Full
Outline
To explore the clinical efficacy and safety of Simo Decoction Oral Liquid（四磨汤口服液）in the treatment of functional constipation（Qi stagnation constipation）.
A multicenter, randomized, double-blind and placebocontrolled design was used to randomly divide 80 patients with functional constipation（Qi stagnation constipation）in 7 hospitals from March 2022 to June 2023 into two groups, 40 cases in the experimental group were given oral administration of Simo Decoction Oral Liquid, and 40 cases in the control group were given Simo Decoction Oral Liquid simulant. Both groups took the medicine two sticks for each time, twice a day, and the course was 8 weeks. The response rate of complete spontaneous defecation（CSBM）, the improvement of bowel movement - related symptoms, the scores of TCMsyndromes, the number of emergency drugs taken and the adverse reactions of the two groups were observed.
The overall CSBM response rate in the experimental group（FAS: 77.50%；PPS: 83.80%）was better than that in the control group（FAS: 22.50%；PPS: 17.10%）, with a statistically significant difference（P<0.001）. The weekly CSBMresponse rate of the experimental group（FAS: 82.5%）was significantly better than that of the control group（FAS: 22.50%）, with a statistically significant difference（P<0.001）. The change value of CSBMin the experimental group（FAS: 2.95±1.79）was higher than that of the control group（FAS: 0.74±1.53）, and the difference was statistically significant（P<0.001）. The abdominal pain in defecation, abdominal distension, effortful defecation and medication assisted defecation frequency, the primary symptoms（abdominal distension and unpleasant defecation）and the secondary symptoms（intestinal sounding and fullness in the chest and ribs points）of TCMsyndromes, as well as the amount of emergency medication intake before and after the treatment in the experimental group were better than those in the control group, with a statistically significant difference（P<0.05）. No adverse reactions related to the study drug occurred in neither group, the incidence of adverse reactions was 0.
The total CSBMresponse rate of functional constipation（Qi stagnation constipation）treated with Simo Tang Oral Liquid was more than 50% higher than that of the control group, and it significantly improved the bowel movement-related symptoms such as abdominal pain, abdominal distention, unpleasant defecation, bowel sound, and chest and rib tightness, and the medication was safe.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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