Objective: To evaluate whether herbs of supplementing Qi and nourishing Yin combined with chemotherapy (versus chemotherapy alone) improve survival, increase tumor response, improve performance status or reduce ch...Objective: To evaluate whether herbs of supplementing Qi and nourishing Yin combined with chemotherapy (versus chemotherapy alone) improve survival, increase tumor response, improve performance status or reduce chemotherapy toxicity in patients with lung cancer. Methods: Searching the randomized controlled trials (RCT) studies from the databases (China HowNet database, Wan Fang database, VIP database, Master Thesis and Pubmed) between January 2013 and January 2017. RevMan 5.3 software was used to evaluate the quality of these collected papers. Results: Of 48 potentially relevant publications, 10 randomized studies representing 691 patients met inclusion criteria with 369 cases in the supplementing Qi and nourishing Yin plus Chemotherapy group (Herbs + Chem group) and 322 cases in Chemotherapy group (Chem only group). There were significant differences between Herbs + Chem group and Chem only group in improving the treatment efficacy and reducing the side effects of chemotherapy (P 〈 0.001 for all). There were also significant differences between the two groups in tumor response and quality of life (P 〈 0.001 for all). Conclusion: Herbs of supplementing Qi and nourishing Yin may increase chemotherapy effectiveness, reduce chemotherapy toxicity and improve the quality of life of patients with lung cancer when combined with chemotherapy.展开更多
Objective:To observe the effects of Chinese drugs for supplementing qi,nourishing yin and activating blood circulation on the myocardial perfusion in acute myocardial infarction(AMI) patients after revascularization.M...Objective:To observe the effects of Chinese drugs for supplementing qi,nourishing yin and activating blood circulation on the myocardial perfusion in acute myocardial infarction(AMI) patients after revascularization.Methods:Eighty patients with anterior or inferior ventricular wall AMI,who had received revascularization by intravenous thrombolysis or coronary bypass,were randomized into the treated group and the control group equally,both treated with conventional Western medical treatment,but combined,resp...展开更多
Objective: To observe the effect of Chinese herbal medicine for nourishing yin, supplementing qi, and activating blood on the expression of interferen- γ (IFN-γ,)/interleukin-4 (IL-4) in peripheral blood and di...Objective: To observe the effect of Chinese herbal medicine for nourishing yin, supplementing qi, and activating blood on the expression of interferen- γ (IFN-γ,)/interleukin-4 (IL-4) in peripheral blood and disease activity in primary Sjogren's syndrome (pSS) patients, and to study the relationship between the immune balance of Th1/Th2 and the disease activity. Methods: A total of 66 pSS patients were randomized with tossing coins method into two groups: the integrative therapy group (34 cases) and the control group (32 cases); and 28 healthy subjects were taken as the normal group. The integrative therapy group was treated by Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood combined with hydroxychloroquine sulfate tablets and the control group was treated with hydroxychloroquine sulfate tablets. The treatment course was 3 months for both groups. The levels of serum immunoglobulin G (IgG), erythrocyte sedimentation rate (ESR), IFN-γand IL-4 in peripheral blood were measured before and after treatment. Results: Compared with the normal group, the levels of IgG, ESR, IFN- γ and IL-4 were significantly increased in pSS patients (P〈0.05). Remarkably, after 3 months of treatment, these levels were dramatically decreased in both the integrative therapy group and the control group, although still higher than the normal group. The levels of IgG, ESR, IFN- and IL-4 in the integrative therapy group were lower than the control group and the same group before treatment (P〈0.05). The ratio of IFN-γ/IL-4 also significantly decreased after treatment. Moreover, the level of IFN- γ, and the ratio of IFN- γ/IL-4 in the integrative theraphy group were significantly lower than the control group (P〈0.05). For all patients the ratio of IFN-γ/IL-4 before and after treatment was positive correlated with the levels of IgG and ESR. Conclusion: Chinese herbal medicine for nourishing yin, supplementing qi, and activating blood can alleviate the disease activity of pSS by regulating the immune balance of Th1/Th2.展开更多
