| Objective:Firstly, this study retrospectively collected and analyzed clinical data of HIV/AIDS patients in Xinjiang prior to initiation of HAART to understand clinical feature of HIV/AIDS patients prior to HAART, and to find the risk factors of death after initiation of HAART, to find the treatment points of traditional Uighur medicine; Secondly, based on traditional Uighur theory and criteria of humor classification standard, we carried out traditional Uighur syndrome differentiation of HIV/AIDS among307HIV/AIDS patients in2010to find the main syndrome of HIV/AIDS, and further describe the difference of abnormal savda syndrome and non-abnormal savda syndrome in terms of hematological characteristics, clinical symptoms and signs, immune function, health-related quality of life, and depression. Finally, by using randomized clinical trials, we evaluated the effectiveness and safety of abnormal savda Munziq and HAART combining therapy in relieving depression and improving health quality of life of HIV/AIDS patients.Materials and Methods(1) We retrospectively collected prior-HAART clinical data of3513patients who initiated HAART in10hospitals of Urumqi, Yili, Hetian, Akesu, Tulufan and Hami from2005to2011. These data is from national free antiretroviral program database. Clinical data of these patients were used to analyze clinical features of HIV/AIDS patients in Xinjiang China, and further assess the prevalence of TB, HCV and HBV in HIV/AIDS patients and risk factors, and assess the factors influencing the mortality in HIV/AIDS patients. (2) We conducted a cross-sectional study from2012May to2012October in Xinjiang Uighur Autonomous region infection disease hospital in Urumqi.307HIV/AIDS patients were investigated using questionnaire, laboratory examination and physical examination. Based on Uighur medicine theory, we classified the patients using abnormal hilit criteria, and used component analysis modified multivariable logistic regression analysis to analyze the syndrome features, and further analyzed abnormal savda type HIV/AIDS patients in terms of demographics, clinical symptoms, hematological abnormality, imuune function health-related quality of life and depression.(3) We conducted a randomized controlled clinical trial. We randomly assigned100patients with depression and abnormal savda to intervention group (abnormal savda munziq+HAART) and control group (HAART), followed up the patients for4weeks. At baseline and week4, patients underwent laboratory examination (hemoglobin, white blood cell, platelet, total cholesterol, serum creatine, ALT, AST, and CD4count), depression and health quality of life of patients is assessed by using Hamilton Scale for Depression, MOS-HIV Scale. We observed the changes of Hamilton depression scale, MOS-HIV scale score and other laboratory indicators such as hemoglobin, CD4counts etc.Results:(1) Clinical data of3513HIV patients were collected and analyzed, mean age of patients was35.12±8.23, more than50%of patients reported from Yili region, patients reported from Hami and Tulufan were less than5%,80%of patients were Uighur,60%of patients were married or cohabited, the main transmission routes of HIV was heterosexual (44.9%), intravenous drug use (39.3%), and homosexual or blood donation (1.2%). From2005to2011, we observed an increase of proportion of sexual transmission from26.8%to62.7%, while a decrease of proportion of intravenous drug use from62.5%to26.4%; Proportion of female increased from27.8%to45.5%, while proportion of male decreased from72.2%to54.5%. There are826patients with at least one opportunistic infection or HIV-related tumor, which accounts for23.5%of total patients, patients reporting at least one syndrome and symptoms accounts for35.9%of total patients, which are1260patients, averagely every person reported3.4HIV-related signs and symptoms, the most common symptoms is respiratory symptoms, such as cough (19.2%), fever (17.8%), spiting (15.8%) and night sweating (15.5%), the second most common symptoms was gastrointestinal symptom, such as diarrhea (9.3%) and nausea (8.8%). 3345patients tested CD4counts, CD4counts of310patients was less than50/mm3accounting for9.0%of total patients, CD4counts of362patients was less than50-100/mm3, accounting for10.5%of total patients, CD4counts of880patients was less100-200/mm3, accounting for25.5%of total patients, CD4counts of1492patients was less200-350/mm3, accounting for43.3%of total patients, CD4counts of402patients was more than350/mm3, accounting for11.7%of total patients;41.2%of patients had anemia,39.9%of patients had decreased platelet,30.4%of patients had decreased white blood cell;7.9%of patients had ALT level more than100U/L,4.8%of patients had AST level more than100U/L; mean weight of patients was60.38kg±10.84,16.5%of patients had BMI value less than18.5kg/m2,11.5%of patients had BMI value of25-30kg/m2,1.6%of patients had BMI value more than1.6%;2788patients were diagnosed with TB, and95.3%of them had initiated anti-TB treatment, logistic regression model indicated region, transmission route, and CD4counts and BMI value were associated with TB infection among HIV/AIDS patients;2301patients tested for HBsAg, and6.3%of patients tested positive, gender and nationality was associated with HBsAg positivity;2357patients tested for anti-HCV, and38.0%of patients tested positive, region, gender, age and transmission route was associated with anti-HCV positivity;3436patients tested hemoglobin level,41.2%of patients was diagnosed with anemia,3.2%of patients was diagnosed with sever anemia,17.6%of patients was diagnosed with moderate anemia,20.4%of patients was diagnosed with mild anemia. Region, ethnic group, gender, and CD4counts, ALT level, TB, BMI value was associated with anemia; As of2011,352patients died, accounting for10%of total patients, gender, CD4count, HBV, HCV and anemia was associated with death.