| 1 objectives(1)To observe the overall efficacy of traditional Chinese medicine (TCM) differential diagnosis and complementary treatment to ESWL in the removal of upper urinary tract calculi and its alleviation of patient’s clinical symptoms; to observe the calculi removal efficacy of TCM differential diagnosis and complementary treatment in the Shi Wei San subgroup and Hua Yu Niao Shi Tang subgroup, as well as to analyze the reasons for the differences in calculi removal efficacy and alleviation of clinical symptoms between the two groups. We hope to provide preliminary references for the selection of TCM therapeutic regimens for upper urinary tract calculi.(2) To observe the restorative effects of complementary Hua Yu Niao Shi Tang therapy in ESWL treatment of renal damages after treating kidney stones, as well as to analyze the possible mechanisms; to further observe its calculi removal efficacy and alleviation of clinical symptoms. We hope to provide a clinical therapeutic regimen that has been verified by evidence-based medicine and can alleviate renal damage after lithotripsy while also significantly increasing calculi clearance rate.(3)To explore related factors that might affect renal damage after lithotriptic treatment through analyzing the correlations between baseline data (such as clinical symptoms, age and weight) and changes of serum ET-1, serum MDA, urinary NAG and urinary β2-MG levels, so as to provide theoretical basis to reduce and prevent renal damage after lithotripsy.2 MethodsThis study is composed of two parts, where both parts are prospective, parallel, randomized and controlled clinical trials. The first part included 120 patients with upper urinary tract calculi who were treated in the outpatient clinic of the Department of Urology, Guang An Men Hospital, China Academy of Chinese Medical Sciences according to the inclusion criteria. The patients were randomly assigned to the treatment group and the control group. The latter received extracorporeal shock wave lithotripsy (ESWL) and anti-inflammatory treatment, while the former received TCM differential diagnosis and treatment in addition to the treatments received by the control group. The patients were followed-up four weeks before and after treatment. The second part was a further investigation on the Hua Yu Niao Shi Tang subgroup in the TCM differential diagnosis and treatment group from the first part of the study. 120 patients with kidney stones who were treated in the outpatient clinic of our hospital were included based on the inclusion criteria, and randomly assigned to the treatment group and control group. The latter received ESWL and anti-inflammatory treatment, while the former received Hua Yu Niao Shi Tang in addition to the treatments received by the control group. The patients were followed-up two weeks before and after treatment.Detailed study methodsFor the first part of the study, baseline data between the treatment group and control group were compared; the overall clinical symptom scores, individual symptom scores, maximum stone diameter, number of stones and degree of hydronephrosis before and after treatment were compared within each group. Intragroup differences of the observed indexes after treatment were compared between the two groups, so as to reveal the therapeutic advantages of TCM differential diagnosis and treatment in calculi removal efficacy and symptom alleviation. Next, exploratory analysis and comparison of the Shi Wei San subgroup and Hua Yu Niao Shi Tang subgroup in the treatment group were performed; the contents of comparison were similar to that of the overall treatment group and control group.For the second part of the study, baseline data between the treatment group and control group were compared. Serum ET-1, serum MDA, urinary NAQ urinary β2-MG levels and red blood cell level in routine urinalysis before treatment, on the day of lithotripsy and two weeks after treatment were also compared within each group. Intragroup differences of the observed indexes at three abovementioned time points were also compared between the groups, so as to reveal the restorative and therapeutic efficacy of Hua Yu Niao Shi Tang on renal damages after lithotripsy. Next, the overall clinical symptom scores, individual symptom score, maximum stone diameter and number of stones were compared within the groups before and after treatment. Intragroup differences of observed indexes after treatment were then compared between groups, so as to reveal the advantages of Hua Yu Niao Shi Tang on calculi removal and symptom alleviation. In addition, the correlations between clinical symptoms, baseline data and changes in serum ET-1, serum MDA, urinary NAQ urinary β2-MG levels and red blood cell level in routine urinalysis were analyzed, so as to explore related factors that might affect renal damage after lithotripsy.3 Results3.1 Calculi removal efficacy3.1.1 Comparison results of calculi removal efficacy in TCM differential diagnosis and treatment3.1.1.1 Comparison of calculi removal efficacy between treatment group and control groupFour weeks after treatment, calculi clearance rate was 56.7% in the treatment group and only 31% in the control group. The overall efficacy rate was 86.7% in the treatment group and 55.2% in the control group. The differences were statistically significant (P<0.001).Regarding the difference in the number of calculi before and after treatment, that of the treatment group was significantly greater than the control group (P<0.05). The maximum stone diameter decreased in both groups after treatment. Regarding the intergroup difference in stone diameter, the treatment group showed greater reduction than the control group, and the difference statistically significant (P<0.05).3.1.1.2 Exploratory comparison of calculi removal efficacy between the Qi-stagnation, blood stasis subgroup and the damp-heat in lower Jiao subgroupAfter treatment, Qi-stagnation, blood stasis subgroup