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张国梁1 陆平2 侯勇1
（1 安徽省中医院， 230031；2 安徽省利辛中医院）
内容摘要
1 目的
观察复方芪玄颗粒联合HAART 疗法对120 例气虚血瘀证AIDS 患者症状体征、患者报告结局、生存质量、
焦虑抑郁、社会支持度及免疫学指标的影响，探讨复方芪玄颗粒对艾滋病的作用。
2 方法
筛选符合诊断标准的患者120 例，采用随机对照、单盲试验设计方法，将其分为治疗组和对照组，治疗组
给予复方芪玄颗粒，对照组予性状相似的安慰剂颗粒，连续治疗12 个月。两组患者分别在治疗的第0、12
个月记录各项观察指标并于第0、6、12 个月检测患者安全性指标。
3 结果
3.1 两组临床疗效的比较 治疗组和对照组症状体征总有效率分别为87.5%和75.9%，治疗组总有效率高
于对照组（P＜0.05）。免疫学疗效总有效率无明显差异（P＞0.05）。
3.2 两组症状、体征比较 疗后与疗前比较，两组症状总积分降低（P＜0.05 或P＜0.01）；治疗后两组症
状总积分无差异（P＞0.05），治疗前后积分差比较，治疗组差值较对照组升高（P＜0.05）。治疗后，治疗
组乏力、纳呆、腹泻积分降低（P＜0.05 或P＜0.01），对照组腹泻积分降低（P＜0.05）；与对照组疗后比
较，治疗组乏力、纳呆积分低于对照组（P＜0.05）。疗后与疗前比较，治疗组气短、自汗积分降低（P＜
0.05）；对照组腹痛积分降低(P＜0.05)。治疗组皮疹、疱疹、淋巴结肿大积分降低（P＜0.05），对照组皮疹
积分降低（P＜0.05）；与对照组疗后比较，治疗组疱疹积分降低（P＜0.05）。
3.3 两组患者报告结局比较 疗后与疗前比较，治疗组躯体状况、生活状况积分及总积分升高（P＜0.05
或P＜0.01），对照组躯体状况、生活状况积分升高（P＜0.05）。与对照组治疗后比较，治疗组生活状况积
分升高（P＜0.05）。
3.4 两组生存质量比较 疗后与疗前比较，治疗组生理领域、心理领域积分升高（P＜0.05），对照组生理
领域积分升高（P＜0.05）。与对照组治疗后比较，治疗组心理领域积分升高（P＜0.05）。
3.5 两组焦虑、抑郁比较 疗后与疗前比较，治疗组和对照组治疗后SAS、SDS 积分值降低（P＜0.05 或P
＜0.01），治疗组在改善SDS 水平优于对照组（P＜0.01）。
3.6 两组社会支持度比较 两组患者经治疗，社会支持度均未明显改善（P＞0.05）。
3.7 两组T 细胞亚群比较 两组治疗后T 细胞亚群比较，治疗组CD4+/CD8+升高（P＜0.05），其余指标差
异无统计学意义（P＞0.05）。
4 结论
复方芪玄颗粒能提高患者症状体征疗效和免疫学疗效，改善患者临床症状、体征，增加患者报告结局预期，
提升患者生活质量，缓解患者焦虑、抑郁症状，调节患者T 细胞亚群。
关键词 HIV/AIDS；气虚血瘀证；复方芪玄颗粒；高效抗逆转录病毒治疗；临床疗效观察
Abstract
Objectives：To observe the Affection of Compound Qi-xuan particles complicated with HAART on symptoms
第九届世界中医药大会
The 9th World Congress of Chinese Medicine
·191·
临 床 研 究
Clinical research
and signs, the patient reported outcomes, quality of life, anxiety, depression, social support and immunological
parameters to HIV/AIDS at the Syndrome of Qi deficiency and blood(QDBS). To investigate the clinical efficacy
of the Compound Qi-xuan particles.
Methods：Screening of 120 patients met the diagnostic criteria , randomized controlled , single-blind trial design ,
divided into treatment and control groups , the treatment group received the compound stilbene mysterious
particles, and the control group to a similar trait of placebo particles , continuous treatment for 12 months. Two
groups of patients , respectively, record the observed indicator in the treatment of 0,12 months and at 0, 12 months
detection of patient safety indicators .
Results：
1） Comparison of clinical efficacy：Symptoms and signs of the treatment and control groups , the total
efficiency of 87.5% and 75.9% respectively , the treatment group the total efficiency higher than that in the
control group ( P <0.05 ) . Immunology total effective no significant difference ( P > 0.05 ) .
2） Comparison of symptoms, signs：After treatment than before treatment , the two groups total symptom score
decreased (P <0.05 or P <0.01) ; total score of the two sets of symptoms after treatment , no significant difference
( P > 0.05 ) points difference before and after treatment comparison , the difference between the treatment group
compared with the control group increased ( P <0.05 ) .
