参灵扶正胶囊干预无症状 HIV 感染者的临床研究▲

摘要

Objective To explore the clinical effects of Shenling Fuzheng Capsule on asymptomatic HIV in-fected patients with the syndrome of deficiency of Qi and blood .Methods Eighty asymptomatic HIV infection patients with Qi-blood deficiency syndrome were randomly divided into two groups .The test group ( n=40 ) was given Shenling Fuzheng Capsule (Codonopsis,Astragalus,Atractylodes,Jiaogulan,black ants,Ganoderma lucidum) while the control group(n=40) was given the simulation medicinal preparation .The treatment lasted for 12 months in both groups.The incidence of AIDS,viral load,the amount of CD4 +T and CD8 +T lymphocyte,traditional Chinese medicine ( TCM) common clinical symptom score , Karnovsky score and adverse reactions were observed .Results There were three cases missed during the treatment ,one case in the test group and two cases in the control group .There were 4 cases of AIDS onset in the test group accounted for 10.3% while 7 cases of AIDS onset in the control group accounted for 18.4%,no significant difference was found in the incidence of HIV between two groups (P>0.05).After treatment, CD4 +T lymphocyte count of 35 cases who were not of AIDS onset in the test group was higher than that of 31 cases in the control group(P<0.05),viral load and CD8 +T lymphocyte count showed no significant difference between two groups(P>0.05);In the test group,TCM clinical symptom score and individual symptom scores of patients who were not of AIDS onset after treatment were lower than those before treatment (P<0.05),and Karnovsky score was higher after treatment compared with that before treatment (P<0.05),all scores above in the control group showed no signif-icant difference before and after treatment (P>0.05).No adverse reactions occurred in both groups .Conclusion Syndrome differentiation and treatment with Shenling Fuzheng Capsule for asymptomatic HIV infection with Qi -blood deficiency syndrome can improve the patient ’ s clinical syndromes ,delay the onset of AIDS ,and improve the quality of life in patients with security .%目的观察参灵扶正胶囊干预气血虚证的无症状HIV感染者的临床效果。方法气血虚证无症状HIV感染患者80例，按随机数字表法分为两组：试验组40例给予参灵扶正胶囊（党参、黄芪、白术、绞股蓝、黑蚂蚁、灵芝），对照组40例给予模拟剂，两组均治疗12个月，观察艾滋病发病率、HIV病毒载量、CD4＋T细胞、CD8＋T细胞计数、中医常见临床症状积分、卡洛夫斯基积分和不良反应等。结果治疗过程中试验组脱落1例，对照组脱落2例；试验组发病4例（10．3％），对照组发病7例（18．4％），两组发病率比较差异无统计学意义（ P＞0．05）。治疗后试验组未进展为艾滋病期的35例患者CD4＋T细胞计数较对照组的31例高（ P＜0．05），HIV病毒载量、CD8＋T细胞计数与对照组比较，差异均无统计学意义（ P＞0．05）；试验组未进展为艾滋病期患者中医临床症状积分、单项症状积分均低于治疗前（P＜0．05），卡洛夫斯基积分则高于治疗前（P＜0．05），对照组上述积分治疗前后比较，差异无统计学意义（P＞0．05）。两组均未发生明显不良反应。结论参灵扶正胶囊辨证论治可改善气血虚证HIV无症状感染者临床症状，延缓患者进入艾滋病期，提高患者生存质量，安全性好。