艾灵颗粒协同HAART治疗气虚血瘀型艾滋病患者的长期临床研究
摘要
艾滋病即获得性免疫缺陷综合征(Acquired Immunodeficiency Syndrome,AIDS)是由人类免疫缺陷病毒(Human immunodeficiency virus,HIV)引起的一种传染病,是以免疫系统损害和感染为主要特征的一组综合征。高效抗逆转录病毒疗法(highlyactive antiretroviral therapy,HAART)是公认的至今最有效的干预手段。研究证实:HAART的应用能够有效地抑制病毒复制,但无法彻底清除艾滋病毒。HAART疗法的耐药性、药物毒副作用、每日药片负担量以及服药次数等原因限制了其在临床中的应用,减低了其治疗的效果。中医中药在几千年防治各种急性传染病和慢性病方面积累了十分丰富的经验和理论,特别是中医的“扶正祛邪”、“整体调整”等调动机体抗病毒能力的观点是非常值得借鉴的。自1987年起中国中医科学院即参与和坦桑尼亚国立莫西比利医院合作开展中医药治疗艾滋病项目,运用中医药为艾滋病病人和HIV感染者进行治疗,并在临床和科研方面进行了卓有成效的努力。艾灵颗粒即是在此基础上制成的纯中药制剂,通过本研究评价艾灵颗粒协同HAART治疗艾滋病的长期疗效及安全性,探索适合我国国情的治疗艾滋病的新途径。
1目的
本研究旨在评价益气活血中药艾灵颗粒协同HAART疗法治疗气虚血瘀型HIV/AIDS患者的长期的疗效和安全性,从而为艾灵颗粒协同HAART治疗艾滋病长期应用于临床提供循证学依据,探讨中西医结合治疗艾滋病的可能性和优势。
2方法
本研究采用前瞻性、随机单盲、安慰剂平行对照试验设计方法,筛选符合标准的气虚血瘀型艾滋病患者60例,随机分为中西医结合治疗组和HAART对照组。两组分别给予抗HIV组方(AZT+3TC+NVP)+中药艾灵颗粒和抗HIV组方(AZT+3TC+NVP)+安慰剂。两组患者分别在治疗的第0、3、6、9、12、18、24个月观察临床症状体征变化、运用流式细胞技术和定量PCR技术进行CD4~+T淋巴细胞、CD8~+T淋巴细胞、CD4/CD8、CD4~+CD45RA、病毒载量,在第0、3、6、9月进行树突状细胞的检测,同时在第0、9、24月进行安全性指标血常规、尿常规、X线、心电图、肝功能、肾功能的测定,以评价艾灵颗粒协同HAART治疗艾滋病的长期疗效和安全性,探索合理的中西医结合治疗方案。
3结果
通过24个月的观察,中西医结合治疗组疗后9、12月对症状体征总积分的改善优于HAART对照组(P＜0.05),疗后24月明显优于HAART对照组(P＜0.01)。组内比较疗后24月中西医结合治疗组总积分与疗前比显著性降低(P＜0.01)。HAART对照组总积分与疗前比无差异(P＞0.05)。卡洛夫斯基积分中西医结合治疗组在疗后各月均优于对照组(P＜0.05)。中西医结合治疗组CD4+T淋巴细胞计数在疗后9、12月高于HAART对照组(P＜0.05)。中西医结合治疗组疗后3、6、9月较疗前明显升高(P＜0.01),疗后12月较疗前升高(P＜0.05)。HAART对照组疗后3月较疗前明显升高(P＜0.01),疗后9月较疗前降低(P＜0.05)。CD8~+T淋巴细胞计数、CD4/CD8、CD4~+CD45RA组间比较无差异(P＞0.05),中西医结合治疗组CD8~+T淋巴细胞计数疗后3月较疗前升高(P＜0.05),疗后6月较疗前明显升高(P＜0.01)。HAART对照组CD8~+T淋巴细胞计数疗后12、18月较疗前降低(P＜0.05)。中西医结合治疗组CD4/CD8治疗前后无差异(P＞0.05),HAART对照组CD4/CD8疗后3、12月较疗前明显升高(P＜0.01)。CD4~+CD45RA中西医结合治疗组疗后9月较疗前升高(P＜0.05)。HAART对照组CD4~+CD45RA疗前后比较无差异(P＞0.05)。病毒载量组间组内比较均无差异(P＞0.05)。MDC频率、PDC频率组间比较无统计学差异(P＞0.05),两组MDC、PDC频率疗后9月都较疗前高,但无统计学差异。MDC分泌IL-12的含量中西医结合治疗组疗后9月较HAART对照组高(P＜0.05)。PDC分泌α-IFN的含量中西医治疗组疗后3、6月较HAART对照组高,有显著性差异(P＜0.01)。两组治疗前后组间比较安全性指标(血尿常规、X线、心电图、肝肾功能及血糖、血脂)均无统计学差异。
4结论
艾灵颗粒协同HAART长期治疗气虚血瘀型艾滋病患者改善了患者的临床症状体征,提高生活质量,且随治疗时间的增加,症状体征积分逐渐降低;促进了患者的CD4~+T淋巴细胞计数的升高,促进了MDC、PDC分泌IL-12、α-IFN,增强了患者的免疫功能;艾灵颗粒与HAART同用,未影响HAART抑制病毒复制的作用;同时,验证了艾灵颗粒与HAART同用的安全性。
Highly active antiretroviral therapy(HAART) dramatically changed the course of HIV infection.Currently,this therapy in China involves the use of agents from at least two distinct classes of antivirals:a non-nucleoside reverse transcriptase inhibitor(NNRTI) in combination with NRTIs.Although these agents are highly efficacious in delaying the onset of AIDS,their clinical utility is limited by viral resistance,nonadherence to therapy, and drug toxicity.The treasure of Traditional Chinese Medicine have affluent experience and theories in the field anti-viral.From 1987,professors of China Academy of Chinese Medical Sciences commenced to research in treating AIDS with Traditional Chinese Medicine in Tanzania.The effect and safety of AILING granule was proved in Tanzania.
