期刊 中药联合含依非韦伦的HAART方案对HIV/AIDS病人的中枢神经系统不良反应及疗效分析  被引量:4

CNS adverse reactions and clinical effects of HIV/AIDS treatment with Chinese medicine combined with the first-line HAART administration including Efavirenz

作  者:苏琛[1] 彭鑫 胡增 贾志超[3] 刘晶晶[1] 

SU Chen;PENG Xin;HU Zeng;JIA Zhichao;LIU Jingjing(Sichuan Academy of Chinese Medical Sciences,Chengdu 610041,China;Hospital of Chengdu Affiliated to University of Traditional Chinese Medicine,Chengdu 610072;Chengdu University of Traditional Chinese Medicine,Chengdu 610075)

机构地区:[1]四川省中医药科学院,成都610041 [2]成都中医药大学附属医院,成都610072 [3]成都中医药大学,成都610075

出  处:《中国艾滋病性病》2019年第9期899-901,905,共4页Chinese Journal of AIDS & STD

CNS adverse reactions and clinical effects of HIV/AIDS treatment with Chinese medicine combined with the first-line HAART administration including Efavirenz

基  金:国家“十二五”科技重大专项(2013ZX10005001-002-003)~~

摘  要:目的观察中药艾复康胶囊/艾可清颗粒联合含依非韦伦(EFV)的高效抗反转录病毒治疗(HAART)药物的中枢神经系统不良反应和临床疗效。方法将符合纳入条件的241例病人随机分为两组;治疗组给予艾复康胶囊/艾可清颗粒联合替诺福韦(TDF)+拉米夫定(3TC)+EFV口服,对照组给予安慰剂联合TDF+3TC+EFV口服;记录并统计比较两组病人在服药不同时间点发生的中枢神经系统不良反应人数、所有时间点出现不同中枢神经系统不良反应症状(眩晕、头痛、困倦/注意力不集中、失眠/梦魇、抑郁)的人数以及不同时间点血浆病毒载量、CD4^+T淋巴细胞(简称CD4细胞)计数变化情况。结果治疗组、对照组分别为121人、120人。服药第4、8、12、24、36、48、60和72周治疗组发生中枢神经系统不良反应人数依次为3人、2人、5人、4人、4人、4人、3人和0人,对照组人数依次为3人、1人、1人、0人、0人、4人、1人和1人,组间比较无统计学意义(P>0.05);所有时间上述不同不良反应症状人数,治疗组分别为3人、4人、10人、12人和3人,对照组分别为0人、1人、7人、8人和4人,组间比较无统计学意义(P>0.05)。血浆病毒载量,两组第48周分别为(0.41±1.09)log拷贝/mL、(0.41±1.10)log拷贝/mL,第72周分别为(0.51±1.41)log拷贝/mL、(0.94±1.64)log拷贝/mL;CD4细胞计数,两组第24周分别为(314.85±144.57)个/μL、(294.07±111.99)个/μL,第48周分别为(332.69±167.79)个/μL、(318.15±133.97)个/μL,第72周分别为(387.09±185.84)个/μL、(394.43±172.23)个/μL,以上组间比较均无统计学意义(P>0.05)。结论与单纯HAART相比,中药艾复康胶囊/艾可清颗粒与含有EFV的TDF+3TC+EFV的HAART方案联用,不会明显增加或减少病人的中枢神经系统不良反应;在抗病毒、提高CD4细胞计数方面也不会发生协同或拮抗作用。

Objective To observe the adverse reactions of central nerve system(CNS)and clinical effects of Chinese medicine Aifukang capsules or Aikeqing granules combined with highly active antiretroviral therapy(HAART)drugs of tenofovir(TDF)+lamivudine(3 TC)+Efavirenz(EFV).Methods 241 patients were randomly divided into two groups.Patients in the clinical group were given Aifukang capsule or Aikeqing granule combined with TDF+3 TC+EFV orally,the control group given placebo combined with TDF+3 TC+EFV orally.The following events frequencies were recorded and compared:numbers of CNS adverse reactions in the two groups occurred at different time points,numbers of different CNS symptoms during administration including dizziness,headache,drowsiness/inattention,insomnia/nightmare,depression and the changes of number of plasma viral load and CD4^+T cell counts at different time points.Results The number of patients in the clinical group and the control group was 121 and 120 respectively.The numbers of adverse reactions at the week of 4,8,12,24,36,48,60,72 in the clinical group and the control group were 3,2,5,4,4,4,3,0 and 3,1,1,0,0,4,1,1 respectively with no statistically significant differences(P>0.05).The numbers of different CNS symptoms during administration in the two groups were 3,4,10,12,3 and 0,1,7,8,4 respectively with no statistically significant differences(P>0.05).The records of plasma viral load in the two groups were(0.41±1.09)log copies/ml,(0.41±1.10)log copies/ml respectively in the week 48 and(0.51±1.41)log copies/ml,(0.94±1.64)log copies/ml in the week 72 with no statistically significant differences(P>0.05).The numbers of CD4 counts in the two groups were(314.85±144.57)/μl and(294.07±111.99)/μl respectively in the week 24,(332.69±167.79)/μl and(318.15±133.97)/μl respectively in the week 48 and(387.09±185.84)/μl and(394.43±172.23)/μl respectively in the week 72 with no statistically significant differences(P>0.05).Conclusion The administration of Aifukang capsule or Aikeqing granule of Chinese me

关 键 词:中药 依非韦伦 高效抗反转录病毒 中枢神经系统 不良反应 临床疗效 

Chinese medicine EFV highly active antiretroviral therapy CNS adverse reaction clinical effect 

分 类 号:R512.91[医药卫生—内科学]

 

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