ABSTRACT
OBJECTIVE@#To observe the clinical effect of high suspension and low incision (HSLI) surgery on mixed haemorrhoids, compared with Milligan-Morgan haemorrhoidectomy.@*METHODS@#A multi-centre, randomized, single-blind, non-inferiority clinical trial was performed. Participants with mixed haemorrhoids from Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing Rectum Hospital, Air Force Medical Center of People's Liberation Army of China, and Puyang Hospital of Traditional Chinese Medicine were enrolled from September 2016 to March 2018. By using a blocked randomization scheme, participants were assigned to two groups. The experimental group was treated with HSLI, while the control group was treated with Milligan-Morgan haemorrhoidectomy. The primary outcome was the clinical effect evaluated at 12 weeks after operation. The secondary outcomes included the number of haemorrhoids treated during the operation, pain scores, use of analgesics, postoperative oedema, wound healing, incidence of anal stenosis, anorectal manometry after operation, as well as surgical duration, length of stay and total hospitalization expenses. A safety evaluation was also conducted.@*RESULTS@#In total, 246 eligible participants were enrolled, with 123 cases in each group. There was no significant difference in the clinical effect between the two groups (100.00% vs. 99.19%, P>0.05). Compared with the control group, the number of external haemorrhoids treated during the operation and the pain scores after operation were significantly reduced in the experimental group (P0.05). The surgical duration and length of stay in the experimental group were significantly longer than those in the control group, and the total hospitalization expense was significantly higher than that in the control group (all P<0.05). No adverse events were reported in either group during the whole trial or follow-up period.@*CONCLUSION@#HSLI had the advantages of preserving the skin of anal canal completely, alleviating postsurgical pain and promoting rapid recovery after operation. (Registration No. ChiCTR1900022883).
ABSTRACT
To a certain extent, put forward the concept of " component of traditional Chinese medicine (TCM)" simplifies the complexity of multi-component and multi-target of TCM, which provides a possibility for the clarification of the material basis of the efficacy of TCM, and also provides a new direction for promoting the modernization and industrialization of TCM, promots the high quality development of TCM. The correlation between prescription and disease syndrome has made rapid progress, both basic research and clinical application are fruitful. However, the correlation between components and disease syndrome still needs to be further studied. The syndrome of blood stasis is a common syndrome of TCM science, and it is more common in various diseases, especially cardiovascular and cerebrovascular diseases, kidney disease, diabetes and hyperlipoidemia. A large number of studies have shown that some specific components contained in TCM or TCM compound can improve the related indexes of patients or experimental animal model with blood stasis syndrome. It is manifested in reducing blood viscosity, inhibiting platelet activation and adhesion aggregation, changing erythrocyte deformability index, inhibiting thrombosis and so on. Blood stasis is not only the pathogenic factor of many diseases, but also the pathological product of many kinds of diseases, which involves a wide range of diseases. Therefore, this study will study the progress of different components of TCM in the prevention and treatment of blood stasis syndrome, focusing on saponins, flavonoids, organic acids, polysaccharides, alkaloids and other active components in improving hemorheological abnormalities, hypercoagulability, platelet activation and adhesion aggregation, thrombosis. Based on the thought of component-disease syndrome, this paper searches the relevant literature in recent 20 years, classifies and summarizes the achievements of different components in the prevention and treatment of blood stasis syndrome, and hopes to provide some ideas for the further study of the pharmacological action of TCM components, the study of compatibility of TCM components and the research of TCM components.