| Purpose:To discuss the understanding of traditional Chinese medicine about thyroid nodule, according to clinical researches on treatment to the syndrome of phlegm coagulation and blood stasis of benign thyroid nodule by Nei Xiao pill, observe influences to benign thyroid nodule caused by Nei Xiao pill, including index variations of clinical symptoms, appearances, nodule diameter, function of thyroid, function of liver and kidney, evaluate the curative effects and safety of Nei Xiao pill, find out the mechanism of action how Nei Xiao pill playing a part in treatments of thyroid nodule and provide scientific basis for clinical extension.Method:A randomized controlled trial was conducted by 60 patients with the syndrome of phlegm coagulation and blood stasis of benign thyroid nodule classified into two groups(traditional Chinese medicine treated group and western medicine controlled group,30 patients for each). One course of treatment lasted for three months, during which traditional Chinese medicine treated group patients took Nei Xiao pill while western medicine controlled group took Euthyrox. According to evaluation the indexes included both curative effect indexes,such as clinical symptoms, appearances and other relevant indexes, including max diameter of thyroid nodule detected by color Doppler ultrasound, function of thyroid, function of liver and kidney, and recorded the harmful reaction with every single patient. All the data above carried on statistics analysis by the software SPSS 17.0.Results:All 60 patients have accomplished test. By means of statistics,60 patients had no conspicuous difference in sex, age, stage of disease and max thyroid diameter before treatment (P>0.05), which said that two groups of statistics have comparability. Indexes of curative effect listed as followed:(1)Clinical curative effect contrast:the traditional Chinese medicine treated group has the total effective rate of 76.6% while the western medicine controlled group has the total effective rate of 43.3%, which means the traditional Chinese medicine treated group gained an advantage over the controlled group (P<0.05).(2)Traditional Chinese Medicine syndrome curative effect contrast:the traditional Chinese medicine treated group has the total effective rate of 83.3%, while western medicine controlled group has the total effective rate of 40%, which means the treated group gained an advantage over the controlled group (P<0.05).(3)Max thyroid nodule diameter contrast:the thyroid nodule diameter was smaller in both of the two groups., compared with pre-treatment there is statistically significant(P<0.05).Compared between the two groups, the Traditional Chinese Medicine treated group has more curative effect than Western Medicine controlled group (P<0.05).(4)Relations between the curative effect and the thyroid nodule diameter in the treated group:in this group, patients with thyroid nodule diameter smaller than 1cm get more curative effect than those patients with thyroid nodule diameter bigger than 1cm (P<0.05).(5)Changes of functions of thyroid, liver and kidney in Traditional Chinese Medicine treated group:some factors, including FT3, FT4, TSH, ALT, AST, BUN and Scr, has no conspicuous differences after treatment (P>0.05), which means Nei Xiao pill does no obvious harm to thyroid, liver and kidney.Conclusion:According to the primary clinical trial, Nei Xiao pill, without side-effect, could make improvements on clinical symptoms, appearances and thyroid nodule diameter with the syndrome of phlegm coagulation and blood stasis of benign thyroid nodule which has a better curative effect than Euthyrox, and is worth studying deeply and developing further. |