ABSTRACT Objective: To investigate the effect of Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood on the reproductive endocrine-immune network and its mechanisms in patients with pr...ABSTRACT Objective: To investigate the effect of Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood on the reproductive endocrine-immune network and its mechanisms in patients with primary Sjogren's syndrome (pSS). Methods: Seventy pSS patients were randomly assigned to two groups using a randomized digital table: the integrative therapy group (36 cases) and the control group (34 cases). Thirty healthy subjects were taken as a normal group. The control group was treated with hydroxychloroquine sulfate tablets alone, and the integrative therapy group was treated by Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood combined with hydroxychloroquine sulfate tablets. The treatment course was 6 months for both groups. Before and after treatment, serum estradiol (E2), testosterone (T), luteinizing hormone (LH), prolactin (PRL) by radioimmunoassay and immunoglobulin (IgG) by immunodiffusion, erythrocyte sedimentation rate (ESR) by Westergren, interferon-γ (IFN-γ) and interleukin-4 (IL-4) by enzyme linked immunosorbent assay were determined. Results: E2 and T levels in all patients were lower than those of normal subjects before treatment (P〈0.05) and were increased significantly after 6-month treatment (P〈0.05). ESR, FSH, LH, IgG, IFN - γ, IL - 4 and ratios of E2/T, and IFN --γ/IL in the patients were higher than those of normal subjects before the treatments (P〈0.05), and were reduced significantly after the treatments (P〈0.05). The T and IFN -γ levels and E2/T ratio in the patients treated with integrative therapy were reduced significantly compared with the control group (P〈0.05). However, the PRL levels before and after treatment were not significantly changed in the two groups (P〉0.05). The ratios of E2/T and IFN -γ/IL-4, and levels of IgG and ESR were positively correlated before and after treatment (P〈0.05). Conclusions: The ratios of E2/T and IFN - γ/ IL-4 might be used as indicators of pSS activity. Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood combined with Western medicine could improve the therapeutic effect by regulating the reproductive endocrine-immune network in pSS patients.展开更多
Objective: To investigate the effects of Chinese herbs for supplementing qi, nourishing yin and activating blood circulation on heart function of patients with acute coronary syndrome (ACS) after successful percuta...Objective: To investigate the effects of Chinese herbs for supplementing qi, nourishing yin and activating blood circulation on heart function of patients with acute coronary syndrome (ACS) after successful percutaneous coronary intervention (PCI). Methods: One hundred patients with ACS after successful PCI were randomly assigned to a Western medicine (WM) treatment group (WMG) and a combined treatment group (CMG) treated by Chinese herbs for supplementing qi, nourishing yin and activating blood circulation, besides Western medicine treatment, with 50 cases in each group. Both treatment courses were 6 months. The follow- up was scheduled at baseline, 6 months and 1 year after PCI, and New York Heart Association (NYHA) functional class, Chinese medicine (CM) symptom scores, blood stasis syndrome scores, and major adverse cardiovascular events (MACE) were observed, serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) and hyper-sensitivity C-reactive protein (Hs-CRP) were measured, an echocardiogram was conducted to examine left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), inter-ventricular septal thickness (IVST), left ventricular posterior wall thickness (LVPWT), and ventricular wall motion index (VWMI). Results: Compared with the baseline, LVEF significantly increased (P〈0.01), and CM symptom scores, blood stasis syndrome scores, VWMI, LVEDV, LVESV, NT-proBNP, and Hs-CRP all decreased (P〈0.01) in both groups at 6 months and at 1 year after PCI. There were no significant differences in all the above parameters at 1 year vs those at 6 months after PCI (P〉0.05). VWMI, LVEDV, LVESV, NT-proBNP, Hs-CRP, LVEF, and CM symptom and blood stasis syndrome scores were all improved obviously in CMG than those in WMG (P〈0.05 or P〈0.01) at 6 months and at 1 year after PCI. There were no significant differences in NYHA functional class between CMG and WMG at different follow-up timepoints; it was notable that P value was 0.054 when comparing the cases of NYHA functional class between the two groups at 1-year follow-up. During the 1-year follow-up, 3 MACE and 11 MACE occurred in CMG and WMG, respectively; the MACE rate in CMG was lower than that in WMG (6% vs 22%, P〈0.05). Conclusion: Chinese herbs for supplementing qi, nourishing yin and activating blood circulation could improve heart function, reduce the CM symptom scores and blood stasis syndrome scores, and decrease the incidence of MACE in patients with ACS after successful PCI.展开更多
