CAJ | 학술논문

目的：评价复方青黄散治疗骨髓增生异常综合征（myelodysplastic syndromes，MDS）的安全性。方法108例MDS患者中，60例用青黄散治疗（青黄散组），48例用复方青黄散治疗（复方青黄散组）。3个月为1个疗程，治疗均在1个疗程以上。治疗后，青黄散组出现不良反应的患者更换为复方青黄散。记录治疗过程中的不良反应发生情况。结果复方青黄散组总不良反应发生率为18.8%，低于青黄散组的41.7%（χ2＝6.492，P＜0.05）。复方青黄散组无中度以上不良反应者，但青黄散组有3例。复方青黄散组各种不良反应发生率均低于青黄散组，尤其是下肢浮肿（4.2%比25%；χ2＝9.205，P＜0.05）；胃脘不适（18.8%比41.7%降为；χ2＝6.492，P＜0.05）。青黄散组出现不良反应的20例更换为复方青黄散后仍有5例存在不良反应，较换药前显著降低（25.0%比100.0%；χ2＝24.000，P＜0.05）。各种不良反应均较换药前下降，尤其是面部浮肿（10.0%比30.0%；χ2＝2.500，P＜0.05）、下肢肿胀（5.0%比45.0%；χ2＝8.533，P＜0.05）、腹痛腹泻（10.0%比30.0%；χ2＝2.500，P＜0.05）。复方青黄散治疗后，肝肾功能均未见异常。结论治疗MDS时，复方青黄散较青黄散更安全。
목적：평개복방청황산치료골수증생이상종합정（myelodysplastic syndromes，MDS）적안전성。방법108례MDS환자중，60례용청황산치료（청황산조），48례용복방청황산치료（복방청황산조）。3개월위1개료정，치료균재1개료정이상。치료후，청황산조출현불량반응적환자경환위복방청황산。기록치료과정중적불량반응발생정황。결과복방청황산조총불량반응발생솔위18.8%，저우청황산조적41.7%（χ2＝6.492，P＜0.05）。복방청황산조무중도이상불량반응자，단청황산조유3례。복방청황산조각충불량반응발생솔균저우청황산조，우기시하지부종（4.2%비25%；χ2＝9.205，P＜0.05）；위완불괄（18.8%비41.7%강위；χ2＝6.492，P＜0.05）。청황산조출현불량반응적20례경환위복방청황산후잉유5례존재불량반응，교환약전현저강저（25.0%비100.0%；χ2＝24.000，P＜0.05）。각충불량반응균교환약전하강，우기시면부부종（10.0%비30.0%；χ2＝2.500，P＜0.05）、하지종창（5.0%비45.0%；χ2＝8.533，P＜0.05）、복통복사（10.0%비30.0%；χ2＝2.500，P＜0.05）。복방청황산치료후，간신공능균미견이상。결론치료MDS시，복방청황산교청황산경안전。
Objective To evaluate the safety of compound Qinghuang powder for myelodysplastic syndromes(MDS). Methods A total of108 patients with MDSwere collected, 60 patients were treated with Qinghuang powder(Qinghuang powder group)and 48 with compound Qinghuang powder(compound Qinghuang group). The treatment time of 3 months was as one course, and all the patients were treated for more than one course. The patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. The adverse reactions were recorded during the treatment. Results The overall incidence of adverse reactions in the compound Qinghuang powder group was significantly lower than that in the Qinghuang powder group(18.75% vs. 41.7%; χ2=6.492, P<0.05). None in the compound Qinghuang powder group and 3 patients in the compound Qinghuang powder group developed moderate to severe adverse reactions. The incidences of various adverse reactions in the compound Qinghuang powder group were lower than those in the Qinghuang powder group, especially, lower limb swelling (4.17%vs. 25%;χ2=9.205, P<0.05) epigastric discomfort(18.75% vs. 41.67%; χ2=6.492, P<0.05). Twenty patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. Among them, 5 patients (25%) maintained adverse reactions. The various adverse reactions after changing to compound Qinghuang powder were decreased, especially, facial swelling (10% vs. 30%; χ2=2.50, P<0.05), leg swelling (5%vs. 45%;χ2=8.533, P<0.05), and abdominal pain and diarrhea(10%vs. 30%;χ2=2.50, P<0.05). No patient developed liver or kidney dysfunction after the treatment with Qinghuang powder or Compound Qinghuang powder. Conclusion Compound Qinghuang powder is safer than Qinghuang powder in the treatment of MDS.