| 宋欣伟,唐伟杰,关天容,戴巧定.PMC方案联合狼疮扶正解毒胶囊治疗重度活动系统性红斑狼疮的临床观察[J].,2013,33(10):1315-1319 |
| PMC方案联合狼疮扶正解毒胶囊治疗重度活动系统性红斑狼疮的临床观察 |
| Treatment of Severe Active Systemic Lupus Erythematosus by PMC Therapy Combined Langchuang Fuzheng Jiedu Capsule： a Clinical Observation |
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| DOI：10.7661/CJIM.2013.10.1315 |
| 中文关键词: 系统性红斑狼疮 狼疮扶正解毒胶囊 PMC方案 激素撤减 |
| 英文关键词:systemic lupus erythematosus Langchuang Fuzheng Jiedu Capsule PMC therapy the reduction and withdrawal of hormones |
| 基金项目:浙江省中医药管理局资助项目（No2008GA1008） |
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| 中文摘要: |
| 目的 评价泼尼松、甲氨蝶呤、羟氯喹联合狼疮扶正解毒胶囊治疗重度活动系统性红斑狼疮（systemic lupus erythematosus，SLE）的疗效和安全性。方法 选取活动期SLE患者60例，按中心随机化方法分成2组，对照组予PMC方案（泼尼松，每日1 mg/kg，病情稳定后2周或疗程8周后，开始以每2周减10%的速度减量，减至泼尼松每日0.5 mg/kg后，减药速度每2周减2.5 mg，减至15 mg/d以后每4周减2.5 mg。甲氨蝶呤片，10 mg/次，每周1次。硫酸羟氯喹片，每次100 mg，每日2次），治疗组采用PMC方案（同对照组）联合狼疮扶正解毒胶囊（组成：黄芪50 g当归20 g川芎20 g熟地黄30 g六月雪30 g积雪草30 g蜈蚣4 g全蝎10 g露蜂房12 g等，每粒0.5 g，含生药量5.7 g，激素大剂量时，12粒/次，每日3次；激素中剂量时，8粒/次，每日3次；激素小剂量时，6粒/次，每日3次）治疗，两组疗程均为180天。观察治疗前后症状和体征改善情况，以及SLE活动指数（SLE disease activity index，SLEDAI）；中医证候疗效；尿蛋白（upro）定性、血沉（ESR）、补体3（C3）、C反应蛋白（CRP）、激素撤减情况及呼吸道感染情况。结果 治疗组治疗后SLE活动积分差值明显大于对照组（P<0.05）。治疗组治疗后疲劳程度量表（fatigue severity scale，FSS）较治疗前减少，与对照组比较，差异有统计学意义（P<0.05）。治疗后中医证候积分（traditional chinese medicine symptom score，TCMSS）治疗组较治疗前减少，与对照组治疗后差值比较差异有统计学意义（P<0.05）。治疗组与对照组的中医证候疗效总有效率分别为93.33%（28/30）、86.66%（26/30），差异有统计学意义（χ2=6.736， P<0.05）。治疗组在治疗后ESR较治疗前下降，且较对照组显著（P<0.01），而C3较治疗前上升，且较对照组更明显（P<0.05）。治疗组在疗程结束时激素撤减至（13.70±5.42）mg/d，较对照组［（17.63±7.80）mg/d］明显减少（P<0.05）。治疗组继发呼吸道感染7例（上呼吸道感染5例，下呼吸道感染2例），较对照组（上呼吸道感染25例，下呼吸道感染10例）明显减少（P<0.05）。结论 PMC方案联合狼疮扶正解毒胶囊治疗重度活动期SLE（SLEDAI≥15） 较单纯西药更安全有效，能帮助激素撤减。 |
| 英文摘要: |
| Objective To evaluate the efficacy and safety of PMC therapy （Prednisone， Methotrexate， Chloroquine） combined Langchuang Fuzheng Jiedu Capsule （LFJC）， thus choosing a better therapy of integrative medicine for SLE in the period of glucocorticoid use. Methods Sixty active SLE patients were randomly assigned to two groups， the control group and the treatment group. Those in the control group received PMC therapy （As for Prednisone， it was given at the daily dose of 1 mg/kg till 2 weeks after the condition being stable or after 8 weeks of treatment. Then the dose was reduced by 10% every two weeks. When the dose was reduced to 0.5 mg/kg daily， it was reduced by 2.5 mg per two weeks. When the dose was reduced to 15 mg daily， the dose was reduced to 2.5 mg per four weeks. As for Methotrexate， 10 mg each time， once a week. As for Chloroquine， 100 mg each time， twice daily）， while those in the treatment group received PMC therapy （the same way as that for the control group） combined with LFJC （consisting of Astragalus mmebranaceus 50 g， Angelica sinensis 20 g， Ligusticum Chuanxiong 20 g， prepared Rehmannia Rhizome 30 g， Herba Serissae 30 g， Centella 30 g， centipede 4 g， scorpions 10 g， nidus verspae 12 g， et al.， 0.5 g per pill， containing 5.7 g crude drug. When the hormone was given at a large dose， LFJC was administered at 12 pills each time， three times daily）. When the hormone was given at a middle dose， LFJC was administered at 8 pills each time， three times daily. When the hormone was given at a small dose， LFJC was administered at 6 pills each time， three times daily. The treatment course was six months. The improvement of symptoms and signs between before and after treatment， SLE disease activity index （SLEDAI）， efficacy of Chinese medical syndrome， UPro quantitation， erythrocyte sedimentation rate （ESR）， complement 3 （C3）， C reactive protein （CRP）， the reduction and withdrawal of hormones， and infection of the respiratory tract were observed. Results The difference in post SLEDAI was obviously larger in the treatment group than in the control group （P<0.05）. The fatigue severity scale （FSS） was less after treatment than before treatment in the treatment group， showing statistical difference when compared with that of the control group （P<0.05）. The total effective rate was 93.33% in the treatment group， showing statistical difference when compared with that of the control group （86.66%； χ2=6.736， P<0.05）. The ESR decreased after treatment in the treatment group， showing statistical difference when compared with that of the control group （P<0.01）. C3 increased after treatment in the treatment group， showing statistical difference when compared with that of the control group （P<0.05）. The hormone was reduced to （13.70±5.42） mg/d by the end of the therapeutic course in the treatment group， obviously less than that of the control group ［（17.63±7.80） mg/d， P<0.05）. Seven patients suffered from secondary infection of the respiratory tract infection in the treatment group （5 from upper respiratory tract infection and 2 from lower respiratory tract infection）， obviously less than those of the control group （25 from upper respiratory tract infection and 10 from lower respiratory tract infection） （P<0.05）. Conclusions PMC combined LFJC was a better treatment program for severe active SLE （SLEDAI≥15）. It was more safe and effective when compared with using Western medicine alone. It could enhance the efficacy of hormones and help reduction/withdrawal of hormones. |
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