| Purpose：By means of both evaluation scale about Syndrome type of Phlegm andblood stasis with Yin Deficiency in the recovery and NIHSS score scale to assessclinical effect of integrated ChineseWestern therapy in patients withPhlegm-stasis and yin deficiency in restoration stage of ischemic stroke. Itis feasible that practical RCT used in clinical studies in patients withconvalescent phase of ischemic stroke by designing practical RCT.Material and method：A multi-center，three blind，block randomized，parallel-group trial in this study.Recruiting subjects and screening cases arein sub-centers which we selected14national hospitals. Researchers areclinicians, who engaged in Chinese medicine or Integrative Medicine Departmentof Neurology in the various sub-centers, of the attending physician and abovethe attending physician. Qualified subjects randomly assigned by the enrolledorder at a1:1ratio. There were120patients in both the test group and thecontrol group. The therapies of treatment group included oral proprietaryChinese medicine，Chinese medicine injection therapy, acupuncture therapy，massage therapy, basic Western Medicine treatment，Modern rehabilitation androutine care. The treatments in Control group included the basic treatment ofWestern medicine, modern rehabilitation and routine care. The tertiary qualitymanagement system is implemented in4weeks of treatment. By observing the periodof selected, two weeks, four weeks，the follow-up, Compare the Differencesbetween groups of various dimensions of evaluation scale about Syndrome typeof Phlegm and blood stasis with Yin Deficiency in the recovery period, the changesof NIHSS score scale at different time points, evaluation of security andsubjects’ compliance. Using descriptive statistics, chi-square test,independent sample paired t-test statistical methods to analysis the date.Results：119cases were enrolled in the test group,118cases in the control group, a total of237cases.4cases in the test group were over time window,1patients exited the test，1patients merged Nimodipine，1patient combinedwith nimodipine；five cases were over time window in the control group. Ultimately113cases in test group,113cases in the control group meet the program, includedin the PPS data sets, a total of226cases. Demographic data such as gender,age, nature of work and the risk factors associated with the disease: differenceanalysis of high blood pressure, high cholesterol, diabetes, smoking, drinkingand family history have no statistically significant (P>0.05); Syndromes totalscore of efficacy evaluation scale which is about Syndrome type of Phlegm andblood stasis with Yin Deficiency in the recovery period, Sputum integral, Stasisintegral, Yin Deficiency integral improved in0-2weeks,2-4weeks which comparedwith pre-treatment, the difference was significant (P <0.05); No significantimprovement was showed in integration of main symptoms which compared with beforetreatment in0-2weeks,2-4weeks, four weeks-90days of follow-up,90-180days of follow-up. The difference was not statistically significant (P>0.05).NIHSS score scale improved in0-2weeks,2-4weeks which compared withpre-treatment, the difference was statistically significant (P <0.05); thedifference analysis of diachronic changes,which were Syndromes total score inevaluation scale about Syndrome type of Phlegm and blood stasis with YinDeficiency in the recovery period, the integral of the main symptoms, Sputumintegral, Stasis integral, Yin Deficiency integral in the follow-up of90days,was not statistically significant (P>0.05)； the difference analysis ofdiachronic change,which about NIHSS score scale in the follow-up90days, wasnot statistically significant (P>0.05). the difference analysis of diachronicchanges, which were Syndromes total score in evaluation scale about Syndrometype of Phlegm and blood stasis with Yin Deficiency in the recovery period, theintegral of the main symptoms, Sputum integral, Stasis integral, Yin Deficiencyintegral in the follow-up of180days, was not statistically significant (P<0.05); the difference analysis of diachronic change,which about NIHSS scorescale in the follow-up180days, was not statistically significant (P<0.05). Conclusion：1. Integrative Medicine therapy is better than basic Western medicine treatmentin aspects of subjective functional status improvement and objectiveneurological deficits during convalescent phase of ischemic stroke. It reflectedthe advantage of Integrative Medicine therapy in patients with convalescentphase of ischemic stroke.2. By observing evaluation scale about Syndrome type of Phlegm and blood stasiswith Yin Deficiency in the recovery period and NIHSS scale. The Former hassignificant effects on ischemic stroke recovery, whose Syndrome type of Phlegmand blood stasis with Yin Deficiency in the recovery period, with IntegrativeMedicine therapy. The latter reflects the improvement of function in nerve defectbefore and after treatment. It reflected the advantage of combining withDifferential Treatment in TCM and basic Western medicine treatment. |
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