HAART is currently recognized as the most effective treatment for HIV/AIDS patients,With the development of HAART,the quality of life and life expectancy of HIV/AIDS patients have been significantly elevated.However,there still remains 15%-20%of patients who could not regain a satisfactory amount of CD4+T cells even with long-term HAART treatment and complete viral suppression.At present,Western medicine has limitations for the treatment of patients with immune reconstitution,so it is necessary to actively explore TCM interventions for patients with immune reconstruction deficiency.The spleen and kidney are closely related to immunity.Some studies believe that the root cause of AIDS disease progression is spleen and kidney yang deficiency,spleen and kidney yang deficiency plays an important role in the pathogenesis of AIDS.Warming the spleen and kidney method can regulate its immunity and promote immune reconstruction.In clinical practice,warming the spleen and kidney medicine can significantly improve immunity.At present,the number of men who have sex with men in China has become the focus of AIDS prevention and has become a major group of new infections.The MSM population has different immunological characteristics compared with patients with other infection routes.Previous studies of syndromes found that spleen and kidney yang deficiency is one of the main syndromes of MSM AIDS patients.This study used Wenshen Jianpi Recipe to observe the effect of immune reconstitution in AIDS MSM patients with immune reconstruction deficiency after HAART,and tried to explore the mechanism of the function of Wenshen Jianpi Recipe to improve immune function from the energy metabolism pathway,and provide a basis for future clinical use of AIDS.The study is divided into 2 parts:Study 1 Study on immune reconstruction deficiency after HAART in MSM AIDS patients treated by warming and reinforcing Spleen and KidneyPurposeIn this study,114 cases of AIDS MSM patients with immune reconstruction deficiency after HAART were treated with Immunization No,2 granules.To observe the improvement of clinical symptoms and immune indexes of traditional Chinese medicine for warming spleen and kidney,and provide a certain clinical basis for optimizing the treatment of AIDS MSM patients with immune reconstruction deficiency after HAART.MethodsThis study analyze 114 cases of AIDS MSM patients with immune reconstruction deficiency after HAART who met the inclusion criteria from September 30,2013 to February 1,2016.The control group was treated with HAART combined with Immunization No.2 granule placebo.The treatment group was treated with HAART combined with Immunization No.2 granules for 72 weeks.Observe the patient’s clinical symptoms and signs,immune indicators(CD3+,CD4+,CD8+,CD45RA+,CD45RO+),WHO quality of life scale and other efficacy indicators and ECG,hematuria,liver and kidney function and other safety indicators.To observe the effect of Immunization No,2 granules on immune reconstitution in AIDS MSM patients with immune reconstruction deficiency after HAART.Results1 Comparison of immune indicators1.1 Comparison of CD4+T lymphocytes between the two groups after treatmentAfter treatment,the number of CD4+T lymphocytes in the treatment group increased,from baseline(222.81±67.15)cells/ul to(285.55±87.92)cells/ul.Compared with before treatment,the treatment group had a statistically significant difference at the 60th week and the 72nd week(P<0.05).There was a statistically significant difference between the two groups at week 60 and week 72(P<0.05).1.2 Comparison of the number of CD4+T lymphocytes increased by>50 after treatmentThe efficiency of CD4+T lymphocyte rise was compared:the number of CD4+T lymphocytes in the treatment group increased by>50 cells/ul,and the control group did not change significantly.After treatment,the effective rate of immune reconstruction in the treatment group was 45.76%,and the total effective rate in the control group was 32.72%.The immune reconstitution of the treatment group was more effective than the control group.1.3 Comparison of the effective rate of immune reconstruction between the two groups after treatmentThe increase in the number of CD4+T lymphocytes was>30%,which was effective for immune reconstitution.At the 72nd week,45 patients in the treatment group were effective,and 28 patients in the control group were effective.There was a statistically significant difference between the two groups at week 72(P<0.05).The immune reconstitution of the treatment group was more effective than the control group.1.4 Comparison of CD8+T lymphocytes between the two groups after treatmentAfter treatment,the number of CD8+T lymphocytes in the treatment group increased,from baseline(669.63±277.34)cells/ul to(797.39±319.55)cells/ul.Compared with before treatment,the treatment group had a statistically significant difference at week 72(P<0.05).There were significant differences in CD8+T lymphocytes between the two groups after treatment(P<0.05).1.5 Comparison of CD4+/CD8+ratios between the two groups after treatmentAfter treatment,the ratio of CD4+/CD8+increased in both groups.The treatment group increased from 0.38±0.17 to 0.42±0.24.There was no significant difference between