RESUMEN
Objective:To observe the clinical efficacy of addition and subtraction therapy of Shashen Maidongtang for syndrome of Yin deficiency and lung heat at convalescent period in patients with mycoplasma pneumoniae pneumonia， and to investigate its regulatory effect on immune inflammatory response. Method:One hundred and forty-eight patients were randomly divided into control group （74 cases） and observation group （74 cases） by random number table. During the treatment， 70 patients completed the study in control group （loss to follow-up in 2 cases， elimination in 3 cases）， and 71 patients completed the study in observation group （loss to follow-up in 4 cases）. Patients in both groups got Azithromycin tablets for 3 days， 10 mg·kg-1·d-1， pidotimod granules， 0.4-0.8 g/time， 2 times/day， and Ambroxol oral solution， 2.5-15 mL/time， 2 times/day. The patients in control group additionally received Yangyin Qingfei oral liquid， 5-10 mL/time， 2-3 times/day， while the patients in observation group additionally received addition and subtraction therapy of Shashen Maidongtang， 1 dose/day， with a treatment course of 7 days in both groups. Before and after treatment， scores of cough symptom and cough visual analogue score （VAS） were graded， and the time to disappearance of cough， lung rales and expectoration as well as the time to recovery of chest radiograph were recorded. Scores of syndrome of yin deficiency and lung heat and Leicester Cough Questionnaire （LCQ） were also graded. Levels of T lymphocyte subsets （CD3+， CD4+， CD8+ and CD4+/CD8+）， interleukin-6 （IL-6）， IL-10， tumor necrosis factor-α （TNF-α）， substance P （Substance P） and procalcitonin gene related peptide （CGRP） were detected， and the safety was also evaluated. Result:Total effective rate for the disease was 95.77% （68/71） in observation group， higher than 82.86% （58/70） in control group （χ2=6.186， P<0.05）. Scores of cough symptoms and VAS were higher than those in control group （P<0.01）， and scores of various items in LCQ scale and the total score of LCQ were all higher than those in control group （P<0.01）. The time to disappearance of cough， lung rales and expectoration as well as the time to recovery of chest radiograph in observation group were shorter than those in control group （P<0.01）. Levels of CD3+， CD4+ and CD4+/CD8+ were higher than those in control group （P<0.01）， and levels of CD8+， IL-6， IL-10， TNF-α， SP in serum and CGRP in sputum were all lower than those in control group （P<0.01）. Conclusion:On the basis of conventional western medicine treatment， addition and subtraction therapy of Shashen Maidongtang can reduce the degree of cough， shorten the course of disease， improve the quality of life， improve the cellular immune function， reduce the inflammatory injury， and reduce the sensitivity of cough， with better clinical efficacy and safety as compared with Western medicine alone.