OBJECTIVETo 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.

METHODSSixty 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 membranaceus 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 versace 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.

RESULTSThe 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%; chi2 = 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).

CONCLUSIONSPMC combined LFJC was a better treatment program for severe active SLE (SLEDAI > or = 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.