(2) Abnormal sapara syndrome type patients accounts for15.2%of total patients, abnormal khan syndrome patients accounts for10.7%of total patients, abnormal Balham patients accounts for12.4%of patients, and abnormal savda patients account for61.6%of patients. There was no difference in gender, HCV infection, BMI value, receiving HAART between abnormal savda syndrome patients and non-abnormal savda syndrome patients (P>0.05), however, mean age of abnormal savda syndrome patients was significantly higher than that in non-abnormal savda syndrome patients (P<0.05); Proportion of patients who acquired HIV through intravenous drug use was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients, while proportion of patients who acquired HIV through sexual contact was significantly higher in non-abnormal savda syndrome patients than in abnormal savda syndrome patients (P<0.05). TB infection rate was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05). In terms of clinical feature, decrease of white cells, elevated glycerin trilaurate, and elevated total cholesterol was not different between abnormal savda syndrome patients and non-abnormal savda syndrome patients (P>0.05), however, prevalence of anemia was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), decrease of white blood cells was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05). Elevated Cys-C was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05); mean CD4counts was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), Proportion of patients with CD4counts less than200/mm3was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05). KPS (Karnofsky performance scale) score was significantly lower in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05). Regarding MOS-HIV score, total score of mental health was significantly lower in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), while there was no difference in total score of physical health between two groups (P>0.05). Mean Hamilton rating scale for depression (HRSD) score was significantly lower in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), moderate and sever depression patients was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), while mild and no depression patients was significantly lower in in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), Regarding HIV-related symptoms and signs, proportion of patients reporting fatigue, loss of appetite, day sweating, night sweating, abdominal float, backache was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), proportion of patients reporting itchy skin, rash, Kaposi tumor was significantly higher in abnormal savda syndrome patients than in non-abnormal savda syndrome patients (P<0.05), other symptoms was not significantly different between two groups.(3)100abnormal savda syndrome type HIV/AIDS patients with depression who met the study inclusion criteria and exclusion criteria were randomly assigned to abnormal savda munziq granule intervention group (abnormal savda munziq+HAART) and control group (HAART), after the treatment the two groups of patients were followed up for4weeks. After the follow-up,8patients left the study group because of side effects of drugs,16did not visited the clinics and loss to follow-up, in the final,76patients completed the study follow-up. Among them40patients were in intervention group, while36were in control group. At baseline, mean age, female to male ration, HIV infection routes, MOS-HIV total score, and HRSD total score was similar between two groups. At week4, mean HRSD score was lower in intervention group than in control group (T<0.01), mean difference between baseline and week4in two groups was significantly different (P<0.01), MOS-HIV subscale mental health, health transition and health recognition did not change significantly between2groups, while in other subscale scores increased significantly. In control group, physical function, social function and cognition function subscale score did not change significantly (P>0.05), while role function, and health transition decreased significantly ({<0.05), other subscale scores increased significantly (P<0.05). mean difference between baseline and week4in physical function, role function, pain, fatigue, health pressure and quality of life was significantly different between two groups (P<0.05). At week4, CD4counts in intervention group increased significantly from baseline (P<0.05), while CD4counts did not change significantly in control group from baseline. However, mean difference from baseline to week4was not significantly different between2groups (P>0.05). In intervention group, proportion of patients reporting fatigue, loss of appetite, headache, and itchy skin decreased from67.5%,60.0%,37.5%and40.0%at baseline to25%,27.5%,15%and12.5%at week4(P<0.05), while in control group the proportion of patients reporting these symptoms did not change significantly from baseline to week4(P>0.05). At week4, proportion of patients reporting fever, fatigue, headache, loss of hair, and itchy skin was significantly lower in intervention group than in control group (P<0.05). Among76patients,6patients reported adverse drug reaction, of them2reported skin rash,4reported nausea and vomiting, all of which were mild reaction, and all disappeared after1week, the adverse drug reaction rates between two groups had no significant difference (7.5%vs.8.3%, P=0.45). In intervention groups, hemoglobin level increased form baseline to week4(P<0.05), while total cholesterol level decreased (P<0.05), in control group, there was no difference between baseline and week4in control groups in terms of full blood count, kidney and liver function.Conclusion: (1) At current stage, Majorty of HIV/AIDS patiens were Uighur ethnic group, and HIV was mainly transmitted through sexual contact; there was no gender difference in patients with HIV infection. At initiation of HAART, opportunistic infection rate (particularly TB) was high, a significant number of patients had respiratory and gastrointestinal symptoms, anemia and decrease of platelet was common, HBV and HCV co-infection was higher in HIV/AIDS patients than in general population, a number of patients had sever liver damage. Anemia, HBV, HCV was independently associated with death of HIV/AIDS patients.(2) Abnormal savda syndrome was the main syndrome among HIV/AIDS patients, and compared to non-abnormal savda patients, patients with abnormal savda syndrome, had worsen immune function, higher anemia and TB prevalence, and depression, quality of life was lower, these patients with abnormal savda syndrome should be intervened with traditional Uyghur drug and improve their prognosis.(3) This study was exploratory study, study results indicate abnormal savda munziq combined with HAART could relieve patients depression, and improve patients health-related quality of life, and decrease the side effects of HAART (anemia and elevated cholesterol), but in terms of immune function, no difference was observed. The clinical efficacy and safety of abnormal savda munziq should be tested with a long term follow-up study with large sample size. |
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