Objective: To probe the effects of qi-supplementing and yin-nourishing therapy (blood-increasing decoction and blood generating powder) on chronic thrombocytopenia. Methods: Two hundred patients with chronic thrombocy...Objective: To probe the effects of qi-supplementing and yin-nourishing therapy (blood-increasing decoction and blood generating powder) on chronic thrombocytopenia. Methods: Two hundred patients with chronic thrombocytopenia were randomly divided into control (n=100) and test groups (n = 100) with Amino-polypeptide as a basic treatment for both. Test group patients consumed a blood-increasing decoction and blood-generating powder for 1-3 months. Improvements in platelet counts and TCM syndrome were observed. Results: One hundred and sixty-four (80 in the test group and 84 in the control group) of 189 total participants were treated for 3 months. The total effective rate in improving TCM syndrome was 95.00% in the test group and 79.76% in the control group (P<0.05). There was significant difference (P<0.05) in the accumulated score of TCM syndrome between the two groups treated at different time points. The total effective rate of platelet counts was 86.25% in the test group and 59.52% in the control group (P<0.05). There was a significant difference in platelet counts before and after treatment in the two groups (P<0.05). There was no significant differences in platelet count between the two groups treated for 1-2 months; however, a significant difference was found between the two groups after treatment for 3 months (P<0.05). Conclusions: After a 3-month treatment of chronic thrombocytopenia patients with qi-supplementing and yin-nourishing therapy, TCM syndrome was improved and platelet counts increased with no obvious side effects, and the quality of life of the participants was enhanced with noticeable long-term curative effects.展开更多
Objective: To assess the efficacy and safety of Zhongyan-4 (中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detox...Objective: To assess the efficacy and safety of Zhongyan-4 (中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication) in treating HIV/AIDS patients in the early or middle stage. Methods: Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group (36 patients) treated with ZY-4 and the control group (36 patients) treated with placebo. The treatment course was six months. The index of OD4^+, OD8^+ counts, body weight, clinical symptom scoring were estimated at 4 time points (0, 1, 3 and 6 month in the course), and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group. Results: OD4^+ count in the ZY-4 group got elevated by 7.70 4±150.96/mm^3 on average, while that in the control group lowered by 27.33 4±85.28 /mm^3 . Fifteen out of the 30 patients in the ZY-4 group had their OD4^+ count increased, which was evidently much higher than that in the control group (8/33, P〈0. 05), suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating OD4^+ count. Moreover, ZY-4 showed actions in elevating OD45RA^+ and OD8^+ count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial. Conclusion: ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.展开更多
文摘Objective: To evaluate whether herbs of supplementing Qi and nourishing Yin combined with chemotherapy (versus chemotherapy alone) improve survival, increase tumor response, improve performance status or reduce chemotherapy toxicity in patients with lung cancer. Methods: Searching the randomized controlled trials (RCT) studies from the databases (China HowNet database, Wan Fang database, VIP database, Master Thesis and Pubmed) between January 2013 and January 2017. RevMan 5.3 software was used to evaluate the quality of these collected papers. Results: Of 48 potentially relevant publications, 10 randomized studies representing 691 patients met inclusion criteria with 369 cases in the supplementing Qi and nourishing Yin plus Chemotherapy group (Herbs + Chem group) and 322 cases in Chemotherapy group (Chem only group). There were significant differences between Herbs + Chem group and Chem only group in improving the treatment efficacy and reducing the side effects of chemotherapy (P 〈 0.001 for all). There were also significant differences between the two groups in tumor response and quality of life (P 〈 0.001 for all). Conclusion: Herbs of supplementing Qi and nourishing Yin may increase chemotherapy effectiveness, reduce chemotherapy toxicity and improve the quality of life of patients with lung cancer when combined with chemotherapy.