1 Objective
This prospective,randomized,single-blind,parallel-group study compared the efficacy and safety of AILING granule puls HAART(treatment group) with HAART puls placebo(control group) with HIV/AIDS patients for 24 months.
2 Method
A total of 60 patients living with HIV were enrolled and divided randomly into two groups, HAART(AZT+3TC+NVP) puls AILING granule(treatment group) and HAART (AZT+3TC +NVP) pals placebo(control group),all the patients'symptoms and signs were investigated,and at the same time detecting immune function(CD4~+T cells counts,CD8~+T cells counts、CD4/CD8、CD4~+CD45RA),viral load at baseline,the 3~(rd) month,the 6~(th) month,the 9~(th) month,the 12~(th) month,the 18~(th) month and the 24~(th) month,and testing dendritic cells at baseline,the 3~(rd) month,the 6~(th) month,the 9~(th) month,and investigating salty by blood regular test,urine regular test,liver function,renal function,blood sugar, cholesterol,triglyceride,X ray and ECG at baseline,the9~(th)and 24~(th) month.
3 Results
It showed that there were differences between two groups in accumulated scores of symptoms and signs at the 9~(th) and 12~(th) month(P＜0.05),and significant differences at the 24~(th) month(P＜0.01 ).The treatment group was better than the control group in Karnovsky Score after the treatment(P＜0.05).There were differences between two groups in CD4~+T counts at the 9~(th) and 12~(th) month(P＜0.05),the results showed the treatment group was better than the control group.The changes of the CD8 counts,CD4~+CD45RA,the ratio of CD4/CD8 were similar in both groups(P＞0.05 ).The percent of MDC and PDC and also were similar in both groups(P＞0.05).The function of MDC was higher for patients treated with AILING granule at the 9~(th) month(P＜0.05).The function of PDC was statistically significant higher for patients treated with AILING granule(P＜0.01).There were no difference between two groups in viral load(P＞0.05).
4 Conclusion
Ailing Granule puls HAART has the better effect of improving immune function(boosting CD4~+ cell counts),relieving symptoms,and keeping viral load stabilization for the AIDS patients than HAART only.The compliance of patients was preferably.The antiretrovirus treatment combined with TCM is better safety than only HAART.
1目的
本研究旨在评价益气活血中药艾灵颗粒协同HAART疗法治疗气虚血瘀型HIV/AIDS患者的长期的疗效和安全性,从而为艾灵颗粒协同HAART治疗艾滋病长期应用于临床提供循证学依据,探讨中西医结合治疗艾滋病的可能性和优势。
2方法
本研究采用前瞻性、随机单盲、安慰剂平行对照试验设计方法,筛选符合标准的气虚血瘀型艾滋病患者60例,随机分为中西医结合治疗组和HAART对照组。两组分别给予抗HIV组方(AZT+3TC+NVP)+中药艾灵颗粒和抗HIV组方(AZT+3TC+NVP)+安慰剂。两组患者分别在治疗的第0、3、6、9、12、18、24个月观察临床症状体征变化、运用流式细胞技术和定量PCR技术进行CD4~+T淋巴细胞、CD8~+T淋巴细胞、CD4/CD8、CD4~+CD45RA、病毒载量,在第0、3、6、9月进行树突状细胞的检测,同时在第0、9、24月进行安全性指标血常规、尿常规、X线、心电图、肝功能、肾功能的测定,以评价艾灵颗粒协同HAART治疗艾滋病的长期疗效和安全性,探索合理的中西医结合治疗方案。
3结果
通过24个月的观察,中西医结合治疗组疗后9、12月对症状体征总积分的改善优于HAART对照组(P＜0.05),疗后24月明显优于HAART对照组(P＜0.01)。组内比较疗后24月中西医结合治疗组总积分与疗前比显著性降低(P＜0.01)。HAART对照组总积分与疗前比无差异(P＞0.05)。卡洛夫斯基积分中西医结合治疗组在疗后各月均优于对照组(P＜0.05)。中西医结合治疗组CD4+T淋巴细胞计数在疗后9、12月高于HAART对照组(P＜0.05)。中西医结合治疗组疗后3、6、9月较疗前明显升高(P＜0.01),疗后12月较疗前升高(P＜0.05)。HAART对照组疗后3月较疗前明显升高(P＜0.01),疗后9月较疗前降低(P＜0.05)。CD8~+T淋巴细胞计数、CD4/CD8、CD4~+CD45RA组间比较无差异(P＞0.05),中西医结合治疗组CD8~+T淋巴细胞计数疗后3月较疗前升高(P＜0.05),疗后6月较疗前明显升高(P＜0.01)。HAART对照组CD8~+T淋巴细胞计数疗后12、18月较疗前降低(P＜0.05)。中西医结合治疗组CD4/CD8治疗前后无差异(P＞0.05),HAART对照组CD4/CD8疗后3、12月较疗前明显升高(P＜0.01)。CD4~+CD45RA中西医结合治疗组疗后9月较疗前升高(P＜0.05)。HAART对照组CD4~+CD45RA疗前后比较无差异(P＞0.05)。病毒载量组间组内比较均无差异(P＞0.05)。MDC频率、PDC频率组间比较无统计学差异(P＞0.05),两组MDC、PDC频率疗后9月都较疗前高,但无统计学差异。MDC分泌IL-12的含量中西医结合治疗组疗后9月较HAART对照组高(P＜0.05)。PDC分泌α-IFN的含量中西医治疗组疗后3、6月较HAART对照组高,有显著性差异(P＜0.01)。两组治疗前后组间比较安全性指标(血尿常规、X线、心电图、肝肾功能及血糖、血脂)均无统计学差异。
