| Background:After treatment stones of the upper urinary tract are still easy to relapse with the recurrence rate of25%-75%in ten years. Even after extracorporeal shock wave lithotripsy (ESWL) treatment, the recurrence rate is high to6.70%,28.0%and41to80%in one, three, five years respectively. Such a high rate of recurrence will increase both the suffering and economic burden of patients. It will lead to a significant increasing of incidence to many complications, such as secondary hypertension, renal atrophy, renal dysfunction, etc. after numbers of ESWL and surgeries. Therefore, it takes more and more attention to the diagnosis and preventive treatment for its etiology.With the complex etiology, the prevention of urinary stones has been a problem. Stones prevention method includes the basic prevention and drug prevention. Changing living style and adjusting the diet is the basement of recurrence prevention. Drug prevention includes orally taking citrate, thiazide diuretics, allopurinol, magnesium, meglumine polysaccharides, vitamin B6, etc..Stone prevention is a systematic project; many people who pay attention to basic prevention still get stones relapse. The long-term use of western medicine may cause gastrointestinal irritation, electrolyte imbalance, liver and kidney dysfunction and other side effects. Traditional Chinese medicine (TCM) plays a role in stone prevention, but the lack of systematic clinical and basic research.Basing on the knowledge of TCM and combining with modern treatment methods, Professor Liu Youfang, specialty in urology of integrative medicine, creatively proposed the point of view that for qi&blood stasis is the central TCM syndrome of stones stuck in the kidney or ureter; and created Huayuniaoshi Decoction, with the function of promoting qi and blood flow to remove blood stasis, and softening the mass, received a satisfactory therapeutic result. Previous experimental studies confirmed that the prescription can dissolve the crystallization of calcium oxalate dihydrate Link or section of limestone structure; and it can block the process of L-hydroxyproline and glycolate converted into oxalic acid in rats, which inhibits stone formation. Using Huayuniaoshi Decoction in our department for20years Department, we found that it had the function and potential function on expelling stones from urinary tract, on preventing stone recurrence, and on recovery of renal injury caused by stone obstruction, which indicates advantages and potential of a good preventive effect on upper urinary tract stones.Objective:To observe the effect of Huayuniaoshi Decoction on prevention of recurrence of the upper urinary tract stones; and to lay the foundation for further study of traditional Chinese medicine prevention of upper urinary stones.Methods:It was designed as a randomized single-blind placebo-controlled research. During December2009and April2010in Guang’an Men Hospital,70cases of patients with clinical recovery after ESWL were selected, who were then divided into the treatment group and the placebo control group with35cases in each group. After a period of24months of treatment and follow-up,70cases entered the final analysis.1. Inclusion criteria:(1) age between18and60years;(2) with the diagnosis of upper urinary tract stones;(3) taking ESWL less than2weeks;(4) in line with the cure standard for upper urinary tract stones to(5) with the TCM syndrome of Qi&blood stagnation and damp-heat;(6) with signed informed consent.2. Exclusion criteria:(1) with renal or ureter deformity, renal pelvis or ureter tumors, ureteral stricture, or urinary tract infection;(2) combined with any severe diseases in heart, brain, liver, kidney or hematopoietic system;(3) allergies or allergy to test drugs;(4) participating in other clinical trials;(5) with the conditions of being not adhere to the completion of clinical trials, such as not able to long-term use of TCM decoction, whose work environment often changes, unstable living environment, etc..3. Treatments:(1) Treatment group:orally taking Huayuniaoshi Decoction, a package each time, twice a day for4weeks after recruited; after12months of recruiting, again orally taking Huayuniaoshi Decoction, a package each time, twice a day for4weeks.(2) Control group:orally taking placebo of Huayuniaoshi Decoction, a package each time, twice a day for4weeks after recruited; after12months of recruiting, again orally taking placebo of Huayuniaoshi Decoction, a package each time, twice a day for4weeks. 