基金Supported by the National Key Technologies Research and Development Program of China during the 10th Five-Year Plan Period(No.2003BA712A11)
文摘Objective:To observe the effects of Chinese drugs for supplementing qi,nourishing yin and activating blood circulation on the myocardial perfusion in acute myocardial infarction(AMI) patients after revascularization.Methods:Eighty patients with anterior or inferior ventricular wall AMI,who had received revascularization by intravenous thrombolysis or coronary bypass,were randomized into the treated group and the control group equally,both treated with conventional Western medical treatment,but combined,resp...
文摘Objective: To observe the effect of Chinese herbal medicine for nourishing yin, supplementing qi, and activating blood on the expression of interferen- γ (IFN-γ,)/interleukin-4 (IL-4) in peripheral blood and disease activity in primary Sjogren's syndrome (pSS) patients, and to study the relationship between the immune balance of Th1/Th2 and the disease activity. Methods: A total of 66 pSS patients were randomized with tossing coins method into two groups: the integrative therapy group (34 cases) and the control group (32 cases); and 28 healthy subjects were taken as the normal group. The integrative therapy group was treated by Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood combined with hydroxychloroquine sulfate tablets and the control group was treated with hydroxychloroquine sulfate tablets. The treatment course was 3 months for both groups. The levels of serum immunoglobulin G (IgG), erythrocyte sedimentation rate (ESR), IFN-γand IL-4 in peripheral blood were measured before and after treatment. Results: Compared with the normal group, the levels of IgG, ESR, IFN- γ and IL-4 were significantly increased in pSS patients (P〈0.05). Remarkably, after 3 months of treatment, these levels were dramatically decreased in both the integrative therapy group and the control group, although still higher than the normal group. The levels of IgG, ESR, IFN- and IL-4 in the integrative therapy group were lower than the control group and the same group before treatment (P〈0.05). The ratio of IFN-γ/IL-4 also significantly decreased after treatment. Moreover, the level of IFN- γ, and the ratio of IFN- γ/IL-4 in the integrative theraphy group were significantly lower than the control group (P〈0.05). For all patients the ratio of IFN-γ/IL-4 before and after treatment was positive correlated with the levels of IgG and ESR. Conclusion: Chinese herbal medicine for nourishing yin, supplementing qi, and activating blood can alleviate the disease activity of pSS by regulating the immune balance of Th1/Th2.
基金Supported by the National Natural Science Foundation of China(No.81473604)
文摘ABSTRACT Objective: To investigate the effect of Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood on the reproductive endocrine-immune network and its mechanisms in patients with primary Sjogren's syndrome (pSS). Methods: Seventy pSS patients were randomly assigned to two groups using a randomized digital table: the integrative therapy group (36 cases) and the control group (34 cases). Thirty healthy subjects were taken as a normal group. The control group was treated with hydroxychloroquine sulfate tablets alone, and the integrative therapy group was treated by Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood combined with hydroxychloroquine sulfate tablets. The treatment course was 6 months for both groups. Before and after treatment, serum estradiol (E2), testosterone (T), luteinizing hormone (LH), prolactin (PRL) by radioimmunoassay and immunoglobulin (IgG) by immunodiffusion, erythrocyte sedimentation rate (ESR) by Westergren, interferon-γ (IFN-γ) and interleukin-4 (IL-4) by enzyme linked immunosorbent assay were determined. Results: E2 and T levels in all patients were lower than those of normal subjects before treatment (P〈0.05) and were increased significantly after 6-month treatment (P〈0.05). ESR, FSH, LH, IgG, IFN - γ, IL - 4 and ratios of E2/T, and IFN --γ/IL in the patients were higher than those of normal subjects before the treatments (P〈0.05), and were reduced significantly after the treatments (P〈0.05). The T and IFN -γ levels and E2/T ratio in the patients treated with integrative therapy were reduced significantly compared with the control group (P〈0.05). However, the PRL levels before and after treatment were not significantly changed in the two groups (P〉0.05). The ratios of E2/T and IFN -γ/IL-4, and levels of IgG and ESR were positively correlated before and after treatment (P〈0.05). Conclusions: The ratios of E2/T and IFN - γ/ IL-4 might be used as indicators of pSS activity. Chinese herbal medicines for nourishing yin, supplementing qi, and activating blood combined with Western medicine could improve the therapeutic effect by regulating the reproductive endocrine-immune network in pSS patients.