the two groups(P>0.05).There was no significant difference in the ratio of CD4+/CD8+between the two groups after treatment(P>0.05).1.6 Comparison of the number of CD45RA+lymphocytes in the two groups after treatmentAfter treatment the treatment group from baseline(50.63 ± 44.95)cells/ul to(59.37 ± 28.98)cells/ul,compared with before treatment,the difference was not statistically significant(P>0.05).There was no significant difference in the number of CD45RA+lymphocytes between the two groups after treatment(P>0.05).1.7 Comparison of the number of CD45RO+lymphocytes in the two groups after treatmentAfter treatment,the number of CD45RO+lymphocytes increased in both groups.The treatment group increased from baseline(141.24±51.80)cells/ul to(188.18±76.81)cells/ul,which was statistically significant compared with before treatment(P<0.05).There was no significant difference in the number of CD45RO+lymphocytes between the two groups after treatment(P>0.05).2.2 Comparison of the total scores of the two groupsAfter treatment,the total scores of clinical symptoms in both groups showed a downward trend.The treatment group decreased from baseline of 25.97±12.23 to 11.21±6.25,which was statistically significant compared with that before treatment(P<0.05).There was a statistically significant difference in the total scores between the two groups after treatment(P<0.05)3 Comparison of the total scores of quality of life between the two groups after treatmentAfter treatment,the total quality of life of both groups showed a downward trend.The treatment group decreased from 107.98±19.18 to 89.14±13.34,which was statistically significant(P<0.05).There was a statistically significant difference in the quality of life between the two groups after treatment(P<0.05).4 Security analysisBefore and after treatment,blood routine,urine routine,liver and kidney function,electrocardiogram,chest X-ray and other examinations showed no obvious abnormal changes.Conclusion1 The treatment of warming spleen and kidney can improve the patient’s immunity,increase the number of CD4+T lymphocytes and CD8+T lymphocytes,and improve the efficiency of immune reconstitution and promote immune reconstitution.2 The treatment of warming spleen and kidney can improve the clinical symptoms of patients and improve their quality of life.Study 2 Study on the mechanism of action of warming spleen and kidney method on AIDS MSM patients with immune reconstruction deficiency after HAART from the level of energy metabolismPurposeIn this study,44 clinical observations of AIDS MSM patients with immune reconstruction deficiency after HAART were carried out.From the perspective of cellular energy metabolism and overall level energy metabolism,the mechanism of the traditional Chinese medicine prescription for warming the kidney and strengthening the spleen to improve immune function was discussed.MethodsThis study used a randomized,double-blind,controlled study to analyze 44 AIDS MSM patients with immune reconstruction deficiency after HAART who met the inclusion criteria.The control group was treated with HAART combined with Wenshen Jianpi Recipe placebo.The treatment group was treated with HAART combined with Wenshen Jianpi Recipe for 24 weeks.This study mainly observed the patient’s clinical symptoms and signs,immune indicators(CD3+、CD4+),apoptosis indicators,infrared caloric value and other efficacy indicators.And observe safety indicators such as electrocardiogram.hematuria,liver and kidney function.1 Comparison of immune indicators1.1 Comparison of CD4+T lymphocytes between the two groups after treatmentAfter treatment,the number of CD4+T lymphocytes in the treatment group increased,from baseline(215.61±82.46)cells/ul to(269.88±69.96)cells/ul.Compared with before treatment,the treatment group showed significant difference at week 12 and week 24(P<0.05).There was a statistically significant difference between the two groups at week 24(P<0.05).1.2 Comparison of the increase of CD4+T lymphocytes in the two groups after treatment>50cells/ulCD4+T lymphocytes increased by more than 50 cells/ul,and 13 patients in the treatment group after treatment,the total effective rate was 61.90%.There were 6 cases in the control group after treatment,and the total effective rate was 27.27%.Compared with the control group,the immune reconstitution efficiency of the treatment group was higher than that of the control group.1.3 Comparison of the effective rate of immune reconstruction between the two groups after treatmentAn increase in the number of CD4+T lymphocytes>30%is effective for immune reconstitution,and an increase of<30%is ineffective.At week 24,12 patients in the treatment group were effective,and 6 patients in the control group were effective.Compared with the control group,the immune reconstitution efficiency of the treatment group was higher than that of the control group1.4 Comparison of CD8+T lymphocytes between the two groups after treatmentAfter treatment,CD8+T lymphocytes in the treatment group showed an upward trend,rising from baseline(732.45±231.32)cells/ul to(777.93±342.57)cells/ul.There was a statistically significant difference between the treatment groups(P<0.05).There was a statistically significant difference