摘要
目的评估中医药减少艾滋病患者高效抗逆转录病毒治疗(highly active antiretroviral therapy,HAART)所致胃肠道不良反应的临床疗效及安全性。方法采用随机、多中心、阳性对照的临床试验方法,对符合病例纳入标准的HIV/AIDS患者进行临床治疗观察,试验组患者在常规HAART基础上,采用中医辨证治疗方案,对照组患者在常规HAART基础上,服用吗丁啉片,疗程为4周。结果共纳入HIV/AIDS患者354名,试验结束时,两组在恶心、呕吐、腹胀、腹泻及食欲不振等5种胃肠道不良反应症状的消除情况差异无统计学意义(P>0.05);治疗前后,5种胃肠道不良反应症状的严重程度总体上均有改善,但改善程度的组间差异无统计学意义(P>0.05);治疗结束时,两组检查指标正常转异常的发生率均无统计学差异(P>0.05);两组不良反应发生率分别为1.27%和0.88%,差异无统计学意义。结论中医药能够减少或改善HIV/AIDS患者因HAART导致的胃肠道不良反应,并具有良好的安全性,值得在临床上推广应用。
Objectives To evaluate the clinical effect and safety of Chinese herbal medicine in reducing the gastrointestinal adverse reactions due to HARRT （highly active antiretroviral therapy, HAART）for patients infected with HIV （human im- munodeficiency virus）. Methods With randomized, multi-centric, positive controlled clinical trial method, HIV/AIDS pa- tients that met the case inclusion criteria were observed, the experiential group patients took the TCM treatment program on the basis of conventional HAART treatment, and the control group patients took domperidone tablets on the basis ofconventional HAART treatment. The treatment course lasted for 4 weeks. Results There were 354 patients. At the end of the trial, the elimination situation of five gastrointestinal symptoms of adverse reactions （nausea, vomiting, bloating, di- arrhea and loss of appetite） were not significantly different between two groups （P〉0.05）. Before and after the treatment, the severity level of five gastrointestinal symptoms of adverse reactions has generally improved, but the degree of change between two groups had no statistically significant difference（P〉0.05）; at the end of treatment, the occurrence rate that examination indexes range from the normal to the abnormal situation in two groups had no statistically significant difference （P）0.05） ; the adverse event incidence of the two groups were 1.27% and 0.88% ,that the difference was not statistically significant. Conclusions Traditional Chinese Medicine can reduce the gastrointestinal adverse reactions due to HAART of HIV/AIDS patients, and it possesses a favorable safety, thus it is worthy of applying in clinical practice.
出处
《中国社会医学杂志》
2013年第4期293-295,共3页
Chinese Journal of Social Medicine
基金
国家科技重大专项基金(2008ZX10005-003A)
