| Objective(1)To observe the basic characteristic and distribution of HIV/AIDS patients from Jiangmen area of Guangdong province.(2)To evaluate the long-term clinical effect of Aikeqing Capsule on HIV/AIDS patients by observing symptoms and signs score,Karnovsky Score,CD4+T lymphocyte counts,body weight before and after treatment.(3)Through observing the indexes of blood routine tests,liver and kidney function before and after treatment,to evaluate the long-term safety of Aikeqing Capsule on HIV/AIDS patients.Methods69 HIV/AIDS cases treated with Aikeqing Capsule in the year of 2010-2016 coming from Jiangmen area of Guangdong province were selected from the national Chinese medicine pilot project,and divided into TCM group and TCM combined with western medicine group by whether integrated HAART.Comparisons were performed to the changes of the indexes of symptoms and signs score,Karnovsky Score,CD4+T lymphocyte counts and safety index at 6 time points(before treating,12,24,36,48 and 60 months after treatment).All these data were analyzed by Statisical Product and Service Solutions(SPSS)17.0.Test level is P<0.05.Results(1)Variation of symptoms and signs score and Karnovsky ScoreIndividual score of symptoms and signs score:in TCM group,individual scores of cough,short of breath,spontaneous perspiration,night sweat,nausea,alopecia,headache,muscle pain,joint pain,skin itching,skin rashes and menstrual disorders(women)were declined after treatment,which was statistically significant(P<0.05).In TCM combined with western medicine group,individual scores of fatigue,short of breath,spontaneous perspiration,night sweat,nausea and alopecia were declined after treatment,has statistically significant(P<0.05).Total score:in TCM group,comparison of every time point showed that there was a statistically significant decline(P<0.05).There was no statistically difference(P>0.05)in TCM combined with western medicine groupKarnovsky Score:in TCM group,comparison of every time point showed that there was a statistically significant rise(P<0.05),except 24 months after treatment.In TCM combined with western medicine group,there was a statistically significant decline(P<0.05)at the time point of 24 months after treatment.(2)CD4+T lymphocyte countsFor total CD4+T lymphocyte counts,comparison of every time point showed that there was no statistically difference(P>0.05)in TCM group and a statistically significant rise(P<0.05)in TCM combined with western medicine group(except 12 months after treatment).In TCM group,HIV/AIDS cases of CD4+≤350 cells/μL before treatment,has a statistically significant rise(P<0.05)in 24,36 and 48 months after treatment.CD4+T lymphocyte counts in 12 and 48 months after treatment showed that there was a statistically significant decline(P<0.05)When CD4+>350 cells/μL before treatment.In TCM combined with western medicine group,comparison of every time point showed that there was no statistically difference(P>0.05)whether CD4+≤350 cells/μL or CD4+>350 cells/μL before treatment.(3)safety evaluationIn TCM group,comparison of the indexes of blood routine tests(WBC,Hb,PLT),liver and kidney function(ALT,AST,BUN,Cr)before and after treatment,WBC and PLT had a statistically significant rise(P<0.05),however,all mean values were fell in normal range.In TCM combined with western medicine group,there are no statistically difference(P>0.05).Conclusionlong-term use of Aikeqing Capsule could maintain and improve CD4+T lymphocyte counts,especially those CD4+≤350cells/μL before treatment;Aikeqing Capsule combined with HAART could significantly improve CD4+T lymphocyte counts.Aikeqing Capsule could improve symptoms and signs and quality of living,with no significant toxic and side effects for long-term use. |