After treatment, the treatment group, fatigue, poor appetite, diarrhea points lower (P <0.05 or P <0.01) , reduced
diarrhea integral of the control group ( P <0.05) ; with the control group after treatment , the treatment group,
fatigue , poor appetite points lower than the control group ( P <0.05 ) . After treatment than before treatment , the
treatment group shortness of breath , spontaneous perspiration points lower ( P <0.05 ) ; control group, abdominal
pain points lower ( P <0.05 ) . Treatment group, skin rashes, herpes, swollen lymph nodes points lower ( P <0.05) ,
the control group rash points lower ( P <0.05 ) ; with the control group after treatment compared to treatment
group herpes points lower ( P <0.05) .
3） Comparison of patients report the outcome: After treatment compared with before treatment , the body
status of the treatment group , the living conditions of the integral and the total score increased (P <0.05 or P
<0.01) , the control group, body conditions , living conditions of the integral increased ( P <0.05 ) . Compared
with the control group after treatment , the treatment group living conditions of the integration elevated ( P
<0.05 ) .
4） Comparison of quality of life：After treatment than before treatment , the treatment group physical domain ,
psychological domain points higher ( P <0.05 ) the integral of the physical domain of the control group increased
( P <0.05 ) . Compared with control group after treatment , the psychological field integral of the treatment group
increased ( P <0.05 ) .
5） Comparison of anxiety, depression：After treatment than before treatment , the treatment group and control
group after treatment , SAS, SDS integral value lower (P <0.05 or P <0.01) treatment groups in improving the
SDS level than the control group ( P <0.01 ) .
6） Comparison of social support：The two groups of patients after treatment , and social support were not
significantly improved ( P > 0.05 ) .
7） Comparison of T cell subgroups：After treatment, T cell subsets compared to the treatment group, CD4 + /
CD8 + increased ( P <0.05 ) , the other indexes were no significant differences ( P > 0.05 ) .
Conclusions：Compound stilbene mysterious particles can improve the patients symptoms and signs of efficacy
and immunological efficacy , and improve patients' clinical symptoms , signs , increase the patient reports the
outcome is expected to enhance the quality of life of patients and remission in patients with anxiety , depressive
symptoms, and adjustment in patients with T cell subsets .
Key words HIV / AIDS; QDBS; Compound Qi-xuan particles; HAART; clinical therapeutic observation
第九届世界中医药大会
The 9th World Congress of Chinese Medicine
·19 2·
临 床 研 究
Clinical research
（1 安徽省中医院， 230031；2 安徽省利辛中医院）
内容摘要
1 目的
观察复方芪玄颗粒联合HAART 疗法对120 例气虚血瘀证AIDS 患者症状体征、患者报告结局、生存质量、
焦虑抑郁、社会支持度及免疫学指标的影响，探讨复方芪玄颗粒对艾滋病的作用。
2 方法
筛选符合诊断标准的患者120 例，采用随机对照、单盲试验设计方法，将其分为治疗组和对照组，治疗组
给予复方芪玄颗粒，对照组予性状相似的安慰剂颗粒，连续治疗12 个月。两组患者分别在治疗的第0、12
个月记录各项观察指标并于第0、6、12 个月检测患者安全性指标。
3 结果
3.1 两组临床疗效的比较 治疗组和对照组症状体征总有效率分别为87.5%和75.9%，治疗组总有效率高
于对照组（P＜0.05）。免疫学疗效总有效率无明显差异（P＞0.05）。
3.2 两组症状、体征比较 疗后与疗前比较，两组症状总积分降低（P＜0.05 或P＜0.01）；治疗后两组症
状总积分无差异（P＞0.05），治疗前后积分差比较，治疗组差值较对照组升高（P＜0.05）。治疗后，治疗
组乏力、纳呆、腹泻积分降低（P＜0.05 或P＜0.01），对照组腹泻积分降低（P＜0.05）；与对照组疗后比
较，治疗组乏力、纳呆积分低于对照组（P＜0.05）。疗后与疗前比较，治疗组气短、自汗积分降低（P＜
0.05）；对照组腹痛积分降低(P＜0.05)。治疗组皮疹、疱疹、淋巴结肿大积分降低（P＜0.05），对照组皮疹
积分降低（P＜0.05）；与对照组疗后比较，治疗组疱疹积分降低（P＜0.05）。
3.3 两组患者报告结局比较 疗后与疗前比较，治疗组躯体状况、生活状况积分及总积分升高（P＜0.05
或P＜0.01），对照组躯体状况、生活状况积分升高（P＜0.05）。与对照组治疗后比较，治疗组生活状况积
分升高（P＜0.05）。
3.4 两组生存质量比较 疗后与疗前比较，治疗组生理领域、心理领域积分升高（P＜0.05），对照组生理
领域积分升高（P＜0.05）。与对照组治疗后比较，治疗组心理领域积分升高（P＜0.05）。
3.5 两组焦虑、抑郁比较 疗后与疗前比较，治疗组和对照组治疗后SAS、SDS 积分值降低（P＜0.05 或P
＜0.01），治疗组在改善SDS 水平优于对照组（P＜0.01）。
3.6 两组社会支持度比较 两组患者经治疗，社会支持度均未明显改善（P＞0.05）。
3.7 两组T 细胞亚群比较 两组治疗后T 细胞亚群比较，治疗组CD4+/CD8+升高（P＜0.05），其余指标差
异无统计学意义（P＞0.05）。
4 结论
复方芪玄颗粒能提高患者症状体征疗效和免疫学疗效，改善患者临床症状、体征，增加患者报告结局预期，
提升患者生活质量，缓解患者焦虑、抑郁症状，调节患者T 细胞亚群。
关键词 HIV/AIDS；气虚血瘀证；复方芪玄颗粒；高效抗逆转录病毒治疗；临床疗效观察
Abstract
Objectives：To observe the Affection of Compound Qi-xuan particles complicated with HAART on symptoms
第九届世界中医药大会
The 9th World Congress of Chinese Medicine
·191·
临 床 研 究
Clinical research
and signs, the patient reported outcomes, quality of life, anxiety, depression, social support and immunological
parameters to HIV/AIDS at the Syndrome of Qi deficiency and blood(QDBS). To investigate the clinical efficacy
of the Compound Qi-xuan particles.