基金Supported by the Key Projects in the National Science and Technology Pillar Program during the Eleventh Five-year Plan Period(No.2006BA104A01)
文摘Objective: To investigate the effects of Chinese herbs for supplementing qi, nourishing yin and activating blood circulation on heart function of patients with acute coronary syndrome (ACS) after successful percutaneous coronary intervention (PCI). Methods: One hundred patients with ACS after successful PCI were randomly assigned to a Western medicine (WM) treatment group (WMG) and a combined treatment group (CMG) treated by Chinese herbs for supplementing qi, nourishing yin and activating blood circulation, besides Western medicine treatment, with 50 cases in each group. Both treatment courses were 6 months. The follow- up was scheduled at baseline, 6 months and 1 year after PCI, and New York Heart Association (NYHA) functional class, Chinese medicine (CM) symptom scores, blood stasis syndrome scores, and major adverse cardiovascular events (MACE) were observed, serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) and hyper-sensitivity C-reactive protein (Hs-CRP) were measured, an echocardiogram was conducted to examine left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), inter-ventricular septal thickness (IVST), left ventricular posterior wall thickness (LVPWT), and ventricular wall motion index (VWMI). Results: Compared with the baseline, LVEF significantly increased (P〈0.01), and CM symptom scores, blood stasis syndrome scores, VWMI, LVEDV, LVESV, NT-proBNP, and Hs-CRP all decreased (P〈0.01) in both groups at 6 months and at 1 year after PCI. There were no significant differences in all the above parameters at 1 year vs those at 6 months after PCI (P〉0.05). VWMI, LVEDV, LVESV, NT-proBNP, Hs-CRP, LVEF, and CM symptom and blood stasis syndrome scores were all improved obviously in CMG than those in WMG (P〈0.05 or P〈0.01) at 6 months and at 1 year after PCI. There were no significant differences in NYHA functional class between CMG and WMG at different follow-up timepoints; it was notable that P value was 0.054 when comparing the cases of NYHA functional class between the two groups at 1-year follow-up. During the 1-year follow-up, 3 MACE and 11 MACE occurred in CMG and WMG, respectively; the MACE rate in CMG was lower than that in WMG (6% vs 22%, P〈0.05). Conclusion: Chinese herbs for supplementing qi, nourishing yin and activating blood circulation could improve heart function, reduce the CM symptom scores and blood stasis syndrome scores, and decrease the incidence of MACE in patients with ACS after successful PCI.
基金supported by National Sci-tech support program in the 11th 5-year plan (2007BAI20B064)Zhejiang Provincial TCM Administration (2007CA026)
文摘Objective: To probe the effects of qi-supplementing and yin-nourishing therapy (blood-increasing decoction and blood generating powder) on chronic thrombocytopenia. Methods: Two hundred patients with chronic thrombocytopenia were randomly divided into control (n=100) and test groups (n = 100) with Amino-polypeptide as a basic treatment for both. Test group patients consumed a blood-increasing decoction and blood-generating powder for 1-3 months. Improvements in platelet counts and TCM syndrome were observed. Results: One hundred and sixty-four (80 in the test group and 84 in the control group) of 189 total participants were treated for 3 months. The total effective rate in improving TCM syndrome was 95.00% in the test group and 79.76% in the control group (P<0.05). There was significant difference (P<0.05) in the accumulated score of TCM syndrome between the two groups treated at different time points. The total effective rate of platelet counts was 86.25% in the test group and 59.52% in the control group (P<0.05). There was a significant difference in platelet counts before and after treatment in the two groups (P<0.05). There was no significant differences in platelet count between the two groups treated for 1-2 months; however, a significant difference was found between the two groups after treatment for 3 months (P<0.05). Conclusions: After a 3-month treatment of chronic thrombocytopenia patients with qi-supplementing and yin-nourishing therapy, TCM syndrome was improved and platelet counts increased with no obvious side effects, and the quality of life of the participants was enhanced with noticeable long-term curative effects.
