The Clinic Study Of AI-Kang Capsules In The Treatment Of HIV/AIDS With Manifesting Deficiency Of Both The Spleen And Lung

HARRT is used in the treatment of AIDS in modern medicine, which can inhibit the replication of viruses, maintain and recover immunologic function, cut down mortality and HIV-related morbidity, and improve patients’ quality life. But it was revealed in the process of treatment that antiviral therapy has the following shortcomings: （1） some patients can not tolerate the side effect and can not continue long-term medication; （2） HARRT is likely to induce drug resistance or mutation strain; （3） antiviral drugs are expensive.In the recent years, traditional Chinese medicine has played certain role in the treatment of anti-opportunistic infection, improving patients’ quality of life, improving immunity, and reducing the side effect of HARRT. However there is not yet a breakthrough in the differential treatment of AIDS. Differential treatment is the essence of Traditional Chinese Medicine, thus clinical research on HIV/AIDS must involve the differential treatment based on differentiation of symptoms and signs to give full play of Chinese medicine. This paper is a clinical study of Ai-Kang capsules in the treatment of common syndrome HIV/AIDS manifested as deficiency of both the spleen and lung.Objectives:To conduct random control study of Ai-Kang capsules in the treatment of HIV/AIDS manifesting deficiency of both the spleen and lung, as well as its pharmacodynamics, toxicology, and pharmacologic study, and thus to evaluate its therapeutic effect and safety, and provide active drug for HIV/AIDS.Method:Single blind method, and random parallel control were. adopted of 99 HIV/AIDS patients from 5 townships including Chengjiao and Shangtum in Tanghe County who were divided into two groups, with a proportion of 2:1 between the treatment group and the control group. Completed study was made of 97 patients with 65 in the former group and 32 in the latter.Ai-Kang capsules and same appearance dummies were given respectively to the treatment group and the control group, 5 pills each and 3 times daily with warm water for both groups. Three months make a course and continuously for three courses. Clinical symptoms were closely observed and assessed under strict quality control, and living quality measured by Nottingham Health Profile, CD4 and CD8 detected with flow cytometry, and virus load detected with virus load detection.Results:The baseline statistical analysis of the general state of 97 case shows no marked statistical significance at the levelα= 0.05, and the two groups are comparable.1 Symptom INTGRThe Ai-Kang capsules have improved such symptoms as weakness and debility, anorexia, abdominal distension, dyspnea with rapid and short breath, spontaneous perspiration, aversion to wind, fatigue and unwillingness to speak, gastric fullness, and borborygmus. The symptom INTGR of the treatment group was lower than that of the control group at many time points（P＜0.05）. More than 10 symptoms INTGR of the treatment group shows a general fall which means the symptoms have been improved. The chief symptom INTGR of weakness and debility decreased sharply one month after the treatment, suggesting the patients responded very well to Ai-Kang capsules. Other major symptoms also revealed a decrease 3 months after the treatment, indicative of marked improvement. The symptom of dyspnea with rapid and short breath showed a constant decrease suggesting a constant therapeutic effect of the capsules. The minor symptoms of the treatment group are also on the decrease which means the capsules have an effective intervention. The curve of spontaneous perspiration, borborygmus, and aversion to wind at both groups goes up after 6 months, so does that of fatigue and unwillingness to speak after 4 months. In spit of the fact that seasonal variation, climate, lifestyle, eating habit and farming may invariably affect the symptoms of the patients, statistical significance still exists with the curve of the control group higher than that of the treatment group, which shows the capsule does work on such symptoms. Ai-Kang capsules have therapeutic effect on deficiency of both the spleen and lung, apparent at the 3^rd month with a falling trend of the symptoms, while the integral curve of the control group remains constant at the 2nd months, which shows the capsules have good effect on such symptoms. The effective rate of the capsule Ai-Kang is 100% at the 3rd and 6th months.2 Immune indexesCD₄⁺, CD₈⁺, CD₄⁺/CD₈⁺ levels of the patients were tested prior to the treatment, and at the 6th and 9th months. The CD₄⁺ level of the treatment group is respectively 399.9±95.9, 330.9±156.9, 346.6±131.9, and that of the control group 387.1±90.3, 333.3±114.5, 316.2±153.8. The CD₄⁺ level of the both has no statistical significance prior to the treatment （P=0.554＞0.05）. The CD₄⁺ level of both groups at different time has statistical significance during the treatment （P=0.001＜0.05）. Analysis of CD₄⁺ level revealed there is no statistical significance under available samples and conditions in termsof immune function when comparison was made between that prior to the treatment and that at the 6^th month, and at the 9th month（P＞0.05）. The CD₄⁺ level of the treatmentgroup begins to decrease at the 6th month, but rises at the 9th month with higher effective rate. The CD₄⁺ level of the control group keeps falling during the course of treatment. It is necessary to lengthen the course for further study.3 virus loadValid data was obtained by randomly selecting 22 patients from the treatment group and 11 from the control group to detect the virus load, 14 valid in the former group and 10 in the latter. The virus load of the treatment group prior to the treatment and at the 9th month is respectively 4.28±0.68, 4.08±0.71, that of the control group 4.57±1.00, 4.52±1.06. The result shows no statistical significance prior to the treatment （P = 0.402＞0.05）. Although it is not statistically significant after treatment （P = 0.242＞0.05）, the virus load of the former decreased 0.2 log, higher than that of the latter （0.05 log）.4 Living qualityHealth questionnaire and living quality evaluation from Nottingham Health Profile （NHP） indicate no statistical significance regarding body moving （P=0.014＜0.05）, and yet it is statistically significant at different time of the treatment （P = 0.003＜0.05）. There isstatistical significance regarding strength （P = 0.001＜0.05）, and different time （P = 0.001＜0.05）. Statistical significance also exists concerning pain （P = 0.037＜0.05）, and atdifferent time （P = 0.001＜0.05）. After treatment the latitudinal integrals of body moving, strength and pain in the treatment group are less than those of the control group, which shows a coincidence with the capsule’s function of relieving debility and anorexia. But the latitudinal integral has no difference in emotional responses, social life and sleeping, which shows the great pressure and depression of the patients even in the course of treatment are beyond the reach of medicine.5 Clinical safetyAnalysis reveals no obvious change of WBC, RBC, HGB and PLT. The hepatic and renal function of both groups has no statistical significance prior to and post the treatment （P＞0.05）, which shows that the capsule Ai-Kang does no harm to liver and kidney. There is no marked difference between the treatment group and the control group in terms of urine, stool, electrocardiogram and chest x-ray.6 Pharmacodynamics experimentAi-Kang capsule can markedly improve the immunity, the phagocytosis of macrophage in abdominal cavity, the forming of hemolysin and plaque cell, and the transformation of peripheral lymphocyte in mice model with CY or hydrocortisone induced immuno-suppression.Conclusions:Primary conclusions based on clinical observation are as follows:1 Ai-Kang capsules can markedly relieve symptoms of weakness , anorexia , abdominal distension, short breath, spontaneous perspiration, aversion to wind, weariness, gastric fullness and borborygmus), and reduce the patient’s general INTGR, suggesting it has good clinical effect and helps prevent recurrence.2 Ai-Kang capsules can delay the decrease of CD₄⁺, maintain or raise CD₄⁺. Further study should be made when the course of treatment is lengthened.3 Ai-Kang capsules can lower the patient’s virus load.4 Ai-Kang capsules can improve the patient’s living quality, especially in body movement, strength and pain.5 Ai-Kang capsules have no marked side or toxic effect.6 Ai-Kang capsules can improve immunological function of immuno-suppressed mice.