4. Treatment duration:after recruited for24months, the patients received examine to evaluate the effect.5. Observations(1) Primary efficacy endpoints:the stone recurrence rate, through the kidneys ureter ultra sound (checked at baseline,12th month, and24th month)(2) secondary efficacy endpoints:①PH value of the urinary②uric acid③urinary calcium④urinary oxalate⑤TCM syndrome score (checked at baseline and24th month)6.Statistical analysis method:Statistical analysis acquires SPSS13.0statistical analysis software. All the statistical tests acquire two sided test,providing statistics and exact probability P value. P value less than or equal to0.05will be considered significant. Measurement data from different treatment groups will acquire mean±standard deviation into statistical description, acquiring t test, paired t test. Qualitative data acquires Chi-square test.Ranked data acquires rank sum test.Conclusion:70cases recruited in our study were divided into treatment group with35patients and placebo control group with35patients. At the end,60patients finished the study. Of those,36are male and24are female. Their age varied from21to60years and the average age is39years. The course of disease varied from3months to5years and the average one is11months.1. Conclusion of comparability analysis:the age, disease duration, urine PH value, urinary calcium and urinary oxalate, uric acid, TCM syndrome score in two groups with no significant difference (P>0.05).2. Conclusion of the effects analysis:2.1preventing effects of stone recurrence:it shows in the research that1year recurrence rate is0and3.3%in the treatment group and placebo control group respectively, with no significant difference (P>0.05).2year recurrence rate is3.3%and20%in the treatment group and placebo control group respectively, with significant difference (P<0.05). 2.2The effect on the level of urine PH, urinary oxalate, and calcium2.2.1urine PH value:the PH value of the treatment group after treating showed an increasing trend, compared to baseline data, with a significant difference (P<0.05); and with significant difference compared to the control group after treatment (P <0.05), which shows that Huayuniaoshi Decoction can improve urine PH value.2.2.2The level of urine oxalate: there is a significant reduction (P<0.05) of the level of urine oxalate before and after the treatment in the treatment group; while there is no significant difference in the control group (P>0.05). Compared with the control group, treatment group the level of urine oxalate is significantly lower, with a statistically significant differences (P<0.05).2.2.3The level of urinary calcium:there is a significant reduction (P<0.05) of the level of urinary calcium before and after the treatment in the treatment group; Compared with the control group, the level of urinary calcium is lower, with a significant difference (P<0.05), indicating that this decoction can reduce urinary oxalate levels.2.2.4The uric acid level of urine:there is no statistically significant difference (P>0.05) of the uric acid level of urine before and after the treatment both in the treatment group and control group; neither does the level after treatment in two groups (P>0.05), which indicates that this decoction did not play a role in reducing uric acid of urine.2.3TCM syndrome score:the total effective rate of TCM syndrome score is76.7%and33.3%in the treatment group and the control group respectively, with a significant difference (P<0.01). Circulation urinary stone soup in treatment, Chinese medicine blood stasis and damp-heat syndrome symptoms, showed good efficacy, can improve, patients with blood stasis and damp heat easily into stone physique, fundamentally the prevention of urolithiasis.3. Summary Looking at the entire clinical trial, Huayuniaoshi Decoction can reduce the recurrence rate after ESWL in patients with upper urinary tract stones, with increasing the PH value of urine, reducing the level of urinary oxalate and urinary calcium, which indicates a prevention effect and a bright prospect of using Huayuniaoshi Decoction in preventing upper urinary tract stones. This research inspires future study, which can be studied in laboratory from two aspects:on one hand, from improving the local inflammatory adhesion and fiber wrapped, making better mucosa injury of the renal pelvis and ureter from stones, and reducing the opportunity of stone crystallization attachment. On the other hand, from the metabolistic aspect, to prove Huayuniaoshi Decoction can change the urine PH value and reduce the level of urinary oxalate and calcium as the starting point. If the effects of Huayuniaoshi Decoction on prevention of urolithiasis can be proved from both basic and clinical research, this decoction will fill the gap of urolithiasis prevention with TCM herbs.Because of limitation of study period and finance, the number of patient into the group is not large enough and most of them were the ones underwent ESWL. So the results cannot reflect the prevention effect of Huayuniaoshi Decoction for the upper urinary tract stone. Additionally, the metabolic conditions of cases in our study were not evaluated and the different stone types were not distinguished. So the effect of Huayuniaoshi Decoction in different stone types is not compared. In the afterward future clinical researchment,more cases and stratification are needed.Thus the prevention effect of Huayuniaoshi Decoction can be evaluated wholly. |
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