4结论
艾灵颗粒协同HAART长期治疗气虚血瘀型艾滋病患者改善了患者的临床症状体征,提高生活质量,且随治疗时间的增加,症状体征积分逐渐降低;促进了患者的CD4~+T淋巴细胞计数的升高,促进了MDC、PDC分泌IL-12、α-IFN,增强了患者的免疫功能;艾灵颗粒与HAART同用,未影响HAART抑制病毒复制的作用;同时,验证了艾灵颗粒与HAART同用的安全性。
Highly active antiretroviral therapy(HAART) dramatically changed the course of HIV infection.Currently,this therapy in China involves the use of agents from at least two distinct classes of antivirals:a non-nucleoside reverse transcriptase inhibitor(NNRTI) in combination with NRTIs.Although these agents are highly efficacious in delaying the onset of AIDS,their clinical utility is limited by viral resistance,nonadherence to therapy, and drug toxicity.The treasure of Traditional Chinese Medicine have affluent experience and theories in the field anti-viral.From 1987,professors of China Academy of Chinese Medical Sciences commenced to research in treating AIDS with Traditional Chinese Medicine in Tanzania.The effect and safety of AILING granule was proved in Tanzania.
1 Objective
This prospective,randomized,single-blind,parallel-group study compared the efficacy and safety of AILING granule puls HAART(treatment group) with HAART puls placebo(control group) with HIV/AIDS patients for 24 months.
2 Method
A total of 60 patients living with HIV were enrolled and divided randomly into two groups, HAART(AZT+3TC+NVP) puls AILING granule(treatment group) and HAART (AZT+3TC +NVP) pals placebo(control group),all the patients'symptoms and signs were investigated,and at the same time detecting immune function(CD4~+T cells counts,CD8~+T cells counts、CD4/CD8、CD4~+CD45RA),viral load at baseline,the 3~(rd) month,the 6~(th) month,the 9~(th) month,the 12~(th) month,the 18~(th) month and the 24~(th) month,and testing dendritic cells at baseline,the 3~(rd) month,the 6~(th) month,the 9~(th) month,and investigating salty by blood regular test,urine regular test,liver function,renal function,blood sugar, cholesterol,triglyceride,X ray and ECG at baseline,the9~(th)and 24~(th) month.
3 Results
It showed that there were differences between two groups in accumulated scores of symptoms and signs at the 9~(th) and 12~(th) month(P＜0.05),and significant differences at the 24~(th) month(P＜0.01 ).The treatment group was better than the control group in Karnovsky Score after the treatment(P＜0.05).There were differences between two groups in CD4~+T counts at the 9~(th) and 12~(th) month(P＜0.05),the results showed the treatment group was better than the control group.The changes of the CD8 counts,CD4~+CD45RA,the ratio of CD4/CD8 were similar in both groups(P＞0.05 ).The percent of MDC and PDC and also were similar in both groups(P＞0.05).The function of MDC was higher for patients treated with AILING granule at the 9~(th) month(P＜0.05).The function of PDC was statistically significant higher for patients treated with AILING granule(P＜0.01).There were no difference between two groups in viral load(P＞0.05).
4 Conclusion
Ailing Granule puls HAART has the better effect of improving immune function(boosting CD4~+ cell counts),relieving symptoms,and keeping viral load stabilization for the AIDS patients than HAART only.The compliance of patients was preferably.The antiretrovirus treatment combined with TCM is better safety than only HAART.
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