| Objective :To determine the efficacy of Buyang Huanwu Decoction in the treatment of hypoparathyroidism after thyroid surgery based on invigorating qi and promoting blood circulation method.Methods :The research is a prospective study and random control trial was conducted.From Decemeber 2021 through February 2023,patients with hypoparathyroidism(HP)after thyroid surgery in the 960 th Hospital of PLA,in accordance with the random number table,were randomly divided into TCM(Traditional Chinese Medicine)group(treated with the Buyang Huanwu Decoction and calcium supplement)and Control group(treated with calcium supplement).The patients were divided into 3 groups according to the level of parathyroid hormone(PTH)within 24 hours after operation,Level 1(24h PTH≤5pg/ml),Level 2(5<24h PTH≤10pg/ml)and Level 3(10<24h PTH<15pg/ml).The patients were treated as required until PTH returned to normal level and the longest follow-up time was no more than six months.The time of PTH recovery,the total calcium supplementation,the PTH recovery rate,the total effective rate of drugs,the TCM syndrome scores and adverse reaction were compared among groups.Results :According to the inclusion criteria,a total of 250 patients were included in this study,which were divided into 127 patients in control group and 123 patients in TCM group according to the random number table method.During the follow-up,7 patients in TCM group and 12 patients in the control group dropped off,and 231 patients finally completed the experiment according to the requirements.1.Main outcome measure-the time of PTH recovery.First,in Control group(24h PTH<15pg/ml)vs TCM group(24h PTH<15pg/ml),Control group 1(Level 1)vs TCM group 1(Level 1)and Control group 2(Level 2)vs TCM group 2(Level 2),the time of TCM group was less,and the time of PTH recovery was statistically significant,(P<0.05),especially in Control group(24h PTH<15pg/ml)vs TCM group(24h PTH<15pg/ml)and Control group 1(Level 1)vs TCM group 1(Level 1),(P<0.01).Second,the lower the postoperative 24 h PTH,the longer the time of PTH recovery need to be normal.In this study,the patients of Level 1 took the longest time of PTH recovery,and the patients of Level 3 took the shortest time of PTH recovery in average.2.Main outcome measure-the total calcium supplementation.First,in Control group(24h PTH<15pg/ml)vs TCM group(24h PTH<15pg/ml),Control group1(Level 1)vs TCM group 1(Level 1)and Control group 2(Level 2)vs TCM group2(Level 2),the total calcium supplementation was statistically significant(P<0.05),especially in Control group(24h PTH<15pg/ml)vs TCM group(24h PTH<15pg/ml)and Control group 1(Level 1)vs TCM group 1(Level 1),(P<0.01).In above groups,the TCM groups needed was less than Control groups needed.Second,the lower 24 h PTH,the more calcium supplementation was needed and the amount of total calcium supplementation of Level 1 was the largest in average above all groups.3.Main outcome measure-PTH recovery rate.In half a year,Control group vs TCM group [(97.39%)vs(100.00%)],Control group 1 vs TCM group 1 [(94.92%vs 100.00%)],Control group 2 vs TCM group 2 [(100.00%)vs(100.00%)] and Control group 3 vs TCM group 3 [(100.00%)vs(100.00%)].4.Main outcome measure-the total effective rate of drugs.There was no significant difference between the Control group vs TCM group [(99.13%)vs(100.00%)],Control group 1 vs TCM group 1 [(98.31%)vs 100.00%)],Control group 2 vs TCM group 2 [(100.00%)vs(100.00%)] and Control group 3 vs TCM group 3 [(100.00%)vs(100.00%)],(P>0.05).5.Secondary outcome measure-the TCM syndrome scores.After 2 weeks of treatment,firstly,in Control group(24h PTH<15pg/ml)vs TCM group(24h PTH<15pg/ml),Control group 1(Level 1)vs TCM group 1(Level 1),Control group 2(Level 2)vs TCM group 2(Level 2),total TCM syndrome score was statistically significant,(P<0.01).The total TCM syndrome score of the TCM group was lower than that in the control group.And the remission of symptoms and signs in the TCM groups were better than those in the control groups.Secondly,for patients with 24 h PTH<15pg/ml,there were statistically differences between the two groups in numbness of limbs and face,fatigue,spontaneous sweating,coated tongue and pulse condition of total TCM syndrome score,(P<0.05),especially in fatigue and spontaneous sweating,(P<0.01).The TCM groups scored lower than those of the control groups.Thirdly,for patients of Level 1,there were statistically differences in the TCM syndrome scores of numbness of limbs and face,fatigue,spontaneous sweating,coated tongue and pulse condition between the two groups,(P<0.05),especially in the TCM syndrome scores of spontaneous sweating and coated tongue,(P<0.01).And the TCM syndrome scores of TCM group 1 were lower than those in the Control group1.Fourthly,for patients of Level 2,there were statistically differences in the TCM syndrome scores of numbness of limbs and face,fatigue and spontaneous sweating between the two groups,(P<0.05),and the TCM syndrome scores of TCM group 2 were lower than those of the Control group 2.Fifthly,for patients of Level 3,there was statistically difference in spontaneous sweating in TCM syndrome scores between the two groups,(P<0.05),and the TCM syndrome score of TCM group 3 were lower than that of Control group 3.6.Safety evaluation.There was no significant difference in the incidence of adverse reactions between the Control group and the TCM group,(P>0.05).Conclusion :1.Based on the invigorating qi and promoting blood circulation method,Buyang Huanwu Decoction combined with calcium supplementation can shorten the recovery time of PTH,reduce the use amount of calcium supplementation required for PTH to return to normal level,improve the recovery rate of PTH,relieve HP-related discomfort symptoms more immediately and promote the recovery of parathyroid function in HP patients after thyroid surgery.2.Firstly,the lower the level of 24 h PTH after operation,the more severe the parathyroid gland was damaged,the longer it took for PTH to return to normal level,the more the calcium supplement needed and the differences between the TCM groups and the control groups was more obvious.Secondly,the lower the level of 24 h PTH after operation,the clearer the advantage of Buyang Huanwu Decoction in promoting the recovery of parathyroid function. |
