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.
RESUMEN
Objective:To investigate the clinical efficacy of Shashen Maidongtang plus total glucosides of paeony capsule on primary Sjogren's syndrome (pSS) based on the theory of fluid metabolism. Method:In this study, 84 patients of Qi-Yin deficiency type pSS admitted in Zhengzhou Chinese Medicine Hospital from January 2018 to January 2019 were divided into observation group (42 cases) and control group (42 cases) on the basis of random number table. The control group was orally given total glucosides of paeony capsule and iguratimod tablet, while the observation group was orally given Shashen Maidongtang combined with glucosides of paeony capsule. After 3 months of continuous treatment to all subjects, the clinical efficacy was evaluated, and side effects were recorded. Before and after the treatment, the saliva flow rate and basal tear secretion Schirmer I test (SIt) value were measured, European League Against Rheumatism Sjogren's syndrome patient reported index and Sjogren's syndrome disease activity index (ESSPRI and ESSDAI) were scored, the erythrocyte sedimentation rate (ESR) was determined by Westergren, and the levels of serum rheumatoid factor (RF) and immunoglobulin (Ig) G were tested by immunoturbidimetry and rate scattering turbidimetry, respectively. Result:The overall effective rate of the observation group was 90.48% (38/42), which was much higher than 69.05% (29/42) of the control group (χ2=5.974，P<0.05). After treatment, the saliva flow rates and SIt values of both groups got significantly increased compared with those before the treatment (P<0.05), but the saliva flow and SIt of the observation group were significantly better than those of the control group over the same period after treatment (P<0.05). After treatment, both groups had a great decrease in ESSPRI and ESSDAI scores compared with those before the treatment (P<0.05), and the above scores of the observation group were dramatically lower than those of the control group over the same period (P<0.05). After treatment, ESR, serum RF, and IgG levels of both groups were significantly lower than those before the treatment (P<0.05), and the observation group showed higher levels of ESR, serum RF and IgG than the control group over the same period after treatment (P<0.05). Side effects were few and mild in both groups. Conclusion:In treating patients of Qi-Yin deficiency type pSS, Shashen Maidongtang plus total glucosides of paeony capsule was proven to be effective generally. It could significantly inhibit excessive inflammation and hyperhumoral immunity in patients, and control their disease activity. This may be related to the effect of Shashen Maidong decoction and its decomposed recipes in correcting body fluid infusion and metabolic disorder in patients of Qi-Yin deficiency type pSS.