Evaluation Of The Comprehensive Curative Effect Of Traditional Chinese Medicine In The Treatment Of HIV/AIDS In Guangxi Based On Longitudinal Research Methods

1.Background and significanceWith the development of the "Real World Study",the longitudinal data analysis and longitudinal study has become an area of research focus in recent years,although some scholars put forward as early as ten years ago that "the longitudinal research method is suitable for evaluation of efficacy and safety of traditional Chinese medicine(TCM),and this method would be very important for TCM reseach".But in the past decade,longitudinal research of TCM efficacy evaluation was still relatively lack.Longitudinal study is suitable for evaluation chronic diseases which has long course of the disease.HIV/AIDS as a important chronic infectious diseases in China.Since 2004,our country has invested a large amount of funds to patients with HIV/AIDS for free treatment of TCM.So far,has collected ten years of observational data,however,due to observational data has the problem of missing data and lacking interclass equilibration,the existing research is not thorough research on this part of the data,using the method of longitudinal study to evaluate the effect and security of TCM treatment for HIV/AIDS patients is very important and beneficial for methodology reseach.It is worth further research and discussion.2.PurposesThis study used longitudinal study method,inductive HIV/AIDS symptom and syndrome types of evolution for patients who used TCM.We explored the effect on quality of life(QOL)of TCM for HIV/AIDS patients.This study also explored the effectiveness and safety TCMfor patients with HIV/AIDS.3.MethodsThis study extracted data from database of The National Free Traditional Chinese Medicine HIV/AIDS Treatment Program(NFTCMP)in Guangxi Province.We described demographic characteristics of patients.Analysis was carried out on to detect and summarize the distribution of TCM syndromes with time.Patients in this database were divided into two groups by the therapy they accepted,TCM alone or TCM combined highly active anti-retroviral therapy(HAART).We analysed the long-term effect of TCM for QOL.Due to all patients in TCM database were accepted TCM,to explore the effect and safety of TCM for HIV/AIDS,we introduce another database.Center for Disease Control(CDC)database included part of longitudinal data of HAART for HIV/AIDS in Guangxi province.Patients were divided into 3 groups according to their recorded treatment regimens:TCM alone,TCM combined HAART,and HAART alone.Longitudinal data analyses were applied for explore the long-term effect and safety of TCM for HIV patients.4.ResultsA total of 2572 patients took TCM,major(85.44%)cause of infection was sexual contact.70%of them were in asymptomatic period.Mean age was 47.87±13.97 years,25%of them older than 60.And 64.84%patients were male,for patients aged from 20 to 29 years,female took a higher proportion(57%),for patients over 70 years old,the proportion of male as high as 83%.64.9%patients were married,16.38%were single,11.59%were widowed,and 7.12%were divorced.Only 20%patients had senior high diploma or above,6.12%were illiterates.The patients were mainly from the four cities of Liuzhou,Hezhou,Nanning and Qinzhou.In the case of syndrome distribution,the patients in asymptomatic period were mainly"deficiency of qi and blood",patients in period of AIDS were mainly "wind-fire in liver meridian complicated with damp toxin accumulation".There were significant differences between male and female patients in syndrome distribution.The proportion of "deficiency of qi and blood" in female patients was significantly 14.71%higher than that of male patients(?2=64.52,P<0.01,RR=1.73).There was no significant difference between infection pathway and syndrome distribution.It was found that the "deficiency of qi and blood" was always the main syndromes and showed a significant growth trend over time during four years of TCM treatment.After two years of treatment,the main syndrome types of patients in the stage of AIDS transformed into"The accumulation of heat and toxic,phlegm heat obstructing lung type".The proportion of"liver depression and gas stagnation" showed a significant decrease over time,and the proportion of "phlegm heat internal disturbance type" increased significantly.The pattern of syndrome of 61.15%patients stayed the same in the first year treatment(weighted Kappa=0.66,95%CI:0.63-0.69),and the consistency of the syndromes before and after treatment was substantial.In the second year after treatment,the syndrome type of 67.52%patients did not change(weighted Kappa=0.73,95%CI:0.69-0.76),and the consistency was substantial.In the third year after treatment,71.24%of the patients had no change in the syndrome type,and In the fourth year of treatment,75.78%of the patients had not changed in the pattern of syndrome.The main symptoms were fatigue(49.35%),shortness of breath(33.07%),nausea(32.66%),perspiration(32.13%)and night sweats(31.36%).After receiving TCM,the main symptoms of the patients were significantly improved,and half of the patients did not feel fatigue.And patients almost no longer had the symptoms of anorexia and diarrhea.Cough symptoms were also reduced from nearly a fifth to one in 15.The incidence of vomiting and fever decreased to less than 1%.The abnormal rate of liver function in patients was about 20%,and the abnormal rate of renal function was about 10%,and no significant change was observed in patients with liver and kidney function after long-term TCM treatment.In 2572 patients,1374 individuals used TCM,1198 individuals used TCM combined with HAART.In the first year,TCM combined with HAART significantly improved patients'WHO-HIV QOL(increased by 4.88 points),and the effect is mainly embodied in the field of social relations and spiritual world/religion/personal.The QOL of the patients in TCM group was almost unchanged,and only increased by 0.26 points.When treatment lasted more than one year,the two groups showed a decline in QOL.After four years of treatment,comparing with those before treatment,the QOL of TCM group and TCM combined HAART group decreased by 2.58 points and 1.63 points respectively.In the first year,the difference of QOL between the two groups gradually increased,and the difference was up to 5 points,which was clinically significant and statistically significant.However,after three years of treatment,there was no significant difference in the QOL between different groups.We extracted data of 382 individuals who used HAART alone.TCM regimens users had baseline CD4 cell counts(380.11±240.59 cell/?L),approximately 100 cell/?L significantly higher than the patients with TCM combined HAART regimens or HAART regimens.TCM regimens users were more likely to have higher CD8 cell counts(1057.74±550.32 cell/?L).During the study period,7 patients(0.51%)in TCM group died,compared with 8 deaths in TCM combined HAART group(0.67%)and 5 deaths in HAART group(1.31%).All three regimens improved patients' CD4 cell counts.Compared to the sharp improvement in HAART group during the first 6 months,CD4 cell counts of patients in TCM group and TCM combined HAART group showed a smooth and steady rise.CD4 counts of the integrated group remained much lower than HAART group in the first 3 years,but overtook HAART group in the forth year.5.ConclusionsThe major patient syndrome pattern is always "deficiency of qi and blood",and long-term treatment of TCM can significantly improve the symptoms of patients.Through longitudinal study and analysis,the QOL of HIV patients is mainly related to the symptoms of itchy skin and sexual function in the body.On the psychological side,it is mainly reflected in the opinion of others and irritability.There was significant difference of QOL between males and females.TCM combined HAART could improve the QOL of patients in the first year of treatment.However,the QOL was significantly reduced after more than one year of treatment.Further research should explore the reason for the decline of QOL after long-term treatment,and how to sustainably improve QOL of patients through dialectic.CHM alone appeared improve CD4 cell counts of patients despite their relatively better baseline status.It is noteworthy that compared to patients who only took ART,patients taking CHM were more likely to have a steady rise in CD4 cell counts.