showed a 78.3% calculi clearance rate and a 95.7% overall efficacy; while the damp-heat in lower Jiao subgroup showed a 47.2% calculi clearance rate and an 86.1% overall efficacy. The difference was statistically significant (P=0.014). The differences in the number of calculi before and after treatment were similar between the two subgroups, with no statistical significance (P>0.05). The differences in maximum stone diameter and the pelvicalyceal height before and after treatment were not statistically significant between the two subgroups.3.1.2 Comparison of calculi removal efficacy in the study on post-lithotripsy renal damage treated using Hua Yu Niao Shi TangAfter treatment, calculi clearance rate was 54.7% in the treatment group and only 21.2% in the control group. The overall efficacy rate was 86.8% in the treatment group and 69.8% in the control group. The differences were statistically significant (P<0.001). Regarding the difference in the number of calculi before and after treatment, that of the treatment group was significantly greater than the control group and the intergroup difference was statistically significant (P<0.001). Regarding the differences in maximum stone diameter before and after treatment within each group, that of the treatment group was greater than the control group and the intergroup difference was statistically significant (P<0.001).3.2 Analysis of clinical symptom alleviation3.2.1 Comparison of patient’s clinical symptom alleviation in the study on TCM differential diagnosis and treatment3.2.1.1 Comparison of the degrees of clinical symptom alleviation between the treatment group and the control groupAfter treatment, scores on waist and abdominal pain, hematuria, frequent urination urgency and astringent pain, abdominal distension, nausea and vomiting, dry stools and other symptoms within both groups were all significantly improved compared with scores before treatment; the differences were statistically significant (P<0.001). Regarding the differences in the overall score of clinical symptoms before and after treatment, the decrease in the treatment group was significantly greater than that of the control group; the intergroup difference was statistically significant (P<0.05).3.2.1.2 Exploratory comparison ofthe degrees of clinical symptom alleviation between Qi-stagnation, blood stasis subgroup and damp-heat in lower Jiao subgroupThe difference in overall symptom score before and after treatment was statistically significant within both subgroups (P<0.001). The intergroup difference in the improvement of overall symptom scores was statistically significant (P=0.001).3.2.2 Comparison of symptom changes in the study on post-lithotripsy renal damage treated using Hua Yu Niao Shi Tang3.2.2.1 Analysis of symptom changes in both groups before the treatment and on the day of lithotripsyPatients in both groups showed statistically significant differences (P<0.05) between scores on waist and abdominal pain, hematuria, frequent urination urgency and astringent pain, abdominal distension and dry stools before the treatment and on the day of lithotripsy, and statistically insignificant differences in nausea and vomiting (P>0.05). Regarding the overall score of clinical symptoms, statistically significant elevated were shown in both groups before and after treatment (P<0.001), while the intergroup difference in the overall score of clinical symptoms was not statistically significant (P=0.756).3.2.2.2 Analysis of symptom changes in both groups on the day of lithotripsy and after the treatmentPatients of control group showed statistical differences (P<0.05) between the scores on hematuria, frequent urination urgency and astringent pain, abdominal distension on the day of lithotripsy and after the treatment, and statistically insignificant differences in waist and abdominal pain, nausea and vomiting, and dry stools (P>0.05). Patients in the treatment group showed statistically significant differences (P<0.05) between the scores on hematuria, waist and abdominal pain, dry stools, frequent urination urgency and astringent pain, and abdominal distension on the day of lithotripsy and after the treatment, and statistically insignificant difference in nausea and vomiting (P>0.05). Regarding the overall score of clinical symptoms on the day of lithotripsy and after the treatment, statistically significant differences were observed (P<0.001). Regarding the intergroup difference in the improvements in the overall score of clinical symptoms, that of the treatment group was significantly greater than control group (z=2.648, p=0.008).3.2.2.3 Analysis of symptom changes in both groups before and after treatmentPatients in the control group showed statistically significant improvements (P=0.001) in score on waist and abdominal pain after the treatment compared to that before the treatment, and statistically insignificant differences in other symptoms (P>0.05). Patients in the control group showed statistically significant decreases (P<0.05) in scores on waist and abdominal pain, hematuria and dry stools after the treatment compared to that before the treatment, and statistically insignificant differences in frequent urination urgency and astringent pain, abdominal distension, and nausea and vomiting (P>0.05). Regarding the overall score of clinical symptoms in the control group before and after the treatment, there was no statistically significant difference (P=0.143). Regarding the overall score of clinical symptoms in the treatment group before and after the treatment, there was a statistically significant difference (P<0.001).3.3 Analysis of index changes in both groups after treatment of post-lithotripsy renal damage using Hua Yu Niao Shi Tang3.3.1 Analysis of index changes in both groups before treatment and on the day of lithotripsyUrinary NAG, urinary β2-MQ serum MDA and serum ET-1 levels were significantly elevated on the day of lithotripsy; the differences were