The clinical study of internal and external combined treatment of HT by Professor Ding Zhiguo based on"dimple corresponding theory"
Objective To evaluate the clinical efficacy of Professor Ding Zhiguo's internal and external combined treatment of Hashimoto's disease,and to explore its mechanism.Methods Prospective cohort study.A total of 85 patients of professor Ding Zhiguo from Sun Simmiao Hospital of Beijing University of Chinese Medicine and Dongzhimen Hospital of Beijing University of Chinese Medicine from August 2022 to March 2023 were selected and divided into control group(43 cases)and drug group(42 cases)by random number table method.Another 20 healthy volunteers were recruited for health control observation.The control group was given iodine restricted diet,the drug group was treated with Qinggan Sanjie Xiaoying Prescription combined with Liqi Sanjie Xiaoying Ointment,and the healthy control group was not treated with any intervention.Both drug group and control group were observed continuously for 4 weeks.TCM syndrome scores were performed before and after treatment.Hamilton Anxiety Scale(HAMA)and Hamilton Depression Scale(HAMD)were used to assess the degree of anxiety and depression,Pittsburgh Sleep Quality Index(PSQI)was used to assess sleep quality,and fatigue severity Scale(FSS)was used to assess the degree of fatigue.Lower limb lymphedema self-sensory symptoms assessment questionnaire was used to evaluate the symptoms of lower limb lymphedema.The serum levels of thyroid peroxidase antibody(TPOAb)and thyroglobulin antibody(TGAb)were measured by automatic electrochemiluminescence immunoassay,and the reduction rate was calculated.The levels of serum Akt,ERK and protein kinase C(PKC)were detected by ELISA.The thyroid volume was calculated and the anterior and posterior diameter of the isthmus was recorded.The clinical efficacy and safety were evaluated.Results The total effective rate was 71.43％(30/42)in the drug group and 27.91％(12/43)in the control group,with statistical significance(χ2=16.10,P＜0.01).The serum TPOAb[137.95(141.44)IU/ml vs.153.40(154.93)IU/ml,Z=-4.37]and TGAb[182.00(238.52)IU/ml vs.190.50(257.55)IU/ml,Z=-2.13]levels in the drug group were lower after treatment(P＜0.01 or P＜0.05),and the decrease rate of TPOAb[15.62(21.90)％vs.-6.42(32.89)％,Z=-4.12]and TGAb[5.25(20.49)％vs.-0.72(17.67)％,Z=-2.67]were higher than that in the control group(P＜0.01).The thyroid volume[11.37(6.48)cm3 vs.12.89(6.63)cm3,Z=-2.95]and isthmus thickness[0.27(0.14)cm vs.0.28(0.15)cm,Z=-2.18]in the drug group were reduced after treatment compared with that before treatment(P＜0.05).TCM syndrome scores(6.10±1.38 vs.14.42±7.35,t=-7.29),HAMA(5.21±1.32 vs.9.28±2.25,Z=-7.02),HAMD(8.28±3.17 vs.10.42±5.28,t=-2.26),PSQI(6.00±2.16 vs.9.47±3.08,t=-6.01),FSS(34.71±5.51 vs.38.23±8.35,t=-2.30),lower limb lymphedema self-induced symptom evaluation questionnaire scores(4.95±2.56 vs.7.86±3.07,t=-4.74)after treatment were lower than before treatment and lower than control group(P＜0.001 or P＜0.05).The serum levels of Akt[52.28(17.72)μmol/L vs.44.38(2.75)μmol/L],ERK[2 843.43(607.90)ng/L vs.2 648.25(290.74)ng/L],PKC[8.87(3.10)pmol/L vs.7.88(1.25)pmol/L]in drug group were higher than those in the healthy control group before treatment(P＜0.05),the levels of Akt[37.37(7.90)μmol/L vs.44.38(2.75)μmol/L],ERK[2 432.74(402.56)ng/L vs.2 648.25(290.74)ng/L]in drug group were lower than those in the healthy group after treatment(P＜0.05).After treatment,the levels of Akt[37.37(7.90)μmol/L vs.52.28(17.72)μmol/L,49.56(9.12)μmol/L],ERK[2 432.74(402.56)ng/L vs.2 843.43(607.90)ng/L,3 021.76(360.22)ng/L],PKC[7.37(1.84)pmol/L vs.8.87(3.10)pmol/L,10.00(2.42)pmol/L]in drug group were lower than before treatment and lower than control group(P＜0.01).There were no adverse events during treatment in both groups.Conclusion The internal and external treatment of Hashimoto's disease by Professor Ding Zhiguo can effectively reduce the level of thyroid antibody titer,reduce the thyroid swelling and isthmus thickness,improve the clinical symptoms of patients with Hashimoto's disease,and may play a therapeutic role by interfering with MAPK signaling pathway.
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