A clinical study of modified Huanglian Jiedu Tang(黄连解毒汤)for treatment of preoperative swelling of cal-caneal fractures
Objective:To observe the clinical outcome and safety of modified Huanglian Jiedu Tang(黄连解毒汤,HLJDT)in treatment of preoperative swelling in patients with calcaneal fractures,and to explore its underlying mechanism.Methods:Seventy patients with Sand-ers type Ⅱ-Ⅳ calcaneal fractures were enrolled in the study and were randomized into conventional treatment group and HLJDT treatment group,35 ones in each group.All patients in the 2 groups were treated with conventional treatment including plaster fixing,braking,raising the injured limbs,intravenous drip infusion of mannitol injection and subcutaneous injection of nadroparin calcium after the hospital admis-sion.In addition,the patients in conventional treatment group were treated with oral application of diosmin tablets,once a day(after sup-per),0.9 g at a time for consecutive 7 days;and the patients in HLJDT treatment group were treated with oral application of modified HLJDT,twice a day in the morning and evening respectively for consecutive 7 days.The swelling rate of the affected limb,pain visual ana-logue scale(VAS)score,serum levels of C-reactive protein(CRP),tumor necrosis factor-α(TNF-α)and interleukin 6(IL-6),TCM syn-drome score and complications were compared between the 2 groups.Results:①The swelling rate of the affected limbs presented a upward firstly and downward subsequently trend over time in the 2 groups(F=246.771,P=0.000;F=282.982,P=0.000).The comparison of swelling rate of the affected limbs between the 2 groups revealed no significant differences before the treatment(t=0.596,P=0.553);while,after 3-and 7-day treatment,the swelling rate of the affected limbs was lower in HLJDT treatment group compared to conventional treatment group(t=2.147,P=0.035;t=2.799,P=0.007).②The pain VAS score presented a gradual downward trend over time in the 2 groups(F=262.877,P=0.000;F=462.471,P=0.000).There was no statistical difference in the pain VAS score between the 2 groups before the treatment(t=0.432,P=0.667);while,after 3-and 7-day treatment,the pain VAS score was lower in HLJDT treatment group compared to conventional treatment group(t=3.200,P=0.002;t=8.735,P=0.000).③The serum level of CRP presented a up-ward firstly and downward subsequently trend over time in the 2 groups(F=1 355.001,P=0.000;F=2 271.167,P=0.000).The differ-ence was not statistically significant in serum level of CRP between the 2 groups before the treatment(t=-0.470,P=0.570);while,after 3-and 7-day treatment,the serum level of CRP was lower in HLJDT treatment group compared to conventional treatment group(t=4.575,P=0.000;t=25.065,P=0.000).④The serum level of TNF-α presented a upward firstly and downward subsequently trend over time in the 2 groups(F=366.536,P=0.000;F=811.863,P=0.000).The difference was not statistically significant in serum level of TNF-αbetween the 2 groups before the treatment(t=-1.019,P=0.312);while,after 3-and 7-day treatment,the serum level of TNF-α was low-er in HLJDT treatment group compared to conventional treatment group(t=3.222,P=0.002;t=17.223,P=0.000).⑤The serum level of IL-6 presented a upward firstly and downward subsequently trend over time in the 2 groups(F=895.505,P=0.000;F=1 184.801,P=0.000).The difference was not statistically significant in serum level of IL-6 between the 2 groups before the treatment(t=1.606,P=0.113);while,after 3-and 7-day treatment,the serum level of IL-6 was lower in HLJDT treatment group compared to conventional treat-ment group(t=4.432,P=0.000;t=9.249,P=0.000).⑥There was no statistical difference in the TCM syndrome score between the 2 groups before the treatment(t=-0.595,P=0.554).The TCM syndrome score decreased in the 2 groups on the 7th day after the begin-ning of the treatment compared to pre-treatment(t=24.128,P=0.000;t=40.200,P=0.000),and it was lower in HLJDT treatment group compared to conventional treatment group(t=9.272,P=0.000).⑦The lower extremity deep venous thrombosis was found in 2 pa-tients in each group,and the thrombus became smaller or absorbed after treatment with natroparin calcium and warfarin for 1 week;moreover,2 patients experienced gastrointestinal discomfort in HLJDT treatment group,and 2 ones experienced rash in conventional treat-ment group,and the symptoms disappeared spontaneously without any medication treatment.There was no statistical difference in complica-tion incidences between the 2 groups(x2=0.000,P=1.000).Conclusion:The modified HLJDT can effectively alleviate preoperative swelling and pain in patients with calcaneal fractures,and it exhibits a high level of safety.It may exert the effects by reducing the serum level of inflammatory factors in patients.
Huang Lian Jie Du Tangfractures,bonecalcaneusswellinginflammatory factorfracture complication