文摘目的 探讨中医益气养阴活血法辨证治疗2型糖尿病(Type 2 diabetes, T2DM)合并慢性心力衰竭(Chronic heart failure, CHF)患者的临床疗效。方法 选取2021年1月—2022年1月期间唐山市中医医院内分泌一科收治的T2DM合并CHF患者102例作为研究对象,按随机数字表法分为对照组与治疗组,每组各51例。对照组给予常规西医治疗,治疗组在对照组基础上联合中医益气养阴活血法辨证治疗,均治疗12周。观察比较两组患者西医疗效、中医证候疗效、安全性及治疗前后血糖水平[空腹血糖(Fasting blood glucose, FPG)、餐后2 h血糖(Blood glucose 2 h after a meal, 2 h PG)、糖化血红蛋白(Glycosylated hemoglobin, HbAlc)]、心功能指标[6分钟步行试验距离(6 min walking test, 6MWT)、左室射血分数(Left ventricular ejection fraction, LVEF)、N末端B型脑钠肽前体(N-terminal B-type brain natriuretic peptide precursor, NT-pro BNP)]、生活质量评分[T2DM生活质量(Quality of life specific scale for diabetes patients, DSQL)、CHF生活质量(Minnesota Living with Heart Failure Questionnaire, MLHFQ)]变化。结果 临床疗效:治疗后治疗组西医疗效总有效率96.08%(49/51)高于对照组82.35%(42/51),差异有统计学意义(P<0.05);治疗组中医证候疗效总有效率92.16%(47/51)高于对照组68.63%(35/51),差异有统计学意义(P<0.05)。血糖水平:治疗后两组患者血糖FPG、2 h PG及HbAlc水平均较治疗前降低,差异有统计学意义(P<0.05);且治疗组血糖FPG、2 h PG及HbAlc水平均明显低于对照组,差异有统计学意义(P<0.05)。心功能指标:治疗后两组患者心功能6MWT、LVEF水平较治疗前升高,NT-pro BNP水平较治疗前降低,差异有统计学意义(P<0.05);且治疗组6MWT、LVEF水平高于对照组,NT-pro BNP水平低于对照组,差异有统计学意义(P<0.05)。生活质量:治疗后两组患者DSQL、MLHFQ评分均较治疗前降低,差异有统计学意义(P<0.05);且治疗组DSQL、MLHFQ评分均明显低于对照组,差异有统计学意义(P<0.05)。安全性:治疗期间,两组患者不良反应均为轻度或一过性,未影响治疗,且不良反应发生率组间比较,差异无统计学意义(P>0.05)。结论 中医益气养阴活血法辨证治疗T2DM合并CHF效果显著、安全性高,有利于控制患者血糖,改善心功能与生活质量。
基金Supported by the Projects of Ministry of Science and Tech-nology for 10th Five-year Plan (2001BA701A18)
文摘Objective: To assess the efficacy and safety of Zhongyan-4 (中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication) in treating HIV/AIDS patients in the early or middle stage. Methods: Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group (36 patients) treated with ZY-4 and the control group (36 patients) treated with placebo. The treatment course was six months. The index of OD4^+, OD8^+ counts, body weight, clinical symptom scoring were estimated at 4 time points (0, 1, 3 and 6 month in the course), and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group. Results: OD4^+ count in the ZY-4 group got elevated by 7.70 4±150.96/mm^3 on average, while that in the control group lowered by 27.33 4±85.28 /mm^3 . Fifteen out of the 30 patients in the ZY-4 group had their OD4^+ count increased, which was evidently much higher than that in the control group (8/33, P〈0. 05), suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating OD4^+ count. Moreover, ZY-4 showed actions in elevating OD45RA^+ and OD8^+ count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial. Conclusion: ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.