statistically significant compared with that before treatment (P<0.001). The differences in red blood cell levels and grades in routine urinalysis between patients in the two groups were statistically significant compared to that before treatment (P<0.001). Whereas intergroup comparison of the differences in urinary NAQ urinary β2-MG, serum MDA and serum ET-1 levels, as well as red blood cell count in routine urinalysis before treatment and on the day of lithotripsy showed that the differences were not statistically significant (P=0.923).3.3.2 Analysis of index changes in both groups on the day of lithotripsy and after treatmentAfter treatment, urinary NAG, urinary β2-MG, serum MDA and serum ET-1 levels significantly decreased compared to that on the day of lithotripsy in the treatment group (P<0.05),while those laboratory indexes has not show the statistic difference in the control group (P>0.05). Improvements in urinary NAQurinary β2-MG, serum MDA and serum ET-1 levels after treatment were significantly greater in the treatment group than that in the control group(P<0.05).The differences in red blood cell levels in routine urinalysis of both groups after treatment decreased significantly compared to that on the day of lithotripsy(P<0.05). The improvements in red blood cell levels in routine urinalysis of both groups after treatment were similar (z=0.881,p=0.375).3.3.3 Analysis of test index changes in both groups before and after treatmentAfter treatment, urinary NAG and urinary β2-MG levels in the control group did not improve significantly compared to that before treatment (P>0.05). However, serum MDA and serum ET-1 levels of the control group improved significantly compared to that before treatment (P<0.05). The levels of the four indexes in the treatment group were all significantly lower than that before treatment (P<0.05). Regarding the intergroup differences in the levels of the four indexes before and after treatment, improvements in the treatment group were significantly larger than that in the control group (P<0.05). Regarding improvements in red blood cell levels in routine urinalysis, the control group showed no statistically significant difference before and after treatment (P>0.05), while the treatment group showed statistically significant improvement after treatment (P<0.05).3.4 Correlational analysis in the study on post-lithotripsy renal damage treated with Hua Yu Niao Shi Tang3.4.1 Correlational analysis between test and baseline indexesUrinary NAG, urinary β2-MG, serum MDA and serum ET-1 levels had significant correlations with disease course:(r=0.212, P<0.05), (r=0.206, P<0.05), (r=0.192, P<0.05) and (r=0.236, P<0.01), respectively; no significant correlations were found with gender, age, weight, height, history of upper urinary tract calculi, extracorporeal lithotripsy history, medication history for upper urinary tract calculi and history of complications (P>0.05).3.4.2 Correlational analysis between baseline and test index level changes (on the day of lithotripsy and after treatment)Age had statistically significant correlations with differences in urine NAG and serum MDA:(r=-0.209, P<0.05) and (r=-0.191, P<0.05), respectively; whereas gender, age, weight, height, history of upper urinary tract calculi, extracorporeal lithotripsy history, medication history for upper urinary tract calculi and complications history had no correlations with differences in urinary NAG, serum MDA, serum ET-1 and urinary β2-MG (on the day of lithotripsy and after treatment) (P>0.05).3.4.3 Correlational analysis between differences in patients’ individual symptom scores and differences in test index levels on the day of lithotripsy and after treatmentThe correlations between difference in routine urinalysis grades and differences in urinary NAG, urinary β2-MQ serum MDA and serum ET-1 were of statistical significance:(r=0.446, P<0.05),(r=0.103, P<0.05), (r=0.190, P<0.01) and (r=0.190, P<0.01), respectively. Correlations between difference in hematuria scores and differences in urinary NAQ urinary β2-MG, serum MDA and serum ET-1 were of statistical significance:(r=0.446, P<0.01), (r=0.193, P<0.05), (r=0.196, P<0.05) and (r=0.231, P<0.05), respectively.4 Conclusions(1 Complementary TCM differential diagnosis in ESWL treatment for upper urinary tract calculi could significantly increase calculi clearance rate and overall efficacy in patients, while also significantly alleviating patient’s clinical symptoms.(2) Through exploratory analysis of the subgroups, it was found that Hua Yu Niao Shi Tang, which primarily focuses on promoting circulation and removing stasis, had significant efficacy in treating upper urinary tract calculi, while also significantly alleviating patient’s clinical symptoms, especially waist and abdominal pain.(3) Hua Yu Niao Shi Tang had significant restorative effect on renal damage caused by ESWL. The restorative effect can be achieved by the effect of Hua Yu Niao Shi Tang in improving microcirculation, regulating blood rheology, suppressing and reducing the formation of ET-1, encouraging anti-oxidation, anti-inflammation and anti-bacterial properties, inhibiting the formation of granulation tissue, inhibiting and alleviating renal fibrosis and so on.(4)This study has demonstrated that complementary Hua Yu Niao Shi Tang therapy in ESWL treatment for kidney stone could significantly increase patient’s calculi clearance rate and significantly alleviate patient’s clinical symptoms, especially for waist and abdominal pain.(5)Correlational analysis showed that:patients with longer disease courses were moe likely to suffer from more severe renal damages after lithotripsy; older patients might recover more slowly from post-lithotripsy renal damage; after lithotripsy, red blood cell levels in routine urinalysis and hematuria score could reflect the degree of renal damage after lithotripsy to a certain extent. |
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