Objective： To assess the efficacy and safety of Zhongyan-4 （中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detox...Objective： To assess the efficacy and safety of Zhongyan-4 （中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication） in treating HIV/AIDS patients in the early or middle stage. Methods： Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group （36 patients） treated with ZY-4 and the control group （36 patients） treated with placebo. The treatment course was six months. The index of OD4^＋, OD8^＋ counts, body weight, clinical symptom scoring were estimated at 4 time points （0, 1, 3 and 6 month in the course）, and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group. Results： OD4^＋ count in the ZY-4 group got elevated by 7.70 4±150.96/mm^3 on average, while that in the control group lowered by 27.33 4±85.28 /mm^3 . Fifteen out of the 30 patients in the ZY-4 group had their OD4^＋ count increased, which was evidently much higher than that in the control group （8/33, P〈0. 05）, suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating OD4^＋ count. Moreover, ZY-4 showed actions in elevating OD45RA^＋ and OD8^＋ count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial. Conclusion： ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.展开更多
目的观察滋阴清热法防治鼻咽癌患者急性放射性口腔炎属阴虚内热证的效果。方法将60例确诊为鼻咽癌并进行首次放疗的患者,分为两组:治疗组(31例)采用滋阴清热法治疗方案,对照组(29例)采用西医治疗方案。观察治疗期间口腔黏膜情况,检测唾...目的观察滋阴清热法防治鼻咽癌患者急性放射性口腔炎属阴虚内热证的效果。方法将60例确诊为鼻咽癌并进行首次放疗的患者,分为两组:治疗组(31例)采用滋阴清热法治疗方案,对照组(29例)采用西医治疗方案。观察治疗期间口腔黏膜情况,检测唾液中表皮生长因子(epidermal growth factor,EGF)的含量,并利用欧洲癌症研究与治疗组织(European Organization for Researeh and Treatment of Cancer,EORTC)的生活质量核心量表QLQ-C30(quality of life questionnaire-core 30)评价患者的生活质量。结果所有患者在放疗中均出现放射性口腔黏膜反应,治疗组的反应轻于对照组(P<0.01)。随着放疗剂量的增加,两组唾液中EGF的含量呈下降趋势,在放疗至40 Gy时下降明显(P<0.01),至70 Gy时降到最低值(P<0.01),治疗组下降程度均较对照组轻,差异有统计学意义(P<0.01)。两组患者放疗后QLQ-C30生活质量比较显示:治疗组患者的生活质量总健康状况要优于对照组,两组比较差异有统计学意义(P<0.01)。结论滋阴清热法可推迟放射性口腔炎出现的时间,减轻放疗反应,能改善患者总体生活质量,对防治急性放射性口腔黏膜炎有较好的疗效,具有一定的临床推广应用价值。展开更多
基金Supported by the Projects of Ministry of Science and Tech-nology for 10th Five-year Plan (2001BA701A18)
文摘Objective： To assess the efficacy and safety of Zhongyan-4 （中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication） in treating HIV/AIDS patients in the early or middle stage. Methods： Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group （36 patients） treated with ZY-4 and the control group （36 patients） treated with placebo. The treatment course was six months. The index of OD4^＋, OD8^＋ counts, body weight, clinical symptom scoring were estimated at 4 time points （0, 1, 3 and 6 month in the course）, and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group. Results： OD4^＋ count in the ZY-4 group got elevated by 7.70 4±150.96/mm^3 on average, while that in the control group lowered by 27.33 4±85.28 /mm^3 . Fifteen out of the 30 patients in the ZY-4 group had their OD4^＋ count increased, which was evidently much higher than that in the control group （8/33, P〈0. 05）, suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating OD4^＋ count. Moreover, ZY-4 showed actions in elevating OD45RA^＋ and OD8^＋ count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial. Conclusion： ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.
文摘目的观察滋阴清热法防治鼻咽癌患者急性放射性口腔炎属阴虚内热证的效果。方法将60例确诊为鼻咽癌并进行首次放疗的患者,分为两组:治疗组(31例)采用滋阴清热法治疗方案,对照组(29例)采用西医治疗方案。观察治疗期间口腔黏膜情况,检测唾液中表皮生长因子(epidermal growth factor,EGF)的含量,并利用欧洲癌症研究与治疗组织(European Organization for Researeh and Treatment of Cancer,EORTC)的生活质量核心量表QLQ-C30(quality of life questionnaire-core 30)评价患者的生活质量。结果所有患者在放疗中均出现放射性口腔黏膜反应,治疗组的反应轻于对照组(P<0.01)。随着放疗剂量的增加,两组唾液中EGF的含量呈下降趋势,在放疗至40 Gy时下降明显(P<0.01),至70 Gy时降到最低值(P<0.01),治疗组下降程度均较对照组轻,差异有统计学意义(P<0.01)。两组患者放疗后QLQ-C30生活质量比较显示:治疗组患者的生活质量总健康状况要优于对照组,两组比较差异有统计学意义(P<0.01)。结论滋阴清热法可推迟放射性口腔炎出现的时间,减轻放疗反应,能改善患者总体生活质量,对防治急性放射性口腔黏膜炎有较好的疗效,具有一定的临床推广应用价值。