Methods：Screening of 120 patients met the diagnostic criteria , randomized controlled , single-blind trial design ,
divided into treatment and control groups , the treatment group received the compound stilbene mysterious
particles, and the control group to a similar trait of placebo particles , continuous treatment for 12 months. Two
groups of patients , respectively, record the observed indicator in the treatment of 0,12 months and at 0, 12 months
detection of patient safety indicators .
Results：
1） Comparison of clinical efficacy：Symptoms and signs of the treatment and control groups , the total
efficiency of 87.5% and 75.9% respectively , the treatment group the total efficiency higher than that in the
control group ( P <0.05 ) . Immunology total effective no significant difference ( P > 0.05 ) .
2） Comparison of symptoms, signs：After treatment than before treatment , the two groups total symptom score
decreased (P <0.05 or P <0.01) ; total score of the two sets of symptoms after treatment , no significant difference
( P > 0.05 ) points difference before and after treatment comparison , the difference between the treatment group
compared with the control group increased ( P <0.05 ) .
After treatment, the treatment group, fatigue, poor appetite, diarrhea points lower (P <0.05 or P <0.01) , reduced
diarrhea integral of the control group ( P <0.05) ; with the control group after treatment , the treatment group,
fatigue , poor appetite points lower than the control group ( P <0.05 ) . After treatment than before treatment , the
treatment group shortness of breath , spontaneous perspiration points lower ( P <0.05 ) ; control group, abdominal
pain points lower ( P <0.05 ) . Treatment group, skin rashes, herpes, swollen lymph nodes points lower ( P <0.05) ,
the control group rash points lower ( P <0.05 ) ; with the control group after treatment compared to treatment
group herpes points lower ( P <0.05) .
3） Comparison of patients report the outcome: After treatment compared with before treatment , the body
status of the treatment group , the living conditions of the integral and the total score increased (P <0.05 or P
<0.01) , the control group, body conditions , living conditions of the integral increased ( P <0.05 ) . Compared
with the control group after treatment , the treatment group living conditions of the integration elevated ( P
<0.05 ) .
4） Comparison of quality of life：After treatment than before treatment , the treatment group physical domain ,
psychological domain points higher ( P <0.05 ) the integral of the physical domain of the control group increased
( P <0.05 ) . Compared with control group after treatment , the psychological field integral of the treatment group
increased ( P <0.05 ) .
5） Comparison of anxiety, depression：After treatment than before treatment , the treatment group and control
group after treatment , SAS, SDS integral value lower (P <0.05 or P <0.01) treatment groups in improving the
SDS level than the control group ( P <0.01 ) .
6） Comparison of social support：The two groups of patients after treatment , and social support were not
significantly improved ( P > 0.05 ) .
7） Comparison of T cell subgroups：After treatment, T cell subsets compared to the treatment group, CD4 + /
CD8 + increased ( P <0.05 ) , the other indexes were no significant differences ( P > 0.05 ) .
Conclusions：Compound stilbene mysterious particles can improve the patients symptoms and signs of efficacy
and immunological efficacy , and improve patients' clinical symptoms , signs , increase the patient reports the
outcome is expected to enhance the quality of life of patients and remission in patients with anxiety , depressive
symptoms, and adjustment in patients with T cell subsets .
Key words HIV / AIDS; QDBS; Compound Qi-xuan particles; HAART; clinical therapeutic observation
第九届世界中医药大会
The 9th World Congress of Chinese Medicine
·19 2·
临 床 研 究
Clinical research
