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目的评价中医辨证联合西药对高效抗反转录病毒疗法(HAART)致血液毒性反应的有效性及安全性。方法将226例艾滋病HAART致血液毒性的患者随机分为治疗组149例和对照组77例。对照组采用原HAART疗法+西药基础治疗,治疗组在对照组治疗的基础上根据辨证分型加用加味八珍汤(气血两虚证)和肾气丸合人参养荣汤(脾肾阳虚证),每日1剂。两组均治疗16周。第0、4、8、12、16周观察两组患者症状体征,治疗前后观察两组患者生活质量,治疗后评价临床疗效及其安全性。结果治疗组临床疗效总有效率为77.7%,对照组为65.7%,治疗组明显高于对照组(P<0.05)。两组患者不同时间点症状体征积分逐次下降,组内比较差异有统计学意义(F=108.412,P=0.000);组间比较,差异无统计学意义(F=1.858,P=0.174)。治疗后两组患者生活质量均明显提高(P<0.05);治疗后两组患者生活质量比较,差异无统计学意义(P>0.05)。两组患者治疗过程中无严重不良事件发生。结论中医辨证联合西药治疗能够减轻HAART血液毒副作用,使患者的临床症状体征和生活质量得到明显改善。
Objective To evaluate the efficacy and safety of traditional Chinese medicine combined with western medicine in the hematologic toxicity induced by highly effective antiretroviral therapy (HAART). Methods A total of 226 patients with HAART-induced hematotoxicity were randomly divided into treatment group (n = 149) and control group (n = 77). The control group was treated with the original HAART therapy plus western medicine. The treatment group was treated with JiaZhiBazhen decoction (Qi and blood deficiency syndrome) and Shenqi pill combined with ginseng yangrong decoction (with spleen and kidney yang deficiency Card), a day. Both groups were treated for 16 weeks. At the 0th, 4th, 8th, 12th and 16th weeks, symptoms and signs of the two groups were observed. Before and after treatment, the quality of life of the two groups was observed. After treatment, the clinical efficacy and safety were evaluated. Results The total effective rate was 77.7% in the treatment group and 65.7% in the control group, which was significantly higher in the treatment group than in the control group (P <0.05). The symptom and symptom score of two groups of patients decreased gradually at different time points. The difference was statistically significant (F = 108.412, P = 0.000). There was no significant difference between the two groups (F = 1.858, P = 0.174). After treatment, the quality of life of both groups was significantly improved (P <0.05). There was no significant difference in quality of life between the two groups after treatment (P> 0.05). Two groups of patients without serious adverse events occurred during treatment. Conclusion TCM syndrome differentiation combined with Western medicine can reduce the side effects of HAART blood, so that patients with clinical signs and quality of life have been significantly improved.