善情况等。结果完成治疗的病人共68例,治疗组36例,对照组32例。两组病人性别、年龄、CD4+T淋巴细胞计数和生命体征均无差异。治疗第7天时,治疗组的中医证候积分为(21.56±3.73)分,低于对照组(23.84±3.86)分,第14天时治疗组积分为(13.69±4.77)分,低于对照组(16.26±3.65)分,差异均有统计学意义(P<0.05);治疗有效率:治疗组第7天为66.67%,第14天为91.67%;对照组第7天为37.50%,第14天为84.38%,差异均有统计学意义(P<0.05)。治疗第0、7、14天时两组的白细胞计数比较差异无统计学意义(P>0.05);第0天及第7天时两组CRP差异无统计学意义(P>0.05),第14天时治疗组CRP为(7.24±8.74)mg/L,低于对照组(15.88±16.91)mg/L,两组比较差异有统计学意义(P<0.05)。治疗第7天时两组的肺部CT改善率比较差异无统计学意义(P>0.05),第14天时,治疗组改善率(61.11%)优于对照组(37.5%),两组差异有统计学意义(P<0.05)。结论艾肺I号与抗生素联合使用可提升HIV/AIDS病人合并肺部感染痰热壅肺证临床疗效。

Objective To observe the effect of hospital-made Aifei No.1 traditional Chinese medicine（TCM） in treatment of HIV/AIDS patients with pulmonary infection of phlegm heat obstructing lung syndrome（PHOLS） in Fujian. Methods A randomized, parallel control method was adopted with the AIDS patients divided into two groups. The control group received routine anti-infection treatment and the treatment group were treated with Aifei No.1. Then, score of TCM syndromes, white blood cell count（WBC）, c-reactive protein（CRP）, improvement of lung CT and others were observed at the 0, 7 th and 14 th day. Results There was no difference at baseline level between the two groups. On the 7 th day, the score of TCM syndromes of the treatment group was 21.56 ± 3.73, lower than that of the control group 23.84 ± 3.86. On the 14 th day, the score of TCM syndromes of the treatment group was 13.69 ± 4.77, lower than that of the control group 16.26 ±3.65, with the difference statistically significant（P〈0.05）. The effective rate of the treatment group was 66.67% on the 7 th day and 91.66% on the 14 th day, and that of the control group was 37.5% on the 7 th day and 84.38% on the 14 th day, with the difference statistically significant（P〈0.05）. And there was no significant difference in WBC between the two groups on the 0, 7 th and 14 th day（P〉0.05）.There was no significant difference in CRP between the two groups on 0 and 7 th day（P〉 0.05）. But on the 14 th day, the CRP of the treatment group was 7.24 ± 8.74 mg/L, lower than that of the control group 15.88± 16.91 mg/L, with the difference statistically significant（P〈0.05）. There was no significant difference between the two groups regarding the improvement rates of lung CT, on the 7 th day, but on the 14 th day, the improvement rate of treatment group was 61.11%, better than that of the control group（37.5%）, and the difference between the two groups was statisticallysignificant（P〈0.05）. Conclusion Combination of Aifei No.1 and antibiotics can improve the curative effect of treatment of HIV/AIDS patients with pulmonary infection of phlegm heat obstructing lung syndrome.