| Speciality:Traditional Chinese MedicineAuthor:Lai YangTutor:Xiang Zheng1. Purpose of StudyTo observe the clinical effect of the Shu Gan Li Dan Hua Yu Tang (SGLDHYT), which belongs to the liver depression bile hot type,we use it to heal the Postcholecystectomy Syndrome (PCS) and assess its validity and safety.2. Methods of Study2.1 Group of StudyAll of the 116 patients are from the Digestion Branch Outpatient Service and Inpatient Department of Wuhan City Hubei Province Chinese Medicine Hospital.Some of 116 patients are randomly divided into the treatment group, including 67 cases, the others is the comparision group.2.2 Experimental drugThe treatment group follows the principle of Shu Gan Li Dan, Hua Yu. The name of the prescription is SGLDHYT. Every patient takes 250ml each time,2 times every day. The experiment will last 4 weeks.The comparision group is given Xiao Shi Li Dan Wan (XSLDW). And every patient takes 10 gram each time,2 times every day, the experiment will last 4 weeks.Both of them must not take the antibiotics and gallbladder drugs. And they should eat light diet, not high protein, high fat or high cholesterol food.2.3 Observation ProjectWe observe the most common symptoms of PCS, such as hypochondriac pain, stomach distention, and stool sometimes sloppy and sometimes bound. According to the degree of symptoms, we distinguish the level of symptoms from light to severe symptoms.2.4 Observation MethodsThe experiment will last 4 weeks. Under the help with the quantitative indicators of the symptoms, we assess the TCM symptoms in the treatment phase of the first and fourth week, and than compute the sum of each group. When the experiment is over, we record the results and assess the clinical effect rating points. And we record the level of their health again one month later.2.5 Statistical MethodsAll of the date is described by SPSS13.0. The measurement data of each group is described by t-test. Some of the date is researched by x2-test. The level data is described by Ridit-test.2.6 Safety EvaluationWith the help of blood routine, urine routine, stool routine, liver function, renal function and ECG, we evaluate the security of two groups.3. Results3.1 When the experiment is over, both of the treatment group and the comparision group can effectively improve the clinical symptoms, but the descent of the clinical symptoms points of the treatment group is significantly different than the comparision group (P<0.05).3.2 The clinical cure rate of the treatment group is 20.9% and its total effective rate was 94.0%, while the comparision group is 16.3%, which total effective rate is 83.7%. The effect of the treatment group is significantly different than the comparision group (P <0.05).3.3 During the clinical experiment, no adverse reaction is observed. Follow-up results suggest that SGLDHYT has a more stable long-term effect.4. ConclusionDuring the experiment, the treatment group can obviously improve hypochondriac pain, stomach distention and stool sometimes sloppy and sometimes bound of the PCS. Compared the treatment group with the comparision one, the efficacy of the treatment group is better than the standard one and P is less than 0.05. For a long-term recurrent jaundice caused by biliary tract infection, it is more effective than the comparision group in protecting liver. Not any serious adverse reactions is observed, indicating that SGLDHYT is an effective and safe traditional Chinese medicine prescriptions for PCS... |
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