Clinical Study On Treatment Of Non - Small Cell Lung Cancer By Traditional Chinese Medicine In Treatment Of Related Diarrhea

Diarrhea is a common side effect in the tumor sufferer who taking targeted drugs, which has a high incidence.It may cause inconvenience of patient’s life and work, and even becoming t he factor restricting the clinical application. Since related research’s absence, clinical treatme nt lack of guidance. Clinical common anti-diarrhea medicine has good effect of diarrhea, but there is limitation problem such as short function, adverse reactions, not convenient for long-term use. Traditional Chinese medicine (TCM) treat diarrhea by getting the balance of yin an d yang, in the process, the function of body may get improve. To examine the curative effec t of cid-associated diarrhea in targeted therapy of traditional Chinese medicine,we start this clinical trial research.Objective:to observe the effect of TCM on associated diarrhea in NSCLC targeted therapy. Methods:this study is a prospective randomized controlled study. We randomized 70 NSCLC cases who get diarrhea in the targeted therapy into two group, the experimental group use TCM treatment, while the control group Imodium. After 2 courses of treatment (1 week is a course) and 2 weeks of f ollow-up, we observe the difference between two groups with remission rate of diarrhea, symptoms, diarrhea severity, recurrence time, KPS score, and drug safety. Results:70 cases were included, and finally 66 cases were actually completed, both treatment g roup and control group are 33 cases. Diarrhea focus on a slight degree ratings on NCI CTC AE c lass 1-2. The study shows that TCM syndrome of Qi deficiency or(&) Yin deficiency are ob served frequently, followed by phlegm-damp syndrome and heat-toxin syndrome, blood defic iency is fewer be seen.Main efficacy:We calculated the remission rate of diarrhea, control group got 60.61% and ex perimental group got 63.64% after the first course, there was no statistically significant differ ence between two groups (P= 0.387). And the rate turned into 76.67% and 81.82% after 2 c ourses,at which time the difference had statistically significant (P= 0.029).Secondary outcomes:(1) In total points of symptom, both groups get lower scores after 2 cou rses of treatment, and test group is lower (P= 0.023), which shows TCM have more advanta ges to the symptoms relief. (2) In the symptoms of diarrhea, abdominal distension and inapp etence get better relieve by TCM than Imodium (P< 0.05). (3) A follow-up with diary card is continued after the therapy. Finally,29 effective diary card were used in the statistics,13 of them come from control group,16 from test group.9 people in control group get relapse, the recurrence rate is 69.23%, and the overall recurrence time is 7.38 days. While the number of t est group is 9,56.25%,and 8.75 days. The difference between two groups is not obviously (P> 0.05). (4) There’s no observed difference between two groups in KPS score after the the rapy (P> 0.05).Safety evaluation:experimental group did not see obvious adverse reaction, mild adverse eve nts was seen in 4 cases in control group, which could get relieve by medication termination. Conclusion:TCM can play a positive role in the therapy of diarrhea associated with targeted therapy in NSCLC. TCM’s effect on clinical remission rate and the improvement of the sym ptoms of diarrhea is better than Imodium, and clinical use is safe.