Objective:Objective To observe the clinical efficacy and safety of the self-made formula(warming yang,invigorating spleen and resolving dampness formula)cut by warming yang,invigorating spleen and resolving dampness method,so as to provide ideas for the clinical treatment of AIDS in the elderly and solve the difficult problems in the treatment.Method:A total of 72 elderly patients who met the diagnostic criteria for AIDS(yang deficiency and dampness stagnation type)were included in the study and were recruited from the Third Affiliated Hospital of Yunnan University of Chinese Medicine and the Third People’s Hospital of Kunming.They were randomly divided into two groups: 36 cases in the control group(simple HAART group)and 36 cases in the treatment group(HAART+ Chinese medicine group).The treatment course was24 weeks.In the study,four patients in the experimental group failed to receive follow-up visit of traditional Chinese medicine due to the isolation policy related to the "Covid-19 pneumonia epidemic" in 2020;Two patients in the control group changed the HAART regimen and voluntarily withdrew from the trial.A total of 66 cases were completed.The HIV/AIDS symptom scale(1.Common symptom scale;2.Quantified scale of Yang deficiency and dampness stagnation syndrome in traditional Chinese medicine)to observe the common symptoms of HIV/AIDS in subjects and laboratory tests such as fatigue,intolerance of cold,soreness and weakness of waist and knees,flatulence,nausea,loose stool,immunological indicators and to evaluate the efficacy and observe the safety,and statistically analyze the relevant data.Result:1.Observation of common symptom score in HIV/AIDSAt week 0,the difference in the total scores of common symptoms of HIV/AIDS between the two groups was not statistically significant.At week 24,the total scores of common symptoms of HIV/AIDS in the experimental group were lower than those in the control group(P < 0.01),and the difference was statistically significant.2.Observation on TCM syndrome score of Yang deficiency and dampness stagnation syndromeAt week 0,the difference in the total score of traditional Chinese medicine(TCM)syndrome of Yang deficiency and wet stagnation was not statistically significant.At 24 weeks of treatment,the total score of TCM syndrome of Yang deficiency and wet stagnation in the experimental group was lower than that in the control group(P < 0.01),and the difference was statistically significant.There were significant differences in scores of fatigue,soreness and weakness of waist and knees,intolerance of cold,cold limbs,nausea,flatulence,loose stool and other concurrent diseases(P < 0.01).3.CD4+ lymphocyte absolute value count observationAt week 0,the absolute CD4+ lymphocyte counts between the two groups were not statistically significant.At week 24 of treatment,the absolute CD4+lymphocyte counts in the experimental group and the control group were 353.13 ± 115.87 and281.93 ± 87.96 respectively,which were significantly higher than those in the control group(P < 0.01).4.observation of HIV-RNA viral loadBoth groups had HIV-RNA viral loads below the lower limit of detection(< 100copies/m L)and stable viral suppression at Weeks 0 and 24.5.safety index observation DuringThe observation period of 24 weeks after treatment,there was no adverse reaction in the experimental group and no significant change in safety indicators.In the control group,two patients who changed TDF due to osteoporosis were automatically withdrawn from the trial.There was no significant change in other safety indicators.Conclusion:1.Warming yang,invigorating spleen,removing dampness method combined with HAART treatment can improve the immune function of AIDS in the elderly with yang deficiency and damp stagnation,and does not affect the virus inhibition of HAART treatment on AIDS in the elderly with yang deficiency and damp stagnation;2.Warming yang,invigorating spleen,removing dampness method combined with HAART in the treatment of senile AIDS due to yang deficiency and dampness stagnation has a significant effect on improving the common toxicities and side effects of fatigue,nausea and flatulence in HAART treatment;3.Warming yang,invigorating spleen,removing dampness method combined with HAART can improve the clinical symptoms of soreness and weakness of waist and knees,intolerance of cold,cold limbs,loose stool and other symptoms in elderly patients with AIDS of yang deficiency and dampness stagnation type.4.The intervention effect of warming yang,invigorating spleen and resolving dampness method combined with HAART on osteoporosis in elderly patients with AIDS of yang deficiency and dampness stagnation type deserves further study;5.It is recommended that the combination of syndrome differentiation and traditional Chinese medicine treatment in the elderly patients with HAART treatment can help patients to improve immune function,and does not affect the inhibition of virus by HAART treatment. |