between the two groups after treatment(P<0.05)1.5 Comparison of CD4+/CD8+ratios between the two groups after treatmentAfter treatment,the ratio of CD4+/CD8+increased in both groups,and the treatment group increased from baseline of 0.36±0.46 to 0.45±0.22.Compared with before treatment,the difference between the treatment group and the treatment group was statistically significant(P<0.05)..There was no significant difference in the ratio of CD4+/CD8+between the two groups after treatment(P>0.05).2 Comparison of percentage of lymphocyte apoptosis after treatment2.1 Comparison of percentage of early lymphocyte apoptosis after treatmentAfter treatment,the percentage of early apoptosis in both groups showed a downward trend.The treatment group decreased from 5.47±2.29 at baseline to 0.31±0.25.Compared with before treatment,the difference was statistically significant(P<0.05).There was a statistically significant difference in the percentage of early apoptosis between the two groups after treatment(P<0.05).2.2 Comparison of percentage of late lymphocyte apoptosis after treatmentAfter treatment,the percentage of late apoptosis in both groups showed a downward trend.The treatment group decreased from 4.60±3.14 at baseline to 1.38±1.17.Compared with before treatment,the difference between the treatment groups was statistically significant(P<0.05).There was a statistically significant difference in the percentage of late apoptosis between the two groups after treatment(P<0.05).3 Comparison of visceral calories after treatment3.1 Comparison of calorific value after treatmentUpper focus AT:Compared with before treatment,the treatment group showed a downward trend(P<0.05),and the control group showed a downward trend(P<0.05).There was no significant difference between the two groups(P>0.05).Lower focus ΔT:Compared with before treatment,the treatment group showed an upward trend(P<0.05),and the control group showed an upward trend(P<0.05).There was no significant difference between the two groups(P>0.05).).3.2 Comparison of caloric value of five internal organs after treatmentLung AT:Compared with before treatment,the treatment group showed a downward trend(P<0.05),and the control group showed a downward trend(P<0.05).There was no significant difference between the two groups(P>0.05).Spleen ΔT:Compared with before treatment,the treatment group showed an upward trend(P<0.05),and the control group showed an upward trend(P<0.05).There was no significant difference between the two groups(P>0.05).Kidney ΔT:Compared with before treatment,the treatment group showed an upward trend(P<0.05).There was significant difference between the two groups(P<0.05).3.3 Comparison of calorific value of acupoints after treatmentLife gate AT:Compared with before treatment,the treatment group showed an upward trend(P<0.05),and the control group showed no significant increase(P>0.05).There was significant difference between the two groups(P<0.05).Du impulse ΔT:Compared with before treatmenth,the treatment group showed an upward trend(P<0.05).Compared with before treatment,the control group was no significant difference(P>0.05).There was significant difference between the two groups(P<0.05).Shenque AT:Compared with before treatment,the treatment group showed an upward trend(P<0.05).The upward trend of the control group was not statistically significant(P>0.05).There was no significant difference between the two groups(P>0.05).4 clinical symptoms4.1 Comparison of symptom improvement rates between the two groupsAfter treatment,the clinical symptoms and signs of both groups were improved.Compared with the control group,the treatment group was better than the control group in improving the patients’ fatigue,abdominal distension,weak waist and knees,cold limbs and dry mouth.The difference was statistically significant(P<0.05).4.2 Comparison of the total scores of clinical symptoms in the two groups after treatmentAfter treatment,the total scores of clinical symptoms in both groups showed a downward trend.The treatment group decreased from 13.43±6.21 to 7.85±3.15 at baseline,and the difference was statistically significant(P<0.05).There was a statistically significant difference in the total scores between the two groups(P<0.05).5 Security analysisBefore and after treatment,blood routine,urine routine,liver and kidney function,electrocardiogram,chest X-ray and other examinations showed no obvious abnormal changes.Conclusion1 Wenshen Jianpi Recipe can reduce cell apoptosis,increase the caloric value of kidney,life gate and Du impulse,and improve energy metabolism at the cellular level and overall level.Wenshen Jianpi Recipe can increase CD4+T lymphocytes and CD8+T lymphocytes,improve the efficiency of immune reconstitution,and promote immune reconstitution.2 Spleen and kidney deficiency is the main syndrome of patients with immune reconstitution after HAART in AIDS.Energy metabolism disorder is the pathological basis of MSM AIDS immune reconstitution patients.The study found that energy metabolism disorder is the material basis of spleen and kidney yang deficiency,and the improvement of energy metabolism in the body may be the mechanism of warming spleen and kidney medicine to promote immune reconstitution. |